Document:

Development and License Agreement

 Exhibit 10.8 
 ***Text Omitted and Filed Separately 
 with the Securities and Exchange
Commission. 
 Confidential Treatment Requested 
 Under 17 C.F.R. Sections 200.80(b)(4) 
 and 230.406. 

EXECUTION COPY 

DATED 20 AUGUST 2004 
 JAGOTEC AG 
 and 

SKYEPHARMA AG 
 and 
 NITEC PHARMA AG 

 
  
 DEVELOPMENT & LICENCE AGREEMENT 
  

 

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 THIS DEVELOPMENT and LICENCE AGREEMENT (this “Agreement”) is made on 20 August 2004 by and between: 
  

	(1)	JAGOTEC AG, a Swiss corporation having its place of business at Eptingerstrasse 5 1, CH-4 132 Muttenz, Switzerland (hereinafter referred to as
“Jagotec”); 

  

	(2)	SKYEPHARMA AG, a Swiss corporation having its place of business at Eptingersttasse 5 1, CH-4 132 Muttenz, Switzerland (hereinafter referred to as
“SkyePharma”; and SkyePharma and Jagotec hereinafter sometimes collectively referred to as “Skye”), and 

  

	(3)	NITEC PHARMA AG, a Swiss corporation, having a place of business at Röschenzerstrasse 9, CH-4153 Reinach, Switzerland (hereinafter referred to as
“Nitec”). 

 WITNESSES AS FOLLOWS: 
  

	A.	 By an agreement effective as of 18th day of August 1998, Skye and Merck KGaA, a German corporation, having a place of business Frankfurterstrasse 250,
D-64271 Darmstadt, Germany (hereinafter referred to as “Merck) entered into an agreement relating to the development of the product, Prednisone using certain proprietary technology and know-how owned by Jagotec relating to pharmaceutical
systems for the controlled and/or modified release of active substances, including but not limited to, Jagotec’s patented GEOMATRIX® Technology (as defined below) (hereinafter called the “Merck Agreement”). 

 

	B.	By an agreement between Merck and Nitec signed by Merck on 14 July 2004 and by Nitec on 2 August 2004 (the “Technology Transfer Agreement”), Merck
assigned the Merck Agreement to Nitec, effective as of the Effective Date of this Agreement. 

  

	C.	Skye has consented to the assignment of the Merck Agreement pursuant to the Technology Transfer Agreement, provided that certain modifications agreed between the
Parties (as defined below) are made to the contractual arrangements under the Merck Agreement. 

  

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	D.	On signature of this Agreement, the provisions of the Merck Agreement shall be terminated and replaced in their entirety with the terms and conditions set out below.

 NOW, THEREFORE, in consideration of the premises, mutual covenants and agreements contained in this Agreement and intending to
be legally bound by it, the Parties hereby agree as follows: 
  

	1	Definitions 

 For purposes of this
Agreement, the terms defined in this Section 1 shall have the following meanings: 
  

	1.1	“Active Drug” shall mean each of the substances Prednisone, Prednisolone and Methylprednisolone of a quality suitable for the manufacture of Product
meeting the Specifications; 

  

	1.2	“Affiliate” shall mean, any corporation, partnership or other entity controlled by, controlling or under common control with, either Party, with
“control” meaning (i) with respect to either Party direct or indirect beneficial ownership of more than 50% of the voting power of, or more than 50% of ownership interest in, such corporation, partnership or other entity and for the
avoidance of doubt, Jagotec and SkyePharma shall be regarded as Affiliates; 

  

	1.3	“Background IP” shall mean any intellectual property owned by the respective Parties on the Effective Date of this Agreement in respect of the Nitec
Know-How or the Skye Know-How which is or may be used under this Agreement and in the case of Nitec shall include all relevant rights intellectual property owned or used by Merck under the Merck Agreement necessary or desirable for use under this
Agreement; 

  

	1.4	 “Commercially Reasonable Efforts” means those efforts and resources that would be used by an established pharmaceutical company were
it developing, manufacturing, promoting and detailing its own pharmaceutical products which are of similar market potential as the Product, taking into account product labelling, market potential, past performance, economic return, the regulatory

  

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environment and competitive market conditions in the therapeutic area, all as measured by the facts and circumstances at the time such efforts are due. 

 

	1.5	“Confidential Information” shall mean any and all of the Skye Know-How and the Nitec Know-How, as well as any and all information developed during the
course of this Agreement, including, but not limited to, materials and techniques, analytical and testing methods, chemical formulae and specifications, product design criteria and test data, and technical information relating to product production
and commercial plans; 

  

	1.6	“Development Costs” shall mean all reasonable out-of-pocket costs (except those resulting from any breach by Skye hereunder) of the Development
Programme performed by Jagotec hereunder; 

  

	1.7	“Development Programme” shall mean the programme of work to be carried out by the Parties attached hereto as Exhibit C as may be amended by the Parties
in writing acting in good faith within thirty (30) days of the signature of this Agreement and thereafter as may be amended in writing by the Parties from time to time and “Development” shall be construed accordingly;

  

	1.8	“Dose Strength” shall mean with respect to Product each of the formulations containing 1, 2, 5 and 10 mg of Active Drug, respectively;

  

	1.9	“Effective Date” shall mean the date of signature of this Agreement; 

 

	1.10	“FDA” shall mean the U.S. Federal Food and Drug Administration and any successor agency thereof; 

 

	1.11	“First Launch” shall mean the first commercial sale of the Product in any country of the Territory to any unaffiliated third party in commercial
quantities following receipt of all applicable pricing and reimbursement approvals; 

  

	1.12	“Foreground IP” shall mean any intellectual property that arises or is developed by either party arising out of this Agreement;

  

	1.13	
“GEOMATRIX® Technology”
shall mean all of Skye’s oral controlled and/or modified drug release delivery and related technologies together with all improvements thereon and thereto; 

 

	1.14	 “Intellectual Property” shall mean any patent, including patent applications, divisional, continuation or continuation-in-part
applications, re-issues, registered 

  

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design copyright, database right, design right, topography right, trademark, service mark application to register any of such rights, trade secret, right in unpatented know-how and any other
intellectual or industrial property right of any nature whatsoever in any part of the world; 

  

	1.15	“Jagotec Manufacturing Agreement” shall mean the Manufacturing and Supply Agreement to be negotiated in good faith at the appropriate time by and
between Jagotec or any of its Affiliates and Nitec or any of its Affiliates on the manufacturing and supply of Product; 

  

	1.16	“Licence” shall mean the licence granted to Nitec as set out in Section 5.1; 

 

	1.17	“Mutual Recognition Procedure” shall mean the decentralized procedure to obtain a marketing authorisation for prescription drugs in EU countries;

  

	1.18	“Net Sales” shall mean, with respect to any Product, the invoiced sales price of such Product in finished package form invoiced by Nitec and/or its
Affiliates and/or its sub-licensee(s) to any independent customer other than Nitec Affiliates or sub-licensee(s), less only (a) sales, use, value added and other direct taxes (but excluding any income tax) actually incurred and paid by Nitec
and/or its Affiliates and/or its sub-licensee(s); and (b) customs duties, surcharges and other governmental charges incurred by Nitec and/or its Affiliates and/or its sublicensee(s) in connection with the exportation or importation of such
Product in final form, and (c) a lump sum deduction of [...***...] for all trade discounts, rebates, commissions, retroactive price reductions, amounts repaid or credited by reason of rejections, returns, and the like;

  

	1.19	“Nitec Know-How” shall mean all of Nitec’s and/or its Affiliates’ information and data (including, without limitation, information and data
of Merck under the Merck Agreement), which are not generally known including, but not limited to, patent claims and related information not yet disclosed to the public, formulae, procedures, protocols, techniques and results of experimentation and
testing which relate to Active Drug, and/or are useful and/or necessary to develop, make, use or sell any product containing Active Drug; 

  

	1.20	“Nitec Manufacturing Licence” shall mean the licence to Nitec granted pursuant to the option set out in Section 5.2; 

 

	1.21	“Party” or “Parties” shall mean SkyePharma, Jagotec and Nitec or any of them; 

 

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	1.22	 “Patents” shall mean all patents and patent applications heretofore or hereafter filed or having legal force in any country owned by
or licensed to Skye and/or its Affiliates relating to the Product, which claim the GEOMATRIX® Technology or the
process of manufacture by use of, or the use of, the GEOMATRIX® Technology and are set out in the attached
Exhibit A. Exhibit A is hereby deemed to be amended to include any and all patent applications relating to the subject matter of this Agreement eventually to be filed by or owned by or licensed to Skye or its Affiliates after the Effective Date,
together with any and all corresponding foreign patents and patent applications which issue therefrom, and all divisionals, continuations, continuations-in-part, reissues, renewals, extensions, substitutions, confirmations or additions to any such
patents or patent applications; 

  

	1.23	“Phase III Clinical Study” shall mean a large scale clinical trial in patients suffering from rheumatoid arthritis, the primary goal of which is to
establish Product efficacy (and chronic safety) according to Regulatory Authority registration rules or regulations; 

  

	1.24	 “Product” shall mean the pharmaceutical orally-administered controlled-release formulation (intended to exhibit a lag phase of at
least one hour, with substantially all of the drug release immediately thereafter) containing Prednisone, Prednisolone and/or Methylprednisolone, presented as a compressed tablet developed pursuant to this Agreement and using the GEOMATRIX® Technology, and shall include all Dose Strengths unless otherwise explicitly stated; 

 

	1.25	“Registration” shall mean the granting of any and all approvals and registrations of Product by any Regulatory Authority, including without limitation
price approval, which are required and/or necessary under any applicable law, rule, regulation or other governmental order to manufacture, market, distribute and sell Product in any country of the Territory; 

 

	1.26	“Regulatory Authority” shall mean the FDA and any equivalent competent regulatory authority in the other countries of the Territory;

  

	1.27	 “Skye Know-How” shall mean all of Skye’s and/or its Affiliates’ information and data, which are not generally known
including, but not limited to, patent 

  

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claims and related information not yet disclosed to the public, formulae, procedures, protocols, techniques and results of experimentation and testing, which relate to the GEOMATRIX® Technology and/or are useful and/or necessary to develop, make, use or sell Products using the GEOMATRIX® Technology; 

  

	1.28	“Specifications” shall mean the preliminary specifications of the Product set forth in Exhibit B attached hereto to be updated from time to time by
mutual agreement of the Parties; 

  

	1.29	“Technical Agreement” shall mean the additional contract to be entered into by Nitec as contract giver and Jagotec as contract acceptor, allocating the
respective pharmaceutical responsibilities relating to the manufacture and control of Products; 

  

	1.30	“Territory” shall mean all countries and territories in the world. 

 

	2	Development Preamble and further Development Programme 

  

	2.1	Jagotec has, prior to the execution of this Agreement, developed the Product under the Development and Licence Agreement with Merck, which shows some promising results.
In particular, the Parties have agreed to use the results as the basis of further development under this Agreement, the terms of which are hereby incorporated into this Agreement as set out below. 

 

	2.2	 Jagotec and Nitec undertake to conduct the further development of the Product in rheumatoid arthritis (and such other indications (e.g. asthma, IBD) as
may be agreed between the Parties in writing from time to time) in accordance with the Development Programme in an efficient and professional manner, and shall apply generally accepted Good Laboratory, Good Clinical and Good Manufacturing Practices
(each as applicable to pharmaceutical products for human use in the European Union and similar regulations applicable in other territories),. The Development shall also comply with the current guidelines of the European Union (e.g. Note for guidance
on quality of modified release products). Nitec shall actively support Jagotec regarding the development and studies to be executed by Jagotec under this Agreement as may be reasonably required by Jagotec from time to time. In particular, Nitec
shall provide information 

  

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reasonably requested by Jagotec relating to the Active Drug for the purposes of carrying out this development, including, but not limited to physico-chemical characteristics, safe-handling
instructions, in-vitro analytical methods, degradation products and standards and analytical methods therefore, all to the extent that any such information has not been delivered to Jagotec under the development and Licence Agreement with Merck. Any
costs and expenses incurred by Nitec in connection with such support shall be borne by Nitec. 

  

	2.3	Jagotec shall use all Active Drug supplied to it by Nitec hereunder solely and exclusively in connection with the Development. 

 

	2.4	Due to the nature and complexity of the development and the respective studies as set forth in this Agreement, the Parties recognize and acknowledge that problems and
delays might render the timeframe of the development difficult or impossible to accomplish. The Parties agree that they shall immediately inform each other in writing in the event that significant problems or delays are encountered or envisaged
during the course of the development and shall discuss such problems and delays in order to mutually agree on Commercially Reasonable Efforts to resolve such problems or delays. Nothing under this Section 2.4 shall affect the timelines set out
in Section 3 except to the extent of delays resulting directly from the breach of its obligations under this Agreement by Jagotec. 

  

	2.5	Nitec acknowledges and agrees that Jagotec’s obligations under this Agreement shall be strictly limited to the development steps and tasks explicitly listed and
described in the Development Programme, and that any amendment, change and alteration to, or extension of, any such development steps and tasks shall require the mutual agreement by the Parties. 

 

	2.6	Nitec shall bear all Development Costs. Nitec and Jagotec shall have the right to approve any additional activities not listed in Exhibit C which are proposed by
Jagotec or Nitec. 

  

	2.7	Nitec shall reimburse Jagotec on a quarterly basis any and all Development Cost incurred by Jagotec hereunder upon receipt of the respective invoices pursuant to
Section 2.9 below. 

  

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	2.8	During the term of this Agreement, Jagotec shall provide Nitec on a quarterly basis with an overview of the work intended by Jagotec to be performed according to the
Development Programme during the following three (3) months (hereinafter the “Quarterly Workplan”). Each such Quarterly Workplan shall contain information regarding the steps to be performed by Jagotec hereunder together with an
estimate of the man-hours expected to be spent on such steps and the anticipated Development Costs. Upon receipt of any such Quarterly Workplan, Nitec may comment thereon or disapprove certain steps included therein by written notice within five
(5) business day after receipt of each such Quarterly Workplan, provided that each Quarterly Workplan shall be deemed approved by Nitec if no such written notice is received by Jagotec within such five (5) business days, and provided
further that Jagotec shall have no responsibility for any delay in the Development Programme caused by or resulting from any such notice from Nitec. 

  

	2.9	Jagotec shall issue quarterly a report (“Quarterly Report”) reasonably detailing all development steps performed during the preceding three (3) month
period, and Jagotec shall, simultaneously with each such Quarterly Report, issue an invoice covering all cost and expenses incurred by Jagotec hereunder in accordance with the terms of this Agreement including any Development Costs over the period
covered by such Quarterly Report applying a rate of [...***...] per man-hour spent. Any excess of the aggregate amount of development fees paid by Nitec over the aggregate amount(s) invoiced by Jagotec shall be credited by Jagotec
against future invoices hereunder. 

  

	2.10	Nitec undertakes to settle each invoice so issued, which shows a balance in favour of Jagotec, within [...***...] as of the respective invoice date.

  

	3	Responsibilities 

  

	3.1	Nitec will use all Commercially Reasonable Efforts to perform at its sole cost and expense, the following: 

 

	(a)	all clinical studies, including without limitation: 

  

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	 	(i)	 commence the Phase III Clinical Study in Rheumatoid Arthritis as agreed with the German authority February, 17th 2004 within [...***...] of the Effective Date;

  

	 	(ii)	complete the above mentioned (3.1(a)(i) Phase III Clinical Study within [...***...] of commencing the Phase III Clinical Study, and;

  

	 	(iii)	other development steps and tasks (other than those which are assigned to Jagotec as may be agreed between the parties from time to time) which are required and/or
necessary and/or deemed reasonable to be performed pursuant to all applicable law, statute or regulation, in order to apply for, and subsequently receive, Registrations for Product in at least one major European market and eventually other countries
of the Territory; 

  

	(b)	apply for and diligently pursue, in Nitec’s (or its Affiliates’) own name; Registrations for Product in Rheumatoid Arthritis with the Regulatory Authorities
in at least one major European market within [...***...] of the completion of the Phase III clinical studies, and eventually other countries of the Territory; 

 

	(c)	apply for and diligently pursue (except where the primary obligation for doing so is placed on Jagotec under relevant legislation) any and all approvals required by any
applicable law, statute or regulation to manufacture Product at the manufacturing site as set forth in the Jagotec Manufacturing Agreement or any other facility to subsequently manufacture Product; 

 

	(d)	within [...***...] of the receipt of first Registration for Product in the reference member state, being such country referred to in Section 3.1(b), to start
and thereafter diligently pursue the Mutual Recognition Procedure or other procedure to obtain Registration in at least three other countries of the Territory; and 

 

	(e)	launch or have launched the Product in at least three European Union countries within [...***...] following receipt of Registration in those countries of the
European Union. 

  

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	3.2	Nitec may decide at its own discretion and according to its business strategy, in which country of the Territory to first apply for Registration of Product and initiate
and pursue the steps required to be performed for successful Registration of Product. 

  

	3.3	In the event that Nitec does not in any material respect meet any of its obligations pursuant to Section 3.1 above, Skye may thereafter call a meeting with Nitec
at which Skye will determine, at Jago’s sole option, either to (i) allow Nitec a further [...***...] to complete such obligation, or (ii) Skye to terminate the Agreement in which case the terms of Section 10.4
(c) shall apply. 

  

	3.4	Jagotec agrees to provide such technical assistance and consultation in addition to the tasks assigned to Jagotec pursuant to this Agreement as may be reasonably
required by Nitec in connection with the development, testing, performance of clinical studies, applications for Registrations or similar services, provided that Nitec shall pay to Jagotec an amount of [...***...] spent by Jagotec personnel in
providing such additional assistance and consultation. In addition to such fee, Nitec undertakes to reimburse Jagotec for all cost and expenses incurred in connection with travel and accommodation of Jagotec personnel providing upon specific request
by Nitec any such assistance and consultation at locations remote from their usual working location to the extent separately agreed upon. 

  

	3.5	Jagotec shall have no responsibility whatsoever in respect of the availability or quality of the results of the development steps to be performed by Nitec pursuant to
Section 3.1 above, unless otherwise agreed upon by the Parties in writing with respect to any specified development step or part thereof to be performed by Jagotec in accordance with Section 3.4 above. 

 

	3.6	 Nitec undertakes to provide to Jagotec upon availability with all information on any of the development steps performed by Nitec under Section 2.1
above in reasonable detail or as reasonably required by Jagotec to perform its obligation under this Agreement. In particular, but without limitation, Nitec shall provide Jagotec upon availability with results, data, reports and similar information
obtained by any of the studies, testing, Registration procedures or the like performed by Nitec under this Agreement. Any and all such information provided by Nitec to Jagotec shall be treated by Jagotec as Confidential Information and

  

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remain subject to the confidentiality and non-use obligations contained in Section 8 below. 

  

	3.7	In the event that the Parties shall deem the results of any of the development steps to be performed by Nitec under this Section 3, including without limitation,
the results of any clinical study (including Phase III Clinical Study) performed hereunder, to be unsatisfactory for any reason, the Parties may mutually agree to abandon the development of the Product under this Agreement and terminate this
Agreement with immediate effect. 

  

	3.8	The allocation of all technical and pharmaceutical responsibilities shall be included in the Technical Agreement which the Parties shall negotiate in good faith within
thirty (30) days of the Effective Date. 

  

	4	Proprietary Rights and Patents 

  

	4.1	Rights to Foreground IP 

  

	(a)	 Any Foreground IP relating specifically and exclusively to the GEOMATRIX® Technology or the process of manufacture by use of, or the use of the GEOMATRIX® Technology, including the formulation of any compound (including Active Drug) with GEOMATRIX® Technology shall vest in and be owned absolutely by Jagotec, irrespective which party has created or developed such Foreground IP or its contribution to it
(hereinafter referred to as “Skye IPR”). 

  

	(b)	Any Foreground IP relating specifically and exclusively to the Product containing Active Drug, any use of the Active Drug, or any attribute or property of the Active
Drug, shall vest in and be owned absolutely by Nitec, irrespective which party has created or developed such Foreground IP or its contribution to it (hereinafter referred to as “Nitec IPR”). 

 

	(c)	All Foreground IP other than that set out in Section 4.1(a) and (b) will be owned (i) by the Party developing or discovering it; or (ii) if jointly
developed or discovered, shall be owned jointly (together, “Other IP”) all as determined in accordance with the legislation applying in the country or jurisdiction where such development or discovery shall take place.

  

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	4.2	Rights to Background IP 

  

	(a)	All Background IP is and shall remain the exclusive property of the party owning it (or if applicable from the third party from whom its rights to use the Background IP
has derived). 

  

	(b)	In case the Foreground IP of either party is dependent on any or all Background IP of the other party, the parties agree to the following: 

 

	 	(i)	in case Skye IPR or Other IP is dependent on any or all Background IP of Nitec (hereinafter referred to as “Dependent Skye IPR”), Nitec shall grant to Jagotec
a non-exclusive, perpetual, royalty-free right to use such Background IP with a right to grant sublicenses to the extent necessary for Jagotec and its licensees and sublicensees to make unrestricted use of its Foreground IP;

  

	 	(ii)	in case Nitec IPR or Other IP is dependent on any or all Background IP of Jagotec (hereinafter referred to as “Dependent Nitec IPR”), Jagotec shall grant to
Nitec a non-exclusive, perpetual, royalty-free right to use such Background IP with a right to grant sublicenses to the extent necessary for Nitec and its licensees and sublicensees to make unrestricted use of its Foreground IP.

  

	4.3	Confirmation by Jagotec 

 Jagotec
hereby confirms that neither it nor any of its Affiliates currently own any patent or patent application not included in the term “Patents”, which is reasonably necessary or useful to develop, manufacture, sell or otherwise dispose of a
Product under this Agreement. Future Skye IPR which may be necessary to develop, manufacture, sell or otherwise dispose of a Product under this Agreement will be deemed added to Exhibit A on filing. 

 

	4.4	Prosecution of Patent Applications 

  

	(a)	 During the term of this Agreement, Jagotec shall use all Commercially Reasonable Efforts, at its own cost, to prepare, prosecute and maintain all
patent applications and patents constituting Patents, and shall keep Nitec fully and promptly informed on any developments or changes relating thereto. If Jagotec decides not to further prosecute or not to maintain any patent application
constituting Patents, Jagotec shall promptly inform Nitec of such decision in writing, and the Parties shall, upon Nitec’s written request, meet to discuss any 

 

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appropriate action taking into due consideration Nitec’s interests under this Agreement. 

  

	(b)	Nitec shall be responsible for and shall use all Commercially Reasonable Efforts to control, at its own cost, the preparation, prosecution and maintenance of all Nitec
IPR and shall keep Jagotec fully and promptly informed on any developments or changes relating thereto. During the term of this Agreement, Nitec shall, at its sole cost, take all steps necessary to prosecute and maintain all Nitec IPR to the extent
Nitec deems commercially reasonable. If Nitec intends not to further prosecute and/or maintain any of the Nitec IPR, Nitec shall promptly inform Jagotec of such intention in writing, and Jagotec shall meet with Nitec to discuss any appropriate
action taking into due consideration Jagotec’s interests under this Agreement. 

  

	4.5	Notification of Infringement 

  

	(a)	If Nitec becomes aware of (i) any product or activity of any kind that involves or may involve an infringement or violation of Skye IPR, or (ii) any
third-party action, claim or dispute (including, but not limited to, actions for declaratory judgment alleging the invalidity or non-infringement) based upon or arising out of Skye IPR, then Nitec shall promptly notify Jagotec in writing of any such
infringement, violation, action, claim or dispute. 

  

	(b)	If Jagotec becomes aware of (i) any product or activity of any kind that involves or may involve an infringement or violation of Skye IPR with respect to Product
or of Nitec IPR, or (ii) any third-party action, claim or dispute (including, but not limited to, actions for declaratory judgment alleging the invalidity or non-infringement) based upon or arising out of Skye IPR with respect to Product or of
Nitec IPR, then Jagotec shall promptly notify Nitec in writing of any such infringement, violation, action, claim or dispute. 

  

	4.6	Enforcement of Skye IPR 

  

	(a)	 Jagotec, at its sole expense, shall have the right, but not the obligation, (1) to determine the appropriate course of action to enforce, or
otherwise abate the infringement of, or defend third-party actions regarding, Skye IPR and its Background IP to the extent necessary for the Dependent Nitec IPR (hereinafter referred to as “Skye IPR plus Background”), (ii) to take, or
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appropriate action to enforce, or defend third-party actions regarding, Skye IPR plus Background, (iii) to control any litigation or other enforcement action regarding Skye IPR plus
Background, and (iv) to enter into, or permit, the settlement of any such litigation or other enforcement action regarding Skye IPR plus Background. Notwithstanding anything contained in the preceding sentence, Jagotec shall not settle any suit
or action or otherwise consent to an adverse judgement in such suit or action without Nitec’s prior written consent, which consent shall not be withheld unreasonably. Jagotec shall keep Nitec informed on a regular basis on its taking or
refraining from taking, and the development of, any of the foregoing actions, and shall consider, in good faith, the interests of Nitec under this Agreement when taking any of the foregoing actions. Nitec shall, at its own cost, fully cooperate with
Jagotec in the planning and execution of any suit or other action to enforce, or defend third-party actions regarding, Skye IPR plus Background to the extent affecting Product and as reasonably required by Jagotec. 

 

	(b)	If Jagotec does not within [...***...], or any shorter delay imposed by any applicable law or regulation or court or authority having jurisdiction, after
receiving notice of any infringement or violation of Skye IPR plus Background which may adversely affect Product, or of any third-party action, claim or dispute based upon or arising out of Skye IPR plus Background which may adversely affect
Product, commence or take an action to enforce, or otherwise abate such infringement, or defend against such third-party action, then the Parties shall, upon Nitec’s written request, promptly meet to discuss any appropriate action with regard
to such enforcement of Skye IPR plus Background which may adversely affect Product. 

  

	(c)	Nitec, upon its written request and at its sole expense, shall be made an additional, not controlling party in any such suit or other action where necessary to obtain
complete relief regarding the subject infringement or violation. 

  

	4.7	Enforcement of Nitec IPR 

  

	(a)	 Nitec, at its sole expense, shall have the right, but not the obligation, (i) to determine the appropriate course of action to enforce, or
otherwise abate the infringement of, or defend third-party actions regarding, Nitec IPR and its 

  

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Background IP to the extent necessary for the Dependent Skye IPR (hereinafter referred to as “Nitec IPR plus Background”), (ii) to take, or refrain from taking, appropriate action
to enforce, or defend third-party actions regarding, Nitec IPR plus Background, (iii) to control any litigation or other enforcement action regarding Nitec IPR plus Background, and (iv) to enter into, or permit, the settlement of any such
litigation or other enforcement action regarding Nitec IPR plus Background. Notwithstanding anything contained in the preceding sentence, Nitec shall not settle any suit or action or otherwise consent to an adverse judgment in such suit or action
without the prior written consent of Jagotec, which consent shall not be withheld unreasonably. Nitec shall keep Jagotec informed on a regular basis on its taking or refraining from taking, and the development of, any of the foregoing actions, and
shall consider, in good faith, the interests of Jagotec under this Agreement and in Skye IPR, when taking any of the foregoing actions. Jagotec shall, at its own cost, fully cooperate with Nitec in the planning and execution of any suit or other
action to enforce, or defend third-party actions regarding, Nitec IPR plus Background to the extent affecting Product and as reasonably required by Nitec. 

 

	(b)	If Nitec does not, within [...***...], or any shorter delay imposed by any applicable law or regulation or court or authority having jurisdiction, after
receiving notice of any infringement or violation of Nitec IPR plus Background, or of any third-party action, claim or dispute based upon or arising out of Nitec IPR plus Background, commence or take an action to enforce, or otherwise abate such
infringement, or defend against such third-party action, then the Parties shall, upon Jagotec’s written request, promptly meet to discuss any appropriate action with regard to such enforcement of Nitec IPR plus Background which may adversely
affect Product 

  

	(c)	Jagotec, upon its written request and at its sole expense, shall be made an additional, not controlling party in any such suit or other action where necessary to obtain
complete relief regarding the subject infringement or violation. 

  

	4.8	Application of Monies Recovered 

All monies recovered upon the final judgment or settlement of any suit or other action under these Sections 3.6 or 3.7 above shall be
applied as follows: 
  

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	 	(i)	firstly, to cover any and all costs and expenses (including attorney’s fees) incurred by the Party controlling such suit or other action; 

 

	 	(ii)	secondly, to cover any and all costs and expenses (including attorney’s fees) reasonably, or upon request of the controlling Party, incurred by the other Party in
connection with such suit or other action, if any; 

  

	 	(iii)	finally, the remainder, if any, to the Party controlling any such suit or other action. 

 

	5	Licence Grant 

  

	5.1	 Jagotec hereby grants to Nitec the royalty bearing exclusive and sub-licensable right and licence to market, distribute, sell, offer for sale and use
the Product in the Territory and to use the Patents, GEOMATRIX® Technology and Skye Know How exclusively for
that purpose. 

  

	5.2	 Furthermore, subject to the provisions of Section 6.2, Jagotec hereby grants to Nitec the option (the “Option”) to acquire the exclusive
and sublicenseable right and licence (hereinafter referred to as the “Nitec Manufacturing Licence “) to make or have made Product in the Territory and to use the Patents, GEOMATRIX® Technology and Skye Know How exclusively for that purpose at any time on twenty four month notice to expire no earlier than five years after the First Launch of the
Product in the Territory. The Option may be exercised in accordance with Section 6.2 below. For the avoidance of doubt, no royalty in addition to that set out in Section 7 shall be payable by Nitec to Jagotec in respect of the Nitec
Manufacturing Licence. The Nitec Manufacturing Licence shall be co-terminus with the licence granted under Section 5.1. 

  

	5.3	Subject to the provisions of Section 5.5, the rights of Nitec to grant any sub-license under the Licence and/or the Nitec Manufacturing Licence, as the case may
be, in any part of the Territory shall not require Nitec to receive the written approval of Jagotec. 

  

	5.4	 In any event, Nitec shall be responsible for any and all acts, deeds and undertakings of its sub-licensee(s) and shall continue to be bound by all
terms and provisions under this Agreement throughout its term. In case that Nitec sub-

  

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licenses rights and/or the Licence and/or the Nitec Manufacturing Licence, as the case may be, to any sub-licensee(s), such sub-licensee(s) shall agree in writing to any and all of Nitec’s
obligations and undertakings under this Agreement, including but not limited to its confidentiality obligations set out below. Furthermore, Nitec undertakes that any and all sub-licence agreements shall provide for inspection and audit provisions
identical to the provisions set forth below in order to enable Jagotec to control and audit and receive any and all Royalties due as provided in this Agreement. Nitec shall provide Jagotec promptly with appropriate information on its sub-licensee(s)
and, subject to applicable confidentiality restrictions, copies of all agreements with such sub-licensee(s). 

  

	6	Manufacturing and Product Liability 

  

	6.1	 Subject to the exercise by Nitec of its rights under Section 6.2, Jagotec shall exclusively manufacture, package and supply, or have manufactured,
packaged and supplied by an Affiliate, Product in bulk in accordance with the terms and conditions to be agreed upon in the Jagotec Manufacturing Agreement, which Jagotec Manufacturing Agreement shall contain provisions (i) that Nitec shall
supply to Jagotec or its Affiliate free of charge all Active Drug in quantities required for such manufacturing of Product, and (ii) on manufacture and packaging of Product in bulk and reimbursement of cost at [...***...] of
Jago’s fully allocated manufacturing cost therefore (calculated in substantially the same manner as Jago’s other manufactured products of similar production process, run and complexity) as required by the Parties. If Jagotec wants to have
the product manufactured, packed and supplied by an affiliate other than SkyePharma SAS, the costs of the manufacturing site change to such an affiliate (including but not limited to technical transfer, process validation, bioequivalence study and
regulatory expenses) shall be borne by Skye. Furthermore, the Jagotec Manufacturing Agreement shall contain provisions on lead times, order quantity and supply and purchase obligations of such quantities ordered (or part thereof), as may be mutually
agreed upon by the Parties and in the event of a failure by the Parties to agree by 31 March, 2005, each Party shall submit the matter to be resolved by an expert, to be appointed by

  

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a single arbitrator appointed under ICC Rules. With the exception of the principles applied in calculating the fully allocated manufacturing cost referred to above, in relation to any particular
proposed clause of the Jagotec Manufacturing Agreement on which the Parties are unable to agree, each Party shall propose terms, only one of which, subject to such amendments specified by the expert as shall be required to ensure that the Jagotec
Manufacturing Agreement operates as a whole, shall be selected by the expert as the relevant clause of the Jagotec Manufacturing Agreement binding on the Parties. In the case of the principles applied in calculating the fully allocated manufacturing
cost referred to above, the expert shall not be bound only to select terms proposed by one Party or the other as described above but shall be free to make such amendments to proposed terms as the expert shall think fit. 

 

	6.2	In the event that Nitec wishes to manufacture the Product under the Nitec Manufacturing Licence rather then having Jagotec manufacture the Product under the Jagotec
Manufacturing Agreement, then Nitec shall exercise its Option under Section 5.2 above by serving notice on Jagotec to that effect in writing. Subject to the proviso to this sentence, the right of Nitec under Section 5.2 shall not take
effect for a period of [...***...] from the date of notice and during such period, (i) all pending orders for Product shall be satisfied by Jagotec in accordance with the Jagotec Manufacturing Agreement, and (ii) the Parties will
agree the terms of the royalty free Manufacturing Licence to include such provisions as are customary in the circumstances, failing which either Party may refer the matter to an expert for determination. Jagotec agrees that it shall provide
technical assistance in connection with such transfer to a third party manufacturer as set out in Section 3.4. The costs of the manufacturing site change (including but not limited to technical transfer, process validation, bioequivalence study
and regulatory expenses) shall be born by Nitec. Notwithstanding anything to the contrary contained herein, following exercise of the Option, the Manufacturing License shall be an irrevocable worldwide, fully paid-up, royalty-free license, pursuant
to which Nitec and its licensees shall have a right of sublicense. 

  

	6.3	 Nitec shall indemnify, defend and hold Jagotec and its Affiliates, directors, officers and shareholders harmless from and against any losses, claims,
liabilities, 

  

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costs and expenses (including reasonable attorney’s fees) that may be imposed upon or asserted against Jagotec and/or its Affiliates, directors, officers and shareholders as a result of the
manufacture of Product under the Manufacturing License, or the marketing, distribution, use or sale of Product under the License by or on behalf of Nitec, its Affiliates, agents or sub-licensee(s), except for those claims, liabilities, costs and
expenses arising from negligence or intentional misconduct on the part of Jagotec or its Affiliates and except for claims to the extent any relate to the Patents, GEOMATRIX® Technology and Skye Know How. 

  

	6.4	In the event that Jagotec wishes to cease to manufacture the Product under the Jagotec Manufacturing Agreement, Jagotec shall be permitted to do so by serving notice on
Nitec to that effect in writing. The termination under this Section 6.4 shall not take effect for a period of twenty four (24) months from the date of notice and in any event no earlier than five years after the First Launch of the Product in
the Territory and during such period all pending orders for Product shall be satisfied by Jagotec in accordance with the Jagotec Manufacturing Agreement. Jagotec agrees that it shall provide technical assistance in connection with transfer of
manufacturing rights to a third party manufacturer as set out in Section 3.4. The costs of the manufacturing site change (including but not limited to technical transfer, process validation, bioequivalence study and regulatory expenses) shall
be born by Nitec. 

  

	7	Royalties 

  

	7.1	In consideration of the License granted by Jagotec to Nitec hereunder, the royalty (the “Royalty”) payable by Nitec to Jagotec shall be:

  

	 	7.1.1	in the case of all countries of the Territory (other than North America): 

  

	 	(a)	[...***...] of Net Sales of Product in the Territory (other than North America), and 

 

	 	(b)	[...***...] of sublicensing income in the Territory (other than North America) being any payment not calculated based on Net Sales (to include, without
limitation, licence fees, lump sums and milestone payments.). 

  

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	 	7.1.2	in the case of North America: 

  

	 	(a)	[...***...] of Net Sales of Product in North America, and 

  

	 	(b)	[...***...] of sublicensing income in North America being any payment not calculated based on Net Sales (to include, without limitation, licence fees, lump sums
and milestone payments.). 

  

	7.2	All Royalties shall be payable on a quarterly basis. Nitec shall remit to Jagotec within [...***...] days after the end of each calendar quarter the amount of
Royalties, if any, due in respect of the preceding quarter, beginning with the calendar quarter in which the First Launch takes place. Nitec shall deliver to Jagotec, along with such remittance of Royalty payments a detailed statement (hereinafter
referred to as the “Royalty Report’) of Net Sales of Product and sublicensing income received on a country-by-country basis to which the Royalty payment relates. 

 

	7.3	All Royalty Reports shall be prepared in accordance with generally accepted accounting principles consistently applied from applicable period to period and shall be
certified by an officer of Nitec as being so prepared, true, accurate and correct. 

  

	7.4	Unless otherwise agreed by the Parties in writing, all payments of Royalties shall be made in EURO and to such place or account as Jagotec reasonably requests from time
to time in writing. Any conversions into EURO from the currency in which the corresponding Net Sales for such Royalties and sublicensing income were made, are to be calculated by using the average closing buying rate for such currency quoted in the
continental terms method of quoting exchange rates (local currency per EURO 1) published by the Financial Times on the last business day of the applicable reporting period covered by such Royalty Report. 

 

	7.5	 In the event that Nitec is required to withhold any tax to the tax or revenue authorities in the Territory regarding any payment to Jagotec, such
amount shall be deducted from the payment to be made by Nitec, and Nitec shall promptly notify Jagotec of such withholding and, within a reasonable amount of time after making such deduction, furnish Jagotec with copies of any tax certificate or
other documentation evidencing such withholding. Each Party agrees to cooperate 

  

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with the other Party in claiming exemptions from such deductions or withholdings under any agreement or treaty from time to time in effect. 

 

	8	Inspection and Audit 

  

	8.1	During the term of this Agreement and during a period of twelve (12) months after its expiration or termination for any reason, upon the written request of Jagotec
and not more than once each calendar year, Nitec shall permit an independent certified public accountant of internationally recognized standing selected by Jagotec, to have access during regular business hours to such of the records of Nitec and its
Affiliates and sub-licensee(s), if any, as may be reasonably necessary to verify the accuracy of the Royalty Reports for any year ending not more than twenty-four (24) months prior to the date of such request. The accounting firm shall disclose
to Jagotec only whether the Royalty Reports and records of Nitec and its Affiliates and sub-licensee(s), if any, and the amount of Royalties, if any, actually paid are correct or not and the specific details concerning any discrepancies; no other
information shall be shared. The Parties agree to accept such written audit report as final and binding upon them. 

  

	8.2	If such independent accounting firm correctly concludes that additional Royalties were owed during any such period audited, Nitec shall pay such additional Royalties
within thirty (30) days of the date Jagotec delivers to Nitec such accounting firm’s written report so concluding. The fees and expenses charged by such accounting firm with respect to such audit shall be paid by Jagotec, provided however,
if any such audit discloses that Royalties payable by Nitec for the audited period are more than [...***...] of the Royalties actually paid for such period, then Nitec shall pay all reasonable fees and expenses charged by such
accounting firm with respect to such audit. 

  

	8.3	Jagotec shall treat all financial information subject to review under this Section 7 as confidential and subject to the confidentiality obligations in Article 8
below. 

  

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	9	Confidentiality 

  

	9.1	During the term of this Agreement and in the course of the development work by Jagotec, it may be necessary for each Party to disclose to the other Party, orally or in
writing, certain of its Confidential Information, which each Party considers to be confidential and proprietary. Each Party agrees to hold in strict confidence and not to use, except for purposes of this Agreement, all Confidential Information
obtained from the other Party during the term of this Agreement. 

  

	9.2	The obligations of confidentiality and non-use contained in this Section 8 shall not extend and apply to Confidential Information that: 

 

	(i)	is in or enters the public domain without breach of this Agreement; or 

  

	(ii)	can be shown to have been known to the receiving Party prior to disclosure under this Agreement; or 

 

	(iii)	is disclosed to the receiving Party, without restriction, by a third party having the right to disclose the same; or 

 

	(iv)	is required to be disclosed by a judicial or administrative authority of competent jurisdiction or by law after maximum practical notice to the originally disclosing
Party. 

  

	9.3	Confidential Information of the other Party shall be disclosed or made available by the receiving Party only to those employees of the receiving Party who have a need
to know such Confidential Information for the purposes of this Agreement. Furthermore, the Parties may also disclose Confidential Information to consultants hired by one or both of the Parties, provided the receiving Party’s consultant has a
need to know such Confidential Information for purposes of this Agreement and has previously signed a written confidentiality agreement or has otherwise agreed to such confidentiality obligation with the receiving Party which contains substantially
the same obligations of confidentiality and non-use as set forth in this Section 8, and which is broad enough to cover disclosures of Confidential Information from the originally disclosing Party. 

 

	9.4	 In the event of termination or expiration of this Agreement for whatsoever reason, each Party shall immediately return to the other all of the other
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every and all copies made thereof save for one copy of each item of Confidential Information, which may be retained in the legal department or lodged with the legal advisers of the receiving
Party exclusively in order to provide a record of Confidential Information disclosed and to so determine each receiving Party’s continuing obligations hereunder. 

 

	9.5	The obligations of confidentiality and non-use contained in this Section 8 shall survive the expiration or termination of this Agreement for any reason for a
period of five (5) years commencing upon the effective date of such termination or expiration. 

  

	10	Term and Termination 

  

	10.1	Term and Expiration 

  

	(a)	This Agreement shall terminate on the later of ten (10) years from the Effective Date or on the expiry on a country-by-country basis upon the expiration of the
last to expire of the Patents in each country of the Territory, unless earlier terminated in accordance with Sections 10.2 and 10.3 below. 

  

	(b)	Upon the expiration of this Agreement in each country of the Territory pursuant to Section 10.1 (a) above and payment of all Royalties and Manufacturing
Royalties, if any, due under this Agreement, the License and the Manufacturing License, if applicable, shall be deemed to be a perpetual, fully paid-up and royalty-free license for Product in each such country of the Territory.

  

	10.2	Termination for Cause 

 During the entire term of
this Agreement either Party may terminate this Agreement by giving to the other Party written notice to that effect, if any of the following events occur: 
  

	(a)	the other Party is in default or in breach of a term or provision hereof and such default or breach is material and continues and is not remedied within
[...***...] upon the other Party’s written request to remedy such default or breach; 

  

	(b)	the other Party shall commit a material breach of any of the confidentiality provisions of Section 9 above; or 

 

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	(c)	the other Party goes into liquidation, voluntarily or otherwise, other than for the sole purpose of reorganization, or goes into bankruptcy or makes an assignment for
the benefit of creditors, or in the event of a receiver being appointed of the other Party’s property or parts thereof). 

  

	10.3	Termination prior to Registration 

In addition and not in limitation to Section 3.7 above, as from the Effective Date throughout the term until the first Registration
for Product is granted by any Regulatory Authority in any country of the Territory, this Agreement may be terminated as follows: 
  

	(a)	by either Party, if such Party reasonably considers based on a determination, in accordance with sound scientific, pharmaceutical and medical judgment, of the results
achieved with respect to the Product during the development phase, and that Party can demonstrate that there is a technical, pharmaceutical or medical problem regarding the Product, which would make the Product unapprovable in all of the following
countries, USA, UK and Germany, with [...***...] prior notice, provided that such terminating Party, prior to having the right to terminate this Agreement in accordance herewith, has in all detail disclosed such determination and the
underlying reasons to the other Party and has taken in due consideration any comments of the other Party on such determination; and 

  

	(b)	by Nitec, if the first application for Registration of Product or any material part thereof is finally rejected or denied, or if any Regulatory Authority in the
country, where the first Registration of Product is applied for, imposes restrictions on or conditions for the commercialization of the Product which have a material negative impact on the marketability of the Product, or if all Registrations of
Product in all countries are withdrawn or cancelled by the competent Regulatory Authorities, with [...***...] prior written notice. 

  

	10.4	Effect of Termination 

  

	(a)	 The termination of this Agreement shall be without prejudice to any rights and obligations of either Party accrued prior to the effective date of such
termination. Nitec shall forthwith make all payments due and outstanding to Jagotec at the date of termination. Except as explicitly otherwise stated in this Agreement, 

 

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Jagotec shall not be obliged to refund upon termination of this Agreement to Nitec any payments made by Nitec to Jagotec prior to such termination pursuant to the provisions of this Agreement.

  

	(b)	 In the event of termination of this Agreement pursuant to Sections 10.2 and 10.3 above, then this Agreement (and any agreements entered into in
connection with it) shall immediately be terminated and, except as provided herein, Nitec shall immediately refrain from using directly or indirectly in any way the Patents, GEOMATRIX® Technology and Skye Know-How. Upon termination of this Agreement, except as provided herein, Jagotec shall immediately refrain from using directly or indirectly in
any way all Nitec IPR as well as Nitec Know-How. Furthermore, each Party shall return to the other Party all Confidential Information (other than that relating to the Foreground IP of the other) received from or belonging to the other Party,
together with all copies thereof in such other Party’s possession or under its control, all free of any charge. Either Party shall have the right, but not the obligation, to use, at its sole discretion, any and all such material for its own
purposes. 

  

	(c)	 Subject to any rights of Merck under the Technology Transfer Agreement, in the event of termination by Jagotec under the terms of Section 3.3, the
terms of Section 10.4 (b) shall not apply and the Agreement (and any agreements entered into in connection with it) shall immediately be terminated and Nitec shall immediately refrain from using directly or indirectly in any way the
Patents, GEOMATRIX® Technology and Skye Know-How. At the same time, subject to any rights of Merck under the
Technology Transfer Agreement, Nitec shall grant to Jagotec the exclusive royalty free and, sublicenseable right and license to the Nitec IPR and the Nitec Know-How and any confidential information necessary or desirable for use with the Product in
the Territory and shall provide at no additional cost to Jagotec such information and documentation as shall be reasonably requested by Jagotec in that regard. 

 

	(d)	The termination for cause of this Agreement pursuant to Section 10.2 above by either Party shall not limit remedies which are or may be otherwise available in law
or equity to either Party. 

  

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	11	Representations and Warranties 

  

	11.1	 Jagotec represents and warrants that it shall carry out and undertake the development work until approval of the Product in the Territory in a careful
and diligent manner. Jagotec agrees to carefully choose, instruct and supervise any employees, officers, Affiliates or third parties to be chosen by it pursuant to this Agreement, who are involved in the Development of the Product. Nothing in this
Agreement shall be construed as a representation made, or warranty given, by Jagotec that any development performed by or for Jagotec under this Agreement will be successful in whole or in part, or that any product, including Product, which may be
developed, will be successful in the commercial marketplace. Furthermore, except as provided herein, Jagotec makes no representation or warranty, express or implied, with respect to GEOMATRIX® Technology and/or Skye Know-How, including without limitation, any warranty of completeness, accuracy, merchantability or fitness for a particular purpose.

  

	11.2	 Jagotec represents and warrants that it has all rights regarding Patents, GEOMATRIX® Technology and Skye Know-How necessary to grant the Licence and the Option and the Nitec Manufacturing Licence hereunder. Notwithstanding the preceding sentence but
subject to the following sentence, Jagotec does not assume any responsibility and makes no warranty that the performance of this Agreement and any product developed hereunder, including the Product, do not infringe any third party’s patents,
patent applications or other intellectual property rights. Notwithstanding the preceding sentence, Jagotec represents and warrants that, as of the Effective Date, it is not aware and has no knowledge of any such infringement of any third party
rights. If however, during the course of this Agreement either Party discovers that the Product infringes or may infringe any third party’s intellectual property rights, it shall promptly inform the other Party thereof and the Parties shall
meet to discuss the course of action to be taken with regard thereto. 

  

	11.3	Nothing in this Agreement shall be construed as a representation made, or warranty given by Jagotec that any patent will issue based upon any pending patent application
encompassed by the term Patents, and that any patent encompassed by the term Patents which issues will be valid or enforceable. 

  

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	11.4	Except as provided for in the Jagotec Manufacturing Agreement to be agreed upon in due time as referred to in Section 5.1 above, Jagotec assumes no liability or
responsibility for any damages caused to Nitec, third parties, and/or the environment by the manufacturing, marketing, distribution, sale or use of the Product or the Active Drug contained therein, except to the extent that any of the above are
attributable to the negligence or wilful misconduct of Jagotec in performing its obligations hereunder. 

  

	11.5	Nitec represents and warrants to strictly adhere at all times in all material respects to any and all laws, rules, regulations and conditions imposed by any competent
authority on the marketing, distribution and sale of Product, and Nitec shall during the entire term of this Agreement be solely and fully responsible for the compliance with all such laws, rules, regulations and conditions when marketing,
distributing and selling Product under the Licence. 

  

	11.6	Subject to the specific representations and warranties given and specific disclaimers of representations and warranties included in this Article 10, and further subject
to anything to the contrary contained in this Agreement, either Party shall, as to third parties, be indemnified and held harmless by the other Party from and against any and all losses, liabilities and damages arising from any claim, action or
other proceeding by any third party relating to any acts or omissions of the other Party, its directors, officers, employees or agents, or the gross negligence or wilful misconduct of such other Party, its directors, officers, employees or agents in
performing any of its obligations under this Agreement. 

  

	11.7	Any liability, warranty and undertaking contained herein shall be limited to the payment by either Party for direct damages to the other Party and in any event, neither
Party shall be liable to the other Party for any special, indirect, punitive or consequential damages and/or loss of profits or anticipated profits, respectively. 

 

	11.8	 Nitec shall, at its own expense, purchase from an insurance company of its choice and shall maintain during the entire term of this Agreement and
during [...***...] after its expiration or termination an appropriate and customary policy of general liability and product liability insurance covering its responsibilities, including in particular but without any limitation,
Nitec’s development responsibilities under Section 2 above, regarding Product developed, 

 

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manufactured, marketed, sold and used under this Agreement and the Active Drug contained therein and the use thereof. Upon request, Nitec shall provide Jagotec with evidence that such insurances
are existing and are maintained. 

  

	11.9	Nitec represents and warrants that, to the best of its knowledge and belief, having made due and careful investigation, it has acquired from Merck all relevant rights,
including but not limited to all relevant intellectual property rights of Merck in connection with the Merck Agreement to allow Nitec to carry out its obligations hereunder. Nitec shall indemnify Jagotec in respect of any breach thereof.

  

	11.10	Without prejudice and subject to the other terms of this Agreement, if Nitec determines that it requires a licence from a third party in order to manufacture, use,
sell, offer for sale or import the Product, including, without limitation, avoid infringement of any third party patent or in connection with settlement of any actual or threatened patent infringement claim, or if Nitec shall be subject to an order
or ruling of any court of competent jurisdiction requiring the payment of a royalty or other payment to a third party patent holder in respect of the manufacture, use, sale, offer for sale or import of the Product, then all such payments shall be
made at Nitec’s sole cost and expense. 

  

	12	Miscellaneous Provisions 

  

	12.1	Waivers: A waiver of a breach or default under this Agreement shall not be a waiver of any other or subsequent breach or default. The failure or delay by either Party
in enforcing compliance with any term or condition of this Agreement shall not constitute waiver of such term or condition, unless such term or condition is expressly waived in writing. 

 

	12.2	Headings: The titles and headings used in this Agreement are intended for convenience only and shall not in any way affect the meaning or construction of any provision
of this Agreement. 

  

	12.3	 Force Majeure: Neither Party shall be held in breach of this Agreement by any reason of acts or omissions caused by any Act of God or other causes
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diligence to remove any such causes and to resume performance under this Agreement as soon as it is reasonably feasible. 

 

	12.4	Assignment: Except as otherwise expressly stated herein, this Agreement and the rights and obligations hereunder shall not be assignable by either Party without the
prior written consent of the other Party, provided however, that either Party may, without such consent, assign this Agreement and its rights and obligations hereunder to an Affiliate of such Party, and in connection with the transfer or sale of all
or substantially all of its business, or in the event of its merger, consolidation, change in control or similar transaction. Any permitted assignee shall assume all obligations of its assignor under this Agreement so long as such assignee remains
liable on a joint and several basis for its obligations. 

  

	12.5	Separate Entities: Nothing in this Agreement shall constitute or be deemed to constitute a partnership between the Parties hereto or constitute or be deemed to
constitute either Party as an agent of the other for any purpose whatsoever, and neither Party shall have the authority or power to bind the other Party, or to contract in the name of and create a liability against the other Party in any way or for
any purpose, unless explicitly instructed in writing to do so. 

  

	12.6	Notices: All notices, reports and other writings which are required to be given or submitted pursuant to this Agreement shall be in writing and delivered personally or
sent by international courier service, or by confirmed facsimile transmission, to the addresses set forth below or to such other address as Jagotec or Nitec may from time to time notify to the other Party. Any and all notices sent to the other Party
in accordance with this Section 11.6 shall become effective as of receipt thereof by the other Party. 

 If to Skye,
SkyePharma or Jagotec: 
 Jagotec AG 

Eptingerstrasse 51 
 CH-4132 Muttenz, Switzerland

 Attn.: CEO 
 Fax: ++41-61-467-5574

  

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 with copy to: 
 SkyePharma PLC 
 105 Piccadilly 
 London W1J 7NJ 
 United Kingdom 
 Attn.: General Counsel 
 Tel.: +44-(0)20-7491-1777 

Fax: +44-(0)20-7491-3338 
 If to Nitec:

 Nitec Pharma AG 

Röschenzerstrasse 9 
 CH-4153 Reinach,
Switzerland 
 Attn.:Verwaltungsrat 

Fax: +41 61 711 46 39 
  

	12.7	 Severability: Each Party hereby acknowledges that it does not intend to violate any public policy, statutory or common laws, rules, regulations, treaty
or decision of any government agency or executive body thereof of any country or community or association of countries. Should one or more provisions of this Agreement be or become invalid, the Parties hereto shall substitute, by mutual consent,
valid provisions for such invalid provisions which valid provisions in their economic effect are sufficiently similar to the invalid provisions that it can be reasonably assumed that the Parties would have entered into this Agreement with such
provisions. In case such provisions cannot be agreed upon, the invalidity of one or several provisions of this Agreement shall not affect the validity of this Agreement as a whole, unless the invalid provisions are of such essential importance to
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the Parties would not have entered into this Agreement without the invalid provisions. 

  

	12.8	Interest: In the event any amount due and payable under this Agreement is not paid by the due date, then the Party owing such amount shall pay to the creditor, without
being requested by the other Party, interest on the total outstanding amount at the rate equal to the London Interbank Offered Rate (LIBOR), as published by the Financial Times on the date that such payment falls due, increased by
[...***...] in EURO and adjusted on the first day of every calendar quarter. 

  

	12.9	Entire Agreement: This Agreement, together with the Exhibits referred to herein and attached hereto, represents the entire understanding of the Parties with respect to
the subject matter hereof; and supersede all proposals or agreements, oral or written, and all other communications between the Parties related to the subject matter of this Agreement, including without limitation any representations or warranties
made by either Party hereto or its representatives. This Agreement may not be amended or modified except in a writing duly executed by the Parties. 

  

	13	Governing Law and Jurisdiction 

  

	13.1	The Parties hereto agree that this Agreement, including without limitation, all transactions affected hereunder, its validity and enforceability and all relationships
between the Parties in this connection shall be construed under and be governed in all respects by the laws of Switzerland without reference to the principles of conflicts of laws thereof and shall not be governed by the United Nations Convention on
Contracts for the International Sale of Goods (the Vienna Convention of April 11, 1980). 

  

	13.2	The Parties hereby agree that any and all disputes arising out of or in connection with this Agreement shall exclusively be submitted to and settled by the courts in
Zurich, Switzerland and the Parties hereby submit to such exclusive jurisdiction. 

  

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 This Agreement has been executed by Nitec and by Skye, by their duly authorized representatives, in
three (3) originals effective as of the Effective Date. 
  

									
	SKYEPHARMA AG	 		 		 	
					
	By:	 	/s/ Francesco Patalano	 		 	By:	 	/s/ Tessa Chapman
					
	Name:	 	Francesco Patalano	 		 	Name:	 	Tessa Chapman
					
	Title:	 	Director	 		 	Title:	 	Director
				
	JAGOTEC AG	 		 		 	
					
	By:	 	/s/ Francesco Patalano	 		 	By:	 	/s/ Tessa Chapman
					
	Name:	 	Francesco Patalano	 		 	Name:	 	Tessa Chapman
					
	Title:	 	Director	 		 	Title:	 	Director
				
	NITEC PHARMA AG:	 		 		 	
					
	By:	 	/s/ Dr. Hubertus Ludwig	 		 		 	
					
	Name:	 	Dr. Hubertus Ludwig	 		 		 	
					
	Title:	 	Verwaltungsrat	 		 		 	

  

 32. 

 EXECUTION COPY 

 

  
 Exhibit A 

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	 	 K & S Ref:
	 	 SkypePharma Ref:

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***Confidential Treatment Requested 

  
 33.

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 ***Confidential Treatment Requested 

 34. 

 EXECUTION COPY 

 

													
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 ***Confidential Treatment Requested 

 35. 

 EXECUTION COPY 

 

													
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 ***Confidential Treatment Requested 

 36. 

 EXECUTION COPY 

 

													
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 ***Confidential Treatment Requested 

 37. 

 EXECUTION COPY 

 

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 ***Confidential Treatment Requested 

 38. 

 EXECUTION COPY 

 

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

  

 ***Confidential Treatment Requested 

 39. 

 EXECUTION COPY 

 

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 ***Confidential Treatment Requested 

 40. 

 EXECUTION COPY 

 

  
 Exhibit B 

Preliminary Specifications for Product 

[...***...] 
  

			
	 Test
	 	 Specifications and Requirements

	 [...***...]
	 	[...***...]
	 [...***...]
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 Exhibit C 

Development Programme 
  

	-	[...***...] 

  

	-	[...***...] 

  

***Confidential Treatment Requested 

  
 41.

 EXECUTION COPY 

 

 Exhibit D 
 [...***...] 
  

 ***Confidential Treatment Requested 

 42.Manufacturing and Supply Agreement

 Exhibit 10.10 
 ***Text Omitted and Filed Separately 
 with the Securities and Exchange
Commission. 
 Confidential Treatment Requested 
 Under 17 C.F.R. Sections 200.80(b)(4) 
 and 230.406. 

MANUFACTURING & SUPPLY AGREEMENT 
 This MANUFACTURING & SUPPLY AGREEMENT (“Agreement”), effective as of 3 August 2007, is entered into between NITEC PHARMA AG, a Swiss corporation having a place of
business at Kägenstrasse 17, CH-4153 Reinach, Switzerland (hereinafter referred to as “NITEC”), and JAGOTEC AG, a Swiss corporation having a place of business at Eptingerstrasse 51, CH-4132 Muttenz, Switzerland
(hereinafter referred to as “JAGOTEC”; (NITEC and JAGOTEC hereinafter sometimes referred to as “Party” or “Parties”). JAGOTEC is a 100% owned subsidiary of SkyePharma plc and SkyePharma AG is a
100% owned subsidiary of SkyePharma plc. 
 WHEREAS, the Parties and SkyePharma AG signed a Development and Licence Agreement on
20 August 2004 (“DLA”); and 
 WHEREAS, NITEC is a company engaged directly or through its affiliate Nitec Pharma
GmbH in the manufacture, distribution and licensing of pharmaceutical products, including the Product (as defined below), and is interested in JAGOTEC manufacturing Product for use, marketing, distribution and sale by itself, Nitec Pharma GmbH or a
third party in the Territory (as defined below) under the terms and conditions of this Agreement; and 
 WHEREAS, JAGOTEC is a
company engaged and specialised directly or through its affiliate SkyePharma SAS - inter alia - in the manufacturing of pharmaceutical products and is interested to manufacture Product for NITEC for use, marketing, distribution and
sale by itself or a third party in the Territory under the terms and conditions of this Agreement. 
 NOW, THEREFORE, for and in
consideration of the premises, mutual covenants and agreements contained herein, and intending to be legally bound hereby, the Parties hereby agree as follows: 
  

	1.	Definitions 

 For purposes
of this Agreement, the terms defined in this Artide 1 shall have the following meanings: 
  

	1.1	“Active Ingredient” shall mean prednisone in a form meeting the Specifications and the Quality Agreement and ordered by NITEC from a third party
in accordance with Section 5. 

  

	1.2	“Affiliate” shall have the meaning given to it in the DLA. 

 

	1.3	 “Auxiliary Materials” shall mean any and all material, ingredients and components required and/or necessary for the manufacturing of
Product under 

  

 1. 

	 	 
and pursuant to the Manufacturing Process and procured by JAGOTEC from third parties in accordance with Section 5, but excluding the Active Ingredient. 

 

	1.4	“Batch” shall mean a production lot containing theoretically [...***...] units of Product of the same dosage strength (“Theoretical
Quantity”) and, at a lower actual limit, the Lower Quantity. 

  

	1.5	“Business Day” shall mean a day on which commercial banks are open for business in Lyon, France. 

 

	1.6	“Capacity Plan” shall have the meaning given to it in Section 6.1. 

 

	1.7	“Commercially Reasonable Efforts” shall have the meaning given to it in the DLA. 

 

	1.8	“Committee Members” shall have the meaning given to it in Section 6.1. 

 

	1.9	 “Contract Year” shall mean each twelve (12) months period from 1st January through 31st December during the term of this Agreement. 

 

	1.10	“GMP” shall mean Current Good Manufacturing Practice in accordance with rules governing medicinal products in the European Community and the US good
manufacturing practices (CFR 210&211) and/or becoming applicable during the term of this Agreement. 

  

	1.11	“Delivery” shall mean delivery of the Product Ex Works (Incoterms 2000) by JAGOTEC to NITEC in accordance with Section 6.9.

  

	1.12	“Delivery Day” shall mean the day when the Product is Delivered to NITEC or its nominee. 

 

	1.13	“Effective Date” shall mean the date first written herein above. 

 

	1.14	“Euro” shall mean the single currency of participating members states of the EU. 

 

	1.15	“Finished Product” shall mean the Product packaged by or on behalf of NITEC for commercial release and sale. 

 

	1.16	“First Launch” shall mean the first commercial sale to a third party customer of the Finished Product in a Major Country.

  

	1.17	“Forecast” shall have the meaning given to it in Section 6.2 

 

	1.18	“Joint Product Committee” shall mean a committee established and conducted in accordance with the procedures as set forth in Section 6.1.

  

 ***Confidential Treatment Requested 

2. 

	1.19	“Launch Period” shall mean the period of manufacturing Product for First Launch and for the next Contract Year after said First Launch.

  

	1.20	“Lower Quantity” shall mean [...***...] per Batch or if more than one batch is ordered at one time, the average of all such Batches
ordered of the same strength. 

  

	1.21	“Major Capital Expenditure” shall mean the investment by JAGOTEC at the Manufacturing Site including in equipment, zoning and any utilities, totalling
in excess of [...***...] for the expansion of overall capacity for the manufacture of Product (as opposed to mere replacement). 

  

	1.22	“Major Country” shall mean France, Germany, Italy, Spain, the United Kingdom or the United States of America. 

 

	1.23	“Manufacturing Costs” shall mean with respect to Product JAGOTEC’s fully allocated manufacturing costs applied by JAGOTEC to the Product
calculated in accordance with generally accepted accounting principles in Switzerland, and shall include but not be limited to [...***...]. Manufacturing Costs shall not include costs for Auxiliary Materials and Active Ingredient.

  

	1.23	“Manufacturing Process” shall mean the process for the manufacturing of Product as submitted in the request for registration of Product to any
Regulatory Authority in the Territory attached hereto as part of the Quality Agreement. 

  

	1.24	“Manufacturing Site” shall mean the facilities designated by JAGOTEC for manufacturing Product under this Agreement, which facilities are operated by
JAGOTEC’s Affiliate SkyePharma Production S.A.S. and which are located at 55 rue de Montmurier, BP 45, 38291 Saint Quentin-Fallavier Cedex, France. 

  

	1.25	“Marketing Authorization” shall mean with respect to any country that the applicable health authority has approved Finished Product for marketing in
such country. 

  

	1.26	“Minimum Commercial Yield” shall mean the minimum yield in % of a Batch manufactured according to the Manufacturing Process for market purposes as set
forth in Section 8. 

  

	1.27	“Non-Compliant/Non-Compliance” shall have the meaning given to it in 6.14. 

 

	1.28	“Quality Agreement” shall mean the agreement dated as of the Effective Date on cGMP which agreement shall be attached hereto as Annex 5.

  

***Confidential Treatment Requested 
 3. 

	1.29	“Price Per Unit” shall mean the price per unit of Product manufactured and supplied hereunder composed of the [...***...] of the
Manufacturing Costs plus [...***...] of the costs of the Auxiliary Materials. Costs of the Active Ingredient are not included. The Price per Unit shall be as set out in Annex 4 for the period referred to therein. 

 

	1.30	“Product” shall mean the pharmaceutical formulation named Lodotra containing the Active Ingredient manufactured and supplied hereunder by JAGOTEC in
accordance with the Quality Agreement including the Manufacturing Process and the Specifications, which have been approved for marketing and sale by Regulatory Authorities in the Territory or which are intended to use for commercialisation purposes
or clinical trials. Product is offered in the presentation according to Annex 1. 

  

	1.31	“Regulatory Approvals” shall mean all approvals, price approvals or approvals for reimbursements, product and/or establishment licenses, registrations,
permits, or authorizations (including Marketing Authorizations) of any federal, state or local regulatory agency, department, bureau or other governmental entity or Regulatory Authority, necessary for the manufacture, packaging, distribution, use,
storage, importation, export, transport, marketing and sale of the Products and/or Finished Products for therapeutic use in humans in a country of the Territory. 

 

	1.32	“Regulatory Authority/(ies)” shall mean any governmental authority in any country or group of countries of the Territory competent to approve
pharmaceutical products for manufacturing, marketing, distribution and sale in any country(ies) of the Territory and/or to approve the price for pharmaceutical products to be sold in any country(ies) of the Territory, including without limitation
the FDA and EMEA, and any successor agency thereof. 

  

	1.33	“Regulatory Standards” shall mean all standards, rules and regulations promulgated by a Regulatory Authority and applicable to the product and the
manufacture thereof, including without limitation cGMP. 

  

	1.34	“Release” shall mean release of the Product by the Qualified Person pursuant to the Quality Agreement. 

 

	1.35	“Shelf Life” shall mean in relation to the Product have the meaning given to it in the Quality Agreement/shall mean in respect of each Batch a defined
period of months (“Shelf Life Period”) as per Annex 2a which will be updated from time to time by NITEC) from the date of first contact between the Active Ingredient and Auxiliary Material. 

 

	1.36	“Specifications” shall mean the specifications for the Product as contained in Annex 2. 

 

 ***Confidential Treatment Requested 

4. 

	1.37	“Technical Support” shall mean reasonable assistance provided by JAGOTEC to NITEC strictly limited to providing technical support to an alternative
supplier of Product in connection with (a) the training of their staff, (b) cross-validation of the analytical methods and its production of three consecutive validation Batches (of one strength only) complying with the Specifications. All
other technical support, including but not limited to regulatory support, stability programs and any in vivo study work, is specifically excluded. 

  

	1.38	“Territory” shall mean collectively each country or group of countries of the world, in which a Regulatory Authority has granted Regulatory Approval.

  

	2.	Subject Matter and Grant of License 

 NITEC hereby instructs JAGOTEC, and JAGOTEC hereby agrees under the terms and conditions contained in this Agreement, to manufacture at the Manufacturing Site and supply to NITEC Product in bulk form for
use in the Finished Product for sale to the pharmaceutical trade. JAGOTEC shall manufacture and deliver Product exclusively to NITEC. JAGOTEC shall delegate its responsibilities hereunder to its Affiliate SkyePharma SAS, provided that JAGOTEC
remains solely liable to NITEC for the same. The use, marketing, distribution and sale of the Finished Product may at NITEC’s option also be carried out by NITEC’s affiliate Nitec Pharma GmbH and NITEC may delegate any other
responsibilities under this Agreement to Nitec Pharma GmbH so long as NITEC remains solely liable to JAGOTEC for the same. 
  

	3.	Manufacturing of Product 

  

	3.1	 JAGOTEC shall manufacture the Product for marketing and sale by NITEC in the Manufacturing Site in strict compliance with the Specifications and the
approved Manufacturing Process and in accordance with the Quality Agreement. Furthermore, JAGOTEC shall only use such equipment and personnel which are appropriate or duly qualified for the manufacturing of Product in accordance with the provisions
of this Agreement and the Quality Agreement. It is acknowledged and agreed between the parties that the final dissolution specification for the Product is not approved by the regulatory authorities at signing this contract but will be approved by
the regulatory authorities during the approval process. Therefore, JAGOTEC shall only be liable for failing to manufacture the Product in accordance with such preliminary dissolution specification (as per annex 2) until agreement of the Joint
Product Committee as set out below. After approval by the regulatory authorities of a final dissolution specification, JAGOTEC shall use Commercially Reasonable Best Efforts to implement such final dissolution specification such that the Product may
be manufactured at the Manufacturing Site in accordance therewith. If, having used such efforts, JAGOTEC is able to manufacture in accordance with such final dissolution specification, it shall notify the Joint Product Committee. Upon the unanimous
agreement of the Joint Product Committee that such final dissolution specification has been implemented, the Specifications and/or the 

 

 5. 

	 	 
Quality Agreement shall be amended to incorporate such final dissolution specification and JAGOTEC agrees that the campaigns following such amendment shall be manufactured in accordance
therewith. If, having used Commercially Reasonable Best Efforts to do so, Jagotec is unable to manufacture Product in accordance with such final dissolution specification within a reasonable period of time following approval, it shall continue to
manufacture in accordance with the Specifications at the date hereof, shall not be in breach of this Agreement and shall have no liability to NITEC in connection with such failure. In this clause, “Commercially Reasonable Best Efforts”
shall mean those efforts and resources that would be used by an established pharmaceutical company in its capacity as a contract manufacturer (taking into all relevant factors including but not limited to product labelling, stage in the relevant
product life, market potential, past performance, availability of resource, economic return, the regulatory environment and competitive market conditions in the therapeutic area), utilizing sound and reasonable scientific and business practice and
judgment and its manufacturing expertise, in a diligent and timely manner, all as measured by the facts and circumstances at the time such efforts are due; it being understood however for the avoidance of any doubt that such efforts shall not
include, nor shall be deemed to include, (a) the commitment by JAGOTEC to any Major Capital Expenditure and (b) any obligation on JAGOTEC to manufacture and supply the Product at less than a reasonable margin. 

 

	3.2	 JAGOTEC shall permit duly authorized representatives of (a) NITEC or (b) any third party contracted by NITEC to have an official
responsibility for the release of the Finished Product to the market according to applicable laws and regulations applying in countries of the Territory (so long as such third party has signed a confidentiality agreement on terms acceptable to
JAGOTEC) during Business Days and hours and upon reasonable prior written notice to inspect once a year (or more often if reasonably requested by NITEC on its own behalf or on behalf of its third party contractor) the Manufacturing Site - including
but not limited to manufacturing, testing, warehousing and/or storing and generation and/or disposal of waste - used for the manufacturing of Product and to inspect and take reasonable quantities of Active Ingredient, Auxiliary Materials,
intermediate product and Product manufactured for examination purposes to verify JAGOTEC’s compliance with the Manufacturing Process, the Specifications and its obligations under this Agreement including the Quality Agreement. Furthermore,
JAGOTEC will supply copies to NITEC (on NITEC’s request and at NITEC’s cost) of any and all records relating to manufacturing and testing of the Product. NITEC shall be promptly informed in writing and by fax or email if and when an
inspection by a Regulatory Authority occurs or is scheduled to occur at the Manufacturing Site which in any way involves inspection of the production of Product or any other feature of JAGOTEC’s actions in connection with Product of the
performance of this Agreement. NITEC shall be entitled to send a representative to attend any such 

 

 6. 

	 	 
inspection of the Manufacturing Site. The findings of any such inspection at the Manufacturing Site or of any other inspections including self inspections carried out in relation to production at
the Manufacturing Site of JAGOTEC for the Product shall promptly be made known in their entirety in writing to NITEC insofar and to the extent that they may potentially impact the commercialization, manufacture (including but not limited to quality
and testing) and Delivery of the Product under this Agreement. 

  

	3.3	JAGOTEC undertakes to use any and all Active Ingredient exclusively for the performance of its obligations hereunder and JAGOTEC shall, upon receipt of any supply of
Active Ingredient and Auxiliary Materials, promptly perform the quality and quantity control procedures as provided for in the Quality Agreement. In the event that any Active Ingredient and Auxiliary Materials to be used solely in the manufacture of
the Product, or any part thereof, do not meet with the Specifications and/or quality requirements as set forth in the Quality Agreement, then JAGOTEC shall reject such materials and shall promptly notify NITEC thereof in writing - including a
specific description of the deviation from the Specifications—(a) in every case in relation to Active Ingredient and (b) where such rejection is reasonably likely to impact upon the manufacture of the Product in relation to Auxiliary
Materials. The cost of any rejected Auxiliary Materials, the quality control and related rejection for Auxiliary Materials shall be borne by Jagotec or its suppliers subject to the terms of existing supply agreements between Jagotec and its
suppliers of Auxiliary Materials. The cost of any rejected Active Ingredient, quality control and rejection for Active Ingredient shall be borne by NITEC or its selected supplier subject to the terms of any existing supply agreement between NITEC
and the Active Ingredient supplier unless this failure is caused by a failure of JAGOTEC during the quality control process for the Active Ingredient. 

  

	3.4	JAGOTEC shall store all Active Ingredient, Auxiliary Materials, intermediate product and all Product manufactured hereunder, in a suitable warehouse under suitable
conditions as set forth in the Quality Agreement preventing the deterioration, theft or damage of Active Ingredient, Auxiliary Materials, intermediate products and Product until the agreed Delivery Day to NITEC, and JAGOTEC shall insure against such
risks all Active Ingredient, Auxiliary Materials, intermediate products and all Product manufactured hereunder until Delivery. 

 The Active Ingredient ordered by NITEC for the purposes of manufacturing of Product shall remain NITEC property but shall be stored by JAGOTEC under JAGOTEC’s sole responsibility. 

JAGOTEC shall report to NITEC at least once a month on the level of stocks of Active Ingredient, and Product manufactured, including a
differentiation of the status of the Product manufactured, such as “under quarantine”, “released”, “rejected”). The report frequency may be modified by decision of the Joint Product Committee. 

 

 7. 

 Should Auxiliary Materials ordered exclusively for NITEC need to be re-analysed after being
stored by JAGOTEC in compliance with the Quality Agreement for a period in excess of its intended shelf-life, NITEC shall cover the cost of such analysis. Should Active Ingredient or Auxiliary Materials require re-analysis due to failure to comply
with the storage provisions of the Quality Agreement, or where such re-analysis is carried out by JAGOTEC for its own internal purposes, then JAGOTEC shall cover the cost of such analysis. 

 

	3.5	JAGOTEC hereby agrees to guarantee NITEC, upon two week’s prior written notice, free and full access to any know-how relating to the manufacture of the Product
necessary to enable NITEC to obtain or maintain any Regulatory Approval in the Territory, to perform the Batch release, to ensure that the finished Product is in line with the Regulatory Approval and all other (local) applicable laws and regulations
and to enable qualified NITEC personnel to fulfil NITEC’s legal and regulatory obligations. 

 Each change in
the Product or in the Manufacturing Process proposed by either Party, shall be communicated to the other Party in advance, to enable the other Party to comment on such intended changes before implementation. Any changes proposed by JAGOTEC shall
only be implemented with NITEC’s prior written consent, which consent shall not be unreasonably withheld or delayed. The Joint Product Committee shall discuss any benefit generated by the implementation of changes proposed by JAGOTEC and decide
which party shall bear which proportion of the costs thereof. NITEC shall bear or reimburse JAGOTEC for all of JAGOTEC’s costs (including without limitation any regulatory costs) associated with any change initiated by NITEC or required by a
Regulatory Authority and related specifically to the Product. Further details regarding the change control procedure will be set forth in the separate Quality Agreement. 

 

	3.6	Quality control of Product is under the sole responsibility of NITEC. Therefore JAGOTEC will not analyze the Product in order to determine its suitability for quality
control under this Agreement or applicable requirements of a Regulatory Authority or with any applicable Regulatory Approval. All in-process controls are under the sole responsibility of JAGOTEC. JAGOTEC will not change the in- process controls as
set forth in the Regulatory Approval and the Quality Agreement without the written consent of NITEC. 

 JAGOTEC
shall provide NITEC with the results of the in-process controls after occurrence and with samples of Product to perform the quality control testing within 3 working days of the final press-coating step. NITEC shall inform JAGOTEC on the results of
such analysis also within 3 working days of completion. 
 In the event that JAGOTEC agrees to the implementation of the
analytical method (quality control)for Product at JAGOTEC, NITEC shall reimburse 
  

 8. 

 
JAGOTEC for all of JAGOTEC’s reasonable costs associated with such analytical method transfer, to the extent JAGOTEC has notified NITEC in advance of the estimated amount of such costs.
Otherwise, each Party shall bear its own costs related to such analytical method transfer. 
  

	3.7	Without prejudice to Section 3.6, JAGOTEC shall perform all in-process control tests and confirm the GMP-compliant manufacture of the Product pursuant to the terms
of the Quality Agreement. 

  

	3.8	JAGOTEC agrees to provide sufficient manufacturing capacity subject to the terms hereof to fulfil NITEC’s requirements for the Product as bulk tablets, to the
extent that these requirements of NITEC are reflected in NITEC’s Forecast per Section 6.2 and in JAGOTEC’s Capacity Plan per Section 6.1. 

 

	4.	Obligations of NITEC 

  

	4.1	NITEC shall be responsible, at its own cost and expense, for maintaining and updating from time to time, if needed, any and all Regulatory Approvals.

  

	4.2	NITEC shall appoint a supplier of Active Ingredient and shall ensure that such supplier supplies Active Ingredient in a timely manner which meets with the
Specifications and/or quality requirements as set forth in the Quality Agreement. NITEC agrees that for the avoidance of any shortfalls during the Launch Period it will order [...***...] of the Active Ingredient required for the
manufacturing of Product (as recommended by JAGOTEC pursuant to clause 5.1, firmly ordered by NITEC). 

  

	4.3	NITEC shall be responsible for the qualification of the supplier of the Active Ingredient as set forth in the Quality Agreement. 

 

	4.4	NITEC shall contract with such supplier, be responsible for all dealings with, and settle all invoices of such supplier. NITEC shall negotiate with each such qualified
supplier prices, annual amounts and lead times for the supply of the Active Ingredient. NITEC shall inform JAGOTEC in writing of the relevant parts of the agreements between NITEC and the suppliers of the Active Ingredient. 

 

	4.5	NITEC shall ensure that such supply of Active Ingredient shall be in compliance with the Specifications and the requirements set forth in the Quality Agreement, and
shall be delivered DDP (Incoterms 2000 ICC) to the Manufacturing Site. 

  

	4.6	NITEC shall notify JAGOTEC of any matter of which it becomes aware which is reasonably likely to impact upon the delivery or quality of the Active Ingredient to
JAGOTEC. 

  

 ***Confidential Treatment Requested 

9. 

	5.	Obligations and Responsibilities of JAGOTEC 

  

	5.1	JAGOTEC undertakes to recommend a supplier of the Auxiliary Materials which JAGOTEC shall contract with and from which JAGOTEC shall order the same for the purposes
hereof. 

  

	5.2	JAGOTEC shall be responsible for the qualification of the supplier of the Auxiliary Materials as set forth in the Quality Agreement. 

 

	5.3	JAGOTEC shall negotiate with each such qualified supplier prices, annual amounts and lead times for the supply of the Auxiliary Materials. JAGOTEC shall inform NITEC in
writing of the agreements between JAGOTEC and the suppliers of the Auxiliary Materials. 

  

	5.4	JAGOTEC shall be responsible for the keeping of the contract with the supplier and the usage of Auxiliary Materials for manufacturing of Product which meet with the
Specifications and/or quality requirements as set forth in the Quality Agreement. 

 For the avoidance of any
shortfalls during the Launch Period JAGOTEC shall order [...***...] of the Auxiliary Materials required for the manufacturing of Product firmly ordered by NITEC. JAGOTEC shall ensure that such supply of Auxiliary Materials shall be in
compliance with the requirements set forth in the Quality Agreement, and shall be delivered DDP (Incoterms 2000 ICC) to the Manufacturing Site. 
  

	5.5	Any change in the supplier or the specification of the Auxiliary Materials shall require the prior written consent of NITEC. 

 

	5.6	JAGOTEC shall notify NITEC of any matter of which it becomes aware which is reasonably likely to impact upon the Delivery Day or otherwise on JAGOTEC’s ability to
fully and timely perform its obligations under this Agreement. 

  

	5.7	JAGOTEC may provide support in relation to technology transfer other than Technical Support to NITEC upon agreement by NITEC to the payment of such costs of providing
such support as are agreed. 

  

	6.	Order and Supply of Product 

  

	6.1	 The parties shall establish a “Joint Product Committee” consisting of four (4) individuals (“Committee Members”); two
of whom shall be nominated by JAGOTEC and two of whom shall be nominated by NITEC. 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
the Joint Product Committee meetings. The Joint Product 

  

 ***Confidential Treatment Requested 

10. 

	 	 
Committee shall meet at least once per quarter to review NITEC’s Forecast (as defined in Section 6.2) for the Product, which shall reflect NITEC’s realistically anticipated up-side
scenario for its requirements for Product. JAGOTEC shall provide to NITEC, at the beginning of each quarter for the following eight quarters with a capacity plan for the Product (“Capacity Plan”). The Joint Production Committee
shall compare the Capacity Plan to NITEC’s Forecast. Each member of the Committee shall have one vote in relation to matters discussed by it and save as otherwise set out herein votes shall be carried by a majority. Initial members of the
Committee shall be set out in Annex 9. 

  

	6.2	NITEC shall issue, for the first time on the date of signature hereof, and thereafter during the term of this Agreement at the beginning of each quarter in accordance
with Section 6.3, a rolling forecast (“Forecast”) for the upcoming [...***...] estimating NITEC’s requirements of Product for (a) distribution and sale and (b) for clinical studies in the Territory,
which forecasts shall be used by JAGOTEC for production planning purposes. The submission of each Forecast shall constitute a binding order for the quantity of Product set forth in [...***...] for Delivery at the latest [...***...] after
the submission thereof save that the quantities set forth in [...***...] of the first Forecast issued on the date of signature of this Agreement shall not be binding on the parties unless agreed between them. In each Forecast,
[...***...] shall be (i) within +/- [...***...] of the quantities of the Product set out in [...***...] in the Forecast immediately preceding the most recent Forecast and (ii) within +/- [...***...] of the
quantities set out in [...***...] in the forecast immediately preceding the Forecast referred to in (i). Save as set out herein, it is mutually agreed between the Parties that the Forecast is only a non-binding estimate of NITEC’s
requirements of the Product and that in particular in case of any foreseeable launches in a Major Country such Forecast may be adequately adjusted by mutual agreement of the parties. 

 

	6.3	 Any purchase order (to be sent out by NITEC on a monthly basis) shall be confirmed by JAGOTEC within 5 working days and shall be binding upon JAGOTEC,
provided that the requested Delivery Day is not earlier than [...***...] after the receipt of such purchase order and provided that such order shall correspond with the binding element of the Forecast for the month in question. It is
JAGOTEC’s obligation to negotiate with the Auxiliary Materials supplier lead times for the supply of the Auxiliary Materials in quantities and of quality sufficient for timely manufacturing of Product in accordance with any [...***...]
Forecast. JAGOTEC shall recommend to NITEC and its Active Ingredient supplier (a) the quantity of Active Ingredient and (b) the dates of delivery of the same which would, in JAGOTEC’s reasonable opinion based on Forecasts, be required
in order for JAGOTEC to timely manufacture Product in accordance with any [...***...] Forecast. Further JAGOTEC shall inform NITEC at the same time about the existing stock of Active Ingredient held by JAGOTEC. JAGOTEC shall not be responsible
for any other dealings with such 

  

 ***Confidential Treatment Requested 

11. 

	 	 
supplier nor shall it be liable for the failure of such supplier to supply Active Ingredient in a timely manner or that does not meet with the Specifications and/or quality requirements as set
forth in the Quality Agreement. JAGOTEC shall inform NITEC immediately in writing of any deviation from the aforementioned [...***...] lead time. 

 

	6.4	Notwithstanding anything contained herein, NITEC may always request supply of Product in excess of the quantity set out in Section 6.3 but any such request shall
not be considered a firm order binding upon JAGOTEC unless and to the extent confirmed by JAGOTEC in writing, provided that JAGOTEC shall at all times employ its Commercially Reasonable Efforts to comply with any request of NITEC for Product.

  

	6.5	If (a) in any three consecutive Forecasts, the quantity forecast in respect of [...***...] thereof would, in JAGOTEC’s sole opinion, require
Major Capital Expenditure in order for JAGOTEC to manufacture such quantity (JAGOTEC basing such opinion upon it deciding in its sole discretion that the quantity forecast exceeds the quantity that it could provide on the date of each such Forecast
by [...***...] of the maximum available capacity for NITEC as per Capacity Plan would be required), and (b) in the third such consecutive Forecast, the quantity forecast in respect of [...***...] thereof would so require Major
Capital Expenditure, JAGOTEC within [...***...] of receipt of the third such consecutive Forecast shall notify NITEC and decide, whether or not to commence such Major Capital Expenditure. If JAGOTEC commences such Major Capital Expenditure
NITEC agrees and acknowledges that such Major Capital Expenditure is likely to take [...***...] to complete 

  

	6.6	If JAGOTEC decides, upon receiving the third such consecutive Forecast as set out in Section 6.5 above, not to commence Major Capital Expenditure it shall notify
NITEC of its decision and any subsequent [...***...] Forecast shall only become binding as to the quantity that JAGOTEC is able to manufacture without such Major Capital Expenditure. Upon such decision not to commence Major Capital
Expenditure, NITEC shall be entitled to qualify one second manufacturing site on the foregoing conditions. NITEC may, from the date upon which the third consecutive [...***...] forecast becomes a [...***...] Forecast, as set out in
Section 6.5, use such second manufacturing site to fulfil in any subsequent quarter only such amount of orders as exceed those which JAGOTEC is unable to manufacture as a result of not commencing Major Capital Expenditure. JAGOTEC shall in such
circumstance provide Technical Support to NITEC at NITEC’s cost. 

  

	6.7	 Each order under Section 6.2 above shall consist of not less than [...***...] Batches of Product covering all dosage strengths (save that in
the first two years following First Launch Jagotec agrees to accept individual orders of less than [...***...], without prejudice to the minimum order obligation in the following sentence. NITEC shall order the minimum quantities set out and
according to Annex 3 (the “Minimum Quantities”). The firm order for launch 

  

 ***Confidential Treatment Requested 

12. 

	 	 
stock is at least 1 Batch of Product per dosage strength. NITEC will place orders of Product in units of whole Batches. 

 

	6.8	It is agreed and understood between the parties that the quantities ordered by NITEC shall be based upon the fact that each Batch (or the average of a number of Batches
where more than one Batch is ordered at any one time) may contain [...***...] of units and such Lower Quantity would be, if Delivered, sufficient to satisfy its requirements and NITEC shall supply Forecasts accordingly.

  

	6.9	JAGOTEC shall supply Product firmly ordered by NITEC in accordance with this Agreement at the applicable and agreed Delivery Day upon the preceding and following
conditions; (a) Any Batch (or number of Batches on average as set out in Section 6.8) of Product may not fall short of the Lower Quantity; and (b) All Products shall be Delivered to NITEC Ex Works (Incoterms 2000) the Manufacturing
Site. Together with any such shipment of Product, JAGOTEC shall provide NITEC with the documents and samples specified in the Quality Agreement. JAGOTEC shall be responsible for ensuring that each Delivery of Product shall be delivered to NITEC as
soon as possible (and in any event within 3 months) after its manufacture. 

  

	6.10	Delivery performance and failures. Orders are considered as orders fulfilled on time if the Products meet the standards set out in the Quality Agreement and not
properly rejected on the terms hereof and if the Delivery Day set out in an order acceptance is met by [...***...]. In the case that JAGOTEC does not reach the on time targets above, JAGOTEC shall use all Commercially Reasonable Efforts to
fulfil such orders and NITEC shall, in addition to any other remedy (including under Section 8 in any case in which the Minimum Commercial Yield is not achieved), be entitled to reduce the Price Per Unit of late batches by [...***...] of
delay but to a maximum of [...***...] 

 If JAGOTEC produces a Batch or Batches (on average as above)
containing less than the Lower Quantity JAGOTEC shall immediately inform NITEC in writing. NITEC will thereafter be entitled to place an additional order (not defined as or part of any Minimum Orders) and JAGOTEC agrees to use Commercially
Reasonable Efforts to accept and fulfil this order within such a shortened lead time as is reasonably practicable (and to within five days provide NITEC with a Delivery Day therefor) provided that such quantities of Active Ingredient and Auxiliary
Materials are on stock in order to do so. To avoid any shortfalls during the Launch Period the Parties hereby agree (in Sections 4.2 and 5.4) to order [...***...] of Active Ingredient and Auxiliary Materials respectively of the amount firmly
ordered by NITEC during such Launch Period. 
  

 ***Confidential Treatment Requested 

13. 

 NITEC shall then be obliged to pay the following amounts in respect of the additionally
ordered Batches as set out above; 
  

	 	(a)	in respect of units up to the total Minimum Commercial Yield ordered – the Price Per Unit; 

 

	 	(b)	in respect of the balance of supplied units (i.e. in excess of the Minimum Commercial Yield ordered) – the Price Per Unit [...***...]

 JAGOTEC shall not keep Product on stock except for the purpose of retaining samples as defined in the quality
agreement or as required for analysis in case of a dispute pursuant to clause 6.17 or otherwise. 
  

	6.11	JAGOTEC shall notify NITEC of the Delivery Date for a Delivery at least five (5) days prior of the same and NITEC undertakes to accept Delivery of all Product
Delivered by JAGOTEC on such Delivery Date. JAGOTEC will package and label Product in accordance with the provisions of the Quality Agreement including at least code number, name of product, batch number, order number, quantity of supplied Product
per package and date of manufacture. 

  

	6.12	If following completion of Major Capital Expenditure NITEC does not order quantities equal to (a) those in the Forecasts which triggered such Major Capital
Expenditure [...***...] and (b) that forecast in respect of [...***...] in the subsequent Forecast, the Price Per Unit of quantities actually ordered will be adjusted as follows; 

Where the amounts ordered by NITEC are less than [...***...] but more than [...***...], of maximum available capacity: Price
Per Unit [...***...] 
 Where the amounts ordered by NITEC are [...***...] or less, but more than [...***...]
of maximum available capacity: Price Per Unit [...***...] [...***...] 
 Where the amounts ordered by NITEC are
[...***...] or less of maximum available capacity: Price Per Unit [...***...] 
 The maximum available capacity for
the purposes of this Section 6.12 shall be that available for NITEC as per Capacity Plan at the date upon which JAGOTEC notified NITEC of the need for Major Capital Expenditure under Section 6.5. 

Any amounts in respect of an increase in prices due under this Section 6.12 shall be invoiced at the end of the twelve month period
following completion of Major Capital Expenditure. Payment terms shall be as per order to reflect the price adjustment for the previous twelve month; payment term for this invoice will be as per Annex 4. 

 

 ***Confidential Treatment Requested 

14. 

	6.13	NITEC shall bear the cost of bulk, quality control and rejection of spoiled, damaged, contaminated or defective Active Ingredient provided that such Active
Ingredient’s damage, contamination or defect could not have been discovered by JAGOTEC with standard sampling or analytical procedures as defined in the Quality Agreement. 

 

	6.14	If any shipment of Product or any portion thereof is spoiled, damaged, contaminated or defective upon Delivery or fails to meet the Specifications or the quality
standards set out in the Quality Agreement (together “Non- Compliant”), then NITEC shall have the right to reject such shipment or the portion affected thereby by giving written notice to JAGOTEC within [...***...] following
the Delivery of such shipment of Product, sufficiently specifying the alleged Non-Compliance and the quantities affected. Any shipment or portion thereof so rejected by NITEC shall be held at JAGOTEC’s disposal for examination. JAGOTEC shall
investigate such issue and provide a written report to NITEC as soon as possible after notification. JAGOTEC shall not be liable for any Non-Compliance of the Product arising out of the shipment, storage or handling of Product by NITEC or its
representatives, agents or customers. 

  

	6.15	In the event that any shipment of Product or any portion thereof is rightly rejected by NITEC in accordance with Section 6.14 above, then JAGOTEC undertakes to
take back and, at NITEC’s request, destroy such Non-Compliant Product, and to replace such Non-Compliant shipment or portion thereof with an identical quantity of Product as soon as reasonably possible. 

 

	6.16	In any case of Non-Compliance, NITEC shall pay for the Non-Compliant Product, provided that such payment shall not be deemed to be a waiver of NITEC of any of its
rights on account of such Non-Compliance. 

 Should the Non-Compliance be due to JAGOTEC, such replacement shall be
effected at JAGOTEC’s own cost and expense which includes but is not limited the corresponding amount of Active Ingredient and Auxiliary Materials in the Non-Compliant Batch or part thereof and the Manufacturing Costs. 

The Non-Compliant Product shall, at JAGOTEC’s cost and expense, be returned to JAGOTEC. 

NITEC shall pay for the replacement of Product in accordance with the payment provisions of this Agreement, provided that Product supplied
by JAGOTEC conforms with quality standards as of Annex 5. 
 Should the Non-Compliance be due to NITEC (including for the
avoidance of doubt in situations where the Active Ingredient is contaminated and such Active Ingredient contamination could not be discovered by JAGOTEC with standard sampling or analytical procedures as defined in the Quality Agreement), NITEC
shall pay for the replacement of Product in accordance with the payment provisions of this Agreement. 
  

 ***Confidential Treatment Requested 

15. 

	6.17	In the event of any dispute between the Parties regarding the question whether a shipment of Product or any part thereof timely rejected by NITEC was actually
Non-Compliant, and/or where responsibility for such Non-Compliance, under the terms hereof, lies the Parties agree to have an independent mutually acceptable (each Party acting reasonably) laboratory or expert perform such tests and analysis on the
rejected Product as deemed necessary and/or required to establish the defect alleged by NITEC and the reasons therefore. The result of such independent laboratory or expert shall be binding upon the Parties, and the cost of such examination shall be
borne by the losing Party. 

  

	6.18	In cases in which the resolution of a dispute or investigations is anticipated to take more than 2 weeks, JAGOTEC shall upon NITEC’s request and as soon as
practicable after notification of the rejection deliver replacement Products for the Products under dispute in order to ensure continuity of supply. 

  

	6.19	Together with any shipment of Product, JAGOTEC shall issue a respective invoice for such shipment, applying the then valid Price Per Unit, multiplied by the number of
units of Product actually supplied. NITEC undertakes to pay any and all such invoices within [...***...] as of the delivery date of the respective shipment of Product (“Payment Date”). In the event of late payment JAGOTEC may
charge interest on the outstanding amount at a rate of [...***...] and such interest shall be calculated and payable in respect of the period from Payment Date until the date payment in full is received by JAGOTEC. 

 

	7.	Calculation and Adjustment of Price Per Unit 

  

	7.1	The Price per Unit does not include any Value Added Taxes (VAT), turnover taxes or similar charges in any country, which are to be added and paid by NITEC as
applicable. The Price Per Unit of this Agreement shall remain applicable for all supplies of Product during the term from the Effective Date until 31 Dec 2007. 

 

	7.2	Thereafter, the Price per Unit contained in Annex 4 hereto may be adjusted by JAGOTEC once each Contract Year in the month of October calculated as follows:

  

	 	(a)	Adjustments to Manufacturing Costs shall be calculated on the basis of [...***...]; 

 

	 	(b)	Adjustments to costs of Auxiliary Materials shall be calculated by reference to actual changes to the costs thereof, without any mark up added by JAGOTEC

 In no Contract Year may any increase be in excess of [...***...] of the then current Price Per Unit save
by mutual agreement of the parties. Such adjusted Price 
  

 ***Confidential Treatment Requested 

16. 

 
per Unit shall be attached hereto as new Annex 3 each year and shall remain in force for supplies of Product during the next Contract Year. 

 

	7.3	NITEC shall have the right, through its employees and/or its independent auditing representatives and upon reasonable notice, to audit, during normal business hours,
all records and accounts of JAGOTEC as may under recognised accounting practices contain information bearing upon the Price per Unit. Such audit shall be carried out at NITEC’s expense unless it reveals that a Price Per Unit quoted by JAGOTEC
to NITEC prior to the audit exceeded the Price per Unit calculated in accordance with this Agreement by [...***...] or more, in which case JAGOTEC shall, forthwith reimburse NITEC for the cost of audit and an amount equal to the
overpayment. 

  

	8.	Minimum Commercial Yield 

JAGOTEC commits itself to attaining the Minimum Commercial Yield of the Product as set out in Annex 6 (or as may otherwise be amended on
the terms hereof). The Commercial Yield shall be calculated as follows: 
 (a +b)/c 

 

	 	a    =	number of units delivered by JAGOTEC 

  

	 	b    =	number of sample units necessary for control purposes and retaining samples 

 

	 	c    =	theoretical quantity of units per Batch of Product in bulk Tablets 

 If the actual yield of Product, calculated for a maximum of one (1) year, is below the Minimum Commercial Yield, JAGOTEC shall reimburse NITEC for a proportionate amount of the cost of Active
Ingredient. 
 This Minimum Yield shall be reviewed annually to allow for possible improvements in the Manufacturing Process.

  

	9.	Delivery Conditions: 

JAGOTEC will deliver Product packaged and labelled in accordance with the Quality Agreement and the defined “Logistics” under
Annex 7. 
  

 ***Confidential Treatment Requested 

17. 

	10.	Term and Termination 

  

	10.1	According to the DLA this Agreement shall commence as of the Effective Date and shall continue in full force and effect until the end of the 5th year after First Launch
(“Minimum Term”). It shall be automatically extended on a yearly basis unless terminated by one Party by giving to the other at least (subject to the Section 10.2 below) twenty four (24) months’ written notice to
expire not before the end of the Minimum Term. 

  

	10.2	In the event of the payment of Major Capital Expenditure the notice period for any termination by either party to occur within [...***...] years of such
Major Capital Expenditure shall be [...***...] months. 

  

	10.3	Notwithstanding anything contained in Section 10.1 above, and except as otherwise explicitly provided in this Agreement, this Agreement may be terminated at any
time with immediate effect by giving written notice to that effect, as follows: 

  

	 	a)	by either Party, if the other Party is materially in default or in material breach of a term or provision hereof and such default or breach continues “and” if
curable, is not cured or remedied within [...***...] upon the other Party’s written request to cure or remedy such default or breach; or 

  

	 	b)	by either Party, if the other Party becomes insolvent or goes into liquidation, voluntarily or otherwise, other than for the sole purpose of reorganisation, or goes
into bankruptcy or makes an assignment for the benefit of creditors, or in the event of a receiver being appointed of the other Party’s property or parts thereof. 

 

	10.4	Upon the termination or expiry of this Agreement, regardless of the reason therefor, JAGOTEC shall at NITEC’s written request continue the supply of Product to
NITEC until such time as NITEC has an alternative manufacturing site approved by appropriate Regulatory Authorities for the supply of Product save that it shall be under no obligation to continue such supply for a period exceeding 24 months from the
date of such termination notice. Upon notice of termination or expiry, NITEC shall seek such an alternative manufacturing site with reasonable speed and JAGOTEC shall provide Technical Support to NITEC in relation to technical transfer issues
relating to Product to the alternative manufacturing site chosen by NITEC. If this Agreement is terminated by NITEC for JAGOTEC’s breach of this Agreement, the costs of the Technical Support shall be born by JAGOTEC. In all other circumstances
the costs of the Technical Support shall be borne by NITEC. 

  

***Confidential Treatment Requested 
 18. 

	11.	Effects of Termination 

  

	11.1	In the event of termination or expiry of this Agreement by either Party, no compensation or indemnity shall be payable to or may be claimed by either Party from the
other Party as a result of such termination other than as set forth in this Agreement. Notwithstanding the preceding sentence, the termination of this Agreement by either Party shall not relieve the Parties of any obligation accruing prior to the
effective date of such termination. 

  

	11.2	In the event of termination of this Agreement by JAGOTEC under Section 10.2 above, NITEC shall, upon JAGOTEC’s request together with the respective
termination notice take also delivery of any and all Auxiliary Materials in stock and firmly ordered by JAGOTEC on the basis NITEC’s Forecast against payment of the net procurement price for such Auxiliary Materials paid by JAGOTEC to third
party suppliers (plus Value Added Tax, turnover tax or similar charges, as applicable). All such Auxiliary Material and Active Ingredient shall be collected by NITEC from the Manufacturing Site. 

 

	11.3	The Parties agree that in the event of termination of this Agreement for whatsoever reason, Sections 11, 12, 13 and 17 shall remain in full force and effect in
accordance with such respective provisions. 

  

	11.4	Except as otherwise explicitly provided in this Agreement, nothing contained in this Section 10 shall in any way limit, and shall be without any prejudice to, any
other rights or remedies which may be available to either Party. 

  

	12.	Indemnity and Insurance 

  

	12.1	JAGOTEC does not assume any liability or gives any representation or warranty, whether express nor implied, for the merchantability or fitness for a particular purpose
of Product or Finished Product manufactured and/or supplied hereunder except to the extent that such liability arise from the gross negligence or wilful misconduct of JAGOTEC, its Affiliates or any of its or their respective employees.

  

	12.2	In no event shall JAGOTEC be liable for any direct, indirect, incidental, commercial or other damage, costs, fees, expenses or costs (“Damages”) caused
by Product and/or the Active Ingredient and/or the Auxiliary Materials to NITEC or any third party except to the extent that such Damages arise from the negligence or wilful misconduct of JAGOTEC, its Affiliates or any of its or their respective
employees. 

  

	12.3	 JAGOTEC assumes no liability vis a vis third parties, including without limitation, product liability, with respect to any and all Product or Finished
Product marketed, distributed, sold or used, directly or indirectly, and the 

  

 19. 

	 	 
Active Ingredient and Auxiliary Materials contained in any such Product or Finished Product. NITEC shall indemnify JAGOTEC from and against any and all losses, liabilities, damages and expenses
(including reasonable attorney’s fees and reasonable costs) that JAGOTEC suffers as a result of any claim, demand, action or other proceeding by any third party arising from or relating to NITEC’s actions regarding the manufacturing,
marketing, distribution, safe or use of Product, the Active Ingredient and/or Auxiliary Materials and/or Finished Product, or resulting from any breach of any of NITEC’s obligations and/or responsibilities and/or representations and warranties
hereunder, except to the extent that any such losses, liabilities, damages and expenses arise from the gross negligence or wilful misconduct of JAGOTEC. 

 

	12.4	Each of NITEC and JAGOTEC shall maintain, during the term of this Agreement and for a period of not less than five (5) years after its termination for what so ever
reason, liability insurance, including in the case of NITEC, product liability insurance, with respect to and covering their respective obligations contained in this Section 12, in such amount as is customary for companies undertaking similar
activities as the respective Party with products similar to Product. 

  

	13.	Confidentiality 

  

	13.1	Each Party has disclosed to the other party prior to the Effective Date, and will during the term of this Agreement continue to disclose, proprietary, confidential and
non-public information, including without limitation the Manufacturing Process, price calculations and other business and trade secrets (hereinafter, all collectively referred to as “Confidential Information”). 

 

	13.2	Each Party as recipient (the “Receiving Party”) of Confidential Information of the other Party (the “Disclosing Party”) hereby undertakes to
maintain in confidence all Confidential Information of the Disclosing Party and shall not use, disclose or grant or permit the use of any of the Confidential Information of the Disclosing Party except on a need-to-know basis to its directors,
officers, employees, agents, consultants, clinical investigators or other permitted contractors, to the extent such disclosure is reasonably necessary in connection with the activities of the Receiving Party as expressly authorized by this
Agreement. To the extent that disclosure is authorized by this Agreement, prior to disclosure, the Receiving Party shall obtain agreement in writing of any such person to hold in confidence and not make use of the Confidential Information of the
Disclosing Party for any purpose other than authorized by this Agreement. Each Receiving Party shall notify the Disclosing Party promptly upon the discovery of the unauthorized use or disclosure of any such Confidential Information of the Disclosing
Party. 

  

	13.3	 The obligations of confidentiality and non-use contained in Section 13.2 above shall not apply to the extent that (a) a Receiving Party
(i) is required to 

  

 20. 

	 	 
disclose the Confidential Information by law, regulation or order of a governmental agency or a court of competent jurisdiction, or (ii) is required to disclose Confidential Information of
the Disclosing Party to any Regulatory Authority for purposes of obtaining or maintaining registration for Product and/or Finished Product, provided that the Receiving Party shall request confidential treatment thereof (where available), or
(b) the Receiving Party can demonstrate by written or other tangible evidence that (i) the disclosed information of the Disclosing Party was public knowledge at the time of such disclosure to it, or thereafter became public knowledge,
other than as a result of actions of the Receiving Party, its directors, officers and employees in violation hereof; or (ii) the disclosed information was rightfully known by the Receiving Party (as shown by its written records) prior to the
date of disclosure to it by the Disclosing Party; or (iii) the disclosed information was developed or acquired by the Receiving Party independently of any knowledge or use of the Confidential Information of the Disclosing Party (as shown by its
written records); or (iv) the Confidential Information was previously legally provided to the Receiving Party by a third party without any obligations of confidentiality to the Disclosing Party. 

 

	13.4	The confidentiality obligations under this Section 13 shall be effective during the term of this Agreement and for a period of ten (10) years after the
termination hereof for any reason. Each Disclosing Party shall be entitled to injunctive remedies and relief against the Receiving Party and any third parties for any breach or threatened breach of the confidentiality obligations under this
Section 13 with respect to any of the Confidential Information of the Disclosing Party. 

  

	14.	Exclusivity 

 During the
term of this Agreement, JAGOTEC undertakes (a) not to engage in any production of Product for or on behalf of any third party and (b) to supply to NITEC all of NITEC requirements for the Product subject to the terms hereof. NITEC agrees to
order all its requirements for the Product from JAGOTEC (save as is otherwise provided herein). 
  

	15.	Miscellaneous Provisions 

  

	15.1	 Entire Agreement: The terms, covenants, conditions and provisions contained in this Agreement, including the Annexes referred to herein which
are agreed to form an integral part hereof, constitute the total and complete agreement of the Parties regarding the subject matter hereof and supersede all prior understandings and agreements hereto made, and there are no other representations,
understandings or agreements relating to the subject matter hereof. The provisions of this Agreement may not be waived, altered, amended 

 

 21. 

 
or repealed in whole or in part except by the written consent of both of the Parties to this Agreement. 
  

	15.2	Assignment: Save as set out below, this Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or
transferred by either Party without the prior written consent of the other Party. Either Party may assign in full all its rights and obligations hereunder to an Affiliate of that party (and only for so long as the assignee remains an Affiliate) and
if the assigning party remains fully liable to the other party for the full and timely performance of this Agreement by the party receiving assignment and any of such parties direct or indirect successors in interest. 

Any permitted assignee shall assume all obligations of its assignor under this Agreement or under the respective rights or obligations
actually assigned. 
  

	15.3	Notices: Any consent, notice or report required or permitted to be given or made under this Agreement by one Party to the other shall be in English and in
writing, delivered personally or by international courier service or by facsimile (promptly confirmed by personal delivery or international courier service) addressed to the other Party at its address indicated below, or to such other address as
shall have been notified in writing to the sending Party by the receiving Party from time to time, and shall take effect upon receipt by the addressee. 

  

			
	If to NITEC:	  	NITEC PHARMA AG
		  	Kägenstrasse 9
		  	CH 4153 Reinach
		  	Switzerland
		  	attn.: Jochen Mattis
		  	Tel: ++ 41 61 715.20.40
		  	Fax: ++ 41 61 715.20.49
		  	Email: jochen.mattis@nitecpharma.com
		
	If to JAGOTEC:	  	JAGOTEC AG
		  	Eptingerstrasse 51
		  	CH-4132 Muttenz,
		  	Switzerland
		  	attn.: Francesco Patalano
		  	Fax No: ++41 61 467 55 74
		
	With copy to:	  	SkyePharma Plc
		  	105 Piccadilly
		  	London W1J 7NJ
		  	Great Britain
		  	attn.: Group Counsel
		  	Fax No: ++44 20 7491 3338

  

	15.4	 Independent Contractors: It is expressly agreed that the Parties shall be independent contractors and that the relationship between the Parties
shall not 

  

 22. 

	 	 
constitute a partnership, joint venture or agency. Neither Party shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be
binding on the other Party, without the prior written consent of the other Party to do so. 

  

	15.5	NITEC warranty: NITEC warrants that it owns one hundred percent of the shares of Nitec Pharma GmbH. 

 

	15.6	Severability: Each Party hereby acknowledges that it does not intend to violate any public policy, statutory or common laws, rules, regulations, treaty or
decision of any government agency or executive body thereof of any country or community or association of countries. Should one or more provisions of this Agreement be or become invalid, the Parties hereto shall substitute, by mutual consent, valid
provisions for such invalid provisions which valid provisions in their economic effect are sufficiently similar to the invalid provisions that it can be reasonably assumed that the Parties would have entered into this Agreement with such valid
provisions. 

  

	15.7	Force Majeure: Neither Party hereto shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including but not limited to fire, floods, embargoes, war,
acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labour disturbances, acts of God or acts, omissions or delays in acting by any governmental authority or the other Party hereto.

  

	15.8	Headings: The titles and headings used in this Agreement are intended for convenience only and shall not in any way affect the meaning or construction of any
provision of this Agreement. 

  

	15.9	Waiver: The waiver by either Party hereto of any right hereunder or the failure to perform or of a breach by the other Party shall not be deemed a waiver of any
other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise. 

  

	16.	Dispute Resolution and Jurisdiction 

  

	16.1	In the event of any dispute arising between the Parties concerning this Agreement, the Parties agree that in the first place they shall meet for good faith discussions
in an attempt to negotiate an amicable solution. 

  

	16.2	 For any dispute arising between the Parties out of or in connection with this Agreement, or the interpretation, breach or enforcement thereof, which
cannot be amicably resolved pursuant to Section 16.1 above within two (2) months as from the first appearance of such dispute, the Parties agree and irrevocably 

 

 23. 

	 	 
submit to arbitration under the Rules of Arbitration of the International Chamber of Commerce (the “Rules”) by three (3) arbitrators appointed in accordance with the Rules. The
seat of arbitration shall be Basel, Switzerland, and any such arbitration shall be conducted in the English language. Any judgment upon the award rendered by the arbitrators shall be final and binding upon the parties and may be entered in any court
having jurisdiction thereof. 

  

	16.3	Notwithstanding anything contained in this Section 16, either Party may seek preliminary or injunctive measures or relief in any competent court having
jurisdiction. 

  

	17.	Applicable Law 

 The
Parties hereto agree that this Agreement shall be construed under and be governed by the laws of Switzerland, without reference to the principles of conflict of laws thereof, and shall not be governed by the United Nations Convention on Contracts
for the International Sale of Goods (the Vienna Convention of April 11, 1980). 
 IN WITNESS WHEREOF, the Parties have executed this
Agreement effective as of the Effective Date. 
  

									
	 For and on behalf of
 JAGOTEC AG
	 		 		 	
			
	 /s/ Francesco PATALANO
	 		 	 [Illegible Signature]

	by:	 	Francesco PATALANO	 		 	by:	 	
	its:	 	Director ,3 Aug 07	 		 	its:	 	Director 3 Aug 07
				
	 For and on behalf of
 NITEC PHARMA AG
	 		 		 	
			
	 /s/ Jochen Mattis 3.8.07
	 		 	 3 Aug 2007 /s/ Dr. Achim Schäffler

	by:	 	Jochen Mattis	 		 	by:	 	Dr. Achim Schäffler
	its:	 	Managing Director	 		 	its:	 	EVP RD and Manufacturing

  

 24. 

 List of Annexes: 

 

			
	Annex 1:	 	Presentations
		
	Annex 2:	 	Specifications
		
	Annex 2a:	 	Shelf Life Period
		
	Annex 3:	 	Minimum Orders
		
	Annex 4:	 	Prices
		
	Annex 5:	 	Quality Agreement
		
	Annex 6:	 	Commercial Yield
		
	Annex 7:	 	Logistics
		
	Annex 8:	 	Hygiene, Safety and Working conditions and Protection of the environment
		
	Annex 9:	 	Initial Members of the Committee
		
	Annex 10:	 	Statement of Storage Conditions

  

 25. 

 MANUFACTURING & SUPPLY AGREEMENT 

BETWEEN NITEC and JAGOTEC 
 Annex 1 
  

											
	PRESENTATION 	 		 		 		 		 	

  

	–	Lodotra 

  

	–	DOSAGE : 1,2,5 mg 

  

	–	Bulk tablets stored 30 L plastic drum 

  

 26. 

 MANUFACTURING & SUPPLY AGREEMENT 

BETWEEN NITEC and JAGOTEC 
 Annex 2a 
  

	
	Shelf Life Period

 [...***...] 
  

 ***Confidential Treatment Requested 

27. 

 MANUFACTURING & SUPPLY AGREEMENT 

BETWEEN NITEC and JAGOTEC 
 Annex 2 
  

	
	Specifications

 

	–	[...***...] 

	–	[...***...] 

  

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

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

  

 ***Confidential Treatment Requested 

28. 

 [...***...] 
  

							
	 [...***...] 
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	  	[...***...]	  	[...***...]	  	[...***...]
	 [...***...]
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 ***Confidential Treatment Requested 

29. 

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

  

 ***Confidential Treatment Requested 

30. 

 MANUFACTURING & SUPPLY AGREEMENT 

BETWEEN NITEC and JAGOTEC 
 Annex 3 
  

	
	MINIMUM ORDERS- for the 1st calendar year after Product approval and launch in the first Major Country

[...***...] 
  

	
	MINIMUM ORDERS- starting from the second calendar year after Product approval and launch in 3 out of 5 Major
Countries

 [...***...] 
  

 ***Confidential Treatment Requested 

31. 

 MANUFACTURING & SUPPLY AGREEMENT 

BETWEEN NITEC and JAGOTEC 
 Annex 4 
  

	
	 PRICES

  

	1.	The following prices relate to the packaged Product delivered Ex Works by JAGOTEC 

                 [...***...] 

 
  

	2.	Payment shall be made in Euros by bank transfer within [...***...] of the invoice date, unless otherwise agreed between the parties. Bank transfer shall be made
to such account as Jagotec shall notify to Nitec. 

  

 ***Confidential Treatment Requested 

32. 

 MANUFACTURING & SUPPLY AGREEMENT 

BETWEEN NITEC and JAGOTEC 
 Annex 5 
  

	
	 QUALITY
AGREEMENT

 A Quality Agreement will be signed at the latest after manufacturing of the first campaign of the Product.

  

 33. 

 MANUFACTURING & SUPPLY AGREEMENT 

BETWEEN NITEC and JAGOTEC 
 Annex 6 
  

	
	MINIMUM COMMERCIAL YIELD

 For active ingredient ordered by JAGOTEC on behalf of NITEC, the minimum commercial yield is as follows: 
  

	
	[...***...]            

composed of yield [...***...] 
  

 ***Confidential Treatment Requested 

34. 

 MANUFACTURING & SUPPLY AGREEMENT 

BETWEEN NITEC and JAGOTEC 
 Annex 7 
 Distribution Specifications 

 

	
	LOGISTICS

 Introduction: 
 In order to facilitate transfer, storage, distribution and shipment of
products which are the subject of the present contract, the following recommendations must be applied as from delivery of the first batch, failing this, JAGOTEC undertakes to apply these recommendations within a period agreed with NITEC. 

1 - Packaging: 
 Tablets of Product are
packed as bulk tablets for shipment in containers of 20(±3) kg in drums with PE in-liner. The packaging material is defined in the Quality Agreement. For printing batch number and the expiration date ink based technique must be used instead
of embossing which is less readable. 
 2 - Grouping cartons: 
 The quantity shall be defined in the Quality Agreement (see annex 5). 
 This quantity will be
defined by NITEC in agreement with JAGOTEC. 
 Identification of each drum will be carried out according to the provisions in the Quality
Agreement (see annex 5). 
 3 - Pallets: 
 Type 1’200 x 800, five tiers, total high including pallet must not exceed 1’250 mm. 

Any variation from this norm must be agreed in writing by NITEC. 
 Consigned pallets are not accepted. NITEC can supply pallets to JAGOTEC if necessary. 
 It is
recommended to identify each pallet with similar label to those stuck on the drums. 
 Pallets will be wrapped in a transparent film. A cover
must be placed on incomplete pallets before wrapping. 

  
 35.

 4 - Transport: 
 If product delivery to NITEC is paid by JAGOTEC, it must use a carrier agreed by itself and only use sheet metal trailers. The carrier must be designed for transporting medicines. 

Documents necessary for a good reception must be joined: delivery notes, analysis certificates... 

JAGOTEC shall inform NITEC and NITEC’s partner for packaging by fax of all details concerning the load as soon as possible before the truck
departure. 
 5 - Modifications: 

Any modifications of points one to four above must be agreed by NITEC Distribution. At the very least the NITEC Distribution must be informed at the time
of the start up of the first Batch concerned, if it relates to a modification of regulations. 
 Each pallet of the modified first Batch must
undergo a supplementary special identification mentioning the type of modification. 
 6 - Detailed log book: 

NITEC can provide by simple request JAGOTEC a detailed log book. 
  

 36. 

 MANUFACTURING & SUPPLY AGREEMENT 

BETWEEN NITEC and JAGOTEC 
 Annex 8 
 Hygiene, Safety and Working conditions and Protection of
the environment 
  

	1.	Hygiene, Safety and Working conditions: 

  

	1.1	JAGOTEC is held to know all the relevant legislative, regulatory or conventional requirements relating to hygiene, safety and working conditions, which it is required
to satisfy by reason of its activities hereunder. It undertakes to comply strictly with these at all times with regard to the provisions foreseen in the present contract. 

To this effect, JAGOTEC declares that it has received from NITEC the information which the latter has available concerning: 

 

	 	–	The particular hazards of the Active Ingredient or preparations thereof which are the subject of the present contract, as well as the procedures necessary for their use
or their manufacture 

  

	 	–	The provisions to take to provide against these hazards, notably the particular precautions necessary to take with regard to handling, use and, should the case arise,
storage 

  

	 	–	The rules for packaging and labelling which are applicable to them 

  

	 	–	The action to take in case of an accident 

 This information is founded on existing scientific and technical knowledge, to which NITEC may have had reasonable access. 
  

	1.2	JAGOTEC must, with the least delay and by all means at its disposal, keep NITEC informed of: 

 

	 	–	All incidents or accidents occurring on the occasion of carrying out the provisions foreseen in the present contract, which causes harm to, or may cause harm to the
health and safety of workers 

  

	 	–	The emergency measures which, should the case arise, have been taken by itself or by the competent administrative authority 

According to the same terms JAGOTEC will bring to the knowledge of NITEC: 

All new facts in its actual knowledge concerning: 
  

 37. 

	 	–	the hazardous properties of substances or dangerous preparations which are the subject of the present contract, which result from the improvement of scientific or
technical understanding, or result from the observation of the effects of these products on the health of workers or the environment; 

  

	 	–	The possible modification of physicochemical or toxicological properties of these same substances or preparations, by reason notably of a change in the nature or
concentration of the impurities which they contain; 

 in each case having applied reasonable care to become aware
of developments and changes to the same. 
 In a reciprocal fashion NITEC will, with the least delay and by all means at its
disposal bring to the knowledge of JAGOTEC all information of the same type of which comes to be in possession 
  

	1.3	The parties will meet as often as necessary to examine together the conditions, and possibly the difficulties in the application of: 

 

	 	–	The legislative, regulatory or conventional dispositions relating to hygiene, safety and working conditions to which the provisions of the present contract are
subjected 

  

	 	–	The procedure for reciprocal exchange of information instituted in section 1.2 above 

Furthermore, each party will have the right to request of the other the holding of an ad hoc technical meeting in order to resolve all
questions that particularly relate to hygiene or to industrial safety, or to deal with an emergency situation, whatever the cause. The date and duration of this ad hoc technical meeting will be agreed jointly. 

 

	2.	Protection of the environment 

  

	2.1	JAGOTEC recognises expressly that, in order to have been duly authorised by the competent administrative authority or to have been so declared to it, all the
installations necessary for the execution of the provisions foreseen in the present contract comply with the legislative or regulatory dispositions to which they are subject with regard to the protection of the environment. 

In consequence, it undertakes to maintain this situation during the full duration of the contract and to be in a position to justify this
at any time to NITEC. 
  

	2.2	JAGOTEC will comply strictly, for all the provisions foreseen in the present contract, with all the legislative or regulatory dispositions relating to the disposal of
waste, the term “disposal” describing the operations of collection, transport, storage, sorting and treatment so as to avoid all harm to the environment, including in the long term. 

In particular JAGOTEC undertakes that it will ensure or get assurance that the waste which results from the provisions foreseen in the
present contract is treated only in installations duly authorised or accepted to this effect by the 
  

 38. 

 
competent administrative authority. It will be in a position to justify this at any time to NITEC. 
  

 39. 

  
 ANNEX 9

 INITIAL MEMBERS OF THE COMMITTEE 
 NITEC 
 Achim Schäffler 
 Jochen Mattis 
 JAGOTEC 
 Ken Cunningham 
 Jean-Marc Chevalier 

  

***Confidential Treatment Requested 
 40. 

  
 ANNEX 10 

Statement on the storage condition of Lodotra® tablets 
 This statement clarifies the requirements of temperature-sensitive materials involved in the production of Lodotra bulk tablets (manufacturing site: SkyePharma Production SAS, France), with regard to
in-house storage and handling and shall prevail over any contrary provision in this Agreement 
 For all batches of Product manufactured up to
September 2007, the agreed storage conditions are and shall be at room temperature in accordance with USP. 
 For all batches of Product
manufactured after September 2007, the nominal storage condition of temperature-sensitive materials, i.e. 
 –
[...***...], 
 including samples of these materials (e.g. batch release samples), shall be between [...***...] Compliance with this
temperature range (subject to the following) has to be ensured continuously throughout the presence of the above mentioned materials at the manufacturing site (Monitoring). Proof of this compliance has to be provided by SkyePharma (e.g. temperature
curves). Deviations from the nominal temperature range always require written documentation. 
 After September 2007 the nominal storage
condition will not be exceeded by more than [...***...] 
 The exceptions in the foregoing paragraph do not render temperature monitoring
and documentation of deviations from the nominal storage condition unnecessary. Correspondingly, Certificates of Compliance have to be supplemented by deviation reports and temperature monitoring data, if deviations occur. 

Nitec proposes the following measures to ensure and/or prove appropriate storage of the materials at the manufacturing site: 

 

	 	–	attachment of temperature loggers to the temperature-sensitive materials 

  

	 	–	use of mobile (validated) temperature container for storage 

  

***Confidential Treatment Requested 
 41.

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