Document:

Exclusive Distribution Agreement

 Exhibit 10.17 
 ***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. 

DATED 24th March 2009 
 NITEC PHARMA AG 
 AND 

MUNDIPHARMA INTERNATIONAL CORPORATION LIMITED 

 
  

EXCLUSIVE DISTRIBUTION AGREEMENT 
  

 

 THIS AGREEMENT is made the 24th day of March 2009 

BETWEEN: 
  

	(1)	Nitec Pharma AG a company incorporated in accordance with the laws of Switzerland with its registered office at Kägenstrasse 17, CH-4153 Reinach, Switzerland (the
“Principal”); and 

  

	(2)	Mundipharma International Corporation Limited a company incorporated in accordance with the laws of Bermuda with its registered office at Canon’s Court, 22
Victoria Street, Hamilton, HM 12 Bermuda (the “Distributor”). 

 WHEREAS: 

 

	(A)	The Principal wishes to register itself or to have the Product registered, marketed, sold and distributed by the Distributor in the Field in the Territory (the terms
Product, Field and Territory are defined below), as set forth in further detail in this Agreement. 

  

	(B)	The Distributor wishes to acquire an Exclusive (as defined below) licence to register itself or to have the Product registered by Principal, market, sell and distribute
the Product in the Field in the Territory, as set forth in further detail in this Agreement. 

  

	(C)	The Principal has agreed with the Distributor to grant Exclusive licences and rights as set out and upon and subject to the terms and conditions in this Agreement.

 IT IS AGREED as follows: 
  

	1.	DEFINITIONS AND INTERPRETATION 

  

	1.1	In this Agreement, the following terms shall have the following meanings: 

 

	 “Associate” 
	 with respect to either one of the parties, any person, firm, trust, corporation or other entity or combination thereof which directly or indirectly (a) controls said

  

			
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party, (b) is controlled by said party, or (c) is under common control with said party; the terms “control” and “controlled” meaning ownership of fifty percent (50%) or more,
including ownership by trusts with substantially the same beneficial interests, of the voting and equity rights of such person, firm, trust, corporation or other entity or combination thereof or the power to direct the management of such person,
firm, trust, corporation or other entity or combination thereof; 

  

	 “Calendar Quarter” 
	a calendar quarter ending on 31st March, 30th June, 30th September and 31st December in any Calendar Year; 

 

	 “Calendar Year” 
	the twelve (12) month period from January 1st to December
31st; 

 

	 “Commencement Date” 
	the date of execution of this Agreement; 

  

	 “Commercially Reasonable Efforts” 
	the level of resources, effort and urgency to market and sell the Product in the Territory applied by the Distributor that is consistent with the Distributor’s practices in actively
pursuing the marketing and sales of its other pharmaceutical products at a similar stage of product life to the Product and of similar market potential and profit potential, based on conditions then prevailing, taking into account, without
limitation, competing products, market demand, proprietary position, safety, regulatory status, medical or scientific developments in the Indication, any adverse governmental interventions and any potential legal liability or other legal issues;

  

			
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	 “Development and Licence Agreement” 
	the Development and Licence Agreement dated 20 August 2004 entered into between Jagotec AG (“Jagotec”), SkyePharma AG (“SkyePharma”) and the Principal and all
amendments thereto; 

  

	 “EEA” 
	the European Economic Area as constituted from time to time; 

  

	 “EU DCP” 
	the decentralised procedure for obtaining marketing authorisation for pharmaceutical products across multiple member states of the European Union as prescribed by European Directive 2001/83/EC,
as amended by Directive 2004/27/EC; 

  

	 “Exclusive” 
	exclusive to the Distributor and its Associates and excluding the Principal and all others; 

  

	 “Field” 
	the treatment of human diseases; 

  

	 “Force Majeure” 
	any act, event, non-occurrence, omission or accident beyond the reasonable control of the parties including (without limitation) strikes, lock-outs or other industrial action; civil commotion,
riot, invasion, terrorist attack or threat of terrorist attack, war (whether declared or not) or threat or preparation for war; or fire, explosion, storm, flood, earthquake, subsidence, epidemic or other natural disaster; 

 

	 “Guiding Principles” 
	the guiding principles of Drug Regulatory Affairs (DRA) activities between the Principal and the Distributor as set out in Schedule 6; 

 

	 “Improvements” 
	 any improvement, modification or enhancement (including new presentation(s)) of or to the Product or any of its components or constituent parts and any

  

			
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related Principal Intellectual Property, which shall include (without limitation) all dosage strengths and line extensions to the Product and any improvement thereof;

  

	 “Independent Expert” 
	an independent third party with significant expertise and experience in the strategic marketing, pricing and reimbursement of pharmaceutical products similar to the Product in the Territory;

  

	 “Indication” 
	the treatment of moderate to severe active rheumatoid arthritis in adults particularly when accompanied by morning stiffness as described in the current SMPC documentation of Principal or any
subsequent amendments thereto; 

  

	 “Industry Association” 
	the European Federation of Pharmaceutical Industries and Associations (EFPIA); 

  

	 “Initial Term” 
	fifteen (15) years from the date the Product is first Launched (as defined in Clause 5.8) in a country within the Territory; 

 

	 “Intellectual Property” 
	patents, registered designs, unregistered rights in designs, trade marks, domain names, service marks, logos, trade names, copyright, utility models, rights in know-how and other intellectual
property rights, in each case whether registered or unregistered and including applications for registration, and all rights or forms of protection having equivalent or similar effect anywhere in the world; 

 

	 “Marketing Authorisation” 
	 all necessary regulatory and governmental approvals by a Regulatory Authority or other governmental body required to develop, market, sell or otherwise deal in the

  

			
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Product in the Indication in a particular country but excluding any Pricing Approval; 

  

	 “Milestone Event” 
	each event identified in Schedule 5 which triggers a one-off Milestone Payment; 

  

	 “Milestone Payment” 
	each one-off payment by the Distributor to the Principal identified in Schedule 5 which is triggered by a Milestone Event; 

 

	 “Net Sales” 
	the gross amount invoiced by Distributor, its Associates or sub-licensees for sales of the Product in a particular country within the Territory, less deductions for: 

 

	 	(a)	quantity and cash discounts and sales rebates actually given; 

  

	 	(b)	freight, shipping insurance and other transportation expenses; 

  

	 	(c)	sales, value-added, excise taxes, tariffs and duties, and other taxes directly related to the sale; 

all to the extent that items (a), (b) and (c) are included in the gross invoice price and specified on the invoice (but not including
taxes assessed against the income derived from such sale); 
  

	 	(d)	returns (including withdrawals and recalls) other than returns by third parties to Distributor on account of lack of sufficient remaining shelf life; and

  

	 	(e)	 amounts repaid, discounted or credited by reason of (i) retroactive price reductions, discounts and rebates, which are, in any case, imposed on
Distributor or its Associates or sub-licensees 

  

			
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by any governmental or non-governmental body with the authority to impose such price reductions, discounts or rebates, all to the extent reasonably demonstrated by Distributor by written records,
or (ii) retroactive price reductions, discounts or rebates (not specified in an invoice) granted to a third party without the authority to impose such price reductions, discounts or rebates to the extent these are either pre-agreed with Principal or
do not exceed [...***...] of the gross invoice
price. 

 The transfer of Product by Distributor to an Associate or sub-licensee will not be deemed a sale;

  

	 “New Product” 
	either (a) any corticoid product or formulation (other than an Improvement or the Product), whether alone or in combination for use in the treatment of inflammatory diseases; or (b) any product
or formulation containing prednisone (other than an Improvement or the Product), whether alone or in combination used for the treatment of diseases other than inflammatory diseases, that is developed or acquired by the Principal or its Associates or
to which the Principal or its Associates has or is granted a licence; 

  

	 “North America and Asia Pacific Territory” 
	the countries listed in Schedule 2; 

  

***Confidential Treatment Requested 
  

			
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	 “Pharmacovigilance Agreement” 
	the pharmacovigilance agreement to be entered into between the parties within ninety (90) days of the signing of this Agreement; 

 

	 “Pricing Approval” 
	both pricing and (where approval is required for reimbursement) reimbursement approval as applied for by the Distributor and/or its Associates in any country of the Territory;

  

	 “Principal Intellectual Property” 
	any and all Intellectual Property related to the Product and/or corticosteroids owned by, licensed to or under the control of the Principal including (without limitation) the Trade Mark (as
defined in Clause 2.3) and the Intellectual Property licensed from SkyePharma plc and/or Jagotec AG regarding GeoClock Technology and its use with corticosteroids (the “SkyePharma Intellectual Property”), the patent applications
[...***...] (the “Principal Patent Applications”) (and any patent applications, divisional patent applications, continuation applications, continuation in part applications, patents, supplementary protection certificates and
extensions derived from or granted in relation to such Principal Patent Applications) insofar as they relate to corticosteroids, and any know-how relating to the Product including pharmacokinetic and clinical data, technical information,
manufacturing formulae and methods and further techniques and designs of a confidential nature; 

  

	 “Product” 
	modified release formulation of prednisone 1mg, 2mg, 5mg in all pack presentations and including Improvements; 

 

			
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 ***
Confidential Treatment Requested 

	 “Proof of Concept” 
	a concept for a New Product under development or acquired or licensed by the Principal or its Associates in respect of which either in vitro laboratory data, in vivo pharmacokinetic or clinical
data or other appropriate tests reasonably confirm that such concept is feasible; 

  

	 “Reference Member State” 
	Germany; 

  

	 “Regulatory Authority” 
	any competent regulatory authority or other governmental body (for example, but not by way of limitation the EMEA or other national or international regulatory bodies) responsible for granting a
Marketing Authorisation or Pricing Approval in the relevant country of the Territory; 

  

	 “Semi-Exclusive” 
	excluding all others except the Principal or a licensee of the Principal; 

  

	 “Supply Agreement” 
	the supply agreement entered into between the Principal and Mundipharma Medical Company signed on the same date as this Agreement; 

 

	 “Technical Agreement” 
	the technical agreement to be entered into between Nitec Pharma GmbH, Mannheim/Germany and the Distributor or one of its Associates within ninety (90) days of the signing of this Agreement;

  

	 “Territory” 
	the countries listed in Schedule 1; 

  

	 “Term” 
	the period of time specified by Clause 19.1; 

  

	1.2	Any reference in this Agreement to “writing” or cognate expressions includes a reference to facsimile transmission. 

 

	1.3	The headings in this Agreement are for convenience only and shall not affect its interpretation. 

  

			
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	1.4	References to “persons” includes individuals, bodies corporate (wherever incorporated), unincorporated associations and partnerships.

  

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

  

	2.	APPOINTMENT OF DISTRIBUTOR 

  

	2.1	The Principal appoints the Distributor as an Exclusive distributor of the Product in the Territory, and the Distributor agrees to act in that capacity, in accordance
with the provisions of this Agreement. 

  

	2.2	The rights provided to the Distributor under Clause 2.1 above shall include (without limitation) an Exclusive licence to: 

 

	 	2.2.1	register (where this Agreement allocates registration responsibility to Distributor), import, warehouse, promote, market, distribute, sell and use the Product in the
Field in the Territory; and 

  

	 	2.2.2	use the Principal Intellectual Property if and to the extent that such use is required for Distributor to exercise its rights and to perform its obligations hereunder
in the Field in the Territory, provided that the use of rights licensed to Principal by third parties is granted to Distributor only to the extent that Principal is under its licence agreement with the respective third party authorized to provide
such rights to Distributor. 

  

	2.3	 The rights provided to the Distributor under Clause 2.2.2 above shall include an Exclusive licence to use the Principal’s trade mark
LodotraTM (the “Trade Mark”) and any
registered brand images related to the same and the right to apply for, acquire and/or register domain names specific to the countries comprised in the Territory that incorporate the Trade Mark in the Principal’s name and at its own cost, and
any such domain names shall be owned by the Principal. If the Trade Mark is not acceptable to a Regulatory Authority then the Principal shall grant to the Distributor an Exclusive

  

			
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licence to use a suitable alternative trade mark owned by or under control of the Principal for the relevant country (“Alternative Trade Mark”), which shall then be deemed the
Trade Mark in that country for the purposes of this Clause 2.3. If the Alternative Trade Mark is not acceptable to a Regulatory Authority then the Distributor may either: 

 

	 	2.3.1	require the Principal to grant to the Distributor an Exclusive licence to use any other trade mark owned by or under the control of Principal of the Distributor’s
choice that is acceptable to the relevant Regulatory Authority; or 

  

	 	2.3.2	choose to use any other trade mark for the Product (subject to the prior agreement of the Principal which shall not be unreasonably withheld or delayed) which is
acceptable to the Principal and to the relevant Regulatory Authority provided that such trade mark shall be transferred to and owned by the Principal before any use thereof by the Distributor, 

and such trade mark shall then be deemed the Trade Mark for the purposes of this Clause 2.3 in the relevant country. 

 

	2.4	The Distributor shall have the right to describe itself as an “Authorised Distributor” of the Principal for the Product in the Field in the Territory but
shall not hold itself out as the Principal’s agent for sales of the Product or otherwise as being entitled to bind the Principal in any way. 

  

	2.5	Subject to Clause 2.7, the Distributor shall not put the Product on the market, sell, export or otherwise deal, whether directly or indirectly in the Product outside
the Territory, and shall refer all enquiries for supply outside the Territory to the Principal. 

  

	2.6	Subject to Clause 2.7, the Principal shall not put the Product on the market, sell, export or otherwise deal, whether directly or indirectly in the Product within the
Territory, and shall refer all enquiries for supply within the Territory to the Distributor. 

  

			
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	2.7	The limitations set out in Clauses 2.5 and 2.6 above are subject always to the right of the Principal or the Distributor, as the case may be, to sell or deliver the
Product to countries within the EEA and to Switzerland in response to a passive (i.e. unsolicited) purchase order. 

  

	2.8	The Distributor may not grant sub-licences of its rights or obligations under this Agreement to any third party without the prior written consent of the Principal,
which consent shall not be unreasonably withheld or delayed; provided, however, that the Distributor may grant sub-licences of its rights under this Agreement to its Associates without the right of such Associates to further sub-license their rights
or obligations to non-Associates, without the consent of the Principal. 

  

	3.	RELATED AGREEMENTS 

  

	3.1	Both parties or their Associates shall enter (or shall have entered) into the Supply Agreement, the Technical Agreement and the Pharmacovigilance Agreement. The
Principal shall maintain the Global Safety Database in accordance with (and as defined in) the Pharmacovigilance Agreement. 

  

	3.2	The Distributor shall have the right to register the licences granted to the Distributor and its Associates under Clause 2 with the patent offices and/or trade mark
offices and/or other relevant authorities in each of the countries in the Territory and both parties shall execute such formal licences as the Distributor may reasonably consider necessary or reasonably appropriate for such registration(s), on
condition that the parties shall use reasonable endeavours to ensure that, to the extent permitted by relevant authorities, this Agreement shall not form part of any public record. Any such formal licences so executed shall operate subject to the
terms of this Agreement and, in the event of any conflict, the terms of this Agreement shall prevail wherever possible. 

  

	3.3	 The Principal shall be permitted to enter into an agreement with SkyePharma under which the Principal Patent Applications (in so far as they are still
in force) and any applications derived therefrom will be assigned to SkyePharma in return for which SkyePharma will contemporaneously assign all its rights in divisional applications (and

  

			
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all patents granted in respect thereof) based on the Principal Patent Applications covering at least the Product in the Field, any Improvements and any New Products back to the Principal,
provided that the Principal shall ensure that it will have the continued right to use the Principal Patent Applications (in so far as they are still in force) and any applications derived therefrom under the Development and Licence Agreement.

  

	4.	OBLIGATIONS OF PRINCIPAL 

  

	4.1	The Principal shall promptly procure (or have procured) original Marketing Authorisations using the EU DCP for the First Wave countries listed in Schedule 3 and shall
use all reasonable endeavours to obtain original Marketing Authorisations using the EU DCP for the Second Wave countries listed in Schedule 3, and shall ensure and maintain the same for the Term. The Principal shall promptly transfer all original
Marketing Authorisations obtained under this Clause 4.1 into the name of the Distributor or its Associate at the Principal’s expense. 

  

	4.2	The Principal may obtain a duplicate Marketing Authorisation in the name of the Principal for each original Marketing Authorisation obtained under Clause 4.1 above. The
Principal shall ensure that each duplicate Marketing Authorisation obtained for a particular country will at all times be identical to the provisions of its corresponding original Marketing Authorisation. For the avoidance of doubt, any duplicate
Marketing Authorisation corresponding to an original Marketing Authorisation transferred to the Distributor under Clause 4.1 shall remain in the name of the Principal. 

 

	4.3	 Any and all original and duplicate Marketing Authorisations obtained by the Principal under Clauses 4.1 and 4.2 above (including, for the avoidance of
doubt, any original Marketing Authorisations transferred to the Distributor) shall be obtained and maintained (including where the Distributor is required to maintain such Marketing Authorisations) at the sole expense of the Principal and, without
prejudice to the generality of this Clause 4.3, the Principal shall prepare the necessary paperwork and pay any and all fees charged by Regulatory Authorities for any variations made to such Marketing Authorisations and any related costs and
expenses including, without limitation, any related translation fees, except where such variations are requested by 

 

			
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the Distributor in accordance with the Guiding Principles in which case such costs and expenses shall be paid by the Distributor. 

 

	4.4	The Principal shall use commercially reasonable efforts to comply with the Guiding Principles. The Principal shall provide the Distributor with all documents and
information including the EU-DCP dossier necessary to compile a dossier to obtain, maintain and update the Marketing Authorisations for the Product in each of the countries in the Territory not listed in Schedule 3 (the “Non-EU Countries”)
and any other documentation or information that the Principal must provide to the Distributor in order to comply with the Guiding Principles. 

  

	4.5	The Principal shall furnish the Distributor or its Associate with supplies of the Product as set out in the Supply Agreement and the Technical Agreement.

  

	4.6	The Principal shall share with the Distributor any and all market research study results and any other data procured or conducted by the Principal or made available to
the Principal before or after the Commencement Date relating to the Product in the Field in the Territory and (provided and to the extent the Principal is legally entitled to do so) outside the Territory. The Distributor may use such results and
data in relation to the Indication without limitation or obligations of confidence and may use any results and data not in relation to the Indication for its own internal purposes only unless the Principal provides consent to use otherwise.

  

	4.7	The Principal shall promptly inform the Distributor in writing of any clinical studies with the Product in the Field conducted by or on behalf of the Principal or its
Associates before or after the Commencement Date and will share any and all results related to the same with the Distributor. The Distributor may use such results and data in relation to the Indication without limitation or obligations of confidence
and may use any results and data not in relation to the Indication for its own internal purposes only unless the Principal provides consent to use otherwise. 

 

	4.8	The Principal shall promptly inform the Distributor from time to time of any new data relating to the Product in the Field which shall include (without limitation) any
data concerning marketing activities, new study results, market research data and copies of notices from and correspondence with Regulatory Authorities. 

 

			
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	4.9	The Principal shall make available to the Distributor the consultancy services of [...***...] for a minimum of [...***...] following the Commencement
Date to assist the Distributor in its planning and preparation for Launch, after which the parties may subsequently agree for further provision of consultancy services. 

 

	4.10	The Principal shall (and shall exercise any rights available to the Principal under the Development and Licence Agreement to require that SkyePharma plc shall), at the
Principal’s cost and expense maintain the Principal Intellectual Property which shall include (without limitation) the prosecution, filing, maintenance and renewal of any patents and any reissues or re-examinations of any patents, including the
payment of all related fees. Before the Commencement Date, the Principal shall have provided the Distributor with a reasonably detailed written report of all material matters concerning the maintenance of the Principal Intellectual Property. After
the Commencement Date, upon written request by the Distributor (but not more often than on a quarterly basis), the Principal shall provide the Distributor with reasonably detailed written reports on material matters concerning the maintenance of the
Principal Intellectual Property. The Principal shall (and shall exercise any rights available to the Principal under the Development and Licence Agreement to require that SkyePharma plc shall) promptly sign all documents and take all other actions
as may be necessary or desirable to maintain the Principal Intellectual Property. The Principal shall not (and shall exercise any rights available to the Principal under the Development and Licence Agreement to require that SkyePharma plc shall not)
intentionally abandon or fail to maintain the Principal Intellectual Property including (without limitation) failing to prosecute or failing to pay any fees relating to the maintenance of any patents. If the Principal abandons, declines to consent,
or fails to assume responsibility for the maintenance of the Principal Intellectual Property, the Distributor shall have the right, at its sole cost and expense, to (i) take any steps to maintain the Principal Intellectual Property including
(without limitation) the preparation, filing or prosecution of any patents, and (ii) request reimbursement of such costs and expenses from the Principal, and if the Principal refuses to reimburse, then the Distributor shall be entitled to
credit such costs and expenses against any payments due to the Principal under this Agreement. 

  

***Confidential Treatment Requested 
  

			
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	4.11	In the event of termination of this Agreement by the Distributor pursuant to Clause 19.4, the Principal shall (a) introduce the Distributor to its contacts at the
third party manufacturer and shall facilitate the initiation of negotiations between the Distributor and the third party manufacturer with a view to those parties entering into a licence agreement under which the third party manufacture will
manufacture the Product and supply the same to the Distributor; and (b) use all reasonable endeavours to facilitate good-faith negotiations between the Distributor and Jagotec under which those parties will endeavour to agree that Jagotec will
grant to the Distributor exclusive distribution and manufacture rights in relation to the Product under terms materially the same as provided to the Principal under the Development and Licence Agreement. 

 

	5.	OBLIGATIONS OF DISTRIBUTOR 

 Marketing
Authorisation, Reimbursement and Price 
  

	5.1	Following the transfer of any original Marketing Authorisation from the Principal to the Distributor under Clause 4.1 above, the Distributor shall use Commercially
Reasonable Efforts to comply with the Guiding Principles in order to ensure that the Marketing Authorisation so transferred in the concerned member state is and remains in compliance with the Marketing Authorisation in the Reference Member State.

  

	5.2	 Following the Distributor’s receipt of all documents and information required to be provided by the Principal under Clause 4.4, the Distributor
shall at its own expense and within a reasonable time apply for an original Marketing Authorisation including, if the Principal so elects in writing, a duplicate Marketing Authorisation at the expense of the Principal in each of the Non-EU Countries
in the name of the Distributor and following successful grant shall ensure and maintain the same at the Distributor’s expense (in respect of the original Marketing Authorisations) and at the Principal’s expense (in respect of any duplicate
Marketing Authorisations) for the Term, and at all times shall use Commercially Reasonable Efforts to comply with the Guiding Principles. The Distributor shall ensure that each duplicate Marketing Authorisation obtained for a

  

			
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particular country will at all times be identical to the provisions of its corresponding original Marketing Authorisation. Upon written direction from the Principal, the Distributor shall
promptly transfer any duplicate Marketing Authorisation directed by the Principal into the name of the Principal at the Principal’s expense. For the avoidance of doubt, the original Marketing Authorisation corresponding to any duplicate
Marketing Authorisation so transferred shall remain in the name of the Distributor. 

  

	5.3	The Distributor shall prepare and prosecute, and pay any and all fees charged by Regulatory Authorities for, any variations made to any and all original Marketing
Authorisations obtained by the Distributor under Clause 5.2 above and any related costs and expenses including, without limitation, any related translation fees, except where such variations are requested by the Principal or its Associates or
licensees in which case such costs and expenses shall be paid by the Principal. The Principal shall pay any and all fees charged by Regulatory Authorities for any variations made to any and all duplicate Marketing Authorisations obtained by the
Distributor under Clause 5.2 above and any related costs and expenses including, without limitation, any related translation fees, except where such variations are requested by the Distributor in which case such costs and expenses shall be paid by
the Distributor 

  

	5.4	The Distributor shall use Commercially Reasonable Efforts to obtain in each country in the Territory a price and reimbursement for the Product acceptable to the
Distributor. If having used its Commercially Reasonable Efforts the Distributor does not obtain a price and reimbursement acceptable to the Distributor for an individual country the Distributor may decide (acting reasonably and having consulted and
taken the views of the Principal into consideration) to Launch the Product in the relevant country without reimbursement. 

  

	5.5	The Distributor shall endeavour to agree with the Principal the order of countries in the Territory in which the Distributor will Launch the Product (the
“Launch Sequence”). 

  

	5.6	 The Distributor may elect to not Launch the Product in any country in the Territory for which the Distributor considers (acting reasonably) to do so
would materially impair or 

  

			
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prevent the performance of its obligations under this Agreement or otherwise not be beneficial to or in the commercial interests of the parties, and the Launch Sequence shall be deemed amended
accordingly. The Distributor may only make such election on a country by country basis for commercial reasons, which reasons may include (without limitation) the Distributor failing to obtain an acceptable price or reimbursement in the relevant
country. 

  

	5.7	If the Principal disagrees with the Distributor’s decision to not Launch the Product in a particular country under Clause 5.6 above, the parties shall endeavour to
negotiate in good faith to resolve the matter. If the parties are still in disagreement after fourteen (14) days from commencement of such negotiations the parties shall endeavour to agree on the appointment of an Independent Expert to resolve
the matter. If the parties are unable to agree on such appointment then the parties shall ask the Industry Association to appoint the Independent Expert. Following appointment of the Independent Expert, the parties shall endeavour to agree terms of
reference to be provided to the Independent Expert which shall include (without limitation) terms requiring the Independent Expert to take into account the impact of the Distributor’s decision in relation to the commercial interests of both
parties under this Agreement and in particular the commercial impact in relation to both the country in which the Distributor has elected to not Launch and the impact in the remaining countries in the Territory. If the Independent Expert disagrees
with the Distributor’s decision to not Launch in a particular country, then the Principal shall have the right to make use of the duplicate Marketing Authorisation for the Product in the relevant country using a trade mark other than the Trade
Mark and shall have the right to market the Product in that country on a Semi-Exclusive basis. 

 Launch 

 

	5.8	 Within [...***...] of the later of a Marketing Authorisation and Pricing Approval being obtained in a country within the Territory, the
Distributor shall launch the Product (“Launch”) in that country provided that to do so would fit with the Launch Sequence. If a Launch at that time in that country would not fit with the Launch Sequence, the Launch in that country
shall be deferred until such time as would fit with 

  

***Confidential Treatment Requested 
  

			
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the Launch Sequence. Following Launch in each country in the Territory the Distributor shall: 

  

	 	5.8.1	use Commercially Reasonable Efforts to import, warehouse, promote, market, distribute and develop sales of the Product in the Territory and maintain a competent and
adequate staff and distribution network in the area in which it is carrying out direct sales in the Territory to achieve this; 

  

	 	5.8.2	ensure that it conforms to governmental laws and regulations in the Territory applicable to the promotion of the Product; 

 

	 	5.8.3	arrange at its own expense and in its sole discretion sales promotion, advertising and marketing materials for the promotion and sale of the Product in the Territory;

  

	 	5.8.4	only name the Principal in publicity or similar material where such material is approved in advance by the Principal (such approval not to be unreasonably withheld or
delayed), not itself register any rights over the Product except any trade mark or domain names it is permitted to register in accordance with this Agreement and the Distributor further shall place on the Product such reasonable notices as the
Principal may require; and 

  

	 	5.8.5	be responsible for negotiating and determining the terms of sale with its customers and shall maintain true and accurate records and accounts for all sales and related
activities conducted in the Territory. 

 Minimum Sales 

 

	5.9	 For each country or group of countries set out in Table 1 of Schedule 4 in which the Product is Launched, the Distributor shall attain
[...***...] of the sales forecast for the Product for each of the five years following the Launch of the Product as listed in that table (the “Volume Target”). Any sales made by way of parallel

  
 ***Confidential Treatment Requested 
  

			
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importation to a country shall be considered sales in the importing country for the purposes of this Clause 5.9. 

 

	5.10	For each country in which the Product is Launched, the Distributor shall promptly provide the Principal with a sales report on each quarter year following the date of
Launch in the country showing volume sales and Net Sales for the country. 

  

	5.11	If the Distributor fails to meet the Volume Target for [...***...] following Launch of the Product in a country or group of countries (the “Period of
Non-Performance”) then the Distributor shall make up the shortfall during the [...***...] period following the end of the Period of Non-Performance by paying to the Principal a sum equivalent to [...***...] of the Payment Price (as
defined in and calculated in accordance with the Supply Agreement) multiplied by the number of tablets falling short of the Volume Target for the Period of Non-Performance for that country or group of countries. If the Distributor fails to make up
the shortfall during the [...***...] then the Principal shall have the right to make use of a duplicate Marketing Authorisation for the Product in the country or group of countries in which the shortfall occurred using a trade mark other than
the Trade Mark and shall have the right to market the Product in that country or group of countries on a Semi-Exclusive basis for the remainder of the Term. Clause 5.9 and this Clause 5.11 shall not apply to the extent that the Distributor is
prevented from meeting the Volume Target due to: 

  

	 	5.11.1	any unreasonable act(s) or omission(s) of the Principal that materially reduces the commercial value and/or marketability of the Product in the Territory;

  

	 	5.11.2	any actual or threatened infringement of third-party Intellectual Property rights by the Distributor’s development, manufacture, use, promotion, offering to sell,
sale, distribution, importation or warehousing of the Product in accordance with this Agreement; 

  

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	 	5.11.3	the Principal making variation(s) to any Marketing Authorisation held in its, its Associate’s or its licensee’s name that materially reduce(s) the commercial
value and/or marketability of the Product; or 

 the Principal being in breach of its obligations under this
Agreement or the Supply Agreement or if any shortfall is due to an event of Force Majeure or circumstances otherwise beyond the reasonable control of the Distributor (including without limitation the Principal’s failure to supply the Product).

  

	5.12	Clauses 5.9 and 5.11 above shall immediately cease to apply for a country of the Territory if: (a) a generic version of the Product exhibiting pharmacokinetic
profiles that are bioequivalent to the Product is launched in that country of the Territory; or (b) in respect of a particular country if the Distributor’s rights in that country become Semi-Exclusive. 

Right to Audit Minimum Sales 
  

	5.13	The Distributor shall maintain and shall procure the maintenance of accurate and up-to-date records and books of account showing the quantity, description and value of
the Product supplied in each country of the Territory during the previous six (6) years. 

  

	5.14	The Distributor shall during business hours, on no less than fourteen (14) days’ written notice from the Principal and not more than once in any Calendar
Year, make available for inspection the records and books referred to in Clause 5.13. Such inspection shall be undertaken by an independent auditor appointed by the Principal and reasonably acceptable to the Distributor for the purpose of verifying
whether the Distributor has achieved the Volume Targets and whether the Distributor has made the correct payments for any shortfalls in Volume Targets as required by Clause 5.11. 

 

	5.15	 The Principal shall procure that any independent auditor appointed under Clause 5.14 shall maintain all information and materials received, directly or
indirectly, by it from the Distributor in strict confidence and shall not use or disclose the same to any third 

 

			
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party nor to the Principal save for the sole purpose of reporting the results of the audit pursuant to this Clause 5. 

 

	5.16	 In the event that an auditor appointed pursuant to this Clause 5 concludes that there has been an underpayment or overpayment, the Principal shall
deliver to the Distributor a copy of such auditor’s report. Any deficit payable by the Distributor or any excess refundable by the Principal shall be payable within [...***...] of the Distributor’s receipt of such
report. The fees charged by such auditor shall be payable by the Principal, provided that if the audit reveals that payments due to the Principal for any year have been understated by more than [...***...] the fees charged by such auditor
shall be payable by the Distributor. 

 Purchasing 

 

	5.17	The Distributor or its Associate shall purchase the Product exclusively from the Principal and pursuant to and in accordance with the Supply Agreement.

 Miscellaneous 
  

	5.18	The Distributor shall share any and all market research data and results of mutually agreed clinical studies relating to the Product in the Field and the Territory with
the Principal who may use such data without limitation for its own sole purposes outside of the Territory. 

  

	5.19	The Distributor shall promptly inform the Principal from time to time of any new data relating to the Product and the Field which shall include (without limitation) any
data concerning marketing activities, new study results and market research data. 

  

	5.20	The Distributor shall obtain the prior written approval of the Principal (such approval not to be unreasonably withheld or delayed) for any and all clinical and
regulatory activities relating to the Product undertaken by the Distributor which shall include (without limitation) any new clinical developments and regulatory filings. 

  
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	6.	MILESTONE PAYMENTS 

  

	6.1	Upon occurrence of each Milestone Event, the corresponding Milestone Payment shall become payable by the Distributor to the Principal. 

 

	6.2	Each Milestone Payment shall be due once only upon the first occurrence of the given Milestone Event. 

 

	6.3	 Milestone Payments due under this Clause 6 shall be paid within [...***...] of the date of occurrence of the Milestone
Event. 

  

	7.	COMMITTEE 

  

	7.1	The parties shall establish a joint product committee (“Committee”) consisting of four (4) individuals (“Committee Members”); two of
whom shall be nominated by the Principal; and two of whom shall be nominated by the Distributor. The Committee Members may be replaced by notice to the other party and shall be appropriately qualified and experienced in order to make a meaningful
contribution to Committee meetings. 

	7.2	The purpose of the Committee is to provide a forum for the parties to share such information and knowledge on the on-going development and commercialisation of the
Product as is permitted by law including, but not limited to, monitoring progress on formulation, manufacturing scale up and validation, clinical studies, reviewing clinical trial and regulatory programmes, reviewing marketing and promotional plans,
reviewing market conditions and discussing any regulatory, technical, quality assurance or safety issues in relation to the Product. The Committee shall conduct its discussions diligently and in good faith with a view to operating to the mutual
benefit of the parties and in furtherance of the successful development and marketing of the Product. 

  

	7.3	 The Committee shall meet as often as the Committee Members may determine, but in any event not less than twice per Calendar Year. The Committee may
invite 

  
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individuals with special skills to attend such meetings where considered to be relevant and appropriate. The quorum for Committee meetings shall be two Committee Members, comprising one Committee
Member from each party. Where any issues being considered by the Committee arc deadlocked then: 

  

	 	7.3.1	the Principal shall have the casting vote in respect of: 

  

	 	7.3.1.1	any matters relating to the registration of the Product in the countries of the Territory listed in Schedule 3; and 

 

	 	7.3.1.2	any matters relating to the Manufacturing (as defined in the Supply Agreement) and packaging of the Product in the Territory, 

(provided that such casting vote shall not be used in a way which is materially detrimental to the rights granted to the Distributor in
the Territory under this Agreement); 
  

	 	7.3.2	The Distributor shall have the casting vote in respect of any and all matters relating to: 

 

	 	7.3.2.1	the registration of the Product in the Non-EU Countries; and 

  

	 	7.3.2.2	pricing, reimbursement, formation of the Launch Sequence and commercialisation of the Product in all countries in the Territory, 

(provided that such casting vote shall not be used in a way which is materially detrimental to the rights of the Principal outside the
Territory); 
  

			
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	8.	NORTH AMERICA AND ASIA PACIFIC TERRITORY 

 For three (3) months following the Commencement Date, the Principal grants to the Distributor and its Associates an Exclusive right to enter into good faith negotiations with the Principal during
which the parties shall endeavour to form an agreement for the Exclusive supply of the Product in the Field in the North America and Asia Pacific Territory. 
  

	9.	NEW PRODUCTS 

 If the Principal or its Associates during the Term shall develop themselves or through a third party one or more New Products, then the Principal shall notify the Distributor in writing when the New
Product attains Proof of Concept, together with such data in the Principal’s possession relating to such New Product and shall grant to the Distributor and its Associates an Exclusive right to enter into good faith negotiations with the
Principal for a period of [...***...] for the Exclusive licence to that New Product in the Field in the Territory. 
  

	10.	NON-COMPETE 

 Except for
the Product in accordance with this Agreement, the Distributor shall not, and shall cause its Associates not to, directly or indirectly, including through any acquisition, license, partnership, joint venture or distribution arrangement, promote,
market, sell or distribute any modified release oral solid dosage form of a glucocorticoid product in any country of the Territory in the following indications: the Indication; Polyinyalgia rheumatic (PMR), Asthma and any other indication for the
Product that may be registered by the Principal. 
  

	11.	WARRANTIES 

  

	11.1	Distributor has conducted a due diligence review of Principal and third parties employed by Principal in connection with the activities contemplated hereunder and
during such due diligence the Principal has answered all of the questions of Distributor and complied with all of the document requests of Distributor. 

  

	11.2	The Principal represents and warrants that as at the Commencement Date: 

 
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	 	11.2.1	it has disclosed to the Distributor all material information known to it or its Associates concerning the safety or efficacy of the Product and it is not aware of any
safety or efficacy concerns which are not reflected in the documentation made available in the course of Distributor’s due diligence review and/or summarized in the approval documentation submitted by Principal as part of its DCP efforts,
including (without limitation) the SMPC and disclosed to the Distributor before the Commencement Date; 

  

	 	11.2.2	to its knowledge, there are no litigations, suits, actions, arbitration, judicial or legal, administrative or other proceedings or governmental investigations pending
or threatened against the Principal or its Associates which would be reasonably expected to affect or restrict the activity of the Principal to consummate the transactions under this Agreement or to perform its obligations under this Agreement; nor
to its knowledge are there any litigation, suits, actions, disputes, claims, arbitrations, judicial or legal, administrative or other proceedings or governmental investigations pending against the Principal or its Associates in connection with the
Product or the Principal Intellectual Property; 

  

	 	11.2.3	the Principal Intellectual Property comprises all the Intellectual Property owned, licensed or controlled by the Principal and its Associates relating to the
manufacture, use or sale of the Product in the Territory; 

  

	 	11.2.4	the Principal and its Associates have on the Commencement Date no knowledge that would cast doubt upon the validity or enforceability of the Principal Intellectual
Property, or upon the freedom from any third party rights of the Product or its manufacture; 

  

	 	11.2.5	the Principal has disclosed to the Distributor all Intellectual Property rights licensed to the Principal by third parties and necessary for the Distributor to lawfully
exercise its rights and perform its obligations under this Agreement and the Principal is lawfully authorized to sub-license the same in accordance with this Agreement; 

  

			
		 	Page 25 of 46

	 	11.2.6	the Principal has no knowledge that, with respect to the Product, it will infringe in any material respect any Intellectual Property of any third party in the
Territory. The Principal has not received any notice that, with respect to the Product, it is violating or has violated the trademarks, patents, copyrights, inventions, trade secrets, proprietary information and technology, know-how, formulae,
rights of publicity or other Intellectual Property rights of any third party; 

  

	 	11.2.7	neither the execution and delivery of this Agreement nor the performance hereof by the Principal requires the Principal to obtain any permits, authorisations or
consents from any governmental authority (subject to obtaining all necessary approvals with respect to the manufacture, use or sale of the Product in the Territory) or from any other person, firm or corporation; 

 

	 	11.2.8	the Principal is not under any obligation to any person, contractual or otherwise, that is conflicting or inconsistent in any respect with the terms of this Agreement
or that would impede the diligent and complete fulfilment of the Principal’s obligations under this Agreement in any material respect; 

  

	 	11.2.9	SkyePharma plc and/or Jagotec AG have represented to the Principal that the Principal is the exclusive licensee of SkyePharma plc’s and/or Jagotec AG’s
proprietary rights regarding SkyePharma’s and/or Jagotec’s technology in connection with oral glucocorticoids and Principal has no reason to believe that SkyePharma and/or Jagotec have misrepresented the fact to Principal in this regard;

  

	 	11.2.10	the Principal has full power and authority to lawfully enter into this Agreement and shall not breach any term of any agreement with any third party in doing so; and

  

	 	11.2.11	the Principal is not in default of any provision of the Development and Licence Agreement and no event has occurred that with the giving of notice and/or passage of
time would constitute a default under the same. 

  

	11.3	The Distributor represents and warrants that as at the Commencement Date: 

 

			
		 	Page 26 of 46

	 	11.3.1	to its knowledge, there are no claims or investigations pending or threatened against the Distributor or any of its Associates, relating to the matters contemplated
under this Agreement which would materially adversely affect the Distributor’s ability to perform its obligations hereunder nor to its knowledge are there any other circumstances within its control which can reasonably be expected to prevent,
delay or to have any other detrimental influence on the launch of the Product as contemplated hereunder; and 

  

	 	11.3.2	the Distributor is not under any obligation to any person, contractual or otherwise, that is conflicting or inconsistent in any respect with the terms of this Agreement
or that would impede the diligent and complete fulfilment of the Distributor’s obligations under this Agreement in any material respect. 

  

	11.4	Except as provided herein, neither the Principal nor the Distributor makes any other warranties under this Agreement. 

 

	12.	INDEMNIFICATION AND INSURANCE 

  

	12.1	Subject to mandatory law, neither party shall be liable or responsible for any exemplary, punitive, special, indirect, or incidental damages of any kind whether based
on contract, tort (including negligence), strict liability, or any other theory or form of action even if a party has been advised of the possibility thereof. Subject to Clause 12.3, the Principal shall not be responsible for any damages, claims or
losses which the Distributor or any third parties may suffer by reason of the Distributor’s actions or inactions regarding the Product (other than in accordance with this Agreement or as directed by the Principal). 

 

	12.2	 The Distributor shall indemnify and hold the Principal, and any of its Associates, directors, representatives, officers, employees, shareholders,
agents, successors, and/or assignees named in the proceeding, harmless against any and all losses, liabilities, costs and expenses (including attorneys fees), debts, or other obligations arising or resulting from or relating to claims, actions,
suits, proceedings, demands, assessments, fines, penalties, judgments, damages, arbitral awards, and amounts paid in settlement of any of the foregoing claims, judgements, legal (including judicial, arbitral and administrative) proceedings and the
like which claims, judgements, legal 

  

			
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proceedings and the like arise out of (a) any breach of the Distributor’s warranties, covenants or obligations contained in this Agreement or (b) the Distributor’s clinical
investigation, or direct or indirect research or testing of the Product, or the marketing, sale or distribution of the Product, including but not limited to third party claims arising from those activities of the Distributor except in each case to
the extent such claims are attributable to matters that are subject to indemnification by the Principal. 

  

	12.3	The Principal shall indemnify and hold the Distributor, and any of its Associates, directors, representatives, officers, employees, shareholders, agents, successors
and/or assignees named in the proceeding, harmless against any and all losses, liabilities, costs and expenses (including attorneys fees), debts, or other obligations arising or resulting from or relating to claims, actions, suits, proceedings,
demands, assessments, fines, penalties, judgements, damages, arbitral awards, and amounts paid in settlement of any of the foregoing claims, judgements, legal (including judicial, arbitral and administrative) proceedings and the like which claims,
judgements, legal proceedings and the like arise out of (a) any breach of the Principal’s warranties, covenants or obligations contained in this Agreement or (b) any liability suffered from clinical trials conducted by the Principal
involving the Product prior to the Commencement Date, or (c) the Principal’s development activities, direct or indirect research or testing of the Product by the Principal, or the labelling, manufacturing or packaging of Product by or on
behalf of the Principal, except in each case to the extent such claims are attributable to matters that are subject to indemnification by the Distributor. 

  

	12.4	 The Principal and the Distributor shall notify each other promptly in writing upon learning of any claim, judgement, or legal proceeding or the like
pertaining directly or indirectly to the Product or any indemnification obligation pursuant to this Clause 12. The party obliged to indemnify the other party under this Clause 12 (the “Indemnifying party”) shall be entitled to
defend against any such claims, judgement and legal proceedings or the like with counsel selected by it and reasonably acceptable to the other party (the “Indemnified party”). In any event the Indemnifying party will inform the
Indemnified party of all developments concerning the claim and shall not settle any claim without the Indemnified party’s prior written consent, which consent shall not be unreasonably withheld or delayed (and it is understood that the absence
of a general liability release is a reasonable basis to withhold consent). The 

  

			
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Indemnified party may seek to intervene in such proceedings at any time to protect its own interest and the attorneys of the Indemnifying party shall fully inform and cooperate with the attorneys
of the Indemnified party. Termination shall not in any way affect the provisions of Clauses 12.2 and 12.3 hereof or relieve or discharge any Indemnifying party with respect thereto. 

 

	12.5	 Each party shall, at its own expense, maintain with a reputable insurance company during the Term as well as [...***...]
 thereafter adequate product liability insurance or self-insurance arrangements against liability and claims of liability for personal injury, death or property damage relating to the Product, such coverage providing for a minimum aggregate
liability of [...***...]. The parties’ insurance policies or self-insurance arrangements shall provide cover to the extent required by local laws or pharmaceutical industry practice, whichever is broader and higher. Each party shall upon
the request of the other party produce to such party a copy of the certificate of insurance and/or the policy of insurance together with a copy of the latest renewal receipt or evidence of self-insurance arrangement.

  

	13.	INFRINGEMENT OF THIRD PARTY RIGHTS 

  

	13.1	 In the event of a party becoming aware that the exercise of either party’s rights and obligations pursuant to this Agreement are infringing or may
infringe the rights of a third party, it will promptly so notify the other party and provide it with such details of the third party rights and the extent of the infringement as are known to it. The Principal shall be entitled at its discretion to
contest any such third-party claim or proceedings or otherwise to take such steps to terminate such infringement or remedy the position and where necessary enter any third party licence agreement in respect of such infringement such that the
Distributor will lawfully be able to practice the rights and licences granted hereunder. No later than [...***...] from becoming aware of or receiving notification in relation to such infringement of the rights of a third party, the Principal
shall inform the Distributor whether it intends to contest the claim or take such other steps necessary to terminate any such infringement (including the negotiation of a third-party licence agreement) and if the Principal decides not to contest the
claim or take other steps necessary to terminate such infringement the 

  

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Distributor may thereafter contest any such third-party claim or proceedings at the Distributor’s own cost. If the Principal does contest the claim or take steps to terminate such
infringement it shall keep the Distributor informed of its actions in this regard. If the Principal enters into a third-party licence agreement any third party royalties or licence fees incurred in regard shall be borne solely by the Principal.

  

	13.2	Where the Distributor has assumed responsibility for contesting any such third-party claim or proceedings in accordance with Clause 13.1 (including the negotiations of
a third-party licence agreement), the Distributor shall keep the Principal reasonably informed of its actions in this regard and the Principal will provide the Distributor with all reasonable co-operation in connection with such actions. Without
limitation this shall include the Distributor furnishing the Principal with drafts of any proposed third-party licence agreement and the Distributor seeking the Principal’s approval to the terms of any such agreement. The Distributor shall not
enter into any such third-party licence agreement without the prior written approval of the Principal to such agreement (which shall not be unreasonably withheld or delayed). The Principal shall reimburse the Distributor’s reasonable costs in
defending any such claim. Any third-party licence fees incurred in this regard shall be borne solely by the Principal. 

  

	13.3	Should there be any unresolved dispute between the parties as to the necessity for or the commercial terms of any third-party licence agreement, an expert (which for
these purposes shall be deemed to be suitably expert senior patent counsel) shall be appointed to resolve the issue. 

  

	14.	INFRINGEMENT OF PRINCIPAL INTELLECTUAL PROPERTY 

  

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

  

	14.2	 No later than [...***...] from becoming aware of or receiving notification of any actual or suspected infringement or misuse of the Principal
Intellectual Property or an attack on its validity in the Territory, the 

  

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Principal shall inform the Distributor whether it intends to institute proceedings against the infringer or attacker. 

 

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

  

	14.4	Any damages, award or settlement monies actually received by the Principal in respect to such infringement and paid in compensation for sales lost by the Distributor
shall belong to the Distributor, subject to the Principal deducting its reasonable costs in pursuing such infringement from such damages, award or settlement actually received, and to such payments by way of damages, award or settlement being
treated as Net Sales and the Principal deducting therefrom any payment it would be due had the Distributor achieved such Net Sales. Any damages, award or settlement monies actually received by the Principal in respect to such infringement and not
paid in compensation for sales lost by the Distributor shall belong to the Principal. 

  

	14.5	Should in accordance with Clause 14.2 the Principal notify the Distributor that it does not intend to pursue any such infringement or defend such attack, the
Distributor may thereafter pursue such infringement or defend such attack. Any damages, award or settlement monies actually received by the Distributor in respect to such infringement and paid in compensation for sales lost by the Distributor shall
belong to the Distributor, subject to such payments (net of reasonable costs of pursing the infringement) being treated as Net Sales and the Distributor paying to the Principal therefrom any payment which would be due to the Principal had the
Distributor achieved such Net Sales. Any damages, award or settlement monies actually received by the Distributor in respect to such infringement and not paid in compensation for sales lost by the Distributor shall belong to the Principal, save that
the Distributor shall be entitled to set off its reasonable costs in pursuing such infringement against such damages, award or settlement actually received by the Distributor. 

 15. COMMUNICATIONS 
  

			
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	15.1	Neither Principal nor Distributor nor any of their Associates shall publicly disclose this Agreement in whole or in part, except to the extent required by law or with
the consent of the other party, such consent not to be unreasonably withheld or delayed. 

  

	15.2	Neither party may issue any press release or public communication relating to the Agreement (including the parties’ discussions relating thereto) without prior
written approval of the other which shall not be unreasonably withheld or delayed. 

  

	16.	CONFIDENTIALITY 

  

	16.1	The parties and their Associates shall keep strictly confidential, other than disclosures to Associates for purposes related to this Agreement, and shall not publish or
otherwise divulge or use for any purpose other than as contemplated by this Agreement: 

  

	 	16.1.1	any confidential information received from the other party to this Agreement except such which: 

 

	 	16.1.1.1	can be shown to have been known to the receiving party prior to disclosure by the providing party, 

 

	 	16.1.1.2	is now, or comes into, the public domain by publication or otherwise without the fault of the party seeking exemption from this Clause 16, 

 

	 	16.1.1.3	is made known to the receiving party from another source under no obligation to the providing party, or 

 

	 	16.1.1.4	is required by law, regulation or judicial order to be disclosed. 

  

	16.2	The obligations in this Clause 16 and Clause 19.9 below shall survive this Agreement. 

 

	16.3	 Notwithstanding the foregoing, either party may disclose confidential information to governmental agencies to the extent that this is required or
desirable in proceedings to obtain marketing approval for the Product, to outside consultants, advisers, agents, sub-licensees and to non-clinical and clinical investigators provided the relevant

  

			
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persons are subject to a secrecy agreement, which mirrors the secrecy agreement of this Clause 16. 

 

	16.4	Each of the parties to this Agreement shall be responsible for the imposition of the confidentiality provisions provided for in this Clause 16 upon its own staff, its
Associates, consultants and others prior to disclosing any confidential information in relation to the Product or its mode of manufacture. 

  

	16.5	All written information in connection with the subject matter of this Agreement disclosed by either party prior hereto shall be deemed to be subject to this Clause 16.

  

	17.	GOVERNING LAW AND JURISDICTION 

 THE VALIDITY INTERPRETATION AND PERFORMANCE OF THIS AGREEMENT ITS AMENDMENTS AND EACH OF ITS PROVISIONS SHALL BE GOVERNED EXCLUSIVELY BY AND CONSTRUED IN ACCORDANCE WITH SWISS SUBSTANTIVE LAW. 

 

	18.	ARBITRATION 

 ANY DISPUTE,
CONTROVERSY OR CLAIM ARISING OUT OF OR IN RELATION TO THIS AGREEMENT, INCLUDING THE VALIDITY, INVALIDITY, BREACH OR TERMINATION THEREOF, SHALL BE RESOLVED BY ARBITRATION IN ACCORDANCE WITH THE SWISS RULES OF INTERNATIONAL ARBITRATION OF THE SWISS
CHAMBERS OF COMMERCE IN FORCE ON THE DATE WHEN THE NOTICE OF ARBITRATION IS SUBMITTED IN ACCORDANCE WITH THESE RULES. THE NUMBER OF ARBITRATORS SHALL BE THREE. THE SEAT OF ARBITRATION SHALL BE ZURICH. THE ARBITRAL PROCEEDINGS SHALL BE CONDUCTED IN
ENGLISH. 
  

	19.	TERM AND TERMINATION 

  

	19.1	 This Agreement shall commence as of the Commencement Date and, unless sooner terminated as provided hereunder, shall continue in full force and effect
for the Initial Term. Unless terminated by written notice to the other party served at least six months 

 

			
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prior to expiry, this Agreement shall be extended automatically for successive [...***...] terms at the end of the Initial Term and
any subsequent term. 

  

	19.2	In the event that a party materially fails to fulfil or breaches any material term or condition of this Agreement, and in case such failure or breach should if capable
of remedy not be remedied by the party concerned or if not capable of remedy the party concerned should not have offered and paid full compensation therefor, in each case within [...***...] days of written notice of such breach — which
notice shall have to include specific reference to this section of this Agreement - given by the other party, the other party may terminate this Agreement with a further [...***...] days written notice. Repeated breaches, that are not material
individually, represent a material breach of this Agreement if they are material in the aggregate. Time periods under this section shall be suspended during negotiations among the parties until one party informs the other party that it does not wish
such suspension to occur. 

  

	19.3	Following a valid termination by Principal or expiration of this Agreement and subject to Clause 19.6, the Distributor shall immediately cease all work or activities
regarding the Product. Principal shall have the free right to use any data and information relating to the Product and registration applications or registrations in the Territory without any further obligation or liabilities to the Distributor.

  

	19.4	Either party may terminate this Agreement at any time by giving notice in writing to the other party, which notice shall be effective upon dispatch, if the other party
becomes insolvent, make an arrangement or composition for the benefit of creditors, or in the event that its assets become subject to a receivership, administration or liquidation or come under the control of a receiver, administrator or liquidator
or other official appointed by a court or other governmental body or a like event should occur in any jurisdiction. 

  

	19.5	 The Distributor shall have the continuing right to terminate this Agreement for a specific country immediately by written notice if the Marketing
Authorisation for the Product is cancelled, withdrawn or suspended in any country of the Territory. The Distributor shall also have the right to terminate this Agreement if there is a material

  
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risk that third parties may suffer personal injury or other damage in their using the Product in any country of the Territory. 

 

	19.6	Termination or expiration of this Agreement shall not release either party from the obligation to deliver or to make payment of all amounts then or thereafter due and
payable. Both parties’ obligations pursuant to the secrecy provisions of this Agreement shall survive termination of this Agreement; 

  

	19.7	 In the event of termination or expiration of this Agreement, the Principal may repurchase stocks of Product held by the Distributor at the prices the
Distributor has bought the Product, if the Principal so chooses. Otherwise the Distributor is entitled to distribute the remaining stocks within [...***...] within the Territory. All stocks remaining
after this period of [...***...] including but not limited to all Product which might be returned thereafter, have to be destroyed at the Distributor’s responsibility and costs. 

 

	19.8	Upon expiration of this Agreement or termination of this Agreement by the Principal under Clauses 19.2 or 19.4, the Distributor shall promptly transfer to Principal all
Marketing Authorisations and related rights and documentation obtained by Distributor under or in connection with this Agreement or its activities hereunder. 

 

	19.9	 Upon termination of this Agreement by the Distributor under Clause 19.4 above, the Distributor must along with its Associates immediately cease using
the Principal Intellectual Property and immediately cease making, having made, using, selling, and importing the Product, and return to Principal, or deliver or destroy as Principal directs, the Product, all copies of the Principal Intellectual
Property and any of Principal’s confidential information then in its possession, all of the foregoing to be returned, delivered or destroyed at Principal’s cost. Furthermore, all of the rights granted pursuant to Clause 2 shall revert to
Principal, Distributor shall provide Principal with access to all data pertaining to the Product in the Territory developed pursuant to this Agreement and Distributor shall assign or cause to be assigned to Principal all filings pertaining to the
Product (including any regulatory filings and certifications and trade mark applications, regulatory approvals and Pricing 

  
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Approvals that are in the name of Distributor or any of its Associates), with all of such rights, data, applications, filings and approvals to be delivered, assigned or transferred at
Principal’s cost. 

  

	20.	MISCELLANEOUS 

  

	20.1	Neither this Agreement nor any interest herein shall be assigned or encumbered in any way by a party other than by assignment in whole or in part to an Associate
without the other party’s prior written consent, which shall not be unreasonably withheld or delayed, provided that the assigning party shall remain responsible in addition to the party receiving assignment for the full and timely performance
of this Agreement. 

  

	20.2	Failure by either party to this Agreement to avail itself of one or more clauses of this Agreement shall in no event be construed as a waiver thereof.

  

	20.3	Any notice, request, approval or other document required or permitted to be given under this Agreement shall be in writing and shall be deemed to have been sufficiently
given, and effective upon the date of dispatch, if delivered in person or by internationally recognized courier service or transmitted by facsimile, provided, that in the case of facsimile delivery, such notice shall be confirmed by certified or
registered mail, return receipt requested, addressed to the addresses of the parties shown at the top of this Agreement or to such other address or addresses as may be specified from time to time by written notice. 

 

	20.4	This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof, and supersedes any promise, agreement or consent on the
Product made between the parties hereto by officers or employees of the parties before the execution of this Agreement. Existing confidentiality agreements in force among the parties shall remain in force with the proviso that in each case the
stricter rule shall prevail. 

  

	20.5	 The parties hereto shall not be liable for failure of or delay in performing any obligation under this Agreement, if such failure or delay is due to
Force Majeure provided, however, that the party affected shall promptly notify the other party of the 

 

			
		 	Page 36 of 46

	 	 
Force Majeure and shall exert all reasonable efforts to eliminate, cure or overcome any such causes and to resume performance of its obligation with all possible speed.

  

	20.6	If any provision of this Agreement is held to be invalid, illegal or unenforceable under applicable law the remaining provision shall continue to be in full force and
effect. The parties undertake to replace the invalid provision or parts thereof by a new provision which will approximate as closely as possible the economic result intended by the parties. 

 

	20.7	Nothing in this Agreement shall create, or be deemed to create, a partnership, agency or joint venture between the parties. 

 

	20.8	No amendment, modification or addition hereto shall be binding unless set forth in writing. This includes amendments, modifications and additions to this Clause 20.

  

	20.9	All invoices to be issued by Nitec and all payments to be made to Nitec will be denominated and made in EURO (€) and any amount referred to in this Agreement is
intended to be denominated in EURO (€). In case any currency conversion is required the parties will refer to the average Euro foreign exchange reference rates, as published by the European Central Bank, for the previous 30 days.

  

	20.10	This Agreement may be executed in any number of counterparts, each of which when executed and delivered shall constitute an original of this Agreement, but all the
counterparts shall together constitute the same Agreement. 

 In WITNESS WHEREOF the PARTIES hereto have caused this
Agreement to be executed in duplicate by their duly authorized officers as of the Commencement Date. 
  

							
	 SIGNED for and on behalf of:
	 	 )
	  		 	
	 NITEC PHARMA AG
	 	 )
	  	 /s/ Anders Härfstrand
	 	
	 By: Anders Härfstrand
	 	 )
	  	 Anders Härfstrand
	 	
	 23/3/09
	 		  	 CEO
	 	

  

			
		 	Page 37 of 46

							
		 		  	Print Name	 	
	SIGNED for and on behalf of:	 	)	  		 	
	NITEC PHARMA AG	 	)	  	 /s/ Jochen Mattis
	 	
	By: Jochen Mattis	 	)	  	Jochen Mattis	 	
	23/3/09	 		  	EVP Marketing & Sales, Business Development
		 		  	Print Name	 	
				
	SIGNED for and on behalf of:	 	)	  	 /s/ Douglas Docherty
	 	
	MUNDIPHARMA INTERNATIONAL 	 	)	  	DOUGLAS DOCHERTY	 	
	CORPORATION LIMITED	 	)	  	GENERAL MANAGER	 	
		 		  	Print Name	 	

  

			
		 	Page 38 of 46

 SCHEDULE 1 
 THE TERRITORY 
 Albania 
 Belgium 
 Bosnia-Herzegovina 
 Bulgaria 
 Croatia 
 Cyprus 
 Czech Republic 
 Denmark 
 Estonia 
 Finland 
 France 
 Greece 
 Hungary 
 Iceland 
 Italy 
 Israel 
 Latvia 
 Lithuania 
 Lichtenstein 
 Luxemburg 
 Macedonia 
 Malta 
 Montenegro 
 Netherlands 
 Norway 
 Poland 
 Portugal 
 Ireland 
 Romania 
 Serbia 
 Former Soviet Union Countries 
 Slovakia 
 Slovenia 
 Spain 
 Sweden 
 Switzerland 
 Turkey 
 UK 
  

			
		 	Page 39 of 46

 SCHEDULE 2 
 NORTH AMERICA AND 
 ASIA PACIFIC TERRITORY 

USA 
 Canada 

Mexico 
 Japan 

Korea 
 China 

India 
 Indonesia 

Philippines 
 Malaysia 

Singapore 
 Thailand 

Australia 
 New Zealand 

 

			
		 	Page 40 of 46

 SCHEDULE 3 
 EU DCP COUNTRIES 
 First Wave countries: 

Belgium 
 Denmark

 Finland 
 France 
 Italy 

Luxemburg 

Netherlands 

Norway 
 Poland

 Portugal 
 Spain 
 Sweden 

United Kingdom 
 Second Wave
countries: 
 Bulgaria 
 Greece 
 Iceland 

Ireland 
 Cyprus

 Czech Republic 
 Estonia 
 Hungary 

Latvia 

Lithuania 
 Malta

 Romania 
 Slovak Republic 
 Slovenia 
  

			
		 	Page 41 of 46

  
 SCHEDULE 4

 Table 1 
 Volume Forecast 
  

																					
	 Volume tablets (m)
	  	 	year 1	  	  	 	year 2	  	  	 	year 3	  	  	 	year 4	  	  	 	year 5	  
	 [...***...]
	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  

 Table 2

 Sales Forecast 
  

																					
	 Sales (€m)
	  	 year 1
	  	 year 2
	  	 year 3
	  	 year 4
	  	 year 5
	  	 year 6
	  	 year 7
	  	 year 8
	  	 year 9
	  	 years
 10-15

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

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

  

			
		  	Page 42 of 46

  
 SCHEDULE 5

 MILESTONE PAYMENTS 
  

					
	 Milestone Event
	  	Milestone
Payment	 
	 [...***...]
	  	 	[...***...]	  
		
	[...***...]	  			
		
	 [...***...]
	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  
		
	 [...***...]
	  	 	[...***...]	  
		
	 [...***...]
	  			
		
	 [...***...]
	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  
	 [...***...]
	  	 	[...***...]	  

  

***Confidential Treatment Requested 

  

			
		  	Page 43 of 46

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

  

***Confidential Treatment Requested 
  

			
		  	Page 44 of 46

 SCHEDULE 6 
 GUIDING PRINCIPLES OF REGULATORY AFFAIRS 
 These Guiding Principles establish the rules of
co-operation regarding the Drug Regulatory Affairs (“DRA”) of Principal and Distributor. They do not change the local legal responsibilities of the Marketing Authorisation Holders. 

 

	1.	Principal and Distributor shall nominate one DRA contact person to handle their respective DRA activities (hereinafter referred to as “DRA Principal” and
“DRA Distributor”). 

  

	2.	DRA Principal shall make the current EU CTD file, documents and information directly available to DRA Distributor. 

 

	3.	Principal shall be the Marketing Authorisation Holder (“MAH”) in the Reference Member State and shall maintain the same for the Term. All EU DCP procedures
shall be co-ordinated by DRA Principal and supported by DRA Distributor as best as reasonably possible. 

  

	4.	After the transfer of any national EU Marketing Authorisation from the Principal to the Distributor under Clause 4.1, DRA Distributor shall require the written approval
from DRA Principal (subject to paragraph 11 below) on any changes to the dossiers and documents before submission to the Regulatory Authorities. DRA Principal shall take into account all commercial considerations as Distributor may submit to
Principal in deciding whether to provide such approval. 

  

	5.	DRA Principal shall provide DRA Distributor with all documents and information necessary for DRA Distributor to compile, obtain, maintain, update, transfer or withdraw
the Marketing Authorisations for the Product in the Non-EU Countries in a format that complies with the local authorities’ requirements. 

  

	6.	The responsibility for the technical and scientific content of the dossiers and documents lies with the Principal through DRA Principal. 

 

	7.	The prior written consent of DRA Principal (subject to paragraph 11 below) is required before any regulatory activities, e.g. variations, updates, withdrawals, or
transfers to a third party, on existing, or pending MAs are undertaken by DRA Distributor. DRA Principal shall take into account all commercial considerations as Distributor may submit to Principal in deciding whether to provide such consent.

  

			
		 	Page 45 of 46

	8.	DRA Distributor shall inform DRA Principal about the submission date at the earliest opportunity and shall provide copies of all relevant correspondence with the
Regulatory Authorities as well as their English translation. 

  

	9.	DRA Distributor shall keep DRA Principal informed of relevant changes to local legislation or guidelines of which it is aware to promote a good flow of regulatory
intelligence. 

  

	10.	Communication between DRA Principal and DRA Distributor and exchange of dossiers or documents will preferably be made by electronic media. 

 

	11.	Any variation that either Principal or Distributor wishes to make to any Marketing Authorisation (including that in the Reference Member State) shall be first referred
to the Committee by the DRA Principal or DRA Distributor as appropriate and the Committee shall decide whether to proceed with such variation. 

  

			
		 	Page 46 of 46Technical Transfer Agreement

 Exhibit 10.19 
 ***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. 

TECHNICAL TRANSFER AGREEMENT 
 This Technical Transfer Agreement (together with the Schedules hereto, this “Agreement”) is entered into as of November 9, 2009 (the “Effective Date”) 

by and between 
 SANOFI-AVENTIS U.S. LLC, a
limited liability company duly organized and existing under the laws of the State of Delaware with offices at 55 Corporate Drive, Bridgewater, New Jersey 08807 (“sanofi-aventis US”) 
 and 
 HORIZON THERAPEUTICS, INC., a corporation with offices at 1033 Skokie Boulevard, Suite 355,
Northbrook, Illinois 60062 (“Horizon”). 
 Horizon and sanofi-aventis US may be referred to herein individually as a “Party”
and collectively as the “Parties” 
 WHEREAS, sanofi-aventis US is engaged in the manufacture, marketing, sales and
distribution of pharmaceutical products and operates directly or through one or more Affiliates certain manufacturing or packaging facilities located in Laval Quebec, St Louis MO and Compiegne France (the “Facilities”); and 

WHEREAS, Horizon is engaged in the development of pharmaceutical products and desires to have sanofi-aventis US or an Affiliate
designated by sanofi-aventis US undertake the technical transfer of HZT-501 tablets (the “Product”), and confirms Horizon’s intent to engage sanofi-aventis US to undertake, whether directly or through one or more designated
Affiliates, exclusive commercial supply of the Product under an agreement (the “Commercial MSA”) to be negotiated in good faith between the Parties. 
 NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties
hereby agree as follows: 
  

	1.	DEFINITIONS 

  

	1.1	“Affiliate” shall mean, with respect to either Party, any corporation, partnership or other entity controlled by, controlling or under common control
with, such Party, with “control” meaning direct or indirect beneficial ownership of more than 50% of the voting power of, or more than 50% ownership interest in, such corporation, partnership or other entity. More specifically with respect
to sanofi-aventis US, Affiliate refers to legal entities controlled by, controlling or under common control with sanofi-aventis US that own or operate the Facilities. 

 

 1 

	1.2	“Certificate of Analysis” shall mean a document signed by an authorized representative of a Facility, certifying the specifications for, and
testing methods applied to, the Product, and the results thereof, and which includes the Product date of manufacture, date of release, and expiration date. 

 

	1.3	“Certificate of Manufacturing” shall mean a document, signed by an authorized representative of a Facility, certifying that the bulk Product
being delivered to Horizon has been manufactured in conformity with cGMPs. 

  

	1.4	“cGMP” or “current Good Manufacturing Practice” shall mean current good manufacturing practices for medicinal products
established by U.S. laws, rules and regulations (including 21 CFR Parts 210 and 211, as amended, and any successor regulations thereto, each as in effect from time to time). 

 

	1.5	“Facility Equipment” shall mean such equipment owned by a sanofi-aventis Affiliate used in the manufacture of the Product at the Facility.

  

	1.6	“Horizon Equipment” shall mean the equipment listed in Exhibit 2, to be purchased by Horizon in order to allow, in combination with the Facility
Equipment, the manufacture of the Product at the Facilities. 

  

	1.7	“Horizon Materials” shall mean Ibuprofen DC-85 and Famotidine, in each case meeting the specifications for such materials set forth in Schedule
1.7 hereto. 

  

	1.8	“HZT-501 IP” shall mean all Intellectual Property Rights made available to sanofi-aventis US or its affiliates by Horizon pursuant to this
Agreement, including, without limitation, the Base Technology, Know-How, information, documents and tangible and intangible materials made available to sanofi-aventis US or an Affiliate designated by sanofi-aventis US by Horizon that are required
for sanofi-aventis US or its designated Affiliate to perform sanofi-aventis US’s obligations under this Agreement. 

  

	1.9	“Information” shall mean, as the case may be, any and all information relating to the Product, manufacture of the Product or the business of
either Party, owned and/or disclosed by one Party to the other in written, electronic or any other form. This includes, but is not limited to, Know-How, operational methods, formulae, samples, Specifications, analytical methods as well as any
details of a commercial, technical, pharmaceutical, scientific and industrial nature whether disclosure of such information occurred prior to or after the Effective Date. 

 

	1.10	“Intellectual Property Rights” shall mean patents and patent applications, Know-How, utility models, trademarks, design rights, copyrights and
any other proprietary rights. 

  

	1.11	“Know-How” shall mean all confidential and identified technical and scientific information and data, irrespective of its subject-matter and
form, including, but not limited to, processes, formulae, designs and data as well as inventions and improvements whether patentable or not. 

  

	1.12	 “SAUS IP” shall mean all Intellectual Property Rights provided by sanofi-aventis US or its affiliates pursuant to this
Agreement, including, without limitation, the Base Technology, Know-How, information, documents and tangible and intangible materials provided by sanofi-aventis US or an Affiliate designated by sanofi-aventis US that are required for

  

 2 

	 	 
sanofi-aventis US or its designated Affiliate to perform sanofi-aventis US’ obligations under this Agreement. 

 

	1.13	“Product Specifications” means the specifications for the Product set forth in Schedule 1.12 hereto. 

 

	2.	TECHNICAL TRANSFER 

  

	2.1	Technical Transfer 

 Horizon shall
provide to sanofi-aventis US or its designated Affiliate without any cost or expense to sanofi-aventis US and such Affiliate, all analytical, manufacturing, technical and other methods, processes, records and Know-How in Horizon’s control and
necessary or useful to enable sanofi-aventis US or such Affiliate to produce the Product in conformance with the Product Specifications and current Good Manufacturing Practice, including, but not limited to, any manufacturing instructions,
specifications (including, without limitation, Product Specifications, starting material specifications, and specifications for the Product or any intermediate version of the Product), development reports, production summaries, regulatory filings,
validation reports, quality control and quality assurance documents, analytical methods and validation reports and any production or development batch records (the “Technical Transfer”). Should sanofi-aventis US or its designated
Affiliate reasonably require any analytical, manufacturing, technical and other methods, processes, records and Know-How to perform its obligations under this Agreement, Horizon is responsible for obtaining such information at its own cost and
providing it to sanofi-aventis US or such Affiliate as promptly as reasonably practicable. 
 A preliminary manufacturing process description is
attached hereto as Exhibit 1. The Parties acknowledge that a final manufacturing process has not yet been developed. Accordingly, the Parties agree that, to the extent that the definitive manufacturing process or final Product Specifications have an
adverse financial impact on the projected costs set forth in Section 4 hereto, including, without limitation, any supply price, each Party agrees to negotiate revisions to such costs in good faith. To the extent that, despite good faith
efforts, the Parties cannot reach agreement on modified costs, either Party may terminate this agreement. 
  

	2.2	Analytical Method Transfer 

 The
Parties shall cooperate to transfer any and all analytical methods for existing Product from Horizon to sanofi-aventis US or its designated Affiliate as promptly as practicable following the execution of this Agreement, but in no event later than 60
days prior to the date on which the manufacture of the validation batches is scheduled to commence. Sanofi-aventis US’ or its designated Affiliate’s costs in relation with any such transfer shall be deemed included in the expenditure set
forth in Section A of Exhibit 3. Horizon shall bear its own costs in connection with said analytical transfer. For purposes of clarification, the costs outlined in Exhibit 3 are merely for transfer of any such analytical methodologies and do not
include costs associated with method optimization. 
  

	2.3	Engineering Study Batches 

 Horizon
shall provide sanofi-aventis US or its designated Affiliate, without any cost or expense to sanofi-aventis US or such Affiliate, all Horizon Materials necessary for the production of the engineering study batches. Sanofi-aventis US or an Affiliate
designated by sanofi-aventis US will utilize its current suppliers for other raw materials and excipient unless otherwise required by 

 

 3 

 
Horizon. Should there be a need for sanofi-aventis US or its designated Affiliate to qualify a new supplier (or new material), Horizon will bear the added cost involved with such activities. The
manufacturing cost, cost of excipients and physical destruction of the Product resulting from the engineering study batches shall be deemed to be included in the expenditure set forth in Section A of Exhibit 3. The planned costs outlined in Exhibit
3 A, include one (1) core tablet engineering study and two (2) finished product engineering studies. It may be necessary, as determined by mutual agreement of the Parties, for sanofi-aventis US or its designated Affiliate to perform one or
more additional engineering study batches to ensure successful validation or to address changes in the formulation of the Product. In such cases, Horizon shall supply free of charge to sanofi-aventis US or its designated Affiliate any Horizon
Materials necessary for the production of such additional engineering study batches and shall pay sanofi-aventis US a sum of
[...***...]
 per additional core batch and [...***...] per additional finished goods batch, unless the need for additional batches results from the gross negligence or willful misconduct of sanofi-aventis US or its designated Affiliate, in which case
sanofi-aventis US or its designated Affiliate shall bear all costs associated with any such additional batch. 
  

	2.4	Installation Qualification 

Sanofi-aventis US or its designated Affiliate shall be responsible for performing any installation qualification for the Facility Equipment and Horizon
Equipment and for setting up protocols and reports thereof. Horizon shall provide sanofi-aventis US or its designated Affiliate, without cost or expense to sanofi-aventis US or such Affiliate, any Horizon Materials required by sanofi-aventis US or
such designated Affiliate to conduct the installation qualification of the Facility Equipment and Horizon Equipment. Participation in factory acceptance testing, labor hours, any cost of excipients, and physical destruction of the materials
resulting from installation qualification shall be deemed included in the expenditure set forth in Section A of Exhibit 3. Horizon will bear the cost of vendor visits, provision of the tablet press qualification package, and training performed by
the vendors of the Horizon Equipment. 
  

	2.5	Validation Batches 

 The three
(3) planned validation batches shall be manufactured under current Good Manufacturing Practices, sanofi-aventis US or its designated Affiliate local site requirements and all applicable laws rules and regulations. Horizon shall provide
sanofi-aventis US or its designated Affiliate, without any cost or expense to sanofi-aventis US or such Affiliate, all required Horizon Materials and shall pay the price set forth in Section 4.2 for such validation batches. The batch size used
to manufacture such validation batch shall be determined in good faith by the Parties. Sanofi-aventis US or its designated Affiliate shall provide a written report for the manufacturing of the validation batches to support Horizon’s preparation
of the regulatory dossiers. Following approval of the NDA each Party understands and agrees that some of the Product manufactured in the validation activities and meeting all release specifications may be packaged and distributed for patient use as
pharmaceutical samples. However, for any validation material deemed not saleable due to dating or hold time constraints, Horizon shall pay the price set forth in section 4.2. 

 

	2.6	Filing 

 Neither Sanofi-aventis US
nor its designated Affiliate will be required to write any section of any regulatory dossier, but sanofi-aventis US and its designated Affiliate will provide reasonable support in the review of the Chemistry, Manufacturing and Controls
(“CMC”) sections, and will use reasonable efforts to provide comments or supporting data on the CMC sections connected with 

 

					
		 	4	 	***Confidential Treatment Requested

 
drug product manufacturing and Facility Equipment used. Horizon represents that it will take into account all reasonable comments so provided by sanofi-aventis US or designated Affiliate.

  

	2.7	Need for Additional Batches 

Horizon shall provide sanofi-aventis US or its designated Affiliate, without any cost or expense to sanofi-aventis US or its designated Affiliate, all
required Horizon Materials and shall pay the unit price set forth in Section 4.2 for any additional validation batches it may request from sanofi-aventis US or its designated Affiliate, unless the need for additional validation batches results
from the gross negligence or willful misconduct of sanofi-aventis US and its designated Affiliate, in which case sanofi-aventis US shall bear all costs associated with the additional validation batches. 

 

	2.8	Right to Audit 

 Sanofi-aventis US
or its designated Affiliates reserve the right to audit any supplier of Horizon Materials to ensure it is fulfilling its obligations under cGMP. Nothing in the foregoing sentence, however, discharges Horizon from its obligation, as auditor of record
for any Horizon Materials, to audit such suppliers. Horizon will supply a copy of any audit reports for such suppliers to sanofi-aventis US or its designated Affiliates to the extent necessary to comply with applicable law or regulations.

  

	2.9	Documentation and Change Control 

 A. Sanofi-aventis US or its designated Affiliate will develop and release master batch records in accordance with its existing standard operating procedures. Sanofi-aventis US and its designated Affiliate
are responsible for its own batch numbering system. Batch numbers are assigned by sanofi-aventis US in accordance with its standard operating procedures and are unique to a given item. 

B. Sanofi-aventis US or its designated Affiliate will draft engineering study protocols necessary to commence the transfer and scale-up
activities. These protocols will follow sanofi-aventis US or its designated Affiliate internal cGMP formats to comply with the Facility’s local compliance requirements. Horizon shall participate in the review of the engineering study protocols
and final reports for the development/scale up work up to validation batches. Such review and involvement should occur within reasonable review time to avoid delays of the project proceeding to next steps. 

C. Once validation phase begins, sanofi-aventis US or its designated Affilates will prepare validation master plan and individual
validation protocols for each of the major manufacturing stages (granulation, core tablets, etc.) in accordance with sanofi-aventis US or its designated Affiliate internal cGMP formats to comply with the Facility’s local compliance
requirements. Horizon can review such protocols and provide comments as desired. 
 D. Certificate of Analysis / Certificate of
Conformance 
 Sanofi-aventis US or its designated Affiliate will furnish Horizon’s quality unit with a signed Certificate of Analysis and
Certificate of Manufacturing upon shipment of each bulk batch of Product to Horizon. 
 E. Change Control 

 

 5 

 Sanofi-aventis US or its designated Affiliate will follow its internal procedures established to meet cGMP
requirements. Changes to master batch record and specifications to the established manufacturing process (established via the technical transfer) shall be made in accordance with sanofi-aventis US’s or its designated Affiliate change control
procedure. All change control documentation will be made available to Horizon upon request. 
 F. Electronic Records /
Signatures 
 Sanofi-aventis US or its designated Affiliate shall comply with 21 CFR Part 11 requirements regarding the use of electronic records
/ signatures involved in the manufacture, packaging, and testing of the Product. Originals of all batch and laboratory documents (including raw data) will be retained by Sanofi-aventis for the duration of the labeled Product shelf life plus one
year, but in all cases for not less than ten (10) years. 
  

	2.10	Quality Roles and Responsibilities 

Horizon will be responsible for final release of validation batches for the market. Sanofi-aventis US or its designated Affiliate will be responsible for
the quality review of the manufacturing batch records, testing of the Product, preparing a Certificate of Analysis and Certificate of Manufacturing following its internal standard format. The batch records will be available for review upon request.

  

	2.11	Stability Program 

 Sanofi-aventis
US or its designated Affiliate will perform stability study on the final validation batches on stability program following its internal established programs based on typical ICH stability guidelines for Zone I & II climate. The stability study
will be carried out at 25C/60%RH through product expiry and under accelerated conditions at 40C/75%RH up to 6 months. Samples will be stored at 30C/65%RH but will not be tested unless required (subject to an additional fee). The program includes
bulk tablets hold time study (up to 6 months), three validation batches carried out to a 5 year program, and one batch per year for routine study to support product shelf life confirmation. If there are requests to include additional conditions that
are not typically required for the conditions mentioned above, Horizon will bear the added cost to support such additional program. Sanofi-aventis will develop stability protocol following its internal procedures. The protocol will be jointly
reviewed and approved by Horizon Regulatory prior to commencing the validation stability study. Specific testing requirements and time-points will be provided in the stability protocol which should include all necessary regulatory requirements to
register the Facility as the manufacturing site. 
  

	3.	CAPITAL EXPENDITURE 

  

	3.1	Horizon Equipment 

 Horizon shall
bear at its own cost and shall be responsible for procurement, installation, and qualification of the Horizon Equipment identified on Exhibit 2. The Horizon Equipment shall be delivered to the Facility and installed at the Facility at Horizon’s
sole cost and expense. Estimated milestone dates in Exhibit 3b assume delivery of tablet tooling for core tablets in [...***...] and delivery of Kikusui tablet presses and tooling by [...***...]. 

In the event that additional equipment or modification of the Horizon Equipment is requested by Horizon, or necessary for manufacturing, Horizon will pay
for the purchase, installation and qualification performed by sanofi-aventis US or its designated Affiliate in relation with such 

 

					
		 	6	 	***Confidential Treatment Requested

 
additional equipment or modification. Upon payment by Horizon, any additional equipment shall be deemed Horizon Equipment. 
 Both Parties acknowledge that the Horizon Equipment will not fulfill the currently anticipated commercial demand for Products and that additional presses required for market supply will be purchased by
Horizon. 
  

	3.2	Ownership of Equipment 

 Horizon
owns all Horizon Equipment as listed in Exhibit 2 and any additional equipment purchased by Horizon pursuant to the second paragraph of Article 3.1. The Parties will take appropriate measures to ensure that any equipment owned by Horizon located at
a sanofi-aventis US or its designated Affiliate facility will be clearly identified for future audit purposes, and Horizon shall have the right to secure possession of such equipment, at its sole cost and expense, at the expiry or termination of
this Agreement in accordance with the terms and conditions set forth herein. Removal of any Horizon Equipment is conditional on Horizon bearing responsibility for the reasonable cost and expense of restoring any sanofi-aventis US or its designated
Affiliate equipment affected by the installation, modification or use of the Horizon Equipment to the status of such equipment at the time immediately prior to the installation or modification of any Horizon Equipment (ordinary wear and tear
excepted and not including any modification made by sanofi-aventis US or an Affiliate without the approval of Horizon). Sanofi-aventis US and its designated Affiliate will remove any Horizon Equipment and restore any sanofi-aventis US or Affiliate
equipment, but any such removal or restoration may, at the option of Horizon, be witnessed by Horizon. 
  

	3.3	Maintenance of Equipment 

Sanofi-aventis US and its designated Affiliates are responsible for the cost of routine maintenance of the Horizon Equipment while installed at the
Facility. Horizon is responsible for the cost of replacement parts, third party service, and any installation costs, except where any replacement costs results from the gross negligence or willful misconduct of sanofi-aventis US or its designated
Affiliate with respect to the Horizon Equipment, in which case sanofi-aventis US or its designated Affiliate shall bear said replacement cost. 
  

	3.4	Liability in relation to Equipment and Horizon Materials 

 Title to the Horizon Equipment and title to any Horizon Materials and any other consignment stock and risk of loss, damage to or destruction of such Horizon Equipment, Horizon Materials, or any other
consignment stock remain with Horizon. Sanofi-aventis US or designated Affiliate will have no liability for loss, damage or destruction of the Horizon Equipment, Horizon Materials, or other consignment stock unless such loss, damage or destruction
resulted from the gross negligence or willful misconduct of sanofi-aventis US or designated Affiliate. Horizon will maintain commercially reasonable levels of insurance on any Horizon Equipment to cover any potential liability associated therewith.

  

	4.	PAYMENT 

  

	4.1	Payments related operational expenditure 

  

 7 

 Section B of Exhibit 3 sets forth the schedule of milestones and the estimated dates at
which and amounts that sanofi-aventis US shall invoice to Horizon in relation with the operational expenditure costs. Payment shall be made by Horizon in US dollars by transfer to the bank account indicated on the invoice within [...***...]
 after the date of the invoice. 
  

	4.2	Payment for Validation Batches 

 In
addition to the technical transfer costs outlined in Exhibit 3b, Horizon will pay sanofi-aventis US a selling price for any validation batch, whether manufactured pursuant to Section 2.5, 2.7 or otherwise, equal to either
(i) [...***...] per 1000 bulk tablets (ii) or [...***...] for each 90 count container or [...***...] for each 3 count container. Such purchase price will be due within [...***...] of the later of (i) receipt of
an invoice from sanofi-aventis US or (ii) issuance of a Certificate of Analysis for such validation batch. 
  

	4.3	Taxes 

 Amounts referred to under
this Article 4 are exclusive of any taxes, duties, such as sales, export, import, value added tax, excise duty, which shall be additionally invoiced by sanofi-aventis US (other than taxes on sanofi-aventis US income) as appropriate. 

 

	5.	INTELLECTUAL PROPERTY 

  

	5.1	Ownership of Rights 

 Each Party
shall exclusively own and retain all right, title and interest in and to all Intellectual Property Rights, information, documents and tangible and intangible materials (with respect to each Party, its “Base Technology”) (i) owned by
it as of the Effective Date, and (ii) conceived, reduced to practice, or created by such Party or its Affiliates or agents (including without limitation Intellectual Property Rights, information, documents and tangible and intangible materials
based upon any background or preexisting technology of such Party) from and after the Effective Date. Each Party shall be solely responsible for the conduct and costs of filing, prosecution and maintenance of patents and patent applications on its
own Intellectual Property Rights, information, documents and tangible and intangible materials. Except as expressly set forth herein, nothing in this Agreement grants either Party any right, title or interest in the Intellectual Property Rights of
the other Party hereto. Sanofi-aventis US represents that, to its knowledge, sanofi-aventis US does not currently have any right, title, or interest in any Intellectual Property Rights primarily relating to the Product. Each Party shall have the
right to bring, defend, maintain and settle any suit, action or proceeding involving infringement of its Intellectual Property Rights, including without limitation its patent rights. Each Party shall pay all expenses incurred in connection with such
suit, action or proceeding. Any amount recovered in any such suit, action or proceeding, whether by judgment or settlement shall be retained by the Party bringing the action. 
 Horizon represents and warrants that, to the best of Horizon’s knowledge, practice by sanofi aventis US or designated Affiliate of the HZT 501 IP that Horizon provides to sanofi-aventis US or
designated Affiliate pursuant to this Agreement to perform the services to be performed by sanofi aventis in compliance with this Agreement do not and, will not infringe the Intellectual Property Rights of any third party. 

Sanofi-aventis US represents and warrants that, to the best of sanofi-aventis US’s knowledge, practice by sanofi aventis US of the SAUS IP that
sanofi-aventis US provides pursuant to this 
  

					
		 	8	 	***Confidential Treatment Requested

 
Agreement to perform the services to be performed by sanofi aventis US in compliance with this Agreement do not and, will not infringe the Intellectual Property Rights of any third party.

  

	5.2	License from Horizon 

 Horizon
hereby grants to sanofi-aventis US and its Affiliates a royalty-free, non-exclusive, license during the Term to use and/or practice the HZT-501 IP solely to perform sanofi-aventis US’ or designated Affiliates’ obligations in accordance
with the terms of this Agreement. 
  

	6.	INDEMNIFICATION 

  

	6.1	By sanofi-aventis US 

Sanofi-aventis US shall indemnify, defend and hold harmless Horizon and its officers, directors, agents, affiliates and their respective employees and
representatives, from and against any and all loss, damage, claim, injury, cost or expenses, including reasonable attorneys’ fees and expenses of litigation, including any illness or personal injury, including death, or property damage
(collectively, “Losses”) that arise out of or are attributable to (a) the failure of the Product to meet the Product Specifications set forth in Schedule 1.12 hereto at the time of delivery to Horizon; (b) any claim by a third
party that the use by sanofi-aventis US of the SAUS IP to perform the obligations of sanofi-aventis US under this Agreement in compliance with the terms of this Agreement, including, without limitation, the manufacture or testing of the Products,
infringes its intellectual property rights; (c) any breach of any representation, warranty or covenant made by sanofi-aventis US hereunder; or (d) the gross negligence or willful misconduct or wrongdoing of sanofi-aventis US or any person
whose actions or omissions sanofi-aventis US is legally liable for, except, in each of (a), (b), (c), or (d) to the extent that such Losses are indemnified by Horizon pursuant to Section 6.2. 

 

	6.2	By Horizon 

 Horizon shall
indemnify, defend and hold harmless sanofi-aventis US and its officers, directors, agents, affiliates and their respective employees and representatives from and against any and all Losses that arise out of or are attributable to (a) the
failure of the Horizon Materials to meet the specifications for such materials set forth in Schedule 1.7 hereto at the time of delivery to sanofi-aventis US; (b) any claim by a third party that the use by sanofi-aventis US of the HZT-501 IP to
perform the obligations of sanofi-aventis US under this Agreement in compliance with the terms of this Agreement or as directed by Horizon, including, without limitation, the manufacture or testing of the Products, infringes its intellectual
property rights; (c) any breach of any representation, warranty or covenant made by Horizon hereunder; (d) any development, testing, use marketing, distribution, importation, sale or offer for sale of the Product by or on behalf of Horizon
(including, without limitation, product liability claims) or (e) the gross negligence or willful misconduct or wrongdoing of Horizon or any person whose actions or omissions Horizon is legally liable for, except, in each of (a), (b), (c), (d),
or (e) to the extent that such Losses are indemnified by sanofi-aventis US pursuant to Section 6.1. 
 If a party becomes aware of any
claim or allegation by any third party that the performance of any services contemplated by this Agreement infringe such third party’s intellectual property rights, it shall promptly inform the other party, and the parties shall discuss such
matter and a proposed resolution. Either party may, following such discussion, delay performance of its obligations 

 

 9 

 
hereunder pursuant to the force majeure provision in Section 9.1 pending satisfactory resolution of such matter or terminate this Agreement upon written notice to the other party. If the use
of the HZT-501 IP in the manufacture or testing of the Product pursuant to this Agreement becomes, or in Horizon’s opinion is likely to become, the subject of an action by a third party alleging infringement of such third party’s
intellectual property rights, Horizon may, at Horizon’s’ sole election and expense, either (a) procure, in form an manner satisfactory to sanofi-aventis US, the right to continue using the relevant the HZT-501 IP to permit
sanofi-aventis US to perform its obligations under this Agreement without infringing such rights, or (b) replace or modify the HZT-IP or the process for manufacturing or testing the Product with non-infringing intellectual property. If the use
of the SAUS IP in the manufacture or testing of the Product pursuant to this Agreement becomes, or in sanofi-aventis US’s opinion is likely to become, the subject of an action by a third party alleging infringement of such third party’s
intellectual property rights, sanofi-aventis US may, at sanofi-aventis US’s sole election and expense, either (a) procure, in form an manner satisfactory to Horizon, the right to continue using the relevant the SAUS to permit
sanofi-aventis US to perform its obligations under this Agreement without infringing such rights, or (b) replace or modify the SAUS IP with non-infringing intellectual property. 

 

	6.3	Third Party Claims 

 If any third
party notifies a Party or any of its officers, agents or affiliates, or their respective employees or representatives (an “Indemnified Party”) with respect to any matter (a “Third Party Claim”) that may give rise to
a claim against the other Party (the “Indemnifying Party”) under this Article, then the Indemnified Party will promptly give written notice to the Indemnifying Party; provided, however, that no delay on the part of the Indemnified
Party in notifying the Indemnifying Party will relieve the Indemnifying Party from any obligation under this Article, except to the extent such delay actually prejudices the Indemnifying Party. The Indemnifying Party will be entitled to participate,
at its sole expense, in the defense of any Third Party Claim that is the subject of a notice given by an Indemnified Party pursuant to this Section. In addition, the Indemnifying Party will have the right to defend the Indemnified Party against the
Third Party Claim with counsel of its choice reasonably satisfactory to the Indemnified Party so long as (i) the Indemnifying Party gives written notice to the Indemnified Party of its assumption of responsibility for any Losses arising out of
such Third Party Claim and its assumption of control and defense of the Third Party Claim within fifteen (15) days after the Indemnified Party has given notice of the Third Party Claim to the Indemnifying Party, (ii) the Indemnifying Party
provides the Indemnified Party with evidence reasonably acceptable to the Indemnified Party that such Indemnifying Party has and will have adequate financial resources to defend against the Third Party Claim and fulfill its indemnification
obligations hereunder, (iii) the Third Party Claim does not seek an injunction or other equitable relief against the Indemnified Party (provided, however, that to the extent that sanofi-aventis US has sought indemnification from Horizon
regarding a Third Party Claim that the HZT-501 IP infringes the intellectual property rights of a third party, Horizon shall have the right to defend such Third Party Claim with counsel of its choice reasonably satisfactory to sanofi-aventis US and,
provided further that to the extent that Horizon has sought indemnification from sanofi-aventis US regarding a Third Party Claim that the SAUS IP infringes the intellectual property rights of a third party, sanofi-aventis US shall have the right to
defend such Third Party Claim with counsel of its choice reasonably satisfactory to Horizon), (iv) the Third Party Claim does not relate to or otherwise arise in connection with any criminal or regulatory enforcement action, and (v) the
Indemnifying Party conducts the defense of the Third Party Claim actively and diligently. The Indemnified Party may retain separate co-counsel at its own cost and expense and participate in the defense of the Third Party Claim. The Indemnifying
Party will not consent to the entry of any judgment or enter into any compromise or settlement with respect to the Third Party Claim without the prior written consent of the Indemnified Party unless such judgment, compromise or

  

 10 

 
settlement (i) provides for the payment by the Indemnifying Party of money as sole relief for the claimant, and (ii) results in the full and general release of the Indemnified Party
from all liabilities arising or relating to, or in connection with, the Third Party Claim. The Indemnifying Party is expressly prohibited from consenting to the entry of any judgment or entering into any compromise or settlement that
(i) involves a finding or admission of any violation of legal requirements or the rights of any Person by the Indemnified Party or (ii) grants an injunction or other equitable relief against the Indemnified Party, and any such purported
consent, compromise or settlement entered into without the prior written consent of the Indemnified Party shall be null and void ab initio. The Indemnified Party may not consent to the entry of any judgment or enter into any compromise or settlement
with respect to a Third Party Claim with respect to which indemnification is being sought hereunder without the prior written consent of the Indemnifying Party. If the Indemnifying Party does not assume the control and defense of a Third Party Claim
under this Section, the Indemnified Party may defend such Third Party Claim and seek indemnification hereunder from the Indemnifying Party for any Losses associated therewith. The Indemnifying Party or the Indemnified Party, as the case may be,
shall at all times use reasonable efforts to keep the other reasonably apprised of the status of the defense of any Third Party Claim and to cooperate in good faith with each other with respect to the defense of any such matter. 

 

	6.4	Disclaimer of Warranties 

 EXCEPT
FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES IN THIS AGREEMENT NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER
MATTER RELATING TO THE PRODUCT, INFORMATION, MATERIALS OR EQUIPMENT PROVIDED UNDER THIS AGREEMENT. 
  

	6.5	Damages 

 NEITHER PARTY SHALL BE
LIABLE TO THE OTHER UNDER THE TERMS OF THIS AGREEMENT OR OTHERWISE BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, SPECIAL OR
INCIDENTAL OR PUNITIVE LOSS OR DAMAGE, WHETHER FOR LOSS OF CURRENT OR FUTURE PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE AND WHETHER OCCASIONED BY THE NEGLIGENCE OR INTENTIONAL ACTS OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR AGENTS OR
OTHERWISE, EXCEPT TO THE EXTENT SUCH CONSEQUENTIAL, SPECIAL OR INCIDENTAL OR PUNITIVE LOSS OR DAMAGE SHALL BE PAYABLE TO A THIRD PARTY; PROVIDED THAT, THE LIMITATIONS IN THIS SECTION 6.5 ON CLAIMS FOR CONSEQUENTIAL, SPECIAL OR INCIDENTAL DAMAGES
(BUT NOT PUNITIVE DAMAGES) SHALL NOT APPLY TO LOSSES SUSTAINED AS A RESULT OF BREACH OF THE CONFIDENTIALITY PROVISIONS OF ARTICLE 7. 
  

	6.6	Limitation 

 IN NO EVENT SHALL
SANOFI-AVENTIS US’ TOTAL AGGREGATE LIABILITY FOR ALL CLAIMS ARISING OUT OF OR RELATED TO THIS AGREEMENT EXCEED, ON A CUMULATIVE BASIS, [...***...], REGARDLESS OF THE CAUSE OF ACTION UPON WHICH SUCH CLAIM IS BASED. NOTHING IN THIS
AGREEMENT WILL PERMIT ANY PARTY TO RECOVER TWICE FOR THE SAME LOSS. 
  

					
		 	11	 	***Confidential Treatment Requested

	7.	CONFIDENTIALITY 

 7.1 The
Party receiving Information (the “Receiving Party”) from the other Party (the “Disclosing Party”) undertakes to treat the Information as strictly confidential and to use the Information in accordance with the terms
and conditions set forth herein and will use such Information strictly to comply with its obligations set forth in this Agreement. 
 7.2
The Receiving Party undertakes to make the Information available only to its employees on a need-to-know basis and to take all steps necessary to protect the Information and to ensure that these employees shall not disclose or use at any time such
Information in a manner which is not authorized under this Agreement. In no event shall the Receiving Party communicate the Information to third parties without the prior written approval of the Disclosing Party. Notwithstanding the foregoing,
should the Receiving Party require the assistance of third parties, these third parties will be subject to substantially similar conditions of confidentiality as the Receiving Party. 
 In the case of a breach of these obligations by these third parties, the Receiving Party remains responsible for them towards the Disclosing Party. 

7.3 The obligations of this Section 7 shall not apply however to Information that: 

 

	a.	was known to the Receiving Party prior to its receipt from the Disclosing Party as documented by the Receiving Party’s written records, or,

  

	b.	was known to the public, or generally available to the public prior to its receipt from the Disclosing Party, or, 

 

	c.	became known to the public or generally available to the public subsequent to its receipt from the Disclosing Party, through no breach of this Agreement by the
Receiving Party, or, 

  

	d.	was received by the Receiving Party, at any time, from a third party under no obligation of confidentiality to the Disclosing Party concerning such part of the
Information, or, 

  

	e.	was independently developed by the Receiving Party prior to disclosure or thereafter by the Disclosing Party, as documented by the Receiving Party’s written
records. 

 7.4 For the purposes of this Agreement, no Information shall be deemed to be in the public domain or knowledge
or in the possession or knowledge of the Receiving Party merely because such Information is embraced by more general information in the public domain or knowledge or in the possession or knowledge of the Receiving Party. 

7.5 The Receiving Party may disclose the Information without violating its obligations under this Article 7, to the extent such disclosure is
required by law or by court, provided that, in the event the Receiving Party is required to disclose Information, the Receiving Party shall provide prompt written notice to the Disclosing Party of such requirement so that the Disclosing Party may
seek a protective order or other appropriate remedy. In the event no such protective order or other remedy is obtained, the Receiving Party agrees to disclose only that portion of Information it is legally required to disclose and to exercise all
reasonable efforts to obtain confidential treatment for such Information. 
  

 12 

  
 7.6 Within thirty
(30) days after the termination or expiration of this Agreement and upon the written request of the Disclosing Party, the Receiving Party shall return or destroy all such Information and copies thereof in its possession, except that each Party
may keep one copy of such Information in its Legal Department confidential files solely for archival purposes and this copy will not be distributed in any manner other than as provided in this Agreement, without the express prior written permission
of the Disclosing Party. 
 7.7 Each Party specifically recognizes that any breach by it of this Article 7 may cause irreparable injury
to the other Party and that actual damages may be difficult to ascertain, and in any event, may be inadequate. Accordingly (and without limiting the availability of legal or equitable, including injunctive, remedies under any other provisions of
this Agreement), each Party agrees that in the event of any such breach, notwithstanding the provisions of this Agreement, the other Party shall be entitled, by way of private litigation in the first instance, injunctive relief and such other legal
and equitable remedies as may be available, without an obligation to post bond. 
 7.8 Except as otherwise required by law or by any
securities exchange, regulatory or governmental body having jurisdiction over it, neither Party shall issue a press release or make any other public disclosure of the terms of this Agreement or regarding the manufacture of the Product without the
prior approval of the press release or public disclosure by the other Party. Each Party shall submit any such press release or public disclosure to the other Party which the other Party shall acknowledge in writing. 

7.9 This Article 7 shall survive the expiration or termination of this Agreement for a period of [...***...]. 

 

	8.	TERM AND TERMINATION 

  

	8.1	Term 

 This Agreement shall
commence on the Effective Date and shall, unless earlier terminated in accordance with this Article 8, remain in effect until the earlier of the completion of the activities described in Article 2 of this Agreement (the “Term”) or
December 31, 2011, unless extended by a mutual written agreement of both Parties. 
  

	8.2	Termination 

 Either Party may
terminate this Agreement prior to the expiration of the Term upon [...***...] days written notice to the other Party (i) upon the bankruptcy, insolvency, dissolution or winding up of the other Party (other than dissolution or winding up
for the purposes or reconstruction or amalgamation) or (ii) upon or after the breach of any material provision of this Agreement by the other Party if the breaching Party has not cured such breach, or if the Parties have not agreed upon a
written plan for curing such breach, within [...***...] days after written notice thereof by the non-breaching Party, (iii) in case of termination by either Party of the negotiations regarding the Commercial MSA (except by reason of the
execution and delivery of a definitive Commercial MSA), (iv) in case of expiration or termination by either Party of the Commercial MSA, or (v) pursuant to Section 2.1 hereof in accordance with the terms and conditions set forth
herein and therein. In addition, either Party may terminate this Agreement as provided in the second paragraph of Section 6.2. 

  

					
		 	13	 	***Confidential Treatment Requested

	8.3	Duties Upon Termination 

 Upon the
termination or expiration of this Agreement, neither Party shall have any obligation whatsoever hereunder, except (i) for obligations that by their terms may be or are to be performed after the termination or expiration of this Agreement, and
(ii) for any obligation or liability arising prior to such termination or expiration including but not limited to any remaining materials, work in process or finished goods. 
 Upon termination of this Agreement and if mandated, (i) each Party shall return Information received from the other Party (save for one copy the Receiving Party shall keep in confidence in its files
for the sole purpose of identifying its obligations hereunder) or as needed to comply with applicable regulatory requirements, (ii) sanofi-aventis US or its designated Affiliate shall, at Horizon’s expense and request, make available to
Horizon all property and materials in sanofi-aventis US’ and its designated Affiliate possession or control owned by and paid for by Horizon, and (iii) sanofi-aventis US and its designated Affiliate shall return to Horizon any unexpended
funds delivered by Horizon to sanofi-aventis US or designated Affiliate pursuant to Section B of Exhibit 3, less any applicable development costs, including, without limitation, any out-of-pocket commitments or costs associated with early
termination of any such commitments. 
  

	9.	MISCELLANEOUS 

  

	9.1	Force Majeure 

 Neither Party shall
be liable to the other for such Party’s failure to perform any provision of this Agreement if such failure or delay results from an act of God, war conditions, sabotage, governmental regulations or actions, embargo, fire, strike, failure of
supply, or any other cause beyond the affected Party’s reasonable control; provided, however, that such performance shall be excused only to the extent of and during such disability. Upon the occurrence of any such event that results or will
result in failure or delay to perform hereunder as described above, the Party whose performance is hereby prevented or delayed shall immediately give notice of such occurrence and the effect and/or anticipated effect of such occurrence on the
performance of such Party to the other Party. The Party whose performance is so affected shall use commercially reasonable efforts to minimize disruptions in performance and to resume full performance hereunder as soon as possible under the
circumstances. 
  

	9.2	Severability 

 If and to the extent
that any provision (or any part thereof) of this Agreement is held to be invalid, illegal or unenforceable, such holding shall in no way affect the validity, legality or enforceability of the remainder of this Agreement. In the event any provision
of this Agreement shall be held invalid, illegal or unenforceable, the Parties shall negotiate in good faith to substitute a valid, legal and enforceable provision which, insofar as practical, implements the purposes hereof. 

 

	9.3	Assignment 

 Neither Party may
assign its interests, rights, duties or obligations under this Agreement to a third party without the prior written consent of the other Party, which shall not be unreasonably withheld. However, each Party may assign without the other Party’s
consent its interests, rights, duties or obligations under this Agreement to (i) a successor in interest to all or substantially all of the business to which this Agreement relates, whether by merger, sale of stock, sale of assets or

  

 14 

 
otherwise, or (ii) any Affiliate, provided that such third party or Affiliate can reasonably assume all the obligations of that Party under this Agreement. 

 

	9.4	Modifications and Amendments 

 This
Agreement shall not be modified or otherwise amended except pursuant to an instrument in writing executed and delivered by each of the Parties hereto. 
  

	9.5	Governing Law 

 This Agreement
shall be governed by and shall be construed in accordance with the laws of New York. 
  

	9.6	Waiver 

 The failure of either
Party to require the performance of any term of this Agreement, or the waiver of either Party of any breach of this Agreement, shall not prevent a subsequent exercise or enforcement of such terms or be deemed a waiver of any subsequent breach of the
same or any other term of this Agreement. 
  

	9.7	No Agency 

 Except as expressly
provided for herein, the Parties are not authorized to act as agents of one another as to any matter or make any representations to any third parties indicating or implying the existence or any such agency relationship. 

 

	9.8	Headings 

 The Section headings
contained in this Agreement are for reference purposes only and shall not affect in any way the meaning and interpretation of this Agreement. 
  

	9.9	Interpretive Rules 

 In the event
of an ambiguity or if a question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties, and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of the
authorship of any provisions of this Agreement. The definitions of the terms used in this Agreement shall apply equally to the singular and plural forms of the terms defined. Whenever the context may require, any pronoun shall include the
corresponding masculine, feminine and neuter forms. References in this Agreement to a Party or other person or entity include their respective successors and permitted assigns. The words “include,” “includes” and
“including” when used in this Agreement shall be deemed to be followed by the phrase “without limitation” unless such phrase otherwise appears. 
  

	9.10	Counterparts and Facsimile 

 This
Agreement may be executed in two or more counterparts and via facsimile, each of which shall be deemed to be an original and all of which shall be deemed to constitute the same Agreement. 

 

	9.11	Entire Agreement 

  

 15 

 This Agreement, together with its Exhibits, constitutes the entire agreement and understanding between the
Parties and supersedes all previous understandings, agreements and representations between the Parties, written or oral, with respect to the subject matter hereof. 

 

 16 

 IN WITNESS hereof, the Parties hereto have caused this Agreement to the executed as of the date first
written above by their duly authorized officers. 
 Executed in two copies, each Party receiving an original copy. 

 

									
	Horizon Therapeutics, Inc.	 		 	sanofi-aventis US. LLC
				
	 11-9-09
	 		 		 	
					
	By:	 	 /s/ Timothy P. Walbert
	 		 	By:	 	 /s/ Osric Reavis

	Name:	 	Timothy P. Walbert	 		 	Name:	 	Osric Reavis
	Title:	 	President & CEO	 		 	Title:	 	Vice President U.S. Industrial Affairs
					
		 		 		 	By:	 	  

		 		 		 	Name:	 	
		 		 		 	Title:	 	

  

 17 

  
 EXHIBIT 1

 A—Bulk Manufacturing Process Description 
 B—Manufacturing Specifications: 

  

					
		 	18	 	

  
 Exhibit 1-A

 HZT-501 MANUFACTURING FLOW DIAGRAM OF PROCESS 
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***Confidential Treatment Requested 

  

EXHIBIT 1-B 
 EXCIPIENT RELEASE TEST REPORT 
 [...***...] [...***...] [...***...]
[...***...] [...***...] [...***...] 

  

					
		 	19	 	***Confidential Treatment Requested

  

EXHIBIT 2 
 Outline of capital expenditure and equipment ownership. 
  

					
	 [...***...]
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EXHIBIT 3 

A—Operational expenditures estimate 
  

			
	 Operational Expenditure Estimate

Total OPEX
	  	 [...***...]

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

 B—Invoicing
Schedule 
 EXHIBIT 3(B) 

 

					
	 Milestone
	  	Estimated
Invoice
Date	 	Amount
	[...***...]	  	[...***...]	 	[...***...]
	[...***...]	  	[...***...]	 	[...***...]
	[...***...]	  	[...***...]	 	[...***...]
	[...***...]	  	[...***...]	 	[...***...]
	[...***...]	  	[...***...]	 	[...***...]
	[...***...]	  	[...***...]	 	[...***...]
	[...***...]	  	[...***...]	 	[...***...]
	[...***...]	  	[...***...]	 	[...***...]
	[...***...]	  	[...***...]	 	[...***...]
	[...***...]	  	[...***...]	 	[...***...]
	[...***...]	  	[...***...]	 	[...***...]

  

					
		 	6	 	***Confidential Treatment Requested

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00179-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00179-of-00352.parquet"}]]