EX-10.21





 Exhibit 10.21 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE HORIZON THERAPEUTICS PLC HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO HORIZON THERAPEUTICS PLC IF PUBLICLY DISCLOSED. 

COMMERCIAL SUPPLY AGREEMENT 

between 
 SAVIENT PHARMACEUTICALS
INC. 
 and 
 BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. 












 COMMERCIAL SUPPLY AGREEMENT 

This Commercial Supply Agreement (the “Agreement”) is made and entered into as of the 20th day of March 2007, (hereinafter the “Effective Date”), by and between Savient Pharmaceuticals, Inc., a public company organized under the laws of the State of Delaware having its principal
place of business at One Tower Center, 14th Floor, East Brunswick, New Jersey 08816, USA (“Savient”), and Bio-Technology General (Israel) Ltd., a
private company organized under the laws of the State of Israel having its principal place of business at Beer Tuvia Industrial Zone, POB 571, Kiryat Malachi 83104, Israel (“BTG”) (hereinafter, each of Savient and BTG a “Party”
and, collectively, the “Parties”). 
 WITNESSETH: 

WHEREAS, pursuant to the Share Purchase Agreement (the “SPA”) and the Asset Purchase Agreement (“APA”), each dated
March 23, 2005 (the SPA and APA, collectively, the “Divestiture Agreements”), Savient has, on 17 July 2005, sold to Ferring B.V. all of the issued and outstanding share capital of BTG, and to Ferring International Centre S.A. all
of Savient’s right, title and interest in certain drug products and drug candidates developed and/or manufactured by BTG, but not in any case in the drug candidate known as “PEG-uricase” (or
also known as “Puricase”); and 
 WHEREAS, the Parties to this Agreement have entered into a development agreement dated
March 20, 2007, (the “Development Agreement”) according to which BTG renders continued development, manufacturing and other services in relation to Puricase. 

WHEREAS, Savient wishes BTG, and BTG is willing, to supply Bulk Product for Commercial Launch and further commercial sales. 

NOW THEREFORE, in consideration of the foregoing premises, which are incorporated into and made a part of this Agreement, and of the
mutual covenants which are recited herein, the Parties agree as follows: 
 ARTICLE 1 

DEFINITIONS 

1.01    “AE” shall mean, with respect to the Product, any adverse event associated with the use of the Product in a
patient or clinical investigation, whether or not considered drug related, including the following: an adverse event occurring in the course of the use of the Product in professional practice; an adverse event occurring from drug overdose whether
accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any significant and consistent failure of expected pharmacological action. AE shall include, without limitation, any
unfavorable and unintended sign (including, without limitation, an abnormal laboratory finding), an exacerbation of a pre-existing condition, intercurrent illness, drug interaction, significant worsening of a
disease under investigation or treatment, significant failure of expected pharmacological or biological action, symptom or disease temporally associated with the use of the Product, whether or not considered related to


  
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the Product. Notwithstanding anything foregoing to the contrary, with respect to the Territory in which the Product is marketed, AEs shall include any experience required to be reported to a
relevant authority in any such country. 
 1.02    “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. If
the laws of the jurisdiction in which such entity operates prohibit ownership by a Party of fifty percent (50%) or more, “control” shall be deemed to exist at the maximum level of ownership allowed by such jurisdiction; provided,
however, that there is a de facto ability to direct or control its management. 
 1.03    “BLA” means a regulatory
application filed with a governmental agency in a country or a group of countries (e.g. FDA or EU 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; a BLA shall include, without limitation, a Product License Application or Marketing Authorization in the European Union, and a Biologics License Application or
a New Drug Application in the United States. 
 1.04    “BTG Assigned Improvements” shall mean all developments,
discoveries, inventions, improvements, designs, methods, processes, techniques, devices, formulae and trade secrets related to the Product (including, without limitation, its pharmaceutical utility) and/or Processing of the Bulk Product or Product
which are (i) made, created, developed or conceived, or reduced to practice, by BTG or an Affiliate of BTG and (ii) dominated by the Savient Patent Rights or necessary or useful in the Processing of the Bulk Product or Product.
Notwithstanding the foregoing, BTG Assigned Improvements shall not include any innovations which are of general use in biopharmaceutical manufacturing. 

1.05    “BTG Licensed Improvements” shall mean all developments, discoveries, inventions, improvements, designs, methods,
processes, techniques, devices, formulae and trade secrets related to the Product (including, without limitation, its pharmaceutical utility) and/or Processing of the Bulk Product or Product which are (i) made, created, developed or conceived,
or reduced to practice, by BTG or an Affiliate of BTG, and (ii) necessary or useful in the Processing of the Bulk Product or (iii) of general use in biopharmaceutical manufacturing. 

1.06    “BTG Indemnitee” shall mean BTG and its Affiliates, and each of their respective directors, officers, employees
and agents. 
 1.07    “BTG Know-How” shall mean all Know-How developed by BTG or any of its Affiliates during the Term or by BTG prior to July 17, 2005 relating to (i) the Bulk Product or Product (including, without limitation, its pharmaceutical utility)
or (ii) the Processing of the Bulk Product or Product , and shall include, without limitation, all data (in any form, raw or analyzed or reported and whether maintained in paper, electronic or other media forms) relating to


  
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formulation, analytical methods, pre-clinical and clinical trials, pharmacology, toxicology, regulatory information, and data relating to the manufacture
and use of such Bulk Product or Product. 
 1.08    “Bulk Product” shall mean the bulk solution of polyethylene glycol
(PEG) conjugate of uricase ordered by Savient from BTG pursuant to this Agreement. 
 1.09    “Business Day” shall mean
any day other than (i) Friday, Saturday or Sunday or (ii) a day on which banking institutions located in New York, New York, United States of America or in Israel are permitted or required by law, executive order or governmental decree to
remain closed. 
 1.10    “cGMP” shall mean current good manufacturing practices as set forth in Title 21, Parts 210
and 211 of the C.F.R. and 21 C.F.R. Part 312 (IND) and Part 314 (NDA), and 21 C.F.R. Part 600 (Biological Products), as established and amended by the FDA. 

1.11    “Claim” shall mean all charges, complaints, actions, suits, proceedings, hearings, investigations, claims,
demands, judgments, orders, decrees, stipulations, injunctions, damages (including all incidental and consequential damages claimed by Third Parties), deficiencies, defaults, assessments, dues, penalties, fines, costs, amounts paid in settlement,
liabilities, obligations, taxes, liens, losses, lost profits claimed by Third Parties, expenses, costs and fees (including without limitation interest, court costs, reasonable fees of attorneys, accountants and other experts or other expenses of
litigation or other proceedings or of any claim, default or assessment), and includes all damages awardable pursuant to statute and treble damages. 

1.12    “Commercial Bulk Product Specifications” shall mean the manufacturing and quality specifications for the Bulk
Product, including, without limitation, unit descriptions established initially in accordance with Section 3.01(ii) and amended from time to time in accordance with Section 3.01(iii) . 

1.13    “Commercial Launch” shall mean the first commercial sale of the Product in any country of the Territory. 

1.14    “Competing Product” shall mean any prescription pharmaceutical product that (i) contains uricase as an
active ingredient or (ii) is used for the therapeutic or prophylactic treatment of gout (in any form) or other diseases and conditions involving hyperuricemia and/or monosodium urate crystals. 

1.15    “Current Provisional Bulk Product Specifications” shall mean those provisional specifications set forth on
Exhibit C hereto and any amended and restated Bulk Product specifications which are agreed to by the Parties in accordance with Section 3.01(i) . 

1.16    “Development Agreement” shall mean that certain Development Agreement by and between the Parties hereto, dated as
of the date hereof. 
 1.17    “Dollar” shall mean the United States dollar. 

  
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 1.18    “FDA” shall mean the United States Food and Drug Administration
or its foreign equivalent as may be appropriate in any given context. 
 1.19    “Facility” shall mean, the BTG
facility located at Be’er Tuvia Industrial Zone, POB 571, Kiryat Malachi 83104, Israel, within which, and for the purposes of the calculation of “Pro Rata Basis” as defined in Section 1.37 there is the: 

(i)       “Purification Area” of the Facility used in the Processing of Bulk
Product and comprising the small purification line totaling166 square meters; 

(ii)      “Fermentation Area” of the Facility used from time to time for the
Processing of Bulk Product and comprising the fermentation suite, totaling 245 square meters; 

(iii)      “Recovery Area” of the Facility used from time to time for the Processing
of Bulk Product and comprising the recovery suite, totaling 124 square meters, and; 

(iv)      “Total Manufacturing Area” of the Facility comprising the portion of the
Facility dedicated to product manufacturing, excluding common areas such as buffer preparation, totaling 1182 square meters. 

1.20    “Field” shall mean human therapeutic or prophylactic or diagnostic applications for the prevention, treatment
and/or cure of diseases and physical conditions. 
 1.21    “Filled Product” shall mean sterile Product that is in
Process and has been filled into its final primary packaging for further labeling or packaging activities. 
 1.22    “Genetic
Material” shall mean the master cell bank of the E. coli strain expressing the recombinant uricase variant used in the Processing of the Bulk Product. 

1.23    “IND” shall mean an Investigational New Drug application, as defined in 21 C.F.R. 312.3, and filed with the FDA
or any equivalent foreign Regulatory Agency. 
 1.24    “Joint Inventions” shall mean (i) all patentable
inventions jointly invented (as determined in accordance with United States patent law) by Savient (or its Affiliates) and BTG (or its Affiliates) pursuant to their activities relating to this Agreement during the Term, and (ii) all Know-How that Savient (or its Affiliates) and BTG (or its Affiliates) jointly make, create, develop, discover, conceive or reduce to practice pursuant to their activities relating to this Agreement during the Term
other than those inventions described in the preceding clause (i). 

1.25    “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, and includes,
without limitation, BTG Know-How. 
 1.26    “Legal Requirements” shall mean
(i) any present and future national, state, local or similar laws (whether under statute, rule, regulation or otherwise), (ii) requirements under permits, orders, decrees, judgments or directives, and requirements of applicable Regulatory
Agencies (including, without limitation, cGMP) and (iii) regulations pertaining to commercially 

  
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 available biologic pharmaceutical products or to maintaining a BLA (with respect to each of the foregoing,
as amended or revised from time to time). 
 1.27    “Negligence” shall mean an act or omission implying either a
failure to exercise the care which a reasonable or prudent person would do in the circumstances, or taking action which such a reasonable person would not; as used herein, a reasonable or prudent person shall be considered to have such expertise as
would be required in order to allow such party to perform the obligations of the parties hereunder with the level of skill and competence which prevail in the pharmaceutical industry. 

1.28    “Non-Conforming Bulk Product” shall mean any Bulk Product which, at the
time of delivery in accordance with ARTICLE 7, does not meet the Commercial Bulk Product Specifications. 

1.29    “OCS” shall mean Office of Chief Scientist, The Ministry of Industry and Trade, State of Israel. 

1.30    “OCS Requirements” shall mean the requirements of OCS which apply to the Product, including, without limitation,
as specified pursuant to The Encouragement of Research and Development in Industry Law of 1984, as amended, and in the agreements by and among Savient, BTG and the OCS. 

1.31    “Person” shall mean any individual, partnership, corporation, limited liability company, unincorporated
organization or association, any trust or any other business entity. 
 1.32    “Process” or
“Processing” shall mean the act of purification, preparation, filling, testing and any other pharmaceutical manufacturing procedures, or any part thereof (including, but not limited to, product or process specifications, testing or
test methods, raw material specifications or suppliers, equipment, etc.), relating to, as applicable, the Bulk Product and Product. 

1.33    “Product” shall mean pharmaceutical products containing Bulk Product ordered by Savient pursuant to this
Agreement. 
 1.34    “Product Liability Claim” shall mean a Claim of a Third Party (other than a Claim arising out of
use of the Product in a clinical trial) that (i) arises as a result of the use of the Product during the Term that results in personal injury or death or (ii) is in anticipation of or intended to prevent or forestall personal injury or
death as a result of the use of the Product during the Term. 
 1.35    “Product Technology” shall mean the
(i) Savient Patent Rights, (ii) Savient Know-How, (iii) BTG Assigned Improvements, (iv) BTG Licensed Improvements, (v) BTG Know-How,
(vi) any developments, discoveries, inventions, improvements, designs, methods, processes, techniques, devices, formulae, and trade secrets which are or may be (A) developed, acquired or conceived by Savient and/or BTG and are derived from
the Development Plan performed under the terms of the Development Agreement, developed by BTG prior to July 17, 2005 and related to the Bulk Product or used in the Processing of Bulk Product, or are derived from the manufacture and supply of
Bulk Product, or (B) used in the Processing of Bulk Product. 

  
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 1.36    “Product Specifications” shall mean the manufacturing and quality
specifications for the Product as attached hereto as Exhibit G as they may be modified from time to time. 
 1.37    “Pro-Rata Basis” shall mean when Facility changes will be implemented pursuant to the provisions of Section 6.03(ii)(B) and: 

(i)      such Facility changes will impact the totality of the Total Manufacturing Area and/or
the common and technical areas related to manufacturing, the cost of the changes multiplied by a percentage, where such percentage equals 
  

											
	 Purification Area
	 	     PLUS     
	 	 Fermentation Area
	 	     X Time PLUS    

 
	 	 Recovery Area
	 	     X Time    

 

	Total Manufacturing Area	 	Total Manufacturing Area	 	Total Manufacturing Area

 (ii)      when such Facility changes will impact only the
Fermentation Area, the cost of the changes multiplied by Time; 
 (iii)      when such
Facility changes will impact only the Recovery Area, the cost of the changes multiplied by Time; 
 1.38    “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 as Exhibit D. 

1.39    “Regulatory Agency” shall mean with respect to the United States, the FDA, or, in the case of a country in the
Territory other than the United States, such other appropriate regulatory agency with similar responsibilities. 

1.40    “Residual Rights Agreement” shall mean that certain Amended and Restated Residual Rights Agreement by and between
Savient and BTG, effective as of July 17, 2005, and attached hereto as Exhibit F. 
 1.41    “SAE” shall
mean, with respect to the Product, any serious adverse event occurring during clinical trials of the drug at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or
prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening or require hospitalization may be
considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in patient hospitalization, or the development of drug dependency or drug
abuse. 
 1.42    “Savient Improvements” shall mean all inventions related to the Bulk Product or Product (including,
without limitation, its pharmaceutical utility) and/or Processing of the Bulk Product or Product which are made, created, developed or conceived, or reduced to practice or come to be owned, by Savient or an Affiliate of Savient and are dominated by
the Savient Patent Rights. 

  
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 1.43    “Savient Indemnitee” shall mean Savient and its Affiliates, and
each of their respective directors, officers, employees and agents. 
 1.44    “Savient
Know-How” shall mean all Know-How developed by Savient or any of its Affiliates during the Term relating to (i) the Bulk Product or Product (including,
without limitation, its pharmaceutical utility) or (ii) the Processing of the Bulk Product or Product, and shall include, without limitation, all data relating to formulation, analytical methods,
pre-clinical and clinical trials, pharmacology, toxicology, regulatory information, and data relating to the manufacture and use of such Bulk Product or Product. 

1.45    “Savient Patent Rights” shall mean all valid patent claims contained in (i) the patent(s) and patent
applications listed on Exhibit A; (ii) all converted provisionals, divisions, continuations, continuations-in-part, reissues, reexaminations or extensions
thereof; (iii) any corresponding foreign counterparts and equivalents thereof; and (iv) any patents or patent applications filed after July 17, 2005. 

1.46    “Sublicensee” shall mean any Third Party or Affiliate to whom a sublicense has been granted pursuant to
Section 2.05. 
 1.47    “Term” shall have the meaning set forth in Section 11.01. 

1.48    “Territory” shall mean, collectively, each country in the world. 

1.49    “Third Party” shall mean any Person who is not a Party or an Affiliate under this Agreement. 

1.50    “Time” shall mean for the purposes of the calculation of Pro Rata Basis, as defined in Section 1.37, the
percentage based on the number of weeks that either the Fermentation Area or the Recovery Area, as applicable, is used for the Processing of Bulk Product divided by (i) 46 in the case of an entire year or (ii) the respective number of weeks in
the billing term if the period is less than a year. 
 1.51    “United States” shall mean the fifty states of the
United States of America, the District of Columbia and all territories and possessions of the United States of America and any other location where the FDA has jurisdiction over medicinal products intended for human use. 

ARTICLE 2 
 INTELLECTUAL
PROPERTY LICENSES 
 2.01    Grant of Licenses; Assignment. 

(i)      No restriction of license rights under the Residual Rights Agreement. The
parties are agreed that the following provisions shall not in any way remove or restrict the rights pertaining to the grant of licenses to either party (“RRA License Rights”) as they exist pursuant to the Residual Rights Agreement. In the
event of a conflict between this Agreement 

  
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and the Residual Rights Agreement with respect to the RRA License Rights, the relevant provisions of the Residual Rights Agreement shall take precedence. 

(ii)    Grant by Savient. Savient hereby grants to BTG, and, if applicable, shall cause its
Affiliates to grant to BTG, a fully paid-up, royalty-free, non-exclusive license within the State of Israel (“BTG Territory”) to manufacture, have
manufactured, produce, have produced, develop, have developed, use, have used, offer for sale, have offered for sale, sell, have sold, export, and have exported Bulk Product under the Savient Patent Rights, the Savient
Know-How, and the rights to the Savient Improvements for supply exclusively to Savient. 

(iii)    Grant by BTG. BTG hereby grants to Savient and, if applicable, shall cause its Affiliates
to grant to Savient, a fully paid-up, royalty-free, non-exclusive license in the Territory to manufacture, have manufactured, produce, have produced, develop, have
developed, use, have used, offer for sale, have offered for sale, sell, have sold, export, and have exported Bulk Product under the BTG Licensed Improvements and BTG Know-How. 

(iv)    Assignment by BTG. BTG shall promptly assign (and, if applicable, shall cause its
Affiliates to assign) to Savient all right title and interest in and to any invention or discovery which may be claimed as a BTG Assigned Improvement. BTG shall execute (and, if applicable, shall cause its Affiliates to execute) such documents as
may be necessary to obtain, perfect or maintain any patent rights arising out of the BTG Assigned Improvements, and shall cooperate with Savient so far as reasonably necessary with respect to furnishing all information and data in its possession
which is reasonably necessary or useful to obtain and maintain such patent rights. 
 2.02    Notice of
Improvements & Joint Inventions. BTG shall give Notice to Savient of all BTG Assigned Improvements, BTG Licensed Improvements and Joint Inventions promptly within due course of the discovery or creation thereof, but
in any event at least thirty (30) days prior to any proposed publication thereof by BTG, its Affiliates or Sublicensees. Savient shall give Notice to BTG of all Savient Improvements and Joint Inventions promptly within due course of the
discovery or creation thereof, but in any event at least thirty (30) days prior to any proposed publication thereof by Savient, its Affiliates or Sublicensees. The Parties shall, in any event, notify each other no less than annually, of whether
they have made any BTG Assigned Improvements, BTG Licensed Improvements, Savient Improvements or Joint Inventions, as the case may be. 

2.03    Disclosure of Know-How. BTG shall disclose, and shall cause its Affiliates to
disclose, as soon as reasonably practicable, to Savient all BTG Know-How acquired, developed or which comes to be possessed by the BTG or any of its Affiliates after the date hereof (and upon reasonable
request by Savient, shall make such disclosure in writing). 
 2.04    Use of Joint Inventions. 

(i)       Subject to subsections (ii) and (iii) hereof, each Party shall have the
right to practice under the Joint Invention rights without any duty of accounting to the other Party. 

(ii)      BTG agrees that, except as otherwise agreed by the Parties in writing, it shall not
(and shall, if applicable, ensure that its Affiliates shall not) (A) grant any license under the 

  
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Joint Invention Rights to any other Person to manufacture, have manufactured, produce, have produced, develop, have developed, use, have used, market, have marketed, import, have imported,
export, have exported, sell or have sold any Competing Product, or (B) practice any Claim under the Joint Inventions rights to manufacture, have manufactured, produce, have produced, develop, have developed, use, have used, market, have
marketed, import, have imported, export, have exported, sell or have sold any Competing Product. 

(iii)      Each Party agrees that it shall (and shall, if applicable, ensure that its Affiliates
shall) notify the other Party before granting any license to any other Person to manufacture, have manufactured, produce, have produced, develop, have developed, use, have used, import, have imported, export, have exported, offer for sale, have
offered for sale, sell or have sold any product outside the Field under the Joint Invention rights; provided, however, that neither Party shall grant or purport to grant any license under the Joint Invention rights that is exclusive as to the
other Party or its assignees or Sublicensees without the prior written consent of such other Party. 
 2.05    Sublicensing.
Savient shall have the right to grant sublicenses of licenses granted to it in Section 2.01 of this Agreement to its Affiliates and to any Third Party; provided, however, that Savient, to the extent applicable, (i) ensures
that each such Sublicensee and Third Party shall consent to be bound by the terms of this Agreement as a Sublicensee or Third Party and to the same extent as Savient with respect to such Sublicenses or Third Party’s activities,
(ii) informs BTG, in confidence, of each sublicense granted, and any modification or termination thereof, within sixty (60) days after the modification, or termination of a sublicense and (iii) guarantees to BTG the performance of any
of its obligations which it fulfills through sublicensing and remains primarily liable for the performance of such obligations. 

2.06    OCS Requirements. BTG shall not without prior written approval of Savient (and, if applicable, shall ensure that its
Affiliates shall not) take any action (including, without limitation, Processing the Bulk Product outside the State of Israel) which would (i) cause either Party (or any of their Affiliates) to violate any of the OCS Requirements or
(ii) result in any increase of royalties due to OCS. Additionally, upon request by Savient, BTG shall cooperate and collaborate with Savient in applying to the OCS for Savient to carry out the manufacture of the Bulk Product through a Third
Party outside the State of Israel. The Parties acknowledge the rights and obligations of each Party under Section 5 of the Residual Rights Agreement and each Party shall honor such rights and obligations set forth therein. 

ARTICLE 3 

SPECIFICATIONS; ONGOING REGULATORY ASSISTANCE 

3.01    Specifications. 

(i)       Current Provisional Bulk Product Specifications. The Current Provisional
Bulk Product Specifications are attached as Exhibit C. The Parties are agreed that the Current Provisional Bulk Product Specifications may still be subject to modification based on the outcome of the Validation, as defined and performed
pursuant to the Development 

  
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 Agreement, and subject to the mutual agreement of the parties, such agreement not to be
unreasonably conditioned, delayed or withheld. 
 (ii)      Initial Commercial Bulk Product
Specifications. The initial Commercial Bulk Product Specifications shall be agreed upon in writing by the Parties, as soon as reasonably practicable after the conclusion of the Validation, as defined and performed pursuant to the Development
Agreement, but in no event later than ninety (90) days from the conclusion of the Validation, unless the Parties shall mutually agree to extend such time period (hereinafter the “Commercial Bulk Product Specifications”). The
Commercial Bulk Product Specifications shall be incorporated into this Agreement by formal amendment as Exhibit C-1 and shall be the controlling standards for the manufacture of Bulk Product pursuant to this
Agreement unless and until they are changed by written agreement between the parties. In determining the Commercial Bulk Product Specifications, the Parties shall take into consideration particularly (i) the results of the subsequent
development activity of BTG under the Development Agreement and (ii) the results of the Validation as defined and performed pursuant to the Development Agreement. 

(iii)      Amendment of Commercial Bulk Product Specifications. Subject to the provisions
of Section 6.02 and 6.03 (including the cost reimbursements provisions thereof), Savient shall have the right to amend the Commercial Bulk Product Specifications from time to time; provided, however, that (i) Savient shall
use commercially reasonable efforts to minimize the frequency of such changes and shall provide BTG with reasonable advanced Notice of any changes to the Commercial Bulk Product Specifications (but, in any event, at least ninety (90) days
advance notice) and (ii) the Parties have agreed in writing upon the implications and costs related to any contemplated changes pursuant to this Section 3.01, which agreement shall not be unreasonably conditioned, withheld or delayed.
Without in any way limiting the foregoing, any modifications to the Commercial Bulk Product Specifications required by any Regulatory Agency with jurisdiction to require such modifications shall be made in accordance therewith. 

3.02    Ongoing Assistance by BTG for Initial and Subsequent Filings or Applications. 

(i)      Upon the expiration or earlier termination of the Development Agreement, BTG hereby
agrees to provide, in respect to any jurisdiction within the Territory (A) all information and assistance which is reasonably necessary for or useful in the preparation of (i) comprehensive and complete INDs and BLAs, including, without
limitation, the Chemistry Manufacturing and Controls (CMC) section of the BLAs for the Product, (ii) any amendments and supplements to such filings and applications, (iii) subsequent filings and applications for secondary indications or
additional marketing, sale, importing, exporting authorizations, or (iv) similar filings and applications and (B) access to the Facility and pertinent information to FDA inspectors conducting the
pre-approval inspection. All documents to be supplied by BTG pursuant to this Section 3.02 or any other provision of this Agreement shall be translated by BTG into the English language as may be
necessary. Any labor costs of BTG employees and/or Third Party expenses incurred by BTG related to this assistance shall be reimbursed by Savient in the manner and at the rates set forth on Exhibit B hereto. 

  
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 (ii)      Ownership. The Parties agree
that all INDs and BLAs arising under this Agreement, including any and all modifications and supplements thereto, will be owned by and held in the name of Savient and will list BTG in accordance with its role as contemplated under this Agreement and
in compliance with the Legal Requirements. BTG shall have no rights in or to the IND or BLA and any and all modifications and supplements thereto, other than any rights specifically granted pursuant to this Agreement. 

3.03    Record and Files. Upon the expiration or earlier termination of the Development Agreement, BTG shall maintain those
documents required by the applicable Legal Requirements during the Term and for any period required by such Legal Requirements. BTG shall maintain those records specified in 21 C.F.R. § 600.12(e) for cases of divided manufacturing
responsibility for biologics and shall provide the records as specified therein to any Third Party fillers or manufacturers designated by Savient. 

ARTICLE 4 
 SUPPLY OF
INGREDIENTS AND MATERIALS 
 4.01    Procurement of Ingredients and Materials. 

(i)      Ordinary and Safety Stocks. Ingredients and materials necessary for the
Processing of Bulk Product shall be purchased and stored by BTG in accordance with the terms of the Quality Agreement and in commercially reasonable and prudent production and safety stock quantities necessary to meet the Bulk Product Forecast (as
defined in Section 5.03) giving due regard to the potential for production and batch failures, Bulk Product loss until delivery to Savient and the amendment of the Bulk Product Forecast in accordance with Section 5.06. 

(ii)      PEG Purchases from NOF. The foregoing notwithstanding, Savient, in its sole and
absolute discretion, shall have the right, but not the obligation, to directly contract with NOF Corporation for m-PEG-NPC (mono-methoxy polyethylene glycol nitro-phenyl
carbonate) (hereinafter the “PEG”) necessary for BTG to Process the Bulk Product, provided, however, in the event Savient elects to do so, then (i) Savient shall use best efforts to ensure that adequate stock, including
safety stock quantities, of PEG, in amounts to be agreed upon between the Parties, are delivered to BTG in a timely manner in order to enable BTG to fulfill its obligations to Process Bulk Product to meet the requirements of all Purchase Orders
placed by Savient pursuant to Section 5.05; (ii) BTG agrees that it will, in accordance with the terms of the Quality Agreement, store and test, as applicable, such stock of PEG delivered by NOF; (iii) BTG shall reimburse Savient for the
cost of any PEG utilized in the Processing of Bulk Product that is determined to be (a) Non-Conforming Bulk Product, or (b) a failed batch; (iv) that such agreement between Savient and NOF shall
not materially interfere with the terms of this Agreement or unduly interfere with BTG’s ability to carry out its work; and (v) the inability of BTG to perform under the terms of this Agreement, where such failure is due to the failure of
Savient to ensure the timely delivery to BTG of adequate stock of PEG shall not be deemed to be a breach by BTG of its obligations under this Agreement. 

  
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 4.02    Maintenance of Genetic Material. From the Effective Date, BTG shall (or
shall procure one of its Affiliates to) maintain such quantity of Genetic Material to meet Purchase Orders placed and the Bulk Product Forecast provided by Savient pursuant to ARTICLE 5. In the event of the expiration or termination of this
Agreement, BTG shall, within thirty (30) days of the effective date of such expiration or termination, transfer to Savient or its designee any and all remaining quantities of Genetic Material. Any labor costs of BTG employees and/or Third Party
expenses incurred by BTG related to transfer of Genetic Material shall be reimbursed by Savient in the manner and at the rates set forth on Exhibit B hereto. 

4.03    Reference Materials. BTG shall provide Savient with any physical, chemical or biological material that is otherwise
unavailable, which is to be used as a reference standard in the testing of Bulk Product, ingredients or raw materials. Such physical, chemical or biological material shall be provided to Savient at cost plus 50% (fifty percent). Payments due by
Savient under this Section 4.03 shall be payable by Savient no later than forty-five (45) days after the invoice date. 

ARTICLE 5 
 BTG FACILITY
CAPACITY, FORECASTING, PURCHASE ORDERS 
 AND ORDER CONFIRMATIONS 

5.01    BTG Facility Bulk Product Processing Capacity and Capacity Reservation Fee. 

(i)      Existing Facility Capacity. Savient and BTG acknowledge that based on the
(A) Purification Area used in the Processing of Bulk Product, (B) the Fermentation Area and the Recovery Area used from time to time for the Processing of Bulk Product, (C) methods, processes and procedures currently utilized in the
Processing of Bulk Material as of the Effective Date, and (D) the current shift arrangement (one (1) — eight (8) hour shift operating five (5) days per calendar week during a forty-six
(46) work week calendar year) in the Facility as of the Effective Date (hereinafter the “Capacity Parameters”), the BTG Facility has the projected capacity to Process up to forty-two
(42) batches of Bulk Product per calendar year in the absence of other products manufactured in the areas specified above. Additionally, Savient and BTG acknowledge that this capacity could be increased, upon appropriate advance notice, if
additional shift operations were implemented and/or certain Facility changes were made. 

(ii)      Subject to the terms set forth in this Section 5.01(ii), in order to reserve capacity
at BTG for the Processing of Bulk Product, for all Bulk Product forecasted by Savient to be Processed by BTG and purchased by Savient prior to the Commercial Launch of the Product and through December 31, 2010 (hereinafter the “Reservation
Fee Period”), Savient shall remit to BTG a Processing Capacity Reservation Fee in the amounts and manner set forth below: 

(A)      Within ten (10) Business Days of the provision of the Preliminary Bulk Product
Forecast pursuant to Section 5.02, Savient shall remit to BTG a Processing Capacity Reservation Fee of Three Million Dollars ($3,000,000). 

  
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 (B)      Within ten (10) Business Days of
the provision of the Bulk Product Launch Forecast pursuant to Section 5.03, Savient shall remit to BTG a Processing Capacity Reservation Fee equal to the amount required to bring Savient’s Processing Capacity Reservation Fee, when added to
the amount remitted under Section 5.01(ii)(A), to twenty percent (20%) of the applicable Price, as defined in Section 8.01, of the number of batches of Bulk Product reflected on such Bulk Product Launch Forecast, provided, however, if the
amount calculated under this Section 5.01(ii)(B) is less than the Processing Capacity Reservation Fee remitted under Section 5.01(ii)(A) the Processing Capacity Reservation Fee shall remain at such higher amount. In the event that the initial Bulk
Product Launch Forecast pursuant to section 5.03 is not provided by September 30, 2007, then Savient shall remit monthly to BTG an additional Processing Capacity Reservation Fee of $125,000 for each additional month that passes until the
provision of the initial Bulk Product Launch Forecast. 
 (C)      Within ten
(10) Business Days of the provision of any Bulk Product Forecast pursuant to Section 5.03 or any Amended Bulk Product Forecast provided by Savient pursuant to Section 5.06 provided by Savient on or before July 1, 2009, Savient
shall remit to BTG a Processing Capacity Reservation Fee equal to the amount required to bring Savient’s Processing Capacity Reservation Fee, when added to the amount remitted under Sections 5.01(ii)(A) and 5.01(ii)(B), to twenty percent (20%)
of the applicable Price, as defined in Section 8.01, of the number of batches of Bulk Product reflected on such Bulk Product Forecast or Amended Bulk Product Forecast that are projected for purchase during the Reservation Fee Period, provided,
however, if the amount calculated under this Section 5.01(ii)(C) is less than the aggregate of the Processing Capacity Reservation Fee remitted under Sections 5.01(ii)(A) and 5.01(B) the Processing Capacity Reservation Fee shall remain at such
higher amount. 
 (D)      All Processing Capacity Reservation Fee amounts remitted by Savient
to BTG under this Section 5.01(ii) shall: 
 (1) earn interest at the one (1) year London Interbank Offering Rate (“LIBOR”)
with the interest earned thereon inuring to the sole benefit of Savient; 
 (2) be credited, inclusive of interest, by BTG on a per batch
basis by providing a 20% discount on the value of each batch at the time of invoicing for Bulk Product purchased by Savient during the Reservation Fee Period until it is fully utilized, provided however, except as otherwise provided in Sections
5.01(ii)(F), 5.01(ii)(G) and 5.01(ii)(H), any uncredited Processing Capacity Reservation Fee, inclusive of interest, remaining at the end of the Reservation Fee Period due to a failure by Savient to take delivery of Bulk Product which conforms to
the Commercial Bulk Product Specifications and which is ordered pursuant to a Bulk Product Forecast provided pursuant to Section 5.03 or an Amended Bulk Product Forecast provided pursuant to Section 5.06 and which is otherwise properly
amended pursuant to Section 5.05 shall be forfeited by Savient to BTG. For purposes of clarity, the credit of the Processing 

  
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Capacity Reservation Fee shall accrue upon the delivery of the Bulk Product by BTG to Savient and shall be reflected on the invoice which relates to the Bulk Product shipment in question; and

 (3) BTG shall provide to Savient a quarterly statement within ten (10) Business Days of the end of each calendar quarter of the
then current balance of the Processing Capacity Reservation Fee, inclusive of interest, available for credit to the purchase of Bulk Product by Savient. 

(E)      Subject to the last sentence of this Section 5.01(ii)(E), Savient and BTG acknowledge
and agree that by the conclusion of the Reservation Fee Period the demand for Savient’s Product will be sufficiently capable of reliable forecasting as to negate the need for a Processing Capacity Reservation Fee and that such will not be
required for Bulk Product forecasted for purchase beyond the expiration of the Reservation Fee Period. On that basis, the final Processing Capacity Reservation Fee shall be due based on twenty percent (20%) of the applicable Price, as defined in
Section 8.01, of the number of batches of Bulk Product reflected on the Bulk Product Forecast or Amended Bulk Product Forecast that is submitted for the period July 2009 through December 2010. If there is a delay in the commercial launch of the
Product beyond the first calendar quarter of 2009 or any other factor reasonably preventing a reliable Bulk Product forecasting by the conclusion of the Reservation Fee Period, then the Parties will meet in good faith and discuss whether a further
capacity reservation fee is necessary or appropriate and, if it is agreed necessary, for what duration and amount, if any. 

(F)      Anything to the contrary notwithstanding, in the event that any amount of the
Processing Capacity Reservation Fee, inclusive of interest, remains unused or unapplied at the end of the Reservation Fee Period due to a failure by BTG for any reason, including Force Majeure conditions affecting BTG or the import, export or
transportation of the Bulk Product which is beyond the reasonable control of BTG or Savient, to timely deliver any number of batches of Bulk Product properly ordered and accepted in accordance with the terms of this Agreement, then any amount of the
Processing Capacity Reservation Fee, inclusive of interest, which would have been used for or applied to the purchase of Bulk Product but for the non-delivery or untimely delivery thereof, shall be refunded to
Savient by wire transfer within fifteen (15) Business Days of the end of the Reservation Fee Period. For purposes of determining timely delivery pursuant to this section, the delivery dates identified in a Purchase Order submitted and accepted
in accordance with Section 5.05 herein shall be considered binding, except in the event of a Force Majeure condition affecting BTG or the import, export or transportation of the Bulk Product which is beyond the reasonable control of BTG
or Savient, in which case the Parties shall agree upon a reasonable extension of the delivery date in accordance with Section 14.14 hereof. 

(G)      In the event this Agreement is terminated by Savient pursuant to Sections 11.02 (ii)
(for Force Majeure conditions affecting BTG), 11.02 (iii) (Material Breach by BTG), or 11.02 (v) (for insolvency of BTG) hereof, any amount of the Processing Capacity Reservation Fee and accrued interest thereon which has not been applied to
payments for Bulk Product actually purchased by and delivered to Savient, shall be 

  
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 returned to Savient via wire transfer within thirty (30) days of the effective date of
termination of this Agreement. In the event this Agreement is terminated with the mutual consent of both Parties, then, as part of such mutual consent, the Parties shall discuss in good faith and reach resolution with regard to the disposition of
the then-existing Capacity Reservation Fee, including any interest thereon, having due regard for the reasons and basis that lead the Parties to terminate this Agreement by mutual consent. 

(H)      Savient and BTG further acknowledge and agree that in the event the BLA for
Savient’s Product is not filed with the FDA on or before December 31, 2008 then the Processing Capacity Reservation Fee previously paid by Savient to BTG and accrued interest thereon relating to Bulk Product Forecasts provided by Savient
before December 31, 2008 shall be refundable to Savient only in the event and to the extent that BTG is able, with the use of best efforts, to mitigate its losses by scheduling into the Processing Capacity reserved for Savient during such
period production of a product or products on behalf of BTG, an Affiliate, or a third party, or any combination thereof. 

5.02      Preliminary Bulk Product Forecast. As soon as reasonably practicable, but in no event later than thirty
(30) days from the date of full execution of this Agreement, Savient shall provide BTG a preliminary, non-binding projection of its first eighteen month rolling forecast that sets forth Savient’s
then best estimate of the date for the delivery of the first commercial quantity of Bulk Product and the total quantity of Bulk Product for commercial supply that Savient expects to order from BTG within the eighteen (18) month period following
delivery of such first commercial quantity (“Preliminary Bulk Product Forecast”). In the Preliminary Bulk Product Forecast, Savient shall: 

(i)      set forth the assumptions it is utilizing for the establishment of the date for the
delivery of the first commercial quantity of Bulk Product; 
 (ii)      include a breakdown of
the total quantity of Bulk Product by month for the eighteen months following the delivery of the first commercial order; and 

(iii)      identify the variables, Process and regulatory questions and issues and logistical
considerations that could impact the date for the delivery of the first commercial quantity of Bulk Product. 
 Within thirty (30) days of the issuance
of the Preliminary Bulk Product Forecast, Savient and BTG shall meet to commence good faith discussions and agree on the methodology and timeline for bringing to resolution and conclusion any and all Process and regulatory questions, issues and
logistical considerations outlined in the Preliminary Bulk Product Forecast. Savient and BTG shall use their mutual best efforts to conclude these discussions and reach final resolution as soon as reasonably practicable, but in no event later than
July 30, 2007, unless the parties mutually agree that additional time is required. 
 5.03      Bulk Product Launch
Forecast and Bulk Product Forecast. Commencing at least twelve (12) months prior to the delivery date of the first Firm Order, Savient shall submit to BTG its final initial launch Bulk Product forecast which shall set forth month by month
an eighteen (18) month rolling forecast that sets forth the total quantity of Bulk Product for commercial supply 

  
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 that Savient either has ordered, desires to order, or expects to order from BTG within the eighteen
(18) month period following delivery of such first commercial quantity (“Bulk Product Launch Forecast”). Thereafter, Savient shall provide on a monthly basis on or before the first Business Day of each calendar month an updated Bulk
Product forecast for the next ensuing eighteen (18) month rolling period (“Bulk Product Forecast”). In the Bulk Product Forecast, Savient shall: 

(i)    include a breakdown of the total quantity of Bulk Product by month for the following eighteen
(18) month rolling period; and 
 (ii)    in respect of the monthly breakdown under (i) above,
identify the relevant set of Bulk Product Specifications. 
 As used herein, the term “Forecast” shall mean, as applicable, the Bulk Product
Launch Forecast or Bulk Product Forecast, as may be amended from time to time pursuant to Section 5.06 hereof. 

5.04      Firm Orders and Firm Forecasts. The Bulk Product Forecast submitted monthly by Savient shall breakdown by month
of the next ensuing eighteen (18) months of the Bulk Product Forecast and shall consist of: 

i.        a rolling firm irrevocable order for the first two (2) quarters (i.e. quarters 1 and 2)
of the Bulk Product Forecast (“Firm Order”), which shall each be the subject of a Purchase Order delivered and confirmed in accordance with Section 5.05; 

ii.        a rolling two (2) quarter forecast for the second two (2) quarters (i.e. quarters
3 and 4) of the Bulk Product Forecast (each a quarterly “Firm Forecast”); and 

iii.        a rolling two (2) quarter estimate for the third two (2) quarters (i.e. quarters
5 and 6) of the Bulk Forecast (each a quarterly “Estimated Forecast”). 
 5.05      Purchase Orders and Order
Confirmations. Savient will accompany its monthly update of the Bulk Product Forecast with a written purchase order (“Purchase Order”) for each new Firm Order that was only a Firm Forecast in the previous month’s Bulk Product
Forecast. Each Purchase Order shall specify the Bulk Product ordered and the time, manner and address of delivery, all of which shall be subject to this ARTICLE 5. BTG shall confirm each Purchase Order in a written order confirmation within seven
(7) Business Days after receipt of the Purchase Order. 
 5.06      Amending Forecasts. Any Bulk Product Forecast
that is not a Firm Order is to be considered a forecast or estimate to be used for planning purposes, and shall not be construed as a firm commitment by Savient to BTG and thus can be increased or reduced by Savient from time to time. Savient shall
be entitled at any time up until and including the time that a Firm Forecast or Estimated Forecast becomes a Firm Order, to increase or decrease such monthly Firm Forecast or Estimated Forecast for Bulk Product, provided, however, such increases or
decreases on a monthly basis shall not be greater than twenty-five percent (25%) of the originally forecasted quantity for such month and each month may not be increased and decreased more than one time. As a request by Savient to increase the
quantity of Bulk Product in a Firm Forecast prior to its becoming a Firm Order may require longer lead times for delivery than 

  
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 requested by Savient, both Parties shall agree jointly on a new delivery date as close as possible to the
requested date having due regard for BTG’s commercial commitments to Third Parties and its own production needs, such agreement to not be unreasonably withheld, conditioned or delayed. Once a Firm Forecast becomes a Firm Order, Savient may not
reduce it, but may request that BTG increase the quantity of Bulk Product subject to a Firm Order and BTG shall use commercially reasonable efforts to fill the increased order. 

5.07    Fulfillment of Purchase Orders; Review of Forecasts. 

(i)    BTG shall satisfy, in accordance with their terms, Savient’s Purchase Orders, provided and
confirmed in accordance with Section 5.05. BTG shall promptly notify Savient if it becomes aware or believes that it will not be able to satisfy such Purchase Orders on time, in full, or at all, which Notice shall include an explanation in
reasonable detail of the reason for BTG’s failure to comply with a confirmed Purchase Order and its proposed course of action for remedying such failure. Savient shall be entitled to request BTG to produce evidence to support its Notice,
BTG’s response to such request shall not be unreasonably denied or delayed. 
 (ii)    Within ten
(10) Business Days of its receipt of the Bulk Product Launch Forecast or a Bulk Product Forecast or any amendment thereto, BTG shall review such Forecast and in the event that BTG believes that it will not be able to satisfy the quantity, time
or manner for delivery of any portion of the order for any amount of Bulk Product identified in any portion therein (i.e.: in the Firm Order, Firm Forecast or Estimated Forecast portions), BTG shall notify Savient of the same, provide a reasonable
explanation of the cause of its inability to do so and provide alternatives for the delivery of the quantity and/or scheduling or manner of delivery to satisfy the requirements of Savient. 

(iii)    Unless BTG has indicated, in accordance with Section 5.07(ii), an inability to satisfy the
identified quantities of Bulk Product in the Bulk Product Launch Forecast, any Bulk Product Forecast, or any amendment thereto, BTG may not refuse to accept a Purchase Order which does not deviate from the previously provided Bulk Product Launch
Forecast, Bulk Product Forecast or amended forecast, as the case may be when, on a rolling basis, months contained in a Firm Forecast or Estimated Forecast period becomes a Firm Order. 

(iv)    In the event that BTG notifies Savient of its inability to supply any subject quantity of Bulk
Product identified in the Bulk Product Launch Forecast, any Bulk Product Forecast or amended forecast, the parties agree to work together in good faith to expeditiously resolve the discrepancy between the subject forecast and BTG’s inability to
supply Bulk Product in accordance therewith. 
 5.08      Effect of Supply Failure. In the event of a Supply Failure
(as defined herein), no forecast or estimate shall be considered a Firm Order until such time as BTG proves to Savient’s reasonable satisfaction that the cause of such Supply Failure has been corrected. “Supply Failure” shall mean BTG
has experienced three (3) failed batches of Bulk Product within a calendar quarter, or four (4) failed batches of Bulk Product aggregated over the course of two consecutive quarters, or six (6) failed batches of Bulk Product
aggregated over the course of a calendar year. For purposes of this definition, any Bulk Product that is discovered and notified by Savient in accordance with Section 6.04 (iv) to be Non-Conforming Bulk
Product after 

  
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 delivery shall be considered a failed batch. In the event of a Supply Failure during the Reservation Fee
Period, the period covered by the Reservation Fee Period shall be extended by the quarterly or other period of such Supply Failure. 

5.09    Preferential Right of Supply. BTG shall schedule its own products or those of an Affiliate for processing at the Facility
and shall not accept from a customer that is a Third Party any orders for product processed at the Facility to the extent the fulfillment of such scheduling or order could, at the time of BTG’s scheduling or acceptance of such Third Party
order, reasonably be expected to impede BTG’s ability to fulfill Savient’s Bulk Product Requirements as reflected on the then current monthly Firm Orders, Firm Forecast and Estimated Forecast submitted by Savient pursuant to
Section 5.04 and acted upon by the Parties pursuant to Sections 5.05, 5.06, and 5.07 supra. 
 5.10    Alternative
Supplier. Savient shall have the right to establish an alternative supplier for Bulk Product for up to twenty percent (20%) of its annual world-wide Bulk Product requirements; provided, however, 

(i)    in the event of a Supply Failure under Section 5.08 above, Savient shall have the right to
purchase all of its Bulk Product requirements from an alternative supplier upon reasonable prior written notice to BTG until BTG demonstrates to Savient’s reasonable satisfaction that BTG has fully remedied such Supply Failure, and 

(ii)    if despite the good faith efforts of BTG to modify its Capacity Parameters to meet the needs of
Savient, or, as applicable, the Parties good faith efforts to agree on cooperative methods to modify the BTG Capacity Parameters, Savient’s Forecasts for orders of Bulk Product up to the OCS Requirements are reasonably anticipated to exceed
BTG’s available capacity for the Processing of Bulk Product, then Savient shall have the right to purchase any and all of its requirements of Bulk Product that Savient reasonably determines in good faith may exceed BTG’s available capacity
from Savient’s alternate supplier. 
 BTG acknowledges its obligation to assist Savient with Technology Transfer to an alternative contract
manufacturing organization in accordance with the terms and conditions of Section 5.02 of the Development Agreement. 

5.11    Effect of Termination on Purchase Order. Unless otherwise agreed to in writing by the Parties, the termination of this
Agreement shall automatically terminate all then existing Purchase Orders, except when the termination of this Agreement is pursuant to Sections 11.02 (i) (Elective) and 11.02(iv) (Material Breach by Savient), provided such material breach by
Savient is not based on the non-payment of non-disputed amounts for Bulk Product deliveries, in which case BTG shall honor and fulfill any then existing Purchase Order
and Savient shall pay BTG for any Purchase Order so honored and fulfilled by BTG pursuant to the terms of this Agreement. 

  
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 ARTICLE 6 

PRODUCTION 

6.01    Obligation to Supply and Purchase. BTG shall manufacture and supply all Bulk Product quantities ordered by Savient and
confirmed by BTG in accordance with the provisions of this Agreement. The Parties acknowledge and agree that, pursuant to the OCS Requirements and subject to the terms of this Agreement, Savient is obligated to order at least 80% of its annual
world-wide Bulk Product requirements from BTG (“OCS Annual Requirements”) and BTG is obligated to provide such OCS Annual Requirements. BTG shall bear all risk of loss associated with production and batch failures or loss of Bulk Product
until delivery to Savient, in accordance with the provisions of Section 7.01. 
 6.02    Process Changes. 

(i)    Prior Approval of Savient Required. Except as set forth in this Section 6.02, BTG shall
not make any change to the Process for the Bulk Product that would have an impact on the Bulk Product or Product, result in a change to the Commercial Bulk Product Specifications or the Product Specifications or require submissions to or approvals
from any Regulatory Agency, except by prior written approval of Savient for such change, which approval shall not be unreasonably conditioned, withheld or delayed. 

(ii)    Changes Based on Applicable Legal Requirements. BTG shall make such changes to the
Process for the Bulk Product as may be required pursuant to applicable Legal Requirements; provided that BTG shall have notified Savient in advance of any required change and shall have obtained the prior written approval of Savient for such change,
which approval shall not be unreasonably conditioned, withheld or delayed. Costs incurred by BTG in connection with changes to the Process for the Bulk Product that are required pursuant to Legal Requirements applicable solely to the Process for the
Bulk Product, including but not limited to the purchase of equipment, shall be paid by Savient in advance, or on such other basis as the parties may agree at such time, of the incurrence of such charges at (x) one hundred fifteen percent (115%)
of cost excluding labor and equipment; (y) labor costs, if applicable, as per Exhibit B; (z) equipment at one hundred eight percent (108%) of cost; provided, however, that Savient shall have explicitly approved in writing any
contemplated changes pursuant to this Section 6.02(ii) prior to BTG implementing any such changes. To the extent that the cost of any purchase of equipment is fully allocated to Savient, title to such equipment shall vest in Savient and Savient
shall have the right, but not the obligation, to remove such equipment at its sole cost and expense upon the expiration or termination of this Agreement. 

(iii)    Changes Made at the Request of Savient. From time to time, Savient may request that BTG
make certain changes (other than those required by Legal Requirements) to the Processing of the Bulk Product; provided, however, that (A) Savient shall seek to minimize such changes, (B) Savient shall enter into good faith negotiations
with BTG regarding the implementation of any such change to the Processing of the Bulk Product, with BTG’s consent to such change not being unreasonably withheld, conditioned, delayed or denied and (C) after the Parties have agreed upon
the implications and costs related to a change to the Processing 

  
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of the Bulk Product, BTG shall implement such change. Costs incurred by BTG in connection with such changes shall be reimbursed by Savient at (x) one hundred fifteen percent (115%) of cost
excluding labor and equipment; (y) labor costs, if applicable, as per Exhibit B; (z) equipment at one hundred eight percent (108%) of cost. To the extent that the contemplated changes requested by Savient necessitate the purchase of
equipment and the cost of such purchase of equipment is fully allocated to Savient, title to such equipment shall vest in Savient and Savient shall have the right, but not the obligation, to remove such equipment at its sole cost and expense upon
the expiration or termination of this Agreement. 
 (iv)      Improvements by BTG. If
BTG identifies a potential improvement that would (A) require changes to the Process, (B) have an impact on the Product or Bulk Product or (C) require submissions to or approvals from any Regulatory Agency, then BTG shall notify
Savient of such improvement and the Parties shall, in good faith, discuss implementation of such improvement. Such improvement shall not be made unless the Parties reach agreement including, without limitation, agreement on allocation of cost, which
agreement shall be at the sole discretion of the Parties. To the extent that the contemplated changes necessitate the purchase of equipment and the cost of such purchase of equipment is fully allocated to Savient, title to such equipment shall vest
in Savient and Savient shall have the right, but not the obligation, to remove such equipment at its sole cost and expense upon the expiration or termination of this Agreement. 

(v)      Price Adjustment. In the event of any changes to the Process, pursuant to this
Section 6.02, the Parties will meet and discuss the impact such Process changes have on the cost of Processing Bulk Product, either negative or positive, and will negotiate the resulting adjustment to the Price, as defined in Section 8.01,
such adjustment to appropriately reflect the investment made by each Party in such Process changes relative to the manner in which such changes impact the cost of Processing the Bulk Product. To effectuate this Section 6.02(v), both parties shall
exchange appropriately detailed documentation and analysis required to adequately assess the negative or positive impact such Process changes have on the cost of Processing Bulk Product. 

6.03    Facility Changes. 

(i)       Facility Changes by BTG. From time to time, BTG may desire to make certain
changes or modifications to its Facility (other than those required by Legal Requirements) (“Facility Changes”) which Facility Changes impact, directly or indirectly, the Processing of the Bulk Product. BTG shall be entitled to make
Facility Changes which impact, directly or indirectly, the Processing of the Bulk Product without the prior approval of Savient, provided, however: 

(A)    prior to the approval of the BLA for Savient’s Product, BTG shall (x) use its best
efforts to minimize Facility Changes which impact, directly or indirectly, the Processing of the Bulk Product, and (y) not implement any Facility Changes that will inhibit BTG’s ability to meet its obligations to supply Savient’s
requirements under this Agreement or require the approval of a Supplement to the BLA for Savient’s Product, unless such change is unavoidable; 

  
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 (B)      after the approval of the BLA for
Savient’s Product, BTG shall not implement any Facility Changes that will inhibit BTG’s ability to meet its obligations to supply Savient’s requirement under this Agreement unless and until the Parties have agreed to a plan for
inventory stockpiling to satisfy Savient’s requirements, and; 
 (C)      BTG shall
promptly provide Savient notice of its Facility Changes which may impact, directly or indirectly, the Processing of the Bulk Product prior to the anticipated commencement of such Facility Changes and shall enter into good faith negotiations with
Savient regarding the implementation of any such Facility Change and the satisfaction of Savient’s requirements for the stockpiling of safety stocks on Bulk Product in order that Savient can meet the clinical and market demands of its Product.

 Under no circumstances shall BTG implement a Facility Change which may endanger the quality of the Bulk Product. Costs incurred by BTG in connection
with such Facility Changes shall be borne by BTG. As used in this Section 6.03(i), “promptly” shall mean, given the nature and substance of the Facility Change, that period of time commercially reasonably necessary to complete the
discussions and negotiations envisaged herein. 
 (ii)       Facility Changes Based on
Applicable Legal Requirements. BTG shall make such changes to the Facility as may be required pursuant to applicable Legal Requirements; provided that BTG shall promptly notify Savient in advance of such planned Facility Change;
provided, however, that such notice from BTG shall be provided not later than ten (10) Business Days following BTG’s being notified of the necessity of changes to the Facility pursuant to Legal Requirements. Costs incurred by BTG in
connection with such changes shall be reimbursed by Savient as follows: 
 (A)      Changes
Specific to Savient’s Bulk Product. To the extent that changes to the Facility, including but not limited to the purchase of equipment, are required pursuant to Legal Requirements applicable solely to the Bulk Product, costs incurred for
such changes shall be paid by Savient in advance of the incurrence of such charges, or on such other basis as the parties may agree at such time, at (x) one hundred fifteen percent (115%) of cost excluding labor and equipment; (y) labor
costs, if applicable, as per Exhibit B, and; (z) equipment at one hundred eight percent (108%) of cost; provided, however, that the Parties shall have agreed to a plan for the satisfaction of Savient’s requirements for safety stock
of the Bulk Product to meet the clinical and market demands of its Product. To the extent that the cost of any purchase of equipment is fully allocated to Savient, title to such equipment shall vest in Savient and Savient shall have the right, but
not the obligation, to remove such equipment at its sole cost and expense upon the expiration or termination of this Agreement. 

(B)      Changes Not Specific to Savient’s Bulk Product. To the extent that changes
to the Facility are required pursuant to Legal Requirements applicable to biopharmaceutical manufacturing in general, costs incurred for such changes shall be reimbursed by Savient on a Pro Rata Basis, at cost. 

(C)      Changes in Connection With Another Product. If changes to the Facility are
required pursuant to Legal Requirements applicable solely to other activities or the 

  
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manufacture of other products in the Facility (even if such changes would not be required in the absence of the Processing of the Bulk Product at the Facility or if the Processing of the Bulk
Product benefits from such changes) the costs incurred for such changes shall not be reimbursed by Savient. 
 Provided, however, that in the
event of changes to the Facility required pursuant to applicable Legal Requirements, the Parties shall enter into good faith negotiations regarding the implementation of any such Facility Change in a manner intended to minimize the interruption
of the supply of Bulk Product and, in any event, shall agree on a method for the satisfaction of Savient’s requirements for the stockpiling of safety stocks of Bulk Product in order that Savient can meet the clinical and market demands of
its Product. 
 (iii)        Changes Made at the Request of Savient. From
time to time, Savient may request that BTG make certain changes to the Purification Area (other than those required by Legal Requirements); provided, however, that 

(A)      Savient shall seek to minimize such changes, 

(B)      Savient shall enter into good faith negotiations with BTG regarding the implementation
of any such change, with BTG’s consent to such change not being unreasonably withheld, conditioned, delayed or denied and 

(C)      after the Parties have agreed upon the implications and costs related to the Savient
requested changes, BTG shall implement such changes. 
 Costs incurred by BTG in connection with such changes to the Facility shall be reimbursed by Savient
at (x) one hundred fifteen percent (115%) of cost excluding labor and equipment; (y) labor costs, if applicable, as per Exhibit B, and; (z) equipment at one hundred eight percent (108%) of cost. To the extent that the
contemplated changes requested by Savient necessitate the purchase of equipment and the cost of such purchase of equipment is fully allocated to Savient, title to such equipment shall vest in Savient and Savient shall have the right, but not
the obligation, to remove such equipment at its sole cost and expense upon the expiration or termination of this Agreement. 

(iv)        Price Adjustment. In the event of any changes to the Facility,
pursuant to this Section 6.03, the Parties will meet and discuss the impact such Facility changes have on the cost of Processing Bulk Product, either negative or positive, and will negotiate the resulting adjustment to the Price, as defined in
Section 8.01, such adjustment to appropriately reflect the investment made by each Party in such Facility changes relative to the manner in which such changes impact the cost of Processing the Bulk Product. To effectuate this Section 6.03(iv),
both parties shall exchange appropriately detailed documentation and analysis required to adequately assess the negative or positive impact such Facility changes have on the cost of Processing Bulk Product. 

(v)        Alternate Use of Purification Area. BTG shall have the right, but
not the obligation, to utilize the Purification Area for the production, handling or storage of other 

  
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products during periods when the Purification Area is not being utilized for the Processing of Bulk Product pursuant to the terms and conditions of Section 5.7 in the Quality Agreement. 

6.04    Quality Assurance. 

(i)        Testing by BTG. BTG shall perform quality testing using assays
proposed by BTG and acceptable to Savient (which acceptance shall not be unreasonably conditioned, withheld or delayed) in order to assure that the Bulk Product complies with the Commercial Bulk Product Specifications, and shall retain samples of
Bulk Product produced and records of the tests made on each such batch in accordance with applicable Legal Requirements. In addition, except as otherwise agreed by the Parties in writing, no Bulk Product shall be delivered until such Bulk Product
has been processed in accordance with the tests, inspections and controls required under the Commercial Bulk Product Specifications and such other tests as the Parties may mutually agree upon in writing; provided, however, that the
foregoing shall not relieve BTG of its obligation under ARTICLE 5. BTG shall maintain records with respect to the quality testing and shall deliver such records to Savient by facsimile or email and overnight courier prior to shipment of the Bulk
Product. Savient shall pay for any and all costs and expenses related to the delivery of records to Savient by overnight courier. Such records shall also be made available to Savient during normal Israeli business hours, upon prior written request.

 (ii)       Notice of Non-Conforming Bulk
Product. BTG shall promptly notify Savient of any Non-Conforming Bulk Product of which it becomes aware, whether or not such Non-Conforming Bulk Product been
delivered to Savient or its designee, specifying the Bulk Product release testing and batch number. 

(iii)      Testing by Savient. At Savient’s election, Bulk Product may be subjected
to testing by Savient at Savient’s facilities or facilities of a Third Party designated by Savient in order to verify conformance with the Commercial Bulk Product Specifications, using assays proposed by BTG and acceptable to Savient (which
acceptance shall not be unreasonably conditioned, withheld or delayed). Savient shall maintain records with respect to the scope and nature of any such testing and shall disclose such records to BTG in a timely fashion. 

(iv)      Notice of Delivery of Non-Conforming Bulk
Product. Savient shall notify BTG in writing of any Non-Conforming Bulk Product within 

(A)      forty-five (45) days of delivery of such
Non-Conforming Bulk Product in the event of a defect which was discovered or could have been discovered by Savient through the use of reasonable testing methods and procedures mutually agreed to by the Parties
in writing or 
 (B)      ten (10) Business Days of Savient’s discovery of the Non-Conforming status of the Bulk Product in the event of a defect not recognizable for Savient through the use of such testing methods and procedures (hereinafter “Hidden Defect”). 

Savient’s notices of any non-conforming Bulk Product shall specify the manner in which the Bulk Product fails to
meet the Commercial Bulk Product Specifications,. BTG shall have the 

  
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right to examine and test any Bulk Product in Savient’s possession that Savient claims is Non-Conforming. The Parties shall cooperate to determine the
point at which the Bulk Product became Non-Conforming. In the event that the Parties cannot agree as to whether any Bulk Product was Non-Conforming at the time of
delivery, the Parties shall promptly appoint an independent specialist (appointed by mutual agreement between the Parties, which agreement shall not be unreasonably withheld, conditioned or delayed) who shall determine whether such Bulk Product was Non-Conforming at the time of delivery. In the absence of manifest error, the independent specialist’s decision shall be conclusive and binding on the Parties. 

Except as otherwise provided herein relating to Hidden Defects in the Bulk Product, if Savient fails to notify BTG in writing of any non-conforming Bulk Product within forty-five (45) days of delivery, then the Bulk Product delivered by BTG to Savient shall be deemed to be in all respects in accordance with this Agreement and Savient
shall be bound to accept and pay for the same accordingly. For the avoidance of doubt, this shall apply irrespective of whether or not Savient has carried out quality testing in accordance with Section 6.04 (iii). 

(v)    Observation by Savient. During the Term, Savient (including Savient’s agents
and consultants) shall have the right, at Savient’s sole cost and expense, during normal business hours and upon reasonable notice, to visit the Facility as per the Quality Agreement. 

(vi)    Recalls and Voluntary Withdrawals. If either Party becomes aware of information about
distributed Product containing Bulk Product indicating that it may be Non-Conforming with respect to the Bulk Product or that there is potential adulteration, misbranding and/or any potential issues regarding
safety or effectiveness with respect to the Bulk Product, it shall promptly serve Notice to that effect on the other Party. Savient will initiate an investigation and assessment of such circumstances and shall promptly notify BTG of its findings and
any proposed course of action. The Parties shall meet to discuss such circumstances and to consider appropriate courses of action. Savient shall bear all costs associated with a recall of the Product unless such recall is caused by a Hidden Defect
with respect to the Bulk Product, in which case BTG shall pay all costs associated with the recall, up to the maximum value of the Product Price paid by Savient to BTG for the Bulk Product containing such Hidden Defect. 

(vii)    Filled Product Release Testing. The Parties acknowledge that BTG is performing the Filled
Product release testing for Savient under the terms of this Agreement and the Development Agreement until such time as the Filled Product release testing and methods can be transferred to Savient’s new third party fill/finisher of Product
(hereinafter “Third Party Fill/Finisher”) or alternate Bulk Product or Product supplier. Savient will use its best efforts to effectuate the Technology Transfer of Product Technology to enable such Filled Product release testing to be
performed by Savient’s Third Party Fill/Finisher or its alternate Product supplier as expeditiously as commercially practicable, and upon the approval of such amendments to this Agreement, and, if still in effect at such time, the Development
Agreement shall be entered into relieving BTG of its obligation to perform release testing on Filled Product. It is the express intention of the Parties to mutually use best efforts to accomplish this Technology Transfer in adequate time to file the
Product BLA with both BTG and Savient’s Third Party Fill/Finisher as alternate parties designated to perform the release testing of Filled Product, provided, however, the failure to succeed in this regard shall not be deemed


  
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a breach by Savient, nor shall it relieve BTG of its obligations to perform such release testing until such time as Savient’s Third Party Fill/Finisher is approved to perform such release
testing. 
 6.05    Labeling and Packaging. BTG shall label and package the Bulk Product in accordance with Legal Requirements
applicable to pharmaceutical products shipped in bulk for further processing, labeling, or repackaging. 
 6.06    Stability.
Stability related activities for which BTG is responsible shall be completed in accordance with Quality Agreement. All costs incurred by BTG related to such activities shall be reimbursed by Savient in the manner and at the rates set forth on
Exhibit B hereto. 
 ARTICLE 7 

DELIVERY; INVOICES; WARRANTY 

7.01    Shipment and Delivery. BTG shall use its best efforts to deliver Bulk Product in accordance with the delivery dates
specified in its order confirmations or the Purchase Orders, as may be appropriate. All shipments shall be made by BTG pursuant to Savient’s instructions FCA Ben Gurion Airport, Tel Aviv, Israel, (Incoterms 2000) with BTG being responsible for
delivering the Bulk Product cleared for export to the freight forwarder nominated by Savient. 
 7.02    Certificate of Analysis.
An appropriate Certificate of Analysis and all relevant batch records shall precede the shipment of each Bulk Product batch delivered to Savient. BTG shall, for customs purposes, upon delivery of the Bulk Product, provide Savient with a valid
declaration of origin, in a form reasonably acceptable to Savient, in respect of all Bulk Product supplied to Savient under this Agreement, together with such other supporting documents relating to the origin of such Bulk Product as Savient may
reasonably require. If any of the foregoing documents are only available in a language other than English, the Parties shall agree upon an English language template for such document(s), and BTG shall provide to Savient an English language
translation of any deviations from the template(s); provided, however, that any documentation required by any Regulatory Authority to be supplied for the purpose of importing, exporting, selling, storing, transferring, or otherwise disposing of Bulk
Product, shall be provided in the English language. 
 7.03    Method of Invoicing. All orders under this Agreement shall be
invoiced at the price which is in effect at the time of shipment. 
 7.04    Warranty. BTG hereby represents and warrants to
Savient that (i) the quality (purity, physical and chemical properties) of the Bulk Product supplied by it to Savient shall be in accordance with its Specifications, shall not be adulterated or misbranded within the meaning of the applicable US
food and/or drug law or regulation, and shall comply with all Legal Requirements (including cGMP) and those applicable laws, rules and regulations governing the formulation, manufacture, testing prior to delivery, packaging, labeling according to
the Specifications for the Bulk Product and storage and delivery of the Bulk Product and (ii) the Processing of the Bulk Product at the Facility shall be in compliance with the CMC section of 

  
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the BLA, as reviewed and attested to as accurate by BTG. This warranty is exclusive and is in lieu of all other warranties, whether written or oral, express, implied or statutory. 

ARTICLE 8 
 PRICE

 8.01    Price. The Parties agree that the Bulk Product shall be charged to Savient at the price set out in Exhibit
E attached hereto (the “Price”). 
 8.02    Remittance of Payments. Payments due by Savient under Section 8.01
shall be payable by Savient no later than forty-five (45) days after the invoice date; provided, however, that Bulk Product associated with such payment was actually delivered in accordance with Section 7.01. Savient shall
make payment by wire transfer of Dollars from a single source in the United States to a bank account designated by BTG or by such other payment method as the Parties may agree upon from time to time. Except where any amounts payable are in dispute
under this Agreement and to the extent such dispute is resolved in favor of Savient, in the event of late payment, interest on any past due payments shall accrue at the rate of 1.5 percent per month, or if such rate shall exceed the maximum
rate allowed by law, then at such maximum rate, and shall be payable on demand. 
 ARTICLE 9 

REPORTING OF EVENTS 

9.01    Exchange of Drug Safety Information. The Parties shall have the rights and responsibilities pertaining to AEs, SAEs and
biologic product deviations in accordance with the provisions of the Quality Agreement attached hereto as Exhibit D. 

9.02    Events Affecting Integrity or Reputation. During the Term, the Parties shall notify each other immediately of any
circumstances of which they are or become aware of whereby the integrity and reputation of the Product or of the Parties are threatened by the unlawful activity of any Third Party in relation to the Product. In any such circumstances, the Parties
shall cooperate to limit any damage to the Parties and/or to the Product. 
 9.03    Governmental Inspection. Each Party shall
advise the other of any governmental communication, inspection or report which addresses or affects the Bulk Product promptly after becoming aware of it. Savient shall have the right to observe any such governmental inspection; provided,
however that such governmental inspection is specifically related to the Bulk Product. 

  
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 ARTICLE 10 

NON-COMPETITION AND NON-SOLICITATION 

10.01    Non-Competition. During the Term of this Agreement, and for a period of thirty
(30) months after the termination thereof, BTG agrees not to, and shall cause its Affiliates not to, use the Product Technology to manufacture, promote, market or sell any Competing Product in the Territory, nor will BTG acquire directly or
indirectly any rights or interest in or to a Competing Product which is being manufactured, promoted, marketed or sold in the Territory. The Parties agree that an acquisition by BTG’s Affiliates of any rights or interest in or to a Competing
Product which is being manufactured, promoted, marketed or sold in the Territory shall not be deemed to be an indirect acquisition by BTG, provided BTG has not participated in the acquisition process of its Affiliate. 

10.02    Non-Solicitation. During the Term and for a period of thirty (30) months
after the termination of this Agreement, the Parties agree that neither Party shall solicit any employee of the other Party or any of its Affiliates, with whom it has come in contact or interacted for the purposes of the performance of this
Agreement, to leave the employment of the other Party or its Affiliate and accept employment or work as a consultant with the first Party, except in the event the other Party has approved such solicitation in writing. Notwithstanding the foregoing,
nothing herein shall restrict or preclude either Party’s right to make generalized searches for employees by the issue of advertisement in the media (including trade media) or by engaging search firms to engage in searches that are not targeted
or focused on an employee or employees of the other Party. 
 ARTICLE 11 

TERM & TERMINATION 

11.01    Term. This Agreement shall be in effect from the Effective Date and shall continue in effect until terminated pursuant to
a Notice served by either Party in accordance with Section (the “Term”). 
 11.02    Termination. This Agreement may be
terminated in accordance with the following sections: 
 (i)    Elective. Either Party may
terminate this Agreement by giving at least three (3) years’ advance Notice (“Elective Termination Notice”) to the other Party, which Elective Termination Notice may not be given prior to the seventh (7th) anniversary of the
first delivery of Bulk Product by BTG under this Agreement but may be given at any time thereafter. Upon the third (3rd) anniversary of the Elective Termination Notice, this Agreement shall terminate, unless extended by mutual agreement of the
Parties. 
 (ii)    Force Majeure. In the event a Party (“Affected Party”) continues to
experience a Force Majeure condition for a period of at least six (6) months after Notice of the Force Majeure was given pursuant to Section 14.04, the other Party shall be entitled to terminate this Agreement by giving a Notice of
termination to Affected Party at any time while such Force 

  
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Majeure persists thereafter with the termination becoming effective on the date specified in the Notice of termination. 

(iii)    Material Breach by BTG. Savient shall be entitled to terminate this Agreement, in the
event that BTG commits a material breach of this Agreement (including, without limitation, in the event of a Supply Failure pursuant to Section 5.08 that is not due to an event of Force Majeure or a failure on the part of Savient to supply
critical raw materials which it is obligated to supply pursuant to the terms of this Agreement) and BTG fails to cure such breach within sixty (60) days of receiving a Notice of default from Savient (or such longer period as Savient may
reasonably agree if said breach is incapable of cure within such sixty (60) days) (“BTG’s Cure Period”), by giving a Notice of Termination to BTG (after expiration of BTG’s Cure Period, if applicable), with the termination
to take effect on the date specified therein, provided, however, that if BTG experiences a second Supply Failure within any twelve (12) month period then BTG’s Cure Period shall be zero (0) days unless otherwise specified in
the Notice of Termination provided by Savient in its sole discretion. 
 (iv)    Material Breach by
Savient. BTG shall be entitled to terminate this Agreement, in the event that Savient commits a material breach of this Agreement and Savient fails to cure such breach within sixty (60) days of receiving a Notice of default from BTG (or
such longer period as BTG may reasonably agree if said breach is incapable of cure within such sixty (60) days) (“Savient’s Cure Period”), by giving a Notice of termination to Savient (after expiration of the Savient Cure Period,
if applicable), with the termination to take effect on the date specified therein. For purposes of this Section only, any amount of the Processing Capacity Reservation Fee and accrued interest thereon which has not been applied to payments for Bulk
Product actually purchased by and delivered to Savient shall be forfeited by Savient to BTG as of the effective date of termination of this Agreement. 

(v)    Insolvency. Either Party shall be entitled to terminate this Agreement, by giving Notice to
the other Party (“Insolvent Party”), in the event of an Insolvency Event occurring in relation to the Insolvent Party, such termination to take effect upon delivery of the Notice of termination to the Insolvent Party. “Insolvency
Event” for the purpose of this Clause shall mean any commencement – whether voluntarily or involuntarily – of any action seeking any relief by liquidation, reorganization (other than for corporate reorganization), dissolution or
similar act under any bankruptcy, insolvency or similar law or otherwise any action seeking any arrangement between or with its creditors or any commencement of a proceeding or receipt of an order, judgment or decree seeking the liquidation,
reorganization or dissolution of a Party or any other relief under any bankruptcy, insolvency or similar law or an arrangement is made with respect to such Party’s debts or business by its creditors with or without the consent of that Party.

 11.03    Savient’s Rights Upon Termination. In the event Savient terminates this Agreement pursuant to Sections 11.02 (i)
(Elective), 11.02 (ii) (for Force Majeure conditions affecting BTG), 11.02 (iii) (Material Breach by BTG), or 11.02 (v) (for insolvency of BTG) or in the event BTG terminates this Agreement pursuant to Section 11.02 (i), BTG shall promptly,
upon request by Savient, convey to Savient all Know-How, BTG Licensed Improvements and other information related to the Processing of the Product and/or Bulk Product sufficient to enable Savient or any other
Persons engaged by Savient to manufacture, produce or provide the Product 

  
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and/or Bulk Product and BTG shall provide all other assistance that Savient may reasonably request, at no cost to Savient. Such Know-How, BTG Licensed
Improvements and other information shall include, without limitation, all records and reports related to (i) the development of the Bulk Product, Product and/or Process, (ii) the Processing of the Bulk Product and Product,
(iii) testing for compliance with the Specifications, and (iv) batch records. Unless this Agreement is terminated pursuant to Section 11.02 (iii), Savient shall be responsible for the reasonable labor costs and expenses incurred by
BTG in conveying such Know-How, BTG Licensed Improvements and other information and providing such assistance. Such labor costs of BTG employees and/or Third Party expenses shall be reimbursed by Savient in
the manner and at the rates set forth on Exhibit B hereto. 
 11.04    BTG’s Rights Upon Termination. In the event
that BTG terminates this Agreement pursuant to Sections 11.02(i) (Elective), 11.02(ii) (for Force Majeure conditions affecting Savient), 11.02(iv) (Material Breach by Savient) or 11.02(v) (for insolvency of Savient), any and all outstanding non-disputed payments due from Savient pursuant to this Agreement shall become immediately due and payable. Anything to the contrary notwithstanding, upon termination by BTG, BTG shall promptly, upon request by
Savient and at Savient’s cost, convey to Savient, all Know-How, BTG Licensed Improvements and other information related to the Processing of the Bulk Product and/or Product sufficient to enable Savient or
any other Persons engaged by Savient to manufacture, product or provide the Bulk Product and/or Product and BTG shall provide all other assistance that Savient may reasonably request, at Savient’s sole cost. 

11.05    Effect of Termination. Termination of this Agreement for any reason is without prejudice to the Parties’ accrued
rights and shall not be construed to release either Party of any obligation matured prior to the effective date of such termination. 

11.06    Survival. The following provisions shall survive the expiration or termination of this Agreement: 2.01(iii), 2.01(iv),
2.04, 3.02, 3.03, 4.01 (ii), 5.11, 6.04 (i), 6.04(ii), 6.04 (iv), 6.04 (vi), 6.04 (vii), 6.06, ARTICLE 7, ARTICLE 8, ARTICLE 9, Section 10.01 (except in the event of a termination by BTG pursuant to Section 11.02 (iv) (Material Breach by
Savient)), 10.02, 11.03, 11.04, 11.05, 11.06, ARTICLE 12, ARTICLE 13, ARTICLE 14. The survival of Sections 3.02, 3.03, 6.04 (vii) and 6.06 shall be subject to BTG being compensated for any actions on their part under these provisions post expiration
or termination on the basis of the principles set forth in this Agreement. The Parties expressly understand and agree that Section 2.01 (ii) shall not survive the expiration or termination of this Agreement. For the avoidance of doubt, even
after the termination of this Commercial Agreement pursuant to either Section 11.02 (iii) or Section 11.02 (iv), each Party’s rights under the Residual Rights Agreement shall subsist in full and irrespective of the grounds for such
termination, except Savient may not compel BTG to perform any additional manufacturing services as may be required by the Residual Rights Agreement. 

  
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 ARTICLE 12 

REMEDIES 

12.01    Remedies for Non-Conforming Bulk Product. In the event BTG delivers to Savient
Bulk Product that does not meet the Commercial Bulk Product Specifications, Savient shall, at its option, be entitled to (A) the replacement of such Non-Conforming Bulk Product with corresponding Bulk
Product meeting the Bulk Product Specifications and with the cost of the PEG material supplied by Savient and the cost of shipment for such replacement Bulk Product being borne by BTG; or (B) a refund of (x) any price paid by Savient for
such Non-Conforming Bulk Product, (y) the cost of the PEG material supplied by Savient for such Non-Conforming Bulk Product, and (z) the shipment costs
associated with such Non-Conforming Bulk Product, provided, however, that Savient has notified BTG in writing of the non-conforming Bulk Product in accordance
with Section 6.04 (iv). In addition, Savient shall, at BTG’s option and cost, either destroy or return to BTG at its Facility any Non-Conforming Bulk Product. 

12.02    Indemnity by BTG. 

(i)       BTG shall defend, indemnify and hold harmless each Savient Indemnitee from and
against (i) all Claims of Third Parties that arise as a result of a material breach of any covenant, agreement, warranty or representation made by BTG under this Agreement, and (ii) all Product Liability Claims, or such portion of Product
Liability Claims, as are allocated to BTG pursuant to Section 12.04. 

(ii)       BTG shall not be obligated under this Section 12.02 to the extent it is
shown that the Claim was the direct result of a material breach of any covenant, warranty or representation made by Savient under this Agreement. 

(iii)      BTG shall have no obligation under this Section 12.02 unless 

(A)      Savient gives BTG prompt written notice of any Claim for which it seeks to be
indemnified under this Agreement, 
 (B)      BTG is granted full authority and control over
the defense against such Claim, and 
 (C)      Savient cooperates fully with BTG in defense
of the Claim (all reasonable out-of-pocket expenses of such cooperation to be borne by BTG). 

Savient shall have the right to participate in the defense of any such Claim utilizing attorneys of its choice, at its own expense; provided,
however, that BTG shall have full authority and control to handle any such Claim, including without limitation any settlement or other disposition thereof, for which Savient seeks indemnification under this Section 12.02; provided,
however, further that any settlement that includes an admission of fault, culpability or liability on the part of Savient shall not be concluded without Savient’s consent, which consent shall not be unreasonably conditioned, withheld,
delayed or denied. 

  
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 (iv)      BTG shall indemnify and hold Savient
harmless for any income tax or other taxes which Savient may be required by current or future Legal Requirements to pay on behalf of BTG with respect to any monies payable to BTG under this Agreement, including without limitation, any associated
penalties, fines and interest (hereinafter, a “Tax Claim”); provided, however, that if Savient becomes aware of any Legal Requirements according to which Savient is required to pay any taxes on behalf of BTG or to withhold any
amounts with respect to any such Tax Claim, then Savient shall act in strict compliance with such Legal Requirements and shall promptly serve written notice to that effect on BTG. Furthermore, upon learning of the existence of a Tax Claim, Savient
shall provide prompt written notice to BTG where such notice shall include copies of all materials received by Savient which pertain to the Tax Claim. Additionally, upon request by BTG, Savient shall provide reasonable assistance to BTG to enable
BTG to defend any such Tax Claim and/or support a claim for a refund or a foreign tax credit with respect to any such Tax Claim; provided that BTG shall reimburse Savient for any
out-of-pocket expenses which Savient incurs in rendering any assistance to BTG pursuant to this provision within thirty (30) days of receipt of a reasonably
specific demand for reimbursement with accompanying documentation demonstrating such amounts claimed. Savient shall obtain the approval of BTG for any individual
out-of-pocket expense in excess of Fifty Thousand Dollars ($50,000), such approval not to be unreasonably withheld, delayed or conditioned. BTG shall have the sole right
to handle any such Tax Claim utilizing attorneys of its choice, at its own expense; provided, however, that any settlement that includes an admission of fault, culpability, penalty fine or any other liability on the part of Savient
shall not be concluded without Savient’s consent, which consent shall not be unreasonably conditioned, withheld, delayed or denied. 

12.03    Indemnity by Savient. 

(i)       Savient shall defend, indemnify and hold harmless each BTG Indemnitee from and against all Claims
of Third Parties that arise as a result of (A) a material breach of any covenant, agreement, warranty or representation made by Savient under this Agreement, and (B) patent infringement involving the manufacture, use, importation, sale or
marketing of the Bulk Product or Product, and (C) all Product Liability Claims, or such portion of Product Liability Claims, as are allocated to Savient pursuant to Section 12.04. 

(ii)       Savient shall not be obligated under this Section 12.03 to the extent it is shown that the
Claim was the direct result of a material breach of any covenant, warranty or representation made by BTG under this Agreement. 

(iii)      Savient shall not be obligated under this Section 12.03 unless 

(A)      BTG provides Savient with prompt written Notice of any Claim for which it seeks to be indemnified
under this Agreement, 
 (B)      Savient is granted full authority and control over the defense against such
Claim, and 

  
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 (C)    BTG cooperates fully with Savient in defense of the Claim (all
reasonable out-of-pocket expenses of such cooperation to be borne by Savient). 

BTG shall have the right to participate in the defense of any such Claim utilizing attorneys of its choice, at its own expense; provided,
however, that Savient shall have full authority and control to handle any such Claim, including without limitation any settlement or other disposition thereof, for which BTG seeks indemnification under this Section12.03; provided, however,
further that any settlement that includes an admission of fault, culpability or liability on the part of BTG shall not be concluded without BTG’s consent, which consent shall not be unreasonably conditioned, withheld, delayed or denied.

 12.04    Product Liability Claims. Notwithstanding the foregoing Sections 12.02 and 12.03, the Parties’ responsibilities
with respect to Product Liability Claims shall be governed by this Section12.04. 

(i)       BTG shall be solely responsible for all Product Liability Claims that arise out
of Non-Conforming Bulk Product, provided, however, that the following conditions are cumulatively satisfied: (A) such nonconformance existed at the time the Bulk Product was delivered by BTG and
(B) such nonconformance was the result of BTG’s failure to manufacture the Bulk Product in strict adherence with the Process and (C) such Non-Conformance was the result of a Hidden Defect.
Savient shall be solely responsible for all Product Liability Claims that arise out of Non-Conforming Bulk Product in each of the following cases: (A) such
non-conformance occurred after the Bulk Product was delivered to Savient or (B) the Non-Conforming Bulk Product was manufactured by BTG in strict adherence with the
Process or (C) such Non-Conformance was not the result of a Hidden Defect. 

(ii)      Each Party shall give the other prompt written notice of any Product Liability Claim,
but the omission of such notice shall not relieve either Party from its obligations under this Section 12.04, except to the extent the other Party can establish actual prejudice and direct damages as a result thereof. With respect to each
Product Liability Claim, Savient shall have the first right to defend and settle such Product Liability Claim. In the event that Savient does not assume the defense of such Product Liability Claim within ninety (90) days following
Savient’s receipt of notice of the commencement or assertion of such Product Liability Claim, BTG may notify Savient of BTG’s desire to take the lead role in the defense of such Product Liability Claim. If, within ten (10) days after
BTG notifies Savient of such desire, Savient does not assume the defense of such Product Liability Claim, then BTG may take the lead role in the defense of such Product Liability Claim. 

The Party assuming the defense of any Product Liability Claim as permitted under this Section 12.04 (the “Controlling Party”) shall consult
with the other Party on all material aspects of the defense, including without limitation settlement, of such Product Liability Claim, and the Parties shall cooperate fully with each other in connection therewith. The
non-defending Party shall also have the right to participate in the defense of any Product Liability Claim utilizing attorneys of its choice, at its own expense. In furtherance of the Parties’
cooperation, the Controlling Party will consult with the other Party regarding strategic decisions, including without limitation the retention of counsel and defense of each Product Liability Claim. The Controlling Party will otherwise keep the
other Party fully informed of the status and progress of the defense and any 

  
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 settlement discussions concerning the Product Liability Claim. Any settlement of a Product Liability Claim
that would admit liability on the part of any Party or its Affiliates or Agents, or that would involve any relief other than the payment of money damages, shall be subject to the prior written approval of both Parties, such approval not to be
unreasonably withheld or delayed. All damages and expenses (including attorney’s fees) incurred in connection with the defense of a Product Liability Claim shall be allocated between the Parties in accordance with Section 12.04 (i). 

12.05    Limitation of Damages. Notwithstanding anything to the contrary set forth in this Agreement, in no event shall either
Party be liable to the other Party for, and each Party shall procure that none of its Affiliates or Sublicensees shall make any claim against the other Party (or its Affiliates and Sublicensees) for, any lost profits, loss of business, loss of
contracts, diminished goodwill, diminished reputation, or consequential, indirect, incidental or special damages arising under or in connection with this Agreement or the Bulk Product. 

ARTICLE 13 
 DISPUTE
RESOLUTION AND ARBITRATION 
 13.01    Governing Law. This Agreement and any and all matters arising directly or indirectly
herefrom shall be governed by and construed in accordance with the laws of the State of New York, United States of America, without giving effect to (A) its conflict of law principles and (B) the United Nations Convention on Contracts from
the International Sale of Goods. 
 13.02    Arbitration. Any dispute, controversy or claim arising out of or in relation to this
contract, including the validity, invalidity, breach or termination thereof, shall be resolved by arbitration in accordance with the Swiss Rules of International Arbitration of the Swiss Chambers of Commerce in force on the date when the Notice of
Arbitration is submitted in accordance with these Rules. The number of arbitrators shall be three; the seat of the arbitration shall be Zurich, Switzerland; the arbitral proceedings shall be conducted in English and shall take place in London,
England. 
 ARTICLE 14 

MISCELLANEOUS 

14.01    Confidentiality. During the Term of this Agreement or the Commercial Agreement, whichever expires later, and for a period
of three (3) years thereafter, each Party (the “Receiving Party”) shall keep strictly confidential any Confidential Information disclosed by any other Party (the “Disclosing Party”), using at least the same degree of care
that it uses to protect its own confidential or proprietary information, but in no event less than reasonable care. The provisions of this ARTICLE 14 shall apply to all Confidential Information, and to all proprietary information of the Disclosing
Party relating to the Product and/or the Process that is disclosed (or known) to a Receiving Party prior to the date hereof (which shall be deemed to be Confidential Information, subject to the exceptions in clauses (i) through (iv) below, for
purposes of this Agreement). The nature and terms of this Agreement shall be deemed to be Confidential 

  
 - 33 - 













 
Information of each Party, subject to the exceptions set forth in clauses (i) through (iv) below, for purposes of this Agreement. The Receiving Party shall use Confidential Information
solely for the purposes of this Agreement and the activities contemplated hereby and shall not disclose or disseminate any Confidential Information to any Person at any time, except for disclosure to those of its Affiliates, directors, officers,
employees, consultants, accountants, attorneys, advisers and agents that have a need to know such information to permit the Receiving Party to exercise its rights or fulfill its obligations pursuant to this Agreement, provided that such Persons are
bound to maintain the confidentiality of such Confidential Information to the same extent as if they were parties hereto. The obligations set forth in this Section 14.01 are subject to the following exceptions: 

(i)        The Receiving Party may disclose the Disclosing Party’s Confidential
Information that is required to be publicly disclosed by law or by regulation; provided, however, that: (A) the Receiving Party shall, where possible, seek confidential treatment for any Confidential Information of the Disclosing
Party, and shall provide the Disclosing Party with prompt advance notice of such disclosure and reasonable opportunity to review any such disclosure so that the Disclosing Party may, if it desires, seek a protective order or other appropriate
remedy; and (B) the Parties or their Affiliates may disclose the terms of this Agreement in any filings with the U.S. Securities and Exchange Commission (provided that the Parties or their Affiliates, as applicable, use commercially reasonable
efforts to seek confidential treatment for any trade secrets, commercial terms or information, or financial terms or information). 

(ii)       Pursuant to an agreement to maintain confidentiality, any Party may discuss, or
provide a copy of, this Agreement to its accountants, its attorneys, and its current, future or potential investors or shareholders. 

(iii)      Pursuant to an agreement containing confidentiality obligations and subject to the
other Parties’ written consent, either Party may provide a copy of this Agreement or relevant portions thereof to any Third Party sublicensee, if required pursuant to the relevant license agreement with such Third Party. 

(iv)      Any other disclosure of the nature or terms of this Agreement (including, without
limitation, any public announcements, press releases or similar publicity with respect to this Agreement) by any Party, must be approved in advance in writing by Savient, in its sole discretion, as to form and content of such disclosure;
provided, however, that the contents of any public announcement, press release or similar publicity which has been reviewed and approved can be re-released by any Party in any form without a
requirement for re-approval. 
 14.02    BTG Insurance. BTG and/or its Affiliates shall
obtain and maintain during the Term and for five (5) years thereafter comprehensive general liability insurance on a claims-made basis, with endorsements for product liability with annual coverage limits of not less than one million Dollars
($1,000,000) per claim and ten million Dollars ($10,000,000) annual aggregate. All of BTG’s insurance policies shall be issued by “A-rated” insurers as designated by Standard and Poor’s
Corporation and/or by acceptable other means. The minimum level of insurance set forth herein shall not be construed to create a limit on BTG’s liability hereunder. On the Effective Date and upon the request of Savient (provided that such
request shall be made no more than 

  
 - 34 - 













 
once per calendar year), BTG shall furnish to Savient a certificate of insurance evidencing such coverage as of such date. Each such certificate of insurance, as well as any certificates
evidencing new or modified coverages of BTG, shall include a provision whereby thirty (30) days written notice must be received by Savient prior to coverage modification or cancellation by either BTG or the insurer. In addition, BTG shall
promptly notify Savient of any cancellation or modification of such insurance coverage and of any new or modified coverage. In the case of a modification or cancellation of such coverage, BTG shall promptly provide Savient with a new certificate of
insurance evidencing that BTG’s coverage meets the requirements in the first sentence of this Section 14.02. 
 14.03  Savient
Insurance. Savient shall obtain and maintain during the Term and for five (5) years thereafter comprehensive general liability insurance on a claims-made basis, with endorsements for product liability with annual coverage limits of not less
than one million Dollars ($1,000,000) per claim and fifteen million Dollars ($15,000,000) annual aggregate. All of Savient’s insurance policies shall be issued by “A-rated” insurers as
designated by Standard and Poor’s Corporation and/or by acceptable other means. The minimum level of insurance set forth herein shall not be construed to create a limit on Savient’s liability hereunder. On the Effective Date and upon the
request of BTG (provided that such request shall be made no more than once per calendar year), Savient shall furnish to BTG a certificate of insurance evidencing such coverage as of such date. Each such certificate of insurance, as well as any
certificates evidencing new or modified coverages of Savient, shall include a provision whereby thirty (30) days written notice must be received by BTG prior to coverage modification or cancellation by either Savient or the insurer. In
addition, Savient shall promptly notify BTG of any cancellation or modification of such insurance coverage and of any new or modified coverage. In the case of a modification or cancellation of such coverage, Savient shall promptly provide BTG with a
new certificate of insurance evidencing that Savient’s coverage meets the requirements in the first sentence of this Section 14.03. 

14.04  Notices. All notices, requests, demands, claims and other communications hereunder (each, a “Notice”) shall be in writing.
Any notice, request, demand, claim or other communication hereunder shall be deemed duly delivered four (4) Business Days after it is sent by registered or certified mail, return receipt requested, postage prepaid, or one (1) Business Day
after it is sent by overnight delivery via a reputable national courier service, in each case to the intended recipient as set forth below: 
 If to
Savient, to: 
 Savient Pharmaceuticals Inc. 
 One Tower
Center, 14th Floor 
 East Brunswick, New Jersey 08816, USA 

Telecopy: +1-732-418-9065 

Attention: Philip K. Yachmetz, EVP & CBO 

  
 - 35 - 













 with copies, which shall not constitute notice hereunder, sent to: 

 

					
	Savient Pharmaceuticals, Inc.
One Tower Center, 14th Floor 
East Brunswick, NJ 08816 U.S.A. 
Attention: John Petrolino	 	and        	 	Wilmer Cutler Pickering Hale and Dorr LLP
60 State Street 
Boston, MA 02109 
Telecopy:
+1-617-526-5000 
Attention: David E. Redlick, Esq.

 If to BTG, to: 
 Bio-Technology General (Israel) Ltd. 
 Beer Tuvia Industrial Zone 

POB 571 
 Kiryat Malachi 83104, Israel 

Telecopy: +972-8-8612288 

Attention: General Manager 
 with copies, which shall not
constitute notice hereunder, sent to: 
  

					
	 Ferring International Center SA
  

Chemin de la Vergognausaz 50

CH-1162 Saint-Prex 
Switzerland 
Attention: General Counsel
	 	and        	 	 Ferring International Center SA
  

Chemin de la Vergognausaz 50 
CH-1162 Saint-Prex 
Switzerland 
Attention: EVP, Technical
Operations


 Any Party may give any notice, request, demand, claim, or other communication hereunder using any other means (including
personal delivery, expedited courier, messenger service, telecopy, telex, ordinary mail, or electronic mail), but no such notice, request, demand, claim or other communication shall be deemed to have been duly given unless and until it actually is
received by the Party for whom it is intended. Any Party may change the address to which notices, requests, demands, claims and other communications hereunder are not be delivered by giving the other Party notice in the manner herein set forth. 

14.05    Entire Agreement. This Agreement and all attachments, including the exhibits hereto, constitutes the entire agreement
between Savient and BTG with respect to the subject matter hereof, and supersedes any prior agreements or understandings, both written and oral, between Savient and BTG with respect to such matters, other than the Divestiture Agreements and the
Residual Rights Agreement, which shall be read together with this Agreement. 
 14.06    Order of Precedence. In the event of a
conflict or inconsistency that relates to the subject matter hereof between any of the terms of the following documents, the following order of precedence shall control: 

  
 - 36 - 













 (i)        this Commercial Supply
Agreement between the Parties, and Exhibits hereto 
 (ii)       the Development
Agreement between the Parties, and Exhibits thereto 
 (iii)      the Residual Rights
Agreement, and Exhibits thereto 
 Without limiting the generality of the foregoing, and for the avoidance of any doubt, the following sections of the
Residual Rights Agreement are hereby superseded by this Agreement as far as the subject matter hereof is concerned: (A) Section 3 - Research & Development; Regulatory Services; Manufacturing Services; (B) Section 4 - Technology
Transfer; (C) Section 9 - Indemnification; (D) Section 13 – Governing Law and Dispute Resolution; (E) Annex C (Development and Regulatory Work-Puricase); (F) Annex D (Term Sheet Manufacturing Services); and (G) Annex E
(Term Sheet for Technology Transfer). In resolving any such conflicts, these documents shall be read as a whole and in a manner most likely to accomplish their purposes. Any amendments to these documents on which the Parties may agree to in
accordance with the terms of each document shall take precedence over any conflicting terms in the prior release of each document. Each Party shall promptly report to the other in writing any inconsistencies in these documents, even if the
inconsistency is resolvable using the above order of precedence. 
 14.07    Covenant of Further Assurances. The Parties covenant
and agree that, subsequent to the execution and delivery of this Agreement and without any additional consideration, each of the Parties shall execute and deliver any further legal instruments and perform such acts which are or may become reasonably
necessary to effectuate the purposes of this Agreement. 
 14.08    Waivers; Amendments. The failure of either Party to insist,
in any one or more instances, upon the performance of any of the terms, covenants or conditions of this Agreement or to exercise any right hereunder, shall not be construed as a waiver or relinquishment of the future performance of any such term,
covenant or conditions or the future exercise of such right, and the obligation of the other Party with respect to such future performance shall continue in full force and effect. Savient and BTG may (A) mutually amend or waive any provision of
this Agreement at any time and (B), from time to time after the date hereof, modify and/or replace any of the exhibits hereto, which modified or replaced exhibits shall automatically constitute part of this Agreement; provided, however, that
no amendment or waiver of any provision of this Agreement and no modification and/or replacement of any exhibits hereto shall be valid unless the same shall be in writing and duly signed by both of the Parties. 

14.09    Relationship. BTG is an independent contractor engaged by Savient for the provision of the Bulk Product and certain
services as set forth in this Agreement. Nothing in this Agreement shall constitute BTG as an employee, agent or general representative of Savient. This Agreement shall not constitute either Party as the legal representative or agent of the other,
nor shall either Party have the right or authority to assume, create or incur any liability or any obligation of any kind, express or implied, against, or in the name of or on behalf of, the other Party. This Agreement shall not constitute, create
or in any way be interpreted as a joint venture, partnership or formal business organization of any kind. 

  
 - 37 - 













 14.10    Publicity. Except as otherwise required by Legal Requirements, neither
Party shall use the other’s name or refer to it directly or indirectly in an advertisement, news release or release to any professional or trade publication or issue any news release relating to this Agreement, without the prior written
approval from such Party for such use or release. The Parties agree that a news release with respect to the consummation of this transaction and the details thereof will be made, the content and form of which shall be reasonably agreed between the
Parties. In addition, the Parties agree that Savient shall be permitted to disclose this Agreement and the transactions contemplated hereby in filings made with the U.S. Securities and Exchange Commission or other regulatory authorities in
accordance with Section 14.01. 
 14.11    Severability. If any term of other provision of this Agreement is invalid,
illegal or incapable of being enforced by any rule of law or public policy, all other conditions and provisions of this Agreement shall nevertheless remain in full force and effect so long as the economic and legal substance of the underlying
transaction in any country in the Territory is not affected in any manner materially adverse to either Party. Upon such determination that (i) any term of other provision is invalid, illegal or incapable of being enforced and (ii) the
economic or legal substance of the underlying transaction in any country in the Territory is affected in a manner materially adverse to either Party, the Parties shall modify this Agreement, with respect to such country in the Territory, so as to
effect the original intent of the Parties as closely as possible in a mutually acceptable manner to the fullest extent permitted by Legal Requirements in such country in the Territory in order that the underlying transaction be completed as
originally contemplated to the fullest extent possible. 
 14.12    No Assignment. Neither this Agreement nor any of the rights,
interests, or obligations hereunder may be assigned by either Party without the prior written consent of the other Party hereto, except that Savient may assign its rights, interests, or obligations hereunder to any Third Party acquiring rights to
the Product and either Party may assign its rights hereunder to any Affiliates or any entity that acquires all or substantially all of such Party’s business or assets (provided that no such assignment shall relieve the assigning Party of its
obligations hereunder, and the assigning Party shall remain primarily liable for such obligations). Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted
assigns. 
 14.13    Headings. The headings used in this Agreement are included for convenience only and are not to be used in
construing or interpreting this Agreement. 
 14.14    Force Majeure. If either of the Parties is impeded in fulfilling its
undertakings in accordance with this Agreement by circumstances beyond its reasonable control, such as, but not limited to, labor conflict, lightening striking, acts of God, fire, war, mobilization or unforeseen military call-up of a large magnitude, requisition, confiscation, commandeering, public decrees, riots, insurrections, general shortage of transport, goods or energy and faults or delays in deliveries from subcontractor or
suppliers caused by any circumstances referred to in this Section 14.14, the impediment shall be considered a Force Majeure condition and the Party shall be exempted from liability for delays due to such reasons; provided,
however, that it notifies the other Party thereof without undue delay after such a circumstance has occurred. Upon such notification, the Parties shall agree upon a reasonable extension of the time for performance, not to exceed an extension
equal to the period the Force Majeure condition continues to exist. 

  
 - 38 - 













 14.15    Counterparts. This Agreement may be executed in any number of
counterparts, each of which will be deemed an original, but all of which together will constitute one and same instrument. 
 IN WITNESS
WHEREOF, the Parties hereto have caused this Agreement to be executed by their respective officers hereunto duly authorized as of the Effective Date. 
  

									
	SAVIENT PHARMACEUTICALS, INC.	 		 	BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
			
	By:    /s/ Philip K.
Yachmetz                              	 	    	 	By:    /s/ Dov
Kanner                                    
		 	        Name: Philip K. Yachmetz

       Title: EVP & CBO
	 		 		 	        Name: Dov Kanner

       Title: Managing Director



  
 - 39 - 













 Exhibit A 

Savient Patent Rights 













									
	Puricase Patents And Application Licensed To And Owned By Savient Pharmaceuticals, Inc.
	TITLE	 	COUNTRY	 	SERIAL NO	 	PATENT NO  	 	STATUS
	URATE OXIDASE	 	 WO
	 	 PCT/US99/17678
	 	 	 	
PUBLISHED

	URATE OXIDASE	 	 US
	 	09/762,097	 	7,056,713	 	
ISSUED

	URATE OXIDASE	 	 US
	 	11/357,028	 	 	 	
PENDING

	URATE OXIDASE	 	 AU
	 	53365/99	 	766421	 	
ISSUED

	URATE OXIDASE	 	 BR
	 	P19913360-1	 	 	 	
PUBLISHED

	URATE OXIDASE	 	 CA
	 	2,337,967	 	 	 	
PENDING

	URATE OXIDASE	 	 CN
	 	99811738.2	 	 	 	
PENDING

	URATE OXIDASE	 	 CZ
	 	 PV2001-466
	 	 	 	
PENDING

	URATE OXIDASE	 	 EP
	 	99938996.8	 	 	 	
PUBLISHED

	URATE OXIDASE	 	 HK
	 	01108032.2	 	 	 	
PENDING

	URATE OXIDASE	 	 HU
	 	P01032005	 	 	 	
PENDING

	URATE OXIDASE	 	 IL
	 	141221	 	 	 	
PENDING

	URATE OXIDASE	 	 IN
	 	
IN/PCT/2001/00165/CH
	 	 	 	
PENDING

	URATE OXIDASE	 	 JP
	 	2000-563819	 	 	 	
PENDING

	URATE OXIDASE	 	 KR
	 	7001618-2001	 	 	 	
PENDING

	URATE OXIDASE	 	 MX
	 	
PA/a/2001/00134
	 	 	 	
PENDING

	URATE OXIDASE	 	 NZ
	 	509633	 	509633	 	
ISSUED

	URATE OXIDASE	 	 PL
	 	P-346222	 	 	 	
PENDING

	URATE OXIDASE	 	 RU
	 	2001103131/13	 	 	 	
PENDING

	URATE OXIDASE	 	 SG
	 	200100782-2	 	78987	 	
ISSUED

	URATE OXIDASE	 	 ZA
	 	2001/0974	 	2001/0974	 	
ISSUED

	URATE OXIDASE	 	 US
	 	60/095,489	 	 	 	
EXPIRED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 US
	 	60/219,318	 	 	 	
EXPIRED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 WO
	 	 PCT/US99/17514
	 	 	 	
PUBLISHED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 US
	 	09/370,084	 	6,576,235	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 US
	 	09/839,946	 	 	 	
PENDING

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 DE
	 	99937745.0	 	69925917-7	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 DK
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 ES
	 	99937745.0	 	1100542	 	
ISSUED



  
 A-1 














									
	Puricase Patents And Application Licensed To And Owned By Savient Pharmaceuticals, Inc.
	TITLE	 	COUNTRY	 	SERIAL
NO	 	PATENT NO  	 	STATUS
	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 FI
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 FR
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 GB
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 GR
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 IE
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 IT
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 LU
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 MC
	 	9993 7745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 NL
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 PT
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 SE
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 EP
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 AT
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 BE
	 	99937745.0..	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 CH
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 AU
	 	52515/99	 	770014	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 BR
	 	PI 9912974-4	 	 	 	
PENDING

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 CA
	 	2,338,665	 	 	 	
PENDING

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 CN
	 	99811845.1	 	ZL99811845.1	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 CY
	 	99937745.0	 	1100542	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 CZ
	 	PV2001317	 	 	 	
PENDING

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 HK
	 	01108240.0	 	HK1037330	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 HU
	 	P0103003	 	 	 	
PENDING

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 IL
	 	141220	 	 	 	
PENDING

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 IN
	 	IN/PCT/01/00133	 	 	 	
PENDING

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 JP
	 	2000-563311	 	 	 	
PENDING

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 KR
	 	7001569/2001	 	0488848	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 KR
	 	7014428/2004	 	TBA	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 MX
	 	PA/a/2001/001272	 	232518	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 NZ
	 	509595	 	509595	 	
ISSUED



  
 A-2 














									
	Puricase Patents And Application Licensed To And Owned By Savient Pharmaceuticals, Inc.
	TITLE	 	COUNTRY	 	SERIAL NO	 	PATENT NO  	 	STATUS
	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 PL
	 	P346224	 	 	 	
PENDING

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 RU
	 	2001103144	 	 	 	
PENDING

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 RU
	 	2004104953/15	 	2278680	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 SG
	 	200100559-4	 	78843	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 TW
	 	88113406	 	194583	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 ZA
	 	2001/01814	 	2001/01814	 	
ISSUED

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 CN
	 	200610084131.8	 	 	 	
PENDING

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 EP
	 	05011069.1	 	 	 	
PENDING

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 HU
	 	0114194	 	 	 	
PENDING

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 IN
	 	1899/KOLMP/2006	 	 	 	
PENDING

	PEG-URATE OXIDASE CONJUGATES AND USE THEREOF	 	 RU
	 	2006107111	 	 	 	
PENDING

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 WO
	 	PCT/US01/40069	 	 	 	 NAT
PHASE

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 US
	 	09/501,730	 	6,783,965	 	
ISSUED

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 AU
	 	2001249975	 	 	 	
PENDING

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 BR
	 	PI0108386-4	 	 	 	
PENDING

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 CA
	 	2,398,679	 	 	 	
PENDING

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 CN
	 	081807750.1	 	 	 	
PUBLISHED

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 CZ
	 	2002-2982	 	 	 	
PENDING

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 EP
	 	01923265.1	 	 	 	
PENDING

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 HK
	 	03109064.9	 	 	 	
PUBLISHED

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 HU
	 	0204544	 	 	 	
PENDING

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF	 	 IL
	 	151065	 	 	 	
PENDING



  
 A-3 














									
	Puricase Patents And Application Licensed To And Owned By Savient Pharmaceuticals, Inc.
	TITLE	 	COUNTRY	 	SERIAL NO	 	PATENT NO  	 	STATUS
	NON-IMMUNOGENIC POLYMER CONJUGATES	 	 	 	 	 	 	 	 
	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 IN
	 	 IN/PCT/2002/00983
	 	 	 	
PENDING

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 JP
	 	2001-558218	 	 	 	
PENDING

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 KR
	 	7010189/2002	 	 	 	
PUBLISHED

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 MX
	 	 PA/a/2002/007545
	 	233192	 	
ISSUED

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 MX
	 	 PA/a/2005/01389
	 	 	 	
PENDING

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 NZ
	 	520434	 	520434	 	
ISSUED

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 PL
	 	P-358539	 	 	 	
PENDING

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 RU
	 	2002120486(021249)	 	 	 	
PENDING

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 SG
	 	200204601-9	 	90846	 	
ISSUED

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 TW
	 	90102540	 	 	 	
PENDING

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 ZA
	 	2002/7206	 	2002/7206	 	
ISSUED

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 RU
	 	2006107110	 	 	 	
PENDING

	AGGREGATE-FREE URATE OXIDASE FOR PREPARATION OF NON-IMMUNOGENIC
POLYMER CONJUGATES	 	 AU
	 	 TBA
	 	 	 	
PENDING

	AGGREGATE-FREE PROTEIN COMPOSITIONS AND METHODS OF PREPARING SAME	 	 US
	 	10/928,370	 	 	 	
PUBLISHED

	VARIANT FORMS OF URATE OXIDASE AND USE THEREOF	 	 WO
	 	 TBA
	 	 	 	
PENDING

	VARIANT FORMS OF URATE OXIDASE AND USE THEREOF	 	 TW
	 	 TBA
	 	 	 	
PENDING

	VARIANT FORMS OF URATE OXIDASE AND USE THEREOF	 	 US
	 	60/670,573	 	 	 	
EXPIRED



  
 A-4 














									
	Puricase Patents And Application Licensed To And Owned By Savient Pharmaceuticals, Inc.
	TITLE	 	COUNTRY	 	SERIAL NO	 	PATENT NO  	 	STATUS
	VARIANT FORM OF URATE OXIDASE AND USE THEREOF	 	 US
	 	 60/670,541
	 	 	 	
EXPIRED

	VARIANT FORM OF URATE OXIDASE AND USE THEREOF	 	 WO
	 	 TBA
	 	 	 	
PENDING

	VARIANT FORM OF URATE OXIDASE AND USE THEREOF	 	 TW
	 	 TBA
	 	 	 	
PENDING

	PURIFICATION OF PROTEINS WITH CATIONIC SURFACTANT	 	 US
	 	 60/670,520
	 	 	 	
EXPIRED

	PURIFICATION OF PROTEINS WITH CATIONIC SURFACTANT	 	 WO
	 	 PCT/US06/13751
	 	 	 	
PENDING

	PURIFICATION OF PROTEINS WITH CATIONIC SURFACTANT	 	 TW
	 	 TBA
	 	 	 	
PENDING



  
 A-5 













 Exhibit B 

Compensation for Services and Reimbursement of Expenses 

BTG shall submit invoices to Savient on a quarterly basis in arrears, which invoices shall provide an account of (i) detailed
descriptions of the services performed, (ii) the number of hours such services were performed, (iii) the levels of the individuals performing such services and (iv) detailed descriptions of any Third Party expenses incurred
(documentation of such expenses shall be provided to Savient upon request). 
 Payment to BTG shall be due within forty-five (45) days
of the date of the invoice (provided that the invoice is received by Savient within three (3) Business Days of the date thereof) or within forty-five (45) days of Savient’s receipt of the invoice (if received by Savient four
(4) or more Business Days after the date thereof). 
 Compensation Rates: 

 

			
	    Level

 
	 	 Daily Rate

(eight (8) hour day)    
  

	
Vice President or Senior Director
	 	$1,657      
	
Department Head or Director
	 	$1,098      
	 Unit
Head
	 	$757      
	 Exempt Non-Management Employee, Group Leader & others
	 	$577      

 Beginning on January 1, 2008, and on each successive
January 1st thereafter, the above rates shall increase by an amount equal to the average increase in the United States Consumer Pricing Index (CPI) over the immediately preceding twelve
(12) month period. 
 Third Party Expenses: 

Savient shall reimburse BTG for documented expenses paid to a Third Party; provided that, other than BTG’s travel expenses for travel at
the request of Savient, expenses for raw materials, expenses for subcontractors/consultants, BTG shall be required to obtain Savient’s pre-approval in writing for any expenses to be incurred in excess of
Twenty thousand Dollars ($20,000). 












 Exhibit C 

Current Provisional Bulk Product Specifications 












 SPECIFICATION PEG-URICASE API 

 

					
	 Parameter
	  	Test	  	Specification
	 	 	 
	 Appearance

 
	  	 Physical inspection

 
	  	 Clear colorless solution, free of visible
particles
  

	 	 	 
	 General

 
	  	 pH

 
	  	
7.0-7.8
  

	 	 	 
	 	  	 Osmolality

 
	  	 270-368
mOsm/kg
  

	 	 	 
	 Protein Content

 
	  	 SE-HPLC

 
	  	 7.2 — 8.8 mg/ml

 

	 	 	 
	
No. of PEG Strands        

per Subunit
  
	  	 SE-HPLC

 
	  	 9±1

 

	 	 	 
	 Potency

 
	  	 Enzymatic activity

 
	  	 5.0 — 9.5 Units/mg

 

	 	 	 
	Purity/Impurities	  	 Free PEG, SE-HPLC

 
	  	 £
1 mg/ml
  

	  	 Free Uricase; ELISA

 
	  	 To be
established
  

	  	 Xanthine; RP-HPLC
  
	  	 £ 10 ppm (£10 μg/ml)
  

	  	 PNP;
RP-HPLC
  
	  	 £ 500 ppb (£0.5 μg/ml)
  

	  	 Endotoxin (LAL kinetic

turbidimetric)
  
	  	 £ 10 EU/mg
  

	  	 Microbial Limit

 
	  	 £ 10 CFU/100 ml
  



  
 C-1 













 Exhibit D 

Quality Agreement 












 QUALITY ASSURANCE RESPONSIBILITY AGREEMENT 

BETWEEN 
 SAVIENT PHARMACEUTICALS,
INC. 
 AND 
 BIO-TECHNOLOGY
GENERAL (ISRAEL) LTD. 
 (COMMERCIAL PHASE) 

  
 D-2 













 Table of Contents 

 

							
	1	  	Purpose & Scope:	  	 	D-4  	 
			
	2	  	Definitions:	  	 	D-4  	 
			
	3	  	Notification of Process Deviations and Documentation Changes:	  	 	D-6  	 
			
	4	  	Materials:	  	 	D-8  	 
			
	5	  	Manufacturing:	  	 	D-9  	 
			
	6	  	Release and Shipment of Products(s):	  	 	D-11	 
			
	7	  	Deviations in Process or Product:	  	 	D-11	 
			
	8	  	Storage of Products(s):	  	 	D-12	 
			
	9	  	Traceability of Products(s):	  	 	D-12	 
			
	10	  	Conflict of Terms:	  	 	D-12	 
			
	11	  	Compliance with Laws:	  	 	D-12	 
			
	12	  	Inspections:	  	 	D-13	 
			
	13	  	Observations by SAVIENT:	  	 	D-14	 
			
	14	  	Adverse Events:	  	 	D-14	 
			
	15	  	Stability:	  	 	D-15	 
			
	16	  	Regulatory Action:	  	 	D-15	 
			
	17	  	Annual Report to FDA:	  	 	D-15	 
			
	18	  	APPENDIX I:	  	 	D-17	 
			
	19	  	APPENDIX II:	  	 	D-18	 
			
	20    	  	APPENDIX III:	  	 	D-21	 


  
 D-3 













 ARTICLE 1 

PURPOSE AND SCOPE: 

1.01        Savient Pharmaceuticals, Inc. (“SAVIENT”) and Bio-Technology General (Israel) Ltd.
(“BTG”) have entered into a Supply Agreement of (event date) herewith (the “Supply Agreement”). 
 This document (the
“Quality Agreement”) defines the quality assurance responsibilities between SAVIENT and BTG. This Quality Agreement applies only to the manufacture and supply by BTG to SAVIENT of the Product (as defined in the Supply Agreement).

 ARTICLE 2 

DEFINITIONS: 

2.01        Capitalized terms used but not otherwise defined in this Quality Agreement will have the meanings ascribed
thereto in the Supply Agreement. For ease of reference, the following definitions from the Supply Agreement which are used in this Quality Agreement are copied in full below, amended where appropriate for the purposes of this Quality Agreement: 

 

	 	(i)	 “BLA” means a Biologics License Application filed with the FDA and/or any other application required
for the purpose of marketing or selling or using a therapeutic or prophylactic product to be filed with a governmental agency in a non-U.S. country or group of countries, including, without limitation, a Product License Application or Marketing
Authorization in the European Union. 


  

	 	(ii)	 “Bulk Product” shall mean the bulk solution of polyethylene glycol (PEG) conjugate of uricase ordered
by Savient from BTG pursuant to the Supply Agreement. 


  

	 	(iii)	 “Bulk Product Specifications” shall mean the manufacturing and quality specifications for the Bulk
Product, including, without limitation, unit descriptions established from time to time in accordance with section 3.01 of the Supply Agreement. 


  

	 	(iv)	 “Business Day” shall mean any day other than (i) Friday, Saturday or Sunday or (ii) a day on which
banking institutions located in New York, New York, United States of America or in Israel are permitted or required by law, executive order or governmental decree to remain closed. 



 

	 	(v)	 “cGMP” shall mean current good manufacturing practices as set forth in Title 21, Parts 210 and 211 of
the C.F.R. and 21 C.F.R. Part 312 (IND) and Part 314 (NDA), and 21 C.F.R. Part 600 (Biological Products), as established and amended by the FDA. 



  
 D-4 














	 	(vi)	 “FDA” shall mean the United States Food and Drug Administration or, where applicable, its regulatory
equivalent in a foreign jurisdiction. 


  

	 	(vii)	 “Facility” shall mean, as applicable, the Be’er Tuvia manufacturing facility located at Beer
Tuvia Industrial Zone, POB 571, Kiryat Malachi 83104, Israel 


  

	 	(viii)	 “IND” shall mean an Investigational New Drug application, as defined in 21 C.F.R. 312.3, and filed
with the FDA or any equivalent foreign Regulatory Agency. 


  

	 	(ix)	 “Legal Requirements” shall mean (i) any present and future national, state, local or similar laws
(whether under statute, rule, regulation or otherwise), (ii) requirements under permits, orders, decrees, judgements or directives, and requirements of applicable Regulatory Agencies (including, without limitation, cGMP) and (iii) regulations
pertaining to BLAs (with respect to each of the foregoing, as amended or revised from time to time). 


  

	 	(x)	 “Process” or “Processing” shall mean the act of purification, preparation, filling, testing
and any other pharmaceutical manufacturing procedures, or any part thereof (including, but not limited to, product or process specifications, testing or test methods, raw material specifications or suppliers, equipment, etc.), relating to, as
applicable, Bulk Product and Product. 


  

	 	(xi)	 “Product” shall mean pharmaceutical products containing Bulk Product ordered by Savient pursuant to
the Supply Agreement. 


  

	 	(xii)	 “Regulatory Agency” shall mean with respect to the United States, the FDA, or, in the case of a
country in the Territory other than the United States, such other appropriate regulatory agency with similar responsibilities. 



2.03        In addition, the following definitions apply to this Quality Agreement: 

(i)        “Bulk Product” shall mean bulk solution of polyethylene glycol (PEG) conjugate of
uricase in its final formulation which is in Process, and has been produced for sterilization, filling or other finishing activities. 

(ii)        “Filled Product” shall mean sterile Product that is in Process and has been
filled into its final primary packaging for further labelling or packaging activities. 

(iii)        “Final Product” shall mean finished Product in its final packaged and labeled
form which is ready for distribution to the marketplace or third party distributors for sale or clinical use. 

(iv)        “Release” shall mean control, approval and authorization of shipment. 

  
 D-5 













 ARTICLE 3 

NOTIFICATION OF PROCESS DEVIATIONS AND DOCUMENTATION OF CHANGES: 

3.01        BTG shall provide to SAVIENT, within two Business Days of BTG’s discovery of its occurrence, written
notification of (i) any deviation from the Process as set forth in the Bulk Product Specifications and the BLA and any deviation from cGMP requirements, regulations and standards, and any event that represents an unexpected or unforeseeable event
that may affect safety, purity or potency of Bulk Product; and (ii) any deviation in the quality (purity, physical and chemical properties) of the Bulk Product from the Bulk Product Specifications. Appendix I sets forth a list of examples of
deviations from the Process, for purposes of illustration only, and is not intended to be comprehensive or definitive. 

(i)        BTG shall not conduct any retesting or reprocessing as the result of deviations described
above without prior written authorization from SAVIENT Quality Assurance unless a delay of retesting or reprocessing would result in increased risk to the safety, purity or potency of the Bulk Product or Product. 

3.02        Any changes to be made to this Quality Agreement in accordance with the provisions set out in this section
3 must be documented as an addendum to this Quality Agreement, and must be signed by authorized representatives from each of the BTG QA department and the SAVIENT QA department, in addition to authorized representatives from any other departments as
may be specified in relation to the matters set forth in section 3.3 below. This Quality Agreement will be reviewed by BTG and SAVIENT on a periodic basis (approximately once per year) and revised as appropriate. 

3.03        Change Control 

(i)        Specifications that control the Process for the manufacture, including packaging, holding,
and test of Bulk Product and Product, must be signed by authorized representatives from BTG and SAVIENT Quality Assurance, SAVIENT Regulatory Affairs, and SAVIENT Manufacturing. Such documents include, but are not limited to Bulk Product
Specifications (including specifications for intermediate), Product Specifications (including specifications for product, component and packaging). Changes to such documents must be signed by authorized representatives from SAVIENT Quality
Assurance, SAVIENT Manufacturing and SAVIENT Regulatory Affairs. 
 (ii)        Changes to
additional documents that control the Process for the manufacture of Bulk Product and Product (including test methods, manufacturing procedures and batch records) must be assessed according to the BTG change control process described in section 3.4.
Any change that would have an impact on the Process, Bulk Product or Product, or require submissions to or approvals from any Regulatory Agency must receive prior written approval by authorized representatives from SAVIENT Quality Assurance, SAVIENT
Manufacturing and SAVIENT Regulatory Affairs. If there is no such impact, BTG may proceed with the change, but must notify SAVIENT Quality 

  
 D-6 













 
Assurance no later than 5 days from the initiation of the BTG change control process. If SAVIENT does not agree with BTG’s assessment of impact, SAVIENT must respond to BTG no later than
within 5 days of receipt of notification. 
 (iii)       The stability protocol as well as any changes to
the stability protocol must be approved by SAVIENT QA and SAVIENT Regulatory Affairs. 

(iv)       Critical Raw Materials. The current specifications for Critical Raw Materials are attached as
Appendix III. The Parties acknowledge and agree that these specifications may be amended from time to time by the supplier of the material. With respect to such amendments: 

BTG shall notify SAVIENT as soon as reasonable practicable, but no later than within 5 days of receipt of notification by BTG. 

The Parties will meet and agree as to suitability of the material produced according to the amended specification for manufacture of the Bulk
Product. 
 3.04        BTG will utilize a documented system of written procedures for the control of changes to
documents relating to raw materials, packaging materials, labeling, suppliers, equipment, manufacturing methods, batch size, product, intermediates and raw materials specifications, sampling, analytical test methods and Release requirements and any
other Processing by BTG, relating to the Bulk Product. 
 3.05        Any changes to any matter relating to the
manufacture and supply of Bulk Product by BTG shall be governed by the procedures set out in the Supply Agreement at Article 3 in relation to changes to the Bulk Product Specifications, and Article 6 in relation to changes to the Process. 

3.06        SAVIENT Regulatory Affairs will have responsibility for determining the regulatory impact of any proposed
change. SAVIENT Regulatory Affairs will determine the classification and requirements for notification to, or approval by FDA. SAVIENT is responsible for communication of any changes to FDA. SAVIENT Regulatory Affairs will have responsibility to
advise BTG of any changes to the BLA prior to submission. 
 BTG will ensure that changes are evaluated and qualified in accordance with all
applicable ICH (International Conference on Harmonization) requirements in addition to all Legal Requirements, including but not limited to: 
 ICH
Guideline Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. 

  
 D-7 













 ARTICLE 4 

MATERIALS: 
  

	4.01	 Procurement of Components 



BTG will procure all the components described in the Bulk Product Specifications in such quantities as may be necessary to meet
Purchase Orders placed by SAVIENT pursuant to the Supply Agreement, and store the components in appropriate storage conditions under quarantine until tested. 
  

	4.02	 Inspection and Testing of Materials 



Upon receipt, BTG shall sample in accordance with acceptable statistical methods, inspect and test containers of all materials
to be used in the Process or in connection with the supply and manufacture of Bulk Product on a batch-by-batch basis, in accordance with the Bulk Product Specifications. 
  

	4.03	 Bulk Product 



BTG will be responsible for ensuring that Bulk Product is manufactured, tested and stored in compliance with all applicable ICH
guidance documents (including, without limitation, the guidance contained therein for master and working cell banks) in addition to all Legal Requirements. ICH Guidance includes, but is not limited to: 

Q5D Quality of Biotechnological Products: Derivation and Characterization of Cell Substrates Used for Production of
Biotechnological/Biological Products. 
 Q7A, Good Manufacturing Practices Guidance for Active Pharmaceutical Ingredients

  

	4.04	 Retention, Storage and Handling of Materials and Product Samples 



BTG shall sample and retain such amounts of Bulk Product and of all materials to be used in the Process or in connection with
the supply and manufacture of Bulk Product (“Retains”) except water, compressed gasses and any highly volatile compounds as set forth in Appendix II or as otherwise required in accordance with applicable Legal Requirements. BTG will store
for five years, or such longer period as may be required in accordance with Appendix II or by Legal Requirement, sample Product and Retains for each batch or lot of intermediates and raw materials. Reasonably prior to the expiry of such retention
period, or upon termination of this Quality Agreement, BTG shall offer all such materials to SAVIENT. Any labor costs of BTG employees and/or Third Party expenses incurred by BTG related to the transfer of such materials shall be reimbursed by
SAVIENT in the manner and at the rates set forth on Exhibit B to the Supply Agreement. 
 A schedule of specific
Retains, storage conditions and retention periods for Puricase® is listed in Appendix II. 
  

	4.05	 Transmissible Spongiform Encephalopathy (TSE) 



BTG will provide a written TSE declaration that all materials (including non-dedicated equipment) used in the manufacturing
process are free from animal derived material. In addition, BTG must have available, on site, written TSE declarations from the supplier, where appropriate, of raw material used in the manufacturing process verifying exclusion


  
 D-8 













 
of animal derived material. If BTG is unable to provide the above declarations, BTG will comply with applicable TSE laws and regulations and will obtain all associated TSE documentation as
requested by SAVIENT. This documentation may include a TSE Certificate of Suitability in accordance with European directive 75/318/EEC as amended by directive 1999/82/EEC, the note for guidance EMEA/410/01 rev2 as amended and AP-CSP(99)4, Appendix
2, as amended. 
  

	4.06	 Supplier Audits 



BTG and SAVIENT will provide each other with copies of supplier audit reports for materials used in the Process or manufacture
of the Product. 
 ARTICLE 5 

MANUFACTURING, PACKAGING, INSPECTION AND TEST: 

5.01    The Processing, packaging, and labeling of Bulk Product will be performed and documented by BTG. BTG will not
subcontract any of the Processing, packaging, and labeling functions except as may be permitted in accordance with the Bulk Product Specifications, and if so permitted, in accordance with the provision set forth in Section 2.05 of the Supply
Agreement. 
 5.02    BTG shall not Process or store Bulk Product in the same building in which BTG manufactures, stores
or processes potentially hazardous substances (including, without limitation, certain antibiotics such as beta-lactam and cephalosporins, cytotoxic compounds, toxins or poisons such as pesticides or herbicides, (collectively, “Potential
Contaminants”) unless the Potential Contaminants are stored or manufactured in contained environments and in compliance with all Legal Requirements and the Bulk Product is Processed and stored in compliance with building, cleaning, validation
and changeover requirements of all cGMPs and all Legal Requirements. BTG shall promptly notify SAVIENT if any of the Potential Contaminants are manufactured, processed or stored in any portion of the Facility which may result in the
introduction of Potential Contaminants into the areas of such facilities where the Bulk Product is Processed. Savient is aware that other products are processed in the Facility, the nature of those other products existing today and that certain
equipment (multi-use equipment) is used in the processing of both the Bulk Product and these other existing products. Savient has also had the opportunity to assess the risk to the Processing of Bulk Product of the use of such certain multi-use
equipment with respect to the other existing products. However, in the instance where BTG intends to introduce a new product or substance to its Facility which is out of the matrix of existing products and use such multi-use equipment in the
processing or handling of such new product or substance, Savient will need to reassess the risks to the Processing of Bulk Product with this new product or substance utilizing the multi-use equipment. Therefore, whenever BTG plans to introduce a new
product or molecular entity which is out of the matrix of existing products to equipment shared with Puricase production, BTG will provide no less than 30 days prior notice of its intent, and will contemporaneously make supporting cleaning
validation data/rationale available to Savient. Savient will make its assessment of the risk potential for adulteration of its own product through examination of cleaning validation 

  
 D-9 













 
documentation prior to any further Puricase production and will respond to BTG within 5 days of its receipt of cleaning validation data/rationale as to its conclusion(s) about the introduction.

 5.03    BTG will provide to SAVIENT: a copy of all master batch record documents and production and control records,
a Certificate of Analysis (PEG-uricase API and uricase), executed batch records and associated batch documentation, which shall include, without limitation: formulation records, label records, manufacturing records, environmental monitoring data,
microbiological data, in-process and final analytical data, including lab control results, sterility data, deviations/out-of-specification reports and cleaning records for any critical product contact equipment (for example, fermentors or any other
non-dedicated product contact equipment). 
  

	 	(i)	 Translation: BTG will provide an English translation of all such documents, including, without limitation,
all reports, notes or comments on records that are not part of the master batch record but if any of the foregoing documents are only available in a language other than English, the Parties shall agree upon an English language template for such
document(s), and BTG shall provide to Savient an English language translation of any deviations from the template(s). When required by SAVIENT, translations shall be performed by an independent, translation firm. Translations by a third party firm
must be verified by BTG to ensure translation of company or process specific language. Any labor costs of BTG employees and/or Third Party expenses incurred by BTG in relation thereto shall be reimbursed by SAVIENT in the manner and at the rates set
forth on Exhibit B to the Supply Agreement. 


 5.04    Upon request by SAVIENT, BTG will
provide access to additional records that are not normally part of the batch record but which bear a reasonable relation to the Bulk Product for SAVIENT to review, which may include, without limitation, maintenance and use records, water testing
data, training records, raw material release records, log books, receiving and shipping records, inventory records and vendor qualification records Any labor costs of BTG employees and/or Third Party expenses incurred by BTG in relation thereto
shall be reimbursed by SAVIENT in the manner and at the rates set forth on Exhibit B to the Supply Agreement. 

5.05    BTG will retain copies of all completed batch records for a minimum of five years, or such longer period as may be
required by Legal Requirement. Reasonably prior to the expiry of such retention period, or upon termination of this Quality Agreement, BTG shall offer such completed batch records to SAVIENT. Any labor costs of BTG employees and/or
Third Party expenses incurred by BTG related to the transfer of such materials shall be reimbursed by SAVIENT in the manner and at the rates set forth on Exhibit B to the Supply Agreement. 

5.06    Use of BTG Manufacturing Space for Bulk Product 

BTG has allotted an amount of manufacturing floor space at the Facility for the Processing of Bulk Product (Purification Area in the
Agreement). This space may be used for the production of other products subject to the following limitations: 

  
 D-10 














	 	(i)	 BTG may use the Purification Area for alternate product manufacturing only during periods when the Purification
Area is not used for the Processing of Bulk Product. 



	 	(ii)	 BTG adheres to all relevant cGMPs including, without limitation, procedures for prevention of mix-ups,
prevention of contamination, labeling requirements, cleaning requirements and changeover requirements 



	 	(iii)	 BTG, shall not, under any circumstances utilize any equipment dedicated to the Processing of Bulk Product for
such alternate product manufacturing 



	 	(iv)	 BTG adheres to limits and procedures described in section 5.2 for Potential Contaminants.



 ARTICLE 6 

RELEASE AND SHIPMENT OF PRODUCT(S): 

6.01    Bulk Product shall be Released in accordance with the procedures set forth in the Supply Agreement, together with the additional
obligations described in this section 0 of the Quality Agreement. BTG QA will review the records described in section 5.3 above. Following review and acceptance by BTG QA, BTG will send copies of these documents to SAVIENT QA. SAVIENT QA and
Manufacturing will then review the documentation and notify BTG whether or not documentation is acceptable. If such documentation is not reasonably acceptable to SAVIENT, BTG will cooperate in taking such steps as SAVIENT may reasonably require to
ensure that the documentation, and any Processing described therein complies with the Bulk Product Specifications and all Legal Requirements. 

6.02    BTG QA will be responsible for the QC testing of Filled Product until such time as a third party laboratory has been qualified to
perform such testing. BTG will provide a Certificate of Analysis and/or stability results for each batch that BTG tests. Savient QA will be responsible for the review of the manufacturing batch record for Filled Product, review of the Certificate of
Analysis and Release of the Filled Product. 
 6.03    SAVIENT QA will be responsible for the Release of the Final Product. 

6.04    Product shall be delivered in accordance with the provisions of Article 7 of the Supply Agreement. 

6.05    BTG will not ship any SAVIENT products to any destination, as identified by SAVIENT, unless prior approval has been received from
SAVIENT. 
 ARTICLE 7 

DEVIATIONS IN PROCESS OR BULK PRODUCT: 

In the event of a notification of a deviation by BTG in accordance with section 0 above, BTG shall investigate and fully document in English
such deviation within 30 days of its discovery. If BTG cannot resolve the deviation within the 30-day period, BTG will provide 

  
 D-11 













 
weekly updates of the investigation progress. At SAVIENT’s request, BTG shall conduct such additional or more detailed investigation of the deviation as SAVIENT may reasonably instruct.
Investigation documentation will be retained by BTG as part of the batch documentation for the batch affected. When a deviation has occurred, SAVIENT will have the final review and decision making responsibility as to the impact of the deviation on
the Bulk Product or Product, which will include the disposition of affected lots. 
 ARTICLE 8 

STORAGE OF PRODUCT(S): 
 Bulk Product will
be stored under appropriate storage conditions and in a secure area to ensure that they comply with the Bulk Product Specifications, including all the label requirements, quality specifications and attributes as well as Legal Requirements. 

ARTICLE 9 
 TRACEABILITY
OF PRODUCT(S): 
 SAVIENT will be responsible for traceability of products to first consignee within the US. BTG will be responsible for
traceability from the finished product lot number to raw material and component lots used in manufacture. 
 ARTICLE 10 

CONFLICT OF TERMS: 
 To
the extent that there exists any conflict between the terms of this Quality Agreement and the Supply Agreement, the latter shall prevail. To the extent that there exists any conflict between the terms of this Quality Agreement and any Legal
Requirements, the latter shall prevail. 
 ARTICLE 11 

COMPLIANCE WITH LAWS: 

BTG will ensure that all of its activities pursuant to this Agreement are performed in accordance with all Legal Requirements (including
cGMPs), the respective Bulk Product Specifications, conditions of the BLA, and BTG’s Standard Operating Procedures (SOPs). BTG will ensure that the Bulk Product supplied by it to SAVIENT shall not itself cause the Final Product to be
adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act and regulations. 

  
 D-12 













 ARTICLE 12 

INSPECTIONS: 
 Each party
shall advise the other of any governmental communication, inspection or report, including, without limitation, that of any appropriate regulatory agency in any jurisdiction with responsibilities similar to those of the FDA in respect of the United
States, any environmental agency, health agency or other governmental or administrative agency having jurisdiction over the Product or the Processing. The notifying party shall promptly notify the other party by fax and telephone, to the person and
on the contact numbers set out below: 
 TO SAVIENT: 
  

			
	 •   Contact Name:
	  	Robert Lamm, Ph.D., Sr. VP of Quality and Regulatory Affairs
		
	 •   Telephone:
	  	732-418-9300
		
	 •   Fax:
	  	732-418-0766
		
	TO BTG:	  	
		
	 •   Contact Name:
	  	Rivka Zaibel, VP, Quality Assurance
		
	 •   Telephone:
	  	972-8-861-2007
		
	 •   Fax:
	  	972-8-861-2166


  
 D-13 













 ARTICLE 13 

OBSERVATION BY SAVIENT: 

Observation by SAVIENT or its authorized representative shall be governed the following. Observation will be limited to not more than one
quality audit every 12 months. One additional quality audit may be conducted within the 12 month period if BTG receives a communication from any regulatory authority threatening license approval or supply of the Product due to compliance
deficiencies at BTG facilities or if BTG was found to be in material non-compliance of this Agreement during or since the last quality audit. Person-in-Plant visits may be conducted at the discretion of SAVIENT during the manufacture of Bulk Product
at BTG facilities. The frequency and duration of any additional visits must be agreed to by SAVIENT and BTG. 
 ARTICLE 14 

ADVERSE EVENTS: 

14.1    BTG will provide to SAVIENT within 48 hours of becoming aware, any information from any source that suggests an
adverse event or serious adverse event has occurred. This information will include any adverse drug experience or reaction reports or any other information indicating that the product has any toxicity, sensitivity reactions or is otherwise alleged
to cause illness or injury due to a possible product quality problem, adulteration or misbranding. 
 14.2    Quality
Assurance Investigations. Upon notification to BTG that SAVIENT has received an SAE, AE, product complaint or inquiry regarding a Product supplied or incorporating a Bulk Product supplied, BTG shall conduct a quality assurance investigation to
determine if any process or testing deviations or events may have contributed to the SAE, AE, product complaint or inquiry. BTG shall provide a written report on the results of the investigation to SAVIENT in not more than 30 days from
Savient’s notification. In cases where a more comprehensive investigation might be required, the Parties will jointly develop an investigation plan. BTG shall reasonably cooperate with SAVIENT and regulatory agencies regarding an investigation
or inquiry that may be initiated by a regulatory agency or otherwise required in response to a consumer or healthcare professional. BTG shall further provide SAVIENT with all data or other information that SAVIENT may reasonably require in
connection with any reports or correspondence that SAVIENT provides to the regulatory agency, consumer or healthcare professional relative to any such AE, SAE or product complaint. BTG shall make records accessible to SAVIENT for purposes of FDA or
other regulatory agency inspection. 
 14.3    Exchange of Drug Safety Requests. The Parties shall immediately provide
each other with copies of all drug safety requests from all governmental and other regulatory health authorities. Proposed answers affecting the Product will be exchanged between the Parties before submission and the Parties shall cooperate with
respect to such answers. SAVIENT shall 

  
 D-14 













 
have the ultimate decision-making authority with respect to the answers relating to the Product. The Parties shall exchange decisions from applicable health authorities immediately. 

ARTICLE 15 
 STABILITY:

 BTG will perform the stability testing, data interpretation, reporting and updating of stability information to
regulatory documents for the Product and Bulk Product and for Product until such time as a third party laboratory has been qualified to perform such testing. Stability related activities for which BTG is responsible shall be completed in accordance
with the timing specified in stability protocols and BTG procedures. 
 ARTICLE 16 

REGULATORY AFFAIRS: 
 Each
Party shall advise the other Party of any regulatory action of which it is aware which would affect the Product in any country of the Territory. 

ARTICLE 17 
 ANNUAL
REPORT TO FDA: 
 BTG will prepare a summary of all changes to the product, production process, quality controls, equipment or
facilities that have a potential to affect the identity, strength, quality, purity or potency of the Product. Such data will be prepared and sent to SAVIENT within thirty days of the end of the review period. BTG will also ensure that the results of
all stability testing performed within the review period are sent to Savient within thirty days of the end of the review period. 

  
 D-15 













 Approvals 
  

							
	 	 	 	 
	 	  	 Print Name

 
	  	 Signature
  
	  	 Date

 

	 	 	 	 
	 SAVIENT QA

 
	  	 Robert B. Lamm

 
	  	 /s/ Robert B. Lamm

 
	  	 20-Mar-07

 

	 	 		 
	 BTG QA

 
	  	 Rivka Zaibel

 
	  	 /s/ Rivka Zaibel

 
	  	 20 March 2007

 



  
 D-16 













 APPENDIX I 

Listing of Example Deviations 
 The
following is a non-exclusive list of deviations requiring notification in accordance with section 0: 
  

	 	•	 	 Deviation impacting any filed regulatory document. 



	 	•	 	 Use of manufacturing or testing site (finished products, intermediates, API or excipients) other than that
specified in Bulk Product and Product Specifications and/or BLA. 



	 	•	 	 Change of manufacturing scale from that specified in Bulk Product Specifications and/or BLA.




	 	•	 	 Deviation from packaging or packaging specifications from that specified in Bulk Product Specifications and/or
BLA. 



	 	•	 	 Deviation from suppliers, sources or specifications of starting and Critical Raw Materials or supplier of any
filters for Products or intermediates set forth in Bulk Product Specifications and/or BLA. 



	 	•	 	 Change in the layout, functioning or structure of the Facility, equipment or utilities (HVAC, nitrogen, water or
compressed gasses) that may affect the quality of the Bulk Product. 



	 	•	 	 Use of solvents or reagents (including volatile reagents), other than those specified in Bulk Product
Specifications and/or BLA, or change of specifications for such solvents, reagents, or intermediates, or change in analytical methods of solvents, reagents, or intermediates. 



	 	•	 	 Deviation in amounts of solvents or reagents used from that specified in the Process, Bulk Product Specifications
and/or BLA. 



	 	•	 	 Change in Transmissible Spongiform Encephalopathy (TSE) status of any raw material or product(s).




	 	•	 	 Any reprocessing or rework of any step of the Process. 



	 	•	 	 A physical contamination, cross-contamination or other chemical contamination. 



	 	•	 	 Any manufacturing, packaging, labeling, sampling or testing deviation that affects the quality, safety or purity
of the Product. 



	 	•	 	 Departures from the SOPs, IPC tests, stability SOPs, the Stability Protocol or Batch Records outside the filed
limits, excursions or any deviation with potential registration impact. 



	 	•	 	 Any unexpected results from stability testing. 



	 	•	 	 Environmental monitoring results that are out-of-specification. 



  
 D-17 













 APPENDIX II 

Schedule of Retains, Storage Conditions and Retention Periods for Puricase®

 The following is a list of the reserve/retention samples that are taken during the manufacturing processes of bulk uricase and
PEG-uricase as well as from the final bulk uricase and the final bulk PEG-uricase (Bulk Product). 
 The document was prepared based on the following BTG QC
SOPs: 
 1.    SOP 04-68-1288 (v2): QC Sampling Plan for Bulk Uricase 

2.    SOP 04-68-1830 (v1): QC Sampling Plan for PEG-Uricase API 

3.    SOP 04-68-1861 (v1): IPC Testing of Bulk Uricase Batches 

4.    SOP 04-68-1862 (v1): IPC Testing of PEG-Uricase 

Table 1 details the reserve/retention samples that are taken during the manufacturing process of bulk uricase and from the
final bulk uricase. 
 Table 2 details the reserve/retention samples that are taken during the manufacturing process of
PEG-uricase and from the final bulk PEG-uricase (Bulk Product). 
 All IPC samples (including reserve/retention samples) are
to be discarded after the Final Product is released by Savient. 
 Uricase retention and reserve samples will be kept for
one year after manufacturing. PEG-Uricase retention and reserve samples will be kept for six years after manufacturing 

  
 D-18 













   Table 1. Reserve/Retention Samples for Bulk Uricase (IPC and Final) 

 

							
	Process Step	 	Sample name	 	
Number of        

Samples
	 	
Storage

Temperature    

	Fermentation -Beginning of Induction	 	0	 	1 x 0.1 ml	 	-20°C
	Fermentation - After 3 hr of Induction	 	3	 	1 x 0.1 ml
	Fermentation Harvest (End of Induction)	 	6	 	1 x 0.1 ml
	 	1 x 50 ml
	Harvest Supernatant	 	7	 	1 x 1 ml
	Fermentation Bacterial Cake Diluted 10 Fold	 	9	 	1 x 0.1 ml
	Crude Suspension	 	10	 	1 x 0.1 ml
	Supernatant After 1st
Centrifugation	 	11	 	1 x 1 ml
	Pellet After 1st
Centrifugation	 	12	 	1 x 0.1 ml
	Supernatant After 2nd
Centrifugation	 	13	 	1 x 1 ml
	Pellet After 2nd
Centrifugation	 	14	 	1 x 0.1 ml
	Dissolution of IBs	 	DS	 	1 x 7 ml
	 	 	End DS	 	1 x 7 ml
	Centrifugation of Precipitate	 	CP	 	1 x 7 ml
	Concentration / Diafiltration	 	30 ICD Filt.	 	1 x 7 nil
	 	30 KD Ret (only if process   is stopped)	 	1 x 7 ml
	QS-1 Column	 	QS-1 Load	 	1 x 7 ml	 	2-8°C
	 	QS-1 MP	 	1 x 7 ml
	PS Column	 	PS Load	 	1 x 7 ml
	 	PS MP	 	1 x 7 mi
	Xanthine-Agarose Column	 	Xa Load Prep.*	 	1 x 7 ml
	 	Xa Load (from each day)	 	1 x 7 ml
	 	Each Xa MP	 	1 x 7 ml
	Concentration	 	Xa MP (AC)	 	1 x 7 ml
	 	1 x 50 ml
	
 
 Bulk Uricase Reserve Samples

 
	 	  

2 x 10 ml
  

	
 
 Bulk Uricase Retention Samples

 
	 	  

2 x 50 ml
  


 * The number of Xa Load Prep. samples depends on the concentration measured after sample dilution. 

  
 D-19 













   Table 2. Reserve/Retention Samples for PEG-Uricase API (IPC and Final) 

							
	Process Step	 	Sample name	 	
Number of        

Samples
	 	
Storage

Temperature    

	Concentration and dialysis	 	30K AD	 	3 x 5 ml	 	2-8°C
	QS 2	 	QS2 MP	 	3 x 5 ml
	PEGylation	 	PEG Solution	 	1 x 2 ml
	 	End of PEGylation	 	2 x 5 ml
	QS 3	 	QS 3 MP	 	2 x 5 ml
	100K Dialysis	 	Dialysis Buffer	 	1 x 5 ml
	 	Pellicon Final Rinse Water	 	1 x 5 ml
	 	100K Filtrate — After X Volumes (~15, 20, 25 volumes; to be determined based on Free PEG
content)	 	1 x 5 ml after each dialysis volume
	 	100K Retentate	 	2 x 5 ml
	 	1 x 30 ml
	
 
 PEG-Unease API Reserve Samples

 
	 	  

1 x 7 ml
  

	
 
 PEG-Unease API Retention Samples

 
	 	  

2 x 50 ml
  



  
 D-20 













 APPENDIX III 

Critical Raw Materials Used in the Production of Recombinant Uricase and PEG-Uricase 

 

											
	 	 	 	 	 	 
	 Material

 
	  	 Manufacturer

 
	  	 Cat. No.

 
	  	 Testing

 
	  	 Source

 
	  	 Origin

 

	 	 	 	 	 	 
	N-Z-Amine AS	  	Kerry Bio- Science	  	 5X59028/

5X59039
	  	Chem/NIR  	  	 Milk  

derivative  
	  	USA
	 	 		 		 
	N-Z-Amine B	  	Kerry Bio- Science	  	5X59032	  	Chem/NIR  	  	 Milk  

derivative  
	  	USA
	 	 	 	 	 	 
	 Yeast Extract,

microgranulated powder,
 without salt, type D
	  	BioSpringer	  	0251/ 0-MG-L	  	Chem/NIR  	  	Yeast  	  	France
	 	 		 		 
	Q SepharoseTM Fast Flow	  	Amersham Pharmacia	  	17-4510-04	  	Chem  	  	Chemical  	  	Sweden
	 	 	 	 	 	 
	 Phenyl SepharoseTM 6

Fast Flow low
 substitution
	  	Amersham Pharmacia	  	17-0965-04	  	Chem  	  	Chemical  	  	Sweden
	 	 	 	 	 	 
	Xanthine-agarose	  	Sigma	  	X3128	  	CoA  	  	 Plant /  

Chemical  
	  	USA
	 	 		 		 
	 Methoxypoly (ethylene

glycol)-nitrophenyl
 carbonate MW 10 000,

Sunbright MENP-10T
	  	 NOF

Corporation
	  	-	  	Chem  	  	Chemical  	  	Japan
	 	 	 	 	 	 
	 Lysozyme, from egg

white, 50,000 U/mg
 cryst. HCl salt, for

biochemistry EC 3.2.1.17
	  	Merck	  	1.05281	  	Chem  	  	Egg, chicken  	  	Germany
	 	 	 	 	 	 
	 Lysozyme Chloride

(pharmaceutical grade)
 (Mucopeptide N-

Acetylmuramyl
 hydrolase, HCL, E.C.

3.2.1.17)(from egg white)
	  	Belovo	  	PO-VEN-03 Appendix 13a	  	 	  	Egg chicken  	  	 


  
 D-21 













 SPECIFICATION N-Z-AMINE AS 

 

					
	Parameter	  	Test	  	Specification
	Total Nitrogen (TN)  	  	Combustion  	  	11.0% minimum  
	Amino Nitrogen (AN)  	  	HCHO Titration (%)  	  	Record  
	Ratio AN/TN  	  	Ratio  	  	45 minimum  
	Ash Content  	  	Oven  	  	7.5% maximum  
	Loss on drying  	  	Moisture balance  	  	5.0% maximum  
	pH  	  	2% autoclaved solution  	  	6.4 — 7.0  
	Color  	  	 2% autoclaved solution,
ABS  
 @ 420 nm  
	  	0.180 AU maximum  
	Clarity  	  	 2% autoclaved
solution,  
 2100AN  
	  	0.76 NTU maximum  
	Standard Plate Count  	  	USP  	  	10,000 CFU/g maximum  
	Enterobacteriaceae  	  	ISO  	  	10 CFU/g maximum  
	Salmonella  	  	USP  	  	Absent in 25 g  


  
 D-22 













 SPECIFICATION N-Z-AMINE B 

 

					
	Parameter	  	Test	  	Specification
	Total Nitrogen (TN)  	  	Combustion  	  	11.0% minimum  
	Amino Nitrogen (AN)  	  	HCHO Titration (%)  	  	Record  
	Ratio AN/TN  	  	Ratio  	  	39.0 minimum  
	Ash Content  	  	Oven  	  	7.0% maximum  
	Loss on drying  	  	Moisture balance  	  	5% maximum  
	pH  	  	2% autoclaved solution  	  	6.6 — 7.1  
	Color  	  	 2% autoclaved solution,
ABS  
 @ 420 nm  
	  	0.160 AU maximum  
	Clarity  	  	 2% autoclaved
solution,  
 2100AN  
	  	1.36 NTU maximum  
	Standard Plate Count  	  	USP  	  	10,000 CFU/g maximum  
	Enterobacteriaceae  	  	ISO  	  	10 CFU/g maximum  
	Salmonella  	  	USP  	  	Absent in 25 g  


  
 D-23 













 SPECIFICATION YEAST EXTRACT 

 

			
	Parameter	  	Specification
	Dry matter  	  	94.0 — 98.0 g per 100 g product  
	Total nitrogen  	  	10.0 — 11.8 g per 100 g product  
	Amino nitrogen  	  	4.5 — 5.8 g per 100 g product  
	PH  	  	6.8 — 7.2  
	Sodium chloride  	  	< 0.5 g per 100 g product  
	Total plate count  	  	< 5,000 CFU per g product  
	Coliforms  	  	< 5 CFU per g product  
	Spores of Clostridium perfringens  	  	< 10 CFU per g product  
	Yeast  	  	< 50 CFU per g product  
	Mold  	  	< 50 CFU per g product  
	Salmonella  	  	Negative (per 25 g)  
	E. coli  	  	Negative  
	Staphylococcus aureus  	  	Negative  


  
 D-24 













 SPECIFICATION Q SEPHAROSETM 

 

			
	Parameter	  	Specification
	Function - retention volume; ml  	  	 
	- GammaBindTM  	  	40 — 50  
	- b-Lactoglobulin A  	  	59 — 79  
	- b-Lactoglobulin B  	  	72 — 92  
	Total capacity  	  	 
	mmol C1-/mL packed gel  	  	0.18 — 0.25  
	Flow rate at 0.1 MPa  	  	 
	
cm/hour  
 Bed height: 14
— 16 cm  
	  	400 — 700  
	Particle size distribution  	  	 
	Volume share within 45 — 165 μm; %  	  	95 minimum  
	Microbial contamination  	  	 
	microorganisms / mL suspension  	  	100 maximum  


  
 D-25 













 SPECIFICATION PHENYL SEPHAROSETM 

 

			
	Parameter	  	Specification
	 Function —
Separation of Cytochrome C,  
 Myoglobin and Lysozyme  
	  	 
	Retention Time; minutes  	  	 
	Myoglobin  	  	52 — 63  
	Lysozyme  	  	80 — 90  
	Microbial contamination  	  	  
	microorganisms / mL suspension  	  	100 maximum  
	Degree of substitution  	  	 
	μmol phenyl per ml drained gel  	  	Record  


  
 D-26 













 SPECIFICATION XANTHINE AGAROSE 

 

			
	Parameter	  	Specification
	Appearance  	  	White Suspension  
	Binding capacity  	  	> 1.5 mg/ml binding capacity  


  
 D-27 













 SPECIFICATION METHOXYPOLY (ETHYLENE GLYCOL)-NITROPHENYL CARBONATE 

 

					
	Parameter	  	Test	  	Specification
	Physical description  	  	Visual observation  	  	White to off-white powder or   granular solid  
	Appearance of acidic solution  	  	Visual inspection of 1 mg/ml   solution in 1mM HCL  	  	 Colorless and
free of turbidity  
 or suspended matter  

	 Average molecular
weight  
 (Mn) (Daltons)  
	  	SEC monitored by RI  	  	9,000 — 11,000  
	 Polydispersity
(Mw/Mn) main  
 peak  
	  	SEC monitored by RI  	  	NMT 1.1  
	PEG diol content (%)  	  	 SEC monitored by RI, 20
kD  
 Peak  
	  	NMT 2  
	 Content of
active  
 m-PEG-npc (%)  
	  	 Spectrophotometric  

determination of pNP released  

by alkaline hydrolysis / H-  

NMR  
	  	NLT 90  
	Free p-nitrophenol (%)  	  	 Spectrophotometric  

determination of pNP released  

by alkaline hydrolysis / H-  

NMR  
	  	 NMT 5 of total
pNP measured  
 after alkaline hydrolysis  

	Bacterial endotoxins (EU/g)  	  	USP (gel clot)  	  	NMT 20  
	Water content (%)  	  	Karl Fischer  	  	LT 2  
	Bioburden (cfu/g)  	  	Microbial limit test (JP)  	  	LT 100  
	Organic volatile impurities (%)  	  	 GC (Head-space)  

acetonitrile pyridine, toluene,   hexane, ethyl acetate,   triethanolamine  
	  	NMT 0.1  


  
 D-28 













 SPECIFICATION LYSOZYME (MERCK) 

 

			
	Parameter	  	Specification
	 Activity
(Micrococcus luteus, FIP-  
 Standard; pH 7.0; 25° C)  
	  	> 50,000 U/mg  


  
 D-29 













 SPECIFICATION LYSOZYME (BELOVO) 

 

					
	Parameter	  	Test	  	Specification
	Solubility in water (mg,/ml)  	  	 	  	>100  
	Protein purity (%)  	  	 HPLC on TSK-gel
G2000SWXL  
 detection 280 nm  
	  	>99.0  
	Identification  	  	 Nihydrin test: blue-purple color,  

maximum absorbance between 279 nm  

and 281 nm  
	  	Conforms  
	Transmittance @ 650 nm (%)  	  	Of a 1.5% solution in water  	  	>99.5  
	Transmittance @ 400 nm (%)  	  	Of a 10% solution in water  	  	>90  
	pH  	  	Of a 1.5% solution in water  	  	3.0 — 4.0  
	Activity * (FIP U/mg)  	  	
By comparison to a lysozyme standard  

FIP from Center for Standards, Gent  

(Belgium). According to FIP ref. Int.  

Pharm. J (1988) 2(5), 169-171  
	  	>36,000  
	Assay * (mg/mg)  	  	 By comparison to a lysozyme reference  

standard according to the Japanese  

Pharmaceutical Codex. (JPC 1997 Part I)  
	  	30.9  
	Moisture (%)  	  	105 °C — 4 hours  	  	<5  
	Ash (%)  	  	800 °C — 3 hours  	  	<0.3  
	Chloride (%)  	  	 Potentiometric titration with ion  

selective electrode  
	  	<4  
	Nitrogen* (%)  	  	Kjeldhall method  	  	16.8 — 17.8  
	Density (ml/g)  	  	 Bulk density by sieving the powder on  

the top of a cylinder of 30 ml capacity  

(diam. 22 mm, height 79 mm)  
	  	2 - 3  
	Particle size (p.m)  	  	 Opening: 0.077 mm; wire: 0.050mm;     %  

opening 34  
	  	<77  
	Arsenic (ppm)  	  	 Test strips semiquantitative  

Merckoquant 10 026 (Merck)  
	  	<1  
	Heavy metals (ppm)  	  	Atomic Absorption  	  	<10  
	Total viable count (/g)  	  	 Culture medium: OXOID CM1; on  

membrane filters; 0.45 μm pore size;  

30°C 3 days  
	  	<10  
	Pyrogens (IU/mg)  	  	LAL: pyrogentR plus kit Bio   Whittaker  	  	<1  
	VVND  	  	 Viral safety validation study
according  
 to Council Directive 92/66/EEC,  

Annexe III: Diagnostic procedures for  

the confirmation and differential  

diagnosis of Newcastle disease  
	  	Absent  

 * on anhydrous basis 

  
 D-30 













 Exhibit E 

Product Price 
 During the first
three (3) years from the date of the receipt by Savient of the first commercial batch of the Product, the Price of the Product shall be as follows: 

(i)    For each gram, Eight Thousand Two Hundred Ninety United States Dollars (USD$8290) for any aggregated
quantities of the Product up to and including Two point Four kilograms (2.4 kg) ordered during any calendar year that commercial batches of Product are shipped, i.e. after the first commercial batch of Product has been shipped. 

(ii)     For each gram, Seven Thousand Eight Hundred Sixty Five United States Dollars (USD$7865) for any
aggregated quantities of the Product between Two point Four kilograms (2.4 kg) and Four point Eight kilograms (4.8 kg) ordered during any calendar year as above.; and 

(iii)     For each gram, Seven Thousand Four Hundred Forty United States Dollars (USD$7440) for any
aggregated quantities of the Product equal to or greater than Four point Eight kilograms (4.8k g) ordered during any calendar year as above. 
 The Parties
agree that Savient will enter into a supply agreement with NOF, the supplier of m-PEG-NPC (mono-methoxy polyethylene glycol nitro-phenyl carbonate), and will order and pay for PEG needed in Product manufacture on an ongoing basis. In the event that
BTG purchases PEG directly from NOF or any other manufacturer, the cost of the PEG will be invoiced to Savient. 
 Beginning on the Third (3rd) anniversary of the date of receipt of the first commercial batch of Product by Savient, and on each successive first (1st) January thereafter,
the Price of the Product shall increase by an amount equal to the average increase in the United States Consumer Pricing Index (CPI) over the immediately preceding twelve (12) month period; such percentage increase shall be applied to each amount
specified in (i) through (iii) above. 












 Exhibit F 

Residual Rights Agreement 












 AMENDED AND RESTATED 

RESIDUAL RIGHTS AGREEMENT 

This Amended and Restated Residual Rights Agreement (“Agreement”) is entered into on the 17th day of July,
2005, by and between Savient Pharmaceuticals, Inc., a public company duly organized under the laws of the State of Delaware (“Savient”) and Bio-Technology General (Israel) Ltd., a private company duly organized under the laws of the
State of Israel (“BTG”), to replace and supersede the Residual Rights Agreement previously signed and dated 20 June, 2005. 

(Savient and BTG shall be referred to jointly as the “Parties” and individually as a
“Party”). 
 WHEREAS, BTG is a wholly owned subsidiary of Savient; and 

WHEREAS, the Parties are parties to a Manufacturing Services Agreement effective January 1, 1996 (the “Manufacturing
Agreement”) and a Research and Development Services Agreement dated January 1, 1996 (the “R & D Agreement”) (the Manufacturing Agreement and the R & D Agreement being collectively referred to hereunder as the
“Inter-Company Agreements”); and 
 WHEREAS, pursuant to the Share Purchase Agreement (the
“SPA”) and the Asset Purchase Agreement (“APA”), each dated March 23, 2005 (the SPA and APA, collectively, the “Divestiture Agreements”), Savient intends to sell to Ferring B.V. all of the issued
and outstanding share capital of BTG, and to Ferring International Centre S.A. (together with Ferring B.V., the “Buyer”) all of Savient’s right, title and interest in and to certain assets and rights of Savient in the drug
products and drug candidates developed and/or manufactured at BTG pursuant to the Inter-Company Agreements (the “Divestiture” and the “Divested Products”, respectively), but not in any case in the drug candidate
known as “Peguricase” (a/k/a “Puricase”); and 
 WHEREAS, the development of Puricase is
ongoing and Savient shall require, and BTG is willing to render, continued development, manufacturing and other services of BTG in relation to Puricase, following the Closing (as defined in the Divestiture Agreements); and 

WHEREAS, the Parties wish to record certain specific understandings in relation to certain protein purification technology
(the “CPC Technology”) as to which Savient has retained title, in furtherance of the understandings set out in the SPA in relation thereto, which CPC Technology forms part of the Puricase Technology, but which can also be used for
the manufacture of other 

  
 - 1 - 













 
products (all products that may be manufactured using the CPC Technology, other than Puricase, Divested Products and HA (as defined below), being referred to herein as “CPC
Products”); and 
 WHEREAS, the Parties wish to record certain specific understandings in relation to the
OCS-funded project, known as BTG-271 (“BTG-271”), in furtherance of the understandings set out in the SPA in relation thereto; and 

WHEREAS, certain of the Divested Products, Puricase, the CPC Technology and BTG-271 were developed at BTG within the framework
of research and development programs carried out with the support of the Office of the Chief Scientist at the Ministry of Industry, Trade and Labor (“Approved Programs” and the “OCS” respectively) and Savient has
ownerships rights thereto but BTG possesses other rights as set forth in Savient’s letter to the OCS of July 15, 2003 (the “OCS Letter”), a copy of which is attached as Annex “A”; and 

WHEREAS, the Parties have agreed to terminate the Inter-Company Agreements and wish to record their understandings in relation
to the continued development and/or manufacture of Puricase and/or other services that may be rendered by BTG in relation thereto; and 

WHEREAS, the Parties wish to record their understandings in relation to the royalties that may be payable to the OCS
(“Royalties”) in relation to the Divested Products, Puricase, other products embodying Puricase Technology, CPC Products and BTG-271, all subject to and effective as from the Closing. 

Now therefore, in consideration of the foregoing premises, which are incorporated into and made a part of this Agreement, and
of the mutual covenants which are recited herein, the Parties agree as follows: 
  

	 	1.	 Termination of the Inter-Company Agreements 



 

	 	1.1.	 Prior to the Closing, Savient and BTG shall comply with the terms and conditions of the Inter-Company
Agreements, including any payment obligations by Savient thereunder. Notwithstanding anything to the contrary contained in the Inter-Company Agreements, all of the provisions of the Inter-Company Agreements shall automatically terminate effective as
of the Closing, including provisions that were intended to survive termination. Savient shall not have any further obligation to pay BTG in respect of Reimbursable Costs (as such term is defined in the R & D Agreement) or Processing Fees (as
such term is defined in the Manufacturing Agreement) that may be outstanding as of such time in relation to Divested Products, and BTG shall be considered as having waived such payments. 



  
 - 2 - 














	 	1.2.	 In connection with such terminations, and for the avoidance of doubt, the Parties agree that:



  

	 	1.2.1.	 Notwithstanding the provisions of Section 1.1 and Section 3.2 of the Manufacturing Agreement, title to all
work in process relating to Divested Products and inventory of Divested Products shall automatically vest in the Buyer, as of the Closing; 


  

	 	1.2.2.	 Notwithstanding the provisions of Section 1.1 above and Section 11.3 of the Manufacturing Agreement, as of
the Closing, BTG shall process and deliver Divested Products ordered prior to the Closing to the Buyer or the Buyer’s designee, and Savient shall have no responsibilities in relation thereto; 



 

	 	1.2.3.	 As of the Closing, Savient and BTG agree that any liability of Savient to pay BTG for development
activities, regulatory or other services of any nature that may have been carried out by BTG for Savient prior to the Closing under the R & D Agreement or otherwise have been satisfied as of the Closing; and 



 

	 	1.2.4.	 The provisions of the Manufacturing Term Sheet attached hereto as Annex “D” shall
apply to work in process relating to Puricase existing as of the Closing and the delivery of Puricase that may have been ordered prior to the Closing. 


  

	 	2.	 Ownership in Technology; Patent Rights; Other Rights 



 

	 	2.1.	 Savient has and shall have the exclusive right, title and interest in and to Puricase and the Puricase
Technology, subject to (i) BTG’s irrevocable and perpetual right to conduct research and development with the Puricase Technology developed in the course of Approved Programs, excluding clinical trials that BTG is not in a position to monitor
from Israel and (ii) BTG’s right to manufacture Puricase in Israel. BTG shall have commercialization rights with respect thereto only as provided in Section 6 herein or as provided in the Divestiture Agreements. In the case of clauses (i) and
(ii), BTG’s rights shall always remain subject to the terms and conditions of any existing supply, manufacturing or development agreement between the Parties. For the avoidance of doubt, Savient and an additional manufacturer on its behalf
approved by the OCS, will have the right to use the CPC Technology in order to manufacture Puricase. 



  
 - 3 - 














	 	2.2.	 Savient has and shall have the exclusive right, title and interest in the CPC Products and the CPC
Technology subject to BTG’s exclusive, irrevocable, perpetual and unconditional license for purposes of research and development and production. BTG shall have commercialization rights with respect thereto only as provided in Section 6 herein
or as provided in the Divestiture Agreements. 


  

	 	2.3.	 For the purposes of this Agreement, the term “Puricase Technology” means the technology
described in the patent applications listed on Annex “B” as 1.1 (the “Puricase Patents”), and any developments, discoveries, inventions, improvements, designs, methods, processes, techniques, devices,
formulae and trade secrets which may be developed, acquired and conceived by BTG and are derived from any Development Program in relation to Puricase which have been or may be carried out at any time after the submission of the Puricase Patents and
all patents that may be issue from patent applications claiming or describing such technology, information and know-how and filed in addition to the Puricase Patents after their submission. 



For the purposes of this Agreement, the term “CPC Technology” means the technology described in the patent
applications listed on Annex “B” as 1.2 (the “CPC Patents”) and any developments, discoveries, inventions, improvements, designs, methods, processes, techniques, devices, formulae and trade secrets which have
been or may be developed, acquired and conceived by BTG and are derived from any Development Program which have been or may be carried out at any time after the submission of the CPC Patents and all patents that may issue from patent applications
claiming or describing such technology, information and know-how and filed in addition to the CPC Patents after their submission. 

For the purposes of this Agreement, “Development Programs” shall mean research and development work carried
out by BTG for Savient. 
  

	 	2.4.	 The Puricase Patents, and the CPC Patents (collectively, the “Savient Patents”) are owned
by Savient. BTG shall have no rights with respect to the Savient Patents, other than as provided herein or as provided in the Divestiture Agreements. Savient has the sole control over filing and prosecuting applications for United States and foreign
patents covering the Puricase Technology and the CPC Technology and may file and prosecute the same in Savient’s name. The cost for all such filings and 



  
 - 4 - 














	 	 
prosecutions are and shall be borne by Savient. BTG and its employees and consultants shall provide Savient, without compensation other than recovery of out of pocket expenses, with the necessary
authorizations, powers of attorney and other documents and assistance reasonably requested by Savient from time to time to file, secure and maintain Savient’s patent rights in connection with the Savient Patents and BTG hereby grants to Savient
powers of attorney to execute and file on BTG’s behalf any documents reasonably necessary to secure and maintain such patent rights. 



For the purposes of this Agreement, the term “Savient Patents” means the patents listed on Annex B
and any disclosures, continuations, continuations-in-part, divisionals, provisionals, PCT applications, reissuances, revisions, substitutions, conversions, renewals, extensions, prolongations, and reexaminations thereof, any technology and
inventions covered thereby, and any corresponding international, regional, and national applications and patents. 
  

	 	2.5.	 BTG shall, from time to time and as soon as practicable following Savient’s request, provide Savient
with documentation describing the current Puricase Technology and CPC Technology held by or under the control of BTG and any other report reasonably requested by Savient. For the avoidance of doubt, Puricase Technology and CPC Technology shall be
described in sufficient detail to allow Savient to manufacture Puricase, or use the CPC Technology (as the case may be) it being understood and agreed, however, that Savient shall not commence manufacture of Puricase or of a CPC Product (i) unless
so permitted by the OCS, if such permission is required; and (ii) unless in compliance with any agreement between the Parties relating to such manufacture and supply; and (iii) provided that such permission by the OCS does not trigger any additional
obligations of BTG vis-à-vis Savient or the OCS, above and beyond those provided in such agreement of manufacture and supply or in this Agreement. In any event, BTG may retain copies of such documentation for archival purposes.



  

	 	2.6.	 For the sake of clarity: 



 

	 	2.6.1.	 Nothing herein is intended to derogate from BTG’s ownership of the real property, tools, machinery and
equipment which have been or may be acquired by it in furtherance of, or incidental to, the Development Programs; 



  
 - 5 - 














	 	2.6.2.	 Neither “Puricase Technology” nor “CPC Technology” shall be deemed to
include general methods of production or analysis that are generally known in the pharmaceutical industry but have been or will be applied to a Divested Product, HA, Puricase or any CPC Product. 



 

	 	2.7.	 Savient hereby grants BTG and its Affiliates a non-transferable, royalty-bearing, perpetual, worldwide
nonexclusive, unconditional (save for the reasonable consideration to be paid for commercialization rights hereunder) license, under the Puricase Patent to develop products which are not PEGylated recombinant porcine uricase (urate oxidase), and to
manufacture and commercialize any such product, it being understood and agreed, however, that the royalties that will be due and payable by BTG to Savient in respect of the commercialization rights to any such product, and other terms and conditions
of such license, shall be subject to the negotiation, in good faith, of a mutually acceptable license agreement containing normal and customary terms for transactions of a similar nature (the “License Agreement”). Should the Parties
fail to execute the License Agreement within 90 (ninety) days of either Party initiating such negotiations, then the matter may be referred for resolution by either Party, in accordance with the provisions and the procedures attached hereto as
Annex F. Nothing in the Parties’ failing to execute the License Agreement or the initiation or conduct of any such procedures shall bar BTG from exercising the license granted to it pursuant to this Section 2.7 pending the decision of
the expert. 


  

	 	2.8.	 The provisions of this Section 2 shall survive the termination or expiration of this Agreement.



  

	 	3.	 Research & Development; Regulatory Services; Manufacturing Services 



 

	 	3.1.	 BTG hereby agrees to the extent and on the terms set out in Annexes “C” and
“D” hereto (as such Annexes may be modified or superseded by a final definitive agreement between the Parties) to (i) complete the ongoing research and development currently being conducted in respect to Puricase; (ii)
transfer the process to BTG’s facility in Be’er Tuvia, Israel; (iii) produce a sufficient quantity of Puricase as required for Phase 3 clinical trials and the initial commercial launch of Puricase and perform all related stability and
other testing and activities required for worldwide regulatory filing; (iv) render assistance to Savient in 



  
 - 6 - 














	 	 
relation to the worldwide regulatory filings related thereto; and (v) remain a back-up supplier to the new manufacturer (if any) throughout the time period set forth in Section E of Annex
“D” attached hereto or any successive Manufacturing Services Agreement between the Parties. 


  

	 	3.2.	 In the event that BTG breaches any of its obligations to Savient under this Section 3, in addition to any other
remedies that may be available to Savient in law or equity, BTG shall, promptly upon Savient’s request, cooperate and collaborate with Savient in applying to the OCS for Savient to carry out the work in question through a third party. Nothing
in the foregoing should be construed as relieving BTG from its contractual obligations pursuant to Section 3.1, and Annexes “C” and “D” attached hereto. 



 

	 	4.	 Technology Transfer 



Subject to the approval of the OCS, Savient shall be entitled to request BTG to render to Savient and/or its third party manufacturer
technical assistance relating to the transfer of the Puricase Technology or the CPC Technology. The terms and conditions upon which BTG shall be obligated to render such assistance in relation to the Puricase Technology are set out in
Annex “E” attached hereto. 
  

	 	5.	 Compliance with Law for the Encouragement of Research and Development in Industry and the Regulations,
Rules and, Procedures Promulgated Thereunder (collectively, the “Law”) 


  

	 	5.1.	 BTG hereby confirms and acknowledges that as from the Closing BTG and/or the Buyer (as the case may be)
shall be fully responsible for the payment of Royalties pursuant to the Law in relation to income derived from the Divested Products and income derived by BTG from the commercial exploitation of a CPC Product pursuant to the license granted to it by
Savient pursuant to Section 6.2 below, and BTG hereby agrees to indemnify Savient for any liability that may be imposed upon it by the OCS in relation thereto. BTG shall provide Savient with copies of its semi-annual reports to the OCS in relation
to the payment of such Royalties, together with evidence of payment. Moreover, BTG shall notify Savient of any audit conducted by the OCS in respect thereto and the result of such audit, and provide Savient with copies of any written audit report.
BTG has been using the CPC Technology in the production of caroboxpeptidase as of February 2005, and Royalties pursuant to 



  
 - 7 - 














	 	 
the Law in relation to income derived from carboxypeptidase are thus payable to the OCS. As there is uncertainty as to whether these Royalties should be allocated to OCS file 27141 (Puricase)
and/or OCS file 10281 (APA), it is hereby agreed that BTG and Savient shall mutually refer the question of the allocation of such Royalties and the relevant background information to Keren Tmurah at the OCS (“Keren Tmurah”) within
30 days of this Agreement, and Keren Tmurah’s directives shall be binding upon the Parties. 


  

	 	5.2.	 Savient hereby confirms and acknowledges that as from the Closing Savient shall be fully responsible for the
payment of Royalties pursuant to the Law in relation to income derived by Savient from Puricase, Puricase Technology, a CPC Product and the CPC Technology and hereby agrees to indemnify BTG for any liability that may be imposed upon it by the OCS in
relation thereto. 


  

	 	5.3.	 Due to the fact that BTG shall remain a conduit for the payment of Royalties as set forth in Section 5.2,
and in order to ensure Savient’s compliance with the requirements of the Law, Savient irrevocably and unconditionally undertakes to periodically provide BTG with the funds required for making such payments of Royalties in a timely manner. In
furtherance thereof: 


  

	 	5.3.1.	 Savient shall provide BTG with semi-annual reports on its development and commercialization activities in
respect of Puricase, Puricase Technology, the CPC Products and the CPC Technology, and any other information related thereto, that may be requested by the OCS from time to time, for conveyance to the OCS, as required. Such reports shall be
accompanied by a financial report signed by Savient’s Chief Financial Officer showing the calculation of the amounts due to the OCS pursuant to the Law in respect of the period covered by the said report and the funds necessary to make the
appropriate payments to the OCS, it being understood and agreed, however, that the funds will be transferred by Savient to BTG by no later than 15 (fifteen) days before timely payment has to be made by BTG to the OCS. Such financial reports shall be
certified by an independent auditor, once a year, at Savient’s expense. 


  

	 	5.3.2.	 Savient shall keep complete, accurate and correct books of account and records consistent with sound
business and US generally accepted accounting 



  
 - 8 - 














	 	 
principles and practices, in such form and in such details as to enable the verification and the determination of the amounts due to the OCS in respect of Puricase, Puricase Technology, the CPC
Products and the CPC Technology. Savient shall retain such books of account for 7 (seven) years after the end of each calendar year. 


  

	 	5.4.	 BTG hereby undertakes to irrevocably and unconditionally remit the funds received from Savient pursuant to
Section 5.3.1 above to the OCS in a timely manner, without any set-offs, deductions or withholdings of any nature. 


  

	 	5.5.	 BTG and Savient shall comply with any request by the OCS to conduct, inter alia, an audit at Savient.
In such event, BTG and/or the OCS shall be entitled to appoint a representative to inspect, during normal business hours, and to take copies of Savient’s books of accounts, records and other documentation to the extent relevant or necessary for
the ascertainment or verification of the amounts due to the OCS under the Law, at Savient’s expense. 


  

	 	6.	 CPC Patents 



 

	 	6.1.	 In addition to BTG’s rights in relation to the CPC Technology, as set out in Section 2.2 above, Savient
hereby grants BTG and its Affiliates an irrevocable, fully paid-up, transferable, non-royalty-bearing, perpetual, worldwide, exclusive, unconditional license, under the CPC Patents, to offer for sale, sell and import Divested Products and HA.
Nothing in the foregoing shall be construed as a representation on BTG’s part, that such license, or the rights set out in Section 2.2, are required in order to develop, manufacture or commercialize any or all of the Divested Products or HA.



  

	 	6.2.	 Savient hereby grants BTG and its Affiliates a non-transferable, royalty-bearing, perpetual, worldwide
nonexclusive, unconditional (save for the reasonable consideration to be paid for commercialization rights hereunder) license, under the CPC Patents to offer for sale, sell and import CPC Products, it being understood and agreed, however, that the
royalties that will be due and payable by BTG to Savient in respect of the commercialization rights and other terms and conditions of such license, shall be subject to the negotiation, in good faith, of a mutually acceptable license agreement
containing normal and customary terms for transactions of a similar nature (the “CPC License Agreement”). Should the Parties fail to execute the CPC License Agreement within 90 (ninety) days of either Party




  
 - 9 - 














	 	 
initiating such negotiations, then the matter may be referred for resolution by either Party, in accordance with the provisions and the procedures attached hereto as Annex F.
Nothing in the Parties’ failing to execute the CPC License Agreement or the initiation or conduct of any such procedures shall bar BTG from exercising the license granted to it pursuant to this Section 6.2 pending the decision of the expert.
Nothing in the foregoing shall derogate from the terms and conditions of any existing supply, manufacturing or development agreement between the Parties. 


  

	 	6.3.	 Should Savient decide to abandon a CPC Patent at any time during the first 5 (five) years following the
Closing; Savient undertakes to notify BTG in writing at least 60 (sixty) days prior to the date on which such CPC Patent would become finally abandoned in the absence of action on the part of the party prosecuting or maintaining such patent. Savient
shall afford BTG the right, during such 60 (sixty) day period, to acquire such patent application or patents. Should the Parties fail to reach a mutually acceptable agreement as to the terms and conditions upon which BTG may acquire such patent
applications or patents, Savient shall be entitled to abandon the same. 


  

	 	7.	 BTG-271 



 

	 	7.1.	 Prior to the Closing, Savient shall either (a) transfer the patent applications listed in Annex
“G” attached hereto (the “BTG-271 Patents”) to a third party and arrange with the OCS for a full release of BTG’s obligation to pay royalties to the OCS with respect to subsequent sales in relation thereto or
(b) transfer the BTG-271 Patents to BTG. 


  

	 	7.2.	 Subject to OCS approval, BTG undertakes to relinquish its rights in the BTG-271 project under the OCS Letter
in the event that the BTG-271 Patents are transferred to a third party prior to the Closing or as envisaged under Section 7.3 below. 


  

	 	7.3.	 Notwithstanding the foregoing, should negotiations between Savient and Eager BioGroup Ltd., a corporation
registered in Israel, or any affiliated company registered in Israel and controlled by Prof. Max Herzberg, be ongoing at the time of the Closing, Savient shall have an additional period of 90 (ninety) days from the Closing in order to finalize such
transaction (the “Eager Transaction”), and Savient shall bear the cost of the BTG-271 Patents throughout such time period. Should the Eager Transaction not be consummated with OCS approval within such time period, for any reason
whatsoever, then the BTG-271 Patents shall be transferred to BTG. 



  
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	 	7.4.	 Should the BTG-271 Patents be transferred to BTG, then BTG-271 shall be treated as a “Divested
Product” for purposes hereof. 


  

	 	8.	 Promoter Patents 



 

	 	8.1.	 BTG hereby grants Savient a fully paid-up, non-royalty-bearing, perpetual, worldwide nonexclusive license,
with the right to sub-license, under the patents and patent applications listed in Annex “H” attached hereto (the “Promoter Patents”), to use the Osm B promoter claimed therein to make, have made, use, offer
for sale, sell and import Puricase, it being understood and agreed, however, that the manufacture “of Puricase outside of Israel is subject to the approval of the OCS. 



 

	 	8.2.	 BTG shall favorably consider any request by Savient to expand the scope of the license granted to it under
Section 8.1. In such circumstances, the Parties shall negotiate in good faith with a view towards entering into a mutually acceptable license agreement containing normal and customary terms for transactions of a similar nature.



  

	 	8.3.	 Should BTG decide to abandon any of the Promoter Patents at any time during the first 5 (five) years
following the Closing, BTG undertakes to notify Savient in writing, at least 60 (sixty) days prior to the date on which such Promoter Patent would become finally abandoned in the absence of action on the part of the party prosecuting or maintaining
such patent. BTG shall afford Savient the right, during such 60 (sixty) day period, to acquire such patent application or patents. Should the Parties fail to reach a mutually acceptable agreement as to the terms and conditions upon which Savient may
acquire such patent applications or patents, BTG shall be entitled to abandon the same. 


  

	 	9.	 Indemnification 



Each Party shall indemnify, hold harmless and defend the other Party and its officers, directors and employees against
damages, costs and expenses (including reasonable attorney’s fees) incurred as a result of such Party’s failure to comply with its undertakings under this Agreement. 

 

	 	10.	 Term; Effect of Termination 



 

	 	10.1.	 This Agreement shall enter into force and effect upon the Closing and shall continue to be in force for as
long as the Puricase Technology and the CPC Technology is in use by either Party. 



  
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	 	10.2.	 Should the Divestiture Agreements be terminated without the Closing taking place, for any reason whatsoever,
this Agreement shall be null and void. 


  

	 	10.3.	 The termination of this Agreement for whatever cause shall not prejudice or affect the accrued rights and
obligations of either Party. 


  

	 	11.	 Disclosure of Information 



 

	 	11.1.	 BTG and its Affiliates shall not furnish copies of documents, patents, patent applications, copyrights,
drawings, specifications, bills of materials, devices, equipment, prototypes and other information relating to the Puricase Technology other than as contemplated by this Agreement (and other than to any of their respective Affiliates) and shall not,
without the prior approval of Savient, disclose such information to any third party, except to the extent that such disclosure is necessary for BTG’s manufacture of Puricase for Savient, and then only if (i) such disclosure is subject to the
same limitations on the recipient as on BTG, and (ii) such limitations are set forth in a written agreement in form and substance satisfactory to Savient. “Affiliate”, as used herein, means, any corporation which controls, is
controlled by, or is under common control with, BTG, following the Closing. A corporation shall be deemed to control another corporation if it owns, directly or indirectly, more than 50% (fifty percent) of the voting shares, or has the power to
elect more than half the directors, of such other corporation. For purposes of this Section 11.1, “Puricase Technology” shall not include information which is in or becomes, part of the public domains through no act or omission by
BTG or any of its employees. 


  

	 	11.2.	 No publication with respect to any activity undertaken pursuant to a Development Program shall be made, nor
any manuscript submitted for publication, without the prior review and written approval of Savient such approval not to be unreasonably withheld. 


  

	 	11.3.	 The Parties agree that remedies at law may be inadequate to protect against breach of this Section 11, and
in case of such a breach BTG hereby consents to the granting of injunctive relief, whether temporary, preliminary or final, in favor of Savient without proof of actual damages. 



 

	 	11.4.	 The provisions of this Section 11 shall survive the termination or expiration of this Agreement.




  
 - 12 - 














	 	12.	 Non - Compete 



From the Closing Date until the expiration of the later to expire (following issuance) of the Puricase Patents; BTG agrees
not to, and shall cause its Affiliates not to, use the Puricase Technology to manufacture, promote, market or sell any Competing Product in the Territory, or to license or sublicense the Puricase Technology to any third party. As used in this
Agreement, “Competing Product” shall mean any prescription pharmaceutical product that (i) contains uricase as an active ingredient or (ii) has a primary use in a particular country, based on a majority of prescription use in such country,
for the treatment of gout (in any form). As used in this Agreement, “Territory” shall mean, collectively, every country in the world. 
  

	 	13.	 Governing Law and Dispute Resolution 



 

	 	13.1.	 This Agreement and any disputes hereunder shall be governed by and construed in accordance with the laws of
the State of New York, United States of America, without giving effect to any choice or conflict of law provision or rule that would cause the application of any other laws. 



 

	 	13.2.	 Save as provided in Section 6.2 hereof, any disputes, claims or controversies between the Savient and BTG in
connection with this Agreement, including any question regarding its formation, existence, validity, enforceability, performance, interpretation, breach or termination (any such dispute, claim or controversy, a “Dispute”), shall be
finally resolved by binding arbitration. 


  

	 	13.3.	 Any arbitration hereunder shall be conducted under the Rules of Arbitration of the London Court of
International Arbitration. The arbitration shall be conducted in the English language before three arbitrators chosen according to the following procedure: within 20 (twenty) days after commencement of the arbitration, each of Savient and BTG shall
appoint one arbitrator, and within 20 (twenty) days after the appointment of both such arbitrators, the two arbitrators so chosen shall choose the third arbitrator. If the two arbitrators chosen by Savient and BTG cannot agree on the choice of the
third arbitrator within a period of 20 (twenty) days after their appointment, then the third arbitrator shall be appointed by the London Court of International Arbitration. 



 

	 	13.4.	 Each of the arbitrators shall be a lawyer or former judge. The chairman of the three arbitrators shall have
experience arbitrating disputes in the pharmaceutical industry. 


  

	 	13.5.	 Any arbitration that would otherwise be conducted pursuant to this Section 13 that relates to the subject
matter of any arbitration 



  
 - 13 - 














	 	 
conducted pursuant to Section 10.15 of the SPA shall be combined into a single arbitration before the same panel of three arbitrators, conducted in accordance with Section 10.15 of the SPA.



  

	 	13.6.	 Each of the Asset Buyer and the Seller hereby irrevocably waives all rights to trial by jury in any Dispute.



  

	 	13.7.	 The place of the arbitration shall be London, England. 



 

	 	14.	 Miscellaneous 



 

	 	14.1.	 Unless the context explicitly dictates otherwise, all references herein to “patents” and/or
“patent applications” herein shall be deemed to include any disclosures, continuations, continuations-in-part, divisionals, provisionals, PCT applications, reissuances, revisions, substitutions, conversions, renewals, extensions,
prolongations, and re-examinations thereof, any technology and inventions covered thereby, and any corresponding international, regional and national applications. 



 

	 	14.2.	 From time to time after the date hereof and prior to the Closing, the Parties may modify and/or replace any
of Annexes C, D or E hereto, which modified or replaced Annexes shall automatically constitute part of this Agreement. 


  

	 	14.3.	 Nothing in this Agreement or in the Divestiture Agreements shall derogate from BTG’s rights under the
Technology Transfer Agreement effective February 1, 1998, pursuant to which BTG acquired Savient’s process for the manufacture of sodium hyaluronate (“HA”), as described and claimed in U.S. Patent No. 4,780,414, and the related
patent applications, patents, trademarks and domain names listed in Annex “I”. Savient and its employees shall provide BTG, without compensation, with the necessary authorizations, powers of attorney and other documents and
assistance reasonably requested by BTG from time to time to record the assignment of said intellectual property rights from Savient to BTG. 


  

	 	14.4.	 This Agreement constitutes the entire agreement between Savient and BTG with respect to the subject matter
hereof, and supersedes any prior agreements or understandings between Savient and BTG with respect to such matters. 


  

	 	14.5.	 Each Party agrees to execute, acknowledge and deliver such further documents and instruments and do any
other acts, from time to time, as may be reasonably necessary, to effectuate the purposes of this Agreement. 



  
 - 14 - 














	 	14.6.	 Neither this Agreement nor any of the rights, interests, or obligations hereunder may be assigned by either
Party without the prior written consent of the other Party hereto, except that either Party may assign its rights hereunder to any entity that acquires all or substantially all of such Party’s business or assets (provided that no such
assignment shall relieve the assigning Party of its obligations hereunder, and the assigning Party shall remain primarily liable for such obligations). Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the
Parties and their respective successors and permitted assigns. 


  

	 	14.7.	 All notices, requests, demands, claims and other communications hereunder shall be in writing. Any notice,
request, demand, claim or other communication hereunder shall be deemed duly delivered four Business Days after it is sent by registered or certified mail, return receipt requested, postage prepaid, or one Business Day after it is sent by overnight
delivery via a reputable national courier service, in each case to the intended recipient as set forth below: 



If to Savient: 

Savient Pharmaceuticals Inc. 

One Tower Center, l4th Floor 

East Brunswick, New Jersey 08816, USA 

Telecopy: +1-732-418-9065 

Attention: Philip K. Yachmetz, Esq. 

If to BTG: 

Bio-Technology General (Israel) Ltd. 

Kiryat Weizmann 

Building 17 

Rehovot 76326, Israel 

Telecopy: +972-8-9409041 

Attention: Dr. Dov Kanner 

A “Business Day” shall be any day other than (i) a Saturday or Sunday or (ii) a day on which banking institutions
located in New York, New York, United States of America or in Israel are permitted or required by law, executive order or governmental decree to remain closed. 

Any Party may give any notice, request, demand, claim, or other communication hereunder using any other means (including
personal delivery, expedited courier, messenger service, telecopy, 

  
 - 15 - 













 
telex, ordinary mail, or electronic mail), but no such notice, request, demand, claim or other communication shall be deemed to have been duly given unless and until it actually is received by
the Party for whom it is intended. Any Party may change the address to which notices, requests, demands, claims and other communications hereunder are to be delivered by giving the other Party notice in the manner herein set forth. 

 

	 	14.8.	 Savient and BTG may mutually amend or waive any provision of this Agreement at any time. No amendment or
waiver of any provision of this Agreement shall be valid unless the same shall be in writing and signed by both of the Parties. 


  

	 	14.9.	 Any term or provision of this Agreement that is invalid or unenforceable in any situation in any
jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions hereof or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction. If the final judgment
of a court of competent jurisdiction declares that any term or provision hereof is invalid or unenforceable, the Parties agree that the body making the determination of invalidity or unenforceability shall have the power to reduce the scope,
duration or area of the term or provision, to delete specific words or phrases, or to replace any invalid or unenforceable term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of
the invalid or unenforceable term or provision, and this Agreement shall be enforceable as so modified. 


  

	 	14.10.	 Except as otherwise specifically provided to the contrary in this Agreement, each of the Parties shall bear
its own costs and expenses (including legal fees and expenses) incurred in connection with this Agreement and the transactions contemplated hereby. 


  

	 	14.11.	 This Agreement may be executed in one or more counterparts, each of which shall be deemed an original; but
such counterparts shall together constitute but one and the same instrument. 


 [Intentionally Left Blank] 

  
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 IN WITNESS WHEREOF the Parties hereto have set their signatures as of the date first
mentioned above. 
 /s/ Christopher
Clement                                   

SAVIENT PHARMACEUTICLAS, INC. 

By: Christopher Clement 
 Title:
President and Chief Executive Officer 
 /s/ Philip K. Yachmetz
                                         
        
 BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. 

By: Philip K. Yachmetz 
 Title:
Director 
 List of Annexes: 
  

			
	Annex “A”	  	OCS letter
	Annex “B”	  	Puricase Patents
	Annex “C”	  	Development and Regulatory Work - Puricase
	Annex “D”	  	Term Sheet for Manufacture of Puricase
	Annex “E”	  	Term Sheet for Technology Transfer
	Annex “F”	  	Expert Procedures
	Annex “G”	  	BTG-271 Patents
	Annex “H”	  	List of osmB promoter patents/patent applications
	Annex “I”	  	List of HA Patents, Trademarks and Domain Names














 Annex A 

OCS letter 













			
	



	    	 One Tower Center
 Fourteenth Floor

East Brunswick, NJ 08816
 Telephone:
732-418-9300
 Facsimile: 732-418-9065
 www.savientpharma.com


 July 15, 2003 

Mr. Avi Feldman, Esq. 
 General Counsel to the 

Office of the Chief Scientist 
 Ministry of Industry, Trade and
Labor 
 4 Mevo Hamatmid Street 
 Jerusalem 91021 

Dear Mr. Feldman, 

Re:        Bio-Technology General (Israel) Ltd. (“BTG Israel”) 

We have been informed of the meeting that took place in Jerusalem on June 15, 2003 with the participation of representatives of the Chief Scientist (the
“CS”) and BTG Israel. 
 We understand that during the course of the meeting, the parties resolved certain issues that arose in relation to CS-approved R & D programs at BTG Israel (the “Approved Programs”) as follows: 
  

	1.	 BTG Israel will have title to all future Approved Programs, relating to new projects. 



 

	2.	 BTG Israel will have an exclusive irrevocable and perpetual right from us to conduct R&D with technology
developed in the course of Approved Programs which are completed or ongoing, excluding clinical trials that BTG Israel is not in a position to monitor from Israel; and 



 

	3.	 Except as otherwise approved by the CS, BTG Israel will have an exclusive right from us to manufacture in
Israel products developed through Approved Programs.. 


 We understand that the CS will not unreasonably withhold its consent to the
conduct of such R&D activities outside of Israel if BTG Israel is finable to carry out such activities, or the manufacture of such products outside of Israel, if commercially unfeasible or if BTG Israel is unable to carry out such activities.

 We also understand it was agreed that upon receipt of our agreement to the foregoing, funds withheld by the CSO upon the 2002 audit as well as funds that
would otherwise have been payable in 2002 (if properly spent and reported) will be immediately released to BTG Israel. 












 On the basis of such understandings, and without waiving any rights that we may have from time to time under
the Law for the Encouragement of Research and Development in Industry, we hereby confirm our agreement to the understandings set out above. 
 Respectfully
yours, 
 /s/ Sim Fass 
  

			
	Savient Pharmaceuticals, Inc.
	By:	 	  Sim Fass
	Title:	 	  Chairman & CEO
		
	cc:	 	  Mr. Amos Efrati
		 	  Mr. Shaul Freilich
		 	  Deputies to the Chief Scientist
		
		 	  Y. Baratz
		 	  D. Kanner
		 	  R. Shaw













 Annex B 

Puricase Patents 
  

	1.	 New Applications 



 

	 	1.1.	 Puricase 


  

											
	
File

Reference
	  	Country  	  	Status	  	Appln No	  	Appln Date	  	Title
	
557-PRO-US
	  	
USA
	  	
Pending    
	  	60/670573    	  	
11 April, 2005    
	  	Variant Forms of Urate Oxidase and Use Thereof
	
650-PRO-US
	  	
USA
	  	
Pending    
	  	60/670541    	  	
11 April, 2005    
	  	A Variant Form of Urate Oxidase

  

	 	1.2.	 Protein Purification 



 

											
	
File

Reference
	  	Country  	  	Status	  	Appln No	  	Appln Date	  	Title
	
541-PRO-US
	  	
USA
	  	
Pending    
	  	60/670520    	  	
11 April, 2005    
	  	Purification of Proteins with Cationic Surfacant













 Annex C 

Development and Regulatory Work 

Puricase 
 The following
outline summarizes the key elements of ongoing development work and regulatory services relating to Puricase which will be required from BTG as from the Closing, certain elements of which are required under agreement with the OCS. This outline will
form the basis of a detailed work plan covering these activities, which will be concluded prior to the Closing. It is anticipated that the detailed work plan when completed, will include a specific list of deliverables and a timetable for
performance and delivery. 
 While every effort has been utilized to make this outline as comprehensive as possible, certain activities
shown here may need to be expanded to include normal and customary related activities. 
  

	1.	 Project Timeline 



Puricase is currently completing Phase 2 clinical testing and Savient expects to initiate Phase .3 testing in late 2005.
Assuming FDA agreement with the proposed clinical plan and a successful clinical trial, the Puricase Biologics License Application (“BLA”) filing is expected to take place in Q1 2007. Services to be provided by BTG (with the exception of
certain ongoing stability studies) are to be planned for completion by 1 Jan 07. 
  

	2.	 Scope of Work 



 

	 	2.1.	 R& D Services 



The R & D services to be provided involve completion of needed elements in the Chemistry/Manufacturing/Controls
(CMC) section of the Puricase BLA. These elements are listed in Table 1, along with an indication of which tasks will be performed for Phase 3 and which tasks will be completed by BLA filing. 

 

	 	2.2.	 Regulatory Services 



The Regulatory services involve elements needed to complete the relevant sections of the BLA as well as other documentation,
and appropriate support for the various filings. This includes, but is not limited to: 
  

	 	2.2.1.	 preparation of the CMC update for the Phase 3 FDA package including a Rehovot-Beer Tuvia bridging document;



  

	 	2.2.2.	 development and preparation of the requisite assays; 



 

	 	2.2.3.	 analytical method validation; 















	 	2.2.4.	 preparation of process validation documents; 



 

	 	2.2.5.	 annual report preparation (CMC, stability, process updates); 



 

	 	2.2.6.	 preparation of the CMC chapter of the BLA (process, methods, validations, specifications);



  

	 	2.2.7.	 participation in meetings and calls with Savient (e.g. preparation for the end of Phase 2 [EOP21 meeting);



  

	 	2.2.8.	 participation in meetings with regulatory authorities (e.g. the EOP2 meeting); and 



 

	 	2.2.9.	 support for any and all regulatory activities required for worldwide registrations. 



 

	 	2.3.	 Reporting - BTG shall provide Savient with the necessary development reports to support the methods,
specifications and in-process controls that are chosen, in a form acceptable o FDA inspectors and reviewers. 


  

	3.	 Financial provisions 



 

	 	3.1.	 Services will be provided at (i) 115% of BTG-’s fully loaded
cost including only the proportional share of overhead related to this project, as compared to maximum facility utilization, and not including raw Materials or equipment and (ii) 103% of the out-of-pocket cost to BTG of purchasing raw materials for manufacturing Product and equipment used primarily or exclusively to provide the ongoing development work and regulatory services contemplated by this
Annex C. 


  

	 	3.2.	 Reporting and audit rights 



 

	 	3.3.	 Payment terms 


  

	4.	 Miscellaneous Terms 



 

	 	4.1.	 Services will be carried out in a professional and workmanlike manner. 



 

	 	4.2.	 Ownership of results and in any inventions to vest in Savient 



 

	 	4.3.	 Patents to be filed and maintained by Savient 



 

	 	4.4.	 Indemnification of BTG from and against any claims in relation to Savient’s use of the
results/inventions 


  

	 	4.5.	 Confidentiality 


  


	 	4.6.	 No assignment of rights or obligations other than to a party acquiring rights in the Product.















 Annex D 

Term Sheet 

Manufacturing Services 

The following outline summarizes the key elements of manufacturing services that will be required from BTG as contract manufacturer with
respect to the manufacturing Puricase (the “Product”), as required from BTG as from the Closing. This outline will form the basis of a detailed work plan covering these activities, which will be concluded prior to the Closing. It is
anticipated that the detailed work plan when completed, will include a specific list of deliverables and a timetable for performance and delivery. 

While every effort has been utilized to make this outline as comprehensive as possible, certain activities shown here may need to be expanded
to include normal and customary related activities. 
 BTG has to date performed all Product manufacture at its Kiryat Weizmann facility.
For Phase 3 material, the new Biologics GMP-compliant Beer Tuvia facility will be used. BTG will transfer the production process to Beer Tuvia and validate the process by producing three Product batches which
will serve as clinical supply and, if Product stability and timing of BLA approval permit, as initial commercial launch material. Filling (vialling) of finished Product will take place at Dr. Madaus, EITG’s contract filling facility. 

These terms and conditions shall be binding upon the Parties, unless and until superseded by a definitive Manufacturing Services Agreement
and/or a detailed work plan: 
 General Obligations of BTG 
  


	A.	 Transfer of production to Beer Tuvia and manufacture of one batch of Product in Beer Tuvia (by Sep 05), to
be finished into a Phase 3 clinical lot of Product at Madaus (Sep 05); 


  

	B.	 Completion of process validation by production of two additional batches (H1 06); 



 

	C.	 Filling of two additional lots in order to complete production validation (H2 06). 



 

	D.	 BTG and Savient will work together in good faith to prepare prior to Closing a definitive Manufacturing
Services Agreement memorializing the terms and conditions of this Annex D with respect to the Phase 3 and initial commercial supply of the Product and related activities. In addition, BTG and Savient will negotiate in good faith prior to the Closing
with the goal of reaching a long-term exclusive supply agreement for Product on commercially competitive terms, provided that any such agreement would permit the technology transfer, as outlined in Annex E, and qualification of an alternative
supplier chosen by 















	 	 Savient. 


  

	E.	 In the event that no such long-term exclusive supply agreement is reached
between-BTG and Savient prior to the Closing, (i) BTG shall remain available as commercial scale manufacturer of Product until successor manufacturer is selected, technology transfer, as outlined in Annex
E, has been successfully completed and successor manufacturer has been qualified and validated; and thereafter BTG shall remain available as a “back-up” supplier of Product upon reasonable notice and
other terms and conditions and (ii) BTG and Savient will use commercially reasonable efforts to complete the technology transfer as outlined on Annex E within 36 months of its commencement, upon which completion of such technology transfer
BTG’s obligation to supply Product will termination; provided, however, that if such technology transfer will not or cannot reasonably be successfully completed within such 36-month period, BTG and
Savient will enter into good faith discussions to determine an alternative arrangement for continued supply of Product on reasonable terms to be mutually agreed. 



 

	1.	 Clinical Grade Peguricase for Phase 3 clinical trials 



 

	 	1.1.	 BTG to set up capabilities for manufacturing in Be’er Tuvia 



 

	 	1.1.1.	 Product specifications 



 

	 	1.1.2.	 production capacity and quantities to be produced 



 

	 	1.1.3.	 cost of setting up production facilities 



 

	 	1.1.4.	 timetable for setting up production facilities 



 

	 	1.1.5.	 cost of FDA inspections 



 

	 	1.2.	 Savient to acquire all Product so manufactured. 



 

	 	1.2.1.	 Placement of orders 



 

	 	1.2.2.	 Delivery terms - The risk of loss will pass to Savient upon delivery of Product and confirmation that it
meets the specifications. 


  

	 	1.2.3.	 Price – (1) 115% of BTG’s fully loaded cost including only the proportional share of overhead
related to this project, as compared to maximum facility utilization, and not including raw materials or equipment and (ii) 103% of the out-of-pocket cost to BTG of
purchasing raw materials for manufacturing Product and equipment used primarily or exclusively to manufacture Product. 


  

	 	1.2.4.	 Reporting and audit rights 



 

	 	1.2.5.	 Payment terms 


  

	2.	 Supply of Commercial Quantities 



 

	 	2.1.	 Lead time - Savient will advise BTG if and when it requires 














 commercial quantities of the Product, at least 12 months in advance. 

 

	 	2.2.	 BTG to set up capabilities for manufacturing in Be’er Tuvia 



 

	 	2.2.1.	 Product specifications 



 

	 	2.2.2.	 capacity and quantities to be produced 



 

	 	2.2.3.	 cost of setting up production facilities 



 

	 	2.2.4.	 timetable for setting up production facilities and validation: 



 

	 	2.2.5.	 cost of FDA inspections 



 

	 	2.3.	 Purchase of Product 



 

	 	2.3.1.	 Minimum orders over ..X years 



 

	 	2.3.2.	 Placement of orders 



 

	 	2.3.3.	 Price — (i) 115% of BTG’s fully loaded cost including only the proportional share of overhead
related to this project, as compared to maximum facility utilization, and not including raw materials or equipment and (ii) 103% of the out-of-pocket cost to BTG of
purchasing raw materials for manufacturing Product and equipment used primarily or exclusively to manufacture Product. 


  

	 	2.3.4.	 Reporting and audit rights 



 

	 	2.3.5.	 Delivery terms 


  

	 	2.3.6.	 Payment terms 


  

	3.	 General Provisions 



 

	 	3.1.	 Grant of license by Savient to BTG to utilize the Technology required to manufacture the Product, solely for
such purpose. 


  

	 	3.2.	 BTG to set up the production line and manufacture Product in compliance with Good Manufacturing Practices
(“GMPs”) and other applicable regulatory requirements. The production line and facility requirements will be subject to a technical annex to the agreement that will detail the requirements for the establishment of the production line and
operational and performance criteria, without limitation. 


  

	 	3.3.	 If BTG terminates on or prior to December 31, 2005 the employment of any of the 12 employees of BTG who
were employed by BIG on a temporary basis as of March 21, 2005 for the purposes of assisting with activities related to the product transfer to BTG’s Be’er Tuvia facility including the transfer and manufacture of Product, and any such
employee is entitled to any severance payment pursuant to Israel law as a result of such termination, then Savient shall reimburse BTG for the actual amount of such severance payment (without, for the avoidance of doubt, increasing such payment by
15% pursuant to Section 1.2.3 above). 















	 	3.4.	 In the event of failed batches manufactured strictly in adherence with the specifications of the
manufacturing process, the cost of batch failures will be borne equally between Savient and BTG based on the actual labor and raw materials cost with no mark-up or increase in such costs pursuant to
Section 1.2.3; provided however that any batch failure that results from negligence or misconduct by BTG will be borne solely by BTG. 


  

	 	3.5.	 BTG to obtain and maintain all permits, approvals and licenses required to manufacture the Product



  

	 	3.6.	 The definitive Manufacturing Agreement or work plan shall include agreed upon success criteria for all
manufacturing lots, including those for consistency and stability testing and validation criteria for aseptic filling processes which shall be designed to meet all required worldwide regulatory requirements. 



 

	 	3.7.	 Savient shall be entitled, but not obliged, to receive and to test samples of the Product.



  

	 	3.8.	 BTG shall keep true and complete records on all production and shipment of Product in sufficient detail to
enable Savient to determine the quantity of Product produced and the disposition of such Product, and shall grant Savient access during normal business hours following prior written notice. 



 

	 	3.9.	 BTG shall prepare a batch file for each batch of Product demonstrating compliance with the Specifications
and provide same to Savient. BTG will retain copies for its records. 


  

	 	3.10.	 BIG shall perform all analytical activities required by the Technology or as may be requested by Savient
from time to time. 


  

	 	3.11.	 BTG shall store representative samples of Product for the minimum legal period provided by applicable laws
or as reasonably requested by Savient. 


  

	 	3.12.	 BTG shall inform Savient in writing of any significant modification in the manufacturing process.



  

	 	3.13.	 BTG shall permit Savient to inspect the production line and to verify the method and quality of production
and the relative documentation. 


  

	 	3.14.	 Risk of loss will pass to Savient upon delivery of Product and confirmation that it meets the
Specifications. Savient shall analyze or have Product analyzed within 30 days of delivery. Any Product not meeting the Specifications shall be destroyed and replaced by BTG at its sole cost and expense. In the event that BTG disputes Savient’s
evaluation of non-compliance, the disputed Products will be analyzed by an independent laboratory chosen by mutual consent. If the laboratory confirms non-compliance
with the Specifications, BTG shall reimburse Savient for the expense of the analysis and associated expenses. 















	 	3.15.	 Packaging and labeling of commercial Product shall be carried out in accordance with Savient’s
instructions and applicable laws. 


  

	 	3.16.	 BTG shall be responsible for obtaining any export license required under applicable laws.



  

	 	3.17.	 Insurance requirements in respect of both parties. 



 

	 	3.18.	 Term 


  

	 	3.19.	 Termination for breach and effect of termination 



 

	 	3.20.	 Breach by BTG failure to meet the timetable during various phases/failure to produce Product meeting the
Specifications/ any other material breach - Savient shall have the right to direct BTG to (i) stop production of Product; (ii) discontinue the use of the Technology. 



 

	 	3.21.	 No Assignment - None of the rights, duties or obligations hereunder shall be assignable, except that Savient
may assign the same to any party acquiring rights to the Product. 


  

	 	3.22.	 Governing law 


  

	 	3.23.	 Arbitration 


  

	 	3.24.	 Should BTG be unwilling or unable to supply at any time: 



 

	 	3.24.1.	 BTG shall collaborate with Savient in requesting the OCS for permission to manufacture through a third
party; 


  

	 	3.24.2.	 BTG shall assist Savient in transferring the technology as per the provisions of Exhibit E of the Residual
Rights Agreement. 














 Annex E 

Term Sheet 
 Technology
Transfer 
 The following outline summarizes the key elements of the technology transfer relating to Puricase which may be required from BTG, after the
Closing. This outline will form the basis of a detailed work plan covering these activities, which will be concluded prior to the Closing. It is anticipated that the detailed work plan when completed, will include a specific list of deliverables and
a timetable for performance and delivery. 
 While every effort has been utilized to make this outline as comprehensive as possible, certain activities
shown here may need to be expanded to include normal and customary related activities. 
 These terms and conditions shall be binding upon the Parties,
unless and until superseded by a definitive Technology Transfer Agreement and/or a detailed work plan: 
  

	1.	 Scope of Work 



 

	 	1.1.	 Detailed Description 



 

	 	1.2.	 List of deliverables 



 

	 	1.3.	 Timetable for performance and delivery 



 

	2.	 Financial Provisions 



 

	    	 Services will be rendered at the rate of $ 400 per 8 hours man day, pro rata per partial day. payment terms



  

	3.	 General Provisions 



 

	 	3.1.	 Services shall be carried out by BTG in a professional and workmanlike manner. 



 

	 	3.2.	 Technical assistance to be provided in an advisory capacity. 



 

	 	3.3.	 Indemnification of BTG from and against any claims in relation to Savient’s use of the Technology.















 ANNEX F 

Expert Procedures 

Pursuant to Sections 2.5 and 6.2 of the Residual Rights Agreement: 
  

	1.	 Either Party may serve on the other Party notice (a “Referral Notice”) that it wishes to
refer to a single expert (the “Expert”) any dispute relating to the royalties due and payable by BTG to Savient and any other terms and conditions of the License Agreement or the CPC License Agreement. 



 

	2.	 The Expert shall be an independent and impartial person residing in the US or Israel, having significant
experience in the pharmaceutical industry, who shall be agreed upon by the Parties or, and in the absence of such agreement between the Parties, within 30 (thirty) days of the service of a Referral Notice, be appointed by the London Court of
International Arbitration. 


  

	3.	 Thirty (30) days after the appointment of the Expert pursuant to Paragraph 2, both Parties shall
provide the Expert with any information that the Expert may request in relation to the subject matter, with a copy to the other Party. 


  

	4.	 There shall be no hearing except that the Expert may call for a one day hearing if such Expert considers the
same to be desirable and appropriate. The Expert shall issue his/her reasoned decision in writing to the Parties within 30 days alter review of all evidence deemed necessary by him/her has been completed. 



 

	5.	 The seat of the dispute resolution shall be the normal place of business or residence of the Expert.



  

	6.	 The language of the dispute resolution shall be English. 



 

	7.	 The Expert shall not have power to alter, amend or add to the provisions of the Agreement.



  

	8.	 The Expert shall have the power to request copies of any documents in the possession and/or control of the
Parties which may be relevant to the dispute. The Parties shall forthwith provide to the Expert and the other Parties copies of any documents so requested by the Expert. 



 

	9.	 The Expert shall decide the dispute as an expert and not as an arbitrator. The Expert shall decide which
party or parties shall bear the costs involved for the Expert procedure and in what proportion. 


  

	10.	 The decision of the Expert shall be final and binding upon all of the Parties except in the case of manifest
error. The Parties hereby exclude any rights of application or appeal to any court, and in particular in connection with any question of law arising in the course of these procedures. 














 Annex G 

BTG-271 Patents 












 CONFIDENTIAL 

BTG 271 Patent Applications 
  

																	
	 	 	 	 	 	 	 	 	 
	Docket ID	  	File Ref.	  	Country	  	Status	  	Substatus	  	Appl. No	  	Appl. Date	  	Expiry	  	Applicant/ Patentees
	 	 	 	 	 	 	 	 	 
	
368/CA
	  	368-A-WO-CA	  	Canada	  	Pending	  	 	  	2283474	  	4 March 1998	  	4 March 2018	  	Savient
	 	 	 	 	 	 	 	 	 
	
368/EP
	  	368-A-WO-EP	  	EPO	  	Pending	  	 	  	98908909.9	  	4 March 1998	  	4 March 2018	  	Savient
	 	 	 	 	 	 	 	 	 
	
368/11K
	  	368-A/HK	  	Hong Kong	  	Pending	  	 	  	00104775.3	  	4 March 1998	  	4 March 2018	  	BTG Corp.    
	 	 	 	 	 	 	 	 	 
	
368/IL
	  	368-A-WO-IL	  	Israel	  	Pending	  	Published	  	131655	  	4 March 1998	  	4 March 2018	  	Savient
	 	 	 	 	 	 	 	 	 
	
368/US/4
	  	368-A-WO-US	  	USA	  	Pending	  	 	  	09/390225	  	3 September 1999	  	4 March 2018	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/AU
	  	456-1-PCT-AU	  	Australia	  	Pending	  	 	  	2002246737	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/AU/2
	  	456-ABC-PCT-AU	  	Australia	  	Pending	  	 	  	2002246738	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/BR
	  	456-1-PCT-BR	  	Brazil	  	Pending	  	Published	  	P10116763-4	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/BR/2
	  	456-ABC-PCT-BR	  	Brazil	  	Pending	  	 	  	 	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/CA
	  	456-1-PCT-CA	  	Canada	  	Pending	  	 	  	2433227	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/CA/2    
	  	456-ABC-PCT-CA    
	  	Canada	  	Pending	  	 	  	2433225	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/CN
	  	456-1-PCT-CN	  	China	  	Pending	  	 	  	011322885.2	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/CN/2
	  	456-ABC-PCT-CN	  	China	  	Pending	  	 	  	01822884.4	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/CZ
	  	456-1-PCT-CZ	  	Czech Republic    	  	Pending        	  	 	  	PV2003-1983	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/CZ/2
	  	456-ABC-PCT-CZ	  	Czech Republic	  	Pending	  	 	  	PV2003-1982	  	31 December 2001	  	31 December 21321	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/EP
	  	456-1-PCT-EPO	  	EPO	  	Pending	  	Published    	  	01994329.9	  	31 December 2001	  	31 December 2021	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
456/EP/2
	  	456-ABC-PCT-EPO	  	EPO	  	Pending	  	Published	  	01994330.7	  	31 December 2001	  	31 December 2021	  	BIG Corp.
	 	 	 	 	 	 	 	 	 
	
456/HK
	  	456-1-PCT-HK	  	Hong Kong	  	Pending	  	Published	  	04102871.6	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/HK/2
	  	456-ABC-PCT-HK	  	Hong Kong	  	Pending	  	 	  	 	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/HU
	  	456-1-PCT-HU	  	Hungary	  	Pending	  	 	  	P 04 0775	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
455/HU/2
	  	456-ABC-PCT-HU	  	Hungary	  	Pending	  	 	  	 	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/IL
	  	456-1-PCT-IL	  	Israel	  	Pending	  	 	  	156690	  	31 December 2001    	  	31 December 2021    	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/IL/2
	  	456-ABC-PGT-IL	  	Israel	  	Pending	  	 	  	156689	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/IN
	  	456-1-PCT-IN	  	India	  	Pending	  	 	  	01172/DELNP/2003    	  	31 December 2001	  	31 December 2015	  	Savient
	 	 	 	 	 	 	 	 	 
	
455/IN/2
	  	456-ABC-PCT-IN	  	India	  	Pending	  	 	  	01171/DELNP12003	  	31 December 2001	  	31 December 2015	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/JP
	  	456-1-PCT-JP	  	Japan	  	Pending	  	 	  	2002-559551	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/JP/2
	  	456-ABC-PCT-JP	  	Japan	  	Pending	  	 	  	2002-555211	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/KR
	  	456-1-PCT-KR	  	Korea (South)	  	Pending	  	 	  	10-2003-7008885	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/KR/2
	  	456-ABC-PCT-KR	  	Korea (South)	  	Pending	  	 	  	10-20037008890	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/MX
	  	456-1-PCT-MX	  	Mexico	  	Pending	  	 	  	PA/A/2003005944	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/MX/2
	  	456-ABC-PCT-MX	  	Mexico	  	Pending	  	 	  	PA/A/2003/005945	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/NZ
	  	456-1-PCT-NZ	  	New Zealand	  	Pending	  	 	  	527173	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/NZ/2
	  	456-ABC-PCT-NZ	  	New Zealand	  	Pending	  	 	  	527150	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/PL
	  	456-1-PCT-PL	  	Poland	  	Pending	  	 	  	P-365758	  	31 December 2001	  	31 December 2021	  	Savient


  
 1 













 CONFIDENTIAL 
  

																	
	 	 	 	 	 	 	 	 	 
	Docket ID	  	File Ref.	  	Country	  	Status	  	Substatus	  	Appl. No	  	Appl. Date	  	Expiry	  	Applicant/ Patentees
	 	 	 	 	 	 	 	 	 
	
456/PL/2
	  	456-ABC-PCT-PL	  	Poland	  	Pending	  	 	  	P-366223	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/RU
	  	456-1-PCT-RU	  	Russian Federation	  	Pending	  	 	  	2003123100	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/RU/2
	  	456-ABC-PCT-RU	  	Russian Federation	  	Pending	  	 	  	2003123101	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/SG
	  	456-1-PCT-SG	  	Singapore	  	Pending	  	 	  	200303552-4	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/SG/2
	  	456-ABC-PCT-SG	  	Singapore	  	Pending	  	 	  	200303539-1	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/US/3
	  	456-A-US	  	USA	  	Pending	  	Published	  	10/032037	  	31 December 2001	  	31 December 2021	  	BTG Corp.    
	 	 	 	 	 	 	 	 	 
	
456/US/4
	  	456-1-US	  	USA	  	Pending	  	Published	  	10/029926	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/US/5
	  	456-S-US	  	USA	  	Pending	  	Published	  	10/029988	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/US/6
	  	456-C-US	  	USA	  	Pending	  	Published	  	10/032423	  	31 December 2001    	  	31 December 2021    	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
456/US17    
	  	456-0-US	  	USA	  	Pending	  	 	  	10/189258	  	1 July 2002	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/ZA
	  	456-1-PCT-Z4	  	South Africa	  	Pending	  	 	  	2003/5337	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
456/ZA/2
	  	456-ABC--PCT-7A 
   	  	South Africa	  	Pending	  	 	  	2003/5336	  	31 December 2001	  	31 December 2021	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/AU
	  	524-PCT-AU	  	Australia	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/BR
	  	524-PCT-BR	  	Brazil	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/CA
	  	524-PCT-CA	  	Canada	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/CN
	  	524-PCT-CN	  	China	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/EP
	  	524-PCT-EP	  	EPO	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/IL
	  	524-PCT-IL	  	Israel	  	Pending	  	Nat. Phase	  	156063	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/IN
	  	524-PCT-IN	  	India	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/JP
	  	524-PCT-JP	  	Japan	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/KR
	  	524-PCT-KR	  	Korea (South)	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/MX
	  	524-PCT-MX	  	Mexico	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/NZ
	  	524-PCT-NZ	  	New Zealand	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/PL
	  	524-PCT-PL	  	Poland	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/RU
	  	524-PCT-RU	  	Russian Federation	  	Pending    	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/SG
	  	524-PCT-SG	  	Singapore	  	Pending	  	Nat. Phase    	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/US/3
	  	524-A-US	  	USA	  	Pending	  	Published	  	10/611588	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
524/ZA
	  	524-PCT-ZA	  	South Africa	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/AU
	  	573-PCT-AU	  	Australia	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/BR
	  	573-PCT-BR	  	Brazil	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/CA
	  	573-PCT-CA	  	Canada	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/CN
	  	573-PCT-CN	  	China	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/EP
	  	573-PCT-EP	  	EPO	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/IL
	  	573-PCT-IL	  	Israel	  	Pending	  	Nat. Phase	  	166062	  	30 June 2003	  	30 June 2023	  	Savient


  
 2 













 CONFIDENTIAL 
  

																	
	 	 	 	 	 	 	 	 	 
	Docket ID	  	File Ref.	  	Country	  	Status	  	Substatus	  	Appl. No	  	Appl. Date	  	Expiry	  	Applicant/     Patentees    
	 	 	 	 	 	 	 	 	 
	
573/IN
	  	573-PCT-IN	  	India	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/JP
	  	573-PCT-JP	  	Japan	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/KR
	  	573-PCT-KR	  	Korea (South)	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/MX
	  	573-PCT-MX	  	Mexico	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/NZ
	  	573-PCT-NZ	  	New Zealand	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/PL
	  	573-PCT-PL	  	Poland	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/RU
	  	573-PCT-RU	  	Russian Federation	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/SG
	  	573-PCT-SG	  	Singapore	  	Pending	  	Nat. Phase	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/US/3
	  	573-A-US	  	USA:	  	Pending	  	Published	  	10/610843	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
573/ZA
	  	573-PCT-21A    	  	South Africa	  	Pending        	  	Nat. Phase    	  	 	  	30 June 2003	  	30 June 2023	  	Savient
	 	 	 	 	 	 	 	 	 
	
604/PCT
	  	604-PCT	  	PCT	  	Pending	  	Published	  	PCT/US04/021002	  	30 June 2004    	  	30 June 2008    	  	Savient
	 	 	 	 	 	 	 	 	 
	
604/US/3
	  	604-A-US	  	USA	  	Pending	  	 	  	10/880922	  	30 June 2004	  	30 June 2024	  	Savient
	 	 	 	 	 	 	 	 	 
	
606/PCT
	  	606-PCT	  	PCT	  	Pending	  	Published	  	PCT/US041021099	  	30 June 2004	  	 	  	Savient
	 	 	 	 	 	 	 	 	 
	
606/US/3
	  	606-A-US	  	USA	  	Pending	  	 	  	10/881405	  	30 June 2004	  	30 June 2024	  	Savient
	 	 	 	 	 	 	 	 	 
	
604/US/4
	  	604-B-US	  	USA	  	Pending	  	 	  	 	  	27 June,2005	  	 	  	Savient


  
 3 













 Annex H 

osmB promoter patents/patent application 
  

																					
	Docket
ID	 	File Ref	 	Country	 	Annuity
Due	 	Status	 	Applic. No	 	Appl. Date	 	Grant
No.	 	Grant
Date	 	Expiry	 	Application/
Patentees
	
191/EP
	 	191-WO-
EP	 	EPO	 	22-2006-
March	 	Pending    	 	95914162.3	 	22-1995-
March	 	 	 	 	 	22-2015-    
March    	 	Savient    
	
191/IL
	 	191-IL	 	Israel	 	 	 	Pending    	 	113031	 	19-1995-    
March    	 	 	 	 	 	 	 	Savient    
	
191/IN/2
	 	191-Z/IN    	 	India    	 	 	 	Pending    	 	960/Del/99    	 	12-1999-
July	 	 	 	 	 	 	 	Savient    
	
191/JP
	 	191-WO-
JP	 	Japan	 	 	 	Pending    	 	7-524813	 	22-1995-
March	 	 	 	 	 	 	 	Savient    
	
191/US/2
	 	191-A-
US	 	USA	 	28-2007-
Febrauary	 	Granted    	 	08/897043	 	18-1997-
July	 	5945304    	 	31-1999-    
August	 	22-2014-    
March    	 	Savient    
	
191-ZA
	 	191-/ZA	 	South
Africa	 	13-2006-    
March    	 	Granted    	 	95/2056	 	13-1995-
March	 	95-2056    	 	28-1996-    
February	 	13-2015-    
March    	 	Savient    













 Annex I 

List of HA Patents, Trademarks and Domain Names 
  

	1.	 Patents 



Refer to attached list 
  

	2.	 Design Right Registrations 



 

	 	2.1.	 US: Des. 403064 - Filed June 28, 1995, Granted December 22, 1998, Expiration date December 22,
2012. 


  

	 	2.2.	 Israel: Design 23832 - Filed January 22, 1995, Granted June 20, 1995; Expiration date
January 22, 2010. 


  

	3.	 Trademarks 



Refer to attached list 
  

	4.	 Domain Names 


  

			
	 Name  
	  	Domain
		
	 biolon
	  	.info                                     
           
	 biolon
	  	.co.il
	 biolon
	  	.us
	 biolon
	  	.com
	 euflexxa
	  	.com
	 nuflexa
	  	.com
	 nuflexxa
	  	.com













 CONFIDENTIAL 

HA PATENTS 
  

																	
	 	 	 	 	 	 	 	 	 
	File Ref.	  	Country	  	Status	  	Appl. No	  	Appl. Date	  	Grant No	  	Grant Date	  	Expiry	  	Applicant/ Patentees
	 	 	 	 	 	 	 	 	 
	
015-A/WO
	  	Australia	  	Granted	  	53599/86	  	16-Jan-1986	  	600888	  	17-Dec-1990	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A-Z-WO-AU
	  	Australia	  	Granted	  	62319/90	  	16-Jan-1986	  	624023	  	28-Nov-1994	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A/CA
	  	Canada	  	Granted	  	499795	  	17-Jan-1986	  	1336177	  	04-Jul-1995	  	04-Jul-2012	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A-WO-EP

	  	EPO	  	Granted	  	86900929.0	  	16-Jan-1985	  	211037	  	26-Feb-1992	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A-WO-EP-AT
	  	Austria	  	Granted	  	86900929.0	  	16-Jan-1985	  	E72B35B	  	12-Oct-1992	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A/WO-EP-BE

	  	Belgium	  	Granted	  	86900929.0	  	16-Jan-1985	  	211037	  	26-Feb-1992	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A-WO-EP-CH
	  	Switzerland	  	Granted	  	86900929.0    	  	16-Jan-1985	  	211037	  	26-Feb-1992	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A-WO-EP-DE
	  	Germany	  	Granted	  	86900929.0	  	16-Jan-1985	  	3683969.8	  	26-Feb-1992	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A/WO-EP-FR

	  	France	  	Granted	  	86900929.0	  	16-Jan-1985	  	211037	  	26-Feb-1992	  	16-Jan-2006	  	BTG Corp.    
	 	 	 	 	 	 	 	 	 
	
015-A-WO-EP-IT
	  	Italy	  	Granted	  	86900929.0	  	16-Jan-1985	  	211037	  	26-Feb-1992	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-AWO-EP-LU

	  	Luxembourg    	  	Granted    	  	86900929.0	  	16-Jan-1985	  	211037	  	26-Feb-1992	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A/WO-EP-NL

	  	Netherlands	  	Granted	  	86900929.0	  	16-Jan-1985	  	211037	  	26-Feb-1992	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A-WO-EP-SE
	  	Sweden	  	Granted	  	86900929.0	  	16-Jan-1985	  	211037	  	26-Feb-1992	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A-WO-EP-GB    
	  	United Kingdom    	  	Granted	  	86900929.0	  	16-Jan-1985    	  	211037	  	26-Feb-1992	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015A/HK
	  	Hong Kong	  	Granted	  	86900929.0	  	16-Jan-1985	  	1174/1996	  	04-Jul-1996	  	16-Jan-2006    	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A-IL
	  	Israel	  	Granted	  	77625	  	16-Jan-1985	  	77625	  	18-Jul-1991	  	16-Jan-2006	  	BTGIL
	 	 	 	 	 	 	 	 	 
	
015-A-Z/IL
	  	Israel	  	Granted	  	94791	  	16-Jan-1985	  	94791	  	11-Jun-1992	  	16-Jan-2006	  	BTGIL
	 	 	 	 	 	 	 	 	 
	
015-A-WO-JP

	  	Japan	  	Granted	  	61-500791	  	16-Jan-1985	  	2677553	  	25-Jul-1997	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A-Y-WO-JP
	  	Japan	  	Granted	  	6-273821	  	16-Jan-1985	  	3081544	  	23-Jun-2000	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A-Z-WO-JP
	  	Japan	  	Granted	  	6-141201	  	16-Jan-1985	  	2571908	  	24-Oct-1995	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A/SG
	  	Singapore	  	Granted	  	9590363-9	  	16-Jan-1985	  	9590363-9	  	30-Sep-1995	  	16-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-/US
	  	USA	  	Granted	  	692692	  	16-Jan-1985	  	4784990	  	15-Nov-1988	  	15-Nov-2005	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A/US
	  	USA	  	Granted	  	815957	  	09-Jan-1986	  	4780414	  	25-Oct-1988	  	25-Oct-2005	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
015-A/ZA
	  	South Africa	  	Granted	  	86/0366	  	17-Jan-1986	  	86/0366	  	24-Sep-1986	  	17-Jan-2006	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
319-/IL
	  	Israel	  	Granted	  	23832	  	22-Jan-1995	  	23832	  	20-Jun-1995	  	22-Jan-2010	  	BTG Corp.
	 	 	 	 	 	 	 	 	 
	
319-/US
	  	USA	  	Granted	  	29/040830	  	28-Jan-1995	  	Des. 403064    	  	22-Dec-1998	  	22-Dec-2012	  	Savient













 CONFIDENTIAL 

HA TRADEMARKS 
  

																			
	 	 	 	 	 	 	 	 	 	 
	File Ref.	  	Country	  	Trademark	  	Class	  	Reg. Owner	  	Appl. No.	  	Appl. Date	  	Reg. No.	  	Reg. Date	  	Status
	 	 	 	 	 	 	 	 	 	 
	
T2057-Israel
	  	Israel	  	ARTHREASE	  	5	  	BTGIL	  	144847	  	14-Dec-2000	  	144847	  	14-Dec-2000	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2057-A-Israel    
	  	Israel	  	ARTHREASE-English and Hebrew    	  	10	  	BT	  	150544	  	05-Jul-2001	  	150544	  	03-Sep-2002	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2069-Israel
	  	Israel	  	Arthrease Logo	  	10	  	BT	  	159394	  	19-Sep-2002	  	159394	  	14-Apr-2004	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2009-IL
	  	Israel	  	BIOHY	  	5	  	BT	  	77923	  	18-Oct-1990	  	77923	  	10-Mar-1994	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2009-US
	  	USA	  	BIOHY	  	5	  	Savient	  	78532936	  	15-Dec-2004	  	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2010-/OAPI
	  	African Union (AIPO)    	  	BIOLON	  	5	  	BTG Corp.	  	85707	  	12-Apr-1996	  	36215	  	25-Feb-1997	  	Registered    
	 	 	 	 	 	 	 	 	 	 
	
T2010-/DZ
	  	Algeria	  	BIOLON	  	5	  	BTG Corp.	  	960540	  	06-Apr-1996	  	50597	  	06-Apr-1996	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/AR
	  	Argentina	  	BIOLON	  	5	  	BTG Corp.	  	1923104	  	06-Jun-1994	  	1594955	  	27-Mar-1998	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Austria	  	BIOLON	  	5, 10    	  	BTG Corp.	  	2432169	  	22-Oct-2001	  	2432169	  	21-May-2003    	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-Benelux
	  	Benelux	  	BIOLON	  	5	  	BTG Corp.    	  	777702	  	23-Mar-1992	  	509296	  	23-Mar-1992	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Benelux	  	BIOLON	  	5,10	  	BTG Corp.	  	2432169	  	22-Oct-2001	  	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/BO
	  	Bolivia	  	BIOLON	  	5	  	BTG Corp.	  	SM-93-2434	  	01-Oct-1993	  	58548-C	  	24-May-1995	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-A-BO
	  	Bolivia	  	BIOLON	  	5	  	BTG Corp.	  	SM-1162-95    	  	17-Mar-1995	  	69448-C	  	13-Mar-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/BR
	  	Brazil	  	BIOLON	  	 	  	Savient	  	820926656	  	24-Jul-1998	  	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2010-/BG
	  	Bulgaria	  	BIOLON	  	5	  	BTG Corp.	  	31590	  	24-Jul-1995	  	28084	  	24-Jul-1995	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/KH
	  	Cambodia	  	BIOLON	  	5	  	BTG Corp.	  	7235	  	03-May-1996	  	7235	  	12-Jun-1996	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/CA
	  	Canada	  	BIOLON	  	5	  	BTG Corp.	  	726489	  	13-Apr-1993	  	TMA433098    	  	09-Sep-1994	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/CL
	  	Child	  	BIOLON	  	5	  	BTG Corp.	  	251.326	  	31-Aug-1993	  	462254	  	06-Oct-1996	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/CO
	  	Colombia	  	BIOLON	  	5	  	BTG Corp.	  	94050424	  	03-Nov-1994	  	196624	  	31-Jan-1987	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/CR
	  	Costa Rica	  	BIOLON	  	5	  	BTG Corp.	  	91.98	  	16-Dec-1994	  	91.680	  	13-Jun-1995	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/CY
	  	Cyprus	  	BIOLON	  	5	  	BTG Corp.	  	46837	  	25-Nov-1998	  	46637	  	25-Nov-1996	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Cyprus	  	BIOLON	  	5,10	  	BTG Corp.	  	2432169	  	22-Oct-2001	  	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/CZ
	  	Czech Republic	  	BIOLON	  	5	  	BTG Corp.	  	101381	  	20-Jun-1995	  	212355	  	28-Sep-1998	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Czech Republic	  	BIOLON	  	5,10	  	BTG Corp.	  	2432169	  	22-Oct-2001	  	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/DK
	  	Denmark	  	BIOLON	  	5	  	BTG Corp.	  	02238/1992	  	24-Mar-1992    	  	00171/94	  	14-Jan-1994	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Denmark	  	BIOLON	  	5,10	  	BTG Corp.	  	2432169	  	22-Oct-2001	  	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/DO
	  	Dominican Republic	  	BIOLON	  	11	  	BTG Corp.	  	 	  	01-Nov-1994	  	75847	  	15-Jan-1995	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/EC
	  	Ecuador	  	BIOLON	  	5	  	BTG Corp.	  	56.835	  	06-Jul-1995	  	268/97	  	12-Mar-1997	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/EG
	  	Egypt	  	BIOLON	  	5	  	BTG Corp.	  	96258	  	25-Jun-1995	  	96258	  	13-Oct-1998	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/SV
	  	El Salvador	  	BIOLON	  	5	  	BTG Corp.	  	4123-94	  	04-Nov-1994	  	2208.37	  	22-Oct-1998	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Estonia	  	BIOLON	  	5,10	  	BTG Corp.	  	2432169	  	22-Oct-2001	  	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	European Union	  	BIOLON	  	5,10	  	BTG Corp.	  	2432169	  	22-Oct-2001	  	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/FI
	  	Finland	  	BIOLON	  	5	  	BTG Corp.	  	1541/92	  	27-Mar-1992	  	130038	  	20-Jan-1994	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Finland	  	BIOLON	  	5,10	  	BTG Corp.	  	2432169	  	22-Oct-2001	  	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-France
	  	France	  	BIOLON	  	5	  	BTG Corp.	  	92411786	  	24-Mar-1992	  	92411768	  	04-Sep-1992	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	France	  	BIOLON	  	5,10	  	BTG Corp.	  	2432169	  	22-Oct-2001	  	2432169	  	21-May-2003	  	Registered


  
 1 













 CONFIDENTIAL 

HA TRADEMARKS 
  

																			
	 	 	 	 	 	 	 	 	 	 
	File Ref.	  	Country	  	Trademark    	  	Class	 	Reg. Owner	  	Appl. No.	  	Appl. Date	 	Reg. No.	  	Reg. Date	  	Status
	 	 	 	 	 	 	 	 	 	 
	
T2010-Gaza
	  	Gaza	  	BIOLON	  	5	 	BTG Corp.	  	2962	  	18-May-1995	 	2962	  	19-Jun-1995	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-DE
	  	Germany	  	BIOLON	  	5	 	BTG Corp.	  	B98 358/5 WZ	  	21-Apr-1993	 	2 105 144	  	22-Oct-1998	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Germany	  	BIOLON	  	5,10	 	BTG Corp.	  	2432159	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	 	  	Germany	  	BIOLON	  	5	 	Pharma Stutn    	  	P434855WZ	  	25-Sep-1992	 	2025182	  	24-Nov-1992	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Greece	  	BIOLON	  	5, 10	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-A-Greece    
	  	Greece	  	BIOLON	  	5, 10	 	BTG Corp.	  	747553	  	08-Mar-2002	 	147553	  	17-Aug-2004	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/GT
	  	Guatemala	  	BIOLON	  	5	 	BTG Corp.	  	95000215	  	22-May-1985    	 	083194	  	30-Oct-1996	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/HT
	  	Haiti	  	BIOLON	  	5	 	BTG Corp.	  	280/101	  	07-Sep-1995	 	280/101	  	07-Sep-1995    	  	Registered    
	 	 	 	 	 	 	 	 	 	 
	
T2010-/HN
	  	Honduras	  	BIOLON	  	5	 	BTG Corp.	  	7625/94	  	18-Oct-1994	 	82.502	  	07-Aug-1995	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/HK
	  	Hong Kong	  	BIOLON	  	5	 	BTG Corp.	  	95 03898	  	01-Apr-1996	 	4516/1997	  	18-Apr-1997	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Hungary	  	BIOLON	  	5,10	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-ICELAND
	  	Iceland	  	BIOLON	  	5	 	BTG Corp.	  	761/1992	  	27-Mar-1992	 	761/1992	  	29-Jul-1992	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-India
	  	India	  	BIOLON	  	5	 	BTG Corp.	  	615152	  	30-Dec-1993	 	615152	  	30-Dec-1993	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-Indonesia
	  	Indonesia	  	BIOLON	  	5	 	BTGIL	  	D00 2004 01647 01660	  	23-Jan-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2010-/IR
	  	Iran	  	BIOLON	  	5	 	BTG Corp.	  	7508196	  	07-Sep-1996	 	80448	  	07-Sep-1996	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/IE
	  	Ireland	  	BIOLON	  	5	 	BTG Corp.	  	95/0800	  	25-Jan-1995	 	186885	  	25-Jan-1995	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Ireland	  	BIOLON	  	5, 10    	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	 	  	Ireland	  	BIOLON	  	10	 	Kestrel (formerly     Inpharmed)	  	205725	  	07-Jan-1998	 	206725	  	07-Jan-1998	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-IL
	  	Israel	  	BIOLON	  	5	 	BTGIL	  	77924	  	08-Oct-1990	 	77924	  	10-Mar-1994	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-A-IL
	  	Israel	  	BIOLON	  	10	 	BTGIL	  	139336	  	26-Jun-2000	 	139338	  	05-Feb-2002	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Italy	  	BIOLON	  	5, 10	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	 	  	Italy	  	BIOLON	  	5	 	S.I.F.I.SPA	  	1679 2002 RM    	  	25-Mar-2002	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2010-A-Italy
	  	Italy	  	BIOLON	  	5	 	BTG Corp.	  	2424 2002 MI	  	11-Mar-2002	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2010-/JM
	  	Jamaica	  	BIOLON	  	5	 	BTG Corp.	  	5/6031	  	14-Oct-1994	 	27657	  	14-Oct-1994	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/JP
	  	Japan	  	BIOLON	  	5	 	BTG Corp.	  	179472/1997	  	21-Nov-1997	 	4359587	  	02-Apr-2000	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Jersey	  	BIOLON	  	5,10	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-JO
	  	Jordan	  	BIOLON	  	5	 	BTG Corp.	  	40967	  	04-Apr-1996	 	40967	  	04-Apr-1996	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/KR
	  	Korea (South)    	  	BIOLON	  	5	 	BTG Corp.	  	13533/1998	  	28-May-1998	 	446232	  	14-Apr-1999	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/LA
	  	Laos	  	BIOLON	  	5	 	BTG Corp.	  	4584	  	05-Feb-1996	 	4278	  	15-May-1995	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Latvia	  	BIOLON	  	5, 10	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/LB
	  	Lebanon	  	BIOLON	  	5	 	BTG Corp.	  	16217	  	26-Jun-1995	 	69274	  	26-Jun-1998	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-Liechtenstein    
	  	Liechtenstein	  	BIOLON	  	5, 10	 	BTGIL	  	12811	  	20-Jan-2003	 	12811	  	20-Jan-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Lithuania	  	BIOLON	  	5, 10	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Malta	  	BIOLON	  	5, 10	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered


  
 2 













 CONFIDENTIAL 

HA TRADEMARKS 
  

																			
	 	 	 	 	 	 	 	 	 	 
	File Ref.	  	Country	  	Trademark    	  	Class	 	Reg. Owner	  	Appl. No.	  	Appl. Date	 	Reg. No.	  	Reg. Date	  	Status
	 	 	 	 	 	 	 	 	 	 
	
T2010-/MX
	  	Mexico	  	BIOLON	  	5	 	BTG Corp.	  	192582	  	02-Mar-1994	 	497534	  	19-Jul-1995	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/MA
	  	Morocco	  	BIOLON	  	5	 	BTG Corp.	  	59409	  	12-Apr-1996	 	59409	  	12-Apr-1996	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-BU
	  	Myanmar	  	BIOLON	  	5	 	BTG Corp.	  	2616	  	20-Jun-1995	 	2616 or 1996    	  	11-Jul-1996	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/NI
	  	Nicaragua	  	BIOLON	  	5	 	BTG Corp.	  	96-00741	  	02-Mar-1995	 	28938	  	04-Aug-1995    	  	Registered    
	 	 	 	 	 	 	 	 	 	 
	
T2010-NO
	  	Norway	  	BIOLON	  	5	 	BTG Corp.	  	234176	  	24-Mar-1992	 	161914	  	24-Mar-1994	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/PA
	  	Panama	  	BIOLON	  	5	 	BTG Corp.	  	75147	  	07-Apr-1995	 	075147	  	02-Aug-1996	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/PE
	  	Peru	  	BIOLON	  	5	 	BTG Corp.	  	232107	  	 	 	005544	  	25-Feb-1994	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Poland	  	BIOLON	  	5, 10	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-Portugal
	  	Portugal	  	BIOLON	  	5	 	BTG Corp.	  	281783	  	31-Mar-1992	 	281783	  	16-Nov-1993	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Portugal	  	BIOLON	  	5, 10	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-Romania    
	  	Romania	  	BIOLON	  	5	 	BTG Corp.    	  	36419	  	15-Sep-1995	 	31132	  	15-Sep-1995	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-Russia
	  	Russian Federation    	  	BIOLON	  	5, 10    	 	BTGIL	  	2002720948    	  	02-Oct-2002    	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2010-/SG
	  	Singapore	  	BIOLON	  	5	 	Savient	  	1144/95	  	10-Feb-1995	 	1144/95	  	10-Feb-1995	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/SK
	  	Slovakia	  	BIOLON	  	5	 	BTG Corp.	  	PO21720-95	  	20-Jun-1995	 	182122	  	17-Sep-1998	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Slovakia	  	BIOLON	  	5, 10	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Slovenia	  	BIOLON	  	5, 10	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/ZA
	  	South Africa	  	BIOLON	  	5	 	BTG Corp.	  	95/00039	  	04-Jan-1995	 	95/00039	  	12-Jan-1997	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-Spain
	  	Spain	  	BIOLON	  	5	 	BTG Corp.	  	1694642	  	06-Apr-1992	 	1694642	  	06-Apr-1992	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Spain	  	BIOLON	  	5, 10	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-Sweden
	  	Sweden	  	BIOLON	  	5	 	BTG Corp.	  	92-2884	  	24-Mar-1992	 	248654	  	30-Apr-1993	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	Sweden	  	BIOLON	  	5, 10	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432189	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/CH
	  	Switzerland	  	BIOLON	  	5	 	BTG Corp.	  	2608/1992.5	  	25-Mar-1992	 	397.284	  	14-Dec-1992	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/TH
	  	Thailand	  	BIOLON	  	5	 	BTG Corp.	  	306655	  	23-Apr-1996	 	Khor92629	  	23-Apr-1996	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/TT
	  	Trinidad & Tobago	  	BIOLON	  	3	 	BTG Corp.	  	23125	  	13-Oct-1994	 	23125	  	13-Oct-1997	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/TN
	  	Tunisia	  	BIOLON	  	5	 	BTG Corp.	  	EE96.0509	  	25-Apr-1996	 	EE96.0509	  	25-Apr-1996	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-Turkey
	  	Turkey	  	BIOLON	  	5	 	BTG Corp.	  	86 1666	  	06-Feb-1996	 	171989	  	06-Feb-1998	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/GB
	  	United Kingdom	  	BIOLON	  	5	 	BTG Corp.	  	1532336	  	14-Apr-1993	 	1532336	  	15-Jul-1994	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-EM
	  	United Kingdom	  	BIOLON	  	5, 10	 	BTG Corp.	  	2432169	  	22-Oct-2001	 	2432169	  	21-May-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010A/GB
	  	United Kingdom	  	BIOLON	  	10	 	BTG Corp.	  	2152700	  	04-Dec-1997	 	2152700	  	28-Aug-1998	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/US
	  	USA	  	BIOLON	  	5	 	Savient	  	74/630840	  	08-Feb-1995	 	2235976	  	30-Mar-1999	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/VE
	  	Venezuela	  	BIOLON	  	5	 	BTG Corp.	  	15882-94	  	28-Nov-1994	 	P204815	  	08-May-1998	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-/VN
	  	Vietnam	  	BIOLON	  	5	 	BTG Corp.	  	28087	  	09-Apr-1996	 	23650	  	15-Jan-1997	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2010-West Bank    
	  	West Bank	  	BIOLON	  	5	 	BTG Corp.	  	3443	  	20-May-1996	 	3443	  	20-May-1995	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2065-IL
	  	Israel	  	BIOLON PRIME    	  	10	 	BTGIL	  	153026	  	30-Oct-2001	 	153026	  	04-Mar-2003	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2065-A-IL
	  	Israel	  	BIOLON PRIME	  	5	 	BTGIL	  	158014	  	01-Jul-2002	 	158014	  	03-Feb-2004	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2030-/ZA
	  	South Africa	  	BIOLONE	  	5	 	BTG Corp.	  	95/0706	  	22-Jan-1998	 	96/0708	  	22-Jan-1996	  	Registered


  
 3 













 CONFIDENTIAL 

HA TRADEMARKS 
  

																			
	 	 	 	 	 	 	 	 	 	 
	File Ref.	  	Country	  	Trademark	  	Class	 	Reg. Owner	  	Appl. No.	  	Appl. Date	 	Reg. No.	  	Reg. Date	  	Status
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Austria	  	EUFLEXXA	  	5, 10    	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Benchor	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Cyprus	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Czech Republic    	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Denmark	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Estonia	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	European Union	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Finland	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	France	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Germany	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Greece	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Hungary	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Ireland	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-IL
	  	Israel	  	EUFLEXXA	  	5, 10	 	BTGIL	  	174937	  	28-Sep-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Italy	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Jersey	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Latvia	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Lithuania	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Malta	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Poland	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Portugal	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Slovakia	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Slovakia	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Spain	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	Sweden	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-TR
	  	Turkey	  	EUFLEXXA	  	5, 10	 	BTGIL	  	2004/44860    	  	29-Dec-2004    	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2124-EM
	  	United Kingdom	  	EUFLEXXA	  	5, 10	 	BTGIL	  	3919768	  	13-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2122-US
	  	USA	  	NUFLEXXA	  	5, 10	 	Savient    	  	78416687	  	11-May-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2123-Canada    
	  	Canada	  	NUFLEXXA	  	5, 10	 	Savient	  	1224738	  	28-Jul-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2123-US
	  	USA	  	NUFLEXXA	  	5, 10	 	Savient	  	78416699	  	11-May-2004	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2008-IL
	  	Israel	  	OPHTHA	  	5, 10	 	BTGIL	  	76640	  	08-Jun-1990	 	76640    	  	10-Mar-1994    	  	Registered    
	 	 	 	 	 	 	 	 	 	 
	
T2071-IL
	  	Israel	  	PRIME	  	5, 10	 	BTGIL	  	163725	  	14-Apr-2003	 	 	  	 	  	Pending
	 	 	 	 	 	 	 	 	 	 
	
T2070-Israel
	  	Israel	  	PURE RELIEF	  	5, 10	 	BTGIL	  	161041	  	09-Dec-2002	 	161041	  	03-Feb-2004	  	Registered
	 	 	 	 	 	 	 	 	 	 
	
T2017-IL
	  	Israel	  	WING YOUR WAY TO THE FUTURE    	  	5, 10	 	BTGIL	  	96646	  	23-Jan-1995	 	96646	  	05-Aug-1996	  	Registered


  
 4 













 Exhibit G 

Product Specifications 












 - 2 - 

    Summary of Release Testing of Bulk Uricase Intermediate 

 

							
	Parameter	  	Test	  	Provisional Acceptance Criteria	  	Revision
	 	 	 	 
	Appearance	  	Visual inspection	  	Clear colorless solution, free of visible particles	  	None
	 	 	 	 
	General	  	pH	  	10.1-10.4	  	None
	 	 	 	 
	Protein Content	  	Bradford	  	1.0-3.0 mg/mL	  	None
	 	 	 	 
	Potency	  	Enzymatic activity	  	6.0-10.8 Units/mg	  	Addition of Upper Limit
	 	 	 	 
	Identification	  	N-terminal amino acid sequence	  	10 amino acids matching the sequence	  	None
	  	SDS-PAGE	  	Electrophoretogram similar to reference standard	  	None
	  	Peptide Mapping	  	Profile of the chromatogram of test solution corresponds to that of reference solution	  	None
	  	Mass Spectrometry	  	34,193 ± 6 Da	  	Revision to indicate specific molecular weight
	 	 	 	 
	Purity/Impurities	  	HMW Forms by 
SEC-HPLC	  	£ 2%	  	None
	  	HMW Forms by 
SDS-PAGE	  	£ 10%	  	None
	  	LMW Forms by 
SDS-PAGE	  	£ 5%	  	None
	  	E. coli Proteins by Slot Blot	  	£. 25 ppm (£ 25 ng/mg)	  	None
	  	Endotoxin (LAL kinetic 
turbidimetric)	  	£ 10 EU/mg	  	None
	  	CPC by RP-HPLC	  	£ 1 ppm (£ 1 μg/mL)	  	None
	  	DNA by Slot Blot	  	£ 25 pg/mg	  	None
	  	Tetracycline by 
RP-HPLC	  	£ 5 ppb (£ 5 ng/mL)	  	None
	  	Lysozyme by 
ELISA	  	< 3.9 ng/mL	  	Addition of Acceptance Criteria
	  	Microbial Limit	  	£ 10 CFU/mL	  	None


  

                2 













 - 3 - 

    Summary of Release Testing of PEG-uricase API 

 

							
	Parameter	  	Test	  	Provisional Acceptance Criteria	  	Revision
	 	 	 	 
	Appearance	  	Physical 
inspection	  	Clear colorless solution, free of visible
particles	  	None
	 	 	 	 
	General	  	pH	  	7.0-7.8	  	None
	  	Osmolality	  	270-368 mOsm/kg	  	None
	 	 	 	 
	Protein Content	  	SEC-HPLC	  	7.2-8.8 mg/mL	  	Addition of Lower
Limit; Revision to
Upper Limit
	 	 	 	 
	No. of PEG 
Strands per
Monomer	  	SEC-I4PLC	  	9 ± 1	  	None
	 	 	 	 
	Potency	  	Enzymatic 
activity	  	5.0-9.5 Units/mg	  	Addition of Upper
Limit
	 	 	 	 
	Purity/Impurities	  	Free PEG by
SEC-HPLC	  	£ 1 mg/mL	  	None
	 	 	 	 
	 	  	Free Uricase by
ELISA	  	Not yet established (ng/mL)	  	None
	 	 	 	 
	 	  	Xanthine by 
RP-HPLC	  	£ 10 ppm (£10 μg/mL)	  	None
	 	 	 	 
	 	  	pNP by RP-
HPLC	  	£ 500 ppb (£0.5 μg/mL)	  	None
	 	 	 	 
	 	  	Endotoxin (LAL kinetic turbidimetric)	  	£ 10 EU/mg	  	None
	 	 	 	 
	 	  	Microbial Limit	  	£ 10 CFU/100 mL	  	None


  

                3 













 FIRST AMENDMENT TO COMMERCIAL SUPPLY AGREEMENT 

THIS AMENDMENT is made and entered into this 24th day of September, 2007,
(hereinafter the “Effective Date”). 
  

	 BETWEEN:  
	 SAVIENT PHARMACEUTICALS, INC. 



a Delaware corporation, (hereinafter “Savient”) 

AND 

BIO-TECHNOLOGY GENERAL (ISRAEL) Ltd. 

an Israeli corporation, (hereinafter “BTG”) 

WHEREAS: 

Savient and BTG are parties to a Commercial Supply Agreement with an effective date of March 20, 2007, (hereinafter, the
“Agreement”) pursuant to which BTG agreed to manufacture and supply a certain Bulk Product, as defined in the Agreement, to Savient, and Savient agreed to purchase such Bulk Product from BTG; and 

Savient and BTG have held discussions relating to the modification and amendment of the Agreement to clarify a certain
provision relating to the adjustment of Bulk Product Forecasts. 
 NOW THEREFORE in consideration of the mutual promises and
agreements and covenants contained herein, the adequacy of such consideration has been agreed and acknowledged by each party, and in accordance with the provisions of Section 14.08 of the Agreement, the parties hereto agree as follows: 

 

	1.	 Definitions. All of the Definitions contained in Article 1 of the Agreement shall have the same
meanings herein unless specifically stated otherwise. Any capitalized terms not specifically defined herein, shall have the same meaning ascribed to them as set forth in the Agreement. 



 

	2.	 Modification of Bulk Product Forecasts. Section 5.06 of the Agreement is hereby repealed in its
entirety and is replaced with the following, 


 “Any Bulk Product Forecast that is not a Firm Order
is to be considered a forecast or estimate to be used for planning purposes, and shall not be construed as a firm commitment by Savient to BTG and thus can be increased or reduced by Savient from time to time. Savient shall be entitled at any time
up until and including the time that a Firm Forecast or Estimated Forecast becomes a Firm Order, to increase or decrease such monthly Firm Forecast or Estimated Forecast for Bulk Product, provided, however, such increases or decreases on a monthly
basis shall not be greater than twenty-five percent (25%) of the originally forecasted quantity for such month, provided, however, (a) each month may not be increased and 












 - 2 - 
  

decreased more than one time, and, (b) any such monthly increase or decrease as contemplated herein shall be expressed in whole
batch quantities of not less than one (1) batch. As a request by Savient to increase the quantity of Bulk Product in a Firm Forecast prior to its becoming a Firm Order may require longer lead times for delivery than requested by Savient, both
Parties shall agree jointly on a new delivery date as close as possible to the requested date having due regard for BTG’s commercial commitments to Third Parties and its own production needs, such agreement to not be unreasonably withheld,
conditioned or delayed. Once a Firm Forecast becomes a Firm Order, Savient may not reduce it, but may request that BTG increase the quantity of Bulk Product subject to a Firm Order and BTG shall use commercially reasonable efforts to fill the
increased order.” 
  

	3.	 No Modification. Except as expressly provided for herein, the Agreement shall remain in full force
and effect without amendment. If there is any conflict or inconsistency between this Amendment and the Agreement, this Amendment shall prevail. This Amendment contains the entire agreement between the parties hereto with respect to the subject
matter contemplated herein and shall not be modified or amended except by a written instrument signed by both parties hereto. 



IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by their respective duly authorized officers as of the date
first written above. 
  

									
	SAVIENT PHARMACEUTICALS, INC.	 		 	BIO-TECHNOLOGY GENERAL (ISRAEL) Ltd.
					
	By:	 	     /s/Philip K. Yachmetz
	 		 	By:	 	     /s/Dov Kanner

		 	     Philip K. Yachmetz

    Executive Vice President &

    Chief Business Officer
	 		 		 	     Dov Kanner

    Managing Director














 SECOND AMENDMENT TO COMMERCIAL SUPPLY AGREEMENT 

THIS SECOND AMENDMENT is made and entered into this 24th day of January, 2009, (hereinafter the
“Effective Date”). 
  

	 BETWEEN: 
	SAVIENT PHARMACEUTICALS, INC. 

 a Delaware corporation, (hereinafter “Savient”) 

AND 
 BIO-TECHNOLOGY GENERAL (ISRAEL) Ltd. 
 an Israeli corporation, (hereinafter “BTG”) 

WHEREAS: 
 Savient and BTG are parties to a Commercial
Supply Agreement with an effective date of March 20, 2007, (hereinafter, the “Agreement”) pursuant to which BTG agreed to manufacture and supply a certain Bulk Product, as defined in the Agreement, to Savient, and Savient agreed to
purchase such Bulk Product from BTG; and 
 Savient and BTG have subsequently amended the Agreement on September 24, 2007, (the “First
Amendment”) and have issued a Letter Agreement dated July 30, 2008, (the “Letter Agreement”) pertaining to the Agreement; and 
 Savient
and BTG desire to further amend the Agreement in accordance with the terms and conditions of this Second Amendment. 
 NOW THEREFORE in consideration
of the mutual promises and agreements and covenants contained herein, the adequacy of such consideration has been agreed and acknowledged by each party, and in accordance with the provisions of Section 14.08 of the Agreement, the parties hereto
agree as follows: 
  

	1.	 Definitions. All of the Definitions contained in Article 1 of the Agreement shall have the same meanings
herein unless specifically stated otherwise. Any capitalized terms not specifically defined herein, shall have the same meaning ascribed to them as set forth in the Agreement. 



 

	2.	 Replacement of Exhibits to Agreement. The parties agree that the exhibits which are appended to this
Second Amendment shall supersede and replace their counterparts as previously executed by and between the parties. For purposes of clarity the following exhibits to the Agreement are hereby repealed and replaced with the attached exhibits:



  

	 	i)	 Exhibit C, “Current Provisional Bulk Product Specifications” 



	 	ii)	 Exhibit D, “Quality Agreement” 



	 	iii)	 Exhibit G, “Product Specifications” 














 - 2 - 
  

	3.	 No Modification. Except as expressly provided for herein, the Agreement shall remain in full force and
effect without amendment. If there is any conflict or inconsistency between this Amendment and the Agreement, this Amendment shall prevail. This Amendment contains the entire agreement between the parties hereto with respect to the subject matter
contemplated herein and shall not be modified or amended except by a written instrument signed by both parties hereto. 


 IN WITNESS
WHEREOF, the parties have caused this Amendment to be executed by their respective duly authorized officers as of the date first written above. 
  

									
	SAVIENT PHARMACEUTICALS, INC.	 		 	BIO-TECHNOLOGY GENERAL (ISRAEL) Ltd.
					
	By:	 	     /s/Philip K. Yachmetz
	 		 	By:	 	     /s/Dov Kanner

		 	     Philip K. Yachmetz

    Senior Vice President &

    General Counsel
	 		 		 	     Dov Kanner

    Managing Director














 Exhibit C 

Current Provisional Bulk Product Specifications 












 SPECIFICATION-[***] 

    Table 1. Tests Performed on [***] 
  

					
	Parameter	  	Test	  	Specifications
	[***]                     
       	  	[***]                        
    	  	[***]
	[***]	  	[***]	  	[***]
	  	[***]	  	[***]
	[***]	  	[***]	  	[***]
	  	[***]	  	[***]
	[***]	  	[***]	  	[***]
	[***]	  	[***]	  	[***]
	[***]	  	[***]	  	[***]
	  	[***]	  	[***]
	[***]	  	[***]	  	[***]
	  	[***]	  	[***]
	  	[***]	  	[***]
	  	[***]	  	[***]
	  	[***]	  	[***]
	  	[***]	  	[***]
	  	[***]	  	[***]

    [***] 
  

 
 [***] = CERTAIN
CONFIDENTIAL INFORMATION OMITTED 

  
 C-1 













     Table 2. Tests Performed on [***] 

 

					
	Parameter	  	Test	  	Specifications
	[***]                     
       	  	[***]                        
    	  	[***]
	[***]	  	[***]	  	[***]
	[***]	  	[***]	  	[***]
	 	  	[***]	  	[***]
	  	[***]	  	[***]
	[***]	  	[***]	  	[***]

    [***]  

   [***]  

   [***]  

   [***]  
  

 
 [***] = CERTAIN
CONFIDENTIAL INFORMATION OMITTED 

  
 C-2 













 Exhibit D 

Quality Agreement 












 QUALITY ASSURANCE RESPONSIBILITY AGREEMENT 

BETWEEN 
 SAVIENT PHARMACEUTICALS,
INC. 
 AND 
 BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. 
 (COMMERCIAL PHASE) 

  
 D-2 













 Table of Contents 

 

					
	 1.  Purpose and Scope:
	  	 	1	 
		
	 2.  Definitions:
	  	 	1	 
		
	 3.  Notification of Process Deviations and Documentation of Changes:
	  	 	3	 
		
	 4.  Materials:
	  	 	4	 
		
	 5.  Manufacturing, Packaging, Inspection and Test:
	  	 	6	 
		
	 6.  Release and Shipment of Product(s):
	  	 	8	 
		
	 7.  Deviations in Process or Product:
	  	 	8	 
		
	 8.  Storage of Product(s):
	  	 	9	 
		
	 9.  Traceability of Product(s):
	  	 	9	 
		
	 10.  Conflict of Terms:
	  	 	9	 
		
	 11.  Compliance with Laws:
	  	 	9	 
		
	 12.  Inspections:
	  	 	9	 
		
	 13.  Observations by SAVIENT:
	  	 	10	 
		
	 14.  Adverse Events:
	  	 	10	 
		
	 15.  Stability:
	  	 	11	 
		
	 16.  Regulatory Action:
	  	 	11	 
		
	 17.  Annual Report to FDA:
	  	 	11	 
		
	 18.  APPENDIX I:
	  	 	13	 
		
	 19.  APPENDIX II:
	  	 	14	 
		
	 20.  APPENDIX III:
	  	 	17	 


  
 D-3 













 ARTICLE 1 

PURPOSE AND SCOPE: 

1.01    Savient Pharmaceuticals, Inc. (“SAVIENT”) and
Bio-Technology General (Israel) Ltd. (“BTG”) have entered into a Supply Agreement of (event date) herewith (the “Supply Agreement”). 

This document (the “Quality Agreement”) defines the quality assurance responsibilities between SAVIENT and BTG. This Quality
Agreement applies only to the manufacture and supply by BTG to SAVIENT of the Product (as defined in the Supply Agreement). 
 ARTICLE 2

 DEFINITIONS: 

2.01    Capitalized terms used but not otherwise defined in this Quality Agreement will have the meanings ascribed thereto
in the Supply Agreement. For ease of reference, the following definitions from the Supply Agreement which are used in this Quality Agreement are copied in full below, amended where appropriate for the purposes of this Quality Agreement: 

 

	 	(i)	 “BLA” means a Biologics License Application filed with the FDA and/or any other application
required for the purpose of marketing or selling or using a therapeutic or prophylactic product to be filed with a governmental agency in a non-U.S. country or group of countries, including, without
limitation, a Product License Application or Marketing Authorization in the European Union. 


  

	 	(ii)	 “Bulk Product” shall mean the bulk solution of polyethylene glycol (PEG) conjugate of uricase
ordered by Savient from BTG pursuant to the Supply Agreement. 


  

	 	(iii)	 “Bulk Product Specifications” shall mean the manufacturing and quality specifications for the Bulk
Product, including, without limitation, unit descriptions established from time to time in accordance with section 3.01 of the Supply Agreement. 


  

	 	(iv)	 “Business Day” shall mean any day other than (i) Friday, Saturday or Sunday or (ii) a
day on which banking institutions located in New York, New York, United States of America or in Israel are permitted or required by law, executive order or governmental decree to remain closed. 



 

	 	(v)	 “cGMP” shall mean current good manufacturing practices as set forth in Title 21, Parts 210 and 211
of the C.F.R. and 21 C.F.R. Part 312 (IND) and Part 314 (NDA), and 21 C.F.R. Part 600 (Biological Products), as established and amended by the FDA. 



  
 D-4 














	 	(vi)	 “FDA” shall mean the United States Food and Drug Administration or, where applicable, its
regulatory equivalent in a foreign jurisdiction. 


  

	 	(vii)	 “Facility” shall mean, as applicable, the Be’er Tuvia manufacturing facility located at Beer
Tuvia Industrial Zone, POB 571, Kiryat Malachi 83104, Israel 


  

	 	(viii)	 “IND” shall mean an Investigational New Drug application, as defined in 21 C.F.R. 312.3, and filed
with the FDA or any equivalent foreign Regulatory Agency. 


  

	 	(ix)	 “Legal Requirements” shall mean (i) any present and future national, state, local or similar
laws (whether under statute, rule, regulation or otherwise), (ii) requirements under permits, orders, decrees, judgments or directives, and requirements of applicable Regulatory Agencies (including, without limitation, cGMP) and
(iii) regulations pertaining to BLAs (with respect to each of the foregoing, as amended or revised from time to time). 


  

	 	(x)	 “Process” or “Processing” shall mean the act of purification, preparation, filling,
testing and any other pharmaceutical manufacturing procedures, or any part thereof (including, but not limited to, product or process specifications, testing or test methods, raw material specifications or suppliers, equipment, etc.), relating to,
as applicable, Bulk Product and Product. 


  

	 	(xi)	 “Product” shall mean pharmaceutical products containing Bulk Product ordered by Savient pursuant
to the Supply Agreement. 


  

	 	(xii)	 “Regulatory Agency” shall mean with respect to the United States, the FDA, or, in the case of a
country in the Territory other than the United States, such other appropriate regulatory agency with similar responsibilities. 



2.03    In addition, the following definitions apply to this Quality Agreement: 

(i)    “Bulk Product” shall mean bulk solution of polyethylene glycol (PEG) conjugate of uricase
in its final formulation which is in Process, and has been produced for sterilization, filling or other finishing activities. 

(ii)    “Filled Product” shall mean sterile Product that is in Process and has been filled into
its final primary packaging for further labeling or packaging activities. 
 (iii)    “Final
Product” shall mean finished Product in its final packaged and labeled form which is ready for distribution to the marketplace or third party distributors for sale or clinical use. 

(iv)    “Release” shall mean control, approval and authorization of shipment. 

  
 D-5 













 ARTICLE 3 

NOTIFICATION OF PROCESS DEVIATIONS AND DOCUMENTATION OF CHANGES: 

3.01    BTG shall provide to SAVIENT, within two Business Days of BTG’s discovery of its occurrence, written
notification of (i) any deviation from the Process as set forth in the Bulk Product Specifications and the BLA and any deviation from cGMP requirements, regulations and standards, and any event that represents an unexpected or unforeseeable
event that may affect safety, purity or potency of Bulk Product; and (ii) any deviation in the quality (purity, physical and chemical properties) of the Bulk Product from the Bulk Product Specifications. Appendix I sets forth a list of examples
of deviations from the Process, for purposes of illustration only, and is not intended to be comprehensive or definitive. 

(i)    BTG shall not conduct any retesting or reprocessing as the result of deviations described above
without prior written authorization from SAVIENT Quality Assurance unless a delay of retesting or reprocessing would result in increased risk to the safety, purity or potency of the Bulk Product or Product. 

3.02    Any changes to be made to this Quality Agreement in accordance with the provisions set out in this section 3 must
be documented as an addendum to this Quality Agreement, and must be signed by authorized representatives from each of the BTG QA department and the SAVIENT QA department, in addition to authorized representatives from any other departments as may be
specified in relation to the matters set forth in section 3.3 below. This Quality Agreement will be reviewed by BTG and SAVIENT on a periodic basis (approximately once per year) and revised as appropriate. 

3.03    Change Control 

(i)    Specifications that control the Process for the manufacture, including packaging, holding, and test
of Bulk Product and Product, must be signed by authorized representatives from BTG and SAVIENT Quality Assurance, SAVIENT Regulatory Affairs, and SAVIENT Manufacturing. Such documents include, but are not limited to Bulk Product Specifications
(including specifications for intermediate), Product Specifications (including specifications for product, component and packaging). Changes to such documents must be signed by authorized representatives from SAVIENT Quality Assurance, SAVIENT
Manufacturing and SAVIENT Regulatory Affairs. 
 (ii)    Changes to additional documents that control
the Process for the manufacture of Bulk Product and Product (including test methods, manufacturing procedures and batch records) must be assessed according to the BTG change control process described in section 3.4. Any change that would have an
impact on the Process, Bulk Product or Product, or require submissions to or approvals from any Regulatory Agency must receive prior written approval by authorized representatives from SAVIENT Quality Assurance, SAVIENT Manufacturing and SAVIENT
Regulatory Affairs. If there is no such impact, BTG may proceed with the change, but must notify SAVIENT Quality 

  
 D-6 













 
Assurance no later than 5 days from the initiation of the BTG change control process. If SAVIENT does not agree with BTG’s assessment of impact, SAVIENT must respond to BTG no later than
within 5 days of receipt of notification. 
 (iii)    The stability protocol as well as any changes to
the stability protocol must be approved by SAVIENT QA and SAVIENT Regulatory Affairs. 

(iv)    Critical Raw Materials. The current specifications for Critical Raw Materials are attached as
Appendix III. The Parties acknowledge and agree that these specifications may be amended from time to time by the supplier of the material. With respect to such amendments: 

BTG shall notify SAVIENT as soon as reasonable practicable, but no later than within 5 days of receipt of notification by
BTG. 
 The Parties will meet and agree as to suitability of the material produced according to the amended specification
for manufacture of the Bulk Product. 
 3.04    BTG will utilize a documented system of written procedures for the
control of changes to documents relating to raw materials, packaging materials, labeling, suppliers, equipment, manufacturing methods, batch size, product, intermediates and raw materials specifications, sampling, analytical test methods and Release
requirements and any other Processing by BTG, relating to the Bulk Product. 
 3.05    Any changes to any matter
relating to the manufacture and supply of Bulk Product by BTG shall be governed by the procedures set out in the Supply Agreement at Article 3 in relation to changes to the Bulk Product Specifications, and Article 6 in relation to changes to the
Process. 
 3.06    SAVIENT Regulatory Affairs will have responsibility for determining the regulatory impact of any
proposed change. SAVIENT Regulatory Affairs will determine the classification and requirements for notification to, or approval by FDA. SAVIENT is responsible for communication of any changes to FDA. SAVIENT Regulatory Affairs will have
responsibility to advise BTG of any changes to the BLA prior to submission. 
 BTG will ensure that changes are evaluated
and qualified in accordance with all applicable ICH (International Conference on Harmonization) requirements in addition to all Legal Requirements, including but not limited to: 

ICH Guideline Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. 

  
 D-7 













 ARTICLE 4 

MATERIALS 
  

	4.01	 Procurement of Components 



BTG will procure all the components described in the Bulk Product Specifications in such quantities as may be necessary to meet
Purchase Orders placed by SAVIENT pursuant to the Supply Agreement, and store the components in appropriate storage conditions under quarantine until tested. 
  

	4.02	 Inspection and Testing of Materials 



Upon receipt, BTG shall sample in accordance with acceptable statistical methods, inspect and test containers of all materials
to be used in the Process or in connection with the supply and manufacture of Bulk Product on a batch-by-batch basis, in accordance with the Bulk Product Specifications.

  

	4.03	 Bulk Product 



BTG will be responsible for ensuring that Bulk Product is manufactured, tested and stored in compliance with all applicable
ICH guidance documents (including, without limitation, the guidance contained therein for master and working cell banks) in addition to all Legal Requirements. ICH Guidance includes, but is not limited to: 

Q5D Quality of Biotechnological Products: Derivation and Characterization of Cell Substrates Used for Production of
Biotechnological/Biological Products. 
 Q7A, Good Manufacturing Practices Guidance for Active Pharmaceutical Ingredients

  

	4.04	 Retention, Storage and Handling of Materials and Product Samples 



BTG shall sample and retain such amounts of Bulk Product and of all materials to be used in the Process or in connection with
the supply and manufacture of Bulk Product (“Retains”) except water, compressed gasses and any highly volatile compounds as set forth in Appendix II or as otherwise required in accordance with applicable Legal Requirements. BTG will store
for five years, or such longer period as may be required in accordance with Appendix II or by Legal Requirement, sample Product and Retains for each batch or lot of intermediates and raw materials. Reasonably prior to the expiry of such retention
period, or upon termination of this Quality Agreement, BTG shall offer all such materials to SAVIENT. Any labor costs of BTG employees and/or Third Party expenses incurred by BTG related to the transfer of such materials shall be reimbursed by
SAVIENT in the manner and at the rates set forth on Exhibit B to the Supply Agreement. 
 A schedule of specific
Retains, storage conditions and retention periods for Puricase® is listed in Appendix II. 
  

	4.05	 Transmissible Spongiform Encephalopathy (TSE) 



BTG will provide a written TSE declaration that all materials (including non-dedicated
equipment) used in the manufacturing process are free from animal derived material. In addition, BTG must have available, on site, written TSE declarations from the supplier, where appropriate, of raw material used in the manufacturing process
verifying exclusion 

  
 D-8 













 
of animal derived material. If BTG is unable to provide the above declarations, BTG will comply with applicable TSE laws and regulations and will obtain all associated TSE documentation as
requested by SAVIENT. This documentation may include a TSE Certificate of Suitability in accordance with European directive 75/318/EEC as amended by directive 1999/82/EEC, the note for guidance EMEA/410/01 rev2 as amended and AP-CSP(99)4, Appendix 2, as amended. 
  

	4.06	 Supplier Audits 



BTG and SAVIENT will provide each other with copies of supplier audit reports for materials used in the Process or manufacture
of the Product. 
 ARTICLE 5 

MANUFACTURING, PACKAGING, INSPECTION AND TEST: 

5.01    The Processing, packaging, and labeling of Bulk Product will be performed and documented by BTG. BTG will not
subcontract any of the Processing, packaging, and labeling functions except as may be permitted in accordance with the Bulk Product Specifications, and if so permitted, in accordance with the provision set forth in Section 2.05 of the Supply
Agreement. 
 5.02    BTG shall not Process or store Bulk Product in the same building in which BTG manufactures, stores
or processes potentially hazardous substances (including, without limitation, certain antibiotics such as beta-lactam and cephalosporins, cytotoxic compounds, toxins or poisons such as pesticides or herbicides, (collectively, “Potential
Contaminants”) unless the Potential Contaminants are stored or manufactured in contained environments and in compliance with all Legal Requirements and the Bulk Product is Processed and stored in compliance with building, cleaning, validation
and changeover requirements of all cGMPs and all Legal Requirements. BTG shall promptly notify SAVIENT if any of the Potential Contaminants are manufactured, processed OI stored in any portion of the Facility which may result in the introduction of
Potential Contaminants into the areas of such facilities where the Bulk Product is Processed. Savient is aware that other products are processed in the Facility, the nature of those other products existing today and that certain equipment (multi-use equipment) is used in the processing of both the Bulk Product and these other existing products. Savient has also had the opportunity to assess the risk to the Processing of Bulk Product of the use of
such certain multi-use equipment with respect to the other existing products. However, in the instance where BTG intends to introduce a new product or substance to its Facility which is out of the matrix of
existing products and use such multi-use equipment in the processing or handling of such new product or substance, Savient will need to reassess the risks to the Processing of Bulk Product with this new
product or substance utilizing the multi-use equipment. Therefore, whenever BTG plans to introduce a new product or molecular entity which is out of the matrix of existing products to equipment shared with
Puricase production, BTG will provide no less than 30 days prior notice of its intent, and will contemporaneously make supporting cleaning validation data/rationale available to Savient. Savient will make its assessment of the risk potential for
adulteration of its own product through examination of cleaning validation 

  
 D-9 













 documentation prior to any further Puricase production and will respond to BTG within 5 days of its receipt
of cleaning validation data/rationale as to its conclusion(s) about the introduction. 
 5.03    BTG will provide to SAVIENT: a copy of
all master batch record documents and production and control records, a Certificate of Analysis (PEG-uricase API and uricase), executed batch records and associated batch documentation, which shall include,
without limitation: formulation records, label records, manufacturing records, environmental monitoring data, microbiological data, in-process and final analytical data, including lab control results,
sterility data, deviations/out-of-specification reports and cleaning records for any critical product contact equipment (for example, fermentors or any other non-dedicated product contact equipment). 
  

	 	(i)	 Translation: BTG will provide an English translation of all such documents, including, without limitation,
all reports, notes or comments on records that are not part of the master batch record but if any of the foregoing documents are only available in a language other than English, the Parties shall agree upon an English language template for such
document(s), and BTG shall provide to Savient an English language translation of any deviations from the template(s). When required by SAVIENT, translations shall be performed by an independent, translation firm. Translations by a third party firm
must be verified by BTG to ensure translation of company or process specific language. Any labor costs of BTG employees and/or Third Party expenses incurred by BTG in relation thereto shall be reimbursed by SAVIENT in the manner and at the rates set
forth on Exhibit B to the Supply Agreement. 


 5.04    Upon request by SAVIENT, BTG will
provide access to additional records that are not normally part of the batch record but which bear a reasonable relation to the Bulk Product for SAVIENT to review, which may include, without limitation, maintenance and use records, water testing
data, training records, raw material release records, log books, receiving and shipping records, inventory records and vendor qualification records Any labor costs of BTG employees and/or Third Party expenses Incurred by BTG in relation thereto
shall be reimbursed by SAVIENT in the manner and at the rates set forth on Exhibit B to the Supply Agreement. 

5.05    BTG will retain copies of all completed batch records for a minimum of five years, or such longer period as may be
required by Legal Requirement. Reasonably prior to the expiry of such retention period, or upon termination of this Quality Agreement, BTG shall offer such completed batch records to SAVIENT. Any labor costs of BTG employees and/or Third Party
expenses incurred by BTG related to the transfer of such materials shall be reimbursed by SAVIENT in the manner and at the rates set forth on Exhibit B to the Supply Agreement. 

 

	5.06	 Use of BTG Manufacturing Space for Bulk Product 



BTG has allotted an amount of manufacturing floor space at the Facility for the Processing of Bulk Product (Purification Area
in the Agreement). This space may be used for the production of other products subject to the following limitations: 

  
 D-10 













 (i)         BTG may use the
Purification Area for alternate product manufacturing only during periods when the Purification Area is not used for the Processing of Bulk Product. 

(ii)         BTG adheres to all relevant cGMPs including, without limitation,
procedures for prevention of mix-ups, prevention of contamination, labeling requirements, cleaning requirements and changeover requirements 

(iii)         BTG, shall not, under any circumstances utilize any equipment dedicated
to the Processing of Bulk Product for such alternate product manufacturing 
 (iv)
        BTG adheres to limits and procedures described in section 5.2 for Potential Contaminants. 

ARTICLE 6 
 RELEASE AND
SHIPMENT OF PRODUCT(S): 
 6.01    Bulk Product shall be Released in accordance with the procedures set forth in the
Supply Agreement, together with the additional obligations described in this section of the Quality Agreement. BTG QA will review the records described in section 5.3 above. Following review and acceptance by BTG QA, BTG will send copies of these
documents to SAVIENT QA. SAVIENT QA and Manufacturing will then review the documentation and notify BTG whether or not documentation is acceptable. If such documentation is not reasonably acceptable to SAVIENT, BTG will cooperate in taking such
steps as SAVIENT may reasonably require to ensure that the documentation, and any Processing described therein complies with the Bulk Product Specifications and all Legal Requirements. 

6.02    BTG QA will be responsible for the QC testing of Filled Product until such time as a third party laboratory has
been qualified to perform such testing. BTG will provide a Certificate of Analysis and/or stability results for each batch that BTG tests. Savient QA will be responsible for the review of the manufacturing batch record for Filled Product, review of
the Certificate of Analysis and Release of the Filled Product. 
 6.03    SAVIENT QA will be responsible for the Release
of the Final Product. 
 6.04    Product shall be delivered in accordance with the provisions of Article 7 of the Supply
Agreement. 
 6.05    BTG will not ship any SAVIENT products to any destination, as identified by SAVIENT, unless prior
approval has been received from SAVIENT. 
 ARTICLE 7 

DEVIATIONS IN PROCESS OR BULK PRODUCT: 

In the event of a notification of a deviation by BTG in accordance with section 0 above, BTG shall investigate and fully
document in English such deviation within 30 days of its discovery. If BTG cannot resolve the deviation within the 30-day period, BTG will provide 

  
 D-11 













 
weekly updates of the investigation progress. At SAVIENT’s request, BTG shall conduct such additional or more detailed investigation of the deviation as SAVIENT may reasonably
instruct. Investigation documentation will be retained by BTG as part of the batch documentation for the batch affected. When a deviation has occurred, SAVIENT will have the final review and decision making responsibility as to the impact of
the deviation on the Bulk Product or Product, which will include the disposition of affected lots. 
 ARTICLE 8 

STORAGE OF PRODUCT(S): 

Bulk Product will be stored under appropriate storage conditions and in a secure area to ensure that they comply with the Bulk
Product Specifications, including all the label requirements, quality specifications and attributes as well as Legal Requirements. 

ARTICLE 9 
 TRACEABILITY
OF PRODUCT(S): 
 SAVIENT will be responsible for traceability of products to first consignee within the US. BTG will be
responsible for traceability from the finished product lot number to raw material and component lots used in manufacture. 
 ARTICLE 10

 CONFLICT OF TERMS: 

To the extent that there exists any conflict between the terms of this Quality Agreement and the Supply Agreement, the latter
shall prevail. To the extent that there exists any conflict between the terms of this Quality Agreement and any Legal Requirements, the latter shall prevail. 

ARTICLE 11 
 COMPLIANCE
WITH LAWS: 
 BTG will ensure that all of its activities pursuant to this Agreement are performed in accordance with all
Legal Requirements (including cGMPs), the respective Bulk Product Specifications, conditions of the BLA, and BTG’s Standard Operating Procedures (SOPs). BTG will ensure that the Bulk Product supplied by it to SAVIENT shall not itself cause the
Final Product to be adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act and regulations. 

  
 D-12 













 ARTICLE 12 

INSPECTIONS: 
 Each party
shall advise the other of any governmental communication, inspection or report, including, without limitation, that of any appropriate regulatory agency in any jurisdiction with responsibilities similar to those of the FDA in respect of the United
States, any environmental agency, health agency or other governmental or administrative agency having jurisdiction over the Product or the Processing. The notifying party shall promptly notify the other party by fax and telephone, to the person and
on the contact numbers set out below: 
 TO SAVIENT: 

 

					
	 •
	 	 Contact Name:
	  	 Eric Nickerson, Senior Director Quality Assurance

			
	 •
	 	 Telephone:
	  	732-418-9300
			
	 •
	 	 Fax:
	  	732-418-0766


 TO BTG: 
  

					
	 •
	 	 Contact Name:
	  	 Yosefa Bilman, Senior Director Quality Assurance

			
	 •
	 	 Telephone:
	  	972-8-861-2007
			
	 •
	 	 Fax:
	  	972-8-861-2166



  
 D-13 













 ARTICLE 13 

OBSERVATION BY SAVIENT: 

Observation by SAVIENT or its authorized representative shall be governed the following. Observation will be limited to not
more than one quality audit every 12 months. One additional quality audit may be conducted within the 12 month period if BTG receives a communication from any regulatory authority threatening license approval or supply of the Product due to
compliance deficiencies at BTG facilities or if BTG was found to be in material non-compliance of this Agreement during or since the last quality audit. Person-in-Plant
visits may be conducted at the discretion of SAVIENT during the manufacture of Bulk Product at BTG facilities. The frequency and duration of any additional visits must be agreed to by SAVIENT and BTG. 

ARTICLE 14 
 ADVERSE
EVENTS: 
 14.1    BTG will provide to SAVIENT within 48 hours of becoming aware, any information from any source
that suggests an adverse event or serious adverse event has occurred. This information will include any adverse drug experience or reaction reports or any other information indicating that the product has any toxicity, sensitivity reactions or is
otherwise alleged to cause illness or injury due to a possible product quality problem, adulteration or misbranding. 

14.2    Quality Assurance Investigations. Upon notification to BTG that SAVIENT has received an SAE, AE, product complaint
or inquiry regarding a Product supplied or incorporating a Bulk Product supplied, BTG shall conduct a quality assurance investigation to determine if any process or testing deviations or events may have contributed to the SAE, AE, product complaint
or inquiry. BTG shall provide a written report on the results of the investigation to SAVIENT in not more than 30 days from Savient’s notification. In cases where a more comprehensive investigation might be required, the Parties will jointly
develop an investigation plan. BTG shall reasonably cooperate with SAVIENT and regulatory agencies regarding an investigation or inquiry that may be initiated by a regulatory agency or otherwise required in response to a consumer or healthcare
professional. BTG shall further provide SAVIENT with all data or other information that SAVIENT may reasonably require in connection with any reports or correspondence that SAVIENT provides to the regulatory agency, consumer or healthcare
professional relative to any such AE, SAE or product complaint. BTG shall make records accessible to SAVIENT for purposes of FDA or other regulatory agency inspection. 

14.3    Exchange of Drug Safety Requests. The Parties shall immediately provide each other with copies of all drug safety
requests from all governmental and other regulatory health authorities. Proposed answers affecting the Product will be exchanged between the Parties before submission and the Parties shall cooperate with respect to such answers. SAVIENT shall


  
 D-14 













 
have the ultimate decision-making authority with respect to the answers relating to the Product. The Parties shall exchange decisions from applicable health authorities immediately. 

ARTICLE 15 
 STABILITY:

 BTG will perform the stability testing, data interpretation, reporting and updating of stability information to
regulatory documents for the Product and Bulk Product and for Product until such time as a third party laboratory has been qualified to perform such testing. Stability related activities for which BTG is responsible shall be completed in accordance
with the timing specified in stability protocols and BTG procedures. 
 ARTICLE 16 

REGULATORY AFFAIRS: 

Each Party shall advise the other Party of any regulatory action of which it is aware which would affect the Product in any
country of the Territory. 
 ARTICLE 17 

ANNUAL REPORT TO FDA: 

BTG will prepare a summary of all changes to the product, production process, quality controls, equipment or facilities that
have a potential to affect the identity, strength, quality, purity or potency of the Product. Such data will be prepared and sent to SAVIENT within thirty days of the end of the review period. BTG will also ensure that the results of all stability
testing performed within the review period are sent to Savient within thirty days of the end of the review period. 

  
 D-15 













 Approvals 
  

							
	 	 	  Print Name

 
	 	  Signature

 
	 	  Date

 

	  SAVIENT QA

 
	 	  Eric Nickerson
  
	 	  /s/Eric Nickerson

 
	 	  19-FEB-2009
  

	  BTG QA

 
	 	  Yosefa Bilman
  
	 	  /s/Yosefa Bilman

 
	 	  19/02/09

 



  
 D-16 













 APPENDIX I 

Listing of Example Deviations 
 The
following is a non-exclusive list of deviations requiring notification in accordance with Article 3: 

[***] 
  

 
 [***] = CERTAIN
CONFIDENTIAL INFORMATION OMITTED 

  
 D-17 













 APPENDIX II 

Schedule of Retains, Storage Conditions and Retention Periods for Puricase®

 The following is a list of the reserve/retention samples that are taken during the manufacturing processes of bulk uricase and PEG-uricase as well as from the final bulk uricase and the final bulk PEG-uricase (Bulk Product). 

The document was prepared based on the following BTG QC SOPs: 

[***] 
 Table I details the
reserve/retention samples that are taken during the manufacturing process of bulk uricase and from the final bulk uricase. 
 Table 2
details the reserve/retention samples that are taken during the manufacturing process of PEG-uricase and from the final hulk PEG-uricase (Bulk Product). 

All IPC samples (including reserve/retention samples) are to be discarded after the Bulk Product is released by BTG QA. 

Uricase retention and reserve samples will be kept for one year after manufacturing. PEG-Uricase retention and reserve samples will be kept
for six years after manufacturing. 
  
  

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED 

  
 D-18 













 Table 1. Reserve/Retention Samples for Bulk Uricase (IPC and Final) 

 

							
	 Process Step	 	 Sample name	 	  Number of

 Samples
  
	 	
 Storage
  Temperature

	
 [***]
	 	  [***]
	 	  [***]
	 	  [***]

	
 [***]
	 	  [***]
	 	
 [***]

	
 [***]
	 	  [***]
	 	
 [***]

	 	
 [***]

	
 [***]
	 	  [***]
	 	
 [***]

	
 [***]
	 	  [***]
	 	
 [***]

	
 [***]
	 	  [***]
	 	
 [***]

	
 [***]
	 	  [***]
	 	
 [***]

	
 [***]
	 	  [***]
	 	
 [***]

	
 [***]
	 	  [***]
	 	
 [***]

	
 [***]
	 	  [***]
	 	
 [***]

	
 [***]
	 	  [***]
	 	
 [***]

	
 [***]
	 	  [***]
	 	
 [***]

	
 [***]
	 	  [***]
	 	
 [***]

	
 [***]
	 	  [***]
	 	  [***]
	 	
 [***]

	 	  [***]
	 	
 [***]

	
 [***]
	 	  [***]
	 	
 [***]

	
 [***]
	 	  [***]
	 	
 [***]

	
 [***]
	 	  [***]
	 	
 [***]

	 	
 [***]

	
 [***]
	 	
 [***]

	
 [***]
	 	
 [***]


       [***] 
  
  

 
 [***] = CERTAIN
CONFIDENTIAL INFORMATION OMITTED 

  
 D-19 













 Table 2. Reserve/Retention Samples for PEG-Uricase
API (IPC and Final) 
  

							
	  Process Step	  	Sample name	 	 Number of

Samples
  
	 	
Storage
 Temperature

 

	
  [***]
	  	 [***]
	 	 [***]
	 	
[***]

	
  [***]
	  	 [***]
	 	 [***]

	
  [***]
	  	 [***]
	 	 [***]

	
  [***]
	  	 [***]
	 	 [***]

	  	 [***]
	 	 [***]

	
  [***]
	  	 [***]
	 	 [***]

	  	 [***]
	 	 [***]

	  	 [***]
	 	 [***]

	  	 [***]
	 	 [***]

	
  [***]
	 	 [***]

	
  [***]
	 	 [***]


  
  

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED 

  
 D-20 













 APPENDIX III 

Critical Raw Materials Used in the Production of Recombinant Uricase and PEG-Uricase 

 

											
	  

Material
  
	 	  

    Manufacturer    

 
	 	
    Cat. No.    

 
	 	
    Testing    

 
	 	
    Source    

 
	 	
    Origin    

 

	
  [***]
  
	 	 [***]

 
	 	 [***]

 
	 	 [***]

 
	 	 [***]

 
	 	
[***]
  


  
  

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED 

  
 D-21 













 SPECIFICATION [***] 

 
  

					
	
Parameter
	 	Test	 	Specification
	
[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]

  
  

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED 

  
 D-22 













 Exhibit G 

Product Specifications 












 SPECIFICATION- [***] 

 

					
	Parameter	 	Test	 	Specification
	
[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	 	[***]	 	[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	 	[***]	 	[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	 	[***]	 	[***]
	 	[***]	 	[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	 	[***]	 	[***]

 [***] 
  

 
 [***] = CERTAIN
CONFIDENTIAL INFORMATION OMITTED 












 THIRD AMENDMENT TO COMMERCIAL SUPPLY AGREEMENT 

THIS THIRD AMENDMENT is made and entered into this 1st day of July, 2010, (hereinafter the “Effective Date”). 

 

			
	 BETWEEN:
	  	 SAVIENT PHARMACEUTICALS, INC.
 a
Delaware corporation, (hereinafter “Savient”)
  
 AND

 
 BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.

an Israel corporation, (hereinafter “BTG”)

		
	WHEREAS:	  	

 Savient and BTG are parties to a Commercial Supply Agreement with an effective date of March 20, 2007,
(hereinafter, the “Agreement”) pursuant to which BTG agreed to manufacture and supply a certain Bulk Product, as defined in the Agreement, to Savient, and Savient agreed to purchase such Bulk Product from BTG; and 

Savient and BTG have subsequently amended the Agreement on September 24, 2007, (the “First Amendment”) and on January 24,
2009, (the “Second Amendment”), and have issued a Letter Agreement dated July 30, 2008, (the “Letter Agreement”) pertaining to the Agreement; and 

Savient and BTG desire to further amend the Agreement in accordance with the terms and conditions of this Third Amendment. 

NOW THEREFORE in consideration of the mutual promises and agreements and covenants contained herein, the adequacy of such consideration has been agreed
and acknowledged by each party, and in accordance with the provisions of Section 14.08 of the Agreement, the parties hereto agree as follows: 
  

	1.	 Definitions. All of the Definitions contained in Article 1 of the Agreement shall have the same meanings
herein unless specifically stated otherwise. Any capitalized terms not specifically defined herein, shall have the same meaning ascribed to them as set forth in the Agreement. 



 

	2.	 Application of Capacity Reservation Fees. The parties agree that Section 5.01(ii)(D)(2) of the Agreement
is hereby replaced in its entirety as follows: 


 “(2) be credited, inclusive of interest, by BTG on a per batch
basis by providing a 20% discount on the value of each batch at the time of invoicing for Bulk Product purchased by Savient until it is fully utilized, provided however, except as otherwise provided in Sections 5.0l(ii)(F), 5.01(ii)(G) and
5.01(ii)(H), any uncredited Processing Capacity Reservation Fee, inclusive of interest, which is 












 
remaining at the close of business on [***] due to a failure by Savient to take delivery of Bulk Product which conforms to the Commercial Bulk Product Specifications and which is ordered pursuant
to a Bulk Product Forecast provided pursuant to Section 5.03 or an Amended Bulk Product Forecast provided pursuant to Section 5.06 and which is otherwise properly amended pursuant to Section 5.05 shall be forfeited by Savient to BTG.
For purposes of clarity, the credit of the Processing Capacity Reservation Fee shall accrue upon the delivery of the Bulk Product by BTG to Savient and shall be reflected on the invoice which relates to the Bulk Product shipment in question;
and”. 
  

	3.	 No Modification. Except as expressly provided for herein, the Agreement shall remain in full force and
effect without amendment. If there is any conflict or inconsistency between this Amendment and the Agreement, this Amendment shall prevail. This Amendment contains the entire agreement between the parties hereto with respect to the subject matter
contemplated herein and shall not be modified or amended except by a written instrument signed by both parties hereto. 


 IN WITNESS
WHEREOF, the parties have caused this Amendment to be executed by their respective duly authorized officers as of the date first written above. 
  

									
	SAVIENT PHARMACEUTICALS, INC.	  	 	BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
				
	 By:
	 	         /s/ Philip K.
Yachmetz                

        Philip K. Yachmetz

        Senior Vice President &

        General Counsel
	  	 
	By:
	 
	 	         /s/ Dov
Kanner                

        Dov Kanner

        Managing Director


  
  

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED 

  
 - 2 - 













 FOURTH AMENDMENT TO COMMERCIAL SUPPLY AGREEMENT 

THIS FOURTH AMENDMENT TO COMMERCIAL SUPPLY AGREEMENT (this “Fourth Amendment”) is made and effective as of this 21st day of March 2012,
(hereinafter the “Amendment Effective Date”). 
  

			
	BETWEEN:	  	 SAVIENT PHARMACEUTICALS, INC.
 a
Delaware corporation, (hereinafter “Savient”)

		  	  
 AND

 

		  	 BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.

an Israel corporation, (hereinafter “BTG”)


 WHEREAS: 

Savient and BTG are parties to a Commercial Supply Agreement with an effective date of March 20, 2007, (hereinafter, the
“Agreement”, modified as provided in the next paragraph) pursuant to which BTG agreed to manufacture and supply a certain Bulk Product, as defined in the Agreement, to Savient, and Savient agreed to purchase such Bulk Product from BTG; and

 Savient and BTG have subsequently amended the Agreement on September 24, 2007, (the “First Amendment”), on
January 24, 2009, (the “Second Amendment) and on July 1, 2010, (the “Third Amendment”), and have issued a Letter Agreement dated July 30, 2008, (the “Letter Agreement”) pertaining to the Agreement; and 

Savient and BTG desire to further amend the Agreement in accordance with the terms and conditions of this Fourth Amendment. 

NOW THEREFORE in consideration of the mutual promises, agreements and covenants contained herein, the adequacy of such consideration
has been agreed and acknowledged by each Party, and in accordance with the provisions of Section 14.08 of the Agreement, the Parties agree as follows: 
  

	1.	 Definitions. All of the Definitions contained in Article 1 of the Agreement shall have the same meanings
herein unless specifically stated otherwise. Any capitalized terms not specifically defined herein, shall have the same meaning ascribed to them as set forth in the Agreement. 



 

	2.	 Addition and Replacement of Exhibits to Agreement. The Parties agree that the exhibits which are
appended to this Fourth Amendment shall, as applicable, be added or supersede and replace their counterparts as previously executed by and between 















	 	 
the Parties. For purposes of clarity, the following exhibits to the Agreement are hereby repealed and replaced with the attached exhibits: 



 

	 	(a)	 Exhibit C-1, “Current Commercial Bulk Product Specifications”
which are the current regulatory acceptance criteria and are added pursuant to Section 3.01(ii) of the Agreement; 


  

	 	(b)	 Exhibit C-2, “Modified Acceptance Criteria to be Used to Govern
the Commercial Supply Agreement” [***] (the “Modified Acceptance Criteria”); and 


  

	 	(c)	 Exhibit E, “Product Price” [***]. 



 

	3.	 Modified Payment Terms for Bulk Product. Savient and BTG acknowledge and agree that, due to
additions or modifications to the Current Commercial Bulk Product Specifications, additional experience manufacturing Bulk Product may be required in order to provide a higher level of assurance that Bulk Product can be consistently manufactured in
a manner that conforms to the Current Commercial Bulk Product Specifications as set forth in Exhibit C-1 hereto. [***]. As more fully set forth in clauses (a) through (c) herein below, Savient and BTG
agree to share financial responsibility with respect to (x) certain Bulk Product manufactured by BTG under the Agreement [***] and (y) Bulk Product manufactured by BTG under the Agreement beginning with the production of [***] and ending
after the completion of [***] batches under this Agreement (the “[***] Specification Batches”). After completion of the [***] specification batches the Current Commercial Bulk Product Specifications will be reassessed and the Parties will
mutually agree on any revisions thereto deemed necessary or appropriate (which agreement shall not be unreasonably withheld, conditioned or delayed) for submission to Regulatory Authorities in whose territories KRYSTEXXA is licensed. After the
acceptance by such Regulatory Authorities of any revisions to the Current Commercial Bulk Product Specifications as set forth in Exhibit C-1 hereto, unless the Parties mutually agree otherwise in writing, the
risk of failed batches and payment terms set forth in the Agreement (as amended by Section 2(b) above) shall apply, in full force and effect, with respect to all future Bulk Product manufactured by BTG pursuant to the Agreement. During the pendency
between the completion of the [***] Specification Batches and the acceptance of any revisions to the Current Commercial Bulk Product Specifications by the pertinent Regulatory Authorities in whose territories KRYSTEXXA is licensed, the parties agree
that BTG shall continue to manufacture batches of Bulk Product in accordance with the Modified Acceptance Criteria set forth in Exhibit C-2 and 



 
  

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED 

  
 - 2 - 














	 	 
any nonconformities in any such batches shall be resolved in accordance with Section 3(b) of this Fourth Amendment. 



(a) Within [***] business days after the full execution of this Fourth Amendment, Savient shall pay to BTG a one-time payment of [***] Dollars ($[***]), [***]. 
 (b) With respect to any of the
[***] Specification Batches of Bulk Product manufactured by BTG under the Agreement (unless extended by mutual written agreement of the Parties): 

(i) If any of the [***] Specification Batches is deemed not to conform to the Current Commercial Bulk Product
Specifications and (A) such non-conformance does comply with all of the Modified Acceptance Criteria and (B) such non-conformance is not attributable in any
way to human error (each such batch a “Modified Acceptance Criteria Conforming Batch”), Savient shall pay BTG for such batch at a rate of [***] Dollars and [***] cents ($[***]) per gram (e.g., [***] Dollars and [***] cents ($[***]) on the
basis of a [***] batch), rather than the Price. For purposes of clarity, human error may include, but is not limited to, the introduction of foreign material, improper connection of equipment, improper cleaning of equipment, and the failure to
follow established SOPs and master batch records. 
 (ii) If any of the [***] Specification Batches is deemed not to
conform to the Current Commercial Bulk Product Specifications and (A) such batch does not conform to the Modified Acceptance Criteria, or (B) such non-conformance is attributable in any way to human
error caused by BTG, Savient shall have no liability to BTG with respect to such Bulk Product. 
 (iii) For any of the
[***] Specification Batches deemed to conform to the Current Commercial Bulk Product Specifications, Savient shall pay BTG for such batch in accordance with the terms and conditions of the Agreement, including the then-current Price. 

(c)    Savient may, in its sole discretion, apply, on a batch-by-batch basis, [***] Dollar ($[***]) of the Processing Capacity Reservation Fee credit (or such greater amount agreed upon as the then current per batch Processing Capacity Reservation Fee credit
due to the accrual of interest on the Processing Capacity Reservation Fee amount) toward any payment owed to BTG in accordance with clause (b) above. 

In the event either Party determines that a batch of Bulk Product is a Current Commercial Bulk Product
Non-Conforming Batch it shall promptly notify the other Party. If the other Party does not agree with such determination, the Parties shall investigate and fully document such
non-conformance using typical out-of-specification investigation 

 
  

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED 

  
 - 3 - 














	 	 
techniques performed to the mutual satisfaction of the Parties (in the case of specifications for which the analyses are not conducted at BTG, Savient shall enable BTG to review all data related
to those analyses). If following such investigation the Parties do not agree whether a batch of Bulk Product is a Current Commercial Bulk Product Non-Conforming Batch, the Parties shall promptly appoint an
independent specialist (appointed by mutual agreement between the Parties, which agreement shall not be unreasonably withheld, conditioned or delayed) who shall determine whether such batch of Bulk Product is a Current Commercial Bulk Product Non-Conforming Batch. In the absence of manifest error, the independent specialist’s decision shall be conclusive and binding on the Parties. 



 

	4.	 Suspension of Manufacturing. Without limiting the provisions of Section 5.08 of the
Agreement, in the event that [***] or more of the [***] Specification Batches (unless extended by mutual written agreement of the Parties) are deemed to be Modified Specification Non-Conforming Batches, then
Savient may, in its sole discretion and without any penalty under the Agreement, suspend all manufacture of Bulk Product under the Agreement. In the event that manufacture of Bulk Product is suspended in accordance with the preceding sentence,
Savient shall be released from its purchase obligations under Section 6.01 of the Agreement and no forecast or estimate shall be considered a Firm Order until such time as BTG demonstrates to Savient’s reasonable satisfaction that the
manufacture of Bulk Product may be resumed with a reduced and manageable risk of the manufacture of Modified Specification Non-Conforming Batches. 



 

	5.	 Remediation Plan. Prior to the Amendment Effective Date, BTG and Savient (a) [***] and
(b) mutually agreed to implement investigations of [***]. Appendix 1 sets forth the proposals for these investigations that have been agreed to by the Parties and BTG shall, after the Amendment Effective Date, promptly pursue such
investigations and implement such changes which may be determined to be necessary to the Facility to Savient’s reasonable satisfaction. Savient and BTG shall agree on the terms and conditions for the implementation of the Facility Changes, and
the allocation of costs, in accordance with Section 6.03. If Savient and BTG determine that Process Changes or Process development work is needed to prevent Modified Specification Non-Conforming Batches
(as distinguished from equipment changes or work of general applicability to BTG’s manufacturing activities), the Parties shall agree on the terms and conditions for such additional Process development work in accordance with Section 6.02(iii).



  

	6.	 Submission of Data to the FDA. BTG acknowledges that in accordance with the post-regulatory approval
commitments made by Savient to the FDA with respect to the FDA’s approval of the Product, Savient is required to submit to the FDA revised specifications for Bulk Product and the supporting data therefore after the completion of the manufacture
of the [***] Specification Batches. BTG shall provide all information and assistance which is reasonably necessary or useful in the preparation of such submissions in accordance with Section 3.02. All documents to be supplied by BTG pursuant to
this 


  
  

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED 

  
 - 4 - 













 
Section 6 shall be translated by BTG into the English language as may be necessary. Any labor costs of BTG employees shall be reimbursed by Savient in the manner and at the rates set forth
on Exhibit B to the Agreement. 
  

	7.	 Savient Observation Rights. During the Term, BTG shall make best efforts to accommodate
Savient’s requests to visit the facility where the Bulk Product is manufactured and observe the manufacturing of the Bulk Product in order to ensure that the Process complies with Applicable Law and the Product Specifications. These visits will
be at Savient’s sole cost and expense and will take place during normal business hours and upon [***] Business Days notice 


  

	8.	 Additional Agreement. As an additional inducement to Savient for the execution of this Fourth Amendment,
BTG and its parent company, Ferring B.V. will cause Ferring International Centre S.A. to execute, contemporaneously with the execution of this Fourth Amendment, the OsmB Promoter License Agreement in the form attached hereto as Appendix 2.



  

	9.	 No Modification. Except as expressly provided for herein, the Agreement shall remain in full force and
effect without amendment. If there is any conflict or inconsistency between this Amendment and the Agreement, this Amendment shall prevail. The Agreement, as modified by this Amendment, contains the entire agreement between the parties hereto with
respect to the subject matter contemplated herein and shall not be modified or amended except by a written instrument signed by both parties hereto. 



IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by their respective duly authorized officers as of the date
first written above. 
  

							
	SAVIENT PHARMACEUTICALS, INC.	  	BIO-TECHNOLOGY GENERAL (ISRAEL) Ltd.
				
	By:	 	     /s/Philip K. Yachmetz

    Philip K. Yachmetz
    Senior Vice President &
    General Counsel
	  	 By:
	 	     /s/Dov Kanner 

    Dov Kanner
    Managing Director


  
  

 
 [***] = CERTAIN
CONFIDENTIAL INFORMATION OMITTED 

  
 - 5 - 













 EXHIBIT C-1 to Fourth Amendment 

Release Tests Performed on [***] 
  

					
	Parameter	  	Test	  	Acceptance Criteria
	
[***]
	  	[***]	  	[***]
	
[***]
	  	[***]	  	[***]
	  	[***]	  	[***]
	
[***]
	  	[***]	  	[***]
	  	[***]	  	[***]
	
[***]
	  	[***]	  	[***]
	  	[***]	  	[***]
	
[***]
	  	[***]	  	[***]
	  	[***]	  	[***]
	
[***]
	  	[***]	  	[***]
	  	[***]	  	[***]
	
[***]
	  	[***]	  	[***]
	  	[***]	  	[***]
	
[***]
	  	[***]	  	[***]
	
[***]
	  	[***]	  	[***]
	  	[***]	  	[***]

    [***] 

   [***] 
  

 
 [***] = CERTAIN
CONFIDENTIAL INFORMATION OMITTED 

  
 - 6 - 













 Tests Performed on [***] 

 

					
	Parameter	  	Test	  	Acceptance Criteria
	
[***]
	  	[***]	  	[***]
	  	[***]	  	[***]
	
[***]
	  	[***]	  	[***]
	
[***]
	  	[***]	  	[***]
	  	[***]	  	[***]
	  	[***]	  	[***]
	
[***]
	  	[***]	  	[***]
	  	[***]	  	[***]

    [***] 

   [***] 
    [***] 

   [***] 
    [***] 

 
  

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED 

  
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 EXHIBIT C-2 to Fourth Amendment 

[***] Specification 
  

					
	 	 	 
	Parameter	 	U.S. Regulatory Agency Acceptance Criteria	 	 Modified

Acceptance Criteria

	
[***]
	 	[***]	 	[***]
	 [***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	 [***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	 [***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	 [***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	 [***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	 [***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	 [***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	 	[***]	 	[***]
	 	[***]	 	[***]
	 	[***]	 	[***]
	 	[***]	 	[***]
	 [***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]
	 [***]
	 	[***]	 	[***]
	
[***]
	 	[***]	 	[***]

  

			
	  
	  	[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED













 [***] Specification 
  

					
	Parameter	 	U.S. Regulatory Agency Acceptance Criteria	 	
Modified
 Acceptance
Criteria

	  

[***]
  
	 	  

[***]
  
	 	  

[***]
  

	  

[***]
  
	 	  

[***]
  
	 	  

[***]
  

	  

[***]
  
	 	 [***]

 
	 	  

[***]
  

	  

[***]
  
	 	  

[***]
  
	 	  

[***]
  

	  

[***]
  
	 	  

[***]
  
	 	  

[***]
  

	  

[***]
  
	 	  

[***]
  
  
	 	  

[***]
  

	  

[***]
  
	 	  

[***]
  
	 	  

[***]
  

	 	  

[***]
  
	 	  

[***]
  

	  

[***]
  
	 	  

[***]
  
  
	 	  

[***]
  

	  

[***]
  
	 	  

[***]
  
	 	  

[***]
  

	  

[***]
  
	 	  

[***]
  
	 	  

[***]
  

	  

[***]
  
	 	  

[***]
  
	 	  

[***]
  

	  

[***]
  
	 	  

[***]
  
	 	  

[***]
  

	  

[***]
  
	 	  

[***]
  
	 	  

[***]
  

	  

[***]
  
	 	  

[***]
  
	 	  

[***]
  

	  

[***]
  
	 	  

[***]
  
	 	  

[***]
  

	  

[***]
  
	 	  

[***]
  
	 	  

[***]
  


  
  

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED 

  
 - 2 - 













 EXHIBIT E to Fourth Amendment 

Product Price 
 As and from [***],
the Price of the Product shall be as follows: 
 (i)         For each gram, [***]
Dollars (USD$[***]) for any aggregated quantities of the Product up to and including [***] ordered during any calendar year that commercial batches of Product are shipped, i.e. after the first commercial batch of Product has been shipped. 

(ii)        For each gram, [***] Dollars (USD$[***]) for any aggregated quantities of
the Product between [***] and [***] ordered during any calendar year as above; and 

(iii)       For each gram, [***] United States Dollars (USD$[***]) for any aggregated
quantities of the Product equal to or greater than [***] ordered during any calendar year as above. 
 The Parties agree that Savient will enter into a
supply agreement with [***], the supplier of [***], and will order and pay for [***] needed in Product manufacture on an ongoing basis. In the event that BTG purchases [***] directly from [***] or any other manufacturer, the cost of the [***] will
be invoiced to Savient. 
 Beginning on the [***] anniversary of the date of receipt of the first commercial batch of Product by Savient, and on each
successive [***] thereafter, the Price of the Product shall increase by an amount equal to the average increase in the United States Consumer Pricing Index (CPI) over the immediately preceding [***] period; such percentage increase shall be
applied to each amount specified in (i) through (iii) above. 
  

 
 [***] = CERTAIN
CONFIDENTIAL INFORMATION OMITTED 












 APPENDIX 1 

[***] 
  

 
 [***] = CERTAIN
CONFIDENTIAL INFORMATION OMITTED 

  
 - 2 - 













 APPENDIX 2 

OsmB Promoter License Agreement 

This OsmB Promoter License Agreement (the “Agreement”) is entered into as of this 21st day of March, 2012, with a retroactive
effective date of July 18, 2005 (“Effective Date”), between Savient Pharmaceuticals, Inc., a Delaware corporation (“Savient”) and Ferring International Centre S.A., a Swiss corporation (“FIC”). 

Introduction 

WHEREAS on March 23, 2005, Ferring B.V., FIC and Savient executed a Share Purchase Agreement and an Asset Purchase Agreement, and
associated documents, which accomplished the sale of Savient’s global biologics manufacturing business comprising the transfer of all outstanding shares in Bio-Technology General (Israel), Ltd.
(“BTG”) and certain defined assets from Savient to Ferring B.V. and FIC (the “BTG Divestiture”). Part of the BTG Divestiture included the transfer of certain intellectual property rights from Savient and BTG to FIC; 

WHEREAS Savient and BTG entered into an Amended and Restated Residual Rights Agreement dated July 17, 2005, pursuant to which BTG
performed certain manufacturing development and bulk product manufacturing activities pending the finalization of more definitive agreement relating to those activities and wherein the parties stated their intention to license certain intellectual
property rights in certain patents from BTG to Savient in order to assure Savient’s rights and liabilities to manufacture the Puricase product, now known as pegloticase (the “RRA”); 

WHEREAS, pursuant to the terms and conditions of the RRA, Savient and BTG entered into a Development Agreement (the “DA”) and
Commercial Supply Agreement (the “CSA”), each dated March 20, 2007, both of which agreements upon their execution superseded and replaced, in relevant part, the RRA; 

WHEREAS pursuant to the terms and conditions of the DA and CSA, in Sections 2.02 (iii) and 2.01(iii) respectively, BTG has granted, and has
undertaken to cause its Affiliates to grant, to Savient a fully paid-up, royalty-free, non-exclusive license in the Territory (defined in each of the DA and CSA as
meaning, collectively, each country of the world) to manufacture, have manufactured, produce, have produced, develop, have developed, use, have used, offer for sale, have offered for sale, sell, have sold, export, and have exported Bulk Product
under the BTG Licensed Improvements and BTG Know-How, as each term is defined in the DA and CSA (collectively the “Pegloticase Licenses”); 

WHEREAS the Closing of the transactions effectuating the BTG Divestiture occurred on July 18, 2005, upon which all right, title and
interest in and to all intellectual property related to the global biologics manufacturing business of BTG, including the intellectual property defined in the DA and CSA as BTG Licensed Improvements and BTG
Know-How transferred to and was vested in FIC (the “BTG IP”); and 

  
 - 3 - 













 WHEREAS, in view of FIC’s ownership of the BTG IP, Savient and FIC desire to execute
this Agreement in order to effectuate and perfect the Pegloticase Licenses granted by BTG on and in accordance with the terms and conditions as follows. 

NOW THEREFORE in consideration of the recitals in the Introduction above, the covenants and agreements herein, and other good and valuable
consideration, the receipt and sufficiency of which the parties acknowledge, the parties agree as follows: 
 ARTICLE 1 

As used herein, the following terms shall have the meanings ascribed to them as follows: 

 

	1.1	 “Affiliate” shall mean any person or entity controlling, controlled by or under common control
with a party to this Agreement. 


  

	1.2	 “Patents” shall mean those patents listed in Exhibit 1, all foreign counterparts
thereto, and any disclosures, continuations, continuations-in-part, divisionals, provisionals, PCT applications, reissuances, revisions, substitutions, conversions,
renewals, extensions, prolongations, and reexaminations thereof, any technology and inventions covered thereby, and any corresponding international, regional and national applications, whether existing at present or in the future.



  

	1.3	 “Pegloticase” shall mean [***]. 



 

	1.4	 “Territory” shall mean, collectively, each country in the world. 



 

	1.5	 Capitalized terms used but not specifically defined herein shall have the meaning ascribed to them in the DA
and CSA. 


 ARTICLE 2 
  

	2.1	 Grant of License. FIC hereby grants to Savient a fully paid-up,
royalty-free, non-exclusive license in the Territory to manufacture, have manufactured, produce, have produced, develop, have developed, use, have used, offer for sale, have offered for sale, sell, have sold, export, and have exported Pegloticase
bulk product under the intellectual property owned by FIC which embodies the BTG Licensed Improvements and BTG Know-How, as each term is defined in the DA and CSA, including, without limitation the Patents.
Such license includes the right to sublicense solely for the purposes of effectuating the rights granted to Savient hereunder. To the extent necessary or required, upon request by Savient, FIC shall execute, and shall cause its Affiliates to
execute, any such additional documentation as may be necessary in order to give effect to this license grant. 


  

 
  

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED 

  
 - 4 - 













 ARTICLE 3 

This Agreement shall commence as of the Effective Date, and continue in full force and effect until the expiration date of the last to expire
of the Patents or other patents which embody BTG Licensed Improvements or BTG Know-How. 

ARTICLE 4 
  

	4.1	 Entire Agreement. This Agreement constitutes the entire agreement between the parties with respect to
the subject matter hereof, and supersedes any prior agreements or understandings, whether oral or written, between the parties and their respective Affiliates with respect to such matters. 



 

	4.2	 Modification. No modification of the terms hereof shall be effective except by a written instrument
signed by both parties. 


  

	4.3	 Severability. The invalidity or unenforceability of any term or provision of this Agreement shall not
effect the other terms and provisions, and such invalid or unenforceable term or provision will, in all events be construed and enforced to the fullest extent permissible under applicable law. 



 

	4.4	 Assignment. Either party may assign this Agreement and its rights and obligations hereunder, provided
that any such assignee agrees to be bound by the terms, conditions and covenants of such assigning party hereunder. The Agreement shall be binding upon and inure to the benefit of the parties, and their respective successors and permitted assigns.



  

	4.5	 Dispute Resolution. Any dispute arising between the parties with respect to any provision of this
Agreement or any matter relating to the performance of either party hereunder shall first attempt to be resolved if reasonably possible by good faith negotiation between designated executives of each party. In the event of such dispute, the parties
shall promptly designate respective executives who shall then confer in good faith in an attempt to resolve the dispute before any further action is commenced. In the event no mutual resolution is possible using the foregoing method, either party
may require the other party to submit to non-binding mediation using a recognized dispute resolution entity before court litigation is commenced. 



 

	4.6	 Order of Precedence. In the event of a conflict or inconsistency that relates to the subject matter
hereof between any terms of this Agreement and the DA, CSA or RRA, and in each such instance the Exhibits thereto, the terms of this Agreement shall take precedence over any conflicting terms in the earlier agreements. 



 

	4.7	 Governing Law. This Agreement shall be deemed to have been made in the State of New York, and will be
construed and enforced and under and governed by the internal laws of such state, without giving effect to conflicts of laws principles. 



  
 - 5 - 














	4.8	 Counterparts. This Agreement may be signed in any number of counterparts, any of which shall constitute
an original and all of which when taken together shall constitute one and the same instrument. 


 IN WITNESS WHEREOF, each party has
caused it duly authorized representative to execute this Agreement on the date first written above, effective as of the Effective Date. 
  

					
	 Savient Pharmaceuticals, Inc.
  

/s/ Philip K. Yachmetz
	 		  	 Ferring International Centre S.A.
  

/s/ Lars Peter Brunse

	 By:        Philip K. Yachmetz

Title:     SVP & General Counsel
	 		  	 By:        Lars Peter Brunse

Title:     EVP Technical Operations



  
 - 6 - 













 EXHIBIT 1 to OsmB Promoter License Agreement 

 

					
	Patent Number	  	Country	  	Expiry Date
	 [***]
	  	 [***]
	  	 [***]

	 [***]
	  	 [***]
	  	 [***]

	 [***]
	  	 [***]
	  	 [***]


  
  

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED 

  
 -7-