Document:

hznp-ex107_633.htm

Exhibit 10.7

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

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

and 240.24b-2.

Confidential

 

 

Amendment No. 2
(hereinafter the “Amendment No. 2”)

to the Consolidated Supply Agreement
effective 31 July 2013,
(hereinafter the “AGREEMENT”)

between

Horizon Pharma Ireland Limited

Connaught House

1 Burlington Road, Dublin 4

Ireland

(formerly known as Vidara Therapeutics Research Limited, hereinafter called “VIDARA” or “HORIZON”)

and

Boehringer Ingelheim Biopharmaceuticals GmbH

Binger Straße 173,

55216 Ingelheim am Rhein

Germany

(hereinafter called “BI”)

-      each party also hereinafter referred to as “Party” or jointly as “Parties”      -

Except as otherwise indicated, defined terms in this Amendment No. 2 have the same 
meaning as in the AGREEMENT.

This Amendment No. 2 to the AGREEMENT shall be effective as of 1 June 2015 (“Effective Date of Amendment No. 2”).

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I.Preamble

Whereas, the AGREEMENT, effective as of 31 July 2013 was concluded between VIDARA and Boehringer Ingelheim RCV GmbH & Co. KG (“BI RCV”), an AFFILIATE of BI, having its registered office at Dr. Boehringer Gasse 5-11, 1121, Vienna, Austria;

Whereas, the AGREEMENT has been assigned from BI RCV to its AFFILIATE BI, effective as of 1 January 2014, via an assignment letter acknowledged by VIDARA on 13 December 2013. All references to BI in the AGREEMENT shall refer to BI RCV until 1 January 2014;

Whereas, the AGREEMENT was amended (“Amendment No. 1”) effective as of 5 September 2014. Amendment No. 1 covered the manufacturing of a single batch of bulk biological substance (2014 BBS Batch as defined below) to secure HORIZON’s commercial supply of PRODUCT and for use in certain specified development activities;

Whereas, on 5 November 2014, VIDARA provided BI with written notice that Vidara Therapeutics Research Limited was renamed Horizon Pharma Ireland Limited;

Whereas, the Parties wish for Amendment No. 2 to replace and supersede Amendment No. 1 and thus for the 2014 BBS Batch (as defined below in Section 2.1), originally covered by Amendment No. 1, to be regulated by Amendment No. 2 as of the Effective Date of Amendment No. 2.

Whereas, the 2014 BBS Batch shall secure HORIZON’s commercial supply of PRODUCT in [...***...], and support the ongoing validation of the MANUFACTURING PROCESS (Exhibit 1a) as per the FDA approved comparability protocol for the use of [...***...] and, as may be required, may be used for certain clinical and development activities to be agreed on between the Parties;

Whereas, BI has manufactured a BBS batch in 2016 in order to secure HORIZON’s commercial supply of PRODUCT in [...***...] under the AGREEMENT (“1st 2016 BBS Batch”);

Whereas, HORIZON wishes for and BI has agreed to manufacture a further BBS batch (2nd 2016 BBS Batch as defined below in Section 2.2) to secure HORIZON’s commercial supply of PRODUCT in [...***...];

Whereas, HORIZON and BI have agreed to harmonise the current MANUFACTURING PROCESS (Exhibit 1a, 1b) for BBS manufacture in order to implement changes of certain materials no longer supplied by vendors as agreed between the Parties and to optimise yield and incorporate other desired process changes and apply such process to both the PRODUCT and the BI PRODUCT (Imukin®) and subsequently re-validate the HARMONISED MANUFACTURING PROCESS (as defined in Section 3.1 below);

Whereas, Boehringer Ingelheim International GmbH (“BII”), an Affiliate of BI and HORIZON entered into the asset purchase agreement effective as of 18 May 2016, under which HORIZON shall acquire all right, title and interest from BII to the BI PRODUCT (Imukin®) as and from 31 December 2016.

Whereas, the Parties acknowledge and agree that these Whereas-Clauses are legally binding.

Therefore, the Parties agree as follows:

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II.Amendment

1.Definitions

1.1A new Section 1.46 shall be added to the AGREEMENT:

“1.46  EXCESS MATERIAL shall mean any excess BBS material (drug substance) from BBS batches manufactured by BI for the supply of PRODUCT (and BI PRODUCT as the case may be) to HORIZON to be determined by BI after HORIZON’s annual commercial purchase obligations for each commercial year under the AGREEMENT have been met.”

2.Market Supply Security: [...***...]

(BBS Batches Manufactured According To the Current Manufacturing Process) 

2.1.2014 BBS Batch

In Amendment No. 1, the Parties agreed on BI’s manufacture of a single BBS batch according to the current MANUFACTURING PROCESS. The Parties hereby agree that the following regulation shall supersede Amendment No. 1 in its entirety as of the Effective Date of Amendment No. 2:

The Parties agree that the single BBS batch (Batch [...***...]; hereinafter referred to as “2014 BBS Batch”) manufactured by BI under Amendment No.1 according to the current MANUFACTURING PROCESS shall first and foremost be used for fulfilling HORIZON’s commercial requirements of PRODUCT in the TERRITORY, in accordance with Sections 3.2 and 3.3 of the AGREEMENT, for the commercial years [...***...]. HORIZON shall pay to BI for the ordered vials (vial price) in accordance with Section 4 of the AGREEMENT. 

BI agrees to store the 2014 BBS Batch at its or its AFFILIATES’ facilities and maintain it for its intended purposes as set out herein for the duration of BBS shelf life [...***...] and in accordance with cGMP and BI’s internal SOPs for the storage of biopharmaceutical products. 

[...***...] with regards to the 2014 BBS Batch, it is hereby agreed that EXCESS MATERIAL from said 2014 BBS Batch shall be provided to HORIZON [...***...] solely for HORIZON’s development purposes, reflecting the prior understandings and agreement of the Parties, and that HORIZON shall not use such EXCESS MATERIAL from the 2014 BBS Batch for commercial purposes without BI’s agreement. 

HORIZON acknowledges and agrees that it is BI’s sole responsibility to manufacture the 2014 BBS Batch according to the BULK SPECIFICATIONS. Accordingly, the 2014 BBS Batch may fall below the [...***...], and HORIZON may not reject the 2014 BBS Batch meeting the BULK SPECIFICATIONS but not said [...***...]. 

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2.2.2016 BBS Batches

In order to secure the commercial supply of PRODUCT to HORIZON in [...***...] and, depending on the yield of the 2016 BBS Batches (as defined below), in [...***...], BI has manufactured one (1) BBS batch in 2016 from one (1) fermentation run (“1st 2016 BBS Batch”) according to the current MANUFACTURING PROCESS and the Parties now agree that in order to secure the commercial supply of PRODUCT in [...***...] arising from increased commercial demand and/or delay in the completion and regulatory approval of the HARMONISED MANUFACTURING PROCESS, BI shall manufacture a second BBS batch in 2016 from this fermentation run (“2nd 2016 BBS Batch”) (1st and 2nd 2016 BBS Batch are hereinafter referred to collectively as “2016 BBS Batches”) in accordance with the current MANUFACTURING PROCESS and as outlined in Exhibit 1a. 

The Parties agree that the 2016 BBS Batches shall first and foremost be used for fulfilling HORIZON’s commercial requirements of PRODUCT in the TERRITORY, in accordance with Sections 3.2 and 3.3 of the AGREEMENT, for the commercial years [...***...]. HORIZON shall pay BI for the ordered PRODUCT (vial price) in accordance with Section 4 of the AGREEMENT. In the event that the 2nd 2016 BBS Batch is not required for manufacture of commercial PRODUCT, HORIZON shall purchase [...***...] of BBS from this batch as EXCESS MATERIAL as described herein. 

HORIZON acknowledges and agrees that it is BI’s sole responsibility to manufacture the 2016 BBS Batches according to the BULK SPECIFICATIONS. Accordingly, the 2016 BBS Batches may fall below the [...***...], and HORIZON may not reject the 2016 BBS Batches meeting the BULK SPECIFICATIONS but not said [...***...]. 

2.3.The Parties agree that only in the unlikely event that the 2014 BBS Batch and the 2016 BBS Batches should not suffice to fulfil the requirements for the commercial years as set forth above, BI shall supply and HORIZON shall purchase PRODUCT from the HARMONISED MANUFACTURING PROCESS (as defined below under Section 3.1 herein) to fulfil said commercial requirements subject to successful regulatory approval. Further, the Parties agree that BI will supply PRODUCT using BBS from said 2014 BBS Batch and the 2016 BBS Batches from the earliest manufacturing date, i.e. first-in first-out. 

2.4.The Parties agree that non-GMP material from [...***...] shall be used for work packages outlined in Exhibit 2, or development purposes or supplied to HORIZON [...***...]. 

2.5.2016 BBS Batches EXCESS MATERIAL

2.5.1.  In the event of EXCESS MATERIAL from successful manufacturing of the 2016 BBS Batches BI agrees to supply any EXCESS MATERIAL from the 2016 BBS Batches, which is not required to fulfil the requirements for the commercial years set forth under 2.2. above, to HORIZON in accordance with Section 3.8 of the AGREEMENT (as added to the AGREEMENT under Section 4.1 of this Amendment No. 2). As consideration for such EXCESS MATERIAL HORIZON shall pay BI as set forth in Exhibit 2 hereto. EXCESS MATERIAL from the 2016 BBS Batches shall be used for development and clinical activities, including but not limited to new PRODUCT applications. 

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3.Harmonisation of the Current Manufacturing Process

	
3.1
	
The Parties agree that BI shall provide certain services, as set forth in Exhibit 4 of this Amendment No. 2, for harmonising the MANUFACTURING PROCESS, and subsequently re-validating, for both BI PRODUCT (Imukin®) and PRODUCT (Actimmune®), cf. Exhibit 1a and 1b hereto into one (1) manufacturing process, cf. Exhibit 1c hereto. Upon successful establishment and registration of the harmonised manufacturing process, (cf. Exhibit 1c), hereinafter referred to as the “HARMONISED MANUFACTURING PROCESS”, the HARMONISED MANUFACTURING PROCESS shall replace the current MANUFACTURING PROCESS. Consequently, Exhibit 1c of this Amendment No. 2 shall replace Exhibit 5 of the AGREEMENT. 

	
3.2
	
Notwithstanding the foregoing Section 3.1, HORIZON acknowledges that these services are experimental in nature and that no favourable or useful results can be assured by BI. In the event that BI does not succeed in harmonising the MANUFACTURING PROCESS, the Parties shall via the STEERING COMMITTEE and in good faith agree on a path forward. 

	
3.3
	
The Parties agree that all BBS and PRODUCT manufactured during the harmonisation process activities, as set forth in Exhibit 4 hereto, shall be paid for or have already been paid, as applicable (cf. billing plan in Exhibit 6 hereto), under the terms of Exhibit 4 and thereafter be the property of HORIZON and shall first and foremost be used for the successful implementation and validation of the HARMONISED MANUFACTURING PROCESS, including but not limited to the scope outlined in Exhibit 4 hereto and future scope changes, if any. 

	
3.4
	
The Parties agree that subject to the requirements of Section 3.3. above, the BBS and PRODUCT manufactured from the process and performance qualification (“PPQ”) activities specified in Exhibit 4 hereto shall, provided the HARMONISED MANUFACTURING PROCESS has been approved by the regulatory authorities, be used to provide HORIZON’s commercial requirements of PRODUCT in the TERRITORY, in accordance with Sections 3.2 and 3.3 of the AGREEMENT, for the commercial years [...***...], and the Parties acknowledge that such PRODUCT from PPQ fill and finish batches will be paid for as per the billing plan of Exhibit 6 and supplied [...***...] to HORIZON as set forth under Task 3.8 in Exhibit 4. BI shall perform additional fill and finish runs using BBS manufactured under Exhibit 4 and HORIZON shall pay for the fill and finish services only, such price to be agreed upon in good faith by the Parties. For the avoidance of doubt, such fill and finish services as set forth in this Section 3.4 shall only apply in the event described herein. Further, for the sake of clarity, BI’s routine manufacture due to compliance requirements, i.e. every other year, shall remain unaffected. 

	
3.4.1
	
Depending on (i) BI’s compliance requirements for the routine manufacture of BBS, (ii) the expiry date of the remaining BBS from the PPQ batches as set forth in Task 2.3 in Exhibit 4 and (iii) HORIZON’s PRODUCT requirements, the Parties shall agree on the manufacture by BI of additional PRODUCT, and price therefor, using such remaining BBS from the PPQ batches for HORIZON’s commercial, clinical or development requirements. 

	
3.4.2
	
All remaining BBS from the PPQ batches which is not used as provided for above shall be supplied to HORIZON [...***...] and may be used for development and clinical activities, including but not limited to new PRODUCT applications. 

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3.5
	
As consideration for the harmonisation services outlined in Exhibit 4 hereto HORIZON shall pay to BI the amount as set forth in Exhibit 4 in accordance with the relevant terms and conditions of Section 4 of the AGREEMENT. In the event that HORIZON does not complete the purchase of the BI PRODUCT as provided under the aforementioned asset purchase agreement of 18 May 2016, HORIZON shall only be liable to pay [...***...] of the amount set forth in Exhibit 4.

 

4.New Sections Added To The Agreement

4.1.Supply of Excess Material

A new Section 3.8 shall be added to the AGREEMENT: 

“In the event of any EXCESS MATERIAL, the Parties may under a written and mutually executed change order agree for BI to supply such EXCESS MATERIAL to HORIZON for the purpose set out in the change order of certain, and in the change order agreed to, development and clinical activities, including but not limited to new PRODUCT applications. 

Any such EXCESS MATERIAL shall, in accordance with Section 9.3.1, be shipped [...***...] by BI to HORIZON. As consideration for EXCESS MATERIAL HORIZON shall pay BI as set forth in Exhibit 2 of Amendment No. 2, unless otherwise agreed between the Parties in writing. Only the relevant terms and conditions of this AGREEMENT shall apply to such supply of EXCESS MATERIAL. HORIZON will not use EXCESS MATERIAL for any other purposes other than those specifically agreed to by the Parties in the relevant change order. Further, HORIZON will in no event use any expired (non-GMP) EXCESS MATERIAL in humans.” 

4.2.Representations and Warranties

	
 
	
4.2.1.
	
Section 9.3 shall be deleted in its entirety and replaced with the following: 

“9.3  Except as expressly provided for herein, BI makes no further warranties of the merchantability or fitness of the PRODUCT or any warranties of any other nature, express or implied. 

Notwithstanding the foregoing and except for Section 9.2.1, BI’s warranties, as set forth in Section 9.2 above, shall: 

9.3.1  not apply in the event of EXCESS MATERIAL supplied under the AGREEMENT (including amendments). 

	
 
	
4.2.2.
	
A new Section 9.4 shall be added to the AGREEMENT: 

“9.5 HORIZON represents and warrants that any EXCESS MATERIAL supplied under the AGREEMENT (including any amendments) will solely be used for the purposes mutually agreed to by the Parties in writing in each change order. Further, HORIZON represents and warrants that it will in no event use any expired EXCESS MATERIAL in humans.” 

	
5.
	
The Parties agree that the following topics will be discussed in good faith and if agreed hereon, including but not limited to use, pricing etc., shall be incorporated under a global supply 

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agreement, which the Parties intend to finalize by [...***...]: 

	
 
	
(i)
	
one (1) additional fermentation engineering run; and

	
 
	
(ii)
	
one (1) additional GMP batch manufactured subsequent to the PPQ campaign, as set forth in Exhibit 4; and

	
 
	
(iii)
	
extended facility time during the PPQ campaign, as set forth in Exhibit 4 due to prolonged hold-times; and

	
 
	
(iv)
	
the price to be charged by BI for the manufacture of PRODUCT (fill and finish price) using the BBS from PPQ batches as envisaged in 3.4 and 3.5 herein; and

	
 
	
(v)
	
HARMONISED MANUFACTURING PROCESS small scale characterisation studies.

	
6.
	
Other than as set forth herein, the AGREEMENT remains unchanged and in full force and effect. 

SIGNATURES

Boehringer Ingelheim Biopharmaceuticals GmbH

		
	
ppa.

/s/ Alois Konrad

Alois Konrad
Vice President,
Business & Contracts
	
ppa.

/s/ Dr. Andreas Felder

Dr. Andreas Felder
Head, Corp. Division
Biopharmaceuticals

  

Horizon Pharma Ireland Limited

	
	
 

/s/ David Kelly

David Kelly
Executive Vice President

 

Appendices

Exhibit 1 a, b and c: Manufacturing Processes for Imukin, Actimmune and the HARMONISED 
MANUFACTURING PROCESS

Exhibit 2: INTERFERON GAMMA I b BBS Price

Exhibit 3: Additional Scope of Services (Change Order #3, Change Order #10b, Change Order #11, Change Order #21)

Exhibit 4: Additional Scope of Services for Process Harmonisation (Change Order #12, Change Order #17, Change Order #20, Change Order #25, optional Change Order #26)

Exhibit 5: Timeline estimate

Exhibit 6: Billing Schedule for Additional Services

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Exhibit 1A, 1B AND 1C: MANUFACTURING PROCESSES FOR IMUKIN, ACTIMMUNE AND THE HARMONISED MANUFACTURING PROCESS 

[...***...]

 

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Exhibit 1 a: MANUFACTURING PROCESS FOR ACTIMMUNE:

[...***...]

 

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Exhibit 1 b: MANUFACTURING PROCESS FOR IMUKIN:

[...***...]

 

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Exhibit 1 c: HARMONISED MANUFACTURING PROCESS FOR ACTIMMUNE AND IMUKIN PRODUCT AFTER SUCCESSFUL RE-VALIDATION:

[...***...]

 

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Exhibit 2: INTERFERON GAMMA 1 b BBS Price

[...***...]

 

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Exhibit 3: ADDITIONAL SCOPE OF SERVICES (Change Orders (CO))

[...***...]

 

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Exhibit 4: ADDITIONAL SCOPE OF SERVICES FOR PROCESS HARMONISATION

[...***...]

 

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Exhibit 5: TIMELINE ESTIMATE

[...***...]

 

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Exhibit 6:  BILLING SCHEDULE FOR ADDITIONAL SERVICES

[...***...]

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***Confidential Treatment RequestedForm 8-K

 Exhibit 10.8 

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 

  
 - 7 - 

 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 

  
 - 8 - 

 
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 

  
 - 9 - 

 
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. 

  
 - 10 - 

 (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). 

  
 12 

 (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 

  
 - 32 - 

 
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 

  
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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 

  
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 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: 

  
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	 	(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. 

  
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 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) 

 Table of Contents 

 

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

 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. 

  
 1 

	 	(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. 

  
 2 

 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 

  
 3 

 
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. 

  
 4 

 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 

  
 5 

 
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 

  
 6 

 
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: 

  
 7 

	 	(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 

  
 8 

 
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. 

  
 9 

 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

  
 10 

 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 

  
 11 

 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. 

  
 12 

 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

  
 13 

 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. 

  
 14 

 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 

  
 15 

 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. 

  
 16 

 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	  	

  
 17 

 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	  	

  
 18 

 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	  

  
 19 

 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	  

  
 20 

 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	  

  
 21 

 SPECIFICATION Q SEPHAROSETM 

 

					
	 Parameter
	  	Specification	 
	 Function - retention volume; ml
	  			
	 - GammaBindTM
	  	 	40 — 50	  
	 - ß-Lactoglobulin A
	  	 	59 — 79	  
	 - ß-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	  

  
 22 

 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	  

  
 23 

 SPECIFICATION XANTHINE AGAROSE 

 

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

  
 24 

 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

  
 25 

 SPECIFICATION LYSOZYME (MERCK) 

 

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

  
 26 

 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)	  	 	>0.9	  
			
	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 

  
 27 

 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. 

  
 - 10 - 

	 	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. 

  
 - 11 - 

	 	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] 

  
 - 16 - 

 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

  

					
	647/IP/BTG 271 Patent Applications	  	1	  	8 March, 2005

 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

  

					
	647/IP/BTG 271 Patent Applications	  	2	  	8 March, 2005

 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	  	3D 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

  

					
	647/IP/BTG 271 Patent Applications	  	3	  	8 March, 2005

 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

  

			
	lpgp1/647/Intellectual Property/HA Patent Applications TM	  	28 February, 2005

 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

  

					
	lpgp1/647/Intellectual Property/HA Patent Applications TM	  	1	  	28 February, 2005

 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

  

					
	lpgp1/647/Intellectual Property/HA Patent Applications TM	  	2	  	28 February, 2005

 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

  

					
	lpgp1/647/Intellectual Property/HA Patent Applications TM	  	3	  	28 February, 2005

 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

  

					
	lpgp1/647/Intellectual Property/HA Patent Applications TM	  	4	  	28 February, 2005

 Exhibit G 

Product Specifications 

  
 - 1 - 

 CONFIDENTIAL 

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

 CONFIDENTIAL 

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

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00261-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00261-of-00352.parquet"}]]