Document:

Distribution Agreement dated July 27, 2005

 Exhibit 10.10 
 Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. 
 DATED        July 27, 2005 

SKYEPHARMA INC 
 and 
 MUNDIPHARMA INTERNATIONAL HOLDINGS LIMITED 

 
  
 DISTRIBUTION AGREEMENT 
 (Depocyte - Additional Territories)

  
  

  
 1 

 THIS AGREEMENT is made on July 27, 2005 

BETWEEN 
  

	(1)	SKYEPHARMA INC a company incorporated in California whose principal place of business is 10450 Sciences Center Drive, San Diego, California 92121 USA
(“Skye”); and 

  

	(2)	MUNDIPHARMA INTERNATIONAL HOLDINGS LIMITED a company incorporated in Bermuda whose principal place of business is Mundipharma House, 14 Par-la-Ville Road, P.O.
Box HM 2332, Hamilton HM JX, Bermuda (“Mundipharma”). 

 Recitals 

 

	A.	Skye is the owner of certain Skye Technology (as defined below) and possesses expertise relating to the Product (as defined below), which may be useful in the treatment
of cancer and holds the Marketing Authorisation (as defined below) relating to certain countries outside the Territory (as defined below). 

  

	B.	Mundipharma has, among other things, specialist knowledge and expertise in relation to the marketing and sale of pharmaceutical products. 

 

	C.	The Parties are parties to the 2003 Agreement (as defined below). Following good faith discussions carried pursuant to clause 2.12 of the 2003 Agreement, the Parties
wish to enter into a new agreement in respect of the Territory. 

  

	D.	Skye desires to grant and Mundipharma desires to acquire the exclusive right to market the Product (as defined below) in the Territory. 

 

	E.	The Parties recognise and acknowledge that Skye is the holder of the Marketing Authorisation (in respect of countries outside the Territory) which may not be sufficient
to permit Mundipharma to market and sell the Finished Product in the Territory and that Mundipharma shall satisfy itself of its rights to do so prior to any marketing and sale of the Product; 

  
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	F.	The Parties recognise and acknowledge that Skye will provide the Product which may not be sufficient to comply with the requirements of all or any part of the Territory
and that Mundipharma shall satisfy itself of its rights to do so prior to any marketing and sale of the Product. 

 Operative
Provisions 
  

	1.	Definitions 

  

	 	1.1.	In this Agreement the following words and expressions have the following meanings: 

 

			
	“2003 Agreement”	  	means that distribution agreement entered into between the Parties on 30th June 2003 in respect of certain countries of Europe (being outside the Territory);
		
	“Affiliate”	  	means any company, corporation, firm, individual, trust or other entity which controls, is controlled by or is under common control with a party to this Agreement, and for the
purpose of this definition the term “control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such firm, person, trust or company, whether through the ownership
of voting securities, by contract or otherwise, or the ownership either directly or indirectly, including the ownership by trusts with substantially the same beneficial interests, of 50% or more of the voting securities (or, in relation to any
country where ownership of more than 50% of the voting securities is prohibited by law, the

  
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	 	  	maximum percentage permitted, provided such percentage is no less than 30%) of such
company, corporation, firm, individual, trust or other entity;
		
	“Applicable Laws”	  	means all laws, rules, regulations and codes of practice regarding the representation, promotion and marketing of the Product in any jurisdiction in the
Territory;
		
	“Commercial Delivery”	  	means the date of the first commercial sale to a Third Party customer for commercial use or on sale of Finished Product in any country within the Territory following
Regulatory Approval;
		
	“Competing Product”	  	means a product (other than the Product) available in a country in the Territory in which the Product is sold by Mundipharma or its distributors which is indicated
for use in the Field;
		
	“Confidential Information”	  	means all confidential information, data and materials in whatever form disclosed by one party to the other or received in connection with this Agreement including,
without limitation, the terms of this Agreement, Mundipharma’s marketing plans and Mundipharma’s sales forecasts, but excluding information:
			
		  	(a)	  	which, at the time of disclosure by one party to the other, is in the public domain;
			
		  	(b)	  	which, after disclosure by one party to the other, becomes part of the public domain by publication, except by breach of any obligation of
confidentiality;

  
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	 	  	(c)	  	which the receiving party can establish by competent proof was already in its possession
at the time of its receipt and was not acquired directly or indirectly from the other
party;
			
		  	(d)	  	which, after disclosure by one party to the other, was developed independently of the information received; or
			
		  	(e)	  	received from Third Parties who were lawfully entitled to disclose such information;
		
	“EEA”	  	means the European Economic Area as at the Effective Date, together with any other countries joining the European Economic Area thereafter as from the date of their
joining;
		
	“Effective Date”	  	means the date of this Agreement;
		
	“EMEA”	  	means the European Medicines Evaluation Agency or any successors thereto;
		
	“Field”	  	means the intrathecal treatment of malignant disease (including without limitation lymphomatous meningitis and, if an approved indication, the treatment of neoplastic
meningitis);
		
	“Finished Product”	  	means in (i) respect of manufacture and supply by Skye hereunder and under the Supply Agreement Product presented in Vials, packaged and labelled for the European
Market as specified in the 2003 Agreement and (ii) in respect of the grant of rights to Mundipharma hereunder the same or as may otherwise be adjusted by or on behalf of Mundipharma in order to meet labelling and

  
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		  	packaging requirements within the Territory (the parties acknowledge that any adjustments to the labelling and/or packaging beyond those for the European Market as specified in
the 2003 Agreement shall be the responsibility of and at the cost of Mundipharma);
		
	“Force Majeure”	  	means in relation to either party, any cause affecting the performance of this Agreement or the Supply Agreement arising from or attributable to any acts, events, non happenings,
omissions or accidents beyond the reasonable control of the party to perform and in particular but without limiting the generality thereof shall include strikes, lock outs, industrial action, civil commotion, riot, invasion, war, threat of or
preparation for war, terrorist activity, fire, explosion, storm, flood, earthquake, subsidence, epidemic or other natural physical disaster, impossibility of the use of railways, shipping, aircraft, motor transport, or other means of public or
private transport, failure or suspension of utilities, and political interference with the normal operation of either party;
		
	“Improvements”	  	means any discovery, development, improvement, Know-How or Patent relating to the Product and/or the Field generated, conceived, reduced to practice or otherwise created during
the Term by Skye (or any Affiliate or licensee of Skye);
		
	“Intellectual Property”	  	means Patents, Trade Marks, service marks, logos, trade names, rights in designs, copyright, utility models, rights in Know-How and other intellectual

  
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		  	property rights, in each case whether registered or unregistered and including applications for registration, and all rights or forms of protection having equivalent or similar
effect anywhere in the world;
		
	“Know-How”	  	means all information, procedures, instructions, techniques, data, technical information, knowledge and experience (including, without limitation, toxicological, pharmaceutical,
clinical, non-clinical and medical data, health registration data and marketing data), designs, dossiers (including, without limitation, manufacturing assay and quality control dossiers) manufacturing formulae, processing specifications, sales and
marketing materials and technology relating to or concerned with the Product and/or the Finished Product whether in written, electronic or other form including without limitation the Product Data and the Manufacturing Technology;
		
	 “Lymphomatous Meningitis
   Indication”
	  	means the use of the Product for the treatment of lymphomatous meningitis;
		
	“Manufacturing Technology”	  	means all methods, processes, designs, data, procedures and other information relating to the manufacture of the Product, including without limitation final quality assurance
procedures, manufacturing procedures, product and raw material specifications, formulation data and other technology related thereto;
		
	“Marketing Authorisation”	  	means the approval by the EMEA numbered

  
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		  	EU/1/01/187/001 permitting the commercial marketing of the Product in certain countries (outside the Territory) for the intrathecal treatment of lymphomatous
meningitis;
		
	“Marketing Plan”	  	means the plan for the marketing, distribution and sale of the Finished Product in the Territory submitted to the Committee in accordance with Clause
4;
		
	“Neoplastic Indication”	  	means the use of the Product for the treatment of neoplastic meningitis;
		
	“Net Sales”	  	means total gross sales of Finished Product invoiced by Mundipharma, its Affiliates, sub-distributors and sub-licensees to Third Parties, less:
			
		  	(a)	  	transport, freight and insurance costs;
			
		  	(b)	  	sales and excise taxes and duties;
			
		  	(c)	  	normal and customary trade, quantity and cash discounts and rebates;
			
		  	(d)	  	amounts repaid, discounted or credited by reason of (i) retroactive price reductions; (ii) discounts; or (iii) rebates which are, in any case, imposed upon Mundipharma, its
Affiliates, sub-licensees or sub-distributors by any governmental or non-governmental body with the authority to impose such price reductions, discounts or rebates;
			
		  	(e)	  	billing errors; and

  
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		  	(f)	  	amounts repaid or credited (other than in respect of outdated goods) for rejected, returned or recalled goods;
		
	“Patents”	  	means any patent and patent application (including provisional and non-provisional applications) that may be issued or issue in any country, including all additions,
divisions, confirmations, continuations-in-part, substitutions, re-issues, re-examinations, extensions, registrations, patent terms extensions, supplementary protection certificates and renewals of any of the above;
		
	“Pricing Approval”	  	means grant of all necessary pricing and reimbursement approvals by a regulatory, governmental or non-governmental authority in any country of the
Territory;
		
	“Product”	  	means the DepoFoam formulation of cytarabine (a sustained release formulation of cytarabine (ara-C) a pyrimidine analogue (L01BC01));
		
	“Product Data”	  	means all data, information or results generated in the performance of any clinical studies, non-clinical studies (including pharmacological and toxicological
studies) or chemistry and analytical studies in respect of the Product conducted by or on behalf of either party whether before or after the Effective Date;
		
	“Quarter”	  	means a three month period ending on the last day of March, June, September or December in any Year;

  
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	“Regulatory Approval”	  	means the grant of all necessary regulatory and governmental approvals by a Regulatory Authority or other governmental body required to sell the Finished Product in any country
of the Territory, but excluding Pricing Approval;
		
	“Regulatory Authority”	  	means any competent regulatory authority or other governmental body responsible for granting Regulatory Approval in the Territory;
		
	“Skye IP”	  	means all Intellectual Property owned by or in the possession or control of Skye at the Effective Date or coming into its possession or control at any time during the Term
relating to the Product or Finished Product (including any Improvements);
		
	“Skye Patents”	  	means those Patents set out in Schedule I and such other Patents as come into existence during the Term and relate to the Product or Finished Product (including any
Improvements);
		
	“Skye Technology”	  	means the Skye Patents and Skye IP;
		
	“Supply Agreement”	  	means the agreement between Skye and Mundipharma Medical Company dated 30th June 2003 for the manufacture and supply of the Finished Product by Skye;
		
	“Term”	  	means the term of this Agreement as set out in Clause 15;
		
	“Territory”	  	means each of the countries and territories listed or referred to in Schedule IV;

  
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	“Third Party”	  	means any company, corporation, firm, individual or other entity but excluding a party to this Agreement or an Affiliate;
		
	“Trade Marks”	  	means those trade marks registered or applied for set out in Schedule II and such other trade marks as are agreed between the parties from time to time;
		
	“Vial”	  	means a [**] vial containing the Product; and
		
	“Year”	  	means a calendar year.

  

	 	1.2.	In this Agreement, unless the context requires otherwise: 

  

	 	1.2.1.	the headings are included for convenience only and shall not affect the construction of this Agreement; 

 

	 	1.2.2.	references to “persons” includes individuals, bodies corporate (wherever incorporated), unincorporated associations and partnerships;

  

	 	1.2.3.	words denoting the singular shall include the plural and vice versa; 

  

	 	1.2.4.	words denoting one gender shall include each gender and all genders; and 

  

	 	1.2.5.	any reference to an enactment or statutory provision is a reference to it as it may have been, or may from time to time be amended, modified, consolidated or re
enacted. 

  

	 	1.3.	The Schedules comprise part of and shall be construed in accordance with the terms of this Agreement. In the event of any inconsistency between the Schedules and the
terms of this Agreement, the terms of this Agreement shall prevail. 

  
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	2.	Grant of Rights 

  

	 	2.1.	Subject to the terms of this Agreement, Skye hereby exclusively appoints Mundipharma in the Territory to use, import, warehouse, market, distribute, sell and dispose of
the Finished Product in the Field for the Term of this Agreement. 

  

	 	2.2.	Skye hereby grants Mundipharma and its Affiliates an exclusive licence to use the Trade Marks in relation to the use, import, warehousing, marketing, distribution, sale
and disposal of Finished Product in the Field in the Territory for the Term of this Agreement. Mundipharma shall satisfy itself, at its own cost, of its rights to use any Trade Marks prior to Commercial Delivery. 

 

	 	2.3.	Skye hereby grants Mundipharma and its Affiliates an exclusive license to use all other Skye Technology in relation to the use, import, warehousing, marketing,
distribution, sale and disposal of the Product or Finished Product in the Field in the Territory for the Term of this Agreement. 

  

	 	2.4.	The term “exclusive” means to the exclusion of all others, including Skye and its Affiliates, except to the extent necessary to enable Skye to perform its
specific obligations under this Agreement. 

  

	 	2.5.	Skye shall not in the Territory during the Term: 

  

	 	2.5.1.	grant any Third Party the right to use, import, warehouse, market, distribute, sell or dispose of the Product and/or Finished Product; or 

 

	 	2.5.2.	either itself or through or with any Affiliate or Third Party actively conduct or participate in any use, importation, warehousing, marketing, distribution, sale or
disposal of the Product and/or Finished Product, except as specifically permitted by this Agreement. 

  
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	 	2.6.	During the Term, Mundipharma and its Affiliates have an exclusive right to use, import, warehouse, market, distribute, sell and dispose of Improvements in the Product
and/or the Field in the Territory at no additional cost to Mundipharma. Skye shall promptly disclose all Improvements to Mundipharma. 

  

	 	2.7.	Mundipharma and its Affiliates may describe itself as an “Authorised Distributor” of Skye for the Finished Product in the Territory but shall not hold itself
out as Skye’s agent for sales of the Finished Product or otherwise as being entitled to bind Skye in any way. 

  

	 	2.8.	Mundipharma and its Affiliates shall be entitled to conduct clinical research in respect of the Product. The results of any such research (and any and all rights
therein) shall be Mundipharma’s property but shall be made available to Skye on a basis to be agreed between the Parties in good faith in writing. Mundipharma shall satisfy itself, at its own cost, of any requirement to carry out any clinical
research in any part of the Territory prior to Commercial Delivery. 

  

	 	2.9.	Mundipharma and its Affiliates shall be entitled to use the Skye Technology and Skye’s Confidential Information in any submission to any Regulatory Authority
regarding registration, pricing or reimbursement, in each case insofar as it may be relevant. 

  

	 	2.10.	Mundipharma may sell the Finished Products in the Territory through its Affiliates. Mundipharma may also sell the Finished Products through Third Party sales agents or
sub-distributors upon obtaining the express prior written permission of Skye (such permission not to be unreasonably withheld or delayed). Notwithstanding any such permission that may be granted by Skye, Mundipharma shall be and remain responsible
in all respects for the acts and omissions of any Affiliate, sales agent or sub-distributor and those acts and omissions shall for the purpose of this Agreement be deemed the acts and omissions of Mundipharma. Mundipharma or its Affiliate shall
consolidate all orders from any Affiliates, sales agents or sub-distributors. 

  
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	3.	Obligations 

  

	 	3.1.	Skye shall be under no obligation to Mundipharma in relation to obtaining Regulatory Approval of the Product in any part of the Territory for the Lymphomatous
Meningitis Indication, the Neoplastic Indication or any other indication. Mundipharma acknowledges that, to the extent that any Regulatory Approval shall be required, Mundipharma shall satisfy itself at its own cost that it shall be permitted to
market and sell the Product in each country of the Territory before commencing such marketing and sale in such country. 

  

	 	3.2.	Skye shall: 

  

	 	3.2.1.	manufacture and supply, or procure the manufacture and supply of, the Finished Product in accordance with the Supply Agreement both parties recognising that such
Finished Product has been produced to satisfy the requirements of the EEA and may not satisfy the requirements for Products sold in the Territory; 

  

	 	3.2.2.	promptly provide Mundipharma with all information in its possession or otherwise coming to its attention relating to the occurrence of a serious adverse event or an
adverse event (in any jurisdiction throughout the world) in connection with the Product or the Finished Product; 

  

	 	3.2.3.	promptly provide Mundipharma at Mundipharma’s cost with all Product Data and other Know How in its possession or which is or becomes available to it during the
Term which it is entitled to disclose which is relevant or useful to Mundipharma in performing its obligations under this Agreement; and 

  
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	 	3.2.4.	promptly provide Mundipharma with proofs of packaging and package inserts for the Finished Product. 

 

	 	3.3.	Mundipharma’s obligations in respect of Clauses 3.4 and 3.5 in any country in the Territory in any Year shall be subject to timely supply of Finished Product by
Skye pursuant to the Supply Agreement and to Skye complying with its other material obligations under this Agreement in a timely way. In respect of any Year in any country of the Territory in which the exercise of any Third Party Intellectual
Property rights materially prevents Mundipharma, its Affiliates, sub-licensees or sub-distributors from using, importing, warehousing, distributing, marketing, selling or disposing of Product in that country of the Territory the parties shall agree
in good faith, where relevant, an appropriate amendment to Mundipharma’s obligations under Clauses 3.4 and 3.5. If the parties cannot agree, an expert shall be appointed to resolve the issue pursuant to the dispute resolution procedure in
Schedule V. 

  

	 	3.4.	Mundipharma shall: 

  

	 	3.4.1.	prior to any marketing and sale of the Finished Product in any country of the Territory ensure compliance of the Finished Product with all Applicable Laws and shall
obtain all relevant consents and Regulatory Approval (if required) in respect of the Territory and, without limitation, shall ensure compliance of the Finished Product with all packaging and labelling requirements relevant to the Territory;

  

	 	3.4.2.	shall use commercially reasonable efforts to achieve Commercial Delivery and market and sell the Finished Product in each country of the Territory as soon as it is
reasonably practicable; 

  
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	 	3.4.3.	during the Term of this Agreement insofar as is legally permissible, promote, market, sell and distribute the Finished Product to customers within the Territory and use
its commercially reasonable efforts to satisfy the demand for the Finished Product throughout the Territory and to attempt to increase the demand for such Finished Product by, among other things, servicing customer accounts with reasonable
frequency. Mundipharma shall be solely responsible for, and shall bear all costs associated with, all marketing activities related to the Finished Product in the Territory; 

 

	 	3.4.4.	maintain adequate warehouse facilities and employ or procure a sufficient number of experienced, trained and qualified sales and marketing personnel to promote the sale
of the Finished Product in the Territory and perform, or procure the performance of the activities set forth in the Marketing Plan; 

  

	 	3.4.5.	maintain a reasonable inventory of Finished Product taking into account the shelf life of the Product to reasonably fulfil the requirements of its customers in the
Territory; 

  

	 	3.4.6.	maintain adequate records concerning the sale of the Finished Product as required by any applicable Regulatory Authority in the Territory; 

 

	 	3.4.7.	submit advertising literature proposed to be used in connection with the sale of the Product in the Territory to Skye at least [**] ([**]) business days in advance of
its intended use of same to enable Skye to provide Mundipharma with comments within said [**] ([**]) business day period. Mundipharma shall ensure that all such advertising literature complies with all relevant codes of practice and Applicable Laws
and shall indemnify Skye in respect of any breach; 

  
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	 	3.4.8.	promptly provide Skye with all information in its possession or otherwise coming to its attention relating to the occurrence of a serious adverse event or an adverse
event (in any jurisdiction throughout the world) in connection with the Product or Finished Product, and promptly forward to Skye information concerning any and all charges, complaints or claims reportable to any Regulatory Authority relating to the
Product or Finished Product that may come to Mundipharma’s attention, and otherwise comply in all respects with the Pharmacovigilance Agreement to be agreed between the parties and the recall procedures set out in Schedule III; and

  

	 	3.4.9.	obtain and maintain all necessary licenses, permits, records and authorizations required by law in respect of the marketing, distribution and sale of the Finished
Product in the Territory and observe and comply with all Applicable Laws. 

  

	 	3.5.	In connection with the promotion and marketing of the Finished Product (if any) Mundipharma shall: 

 

	 	3.5.1.	observe and comply with such storage, stock control and operational practices and procedures as may be legally required in the Territory and as reasonably specified in
writing by Skye from time to time; 

  

	 	3.5.2.	 subject to the provisions of clause 2.2 market the Product throughout the Territory under the Trade Marks and all marketing materials for the Finished
Product shall display the Trade Marks. In addition, all packaging shall state that “Depocyte® is
distributed by Mundipharma under an exclusive licence from SkyePharma Inc.”. 

  
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	 	3.6.	Except as provided under the 2003 Agreement, Mundipharma shall not actively market distribute and/or sell the Finished Product outside the Territory.

  

	 	3.7.	For [**] ([**]) years from the first Commercial Delivery in the Territory or during the Term, whichever is shorter, Mundipharma shall not market, distribute or sell a
Competing Product in the Territory. Mundipharma shall procure the purchase of its total requirement of Finished Product from Skye under the terms of the Supply Agreement. 

 

	 	3.8.	If Mundipharma receives a request from a customer located both outside the EEA and outside the Territory for supply of the Product and/or Finished Product, Mundipharma
shall forward such request to Skye. 

  

	 	3.9.	Nothing in this Agreement shall entitle Mundipharma to any right or remedy against Skye if the Product is sold in the Territory by any person outside the Territory
other than by Skye or with Skye’s consent. 

  

	 	3.10.	To the extent permissible by applicable law, Skye shall use commercially reasonable efforts to ensure that in the event that Skye grants exclusive marketing and
distribution rights for the Product or Finished Product to a Third Party outside the Territory, provisions having equivalent effect to those contained in Clauses 3.6 to 3.8 inclusive shall be included mutatis mutandis in any agreement for such grant
of rights to such Third Party. 

  

	4.	Committee 

  

	 	4.1.	The Parties shall establish a committee (“Committee”) consisting of 4 individuals (“Committee Members”); 2 of whom shall be nominated by Skye; and 2
of whom shall be nominated by Mundipharma. The Committee Members may be replaced by notice to the other Party and shall be appropriately qualified and experienced in order to make a meaningful contribution to Committee meetings.

  
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	 	4.2.	The purpose of the Committee is to provide a forum for the Parties to share information and knowledge on the on-going development and marketing of the Product
including, but not limited to, monitoring progress on clinical studies, reviewing clinical trial programmes, considering proposed marketing and promotional plans, reviewing market conditions and discussing any regulatory, technical, quality
assurance or safety issues in relation to the Product. The Committee shall conduct its discussions in good faith with a view to operating to the mutual benefit of the Parties and in furtherance of the successful development and marketing of the
Product. 

  

	 	4.3.	The Committee shall meet as often as the Committee Members may determine, but in any event not less than 2 times per Year. The Committee may invite individuals with
special skills to attend such meetings where considered to be relevant and appropriate. The quorum for Committee meetings shall be 2 Committee Members, comprising 1 Committee Member from each Party. 

 

	 	4.4.	Mundipharma shall on or before 15 October of each Year thereafter provide the Committee with its Marketing Plan for the coming Year. Each Marketing Plan shall
include, without limitation, Net Sales targets and projections with respect to sales force staffing levels, marketing research, physician education, marketing expenditure and advertising. 

 

	5.	Product Supply 

  

	 	5.1.	 The Parties acknowledge that Skye’s obligation under the Supply Agreement shall be for the supply of Finished Product and Mundipharma shall
satisfy itself, at its own cost, of its rights to sell Finished Product in the Territory. In consideration of the manufacture, 

  
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packaging and supply of the Finished Product, Mundipharma agrees that the supply price under the Supply Agreement shall be [**] Euros (€[**]) per Vial supplied to Mundipharma in any country
of the Territory during the Term, subject to adjustment in accordance with the other terms of the Supply Agreement. 

  

	 	5.2.	Within 30 days of the end of each Quarter during the Term of this Agreement, Mundipharma shall send to Skye a statement setting out in respect of each country in the
Territory in which Finished Product is sold, details of Finished Product sold during the previous Quarter itemised by presentation form, quantity, total gross receipts, itemised deductions which are applied to achieve the Net Sales figure and Net
Sales of Finished Product. The statement shall (where appropriate) show: 

  

	 	5.2.1.	the total Net Sales for each such country expressed both in local currency and in Euros and the conversion rate used; and 

 

	 	5.2.2.	the total number of Vials sold in each such country (less rejected, returned or recalled Vials other than those rejected, returned or recalled in connection with the
expiry of the shelf life of the Vials). 

  

	 	5.3.	For the avoidance of doubt, Skye shall be liable for any Third Party royalty obligations existing at the date hereof relating to the Skye Technology.

  

	 	5.4.	The supply price specified in Clause 5.1 is for Finished Product supplied ex-works (as defined in Incoterms 2000) Lyon. 

 

	6.	Payments 

  

	 	6.1.	In addition to any amounts payable by Mundipharma or its Affiliates pursuant to Clause 5.1, Mundipharma shall pay a royalty of: 

 

	 	6.1.1.	[**] Euros (€[**]) per Vial of Finished Product supplied to Mundipharma Medical Company pursuant to the Supply Agreement within [**] days of the date of
Skye’s invoice to Mundipharma Medical Company for such Vials; and 

  
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	 	6.1.2.	in the event that [**] per cent ([**]%) of Net Sales in a Quarter is greater than the number of Vials sold (less rejected, returned or recalled Vials other than those
rejected, returned or recalled in connection with the expiry of the shelf life of the Vials) in that Quarter multiplied by [**] Euros (€[**]) Mundipharma shall pay the difference to Skye within [**] ([**]) days of the end of the Quarter.

  

	 	6.2.	The Net Sales of Mundipharma, its Affiliates, sub-licensees and sub- distributors in the Territory in any Marketing Year during the Term under this Agreement shall be
aggregated with Net Sales under the 2003 Agreement for the purposes of clause 6.8 of the 2003 Agreement and this clause 6.2 shall be regarded as a variation of the 2003 Agreement for these purposes. 

 

	 	6.3.	If at any time the continued performance of this Agreement ceases to be commercially profitable or would otherwise involve financial hardship for either party, the
parties shall discuss in good faith ways of restructuring this Agreement with a view to restoring commercial profitability or removing the financial hardship. 

 

	7.	Payment, Accounting, Audit Rights 

  

	 	7.1.	Unless otherwise agreed between the parties, all payments to be made hereunder shall be made in Euros. Net Sales shall be determined in the currency in which the
Finished Product was sold and shall be converted into Euros using closing mid point published in the Financial Times for the last business day of the Quarter for which such payment is being determined. 

  
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	 	7.2.	Any amount payable under this Agreement shall be deemed to be exclusive of Value Added Tax, which shall be payable in addition, if applicable. 

 

	 	7.3.	Mundipharma shall be entitled to deduct from its payments to Skye the amount of any withholding taxes required to be withheld and shall on Skye’s request provide
proof of payment of such taxes. 

  

	 	7.4.	Mundipharma shall maintain and shall procure the maintenance of accurate and up to date records and books of account showing the quantity, description and value of the
Finished Products supplied in each country of the Territory during the previous 6 years. 

  

	 	7.5.	Mundipharma shall during business hours, on no less than 14 days’ notice from Skye and not more than once in any Year, make available for inspection the records
and books referred to in Clause 7.4. Such inspection shall be undertaken by an independent auditor appointed by Skye and reasonably acceptable to Mundipharma for the purpose of verifying the accuracy of any statement or report given by Mundipharma
to Skye and/or the amount of royalties due. 

  

	 	7.6.	Skye shall procure that any independent auditor appointed under Clause 7.5 shall maintain all information and materials received, directly or indirectly, by it from
Mundipharma in strict confidence and shall not use or disclose the same to any Third Party, nor to Skye save for the sole purpose of reporting the results of the audit pursuant to this Clause. 

 

	 	7.7.	 In the event that an auditor appointed pursuant to this Clause concludes that there has been an underpayment or overpayment, Skye shall deliver to
Mundipharma a copy of such auditor’s report. Any deficit payable by Mundipharma or any excess refundable by Skye shall be payable within [**] days of Mundipharma’s receipt of such report. The fees charged by such auditor shall be payable
by Skye, provided that if 

  
 22 

	 	 
the audit reveals that payments due to Skye for any Year have been understated by more than [**]%, the fees charged by such auditor shall be payable by Mundipharma. 

 

	 	7.8.	Should any amount not be paid pursuant to Clause 7.7 by either party on or before the due date for payment the non-payer shall pay to the other party in addition
interest on such amount unpaid at the rate of [**]% above the base rate from time to time of the National Westminster Bank Plc and such interest shall be calculated and payable in respect of the period from the date such amount is due until the date
payment in full is received in cleared funds by the payee. 

  

	8.	Intellectual Property and Trade Marks 

  

	 	8.1.	Except as set out in this Agreement, all right, title and interest in the Skye Technology shall belong to Skye and Mundipharma shall not have any right, title or
interest in the Skye Technology. 

  

	 	8.2.	Mundipharma shall: 

  

	 	8.2.1.	use the Trade Marks in a manner which conforms to the reasonable directions and standards notified to it by Skye from time to time; and 

 

	 	8.2.2.	not do anything which could, in Skye’s reasonable opinion, bring the Trade Marks or Skye into disrepute or otherwise damage the goodwill attaching to the Trade
Marks. 

  

	 	8.3.	Skye shall, at its own cost, take all steps required to maintain those registrations for the Trade Marks subsisting at the Effective Date, and prosecute any
applications subsisting at the Effective Date for registration of the Trade Marks through to grant (including oppositions thereto) in the Territory. 

  
 23 

  

	 	8.4.	Mundipharma may request that Skye use reasonable efforts to obtain trade mark registrations in respect of the Trade Marks, in classifications which cover the Product,
or Finished Product in any countries in the Territory. Skye shall promptly notify Mundipharma if it does not intend to make or pursue a trade mark registration in respect of the Trade Marks in any of the countries in the Territory and Mundipharma
shall thereafter be entitled to make applications for such trade mark registrations in Skye’s name. 

  

	 	8.5.	Mundipharma shall have the right during the Term to register domain names specific to the countries comprised in the Territory that incorporate the Trade Mark which
shall be assigned to Skye on termination. 

  

	 	8.6.	 In the event that the trade mark Depocyte® is unavailable for the Product or the Finished Product in any country of the Territory, the parties shall, via the Committee consider an appropriate alternative trade
mark for registration in that country or territory. Upon registration, such trade marks shall comprise part of the Trade Marks hereunder. 

  

	9.	Representations and Warranties 

  

	 	9.1.	Each of the parties warrants and represents that: 

  

	 	9.1.1.	it has full power and authority and legal right to enter into this Agreement and perform the obligations under it; 

 

	 	9.1.2.	the execution of this Agreement has been duly authorised by all necessary actions; 

 

	 	9.1.3.	this Agreement is a legal and valid obligation, binding on each of the parties and enforceable in accordance with its terms; and 

  
 24 

  

	 	9.1.4.	entry into and exercise of the respective rights and obligations under this Agreement do not, and will not, violate any provision of any agreement or other instrument
or document to which it is party or affect or be in conflict with or result in the breach of or constitute a default under any such agreement, instrument or document. 

 

	 	9.2.	Skye represents and warrants that as at the Effective Date: 

  

	 	9.2.1.	to the best of its knowledge and belief the Skye Technology includes all Intellectual Property in the possession, custody or control of Skye and its Affiliates which is
reasonably necessary for the exploitation of the Product by Mundipharma in accordance with the terms of this Agreement; 

  

	 	9.2.2.	it is the owner of, or has exclusive rights (for at least as long as the Term of this Agreement) to, all of the Skye Technology in existence at the Effective Date, and
is exclusively entitled to grant the rights granted under this Agreement; 

  

	 	9.2.3.	to the best of its knowledge and belief there are no Third Party interests or rights in the Skye Technology that may prevent, encumber or restrict in any way the
exercise by Mundipharma of the rights granted under this Agreement nor will Skye grant any such rights after the Effective Date; 

  

	 	9.2.4.	to the best of its knowledge and belief no Third Party is infringing or has infringed the Intellectual Property rights in any of the Skye Technology;

  

	 	9.2.5.	 at the date hereof, Skye has no notice, and is not aware, that the exercise of Mundipharma’s rights granted under this Agreement infringes or
conflicts with any Third Party Intellectual Property rights and to the best of its knowledge and 

  
 25 

	 	 
belief the exercise of Mundipharma’s rights granted under this Agreement will not infringe or conflict with any Third Party Intellectual Property rights and will not incur any obligation to
any Third Party; 

  

	 	9.2.6.	all renewal and maintenance fees and all steps necessary for the filing, prosecution and maintenance of the Skye Patents have been paid or taken;

  

	 	9.2.7.	at the Effective Date it is the holder of the Marketing Authorisation and to the best of its knowledge such Marketing Authorisation is not subject to any threatened or
pending claim, challenge or review by any Third Party nor is there any pre-clinical or clinical data or correspondence with a Regulatory Authority which suggests that there may exist quality, toxicity, safety or efficacy concerns which may
materially impair the utility or safety of the Product; 

  

	 	9.2.8.	all information, data and Third Party notices in relation to adverse events, serious adverse events or recalls relating to or connected with the Product or the Finished
Product (in any jurisdiction throughout the world) and of which Skye is aware have been disclosed by Skye to Mundipharma; 

  

	 	9.2.9.	to the best of its knowledge and belief Skye has disclosed all information in its possession or control concerning the Products and the Finished Product and the subject
matter of this Agreement which would be material to a prudent distributor’s decision to enter into this Agreement. 

  

	 	9.3.	Skye confirms and agrees that where its representations and warranties in Clause 9.2 are subject to its knowledge, belief or awareness, Skye shall be deemed to have
carried out due and careful enquiries into the subject matter of those representations and warranties. 

  
 26 

  

	10.	Liability, Insurance and Indemnities 

  

	 	10.1.	Skye shall remain solely responsible for discharging creditors and for all Claims (as defined in this Clause 10) relating to the Territory relating to the development,
manufacture, sale and supply of the Product or Finished Product resulting from any act, default, transaction or circumstance occurring prior to the Effective Date (including claims or demands arising after the Effective Date to the extent they are
based on events occurring prior to the Effective Date), and Skye shall indemnify and hold harmless Mundipharma and its Affiliates from and against any and all such Claims or part thereof arising in connection therewith. 

 

	 	10.2.	Skye shall indemnify and hold harmless Mundipharma and its Affiliates from and against; 

 

	 	10.2.1.	Claims arising from or in connection with Intellectual Property infringement proceedings with Third Parties in connection with the Skye Technology (except to the extent
that the claim has arisen from Mundipharma’s use of the Skye Technology other than in accordance with this Agreement) but excluding any Claims which arise out of any lack of Regulatory Approval for the Finished Product or inappropriate
packaging and labelling in the Territory; and 

  

	 	10.2.2.	Claims against Mundipharma arising from or in connection with death or personal injury except to the extent arising out of any breach of this Agreement or the Supply
Agreement by Mundipharma or its Affiliates or out of any negligent act or omission of Mundipharma or its Affiliates or their employees in the course of their employment. 

  
 27 

  

	 	10.3.	Mundipharma shall indemnify and hold harmless Skye from and against Claims arising from or in connection with: 

 

	 	10.3.1.	the use, storage, marketing, distribution or sale of the Finished Product by Mundipharma or its Affiliates to the extent that such Claims arise out of any breach of
this Agreement by Mundipharma or its Affiliates or out of any negligent act or omission of Mundipharma or its Affiliates or their employees in the course of their employment or which arise out of Claims which arise out of any lack of Regulatory
Approval for the Finished Product or inappropriate packaging and labelling in the Territory; and 

  

	 	10.3.2.	death or personal injury to the extent arising out of any breach of this Agreement by Mundipharma or its Affiliates or out of any negligent act or omission of
Mundipharma or its Affiliates or their employees in the course of their employment. 

  

	 	10.4.	Promptly after receipt by a party of any Claim or alleged claim or notice of the commencement of any action, administrative or legal proceeding, or investigation as to
which an indemnity provided for in this Clause 10 may apply, the indemnified party shall give written notice to the indemnifying party of such fact. The indemnifying party shall have the option to assume the defence thereof by election in writing
within [**] ([**]) days of receipt of such notice. If the indemnifying party fails to make such election, the indemnified party may assume such defence and the indemnifying party will be liable for reasonable legal and other expenses subsequently
incurred in connection with such defence. The parties will co-operate in good faith in the conduct of any defence, provide such reasonable assistance as may be required to enable any Claim to be properly defended, and the party with conduct of the
action shall provide promptly to the other party copies of all proceedings relating to such action. 

  
 28 

  

	 	10.5.	Should the indemnifying party assume conduct of the defence: 

  

	 	10.5.1.	the indemnified party may retain separate legal advisors in the event that it reasonably concludes that it may have defences available to it which are additional to,
different from or inconsistent with those available to the indemnifying party, in which case the indemnifying party shall be liable for the indemnified party’s reasonable costs and expenses so incurred; and 

 

	 	10.5.2.	the indemnifying party will not, except with the consent of the indemnified party (such consent not be unreasonably withheld or delayed), consent to the entry of any
judgment or enter into any settlement (other than for the payment of damages by the indemnifying party, which includes as an unconditional term a release from the claimant to the indemnified party from all liability in respect of all claims).

  

	 	10.6.	The indemnified party shall not admit liability in respect of, or compromise or settle any such action without the prior written consent of the indemnifying party, such
consent not to be unreasonably withheld or delayed. 

  

	 	10.7.	Each party shall maintain, at its own cost, either 

  

	 	10.7.1.	comprehensive product liability insurance and general commercial liability insurance. Such insurance shall be with a reputable insurance company and where reasonably
possible (taking into account the availability of such insurance) shall be maintained for not less than 6 years following the expiry or termination of this Agreement; or 

 

	 	10.7.2.	a reasonable level of self-insurance. 

  

	 	10.8.	Any and all liability of Skye to Mundipharma arising in respect of Clauses 9, 10.1 and 10.2.2 of this Agreement, shall be limited (except for death or personal injury
caused by negligence) to [**] Euros (€[**]). 

  
 29 

  

	 	10.9.	Any and all liability of Mundipharma to Skye arising in respect of Clause 10.3 of this Agreement shall be limited (except for death or personal injury caused by
negligence) to [**] Euros (€[**]). 

  

	 	10.10.	Notwithstanding anything contained in this Agreement or the Supply Agreement in no circumstance shall either party be liable to the other in contract, tort (including
negligence or breach of statutory duty) or otherwise howsoever, and whatever the cause thereof, for any special, indirect or consequential loss or damage of any nature whatsoever. 

 

	 	10.11.	Nothing in this Clause shall be construed as excluding or limiting the liability of either party or any of its officers, employees and agents to the other party for
death or personal injury of any person resulting from the negligence of such persons or in respect of fraud. 

  

	 	10.12.	In this Clause 10, “Claims” shall mean any and all claims, actions and demands made or brought by Third Parties, and all judgements, losses, damages,
settlements, costs and expenses in connection therewith, including reasonable legal and expert fees incurred in defending such claims, actions and demands. 

 

	11.	Confidentiality, Press Releases and Publications 

  

	 	11.1.	Skye and Mundipharma undertake to each other to keep confidential, and to procure that their respective Affiliates, employees, directors, officers, contractors, lawyers
and accountants (including those of their Affiliates) keep confidential, Confidential Information disclosed to it by or belonging to the other party, until it ceases to be Confidential Information. 

  
 30 

  

	 	11.2.	Any Confidential Information received from the other party shall not be disclosed to any Third Party or used for any purpose other than as provided or specifically
envisaged by this Agreement, unless it ceases to be Confidential Information through no fault of the receiving party. 

  

	 	11.3.	The confidentiality and non-use obligations contained in this Agreement shall continue for the duration of this Agreement and for a period of [**] years after
termination for any reason of this Agreement. 

  

	 	11.4.	The parties shall consult with each other, in advance, with regard to the terms of all proposed press releases, public announcements and other public statements with
respect to the transactions contemplated under this Agreement. 

  

	 	11.5.	The Confidential Information may be disclosed by the other parties to the extent that such disclosure has been ordered by a court of law or directed by a governmental
authority, provided that, wherever practicable, the party disclosing the Confidential Information has given sufficient written notice in advance to the other party to enable it to seek protection or confidential treatment of such Confidential
Information, and may be disclosed only to the extent that such disclosure has been so ordered or directed. 

  

	12.	Patents 

  

	 	12.1.	Skye shall file, prosecute and maintain the Skye Patents, and meet all related costs and expenses. 

 

	13.	Infringement of Third Party Rights 

  

	 	13.1.	 In the event of a party becoming aware that the exercise of either party’s rights and obligations pursuant to this Agreement are infringing or may
infringe the rights of a Third Party, it will promptly so notify the other party and provide it with such details of the Third Party rights and the extent of the infringement as are known to it. Skye shall be

  
 31 

	 	 
entitled at its discretion to contest any such Third Party claim or proceedings or otherwise to take such steps to terminate any infringement or remedy the position and where necessary enter any
Third Party licence agreement provided in each case that Mundipharma will lawfully be able to practice fully the rights and licenses granted hereunder. No later than [**] days from becoming aware of or receiving notification in relation to any
infringement of the rights of a Third Party, Skye shall inform Mundipharma whether it intends to contest the claim or take such other steps necessary to terminate any infringement (including the negotiation of a Third Party licence agreement) and
Mundipharma may thereafter contest any such Third Party claim or proceedings at its cost. If Skye does contest the claim or take steps to terminate any infringement it shall keep Mundipharma informed of its actions in this regard. If Skye enters
into a Third Party licence agreement any Third Party royalties or licence fees incurred in this regard shall be borne by Skye. 

  

	 	13.2.	Where Mundipharma has assumed responsibility for contesting any such Third Party claim or proceedings in accordance with Clause 13.1 (including the negotiation of a
Third Party licence agreement), Mundipharma shall keep Skye reasonably informed of its actions in this regard and Skye will provide Mundipharma with all reasonable co-operation in connection with such actions. Without limitation this shall include
Mundipharma furnishing Skye with drafts of any proposed Third Party licence agreement and Mundipharma seeking Skye’s approval to the terms of any such agreement. Mundipharma shall not enter into any such Third Party licence agreement without
the prior written approval of Skye to such agreement (which shall not be unreasonably withheld or delayed). Skye shall reimburse Mundipharma’s reasonable costs in defending any such claim and any Third Party licence fees incurred in this regard
and Mundipharma or its Affiliate shall be entitled to credit any Third Party royalties against payments due to Skye pursuant to Clauses 5 and 6 or under the Supply Agreement. 

  
 32 

  

	14.	Infringement of Skye Technology 

  

	 	14.1.	In the event that Mundipharma becomes aware of any actual or suspected infringement or misuse of the Skye Technology or an attack on its validity in the Territory it
shall promptly notify Skye and provide it with all details thereof in its possession. 

  

	 	14.2.	No later than [**] days from becoming aware of or receiving notification of any actual or suspected infringement or misuse of the Skye Technology or attack on its
validity in the Territory, Skye shall inform Mundipharma whether it intends to institute or defend proceedings against the infringer or attacker. 

  

	 	14.3.	Skye shall be entitled at its discretion to take such action to seek an abatement of such infringement, or to defend such attack on validity, as it sees fit, which may
include the institution or defence of proceedings against the infringer or attacker. Mundipharma shall provide all such assistance at Skye’s cost and expense as Skye may reasonably require in the prosecution or defence of any such proceedings.

  

	 	14.4.	Any damages, award or settlement monies actually received by Skye in respect to such infringement and paid in compensation for sales lost by Mundipharma shall belong to
Mundipharma, subject to such payments being treated as Net Sales and Skye deducting therefrom any payment it would be due had Mundipharma achieved such Net Sales. Any damages, award or settlement monies actually received by Skye in respect to such
infringement and not paid in compensation for sales lost by Mundipharma shall belong to Skye. 

  

	 	14.5.	 Should in accordance with Clause 14.2 Skye notify Mundipharma that it does not intend to pursue any such infringement. Mundipharma may

  
 33 

	 	 
thereafter pursue such infringement. Any damages, award or settlement monies actually received by Mundipharma in respect to such infringement and paid in compensation for sales lost by
Mundipharma shall belong to Mundipharma, subject to such payments (net of reasonable costs of pursuing the infringement) being treated as Net Sales and Mundipharma paying to Skye therefrom any payment which would be due to Skye had Mundipharma
achieved such Net Sales. Any damages, award or settlement monies actually received by Mundipharma in respect to such infringement and not paid in compensation for sales lost by Mundipharma shall belong to Skye, save that Mundipharma shall be
entitled to set off its reasonable costs in pursuing such infringement against such damages, award or settlement actually received by Mundipharma. 

  

	15.	Term 

  

	 	15.1.	This Agreement commences on the Effective Date and, subject to earlier termination in accordance with the provisions of Clause 16, shall continue in force until the
expiry or termination (for any reason) of the 2003 Agreement. 

  

	16.	Termination 

  

	 	16.1.	Either party shall be entitled forthwith to terminate this Agreement by notice to the other if: 

 

	 	16.1.1.	the other party commits a material or persistent breach of any obligation under this Agreement or the Supply Agreement, and in the case of a breach which is capable of
remedy fails to remedy it within [**] days of receipt of notice from the first party of such breach and of its intention to exercise its rights under this Clause; or 

  
 34 

  

	 	16.1.2.	a petition is presented, or a meeting is convened for the purpose of considering a resolution, or other steps are taken, for making an administration order against or
for the winding up of the other party or an administration order or a winding up order is made against or a provisional liquidator is appointed with respect to the other party; or 

 

	 	16.1.3.	an encumbrancer takes possession of, or a trustee or administrative receiver or similar officer is appointed in respect of, all or any material part of the business or
assets of the other party, or distress or any form of execution is levied or enforced upon or sued out against any such assets and is not discharged within [**] days of being levied, enforced or sued out; or 

 

	 	16.1.4.	the other party is unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986 or becomes unable to pay its debts as they fall due or suspends
or threatens to suspend making payments with respect to all or any class of its debts; or 

  

	 	16.1.5.	any voluntary arrangement is proposed under section 1 of the Insolvency Act 1986 in respect of the other party; or 

 

	 	16.1.6.	the other party proposes or makes any composition or arrangement or composition with, or any assignment for the benefit of, its creditors; or 

 

	 	16.1.7.	anything analogous to any of the events described in Clauses 16.1.2 - 16.1.6, inclusive, occurs under the laws of any applicable jurisdiction; or

  

	 	16.1.8.	the other party ceases or threatens to cease to carry on the whole or any material part of its business. 

  
 35 

  

	 	16.2.	Skye shall be permitted to terminate this Agreement on a country by country basis (and such termination shall represent Skye’s sole remedy in such event) if
Mundipharma fails to achieve Commercial Delivery in that country as envisaged by clause 3.4.2 above within [**] ([**]) months of the Effective Date. In relation to any termination of this Agreement in respect of breach under clauses 2.2, 2.7, 3.4,
3.5 and 5.1 above, any such termination shall similarly only be permitted and take effect in respect of the particular country in the Territory in respect of which the breach has occurred. 

 

	 	16.3.	Mundipharma or Skye shall be entitled forthwith to terminate this Agreement in the event of the Marketing Authorisation or a relevant Regulatory Approval being
cancelled or withdrawn for a period likely to exceed [**] ([**]) months or in the event of Mundipharma, its Affiliates, sub-licensees or sub-distributors being prevented from selling the Product in the Territory by a final non-appealable judgement
in respect of any infringement by the Skye Technology or the sale of Finished Product in accordance herewith of any Third Party Intellectual Property rights. 

 

	 	16.4.	The termination or expiry of this Agreement shall not release either of the parties from any liability which at the time of termination or expiry has already accrued to
the other party, nor affect in any way the survival of any other right, duty or obligation of the parties which is expressly stated elsewhere in this Agreement to survive such termination or expiry. 

 

	17.	Consequences of Termination 

  

	 	17.1.	On termination of this Agreement for any reason (and, if applicable, in respect of that country in respect of which termination occurs): 

 

	 	17.1.1.	the licences and rights granted and appointments made under Clauses 2.1 and 2.2 shall terminate and Mundipharma shall (and shall procure that its Affiliates and
sub-licensees shall) cease all activities licensed or appointed hereunder, subject to Clause 17.2; 

  
 36 

  

	 	17.1.2.	the Supply Agreement shall be terminated as far as it relates to the Territory; 

 

	 	17.1.3.	the following provisions of this Agreement shall continue in full force and effect: this Clause 17 and Clauses 10 and 11; 

 

	 	17.1.4.	Mundipharma shall return to Skye all Skye IP in its possession; 

  

	 	17.1.5.	Mundipharma shall assign to Skye free of charge any domain name registrations it has registered pursuant to Clause 8.5 and any trade marks for which it has applied
under Clause 8.6; 

  

	 	17.1.6.	Mundipharma shall promptly transfer to Skye or its nominee insofar as it is able to do so, each and every Regulatory Approval (including but not limited to any pricing
and reimbursement approval) relating to the Product, together with all communications with the relevant Regulatory Authorities, and all notes and record thereof. 

 

	 	17.2.	In the event that this Agreement is terminated by Skye in accordance with Clause 16.1, Mundipharma and its Affiliates, sub-licensees and sub-distributors shall be
entitled to continue to sell existing stocks of the Finished Product in the Territory for so long as necessary to sell all such stocks, provided that Mundipharma continues to make any payments due to Skye in respect of such sales in accordance with
the provisions of this Agreement. Immediately upon notification from Skye, such post termination sales shall cease, subject to Skye assuming Mundipharma’s obligations to meet unfulfilled orders and acquiring all stocks of Finished Product held
by Mundipharma, its Affiliates, sub-licensees and sub-distributors at the price paid for such stocks by Mundipharma’s Affiliate. 

  
 37 

  

	18.	Force Majeure 

  

	 	18.1.	Neither Party shall be entitled to terminate this Agreement or shall be liable to the other under this Agreement for loss or damages attributable to any Force Majeure,
provided the party affected shall give prompt notice thereof to the other party. Subject to Clause 18.2, the party giving such notice shall be excused from all affected obligations hereunder for so long as it continues to be affected by Force
Majeure. 

  

	 	18.2.	If such Force Majeure continues unabated for a period of at least 90 days, the parties will meet to discuss in good faith what actions to take or what modifications
should be made to this Agreement as a consequence of such Force Majeure in order to alleviate its consequences on the affected party. 

  

	19.	Notices 

  

	 	19.1.	Any notice or other document given under this Agreement shall be in writing in the English language and shall be given by hand or sent by prepaid airmail, by fax
transmission or e-mail to the address of the receiving Party as set out in Clauses 19.3 below unless a different address or fax number has been notified to the other in writing for this purpose. Notice by email is not permitted.

  

	 	19.2.	Each such notice or document shall: 

  

	 	19.2.1.	if sent by hand, be deemed to have been given when delivered at the relevant address; 

  
 38 

  

	 	19.2.2.	if sent by prepaid airmail, be deemed to have been given 7 days after posting; or 

 

	 	19.2.3.	if sent by fax transmission be deemed to have been given when transmitted provided that a confirmatory copy of such facsimile transmission shall have been sent by
prepaid airmail within 24 hours of such transmission. 

  

	 	19.3.	The address for services of notices and other documents on the parties shall be: 

 

							
	 To Mundipharma
	 	 To Skye

				
	Address: 	  	 Mundipharma House,
 14
Par-la-Ville Road,
 P.O. Box HM 2332,

Hamilton, HM JX,
 Bermuda
	 	Address: 	  	 10450 Sciences
 Center
Drive,
 San Diego,
 California
92121
 USA

				
	Fax: 	  	001 809 292 1472	 	Fax:	  	001 858 623 0376
				
	Attention: 	  	General Manager	 	Attention: 	  	President
				
	Copy To: 	  	[**]	 	Copy To: 	  	 Skye Legal Department,
 105
Piccadilly,
 London

W1J7NJ

		
	Fax: [**]	 	Fax: +44 20 7491 3338

  

	20.	Assignment and Change of Control 

  

	 	20.1.	Each party shall have the right to sub-license, assign, license, transfer or delegate its rights or obligations under this Agreement in whole or in part to an Affiliate
(for so long as such Affiliate remains an Affiliate). Subject to Clause 2.9, neither party shall, nor shall it purport to, assign, license, transfer, delegate or charge any of its rights or obligations under this Agreement to a Third Party without
the prior written consent of the other, such consent not to be unreasonably withheld or delayed. 

  
 39 

  

	 	20.2.	Should there be a material change in the ownership or a change in the control of the Mundipharma (and for the purpose of this Clause the term “control” means
the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of Mundipharma, whether through the ownership of voting securities, by contract or otherwise, or the ownership either directly or
indirectly of 50% or more of the voting securities (or, in relation to any country where ownership of more than 50% of the voting securities is prohibited by law, the maximum percentage permitted, provided such percentage is no less than 30%) of
Mundipharma), Skye may terminate this Agreement by not less than three (3) months written notice to the Mundipharma. 

  

	21.	General Provisions. 

  

	 	21.1.	Nothing in this Agreement is deemed to constitute a partnership between the parties nor constitute either party the agent of the other party for any purpose.

  

	 	21.2.	If there is a disagreement between the Skye and Mundipharma on the interpretation of this Agreement or any aspect of the performance by either party of its obligations
under this Agreement, the parties shall resolve the dispute in accordance with the dispute resolution procedure set out in Schedule V. 

  

	 	21.3.	Each of the parties shall do execute and perform and shall procure to be done executed and performed all such further acts, deeds, documents and things as the other
party may reasonably require from time to time to give full effect to the terms of this Agreement. 

  

	 	21.4.	In performing any respective obligations under this agreement, each party shall comply with the Data Protection Act 1998, any notification requirements under the Data
Protection Act 1998 and the Data Protection Principles specified in that Act and any equivalent legislation in the Territory. 

  
 40 

  

	 	21.5.	Each party shall pay its own costs, charges and expenses incurred in connection with the negotiation, preparation and completion of this Agreement.

  

	 	21.6.	This Agreement, the 2003 Agreement and the Supply Agreement sets out the entire agreement and understanding between the parties in respect of the subject matter of this
Agreement. This Agreement supersedes any heads of agreement which shall cease to have any further force or effect. It is agreed that: 

  

	 	21.6.1.	no party has entered into this Agreement in reliance upon any representation, warranty or undertaking of the other party which is not expressly set out in this
Agreement; 

  

	 	21.6.2.	no party shall have any remedy in respect of misrepresentation or untrue statement made by the other party or for any breach of warranty which is not contained in this
Agreement; 

  

	 	21.6.3.	this Clause shall not exclude any liability for, or remedy in respect of, fraudulent misrepresentation. 

 

	 	21.7.	No variation of this Agreement shall be valid unless it is in writing and signed by or on behalf of both parties. 

 

	 	21.8.	Unless expressly agreed, no variation shall constitute a general waiver of any provisions of this Agreement, nor shall it affect any rights, obligations or liabilities
under or pursuant to this Agreement which have already accrued up to the date of variation, and the rights and obligations of the parties under or pursuant to this Agreement shall remain in full force and effect, except and only to the extent that
they are so varied. 

  
 41 

  

	 	21.9.	If and to the extent that any provision of this Agreement is held to be illegal, void or unenforceable, such provision shall be given no effect and shall be deemed not
to be included in this Agreement but without invalidating any of the remaining provisions of this Agreement. In such event the parties shall negotiate with a view to finding the nearest permissible provision to that found to be illegal, void or
unenforceable. If the parties have been unable to agree as to the provision or provisions to be substituted within two (2) months then the parties shall refer the question of the re-drafting of the Agreement to an expert under the dispute
resolution procedure in Schedule V. 

  

	 	21.10.	No failure or delay by either party in exercising any right or remedy provided by law under or pursuant to this Agreement shall impair such right or remedy or operate
or be construed as a waiver or variation of it or preclude its exercise at any subsequent time and no single or partial exercise of any such right or remedy shall preclude any other or further exercise of it or the exercise of any other right or
remedy. 

  

	 	21.11.	The rights and remedies of each of the parties under or pursuant to this Agreement are cumulative, may be exercised as often as such party considers appropriate and are
in addition to its rights and remedies under general law. 

  

	 	21.12.	This Agreement may be executed in any number of counterparts and by the parties on separate counterparts, each of which is an original but all of which together
constitute one and the same instrument. 

  

	 	21.13.	A person who is not a party to this Agreement, other than an Affiliate, shall have no right under the Contracts (Rights of Third Parties) Act 1999 to enforce any of its
terms. 

  

	 	21.14.	This Agreement and the relationship between the parties shall be governed by, and interpreted in accordance with, English law. 

  
 42 

  

	 	21.15.	Each of the parties agree that the courts of England are to have exclusive jurisdiction to settle any dispute (including claims for set off and counterclaims) which may
arise in connection with the creation, validity, effect, interpretation or performance of, or the legal relationships established by, this Agreement or otherwise arising in connection with this Agreement and for such purposes irrevocably submit to
the jurisdiction of the English courts. 

 AS WITNESS the hands of the parties or their duly authorised representatives the day
and the year first above written 
  

											
	SIGNED for and by behalf of	  	)	  		  	 /s/ Steven Thornton

	SKYEPHARMA INC	  		  	)
		  		  	)
		  		  		  	 Steven Thornton
	  	
		  		  		  	Print Name	  	
				
	SIGNED for and by behalf of	  	)	  		  	 /s/ Douglas Docherty

	MUNDIPHARMA INTERNATIONAL	  		  	)
	HOLDINGS LIMITED	  		  	)
		  		  		  	 Douglas Docherty
	  	
		  		  		  	Print name	  	

  
 43 

 SCHEDULE I 
 PATENTS 
  

													
	 SkyePharma reference
	  	 Country
	  	 Status
	  	 Filing Date
	  	 Application
number
	  	 Grant Date
	  	 Grant
 number

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

 SCHEDULE II 

TRADE MARKS 
  

											
	 Country
	  	 Status
	  	 Filing Date
	  	 Application No.
	  	 Registration
 Date
	  	 Registration
 No.

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

  
 44 

 SCHEDULE III 
 Receipt of adverse events 
 In each of the countries where the Product is marketed or
distributed there will be a process for receiving adverse events from health care professionals and the public and appropriate distribution to the allocated local operating company. All adverse events received by the local operating company will
then be forwarded to Skyepharma in accordance with agreed process and schedule. 
 Regulatory Authorities 

In the countries where the Product is marketed or distributed it is the responsibility of the local company to make arrangements for appropriate
transmission of adverse events to a local regulatory authority in accordance with local procedures, guidelines and directives. 
 Other
Territories 
 In countries of territories where the Product is not marketed, licensed or distributed, there will be no reporting obligation
for adverse events. 
 Product Recall 
 In the event Skye is required or voluntarily decides to initiate a recall, withdrawal or field correction of the Product, Skye shall notify Mundipharma and provide a copy of its proposal, including the
recall letter, for review prior to initiation of such action and the parties shall fully consult and cooperate with each other concerning the need for such a recall and in order to develop and execute a recall plan, as necessary. In conjunction with
such recall, Mundipharma shall assist, at Skye’s sole discretion and expense, in the investigation to determine the cause and extent of the problem. 

  
 45 

 In the event that Mundipharma independently believes that a recall, withdrawal or field correction of the
Product may be necessary or appropriate, Mundipharma shall notify Skye of Mundipharma’s belief, and the parties shall fully cooperate with each other concerning the necessity and nature of such action. 

All coordination of any recall or field correction activities involving Product and/or Finished Product shall be handled by Mundipharma, in cooperation
with Skye. 
 In the event that any Product is recalled as a direct result of the negligent or intentionally wrongful acts or omissions of
Mundipharma or its representatives, then Mundipharma shall bear all of the costs and expenses of such recall, including expenses related to communications and meetings with all required Regulatory Authorities, expenses of replacement stock, the cost
of notifying customers and costs associated with shipment of recalled Product from customers and shipment of an equal amount of replacement Product to those same customers. In the event that any Product is recalled as a direct result of the
negligent or intentionally wrongful acts or omissions of Skye or its representatives or as a result of Product misbranding or failure to meet Specification, then Skye shall bear all of the costs and expenses of such recall, including expenses
related to communications and meetings with all required Regulatory Authorities, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of recalled Product from customers and shipment of an equal amount of
replacement Product to those same customers. To the extent that the reason for any recall of Product hereunder is in part the responsibility of Skye and in part the responsibility of Mundipharma or is not due to the fault of either Party, then the
expenses shall be allocated in an equitable manner between the parties. 

  
 46 

 SCHEDULE IV 
 THE TERRITORY 
  

	1.	Egypt 

  

	2.	Tunisia 

  

	3.	Algeria 

  

	4.	Morocco 

  

	5.	Turkey 

  

	6.	Singapore 

  

	7.	Malaysia 

  

	8.	China 

  

	9.	Korea 

  

	10.	Hong Kong 

  

	11.	Philippines 

  

	12.	Indonesia 

  

	13.	Thailand 

  

	14.	Bahrain 

  

	15.	Jordan 

  

	16.	Kuwait 

  

	17.	Lebanon 

  

	18.	Oman 

  

	19.	Qatar 

  

	20.	Saudi Arabia 

  

	21.	Sudan 

  

	22.	Syria 

  

	23.	United Arab Emirates 

  

	24.	Libya 

  

	25.	Iraq 

  

	26.	India 

  
 47 

 SCHEDULE V 
 DISPUTE RESOLUTION 
  

	1.	Representatives of the parties will, within 14 days of receipt of a written request from either party to the other, convene a meeting of the Committee to discuss in
good faith and try to resolve the disagreement without recourse to legal proceedings. 

  

	2.	If resolution does not occur within 7 days after meeting, the matter shall be escalated for determination by the respective Chief Executive Officer of the parties who
may resolve the matter themselves or by agreement jointly appoint a mediator or independent expert to do so. 

  

	3.	Nothing in this Agreement restricts either party’s freedom to seek urgent relief to preserve a legal right or remedy, or to protect a proprietary trade secret or
other right. 

 Appointment of an Expert 

 

	4.	In the event that the Chief Executive Officers agree to resolve a dispute by referral to an expert (“Referral Notice”) or in the event of one party wishing to
refer a matter under Clause 3.3 or 21.9 of the Agreement to an expert the following procedure shall be followed. 

  

	 	4.1	The dispute or matter shall be determined by a single independent impartial expert who shall be agreed between the parties or, in the absence of agreement between the
parties within 30 days of the service of a Referral Notice, be appointed by the Association of the British Pharmaceutical Industry or any successor thereto, or such other competent body agreed by the parties. 

 

	 	4.2	30 days after the appointment of the expert pursuant to paragraph 4.1 both parties shall exchange simultaneously statements of case in no more than 10,000 words, in
total, and each side shall simultaneously send a copy of its statement of case to the expert. 

  
 48 

  

	 	4.3	Each party may, within 30 days of the date of exchange of statement of case pursuant to paragraph 4.2, serve a reply to the other side’s statement of case in no
more than 10,000 words. A copy of any such reply shall be simultaneously sent to the expert. 

  

	 	4.4	Subject to paragraph 4.6 there shall be no oral hearing. The expert shall issue his decision in writing to both parties within 30 days of the date of service of the
last reply pursuant to paragraph 4.3 above or, in the absence of receipt of any replies, within 60 days of the date of exchange pursuant to paragraph 4.2. 

  

	 	4.5	The seat of the dispute resolution shall be the normal place of residence of the expert. 

 

	 	4.6	The expert shall not have power to alter, amend or add to the provisions of this Agreement, except that the expert shall have the power to decide all procedural matters
relating to the dispute, and may call for a one day hearing if desirable and appropriate. 

  

	 	4.7	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 party copies of any documents so requested by the expert. 

  

	 	4.8	The decision of the expert shall be final and binding upon both parties except in the case of manifest error. The parties hereby exclude any rights of application or
appeal to any court, to the extent that they may validly so agree, and in particular in connection with any question of law arising in the course of the reference out of the award. 

 

	 	4.9	The expert shall determine the proportions in which the parties shall pay the costs of the expert’s procedure. The expert shall have the authority to order that
all or a part of the legal or other costs of a party shall be paid by the other party. 

  
 49 

  

	 	4.10	All documents and information disclosed in the course of the expert proceedings and the decision and award of the expert shall be kept strictly confidential by the
recipient and shall not be used by the recipient for any purpose except for the purposes of the proceedings and/or the enforcement of the expert’s decision and award. 

  
 50Co-development, Collaboration and License Agreement

 Exhibit 10.11 
 Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. 
 EXECUTION COPY 
  
 CO-DEVELOPMENT, COLLABORATION AND LICENSE AGREEMENT 

BY AND BETWEEN 

ENZON PHARMACEUTICALS, INC. 

AND 
 JAGOTEC, AG, 
 SKYEPHARMA,
INC., 
 AND 
 SKYEPHARMA PLC 
 DATED
AS OF 
 JANUARY 2, 2003 

 TABLE OF CONTENTS 

 

							
	 	  	 	  	 	  	Page
	1.	  	DEFINITIONS.	  	1
				
		  	 1.1
	  	“Affiliate”	  	1
				
		  	 1.2
	  	“Agreement”	  	1
				
		  	 1.3
	  	“Annual Operating Plan and Budget”	  	2
				
		  	 1.4
	  	“Audited Party”	  	2
				
		  	 1.5
	  	“Auditing Party”	  	2
				
		  	 1.6
	  	“Bankruptcy Code”	  	2
				
		  	 1.7
	  	“Breaching Party”	  	2
				
		  	 1.8
	  	“cGMP”	  	2
				
		  	 1.9
	  	“Commercially Reasonable Efforts”	  	2
				
		  	 1.10
	  	“Compound”	  	2
				
		  	 1.11
	  	“Confidential Information”	  	2
				
		  	 1.12
	  	“Development Costs”	  	2
				
		  	 1.13
	  	“Development Program”	  	2
				
		  	 1.14
	  	“Early Stage Development Activities”	  	2
				
		  	 1.15
	  	“Effective Date”	  	3
				
		  	 1.16
	  	“Enzon”	  	3
				
		  	 1.17
	  	“Enzon Compound IP”.	  	3
				
		  	 1.18
	  	“Enzon Technology”	  	3
				
		  	 1.19
	  	“Executive Officers”	  	3
				
		  	 1.20
	  	“Expert”	  	3
				
		  	 1.21
	  	“FDA”	  	3
				
		  	 1.22
	  	“Field”	  	3
				
		  	 1.23
	  	“Financial Appendix”.	  	3
				
		  	 1.24
	  	“GAAP”	  	3
				
		  	 1.25
	  	“IND”	  	3
				
		  	 1.26
	  	“Indemnitee”	  	3
				
		  	 1.27
	  	“Infringement”	  	3
				
		  	 1.28
	  	“Initial Development Term”	  	3

  
 (i)

 TABLE OF CONTENTS 

(continued) 
  

							
	 	  	 	  	 	  	Page
				
		  	 1.29
	  	“Invention”	  	3
				
		  	 1.30
	  	“Jagotec”	  	4
				
		  	 1.31
	  	“Joint Development Committee” or “JDC”	  	4
				
		  	 1.32
	  	“Know-how”	  	4
				
		  	 1.33
	  	“Net Sales”	  	4
				
		  	 1.34
	  	“Non-breaching Party”	  	4
				
		  	 1.35
	  	“Operating Profit or Loss”	  	4
				
		  	 1.36
	  	“Party”	  	4
				
		  	 1.37
	  	“Patents”.	  	4
				
		  	 1.38
	  	“Phase I Clinical Trial(s)”	  	4
				
		  	 1.39
	  	“Phase II Clinical Trial(s)”	  	4
				
		  	 1.40
	  	“Phase III Clinical Trial(s)”	  	4
				
		  	 1.41
	  	“Product”	  	5
				
		  	 1.42
	  	“Proof of Concept Activities”	  	5
				
		  	 1.43
	  	“Registration”	  	5
				
		  	 1.44
	  	“Registration Activities”	  	5
				
		  	 1.45
	  	“Registration Application”	  	5
				
		  	 1.46
	  	“Regulatory Authority”	  	5
				
		  	 1.47
	  	“Serious Adverse Drug Experience”	  	5
				
		  	 1.48
	  	“Skye”	  	5
				
		  	 1.49
	  	“SkyePharma”	  	5
				
		  	 1.50
	  	“SkyePharma Compound IP”	  	5
				
		  	 1.51
	  	“SkyePharma Technology”	  	5
				
		  	 1.52
	  	“Sole Developing Party”	  	5
				
		  	 1.53
	  	“Special Arbitration Provisions”	  	6
				
		  	 1.54
	  	“Subcommittee”	  	6
				
		  	 1.55
	  	“Sublicensee”	  	6
				
		  	 1.56
	  	“Sublicensing Income”	  	6
				
		  	 1.57
	  	“Territory”	  	6
				
		  	 1.58
	  	“Third Party”	  	6

  
 (ii)

 TABLE OF CONTENTS 

(continued) 
  

							
	 	  	 	  	 	  	Page
				
		  	 1.59
	  	“Transfer Agreement”	  	6
				
		  	 1.60
	  	“United States” or “U.S.”.	  	6
			
	2.	  	THE DEVELOPMENT PROGRAM.	  	6
				
		  	 2.1
	  	Overview of the Development Program	  	6
				
		  	 2.2
	  	Annual Operating Plan(s)	  	6
				
		  	 2.3
	  	Scope of Development Activities.	  	7
				
		  	 2.4
	  	Responsibilities of Each Party under the Development Program	  	8
				
		  	 2.5
	  	Conduct of Development Program and Commercialization Activities	  	8
				
		  	 2.6
	  	Recall	  	9
			
	3.	  	JOINT DEVELOPMENT COMMITTEE	  	10
				
		  	 3.1
	  	Members; Officers	  	10
				
		  	 3.2
	  	Responsibilities of the Joint Development Committee	  	10
				
		  	 3.3
	  	Meetings	  	11
				
		  	 3.4
	  	Cooperation of Parties for Selection of Compounds	  	12
				
		  	 3.5
	  	Decision-making	  	12
				
		  	 3.6
	  	Minutes	  	12
				
		  	 3.7
	  	Subcommittee(s)	  	13
				
		  	 3.8
	  	Term	  	13
				
		  	 3.9
	  	Expenses	  	13
			
	4.	  	FEES, MILESTONES, AND FUNDING.	  	13
				
		  	 4.1
	  	Up-front Payments	  	13
				
		  	 4.2
	  	Milestone Payments	  	13
				
		  	 4.3
	  	Funding of Development Program	  	13
				
		  	 4.4
	  	Sole Developing Party; Royalties	  	15
				
		  	 4.5
	  	Termination of Development	  	15
			
	5.	  	PAYMENTS AND REPOR1	  	15
				
		  	 5.1
	  	Payments	  	15
				
		  	 5.2
	  	Mode of Payment	  	15
				
		  	 5.3
	  	Records Retention	  	16
				
		  	 5.4
	  	Audits.	  	16

  
 (iii)

 TABLE OF CONTENTS 

(continued) 
  

							
	 	  	 	  	 	  	Page
				
		  	 5.5
	  	Taxes	  	16
			
	6.	  	GRANT OF RIGHTS; RESTRICTIONS; OWNERSHIP; PATENTS.	  	17
				
		  	 6.1
	  	License Grant to Enzon	  	17
				
		  	 6.2
	  	License Grant to SkyePharma	  	17
				
		  	 6.3
	  	Sublicensing	  	17
				
		  	 6.4
	  	Restriction on Activities	  	18
				
		  	 6.5
	  	Ownership.	  	18
				
		  	 6.6
	  	Patent Prosecution and Maintenance.	  	19
				
		  	 6.7
	  	Patent Enforcement,	  	20
				
		  	 6.8
	  	Infringement Action by Third Parties.	  	20
			
	7.	  	ADVERSE REACTION REPORTING.	  	21
				
		  	 7.1
	  	Adverse Reaction Reporting.	  	21
			
	8.	  	REPRESENTATIONS AND WARRANTIES.	  	22
				
		  	 8.1
	  	Representations and Warranties of Both Parties	  	22
				
		  	 8.2
	  	Representations and Warranties of SkyePharma	  	23
				
		  	 8.3
	  	Representations and Warranties of Enzon	  	23
				
		  	 8.4
	  	Disclaimer	  	23
			
	9.	  	PUBLICATION; CONFIDENTIALITY.	  	24
				
		  	 9.1
	  	Notification and Review with Respect to SkyePharma and Enzon.	  	24
				
		  	 9.2
	  	Confidentiality; Exceptions	  	25
				
		  	 9.3
	  	Exceptions to Obligation	  	25
				
		  	 9.4
	  	Limitations on Use	  	26
				
		  	 9.5
	  	Remedies	  	26
			
	10.	  	INDEMNIFICATION.	  	26
				
		  	 10.1
	  	By SkyePharma	  	26
				
		  	 10.2
	  	By Enzon	  	26
				
		  	 10.3
	  	Jointly	  	27
				
		  	 10.4
	  	Notice	  	27
				
		  	 10.5
	  	Complete Indemnification	  	27
			
	11.	  	TERM; TERMINATION.	  	27

  
 (iv)

 TABLE OF CONTENTS 

(continued) 
  

									
	 	  	 	  	 	  	Page	 
				
		  	 11.1
	  	Term	  	 	27	  
				
		  	 11.2
	  	Termination for Cause	  	 	28	  
				
		  	 11.3
	  	Termination for Insolvency.	  	 	28	  
				
		  	 11.4
	  	Termination for Inactivity.	  	 	29	  
				
		  	 11.5
	  	Effect of Expiration or Termination.	  	 	29	  
				
		  	 11.6
	  	Accrued Rights; Surviving Obligations	  	 	31	  
			
	12.	  	FORCE MAJEURE.	  	 	31	  
			
	13.	  	MISCELLANEOUS.	  	 	31	  
				
		  	 13.1
	  	Relationship of Parties	  	 	31	  
				
		  	 13.2
	  	Assignment	  	 	31	  
				
		  	 13.3
	  	Affiliates of SkyePharma	  	 	32	  
				
		  	 13.4
	  	Books and Records	  	 	32	  
				
		  	 13.5
	  	Further Actions	  	 	32	  
				
		  	 13.6
	  	Notice.	  	 	32	  
				
		  	 13.7
	  	Use of Name	  	 	33	  
				
		  	 13.8
	  	Public Announcements	  	 	33	  
				
		  	 13.9
	  	Waiver	  	 	33	  
				
		  	 13.10
	  	Compliance with Law	  	 	33	  
				
		  	 13.11
	  	Severability	  	 	33	  
				
		  	 13.12
	  	Amendment	  	 	33	  
				
		  	 13.13
	  	Governing Law	  	 	33	  
				
		  	 13.14
	  	Arbitration.	  	 	34	  
				
		  	 13.15
	  	Entire Agreement	  	 	35	  
				
		  	 13.16
	  	Parties in Interest	  	 	35	  
				
		  	 13.17
	  	Descriptive Headings	  	 	35	  
				
		  	 13.18
	  	Counterparts	  	 	35	  

  
 (v)

 TABLE OF CONTENTS 

(continued) 

LIST OF EXHIBITS 
  

			
		
	EXHIBIT 1.23	  	FINANCIAL APPENDIX
		
	EXHIBIT 3.1	  	JOINT DEVELOPMENT COMMITTEE MEMBERS

  
 (i)

 CO-DEVELOPMENT, COLLABORATION
AND LICENSE AGREEMENT 
 This
CO-DEVELOPMENT, COLLABORATION AND LICENSE AGREEMENT, dated as of January 2, 2003 (the “Effective Date”), is entered into by and among
Enzon Pharmaceuticals, Inc., a corporation organized and existing under the laws of Delaware, having offices located at 685 Route 202/206 Bridgewater, New Jersey 08807 (“Enzon”), and SkyePharma, Inc., a corporation organized and
existing under the laws of the State of California and wholly-owned subsidiary of Parent, having offices located at 1450 Science Center Drive, San Diego, California 92121 (“Skye”), Jagotec, AG, a corporation organized and existing
under the laws of Switzerland and wholly-owned subsidiary of Parent, having offices located at Eptingerstrasse 51, CH-4132 Muttenz, Switzerland (“Jagotec,” and together with Skye, “SkyePharma”), and solely with
respect to Section 13.3, SkyePharma PLC, a corporation organized and existing under the laws of England and Wales, having offices located at 105 Piccadilly, London W1J 7NJ, England (“Parent”). 

PRELIMINARY STATEMENTS 
 A. Skye and Jagotec, together with their Affiliates (as defined below), own and have all right, title and interest in, or have acquired the exclusive rights to, the SkyePharma Technology and the
SkyePharma Compound IP (each as defined below). 
 B. Enzon, together with its Affiliates, owns and has all
right, title and interest in, or has acquired the exclusive rights to, the Enzon Technology and the Enzon Compound IP (each as defined below). 
 C. SkyePharma and Enzon wish to conduct collaborative co-development activities for the purpose of engaging in a research and development program to discover and develop up to an aggregate total of six
(6) compounds from which the Parties (as defined below) shall choose up to three (3) Products (as defined below) for further development and commercialization, all under the terms and conditions set forth in this Agreement. 

NOW, THEREFORE, in consideration of the foregoing preliminary statements and the mutual agreements and covenants set
forth herein, the Parties hereby agree as follows: 
 1. DEFINITIONS. 

As used in this Agreement, the following terms shall have the meanings set forth in this Section 1 unless context
clearly and unambiguously dictates otherwise: 
 1.1 “Affiliate,” with respect to any Party,
shall mean any entity controlling, controlled by, or under common control with, such Party, for only so long as such control exists. For these purposes, “control” shall refer to: (i) the possession, directly or indirectly, of
the power to direct the management or policies of an entity, whether through the ownership of voting securities, by contract or otherwise, or (ii) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting
securities or other ownership interest of an entity. 
 1.2 “Agreement” shall mean this
co-development collaboration and license agreement together with the preliminary statements and all exhibits, schedules and attachments hereto. 

 1.3 “Annual Operating Plan and Budget” shall mean, as
applicable, each plan and budget defined in Section 2.2 and, when used in the plural, shall mean all such plans and budgets. 
 1.4 “Audited Party” shall have the meaning assigned to such term in Section 5.4.1 and the Financial Appendix, as used in those Sections respectively. 

1.5 “Auditing Party” shall have the meaning assigned to such term in Section 5.4.1 and the
Financial Appendix, as used in those Sections respectively. 
 1.6 “Bankruptcy Code” shall have
the meaning assigned to such term in Section 11.3.2. 
 1.7 “Breaching Party” shall have
the meaning assigned to such term in Section 11.2. 
 1.8 “cGMP” shall mean current Good
Manufacturing Practice as defined in Parts 210 and 211 of Title 21 of the Code of Federal Regulations, as may be amended from time to time, or any successor thereto. 

1.9 “Commercially Reasonable Efforts” shall mean, with respect to a Party, those commercially reasonable
efforts by that Party similar to the efforts that Party in good faith believes it would make in similar circumstances for its own operations at that time, it being understood that a Party’s Commercially Reasonable Efforts will not in any event
require that Party to take any action that would be reasonably likely to result in a breach of any other provision of this Agreement, or any other agreement between the Parties, or any other agreement between a Party Affiliate of such Party and/or
Third Parties existing as of the Effective Date, or that the Party in good faith believes may violate any applicable law, regulation, rule, order, permit, direction or license of any court or governmental authority having appropriate jurisdiction
over the Party and subject matter or would be reasonably likely to be disruptive of any material service conducted or product made at or from any of its facilities or impair its ability to provide services or products hereunder. 

1.10 “Compound” shall mean a chemical compound with application in the Field selected by the Joint
Development Committee for development and which is then subject to ongoing development activities under this Agreement. 
 1.11 “Confidential Information” shall have the meaning assigned to such term in Section 9.2. 
 1.12 “Development Costs” shall have the meaning assigned to such term in the Financial Appendix. 
 1.13 “Development Program” shall mean the program of research, discovery, characterization, optimization, pre-clinical and clinical development of the Compounds and Products to be
conducted by the Parties, as set forth in Section 2. 
 1.14 “Early Stage Development
Activities” shall have the meaning assigned to such term in Section 2.3.1. 

  
 - 2 -

 1.15 “Effective Date” shall have the meaning assigned to
such term in the introductory paragraph of this Agreement. 
 1.16 “Enzon” shall have the
meaning assigned to such term in the introductory paragraph of this Agreement. 
 1.17 “Enzon Compound
IP” shall mean all Know-how and Patents owned or controlled by Enzon or its Affiliates (and to which Enzon has rights to grant licenses or sub-licenses) as of the Effective Date or during the term of this Agreement, to the extent directly
relating to any Compound or Product. 
 1.18 “Enzon Technology” shall mean the PEGylation
technology, including, without limitation, all Know-how and Patents that directly relate to any of the foregoing; in all cases which are owned or controlled by Enzon or its Affiliates (and to which Enzon has rights to grant licenses or sub-licenses)
as of the Effective Date or during the term, of this Agreement. 
 1.19 “Executive Officers”
shall have the meaning assigned to such term in Section 2.2.2. 
 1.20 “Expert” shall have
the meaning set forth in Section 13.14.2(a). 
 1.21 “FDA” shall mean the United States
Food and Drug Administration, and any successor entity thereto. 
 1.22 “Field” shall mean all
human therapeutic or prophylactic uses for the treatment (but not the diagnosis) of diseases and conditions in humans. 
 1.23 “Financial Appendix” shall mean Exhibit 1.23 hereto. 
 1.24 “GAAP” shall mean generally accepted accounting principles in the United States, consistently applied by the Party at issue. 

1.25 “IND” shall mean, with respect to the U.S., an effective Notice of a Claimed Investigational New
Drug Exemption as defined in Title 21 of the Code of Federal Regulations, and, with respect every other country in the Territory, the equivalent of such notice for such country, in each case required to be on file with the applicable Regulatory
Authority in such country prior to the commencement of clinical trials of a Compound or Product in humans in such country. 
 1.26 “Indemnitee” shall have the meaning assigned to such term in Section 10.4. 
 1.27 “Infringement” shall have the meaning assigned to such term in Section 6.7.1. 
 1.28 “Initial Development Term” shall have the meaning assigned to such term in Section 2.1. 
 1.29 “Invention” shall mean any new or useful process, compound or composition of matter, Know-how, Patent, and any improvement, enhancement, modification or derivative work

  
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to any SkyePharma Technology, SkyePharma Compound IP, Enzon Technology or Enzon Compound IP, that is conceived or first reduced to practice or first demonstrated to have utility during the term
of this Agreement in connection with the development or commercialization activities for Compounds and Products contemplated herein. 
 1.30 “Jagotec” shall have the meaning assigned to such term in the introductory paragraph of this Agreement. 

1.31 “Joint Development Committee” or “JDC” shall have the meaning assigned to such
term in Section 3.1. 
 1.32 “Know-how” shall mean any and all unpatented formulae,
processes, trade secrets, technologies and know-how, whether or not patentable, including, without limitation, synthesis, preparation, recovery and purification processes and techniques, control methods and assays, chemical data, toxicological and
pharmacological data and techniques, clinical data, medical uses, product forms and product formulations and specifications. 
 1.33 “Net Sales” shall have the meaning assigned to such term in the Financial Appendix. 
 1.34 “Non-breaching Party” shall have the meaning assigned to such term in Section 11.2. 
 1.35 “Operating Profit or Loss” shall have the meaning assigned to such term in the Financial Appendix. 

1.36 “Party” shall mean, as applicable, SkyePharma or Enzon and, when used in the plural, shall mean
SkyePharma and Enzon. 
 1.37 “Patents” shall mean the patents and patent applications in any
country in the Territory, together with any patents that may issue therefor in any country in the Territory, including any and all extensions, renewals, continuations, continuations-in-part, divisions, patents-of-additions, reissues, supplementary
protection certificates or foreign counterparts of any of the foregoing and any patents based on applications that claim priority from any of the foregoing. 
 1.38 “Phase I Clinical Trial(s)” shall mean studies in humans of a Compound, the purpose of which is preliminary determination of safety in healthy individuals or patients and for which
there are no primary endpoints relating to efficacy in the protocol. 
 1.39 “Phase II Clinical
Trial(s)” shall mean studies in humans of Product including dose exploration, dose response, duration of effect, kinetic/dynamic relationship and initial Phase II efficacy and safety studies. 

1.40 “Phase III Clinical Trial(s)” shall mean a human clinical trial conducted to demonstrate evidence
of the efficacy and safety of a Product for inclusion in a Registration Application to support Registration as more fully defined in Section 312.21(c) of Title 21 of the U.S. Code of Federal Regulations. 

  
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 1.41 “Product” shall mean any pharmaceutical formulation
that contains as the sole active ingredient or as one of its active ingredients a Compound for use in the Field and for which the IDC has determined to undertake the Proof of Concept Activities and, if applicable, the Registration Activities and
commercialization. 
 1.42 “Proof of Concept Activities” shall have the meaning assigned to
such term in Section 2.3.2. 
 1.43 “Registration” shall mean, with respect to each
country in the Territory, approval of the Registration Application for a Product filed in such country, including pricing or reimbursement approvals, where applicable, by the Regulatory Authority in such country. 

1.44 “Registration Activities” shall have the meaning assigned to such term in Section 2.3.3.

 1.45 “Registration Application” shall mean any filing(s) made with the Regulatory Authority
in any country in the Territories for regulatory approval of the marketing, manufacture and sale, and pricing when applicable, of a Product in such country. 
 1.46 “Regulatory Authority” shall mean, the FDA in the U.S., and any health regulatory authority(ies) in any country in the Territory that is a counterpart to the FDA and has
responsibility for granting regulatory approval for the marketing, manufacture, and sale of a Product in such country, including but not limited to pricing and reimbursement approvals. 

1.47 “Serious Adverse Drug Experience” shall have the meaning assigned to such term in
Section 7.1.2. 
 1.48 “Skye” shall have the meaning assigned to such term in the
introductory paragraph of this Agreement. 
 1.49 “SkyePharma” shall have the meaning assigned
to such term in the introductory paragraph of this Agreement. 
 1.50 “SkyePharma Compound IP”
shall mean all Know-how and patents owned or controlled by SkyePharma or its Affiliates (and to which SkyePharma has rights to grant licenses or sublicenses) as of the Effective Date or during the term of this Agreement, to the extent directly
relating to any Compound or Product. 
 1.51 “SkyePharma Technology” shall
mean the Geomatrix® drug release technologies, the IDD® insoluble drug delivery technology, the
DepoFoam® injectable technology, the Biosphere® injectable technology, and the HIT-Oralease technology, including, without limitation, all Know-how and Patents that directly relate to any of the foregoing; in all
cases which are owned or controlled by SkyePharma or its Affiliates (and to which SkyePharma has rights to grant licenses or sublicenses) as of the Effective Date or during the term of this Agreement. 

1.52 “Sole Developing Party” shall have the meaning assigned to such term in Section 4.4.

  
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 1.53 “Special Arbitration Provisions” shall have the
meaning assigned to such term in Section 13.14.2. 
 1.54 “Subcommittee” shall have the
meaning assigned to such term in Section 3.7. 
 1.55 “Sublicensee” shall mean a Third
Party to which a Party has granted a sublicense under a license granted under this Agreement. 
 1.56
“Sublicensing Income” shall have the meaning assigned to such term in the Financial Appendix. 

1.57 “Territory” shall mean all countries world-wide. 

1.58 “Third Party” shall mean any person who or which is neither a Party nor an Affiliate of a Party.

 1.59 “Transfer Agreement” shall have the meaning assigned to such term in Section 4.4.

 1.60 “United States” or “U.S.” shall mean The United States of America,
including its possessions and territories. 
 2. THE DEVELOPMENT PROGRAM. 

2.1 Overview of the Development Program. The Development Program shall commence as soon as practicable after the
Joint Development Committee has selected the first of the six (6) Compounds on which the Parties shall focus their collaborative development efforts and shall include the research and development activities of either or both of the Parties
under this Agreement to: (i) identify for initial development an aggregate of six (6) Compounds for initial preclinical studies up to selection as a lead compound for formal preclinical development, (ii) further develop up to three
(3) Products from the six (6) selected Compound(s) for formal preclinical development and clinical development as determined appropriate by the JDC, including through Phase III Clinical Trials, if appropriate, and (iii) such other
activities as necessary to implement the activities approved by the JDC in the Annual Operating Plan and Budget. Subject to Section 11.4, the initial term of the Development Program (the “Initial Development Term”) shall expire
on the fourth (4th) anniversary of the Effective Date, and thereafter the Development Program shall be automatically extended for successive two (2) year extension periods; provided, however, that at any time following
expiration of the initial Development Term, either Party shall have the right to terminate the Development Program upon ninety (90) days prior written notice. Notwithstanding such termination of the Development Program, the Parties shall
fulfill their respective development obligations under any then current Annual Operating Plan and Budget and this Agreement shall continue to remain in full force and effect with respect to any Products under commercialization at the time of such
termination. 
 2.2 Annual Operating Plan(s). Promptly after the Effective Date and
in any event no later than February 15, 2003, and annually on or before September l5th thereafter, the JDC shall prepare a report of the research, development, marketing, sales, and regulatory activities to be taken during the upcoming year with respect each Compound and Product, if any,
then under 

  
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development. Such report shall include a description of the timelines, milestones and deliverables for such actions, as well as goals and scope of such actions, the allocation of responsibilities
to the respective Parties, and an agreed plan and budget for the activities to be undertaken as part of the Development Program or to commercialize Product(s) in the next succeeding calendar year (each such report, an “Annual Operating Plan
and Budget”). 
 2.2.1 Provided that the JDC is able to establish and approve an
Annual Operating Plan and Budget for the upcoming year (excluding 2003) on or before September 15th of any particular year, development priorities shall be in accordance with such Annual Operating Plan and Budget. 

2.2.2 In the event that the Joint Development Committee is unable to establish and approve an Annual
Operating Plan and Budget for the upcoming year (excluding 2003) on or before September 15th of any particular year, then the Parties agree to submit the issue to the Chief Executive Officer of SkyePharma, or such other person holding a similar position designated by SkyePharma from time to
time, and the Chief Executive Officer of Enzon, or such other person holding a similar position designated by Enzon from time to time (collectively, the “Executive Officers”), for resolution. The Executive Officers shall meet
promptly to discuss each Party’s proposals regarding the Annual Operating Plan and Budget and objections to same in order to reach a mutually acceptable resolution. 

2.3 Scope of Development Activities. 

2.3.1 After the Joint Development Committee selects a Compound for development in the Development Program, the Parties
shall, as directed by the JDC and each Annual Operating Plan and Budget, focus their collaborative development efforts in order to measure the feasibility of developing each such Compound into Products. Such feasibility development efforts shall,
with respect to each Compound, be directed to initial preclinical studies up to selection as a lead compound for formal preclinical development for each Compound pursuant to the applicable Annual Operating Plan and Budget (the “Early Stage
Development Activities”). At the conclusion of the Early Stage Development Activities for each Compound, the JDC shall review available information and decide whether, when, and how to proceed with further development of such Compound as a
Product. The JDC shall select not more than a total of three (3) Compounds for further development as Products. 
 2.3.2 In the event that the JDC selects a Compound for further development as a Product, the Parties shall, as directed by the JDC and each Annual Operating Plan and Budget, focus their collaborative
development efforts with respect to such Product to demonstrate “proof-of-concept” for such Product in the target patient populations, including, without limitation, designing and conducting clinical trials for such Product, conducting
process development and formulation activities necessary or useful for the manufacture of bulk drug substance and/or drug product material for such clinical trials, and preparing for further clinical trials (the “Proof of Concept
Activities”). At the conclusion of the Proof of Concept Activities for each Product, the JDC shall review available information and decide whether, when, and how to proceed with further development of such Product. 

  
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 2.3.3 In the event that the JDC selects a Product for further development
following the conclusion of the Proof of Concept Activities, the Parties shall, as directed by the JDC and each Annual Operating Plan and Budget, focus their collaborative development efforts with respect to such Product in order to design and
conduct appropriate clinical trial(s) and undertake all research, development and regulatory activities necessary up through Registration of Products (the “Registration Activities”). 

2.4 Responsibilities of Each Party under the Development Program. As part of the Development Program for a
Compound and/or Product, and in accordance with the applicable Annual Operating Plan and Budget, the Parties shall undertake such activities as may be assigned to it by the JDC and assist the other Party with its assigned activities in order to:

 2.4.1 conduct such research and development activities deemed necessary or desirable by the JDC, including
without limitation, formulation development, pre-clinical studies, pre-Registration clinical trials and toxicology studies; 
 2.4.2 manufacture and supply the Compounds in bulk form for use in the pre- clinical and clinical trials; 
 2.4.3 during the Development Program, keep the JDC informed, through regular, periodic written reports, which may be brief summaries, at least once in each calendar quarter, of all development progress
being made by such Party with respect to all activities related to the Compounds and Products; 
 2.4.4 prepare
and file with the applicable Regulatory Authorities those regulatory filings deemed necessary or desirable by JDC to undertake development activities and obtain all Registrations that the JDC deems necessary or desirable to market and sell the
Products in the Territory and the applicable Field; 
 2.4.5 perform pre-commercialization analysis, planning,
market preparation, and relating marketing activities for the relevant countries in the Territory as deemed necessary or desirable by the JDC; 
 2.4.6 conduct post-Registration clinical trials and marketing studies as the JDC deems necessary or useful to maintain Registration for each Product for the target indications selected by the JDC in the
relevant countries in the Territory; and 
 2.4.7 perform such other responsibilities with respect to the
Development Program as may be assigned by the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time. 

2.5 Conduct of Development Program and Commercialization Activities. The Parties, acting in accordance with this
Section 2, and the relevant Annual Operating Plan and Budget, shall use Commercially Reasonable Efforts to develop and commercialize the Compounds and Products in the Field, in the Territory. The Parties shall use Commercially Reasonable
Efforts to market and sell all Products in the Field, in the Territory, for the target indications selected by the Joint Development Committee. Without limiting the generality of the foregoing, each Party shall: 

  
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 2.5.1 cooperate with the other Party to implement the Annual Operating Plans
and Budget, and such other activities that, from time to time, the JDC decides are necessary or useful for the success of the Development Program or commercialization of the Products, if any; 

2.5.2 use Commercially Reasonable Efforts to perform the work set out for such Party to perform in the Annual Operating
Plans and Budget; 
 2.5.3 conduct their activities under the Development Program in good scientific manner, and
in compliance in all material respects with all requirements of applicable laws, rules and regulations, and all other requirements of any applicable cGMP, good laboratory practice and current good clinical practice to attempt to achieve the
objectives of the Development Program efficiently and expeditiously; 
 2.5.4 maintain records, in sufficient
detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Development Program in the form required under all applicable laws and
regulations. The other Party shall have the right, during normal business hours and upon reasonable prior written notice, to inspect and copy all such records at its own expense, so long as doing so is not unreasonably disruptive. The other Party
shall maintain such records and information contained therein in confidence in accordance with Section 9 and shall not use such records or information except to the extent otherwise permitted by this Agreement; 

2.5.5 allow representatives of the other Party, upon reasonable prior written notice and during normal business hours, to
visit such Party’s facilities where any activities under the Development Program are being conducted, and consult, during such visits and by telephone, with such Party’s personnel performing work on the Development Program, so long as such
visits and consultations are not unreasonably disruptive. The other Party shall maintain any information received (whether by observation or otherwise) during such visit in confidence in accordance with Section 9 and shall not use such
information except to the extent otherwise permitted by this Agreement; and 
 2.5.6 agree and hereby do agree
that the Parties shall at all times have at least one (1) Compound or Product in development or being commercialized that incorporates the Enzon Technology unless the JDC determines that it is in the best interests of the collaboration not to
do so. 
 2.6 Recall. In the event that a Party shall become aware that the Regulatory Authority in any
country in the Territory alleges or has proved that a Product does not comply with applicable rules and regulations in such country, that Party shall notify the other Party immediately and both Parties shall cooperate fully regarding the
investigation and disposition of any such matter. The details regarding each Party’s rights and obligations in the event of a recall of any such Product shall be stipulated in a separate agreement to be entered into by the Parties prior to the
commercialization of any Product(s) hereunder, or in a separate agreement among the Parties and their respective Affiliates and/or Sublicensees, as the Parties mutually deem to be appropriate. 

  
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 3. JOINT DEVELOPMENT COMMITTEE. 

3.1 Members; Officers. Promptly after the Effective Date, the Parties shall establish a joint development committee
(the “Joint Development Committee” or “JDC”) as more fully described in this Section 3. The JDC shall be comprised of an equal number of representatives from each of SkyePharma and Enzon. The exact number of
such representatives shall be four (4) members, two (2) members from each Party, or such other number as the Parties may agree. The initial members of the JDC are set forth on Exhibit 3.1. Each Party may replace any or all of its
representatives on the JDC at any time upon written notice to the other Party in accordance with Section 13.6 of this Agreement, Such representatives shall include individuals within the senior management of each Party, and those
representatives of each Party shall, individually or collectively, have expertise in business, biopharmaceutical drug development and commercialization of drug products. Any member of the JDC may designate a substitute to attend and perform the
functions of that member at any meeting of the JDC. Each Party may, in its discretion, invite non-member representatives of such Party to attend meetings of the JDC. A chairperson and secretary of the JDC shall serve co-terminous one (1) year
terms, commencing on the Effective Date or an anniversary thereof, as the case may be. The right to name the chairperson and the secretary of the JDC shall alternate annually between the Parties, and each chairperson shall be named no later than ten
(10) days after the commencement of his or her term. The initial chairperson shall be selected by SkyePharma, the initial secretary shall be selected by Enzon and each is designated on Exhibit 3.1. 

3.2 Responsibilities of the Joint Development Committee. The Joint Development Committee shall be responsible for
overseeing the entire collaboration between SkyePharma and Enzon under this Agreement, including both the Development Program and all commercialization activities. Without limiting the foregoing, the JDC shall perform the following functions:

 3.2.1 determine and revise the overall strategy for the Development Program; 

3.2.2 annually determine the Annual Operating Plan and Budget for each Compound and Product, and revise same from time to
time as needed; 
 3.2.3 determine target indications for each Compound and Product, and revise same from time
to time as needed; 
 3.2.4 determine and revise multi-year expense forecasts and projected financial results of
the Parties activities under this Agreement; 
 3.2.5 evaluate progress and provide direction to the conduct of
the Development Program and any commercialization activities undertaken by the Parties; 
 3.2.6 determine, the
selection of (i) Compounds on which to focus collaborative development efforts, (ii) criteria to be met to demonstrate “proof-of-concept” for such Compounds in the target patient populations, (iii) indications for which each
Compound is to be developed (which determination may include adjustments to the respective responsibilities of the Parties, and corresponding financial arrangements between the Parties, with respect to such indication(s)), and (iv) other
development criteria to be met for continued development; 

  
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 3.2.7 determine which pre-clinical studies, clinical trials, and toxicology
studies are necessary or desirable to meet the requirements of the applicable Regulatory Authorities for the Registration of the Products in the countries of interest in the Territory; 

3.2.8 review, approve and determine ownership of all INDs, Registration Applications, Registrations and other regulatory
filings and approvals for the Compounds and Products on a Compound/Product by Compound/Product basis: 
 3.2.9
evaluate data on all Compounds and Products under development; 
 3.2.10 review and approve activities related
to manufacturing and the identification of manufacturer(s) in connection with the development and commercialization of Compounds and Products; 
 3.2.11 select and determine ownership of the trademarks, trade names and logos under which each Product shall be marketed and sold in each country in the Territory; 

3.2.12 decide whether and how to institute Infringement actions against Third Parties based on any Compound or Product
being developed or commercialized by the Parties under this Agreement; 
 3.2.13 review and approve
“go/no-go” decisions and recommendations; and 
 3.2.14 perform such other responsibilities as may be
assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time. 
 3.3 Meetings. The first meeting of the JDC shall be held promptly, and in no case later than thirty (30) days, after the Effective Date, to establish procedures and review proposed compound
candidates for joint development under this Agreement. The Parties acknowledge that the JDC shall identify within six (6) months of the Effective Date the first two (2) of the six (6) Compounds the Parties intend to jointly develop
under the Development Program with the intention of having two new (2) Compounds identified for development in each of the three (3) years of the Term. It is the current expectation of the Parties that several of the six (6) Compounds
selected shall utilize the Enzon Technology, and several shall utilize the SkyePharma Technology. However, final identification and selection of each Compound shall be made by unanimous consent of the JDC, or mutual consent of the Executive Officers
of the Parties as provided in Section 3.5, but shall not be made by further dispute resolution pursuant to Section 3.5 (as both Parties must agree to the selection of any Compound), and in any event shall be subject to conflicts found in
any patent clearance investigations. While development activities under the Development Program are ongoing, the JDC shall meet in person at least once each calendar quarter, and more frequently as the Parties may deem appropriate, on such dates,
and at such places and times, as the Parties shall agree. Thereafter, the JDC shall meet, in person or otherwise, only on an ad hoc basis as needed to perform the responsibilities assigned to it under this Agreement. The members of the JDC may also
convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate. 

  
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 3.4 Cooperation of Parties for Selection of Compounds. Both Parties
shall cooperate to provide all available data and information to the JDC regarding potential compounds each Party has the right to offer for consideration for development under this Agreement. Each Party recognizes that the other Party has, as of
the Effective Date, and may have, during the term of the Development Program, arrangements with Third Parties relating to compounds and products that will prohibit such Party from offering such compounds and/or products for consideration for
development under this Agreement. For instance, and without limiting the generality of the foregoing, SkyePharma acknowledges that Enzon is prohibited from offering PEGylated interferon alpha (licensed to Schering-Plough Corp., Sobering Corp. and
their respective affiliates, successors, assigns, distributors, customers or licensees) and certain PEGylated compounds for which Inhale Therapeutics has a license. The Parties acknowledge and agree that neither Party shall provide any data or
information relating to any such prohibited compounds and/or products to the other Party pursuant to this Agreement, and no rights are granted to the other Party under this Agreement with respect to any such prohibited compounds and/or products.

 3.5 Decision-making. Except as otherwise provided herein, decisions of the JDC shall be made by
consensus, with each Party having collectively one (1) vote in all decisions. In the event that the JDC is unable to reach a consensus decision within fifteen (15) days after it has met and attempted to reach such decision, then either
Party may, by written notice to the other, have such issue referred to Executive Officers for resolution. The Executive Officers shall meet promptly to discuss the matter submitted and to determine a resolution. If the Executive Officers are unable
to determine a resolution in a timely manner, which shall in no case be more than thirty (30) days after the matter was referred to them, the issue shall be conclusively settled in accordance with the Special Arbitration Provisions set forth in
Section 13.14.2; provided that, with respect to decisions regarding the selection of Compounds pursuant to Section 3.3 and any determination of the JDC to be made pursuant to Section 2.5.6, disputes shall not be referred to the
Special Arbitration Provisions. If the JDC or the Executive Officers cannot agree on such decisions, any such compound shall not be selected as a Compound, or no such determination shall be deemed to have been made, as the case may be. For all
purposes under this Agreement, any decision made pursuant to this Section 3.5, whether by the JDC, the Executive Officers, or an Expert, shall be deemed to be the decision of the Joint Development Committee. 

3.6 Minutes. With the sole exception of specific items of the JDC meeting minutes to which the chairperson and the
secretary cannot agree and which are escalated as provided in Section 3.5, definitive minutes of all meetings of the IDC shall be finalized no later than thirty (30) days after the meeting to which the minutes pertain, as follows:

 3.6.1 Within ten (10) days after each meeting, the secretary of the JDC shall prepare and distribute to
all members of the JDC draft minutes of the meeting. Such minutes shall provide a description, in reasonable detail, of the discussions at the meeting and a list of any actions, decisions or determinations approved by the JDC and a list of any
issues to be resolved under the Special Arbitration Provisions. 
 3.6.2 The chairperson of the JDC shall then
have ten (10) days after receiving such draft minutes to collect comments thereon from the members of the JDC and provide them to the secretary. 

  
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 3.6.3 Upon the expiration of such second ten (10)-day period, the
chairperson and the secretary shall have an additional ten (10) days to discuss each other’s comments and finalize the minutes. The secretary and chairperson shall each sign and date the final minutes. The signature of the chairperson and
the secretary of the JDC upon the final minutes shall indicate each Party’s assent to the minutes. 
 3.6.4
If at any time during the preparation and finalization of JDC meeting minutes, the secretary and the chairperson do not agree on any issue with respect to the minutes, such issue shall be resolved by the Executive Officers. The decision resulting
from the escalation process shall be recorded by such secretary in amended finalized minutes for said meeting. 

3.7 Subcommittee(s). From time to time, the JDC may establish subcommittees to oversee particular projects or
activities, as it deems necessary or advisable (each, a “Subcommittee”). Each Subcommittee shall consist of such number of members of each Party as the JDC determines is appropriate from time to time. Such members shall be
individuals with expertise and responsibilities in the areas of preclinical development, clinical development, intellectual property, process sciences, manufacturing, regulatory affairs, product development and/or product commercialization, as
applicable to the stage of development of the applicable Compound(s) or Product(s). Each Subcommittee shall meet with such frequency as the JDC shall determine. Each Subcommittee shall operate by consensus, and each Party shall have collectively one
(1) vote in all decisions. If, with respect to a mailer that is subject to a Subcommittee’s decision-making authority, the Subcommittee cannot reach consensus within fifteen (15) days after it has met and attempted to reach such
consensus, the matter shall be referred to the JDC, which shall resolve such matter in accordance with Section 3.5. 
 3.8 Term. The JDC shall exist throughout the term of this Agreement. 
 3.9 Expenses. Each Party shall be responsible for all travel and related costs and expenses for its members and approved invitees to attend meetings of, and otherwise participate on, the JDC or any
Subcommittee. 
 4. FEES, MILESTONES, AND FUNDING. 

4.1 Up-front Payments. In consideration for access to and use of the Enzon Technology pursuant to this Agreement,
SkyePharma shall pay a non-refundable, non-creditable up-front payment of [**] U.S. Dollars (US$[**]) to Enzon upon the execution of this Agreement by both Parties. 

4.2 Milestone Payments. As consideration to SkyePharma for the license and other rights granted to Enzon under
this Agreement, Enzon shall, upon the commencement under this Agreement of Phase II Clinical Trials for any Products incorporating SkyePharma Technology, pay a non-refundable, non-creditable milestone payment of [**] U.S. Dollars ($[**]) to
SkyePharma. 
 4.3 Funding of Development Program. Pursuant to the Financial Appendix, each of the
Parties shall pay the Development Costs as follows: 
 4.3.1 Each Party shall fund [**] percent ([**]%) of the
Development Costs actually incurred by either Party in undertaking the Early Stage Development Activities for each Compound. 

  
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 4.3.2 Within thirty (30) days after the completion of the Early Stage
Development Activities for each Compound (including the receipt of all results therefrom), the Parties shall meet to discuss: (i) estimated costs and overall development plans if such Compound were to be further developed under the Development
Program as a Product through completion of the Proof of Concept Activities; and (ii) their respective desires to continue to fund [**] percent ([**]%) of the Development Costs for the Proof of Concept Activities. Within twenty (20) days
after such meeting, the JDC shall meet to determine if the Parties shall continue the development of the Compound as a Product under the Development Program and fund, on [**], [**]/[**] ([**]), basis the Development Costs of same. If either Party
elects not to proceed, this Agreement shall be deemed to be terminated by mutual consent as to such Compound and the termination effects set forth in Section 4.5 shall become effective upon such termination. If both Parties elect to proceed,
each Party shall fund [**] percent ([**]%) of the Development Costs actually incurred by either Party in undertaking the Proof of Concept Activities for such Compound. If only one Party wishes to proceed with the development of such Compound, the
Parties shall, pursuant to Section 4.4, negotiate in good faith in order to reach a mutually acceptable agreement pursuant to which such Party would become the Sole Developing Party for such Compound. 

4.3.3 Within thirty (30) days after the completion of the Proof of Concept Activities for each Product (including
the receipt of all results therefrom), the Parties shall meet to discuss: (i) estimated costs and overall development plans if such Product were to be further developed under the Development Program through completion of the Registration
Activities and into commercialization, if appropriate; and (ii) their respective desires to continue to fund [**]% of the Development Costs for such Registration Activities. Within twenty (20) days after such meeting, the JDC shall meet to
determine if the Parties shall continue the Development of the Product under the Development Program and fund, on [**], [**]/[**] ([**]/[**]), basis the Development Costs of same. If either Party elects not to proceed, this Agreement shall be deemed
to be terminated by mutual consent as to such Product and the termination effects set forth in Section 4.5 shall become effective upon such termination. If both Parties elect to proceed, each Party shall fund [**] percent ([**]%) of the
Development Costs actually incurred by either Party in undertaking such Registration Activities and the Parties shall share, in accordance with the Financial Appendix, the Operating Profit or Loss associated with the commercialization of such
Product(s). If only one Party wishes to proceed with the development of such Product, that Parties shall, pursuant to Section 4.4, negotiate in good faith in order to reach a mutually acceptable agreement pursuant to which such Party would
become the Sole Developing Party for such Product. 
 4.3.4 In the event the Registration Activities fail to
result in a Registration for a Product, the Parties shall consider, in good faith, undertaking additional Phase III Clinical Trials for such Product and the provisions of Section 4.3.3 shall apply to the Parties’ decisions regarding
whether and how to proceed with such additional Phase III Clinical Trials. 

  
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 4.3.5 Development Costs actually incurred by either Party under Sections
4.3.1, 4.3.2 or 4.3.3 that are more than [**] percent ([**]%) in excess of the Annual Operating Plan and Budget applicable to such Party’s expenditures shall not be shared by the Parties unless and to the extent such excess Development Costs
are expressly approved in writing by the other Party. 
 4.4 Sole Developing Party; Royalties. In the
event one Party (a “Sole Developing Party”), but not the other Party, desires to continue the development and commercialization of a Compound and/or Product in the Field following the termination of the Development Program with
respect to same as set forth in Sections 4.3.2 or 4.3.3, the Parties shall negotiate in good faith in order to reach a mutually acceptable agreement regarding licensing the intellectual property rights to such Compound and/or Product to the Sole
Developing Party (including possible retention of certain rights by the other Party), and the transfer to the Sole Developing Party of Know-how and other relevant data, as well as any INDs and other regulatory filings, pertaining to such Compounds
and Products, as the case may be, to enable the Sole Developing Party to continue such development and commercialization efforts (each such agreement, a “Transfer Agreement”). Each such Transfer Agreement shall provide that the Sole
Developing Party shall: (i) be solely responsible for, in its sole discretion, and shall have the exclusive right to engage in, all activities relating to the further development and commercialization of such Compound or Product, in the Field,
throughout the Territory; and (ii) pay to the other Party royalties on Net Sales of the Compound(s) and/or Product(s) for which it is a Sole Developing Party and appropriate development milestone payments payable and sharing of Sublicensing
Income with respect to such Compound(s) and/or Product(s) based upon the application of the following factors: (1) the then current market practices for pharmaceutical products of similar commercial promise; (2) the relative financial
contributions of the Parties to the development and commercialization of such Compound or Product; (3) the market potential of such Compound or Product; and (4) the apparent risks of going forward with development and commercialization.

 4.5 Termination of Development. In the event neither Party desires to proceed with the continued
development of a Compound or Product pursuant to Sections 4.4: (i) each Party shall at its own expense promptly return to the other Party all relevant records and materials in its possession or control containing Confidential Information of the
other Party (provided that such Party may keep one copy of such Confidential Information of the other Party for archival purposes only); and (ii) the licenses granted under Sections 6.1 and 6.2, including any sublicenses thereunder,
shall terminate with respect to such Compound and all Products which contain such Compound. 
 5. PAYMENTS AND REPORTS. 

5.1 Payments. Payments to be made in connection with sharing of Development Costs and sharing of Operating Profit
and Loss shall be made in accordance with the Financial Appendix. All other payments to be made under this Agreement shall be made in accordance with the terms set forth in the applicable Section(s) regarding such payments. 

5.2 Mode of Payment. Each Party shall make all payments required under this Agreement in U.S. Dollars, via wire
transfer of immediately available funds as directed by the other Party from time to time, net of any out-of-pocket transfer costs or fees, in accordance with the provisions of this Section 5 and the Financial Appendix. 

  
 - 15 -

 5.3 Records Retention. The Parties shall keep complete and accurate
records pertaining to the development and the sale of Products including, but not limited to, all Development Costs and, if relevant, to the calculation of Operating Profit or Loss, for a period of seven (7) calendar years after the year in
which such sales or costs are actually incurred, and in sufficient detail to permit the other Party to confirm the accuracy of the Development Cost calculations and aggregate royalty and/or Operating Profit or Loss calculations hereunder.

 5.4 Audits. 
 5.4.1 At the request and expense of either Party (“Auditing Party”), the other Party (“Audited Party”) shall permit an independent, certified public accountant appointed
by the Auditing Party and reasonably acceptable to the Audited Party, at reasonable times and upon reasonable written notice, to examine such records as may be necessary to: (i) determine the correctness of any report or payment made under this
Agreement; or (ii) obtain information as to the Development Cost calculations, all other calculations governed by the Financial Appendix and aggregate Operating Profit or Loss and/or royalties payable for any calendar quarter in the case of
either Party’s failure to report or pay pursuant to this Agreement; provided, however, that such accountant shall sign a confidentiality agreement in a form reasonably satisfactory to the Audited Party, and, provided
further, that such examination shall not be permitted more than once in any twelve (12)-month period. Said accountant shall not disclose to the Auditing Party or any other person any information, except that such accountant may disclose to the
Auditing Party the fact of a deficiency, the lack of a deficiency or any overpayment, and the degree thereof, including the dollar amount. All results of any such examination shall be made available to the Audited Party. 

5.4.2 In the event that any audit reveals an over- or under- payment in the amount that should have been paid by one
Party to the other, then the over- or under- payment amount shall be paid within forty-five (45) days after a Party makes a demand therefor, plus interest thereon if such amount is in excess of [**] percent ([**]%) of the amount that actually
should have been paid. Such interest shall be calculated from the date such amount was due until the date such amount is actually paid, at the rate of [**] percent ([**]%) over the prime rate of interest reported in the East Coast edition of The
Wall Street Journal for the date such amount was due. In addition, in the event of underpayment, if the underpaid amount is in excess of [**] percent ([**]%) of the amount that actually should have been paid, then the paying Party shall
reimburse the party due payment for the reasonable cost of such audit. 
 5.5 Taxes. In the event that a
Party is mandated under the laws of a country to withhold any tax to the tax or revenue authorities in such country in connection with any payment to the other Party, such amount shall be deducted from the payment to be made by such withholding
Party, provided that the withholding Party shall take reasonable and lawful actions to avoid and minimize such withholding and promptly notify the other Party so that the other Party may take lawful actions to avoid and minimize such
withholding. The withholding Party shall promptly furnish the other Party with copies of any tax certificate or other documentation evidencing such withholding as necessary to satisfy the requirements of the United States

  
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Internal Revenue Service related to any application by such other Party for foreign tax credit for such payment. Each Party agrees to cooperate with the other Party in claiming exemptions from
such deductions or withholdings under any agreement or treaty from time to time in effect. 
 6. GRANT OF RIGHTS; RESTRICTIONS;
OWNERSHIP; PATENTS. 
 6.1 License Grant to Enzon. Subject to the terms and conditions of this Agreement:

 6.1.1 SkyePharma hereby grants to Enzon during the term of this Agreement: (i) a non-exclusive license
under the SkyePharma Technology, (ii) a non-exclusive license under SkyePharma’s rights in any Inventions to the extent relating to the SkyePharma Technology, (iii) a co-exclusive license under the SkyePharma Compound IP, and
(iv) a co-exclusive license under SkyePharma’s rights in any Inventions to the extent relating to the SkyePharma Compound IP or any Compound or any Product; in each case, the preceding licenses extend solely to the Compounds and Products
identified and selected as provided in Sections 2.1 and 2.2, to enable Enzon to perform its obligations under the Development Program for such Compounds and Products and to commercialize any Products hereunder; and 

6.1.2 Except as expressly set forth in this Agreement, no license is granted by SkyePharma under its rights in any
Patents or Know-how whatsoever for any activities by Enzon that are outside the scope of the license grant in Section 6.1.1. 
 6.2 License Grant to SkyePharma. Subject to the terms and conditions of this Agreement: 
 6.2.1 Enzon hereby grants to SkyePharrna during the term of this Agreement: (i) a non-exclusive license under the Enzon Technology, (ii) a non-exclusive license under Enzon’s rights in any
Inventions to the extent relating to the Enzon Technology, (iii) a co-exclusive license under the Enzon Compound IP, and (iv) a co-exclusive license under Enzon’s rights in any Inventions to the extent relating to the Enzon Compound
IP or any Compound or any Product; in each case, the preceding licenses extend solely to the Compounds and Products identified and selected as provided in Sections 2.1 and 2.2, solely to enable SkyePharma to perform its obligations under the
Development Program for such Compounds and Products and to commercialize any Products hereunder; and 
 6.2.2
Except as expressly set forth in this Agreement, no license is granted by Enzon under its rights in any Patents or Know-how whatsoever for any activities by SkyePharma that are outside the scope of the license grant in Section 6.2.1.

 6.3 Sublicensing. Neither Party shall have the right to grant any sublicensee under the rights and
licenses granted to it under this Section 6 without first obtaining the written consent of the granting Party, which consent shall not be unreasonably withheld or delayed; provided that any sublicense granted under this Agreement shall
provide that: (i) the Party granting the sublicense shall guarantee and be responsible for the making of all payments due, and the making of any reports under this Agreement, with respect to sales of Products by its Affiliates or Sublicensees
and their compliance with all applicable terms of this Agreement; (ii) each Affiliate or Sublicensee agrees in writing to maintain financial and scientific books and records and permit the Parties to review such books and records and to visit
such Affiliate’s or Sublicensee’s 

  
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facilities pursuant to the relevant provisions of pursuant to the relevant provisions, and to observe all other applicable terms, of this Agreement; and (iii) in the event of a breach by
such an Affiliate or Sublicensee in the observance of applicable terms of this Agreement, each Party shall be entitled to proceed against either such Affiliate or Sublicensee or directly against the other Party, as such Party may determine in its
sole discretion, to enforce this Agreement. 
 6.4 Restriction on Activities. Each of the Parties
acknowledge and agree that except as expressly permitted under this Agreement, neither Party nor their respective Affiliates or Sublicensees shall work with any Third Party on the Compounds and Products that are then subject to development or
commercialization activities under this Agreement. 
 6.5 Ownership. 

6.5.1 The Parties shall own all INDs, Registration Applications, Registrations and other regulatory filings and approvals
for the Compounds and Products as determined by the JDC in accordance with Section 3.2.8; provided, however, in the event one Party desires to become a Sole Developing Party for a Compound and/or Product, the Parties shall, as set
forth in Section 4.4, and as may be necessary, enter into good faith negotiations regarding the transfer of ownership of the INDs, Registration Applications, Registrations and other regulatory filings and approvals which pertain to such
Compound and/or Product, taking into consideration what other Compounds, Products, development, and commercialization plans would be impacted by a change in ownership. 

6.5.2 Subject to the licenses granted to Enzon pursuant to Section 6.1, SkyePharma shall retain all right, title and
interest in and to the SkyePharma Technology and SkyePharma Compound IP. 
 6.5.3 Subject to the licenses
granted to SkyePharma pursuant to Section 6.2, Enzon shall retain all right, title and interest in and to the Enzon Technology and the Enzon Compound IP. 
 6.5.4 SkyePharma shall solely own all Inventions to the extent any such Invention is dominated by any Patent included in the SkyePharma Technology or SkyePharma Compound IP, regardless of which Party made
such Inventions. Enzon shall solely own all Inventions, to the extent any such Invention is dominated by any Patent included in the Enzon Technology or the Enzon Compound IP, regardless of which Party made such Inventions. All other Inventions
relating to both the SkyePharmna Technology and/or the SkyePharma Compound IP, on the one hand, and the Enzon Technology and/or the Enzon Compound IP, on the other hand, shall be owned jointly by the Parties, regardless of which Party made such
other Inventions. To the extent ownership of Inventions is not assigned by any of the foregoing sentences: (i) Inventions made solely by employees or contractors of SkyePharma shall be owned solely by SkyePharma, (ii) Inventions made
solely by employees or contractors of Enzon shall be owned solely by Enzon, and (iii) Inventions made jointly by employees or contractors of both Parties shall be owned jointly by the Parties. Each Party shall have the right to exploit any
jointly owned Inventions, to the extent it can do so without infringing on the other Party’s other intellectual property, without compensation, liability or other obligation (including without limitation accounting obligations) to the other
Party. 

  
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 6.5.5 ownership of the trademarks, trade names and logos each Product shall
be marketed and sold under in each country in the Territory shall be determined by the JDC pursuant to Section 3.2.11. 
 6.6 Patent Prosecution and Maintenance. 
 6.6.1 Each Party
shall have full responsibility for, and shall control the preparation and prosecution of all patent applications and the maintenance of all patents relating to the Inventions owned solely by it (including the Patents) throughout the Territory. Each
Party shall pay all costs and expenses of filing, prosecuting and maintaining such patent applications and patents relating to Inventions owned by it. 
 6.6.2 Each Party agrees promptly to provide to the other Party with a complete written disclosure of any Invention made by such Party. SkyePharma shall determine whether any Invention owned solely by it
is patentable, and if so, shall, in its sole discretion, determine whether or not to proceed with the preparation and prosecution of a patent application covering any such Invention. Enzon shall determine whether any Invention owned solely by it is
patentable, and if so, shall, in its sole discretion, determine whether or not to proceed with the preparation and prosecution of a patent application covering any such Invention. If either Party determines not to file an application on an Invention
so disclosed or to abandon an application that has been filed, it shall promptly and timely so notify the other Party. The other Party may at its option pursue such Invention by an application it files or by continued pursuit of an existing
application at its own expense. The non-filing or abandoning Party shall assign all its rights to the Invention and any related application to the filing or continuing Party but shall retain for itself and its Affiliates a covenant-not-to-sue
immunity under any Patent that issues from an Invention and/or application so assigned. 
 6.6.3 Each Party
shall select qualified patent counsel reasonably acceptable to the other Party to prepare and file and prosecute all patent applications such Party may, in its sole discretion, determine to be appropriate pursuant to Section 6.6. Each Party
shall promptly provide copies to the other Party of any filings made to, and any written communications received from, any patent office relating, in whole or in part, to such patent applications or patents granted thereon reasonably in advance of
the relevant proposed filing or response date. Each Party and the selected patent counsel shall give reasonable consideration to any comments that may be made by the other Party reasonably in advance of the relevant proposed filing or response date
relating to the filing and prosecution of such patent applications or the maintenance of patents granted thereon. 
 6.6.4 SkyePharma and Enzon shall together determine whether any Invention jointly owned by SkyePharma and Enzon is patentable. SkyePharma and Enzon shall share equally all costs and expenses of preparing,
filing, prosecuting and maintaining patent applications and patents relating to Inventions that are owned jointly by SkyePharma and Enzon. If either Party elects not to pay for: (i) the filing of a patent application in any country in the
Territory on any jointly owned Invention that the other Party reasonably believes is patentable, or (ii) the further prosecution or maintenance of any patent application or patent on any jointly owned Invention in any country in the Territory,
or (iii) the filing of any divisional or continuing patent application (based on a prior patent application or patent) on a jointly owned Invention in 

  
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any country in the Territory, such Party shall notify the other Party in writing in a timely manner and the other Party may do so at its own expense. In the event that the other Party elects to
proceed with any such filing or further prosecution or maintenance, the Party electing not to pay shall assign its rights in and to such patent or patent application in such country to the other Party, and all of such assigning Party’s rights
in such patent or patent application in such country shall cease. In the case where Enzon is the assigning Party, the license granted to Enzon under Section 6.1 with respect to such assigned patent or patent application (and any associated
sublicense(s)) shall terminate in such country. In the case where SkyePharma is the assigning Party, the license granted to SkyePharma under Section 6.2 with respect to such assigned patent or patent application (and any associated
sublicense(s)) shall terminate in such country. 
 6.6.5 Each Party agrees to cooperate with the other Party to
execute all lawful papers and instruments, to make all rightful oaths and declarations, and to provide consultation and assistance as may be necessary in the preparation, prosecution, maintenance and enforcement of all such patents. 

6.7 Patent Enforcement. 
 6.7.1 If either Party learns of an infringement, unauthorized use, misappropriation or ownership claim or threatened infringement or other such claim (an “Infringement”) by a Third Party
with respect to any Compound or Product within the Territory, such Party shall promptly notify the other Party in writing and shall promptly provide such other Party with available evidence of such Infringement. 

6.7.2 The JDC shall decide whether and how to institute Infringement actions against Third Parties based on such Compound
or Product within the Territory. The costs and expenses of any such action (including fees of attorneys and other professionals) and any award paid by Third Parties as a result of such an Infringement action (whether by way of settlement or
otherwise) shall be included in Operating Profit or Loss and shared between the Parties in accordance with the Financial Appendix. Each Party shall execute all necessary and proper documents and take such actions as shall be appropriate to allow the
other Party to institute and prosecute such Infringement actions. 
 6.8 Infringement Action by Third
Parties. 
 6.8.1 In the event of the institution or threatened institution of any suit by a Third Party
against either Party for patent infringement involving the sale, distribution or marketing of any Products in the Territory, the JDC shall meet to decide how the Parties shall respond to such suit. Each Party shall execute all necessary and proper
documents and take such actions as shall be appropriate to allow the other Party to defend such actions. The costs and expenses of any such action (including fees of attorneys and other professionals) and any award paid to Third Parties as a result
of such an infringement action (whether by way of settlement or otherwise) shall be included in Operating Profit or Loss and shared between the Parties in accordance with the Financial Appendix. 

6.8.2 In the event of the institution or threatened institution of any suit by a Third Party against either Party for
patent infringement involving the sale, distribution or 

  
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marketing of a Product in the Territory where such infringement claim is a result of the use of the SkyePharma Technology or the Enzon Technology, SkyePharma or Enzon, respectively as applicable
shall have the responsibility to defend such suit at its own expense and shall be responsible for all damages incurred as a result thereof. Each Party hereby agrees to assist and cooperate with the other, at the defending Party’s reasonable
request and expense, in the defense of any such suit. 
 7. ADVERSE REACTION REPORTING. 

7.1 Adverse Reaction Reporting. 

7.1.1 Each Party responsible for clinical trials shall, with respect to such trials, record, evaluate, summarize and
review all adverse drug experiences associated with the Compounds and the Products. In addition, supplemental information must be provided regarding Compounds at periodic intervals and adverse drug experiences must be reported at more frequent
intervals depending upon the severity of the experience. Consequently, each Party agrees to: 
 (a) in a timely
manner, provide to the other Party for initial and/or periodic submission to government agencies significant information on the Compound from preclinical laboratory, animal toxicology and pharmacology studies, as well as adverse drug experience
reports from clinical trials and commercial experiences with each Compound and/or Product; 
 (b) in connection
with investigational Compounds and/or Products, promptly report to the other Party the receipt of a report of any unexpected serious adverse drug experience with the Compound and/or Product, if required for either Party to comply with regulatory
requirements; and 
 (c) in connection with marketed Products, promptly report to the other Party any serious
adverse drug experience with the Product that is unexpected. 
 7.1.2 For purposes of this Agreement,
“Serious Adverse Drug Experience” means any adverse drug experience occurring 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. An unexpected adverse drug
experience is one that is not listed in the current labeling for the drug product. This includes events that may be symptomatically and pathophysiologically related to an event listed in the labeling, but differ from the event because of greater
severity or specificity. 
 7.1.3 Each Party shall promptly report to the other Party the information set forth
above affecting any of the Compounds or any of the Products in any country. 

  
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 7.1.4 Each Party agrees that if it contracts with a Third Party for research
to be performed by such Third Party on the drug, that Party agrees to require such Third Party to report to the contracting Party the information set forth above. 

7.1.5 The details of adverse drug experience reporting shall be stipulated in separate agreements to be entered into by
the Parties in due course. 
 7.1.6 Any information required pursuant to this Section 7.1 shall be deemed
to have been sufficiently given if in writing and personally delivered or sent by certified mail (return receipt requested), facsimile transmission (receipt verified), or overnight express courier service (signature required), prepaid, to the Party
for which such notice is intended, at the address set forth for such Party below: 
  

			
	 (a)
	    	 in the case of SkyePharma, to:

		
		    	 SkyePharma, Inc.

		    	 10450 Science Center Drive

		    	 San Diego, CA 92121

		    	 Attention: Dr. Gordon Schooley

		    	 Facsimile No.: (858) 623-0376

		    	 Telephone No.: (858) 625-2414

  

			
	 (b)
	    	 in the case of Enzon, to:

		
		    	 Enzon Pharmaceuticals, Inc.

		    	 685 Route 202/206

		    	 Bridgewater, New Jersey 08807

		    	 Attention: Anthony Killian

		    	 Facsimile No.: (732) 980-4638

		    	 Telephone No.: (732) 980-4523

 or to such other address for such Party as it shall have specified by like notice to the other Party, provided that notices of a change of address shall be effective only upon receipt thereof. If
delivered personally or by facsimile transmission, the date of delivery shall be deemed to be the date on which such notice or request was given. If sent by overnight express courier service, the date of delivery shall be deemed to be the next
business day after such notice or request was deposited with such service. If sent by certified mail, the date of delivery shall, be deemed to be the third business day after such notice or request was deposited with the U.S. Postal Service.

 8. REPRESENTATIONS AND WARRANTIES. 
 8.1 Representations and Warranties of Both Parties. Each Party represents and warrants to the other Party, as of the Effective Date, that: 

8.1.1 such Party is duly organized and validly existing under the laws of the jurisdiction of its incorporation and has
full corporate power and authority to enter into this Agreement and to carry out the provisions hereof; 

  
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 8.1.2 such Party is free to enter into this Agreement; 

8.1.3 in so doing, such Party will not violate any other agreement to which it is a party; 

8.1.4 such Party has taken all corporate action necessary to authorize the execution and delivery of this Agreement and
the performance of its obligations under this Agreement; and 
 8.1.5 such Party has the right to grant the
exclusive and non-exclusive licenses under its respective Patents and Know-how granted in this Agreement. 
 8.2
Representations and Warranties of SkyePharma. SkyePharma represents and warrants to Enzon, as of the Effective Date, that: 
 8.2.1 without having conducted any patent search or other investigation, SkyePharma is not aware of any valid claim or demand which leads it to believe that the Parties’ exercise of any rights to the
SkyePharma Technology or SkyePharma Compound IP as contemplated by this Agreement will infringe any patent or other intellectual property right of any Third Party; and 

8.2.2 other than as set forth in Section 8.2.1, SkyePharma hereby expressly disclaims any representation or warranty
as to the validity or enforceability of any Patents relating to the SkyePharma Technology or SkyePharma Compound IP, the non-infringement of any Third Party patent or other intellectual property right or the prospects or likelihood of development or
commercial success of any Compound or any Product. 
 8.3 Representations and Warranties of Enzon. Enzon
represents and warrants to SkyePharma, as of the Effective Date, that: 
 8.3.1 without having conducted any
patent search or other investigation, Enzon is not aware of any valid claim or demand which leads it to believe that the Parties’ exercise of any rights to the Enzon Technology or Enzon Compound IP as contemplated by this Agreement will
infringe any patent or other intellectual property right of any Third Party: and 
 8.3.2 other than as set
forth in Section 8.3.1, Enzon hereby expressly disclaims any representation or warranty as to the validity or enforceability of any Patents relating to the Enzon Technology or the Enzon Compound IP, the non-infringement of any Third Party
patent or other intellectual property right or the prospects or likelihood of development or commercial success of any Compound or any Product. 
 8.4 Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS SECTION 8, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND EACH PARTY EXPRESSLY
DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE OR USE. 

  
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 9. PUBLICATION; CONFIDENTIALITY. 

9.1 Notification and Review with Respect to SkyePharma and Enzon. 

9.1.1 Both Parties recognize that each may wish to publish the results of their work relating to the subject matter of
this Agreement. However, both Parties also recognize the importance of acquiring patent protection. Consequently, any proposed publication, by either Party (including its Affiliates and/or Sublicensees), that includes information related to the
Compounds or Products, or which otherwise includes proprietary information of the other Party or Confidential Information, shall comply with this Section 9. At least forty-five (45) days before a manuscript is to be submitted to a
publisher, the publishing Party shall provide the JDC with a copy of the manuscript. If the publishing Party wishes to make an oral presentation, it shall provide the JDC with a summary of such presentation at least fifteen (15) business days
before such oral presentation and, if an abstract is to be published, three business days before such abstract is to be submitted. Any oral presentation, including any question period, shall not include any Confidential Information unless both
Parties otherwise mutually agree in writing in advance of such oral presentation. 
 9.1.2 The JDC shall review
the manuscript, abstract, text or any other material provided under Section 9.1.1 to determine whether patentable subject matter is or may be disclosed. The JDC shall notify the publishing Party in writing within thirty (30) days (or two
(2) business days in the case of abstracts) of receipt of the proposed publication if it, in good faith, determines that patentable subject matter is or may be disclosed, or if the JDC, in good faith, believes Confidential Information (as
defined in Section 9.2) is or may be disclosed. To the extent solely determined by the JDC, that patent applications should be filed, the publishing Party shall delay its publication or presentation for a period not to exceed one hundred twenty
(120) days from the JDC’s receipt of the proposed publication or presentation to allow time for the filing of patent applications covering patentable subject matter. In the event that the delay needed to complete the filing of any
necessary patent application will exceed the one hundred twenty (120)-day period, the JDC will discuss the need for obtaining an extension of the publication delay beyond the one hundred twenty (120)-day period. If the JDC determines in good faith
that Confidential Information or proprietary information is or may be disclosed, the JDC will determine mutually acceptable modifications to the proposed publication or presentation to avoid such disclosure. 

9.1.3 Except as expressly provided in this Section 9, each Party agrees not to make any public announcement or
disclosure (including, without limitation, any press release, summary or Q&A) of the terms of this Agreement or the documents ancillary thereto, or the identity or potential applications of any Compound or Product, without first obtaining the
written approval of the other Party and agreement upon the nature and text of such public announcement or disclosure. On and after the Effective Date, either Party may issue a press release, the content of which will be agreed upon in advance by the
Parties, with respect to the execution of this Agreement and the documents ancillary thereto. The Party desiring to make any such public announcement shall provide the other Party with a copy of the proposed announcement for review and comment in
reasonably sufficient time prior to public release. 

  
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 9.1.4 Each Party agrees that it shall cooperate fully with the other with
respect to all disclosures regarding this Agreement and the documents ancillary thereto required under applicable laws and regulations to the United States Securities and Exchange Commission and any other comparable governmental or regulatory
agencies. 
 9.1.5 In addition, each Party agrees not to disclose., under any circumstances except as set forth
in this Section 9 or as otherwise required by law, the terms of this Agreement or the documents ancillary thereto, or the identity or potential applications of any Compound or Products, to any Third Party other than to professional advisors and
financing sources, and in that case, only under confidentiality terms at least as stringent in material respects as this Section 9. 
 9.2 Confidentiality; Exceptions. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing, the Parties agree that, during the term of this Agreement and
thereafter, the receiving Party shall keep, and shall ensure that its employees, officers and directors keep, completely confidential and shall not publish or otherwise disclose and shall not use for any purpose: (i) any information furnished
to it by the other Party or (ii) developed under or in connection with this Agreement by either Party; except in each of subclause (i) and (ii) to the extent that it can be established by the receiving Party by competent proof that
such information: (1) was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the other Party; (2) was generally available to the public or otherwise part of the public
domain at the time of its disclosure to the receiving Party; (3) became generally available to the public or was otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in
breach of this Agreement; or (4) was disclosed to the receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the disclosing Party not to disclose such information to others (all such
information to which none of the foregoing exceptions applies, “Confidential Information”). 

9.3 Exceptions to Obligation. The restrictions contained in Section 9.2 shall not apply to Confidential
Information that: (i) is submitted by the recipient to governmental authorities to facilitate the issuance of Registrations for the Products, provided that reasonable measures shall be taken to assure confidential treatment of such information;
(ii) is provided by the recipient to Third Parties under confidentiality agreements having provisions at least as stringent as those in this Agreement, for consulting, manufacturing development, manufacturing, external testing, marketing trials
and to Third Parties who are Sublicensees or other development/marketing partners hereunder with respect to any of the subject matter of this Agreement; (iii) is otherwise required to be disclosed in compliance with applicable laws or
regulations or order by a court or other regulatory body having competent jurisdiction; provided that if a Party is required to make any such disclosure of the other Party’s Confidential Information such Party will give reasonable
advance written notice to the other Party of such disclosure requirement and, except to the extent inappropriate in the case of patent applications, will use its best efforts to secure confidential treatment of such Confidential Information required
to be disclosed; or (iv) was developed by the receiving Party independent of any disclosure received under this Agreement. In addition, the restrictions contained in Section 9.2 shall not apply to SkyePharma or Enzon to the extent the
Confidential Information relates to any application of the SkyePharma Technology or Inventions solely owned by SkyePharma or the 

  
 - 25 -

 
Enzon Technology or Inventions solely owned by Enzon, as the case may be (i) outside the field or (ii) to any compounds or products other than those Compounds and Products then under
development or commercialization under this Agreement. 
 9.4 Limitations on Use. Each Party shall use
any Confidential Information obtained by such Party from the other Party, its Affiliates, or its Sublicensees, pursuant to this Agreement or otherwise, solely in connection with the activities or transactions contemplated hereby or expressly
permitted hereunder. 
 9.5 Remedies. Each Party shall be entitled, in addition to any other right or
remedy it may have, at law or in equity, to an injunction, without the posting of any bond or other security, enjoining or restraining the other Party from any violation or threatened violation of this Section 9. 

10. INDEMNIFICATION. 
 10.1 By SkyePharma. SkyePharma shall indemnify, defend and hold harmless Enzon and its Affiliates, and their respective directors, officers, employees and agents, from and against any and all
liabilities, damages, losses, costs and expenses (including the reasonable fees of attorneys and other professionals) for claims of any Third Party arising out of or resulting from: 

10.1.1 negligence or wrongful intentional acts or omissions of SkyePharma or its Affiliates or Sublicensees, and their
respective directors, officers, employees and agents, in connection with the activities contemplated under this Agreement; or 
 10.1.2 any warranty claims, Product recalls or any tort claims of personal injury (including death) or property damage relating to or arising out of any sale, offer for sale or importation of any Product
by SkyePharma to the extent due to any a Product manufactured by, or on behalf of, SkyePharma not meeting the specifications for such Product or which was not manufactured in accordance with cGMP, but only to the extent not due to the negligence or
wrongful intentional acts or omissions of Enzon or its Affiliates or Sublicensees, and their respective directors, officers, employees and agents; or 
 10.1.3 any claims relating to or arising out of the marketing or sales activities of SkyePharma or its Affiliates or its Sublicensees, but only to the extent not due to the negligence or wrongful
intentional acts or omissions of Enzon or its Affiliates or Sublicensees, and their respective directors, officers, employees and agents; or 
 10.1.4 any breach of any representation or warranty made by SkyePharma pursuant to Section 8. 
 10.2 By Enzon. Enzon shall indemnify, defend and hold harmless SkyePharma, its Affiliates and its Sublicensees, and their respective directors, officers, employees and agents, from and against any
and all liabilities, damages, losses, costs and expenses (including the reasonable fees of attorneys and other professionals) for claims of any Third Party arising out of or resulting from: 

10.2.1 negligence or wrongful intentional acts or omissions of Enzon or its Affiliates or Sublicensees, and their
respective directors, officers, employees and agents, in connection with the activities contemplated under this Agreement; or 

  
 - 26 -

 10.2.2 any warranty claims, Product recalls or any tort claims of personal
injury (including death) or property damage relating to or arising out of any sale, offer for sale or importation of any Product by Enzon to the extent due to any a Product manufactured by, or on behalf of, Enzon not meeting the specifications for
such Product or which was not manufactured in accordance with cGMP, but only to the extent not due to the negligence or wrongful intentional acts or omissions of SkyePharma or its Affiliates or Sublicensees, and their respective directors, officers,
employees and agents; or 
 10.2.3 any claims relating to or arising out of the marketing or sales activities of
Enzon or its Affiliates or its Sublicensees, but only to the extent not due to the negligence or wrongful intentional acts or omissions of SkyePharma or its Affiliates or Sublicensees, and their respective directors, officers, employees and agents;
or 
 10.2.4 any breach of any representation or warranty made by Enzon pursuant to Section 8. 

10.3 Jointly. In the event of a Third Party claim against either Party relating to or arising out of either
Party’s activities under this Agreement which is not covered under Section 10.1 or 10.2, the Parties agree to share all liabilities, damages, losses, costs and expenses (including the reasonable fees of attorneys and other professionals)
arising out of or resulting from such Third Party claim on [**], [**]/[**] ([**]/[**]), basis as set forth in the Financial Appendix. 
 10.4 Notice. In the event that any person (an “Indemnitee”) entitled to indemnification under Section 10.1 or 10.2 is seeking such indemnification, such Indemnitee shall inform the
indemnifying Party of the claim as soon as reasonably practicable after such Indemnitee receives notice of such claim, shall permit the indemnifying Party to assume direction and control of the defense of the claim (including the sole right to
settle it at the sole discretion of the indemnifying Party, provided that such settlement does not impose any obligation on the Indemnitee or the other Party) and shall cooperate as requested (at the expense of the indemnifying Party) in the defense
of the claim. 
 10.5 Complete Indemnification. As the Parties intend complete indemnification, all costs
and expenses, including without limitation, legal fees and expenses, actually incurred by an Indemnitee in connection with enforcement of Sections 10.1 and 10.2 shall also be reimbursed by the indemnifying Party. 

11. TERM; TERMINATION. 
 11.1 Term. This Agreement shall become effective as of the Effective Date and, unless earlier terminated pursuant to the other provisions of this Section 11.1 shall expire as follows:

 11.1.1 with respect to each Product, on a Product-by-Product, country-by-country basis, upon the expiration
of the last to expire of all patents covering such Product in each country within the Territory; and 

  
 - 27 -

 11.1.2 in its entirety upon the expiration of this Agreement with respect to
all Products in all countries in the Territory. 
 11.2 Termination for Cause. Either Party (the
“Non-breaching Party”) may, without prejudice to any other remedies available to it at law or in equity with respect to any Compound or Product, in the event the other Party (the “Breaching Party”) shall have
materially breached or defaulted in the performance of any of its material obligations hereunder with respect to such Compound or Product and such breach or default shall have continued for sixty (60) days after written notice thereof was
provided to the Breaching Party by the Non-breaching Party (or, if such breach or default cannot be cured within such sixty (60)-day period, if the Breaching Party does not commence and diligently continue actions to cure such breach or default
during such sixty (60) day period). In addition, if a breach or default or group of related breaches or defaults by a Breaching Party within the preceding sentence also materially affects the entirety of this Agreement, and such breach or
default or group of related breaches or defaults shall have continued for sixty (60) days after written notice thereof was provided to the Breaching Party by the Non-breaching Party (or, if such breach(es) or default(s) cannot be cured within
such sixty (60)-day period, if the Breaching Party does not commence and diligently continue actions to cure such noticed breach(es) or default(s) during such sixty (60)-day period), the Non-breaching Party may, without prejudice to any other
remedies available to it at law or in equity with respect to any Compound or Product, terminate this Agreement in its entirety. Any such termination under this Section shall become effective at the end of such sixty (60)-day period unless the
Breaching Party has cured any such noticed breach(es) or default(s) prior to the expiration of such sixty (60)-day period (or, if such breach(es) or default(s) cannot be cured within such sixty (60)-day period, if the Breaching Party has commenced
and diligently continued actions to cure such breach(es) or default(s)). The right of either party to terminate this Agreement as provided in this Section 11.2 shall not be affected in any way by its waiver or failure to take action with
respect to any previous breach or default. 
 11.3 Termination for Insolvency. 

11.3.1 Either Party may terminate this Agreement, if, at any time, the other Party shall file in any court or agency
pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of the Party or of substantially all of its assets, or
if the other Party proposes a written agreement of composition or extension of substantially all of its debts, or if the other Party shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall
not be dismissed within sixty (60) days after the filing thereof, or if the other Party shall propose or be a party to any dissolution or liquidation, or if the other Party shall make an assignment of substantially all of its assets for the
benefit of creditors. 
 11.3.2 All rights and licenses granted under or pursuant to any section of this
Agreement are and shall otherwise be deemed to be for purposes of Section 365(n) of Title 11, United States Code (the “Bankruptcy Code”) licenses of rights to “intellectual property” as 

  
 - 28 -

 defined in Section 101(56) of the Bankruptcy Code. The Parties shall retain and may
fully exercise all of their respective rights and elections under the Bankruptcy Code. Upon the bankruptcy of any Party, the non-bankrupt Party shall further be entitled to a complete duplicate of, or complete access to, any such intellectual
property, and such, if not already in its possession, shall be promptly delivered to the non-bankrupt Party, unless the bankrupt Party elects to continue, and continues, to perform all of its obligations under this Agreement. 

11.4 Termination for Inactivity. 

11.4.1 Either Party may terminate this Agreement as to a particular Compound or Product, effective upon thirty
(30) days prior written notice, if, for a period of [**] ([**]) consecutive months there is no Development Program activity for such Compound and/or Product or, for a Product at the commercialization stage, such Product is not being
commercialized and/or marketed due to lack of Party activity; provided that in the event prior to the expiration of such thirty (30)-day period the Parties agree to resume development or commercialization activities hereunder or the Parties
negotiate a mutually acceptable agreement for one Party to become a Sole Developing Party under Section 4.4, any such termination notice shall be without force or effect. 

11.4.2 Either Party may terminate this Agreement, in its entirety, effective upon thirty (30) days prior written
notice, if, for a period of [**] ([**]) consecutive months no Compounds and/or Products are being developed under the Development Program and no Products are being commercialized and/or marketed by a Party hereunder; provided that in the
event the Parties agree to resume development or commercialization activities hereunder prior to the expiration of such thirty (30)-day period, any such termination notice shall be without force or effect. 

11.5 Effect of Expiration or Termination. 

11.5.1 Following the expiration of the term of this Agreement with respect to a Product in any country in the Territory
pursuant to Section 11.1, each Party shall have a non-exclusive, royalty-free, paid-up, perpetual, irrevocable and sublicensable right and license, to develop, make, have made, use, market, sell, have sold, offer to sell, import, distribute and
otherwise exploit such Product in the such country in the Territory. To that end, each Party may hold and use all data, reports, records, information and materials that relate to or are prepared in the course of the Development Program with respect
to such Product and may in its sole discretion continue any sublicense granted by it under this Agreement. 

11.5.2 If this Agreement is terminated by a Non-breaching Party with respect to particular Compound(s) and/or Product(s)
pursuant to Sections 11.2, in addition to any other remedies available to such Non-breaching Party at law or in equity: (i) at the Breaching Party’s expense, the Breaching Party shall promptly (1) transfer to the Non-breaching Party
all relevant data, reports, records and materials in the Breaching Party’s possession or control that relate to such Compound and/or Product; (2) provide the Non-breaching Party with all information necessary or desirable to
cross-reference and/or assume responsibility for any INDs, Registrations Applications, Registrations and other regulatory filings in the Breaching Party’s name with respect to such Compounds and/or Products; and (3) return to the
Non-breaching 

  
 - 29 -

 Party all relevant records and materials in such Breaching Party’s possession or
control containing Confidential Information of the Non-breaching Party relating to such Compound(s) and/or Product(s) (provided that the Breaching Party may keep one copy of such Confidential Information for archival purposes only);
(ii) to the extent the Breaching Party owns or holds any right, title and interest in any trademarks, trade names, and logos under which such Compound(s) and/or Product(s) have been or are being marketed or sold in the Territory, the Breaching
Party shall assign the same to the Non-breaching Party; (iii) the licenses granted under Section 6.1 or 6.2, as applicable, shall continue if full force, except that such licenses shall bear a royalty payable to the Breaching Party
in accordance with Section 11.5.4; and (iv) all sub-licenses granted by the Breaching Party under this Agreement shall continue in full force and effect in accordance with the terms and conditions of the respective sublicense agreements,
and the Breaching Party will assign to the Non-breaching Party those sublicense agreements to the extent relating to such Compound(s) and/or Product(s); provided, however, that this Section 11.4.2 shall not apply to any
Confidential Information, licenses and sublicenses to the extent relating to any Compound(s) and/or Product(s) for which there has not been a termination. 
 11.5.3 If this Agreement is terminated in its entirety or as to each Compound and Product by (i) a Non-breaching Party pursuant to Section 11.2; or (ii) a Party for the other’s
insolvency pursuant to Section 11.3 (either of subclause (i) or (ii), the “Terminating Party”), in addition to any other remedies available to the Terminating Party at law or in equity: (1) at the non-Terminating
Party’s expense, the non-Terminating Party shall promptly transfer to the Terminating Party (A) all relevant data, reports, records and materials in the non-Terminating Party’s possession or control that relate to the Development
Program; (B) provide the Terminating Party with all information necessary or desirable to cross-reference and/or assume responsibility for all INDs, Registrations Applications, Registrations and other regulatory filings in the non-Terminating
Party’s name with respect to all Compounds and/or Products; and (C) return to the Terminating Party all relevant records and materials in the non-Terminating Party’s possession or control containing Confidential Information of the
Terminating Party (provided that the non-Terminating Party may keep one copy of such Confidential Information for archival purposes only); (2) to the extent the non-Terminating Party owns or holds any right, title and interest in any
trademarks, trade names, and logos under which any Compounds or Products have been or are being marketed or sold in the Territory, the non-Terminating Party shall assign the same to the Terminating Party: (3) the licenses granted under
Section 6.1 or 6.2, as applicable, shall continue in full force, except that such license shall bear a royalty payable to the non-Terminating Party in accordance with Section 11.5,4; and (4) all sublicenses granted by the
non-Terminating Party under this Agreement shall continue in full force and effect in accordance with the terms and conditions of the respective sublicense agreements, and the non-Terminating Party will assign all such sublicense agreements to the
Terminating Party. 
 11.5.4 Each license grant continued pursuant to Sections 11.5.2 and 11.5.3 shall, on a
Product-by-Product basis, bear royalties on Net Sales of the Compound(s) and/or Product(s) that are subject to such termination and appropriate development milestone payments payable and sharing of Sublicensing Income with respect to such
Compound(s) and/or Product(s). Upon such a termination occurring, the Parties shall enter into good faith negotiations regarding: (i) the applicable royalty rate(s); (ii) the development milestone payments; and (iii) the sharing of
Sublicensing Income; in each case: (1) payable with respect to such Compound or Product; and (2) based upon the application of the following factors: (A) the then current market practices for

  
 - 30 -

 
pharmaceutical products of similar commercial promise; (B) the relative financial contributions of the Parties to the development and commercialization of such Compound or Product;
(C) the market potential of such Compound or Product; and (D) the apparent risks of going forward with development and commercialization; provided that the royalties, milestone payments, and sharing of Sublicensing Income shall each
be reduced by [**] ([**]) what each otherwise would have been after application of the foregoing factors. Such matters on which the Parties cannot reach consensus within thirty (30) days after such termination shall be conclusively settled in
accordance with the Special Arbitration Provisions in a manner consistent with the foregoing guidelines. 
 11.6
Accrued Rights; Surviving Obligations. 
 11.6.1 Termination, relinquishment or expiration of this
Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of either Party prior to such termination, relinquishment or expiration. Such termination, relinquishment or expiration shall not relieve either
Party from obligations that are expressly indicated to survive termination or expiration of this Agreement. 

11.6.2 All of the Parties’ rights and obligations under Sections 5.3, 5.4, 6.5, 6.7 6.8 (as to then pending actions)
7, 8, 9, 10, 11.5, 13.4 through and including 13.18 shall survive termination, relinquishment or expiration of this Agreement. 
 12. FORCE
MAJEURE. 
 Any delay in the performance of any of the duties or obligations of either Party hereto (except the
payment of money due hereunder) shall not be considered a breach of this Agreement, and the time required for performance shall be extended for a period equal to the period of such delay, if such delay has been caused by or is the result of acts of
God; acts of public enemy; insurrections; riots; injunctions; embargoes; labor disputes, including strikes, lockouts, job actions, or boycotts; fires; explosions; earthquakes; floods; shortages of energy; governmental prohibition or restriction; or
other unforeseeable causes beyond the reasonable control and without the fault or negligence of the Party so affected. The Party so affected shall give prompt notice to the other Party of such cause, and shall take whatever reasonable steps are
necessary to relieve the effect of such cause as rapidly as reasonably possible. 
 13. MISCELLANEOUS. 

13.1 Relationship of Parties. Nothing in this Agreement is intended or shall be deemed to constitute a partnership,
agency, employer-employee or joint venture relationship between the Parties. No Party shall incur any debts or make any commitments for the other, except to the extent, if at all, specifically provided herein. 

13.2 Assignment. Except pursuant to a sub-license permitted under this Agreement, neither Party shall be entitled
to assign its rights or delegate its obligations hereunder without the express written consent of the other Party hereto, except that each Party may assign its rights and transfer its duties hereunder to any assignee of all or substantially all of
its business (or that portion thereof to which this Agreement relates) or in the event of such Party’s merger, consolidation or involvement in a similar transaction. No assignment and transfer shall be valid

  
 - 31 -

 
or effective unless done in accordance with this Section 13.2 and unless and until the assignee/transferee shall agree in writing to be bound by the provisions of this Agreement. 

13.3 Affiliates of SkyePharma. Parent shall cause the applicable Affiliates of SkyePharma to grant such rights to
SkyePharma and to take such actions as are necessary for SkyePharma to fulfill its obligations under this Agreement, 
 13.4 Books and Records. Any books and records to be maintained under this Agreement by a Party shall be maintained in accordance with GAAP. 

13.5 Further Actions. Each Party shall execute, acknowledge and deliver such further instruments, and do all such
other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement. 

13.6 Notice. 
 13.6.1 Any notice or request required or permitted to be given under or in connection with this Agreement shall be deemed to have been sufficiently given if in writing and personally delivered or sent by
certified mail (return receipt requested), facsimile transmission (receipt verified), or overnight express courier service (signature required), prepaid, to the Party for which such notice is intended, at the address set forth for such Party below:

  

			
	 (a)
	    	 in the case of SkyePharma, to:

		
		    	 SkyePharma, Inc.

		    	 10450 Science Center Drive
 San Diego, CA 92121
 Attention: Steve Thornton

		    	 Facsimile No.: (858) 623-0376

		
	 (b)
	    	 in the case of Enzon, to:

		
		    	 Enzon Pharmaceuticals, Inc.

		    	 685 Route 202/206
 Bridgewater, New Jersey 08807

		    	 Attention: Peter Cicala

		    	 Facsimile No.: (908) 541-8838

 or to such other address for such Party as it shall have specified by like notice to the other Party, provided that notices of a change of address shall be effective only upon receipt thereof. With
respect to notices given pursuant to this Section 13.6.1: (i) if delivered personally or by facsimile transmission, the date of delivery shall be deemed to be the date on which such notice or request was given; (ii) if sent by
overnight express courier service, the date of delivery shall be deemed to be the next business day after such notice or request was deposited with such service; and (iii) if sent by certified mail, the date of delivery shall be deemed to he
the third business day after such notice or request was deposited with the U.S. Postal Service. 

  
 - 32 -

 13.6.2 All correspondence, notices and other communications received by a
Party from a Regulatory Authority in the Territory relating to the parties activities under this Agreement shall be promptly provided to the other Party. 
 13.7 Use of Name. Except as otherwise provided herein, neither Party shall have any right, express or implied, to use in any manner the name or other designation of the other Party or any other
trade name, trademark or logo of the other Party for any purpose in connection with the performance of this Agreement. 
 13.8 Public Announcements. Except as required by law (including, without limitation, disclosure requirements of the U.S. Securities and Exchange Commission, Nasdaq or any other stock exchange on
which securities issued by a Party are traded) and as permitted by Section 9.1.3 or 9.1.4, neither Party shall make any public announcement concerning this Agreement or the subject matter hereof without the prior written consent of the other,
which shall not be unreasonably withheld, provided that it shall not be unreasonable for a Party to withhold consent with respect to any public announcement containing any financial terms or any of such Party’s Confidential Information. In the
event of a required public announcement, to the extent practicable under the circumstances, the Party making such announcement shall provide the other Party with a copy of the proposed text prior to such announcement and with financial terms
sufficiently in advance of the scheduled release of such announcement to afford such other Party a reasonable opportunity to review and comment upon the proposed text. 

13.9 Waiver. A waiver by either Party of any of the terms and conditions of this Agreement in any instance shall
not be deemed or construed to be a waiver of such term or condition for the future, or of any subsequent breach hereof. All rights, remedies, undertakings, obligations and agreements contained in this Agreement shall be cumulative and none of them
shall be in limitation of any other remedy, right, undertaking, obligation or agreement of either Party. 

13.10 Compliance with Law. Nothing in this Agreement shall be deemed to permit a Party to export, re-export or
otherwise transfer any Products sold under this Agreement without compliance with applicable laws. 
 13.11
Severability. When possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be prohibited by or invalid under applicable
law, such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement 
 13.12 Amendment. No amendment, modification or supplement of any provisions of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each
Party. 
 13.13 Governing Law. This Agreement shall be governed by and interpreted in accordance with the
laws of New York without regard to conflict of law principles. 

  
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 13.14 Arbitration. 

13.14.1 Except as expressly otherwise provided in this Agreement, any dispute arising out of or relating to the
interpretation of any provisions of this Agreement or the failure of any Party to perform or comply with any obligations or conditions applicable to such Party pursuant to this Agreement shall be finally settled by arbitration under the then current
commercial arbitration rules of the American Arbitration Association in accordance with the terms set forth in this Section 13.14.1: 
 (a) The place of arbitration of any dispute shall be New York, New York. Such arbitration shall be conducted by three (3) arbitrators, one (1) appointed by each of SkyePharma and Enzon and the
third (3rd) selected by the first two
(2) appointed arbitrators. Each arbitrator shall be a person with relevant experience in the pharmaceutical industry. SkyePharma and Enzon shall instruct such arbitrators to render a determination of any such dispute within four months after
the appointment of the third arbitrator. 
 (b) Any award rendered by the arbitrators shall be final and
binding upon the Parties. Judgment upon any award rendered may be entered in any court having jurisdiction, or application may be made to such court for a judicial acceptance of the award and an order of enforcement, as the case may be. Each Party
shall pay its own expenses of arbitration, and the expenses of the arbitrators shall be equally shared between the Parties unless the arbitrators assess as part of their award all or any part of the arbitration expenses of a Party or Parties
(including reasonable attorneys’ fees) against the other Party or Parties, as the case may be. 
 (c) This
Section 13.14.1 shall not prohibit a Party from seeking injunctive relief from a court of competent jurisdiction in the event of a breach or prospective breach of this Agreement by any other Party which would cause irreparable harm to the first
Party. 
 13.14.2 Whenever a dispute arising out of or relating to the interpretation of any provisions of this
Agreement or the failure of any Party to perform or comply with any obligations or conditions applicable to such Party pursuant to this Agreement arises or any other matter arising under or relating to this Agreement and such dispute is expressly
designated as one to be resolved through the Special Arbitration Provisions, then such dispute shall be finally settled by arbitration under the then current expedited procedures applicable to the then current commercial arbitration rules of the
American Arbitration Association in accordance with the terms set forth in this Section 13.14.2 (the “Special Arbitration Provisions”). The dispute in question shall be referred to the Executive Officers for resolution. The
Executive Officers shall use reasonable efforts to resolve the matter referred to them. If the Executive Officers cannot reach a mutually acceptable decision within thirty (30) days after the matter was referred to them, or such longer period
as the Executive Officers may collectively agree, then either Party shall have the right to refer such dispute to an Expert for expedited arbitration as set forth in Sections 13.14.2(a) through (c). 

(a) Upon written request by either Party to the other Party, the Parties shall promptly negotiate in good faith to
appoint a mutually acceptable independent person, with 

  
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scientific, technical and regulatory experience with respect to the development of pharmaceutical products in the same Field as the Compounds and/or Products in question necessary to resolve such
dispute (an “Expert”). If the Parties are not able to agree within five (5) business days after the receipt by a Party of the written request in the immediately preceding sentence, the American Arbitration Association shall be
responsible for selecting an Expert within ten (10) business days of being approached by a Party. The fees and costs of the Expert and the American Arbitration Association, if applicable, shall be shared equally by the Parties. The place of
arbitration of any dispute shall be New York, New York, unless the Parties agree otherwise or the selection of the Expert requires otherwise. 
 (b) Within five (5) business days after the designation of the Expert, the Parties shall each simultaneously submit to the Expert and one another a written statement of their respective positions on
such disagreement. Each Party shall have fifteen (15) business days from receipt of the other Party’s submission to submit to the Expert and the other Party a written response thereto, which shall include any scientific and technical
information in support thereof. The Expert shall have the night to meet with the Parties, either alone or together, as necessary to make a determination. 
 (c) No later than thirty (30) business days after the designation of the Expert, the Expert shall make a determination by selecting the resolution proposed by one (1) of the Parties that the
Expert deems as a whole to be the most fair and reasonable to the Parties in light of the totality of the circumstances. The Expert, shall provide the Parties with a written statement setting forth the basis of the determination in connection
therewith. The decision of the Expert shall be final and conclusive. 
 13.15 Entire Agreement. This
Agreement, together with the Exhibits hereto and every Annual Operating Plan and Budget, sets forth the entire agreement and understanding between the Parties as to the subject matter hereof and merges all prior discussions and negotiations between
them, and neither of the Parties shall be bound by any conditions, definitions, warranties, understandings or representations with respect to such subject matter other than as expressly provided herein or as duly set forth on or subsequent to the
date hereof in writing and signed by a proper and duly authorized officer or representative of the Party to be bound thereby. 
 13.16 Parties in Interest. All of the terms and provisions of this Agreement shall be binding upon, inure to the benefit of and be enforceable by the Parties hereto and their respective permitted
successors and assigns. 
 13.17 Descriptive Headings. The descriptive headings of this Agreement are for
convenience only, and shall be of no force or effect in construing or interpreting any of the provisions of this Agreement. 
 13.18 Counterparts. This Agreement may be executed simultaneously in any number of identical counterparts, any one of which need not contain the signature of more than one Party, but all such
counterparts taken together shall constitute one and the same agreement. 
 *  *  * 

  
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 IN WITNESS WHEREOF, each of the Parties has caused this Co-development,
Collaboration and License Agreement to be executed by its duly authorized representative as of the date first above written. 
  

			
	ENZON PHARMACEUTICALS, INC.
		
	By:	 	 /s/ Arthur J. Higgins

		 	Arthur J. Higgins, Chairman and Chief Executive Officer
	
	SKYEPHARMA, INC.
		
	 By:
	 	 /s/ Michael R.D. Ashton

		 	Michael R.D. Ashton, Chief Executive Officer of SkyePharma PLC
	
	JAGOTEC, AG
		
	 By:
	 	 /s/ Michael R.D. Ashton

		 	Michael R.D. Ashton, Chief Executive Officer of SkyePharma PLC
	
	Solely with respect to Section 13.3:
	
	SKYEPHARMA PLC
		
	 By:
	 	 /s/ Michael R.D. Ashton

		 	Michael R.D. Ashton, Chief Executive Officer of SkyePharma PLC

  
 - 36 -

 EXHIBIT 1.23 

FINANCIAL APPENDIX 

This provides the definitions of certain financial terms applicable to the parties for purposes of the Agreement. All
capitalized terms used herein without definition shall have the meanings ascribed thereto in the Agreement, unless otherwise expressly provided herein. 
 A.1 Principles of Reporting 
 The presentation of results of
operations of the Parties shall be based on each Party’s respective financial information for each Compound and Product being developed and commercialized by the Parties presented separately, by Party and by Compound and by Product, and on a
consolidated basis, by Party (across all Compounds and Products), by Compound and by Product (across the Parties) and across all Compounds and Products and the Parties, in the reporting format depicted as follows: 

 

													
	 [Product/Compound/all Products and Compounds]
	  	SkyePharma	 	  	Enzon	 	  	Total	 
	 Development Costs
	  				  				  			
				
	 Net Sales*
	  				  				  			
				
	 Sublicensing Income
	  				  				  			
				
	 less Cost of Goods Sold
	  				  				  			
				
	 less Marketing Costs
	  				  				  			
				
	 less Sales Costs
	  				  				  			
				
	 less Post-Registration Development Costs
	  				  				  			
				
	 less Distribution Costs
	  				  				  			
				
	 less Other Operating Income/Expense
	  				  				  			
				
	 = Operating Profit or Loss
	  				  				  			

  

	*	 The components of each Net Sales amount reported by a Party shall also be reported in supporting documentation. 

It is the intention of the Parties that the interpretation of these definitions shall be consistent with GAAP.

  
 A-1

 If necessary, a Party shall make the appropriate adjustments to the
financial information it supplies under the Agreement to conform to the above format of reporting results of operation. 
 A.2 Frequency of Reporting 
 The fiscal year shall be a
calendar year. 
 Reports of results compared to the applicable Annual Operating Plan and Budget shall be made
to the Joint Development Committee on a quarterly basis and on a year-to-date basis, for the Territory, by Party and by Compound/Product, and on a consolidated basis, by Party (across all Compounds/Products), by Compound/Product (across the Parties)
and across all Compounds/Products and the Parties. 
 SkyePharma shall be responsible for the preparation of
consolidated reporting, calculation of the profit/loss sharing, and determination of the cash settlement. SkyePharma shall provide the same within thirty (30) business days of receipt of each Party’s financial information, a statement
showing the consolidated results, and calculations of the sharing of Operating Profit or Loss and cash settlement required in a format agreed to by the parties. 

A.3 Definitions 
 “Allocable Overhead” means costs directly related to the Products or Compounds, as the case may be, and incremental costs actually incurred by a Party or for its account including, but
not limited to, those which are attributable to such Party’s supervisory services, occupancy costs, and its payroll, information systems, or purchasing functions and which are allocated to company departments based on space occupied or
headcount or other activity-based method consistently applied by a Party, or a standard rate if agreed to by the Parties, relating to activities of such Party under the Development Program or as part of its commercialization activities. Allocable
Overhead shall be approved by the JDC and included in the Annual Operating Plan and Budget. Allocable Overhead shall not include any costs attributable to general corporate activities including, by way of example, executive management, investor
relations, business development, legal affairs, human relations, and finance, related to activities of a Party under the Development Program or as part of its commercialization activities. 

“Cost of Goods Sold” means Fully Burdened Manufacturing Costs (as defined below) of each Party relating
to sales of Products. 
 “Development Costs” 

(a) “Development Costs” means the development costs actually incurred by each Party with respect any
Compound or Product in the Field, in all jurisdictions within the Territory from the Effective Date of the Agreement through the later of (i) the date of Registration (not including costs actually incurred thereafter to maintain or expand such
Registration) of such Products in the Field, in such jurisdiction, (ii) the date of termination of all development efforts with respect to Compound or Product in the Field for which Registration is sought in all jurisdictions throughout, the
Territory, or (iii) the date on which the Parties cease to continue joint development of such Compound or Product pursuant to Sections 4.3.2 or 4.3.3. Such costs shall comprise those costs required to maintain and/or expand such first
Registration and to obtain, maintain and/or expand any subsequent Registrations for Product in the Field and to obtain, maintain and/or expand the ability to manufacture, formulate, fill, use, ship, sell and/or distribute such Product in commercial
quantities to Third Parties. 

  
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 (b) “Development Costs” shall include, without limitation,
costs of research or development including costs of studies on the lexicological, pharmacokinetical, metabolical or clinical aspects of a Product conducted internally or by individual investigators or consultants (using an assumed scientific FTE
rate of $[**] per year for preclinical development, and using an FTE rate to be determined by the JDC for clinical development), necessary for the purpose of obtaining, maintaining and/or expanding marketing approval of a Product, costs for
preparing, submitting, reviewing or developing data or information for the purpose of submission to a Regulatory Authority to obtain, maintain and/or expand marketing approval of a Product, and applicable Allocable Overhead. 

(c) “Development Costs” shall also include, without limitation, expenses for data management,
statistical designs and studies, document preparation, and other administration expenses associated with the clinical testing program or post-marketing studies required to maintain product approvals. 

(d) In determining Development Costs chargeable under the Agreement, each Party shall use its respective project
accounting systems and shall review and approve its respective project accounting systems and methodologies with the other Party. 
 (e) In determining Development Costs chargeable under the Agreement, the FTE rate set forth in (b) shall apply for Contract Year One. Thereafter, the FTE rate shall be adjusted annually, to be
effective at the beginning of each Contract Year, to reflect the increase in the Consumer Price Index for All Urban Consumers for All Items over the prior year, as reported in the CPI Detailed Report published by the U.S. Department of Labor Bureau
of Labor Statistics. 
 “Distribution Costs” means the costs, including applicable Allocable
Overhead, specifically identifiable to the distribution of a Product by a Party including customer services, collection of data about sales to hospitals and other end users, order entry, billing, shipping, bad debt, credit and collection and other
such activities. 
 “First Commercial Sale” shall mean, with respect to any Product, the first
sale for which payment has been received for use or consumption by the general public of such Product in the Field in a country in the Territory after all required Registrations, including pricing approvals (if applicable), have been granted by the
Regulatory Authority in such country. 
 “Fully Burdened Manufacturing Costs” of a Product
means 100% of the fully burdened manufacturing cost (as defined through the supplying Party’s consistent application of GAAP to such manufacturing activities) of producing finished, packaged, and labeled Product which shall be comprised of
“the cost of goods produced, including but not limited to, direct labor and material costs and product quality assurance/control costs, as well as applicable Allocable Overhead. 

“Marketing Costs” 

(a) “Marketing Costs” means the costs actually incurred for marketing, promotion, advertising, Product
promotional materials, professional education, Product related public relations, relationships with opinion leaders and professional societies, market research (after the first Registration), healthcare economics studies, post-marketing studies not
required to maintain Registrations, and other similar activities, relating to commercialization activities of a Party for a Product. Such costs of a Party shall include (i) both direct internal costs actually incurred by a Party or for its
account which are attributable to commercialization activities of such Party under the applicable Annual Operation Plan and Budget (e.g., without limitation, salaries, benefits, supplies

  
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and materials, etc.), and (ii) applicable Allocable Overhead, outside services and expenses (e.g., without limitation, consultants, agency fees, meeting costs, etc.),
relating to such commercialization activities of such Party. 
 (b) “Marketing Costs” shall
also include, without limitation, the cost of activities related to obtaining reimbursement from payers and costs of sales and marketing data. 
 (c) “Marketing Costs” shall specifically exclude the costs of activities which promote any Party’s business as a whole without being product specific (such as corporate image
advertising). 
 “Net Sales” means, with respect to each Product, the gross amount invoiced for
sales of a Product in arm’s length sales by the Parties or individual Party and its Affiliates and Sublicensees to Third Parties which are not Sublicensees, commencing with the First Commercial Sale of such Product, less the following
deductions from such gross amounts which are actually incurred, allowed, accrued or specifically allocated: 

(a) credits, price adjustments or allowances for damaged products, returns or rejections of Products; 

(b) normal and customary trade, cash and quantity discounts, allowances and credits (other than price discounts granted
at the time of invoicing which have been already been included in the gross amount invoiced); 
 (c) chargeback
payments and rebates (or the equivalent thereof) granted to group purchasing organizations, managed health care organizations or to federal, state/provincial, local and other governments, including their agencies, or to trade customers; 

(d) any invoiced freight, postage, shipping, insurance and other transportation charges (excluding such charges that are
included in Distribution Costs); and 
 (e) sales, value-added (to the extent not refundable in accordance with
applicable- law), and excise taxes, tariffs and duties, and other taxes directly related to the sale (but not including taxes assessed against the income derived from such sale). 

“Net Sales” shall also include the average selling price for a Product times the number of units
transferred to Third Parties which are not Sublicensees for non-cash consideration or where no invoice is generated. The Parties or Party marketing each Product shall use Commercially Reasonable Efforts to reconcile such amounts invoiced and
deducted annually. For the avoidance of doubt, Net Sales shall not include sales of Products among the Parties or their respective Affiliates or Sublicensees. Net Sales, as set forth in this definition, shall be calculated applying, in accordance
with GAAP, the standard accounting practices each Party customarily applies to other products sold by it. 

“Operating Profit or Loss” means Net Sales of all Products and Sublicensing Income with respect to all
Compounds and Products, less the following items with respect to each Product sold or transferred to a Third Party (including, without limitation, Sublicensees) or relating to commercialization activities of a Party regarding a Product, all for a
given period: Cost of Goods Sold, Marketing Costs, Sales Costs, Post-Registration Development Costs, General and Administrative Costs, Distribution Costs, and Other Operating Income/Expense. 

  
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 “Other Operating Income/Expense” means other operating
income or expense from or to Third Parties, relating to the manufacturing or selling of Products by a Party, which is not part of the primary business activity being conducted by the Parties under this Agreement, but is considered and approved by
the JDC as income or expense for purposes of this activity and is limited to the following, each of which is to be related to manufacturing or selling of Products by a Party: 

 

	 	•	 	 actual inventory write-offs of any Product 

  

	 	•	 	 patent and trademark costs 

  

	 	•	 	 product liability insurance to the extent the Parties obtain a joint policy 

 

	 	•	 	 indemnification costs (as described in Section 10.3 of the Agreement, but excluding costs under Sections 10.1 and 10.2)

  

	 	•	 	 other (to be approved by JDC) 

  

	 	•	 	 cost of capital 

  

	 	•	 	 foreign exchange hedging (gains/losses) 

 The methodology used to determine the amount of each item set forth above shall be approved by the JDC. 
 “Post-Registration Development Costs” means the Development Costs actually incurred by each Party with respect to a Product in the Field, in a jurisdiction within the Territory after the
Registration of such Product in such jurisdiction. 
 “Sales Costs” means costs, including
Allocable Overhead, approved by the JDC within the applicable Annual Operating Plan and Budget, actually incurred by the Parties or for their account and specifically identifiable to the commercialization activities of a Party for a Product in the
Territory in all markets, including without limitation, the managed care market. 
 (a) “Sales
Costs” shall include, without limitation, costs associated with sales representatives for Products, including compensation, benefits and travel, supervision and training of such sales representatives, sales meetings, and other sales related
expenses. 
 (b) “Sales Costs” shall not include the start-up costs associated with any
Party’s sales force relating to that Party’s sales efforts, including recruiting, relocation and other similar costs. 
 “Sublicensing Income” shall mean all monetary consideration (for example and not by way of limitation, up-front payments, royalties, milestones and the like) received by a Party or its
Affiliates from Sublicensees pursuant to a sublicense granted pursuant to this Agreement, excluding (i) any amounts received from Sublicensees to reimburse such Party for reasonably documented research and development services which would not
otherwise be required to be performed by such Party pursuant to this Agreement, and (ii) any consideration received for the issuance of securities at the fair market value for such securities. 

  
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 A.4 Foreign Exchange 

Accounting for Operating Profit or Loss shall be U.S. dollars. For billing and reporting, the statement of operations and sales shall be
translated into U.S. dollars at the average rate of exchange listed in The Wall Street Journal on each business day of the applicable calendar quarter. 
 A.5 Audits and Interim Reviews 
 Either Party shall have the
right to request that the other Party’s independent, certified accounting firm perform an audit or interim review of the other Party’s books in order to express an opinion regarding such Party’s compliance with GAAP. Such audits or
review shall be conducted at the expense of the requesting Party. 
 At the request and expense of either Party
(“Auditing Party”), the other Party (“Audited Party”) shall permit an independent, certified public accountant appointed by the Auditing Party and reasonably acceptable to the Audited Party, at reasonable times and
upon reasonable written notice, to examine such records as may be necessary to: (i) determine the correctness of any report or payment made under this Agreement; or (ii) obtain information as to Development Costs or the aggregate Operating
Profit or Loss payable for any calendar quarter in the ease of the other Party’s failure to report or pay pursuant to this Agreement; provided, however, that such accountant shall sign a confidentiality agreement in a form
reasonably satisfactory to the Audited Party, and, provided further, that such examination shall not be permitted more than once in any twelve (12) month period. Said accountant shall not disclose to the Auditing Party or any other
person any information, except that such accountant may disclose to the Auditing Party the fact of a deficiency, the lack of a deficiency or any overpayment, and the degree thereof, including the dollar amount. All results of any such examination
shall be made available to the Audited Party. 
 In the event that any audit reveals a deficiency in the amount
that should have been paid by one Party to the other Party, then the underpaid amount shall be paid within forty-five (45) days after the Party who is owned payment makes a demand therefor, plus interest thereon if such deficiency is in excess
of [**] percent ([**]%) of the amount that actually should have been paid. Such interest shall be calculated from the date such underpaid amount was due until the date such underpaid amount is actually paid, at the rate of [**] percent ([**]%) over
the prime rate of interest reported in The Wall Street Journal for the date such amount was due. In addition, if such underpaid amount is in excess of [**] percent ([**]%) of the amount that actually should have been paid, then the Party who
is owned payment shall be reimbursed for the reasonable cost of such audit. In the event of an overpayment, such amounts shall be deducted from future amounts due. If such overpaid amounts have not been settled by such future deductions three years
from the date originally overpaid, the Party who is owned payment such overpayment shall invoice the other Party for such amounts. 
 A.6 Payments between the Parties 
 Payments to each Party of
the agreed upon percentages of Development Costs or Operating Profit or Loss shall be made quarterly, based on actual results within forty-five (45) days after the end of each quarter, adjusted for reimbursement of the net expenses or income
actually incurred or received by each Party. A report specifying how each payment was calculated shall also be submitted with each payment to the non-paying Party. Balancing payments by one Party to reimburse the other Party’s Development Costs
for purposes of the sharing of such costs under the Agreement shall be approved by the Development Committee. Within forty-five (45) days of the end of each calendar quarter, there shall be reconciliation of the Development Costs that are to be
shared and that are actually incurred during that year by the Parties, with a payment by one Party to 

  
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the other to the extent necessary so that each Party bears its appropriate percentage of such shared Development Costs. In the event any payment is made after the date specified herein, the
paying Party shall increase the amount otherwise due and payable by adding interest thereon, computed at the rate of [**] percent ([**]%) over the prime rate of interest reported in The Wall Street Journal on the date so specified.

 A.7 Operating Profit and Loss Sharing 

The Parties agree to share the Operating Profit or Loss from the sale of Products in the Field in the following manner:

 (a) Enzon shall be allocated [**] percent ([**]%) of the Operating Profit or Loss from the sale of Products
in the Field, in the Territory; and 
 (b) SkyePharma shall be allocated [**] percent ([**]%) of the Operating
Profit or Loss from the sale of Products in the Field, in the Territory. 
 A.8 Limits on Sharing of Costs in
Excess of Budget 
 Notwithstanding the sharing of Operating Profit or Loss set forth in Section A.7,
Marketing Costs, Sales Costs, Post-Registration Development Costs, expenses within Other Operating Income/Expense, Distribution Costs, and/or General and Administrative Costs actually incurred by either Party more than [**] percent ([**]%) in excess
of the Annual Operating Plan and Budget applicable to such Party’s expenditures shall not be shared by the Parties unless and to the extent such excess costs are expressly approved in writing by the other Party. 

  
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 EXHIBIT 3.1 

JOINT DEVELOPMENT COMMITTEE MEMBERS 

For Enzon: 

Mr. Charles Conover and Mr. Jack Lipman; 
 For SkyePharma: 
 Mr. Carsten Niederlander and Mr. Richard Jones.

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