Document:

Transfer, License and Supply Agreement dated March 26, 2009

 Exhibit 10.14 
 ***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. 

Transfer, License and Supply Agreement 
 between 
 Merck GesmbH 

Zimbagasse 5 
 A-1
147 Vienna, Austria 
 (“Merck”), 
 and 
 Nitec Pharma AG 

Kagenstr 17, 

4153 Reinach, Switzerland 
 (“Nitec AG”) 
 and 

Nitec GmbH 

Joseph-Meyer-Str. 13 –15 
 68167 Mannheim, Germany 
 (“Nitec Germany”) 

Nitec AG and Nitec Germany are collectively referred to as “Nitec” 

(all, Nitec AG, Nitec Germany and Merck are the “Parties” and each of them – as the case may be – a “Party”)

 Preamble 
  

	1.	Whereas, Merck KGaA having its registered office at Frankfurter Str. 250, 64271 Darmstadt, Germany, (“Merck KGaA”) is the parent company of Merck;

  

	2.	Whereas, Nitec AG and Merck KGaA as of October 1st, 2004 have concluded a Technology Transfer Agreement (“TTA”) under which the rights of
Merck’s development activities regarding the medicinal product Prednison Night Time Release for the indication rheumatoid arthritis have been transferred to Nitec AG. Nitec has further developed the Project (as defined in the TTA) and owns any
rights relating to the PRODUCT, as defined; 

  

					
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	3.	Whereas, under the TTA Merck KGaA has been granted by Nitec AG the option to obtain exclusively the distribution and marketing rights pertaining to the PRODUCT in
Germany and Austria and desires to make use of this option in Austria via Merck; 

  

	4.	Whereas, Merck Austria wishes to apply for reimbursement of the PRODUCT within the Austrian Reimbursement Code and further market and sell the PRODUCT once the
reimbursement status has been approved; 

  

	5.	Whereas, Nitec AG, through Nitec Germany, has applied for the MARKETING AUTHORIZATION for the PRODUCT in Austria with the competent authority thereby becoming a
Marketing Authorization Holder (“MAH”), as defined in § 2 subp. 13a Arzneimittelgesetz (“AMG”); 

  

	6.	Whereas, Nitec AG is willing to cause Nitec Germany to transfer the MARKETING AUTHORIZATION to Merck, if and when the MARKETING AUTHORIZATION has been obtained by Nitec
Germany; 

  

	7.	Whereas, Nitec AG is the owner of the registered trademark “Lodotra” and whereas, Nitec AG is willing to grant Merck an exclusive licence in the TERRITORY to
use the TRADEMARK; 

  

	8.	Whereas, neither Nitec AG nor Nitec Germany are holder of manufacturing authorizations and whereas, Nitec AG has entrusted third parties with the manufacture of the
PRODUCT. 

  

	9.	Whereas, Nitec AG – through Nitec Germany– intends to apply for additional marketing authorizations for products which are – except its names –
identical with the PRODUCT (“Duplicate Authorization”) and wheras, Nitec will not make any use of these authorizations in the TERRITORY. 

 Now, therefore, the Parties agree as follows: 
 Article 1 - Definitions 

As used in this AGREEMENT, the following words and phrases shall have the following meanings: 
 “AGREEMENT” means this Transfer, License and Supply Agreement between the Parties as set out and described herein. 
 “ANNUAL MINIMUM SALES” shall mean [...***...] of the TARGET SALES. 
  

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 “EU AVERAGE PRICE” means the arithmetic mean of all officially available prices (EX FACTORY
or pharmacy purchasing prices) of the PRODUCT within the European Union. 
 “EX FACTORY PRICE” is the list price of the PRODUCT
without discounts by Merck to each independent customer. 
 “LAUNCH” refers to the day on which the PRODUCT is included into
the “Yellow Box” of the Reimbursement Code in the TERRITORY. 
 “MARKETING AUTHORIZATION” shall mean the
authorization and related documents granted by the Austrian competent authority, the Bundesamt fur Sicherheit im Gesundheitswesen (“AGES PharmMed”) for the marketing, distribution and sale of the PRODUCT in the TERRITORY.

 “PRODUCTION COSTS” are all costs incurred by Nitec in the complete provision of PRODUCT to one of Merck’s supply
depots. 
 “PRODUCT” shall mean the medicinal product in its finished form ready for sale in the TERRITORY and in accordance
with the SPECIFICATIONS described in Appendix 1 attached hereto. 
 “RED BOX” means the area of restricted reimbursement for
all products following an application for reimbursement within the Austrian Reimbursement Code. The RED BOX spans the time from application until the official decision on acceptance or denial of reimbursement (evaluation phase). Reimbursement in the
RED BOX is subject to ex ante control by the head medical service of the Austrian social insurance companies. The EX FACTORY PRICE in the RED BOX equals the actual EU AVERAGE PRICE. 
 “SPECIFICATIONS” means the specifications for PRODUCT (including shelf life), as per Quality/Technical agreement. 
 “TARGET SALES” shall mean the target sales as set forth in Appendix 2, such sales of the PRODUCT in the TERRITORY by Merck shall be those reported by IMS or by any other source mutually
agreed by the Parties offering a service similar to the one currently offered by IMS. At the date of signature of this AGREEMENT Appendix 2 is a preliminary estimation and the definite number will be calculated in accordance with the actual
daily therapy costs and the special reimbursement requirements as detailed below (YELLOW BOX). An example calculation is incorporated in Appendix 2. 
 “TERM” shall mean the term set forth in Section 16.1. 

“TERRITORY” shall mean the territory of Austria. 
 “TRADEMARK” shall mean the trademark “Lodotra”, reg. no. 877023 registered with the World International Property Organisation for the EU and other territories used in

  

					
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conjunction with the design attached hereto as Appendix 2. If this TRADEMARK should be rejected by the AGES PharmMed in connection with the application for the MARKETING AUTHORIZATION for
PRODUCT filed by Nitec Germany, Nitec shall use an alternative trademark for the PRODUCT, such alternative trademark to become automatically the TRADEMARK. 
 “YELLOW BOX” means the area of restricted reimbursement for innovative products within the Austrian Reimbursement Code. Precise rules on reimbursed indications, subsets of patients and/or
special requirements for prescribing physicians (“Regelvorschlag”) apply for all products within the YELLOW BOX and are determined during the application phase. Reimbursement is subject to ex ante or post hoc control by the head medical
service of the Austrian social insurance companies. The EX FACTORY PRICE in the YELLOW BOX in general lies beneath the actual EU average price. 

Article 2 - Transfer and License 
  

	2.1	Subject to the terms and conditions of this AGREEMENT, Nitec AG hereby untertakes to transfer to Merck – through Nitec Germany – the MARKETING AUTHORIZATION
for the PRODUCT and hereby grants to Merck an exclusive licence to use the TRADEMARK for the PRODUCT during the TERM of this AGREEMENT in the TERRITORY. The term exclusive license shall mean for the purpose of this AGREEMENT that Nitec shall not
grant a license to use the TRADEMARK in the TERRITORY to any other party. 

  

	2.2	Merck is not entitled to transfer, assign or sublicense its granted rights pursuant to Article 2.1 without the prior written consent of Nitec AG.

  

	2.3	Merck shall be considered as an independent contractor and shall not be considered a partner, agent or representative of Nitec. As such, no Party shall have the
authority to create or assume any obligation in the name of the other Party nor to bind the other Party in any manner whatsoever. 

Article 3 - Marketing Authorization and Trademark 
  

	3.1	When the MARKETING AUTHORIZATION in the TERRITORY has been obtained by Nitec Germany, Nitec AG shall cause Nitec Germany to transfer to Merck for the duration of this
AGREEMENT the MARKETING AUTHORIZATION and shall license the TRADEMARK to Merck for Merck’s exclusive use hereof, in each case limited to the TERRITORY. 

 

	3.2	Merck shall not market, sell and distribute the PRODUCT in the TERRITORY under any other name than the TRADEMARK. 

 

	3.3	 At Merck’s sole expense, Merck agrees to (a) maintain the transferred MARKETING AUTHORIZATION in the TERRITORY, (b) diligently promote,

  

					
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market. sell and distribute the PRODUCT in the TERRITORY and (c) promptly assign back to Nitec Germany or any other party, designated by Nitec Germany, the MARKETING AUTHORIZATION and
relating rights in the TERRITORY upon termination of this AGREEMENT. 

  

	3.4	If at any time during the TERM of this AGREEMENT either Party shall become aware of any infringement or threatened infringement by a third party of the TRADEMARK or any
other right belonging to one of the Parties pursuant to this AGREEMENT, the Party having the knowledge thereof shall give prompt notice to the other Party, and the Parties shall consult as to the action to be taken. Any such action shall be taken by
Nitec AG at the cost of Nitec AG. Merck may, at its own cost, assist Nitec AG holding the TRADEMARK infringed upon or threatened to be infringed upon in taking legal action against such infringement or threatened infringement.

  

	3.5	Upon termination of this AGREEMENT, Merck’s right to use the TRADEMARK ceases. 

 Article 4 - Maintenance of Marketing Authorization, Reimbursement 
  

	4.1	Merck shall make all declarations and filings to maintain the MARKETING AUTHORIZATION provided that Nitec Germany maintains and updates its international filing such as
that within the Decentralized Procedure the national license can be adequately maintained. Nitec Germany has to provide Merck a copy of the relevant documents so that Merck can fulfill this obligation. 

Merck shall provide Nitec Germany with drafts of all documents other than those provided by Nitec to Merck to be submitted and shall
obtain Nitec Germany’s written consent prior to any submission to any regulatory authority in connection with the subject matters of this agreement. Nitec Germany shall not unreasonably withhold or delay its consent. Merck shall provide Nitec
Germany with copies of all such submissions including all documents submitted other than those provided by Nitec to Merck. 
  

	4.2	Merck shall make all declarations and filings to apply for inclusion of the PRODUCT into the YELLOW BOX of the Austrian Reimbursement Code at Merck’s own expense.
Nitec Germany shall provide Merck with all documents and certificates required for this application. 

  

	4.3	The exact date of this application for the YELLOW BOX shall be determined by Nitec AG’s ability to deliver minimum quantities of the PRODUCT, required for this
application, to Merck and shall not occur later than 6 weeks after the delivery of such minimum quantities to Merck. 

  

	4.4	It is understood by all parties that during the evaluation phase of Merck’s application for reimbursement (RED BOX), sales of the PRODUCT will be close to zero.

  

					
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	4.5	The PRODUCT, subject to Nitec AG’s ability to deliver the PRODUCT, shall be launched as soon as possible but in no event later than [...***...] after it has;
been officially included into the YELLOW BOX. 

  

	4.6	If LAUNCH of the PRODUCT shall be delayed due to reasons beyond reasonable control of Merck and Nitec, Parties will share those resulting losses [...***...] which
are caused by a reduction of the shelf-life to less than [...***...]. Sharing of such losses shall lead to reimbursement of payments already made by Merck for purchase of the PRODUCT whose shelf-life is so reduced. 

 

	4.7	Should the application for the YELLOW BOX fail to succeed, representatives of both Parties shall discuss in good faith whether this AGREEMENT could be modified in the
best interest of both parties. 

  

	4.8	Should the application for the YELLOW BOX fail to succeed, the costs for the application for the YELLOW BOX, in total 7700€ (§2 Abs. 1 der 1. Änderung
der Verfahrenskostenordnung) will be shared between Merck and Nitec AG in equal parts. 

 Article 5 - Marketing and Sales
Activities 
  

	5.1	Merck will perform all industry-standard and customary pre-marketing activities [...***...] prior to the envisaged LAUNCH of the PRODUCT.

  

	5.2	Merck will use its commercially reasonable efforts to market the PRODUCTS comparable to the common practice of the industry for products of a comparable market size.

  

	5.3	Merck agrees that all material used in connection with the promotion and distribution of the PRODUCT shall comply with the applicable law and any information contained
in such material shall be consistent with the MARKETING AUTHORIZATION. 

 The marketing plan of the PRODUCT for the
following year shall be presented and provided to Nitec AG during the fourth quarter of each year. 
  

	5.4	No written or printed material relating to the PRODUCT shall be used by Merck without Nitec AG’s prior written consent. Any information on written or printed
materials provided to Nitec AG shall be subject to Article 12. If within five (5) business days after receipt of such material, Nitec AG or Nitec Germany does not inform Merck, that it objects to the presented materials or, if Nitec AG or Nitec
Germany, in case of objections, within five (5) more working days do not inform Merck in writing of the reasons for the objection, such material shall be considered approved by Nitec AG. The consent of Nitec AG may not be unreasonably withheld.

  

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 Merck shall not initiate and/or conduct any Phase III/IV clinical studies for the PRODUCT
without Nitec AG’s prior written consent. 
  

	5.5	Each Party will provide the other free of charge with the results of its market research activities for the PRODUCT in the TERRITORY. Additionally, Nitec AG shall
provide Merck with all results obtained by studies conducted by or on behalf of Nitec AG in relation to the indication rheumatoid arthritis. 

  

	5.6	Within [...***...] following each calendar quarter, Merck shall send to Nitec a copy of the Merck’s internal sales report covering the preceding quarter.
Each such quarterly sales report shall show the total distribution of the PRODUCT (sales) in units and values for each dosage form. 

 The sales report shall include separate figures for wholesaler and hospital supply. 

During the twelve (12) month period starting with the first commercial introduction Merck will provide Nitec AG monthly sales (in
units and values). 
 Each Party shall inform the other Party of any proposed and/or approved regulations and/or laws which could
influence the sales of the PRODUCT 
  

	5.7	Should Merck not reach TARGET SALES or, respectively, the ANNUAL MINIMUM SALES as agreed upon same shall not be regarded as a breach of this AGREEMENT. Upon such
occurrence representatives of both Parties shall propose measures to reach the TARGET SALES. The evaluation of achieved versus TARGET SALES will be performed every [...***...] months. 

 

	5.8	Should ANNUAL MINIMUM SALES not be reached in any [...***...] (the first such period to commence upon LAUNCH) during the TERM due to reasons not attributable to
Nitec and/or the third party manufacturer, and same shall not be remedied within [...***...] after respective notice by Nitec to Merck. Nitec reserves the right to terminate this AGREEMENT. Prior to such termination, however, representatives
of both Parties shall discuss in good faith whether this AGREEMENT could be modified in the best interest of both parties. 

  

	5.9	For the purposes of Art. 5.6 and 5.7, the sales of the PRODUCT in the TERRITORY by Merck shall be those reported by IMS or by any other source mutually agreed by the
Parties offering a service similar to the one currently offered by IMS. Monthly hospital sales reported by Merck during the twelve (12) month period starting with the first commercial introduction will be based on Merck data solely, since no
comparable data exist with IMS or other sources. 

 Article 6 - Ex factory Price 

 

	6.1	 Merck shall use its reasonable best efforts to convince the Austrian Health Insurance Institutions (Hauptverband der österreichischen
Sozialversiche-

  

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rungsträger) about the additional benefit of the PRODUCT compared to immediate-release glucocorticoid tablets to justify inclusion into the YELLOW BOX. 

 

	6.2	The target EX FACTORY PRICES and the reimbursement rules (“Regelvorschlag”) will be discussed by the Parties sufficiently in advance of the application
for reimbursement and prior to all negotiations with the Health Insurance Institutions. The EX FACTORY PRICE shall be further discussed by the Parties upon either Party’s written request at any time in light of the then current market
situation. 

  

	6.3	In case of reductions of the price imposed by the Health Insurance Institutions or the possibility of such price reductions, Merck shall promptly notify Nitec and shall
use its reasonable best efforts as described in section 6.1 to avoid or at least delay such occurence. 

 Article 7 - Supply
and Orders 
  

	7.1	Merck agrees to exclusively purchase from Nitec AG, all of Merck’s requirements of the PRODUCT. Nitec AG hereby agrees to use commercially reasonable efforts to
meet Merck’s requirements for the PRODUCT. Nitec AG is entitled to have the PRODUCT in its name directly delivered by the third party manufacturer under contract to Merck. For the avoidance of doubt, Nitec AG remains liable for the delivery of
the PRODUCT. 

  

	7.2	Merck will internally combine purchase orders for PRODUCT to reach minimum purchase order amounts agreed between Nitec AG and Merck Pharma GmbH, Germany, specifying in
each case which portion of an order is designated to be sold in Austria or in Germany. 

  

	7.3	The PRODUCT will be delivered in accordance with the SPECIFICATIONS as per Quality/Technical Agreement. 

 

	7.4	The Parties shall agree upon the packaging design which shall comply with the legal requirements in the TERRITORY. 

 

	7.5	At the end of each calendar quarter Merck shall provide Nitec AG with a written non-binding rolling forecast of Merck’s requirements of the PRODUCT, per month, for
the next [...***...]. The first rolling forecast shall be provided to Nitec AG at the same time as placement of first purchase order. Orders shall also be placed at the end of each calendar quarter. 

 

	7.6	The PRODUCT will be shipped DDP (Incoterms 2000) to one certain location in the Territory specified by Merck according to the product specifications and together with
certificate of analysis confirmed by the signature of an EU Qualified Person as well as according to the requirements of the Arzneimittelbetriebsordnung AMBO, especially regarding temperature control. 

 

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 Article 8 - QUALITY of the PRODUCT 

 

	8.1	The PRODUCT to be delivered by a third party manufacturer in the name of Nitec AG to Merck hereunder shall be finished and released goods, be free from defects, conform
to the analysis certificates which are delivered with the PRODUCT and will be in accordance with the SPECIFICATIONS for the PRODUCT and end-released by the EU Qualified Person of Nitec or the manufacturer. Nitec assures that all third party
manufacturer at any time comply with the requirements of the Arzneimittelbetriebsordnung (AMBO) and of the EC-Guideline of Good Manufacturing Practice for medicinal products, Part I: Basic requirements for medicinal products (GMP) and that the
quality of the PRODUCT complies with the MARKETING AUTHORIZATION dossier. 

 Further details concerning
manufacturing, specifications and the supply relationship shall be set forth in the Quality/Technical Agreement to be concluded in due course. 
  

	8.2	The provisions contained in § 377 Handelsgesetzbuch shall not be applicable. Merck shall, however, inspect PRODUCT (including temperature data logger logs)
delivered within five (5) working days of receiving delivery and shall inform the party effecting the delivery (with a copy to Nitec AG) within such five day period of any shortages, defects or obvious off specification characteristics. Other
defects have to be reported promptly upon discovery, but in no event later than five (5) working days after such discovery. 

Article 9 - Supply Price and Terms of Payment 
  

	9.1.	The prices to be paid by Merck to Nitec AG for the PRODUCT (including samples) shall be at the higher of (i) [...***...] of the EX FACTORY PRICES or
(ii) PRODUCTION COSTS plus [...***...] of the EX FACTORY PRICES. In the event that the PRODUCT becomes subject to mandatory reimbursements imposed by the authorities (e.g. Zwangsrabatte), NITEC AG and Merck shall share the economic
burden of such mandatory reimbursements as follows: 

  

	 	•	 	 In the event that Merck has paid NITEC AG according to lit. (i) above Nitec AG shall re-imburse to Merck [...***...] of the reduction
amounts actually paid by Merck to the authorities. 

  

	 	•	 	 In the event that Merck has paid NITEC AG according to lit. (ii) above Nitec AG shall re-imburse to Merck the share of the reduction amounts
actually paid by Merck to the authorities which is equal to PRODUCTION COSTS plus [...***...] of the EX FACTORY PRICE divided by the EX FACTORY PRICE. Reimbursements by NITEC AG shall be limited to [...***...] of the EX FACTORY PRICES.

 In the event, should the price to be paid by Merck to Nitec AG for the PRODUCT exceed [...***...] of
the EX FACTORY PRICES, representatives of 
  

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both Parties shall discuss in good faith whether this AGREEMENT could be modified in the best interest of both parties, or rather be terminated by Merck. 

 

	9.2.	Invoices shall be payable without discount within [...***...] days from the date of invoice. 

Article 10 - General Obligations of Merck 

Merck shall have the following general obligations: 
  

	10.1	Merck shall comply with all applicable laws and regulations, especially with the AMG and the AMBO. 

 

	10.2	Merck will use its reasonable best efforts to further the marketing, selling and distribution of the PRODUCT in the TERRITORY in accordance with the terms of this
AGREEMENT and to obtain the relevant authorizations, if any; 

  

	10.3	Merck shall promptly respond to all inquiries from customers, including complaints, process all orders, and shall effect all dispatches of the PRODUCT.

  

	10.4	Merck shall promptly provide Nitec AG with written reports of any importation or sale of the PRODUCT in the TERRITORY of which Merck has knowledge from any source other
than Nitec AG, as well as with any other information related to the PRODUCT, which Nitec AG may reasonably request in order to be updated on the market conditions in the TERRITORY 

 

	10.5	The parties shall agree upon the packaging design which shall comply with the legal requirements in the Territory and the internal guidelines of Merck. In case Merck
requests a change of the packaging or related information material and such request is beyond customary practice in the industry (e.g. with regard to either reasonableness of the change or frequency of requested changes) or results in a material
cost increase, the additional costs resulting from such request shall be borne by Merck. Merck shall inform Nitec of any requirements for changes of the packaging, labeling or patient information in the Territory. 

 

	10.6	The Parties agree to establish a joint product committee to meet regularly, at least every four (4) months, to evaluate marketing and sales performance as related
to annual sales and purchase plans delivered to Nitec AG according to Article 7.5 of this AGREEMENT. 

 Article 11 - General
Obligations of Nitec 
 Nitec shall have the following obligations during the TERM of this AGREEMENT: 

 

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	11.1	Nitec AG shall enable Merck to file the required notice with the AGES PharmMed relating to the transfer of the MARKETING AUTHORIZATION to Merck (Austria or Germany) in
accordance with § 25 AMG and informs Merck of that notification by copy. 

  

	112	Nitec AG will supply Merck with all presently available or future documents and information concerning the PRODUCT as far as such documents and information are needed
by Merck for the fulfillment of its obligations under this AGREEMENT, including the assessment report of the reference member state for submission to the Hauptverband and the complete dossier for the PRODUCT. 

 

	11.3	Nitec AG will provide Merck with examples for technical literature, promotional and advertising material, etc. as both Parties consider to be reasonably sufficient to
promote sales of the PRODUCT in the TERRITORY and as far as available within Nitec. 

 Article 12 - Secrecy 

 

	12.1	The Parties agree and undertake that they will keep secret all disclosures by the other Party, written or oral, made either before or during the TERM of this AGREEMENT.
The receiving Party will not without the prior written consent of the other Party use, except as expressly contemplated by this AGREEMENT, or disclose to any third party any information relating to the PRODUCTS learned by or disclosed to the other
Party pursuant to or in connection with this AGREEMENT (together “Information”). 

  

	12.2	The confidentiality obligations hereinabove mentioned shall not apply to: 

  

	 	a)	Information in the public domain 

  

	 	b)	Information known by the receiving Party before the date hereof and which the receiving Party can conclusively prove that it was not obtained, directly or indirectly
from the disclosing Party. 

  

	 	c)	Information legally obtained by the receiving Party after the date hereof from a third party which has it in its possession legally. 

 

	 	d)	Information which the receiving Party is legally obliged to reveal to authorities or clients. 

 

	12.3.	The provisions of this Article shall remain in force during the period of this AGREEMENT and for a further period of two (2) years after the termination thereof.

  

					
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 Article 13 - Responsibility, Liability and Indemnification 

 

	13.1	Merck shall be responsible for fulfilling and securing all requirements, regulations, licenses and permissions which are necessary to distribute, sell and market the
PRODUCT in finished form in the TERRITORY. 

  

	13.2	Nitec AG indemnifies Merck from all damages arising out of any negligent or willful breach of its obligations according to this AGREEMENT or arising out of the use by
Merck in the performance of this AGREEMENT of information or data disclosed by Nitec pursuant to this AGREEMENT. 

Subject to the limitations of Section 13.4, Nitec AG will indemnify Merck and its Affiliates (and their respective officers,
directors and employees) from and against any and all damages sustained or incurred by any of them because of any third party personal injury or wrongful death claim to the extent such damages arise out of: (i) the negligence or wilful
misconduct of Nitec or its Affiliates (or their respective officers, directors or employees), (ii) any breach by Nitec of any provision of this AGREEMENT, including without limitation any PRODUCT warranty made by Nitec in this AGREEMENT; or
(iii) any latent defect in PRODUCT. Nitec AG will indemnify and hold Merck and its Affiliates (and their respective officers, directors and employees) harmless from and against any and all damages sustained or incurred by any of them to the
extent that they arise out of any third party claim of violation or infringement of any proprietary right of said third party relating to Nitec’s proprietary information used in the manufacture of PRODUCT. Notwithstanding the foregoing, Nitec
shall have no such indemnity obligation to the extent such third party claims are based on, arise out of, or are caused by, the negligence or wilful misconduct of Merck or its Affiliates (or their respective officers, directors or employees).

 Upon filing of any such claim, Merck shall immediately notify Nitec AG in writing and shall offer Nitec AG to control the
defense against any such claim. If Nitec AG declines the offer to so control the defense, then Merck shall keep Nitec AG fully informed at all times of its own measures to defend such claim and shall allow Nitec AG to comment on any material
measures prior to Merck taking such measures in the course of the defense. Any settlement or acknowledgement of such claim or any waiver of a defense by Merck shall require the prior written consent of Nitec AG. Failure to obtain such consent shall
exclude Merck’s right to recover damages under this section 14 for the respective claim. 
  

	13.3	Merck, subject to the limitations in Section 13.4, indemnifies Nitec from all damages arising out of the breach of any obligation of Merck according to this
AGREEMENT. Merck will indemnify Nitec for all damage resulting from any third party claims against Nitec, which arise from the distribution, marketing and sale of the PRODUCTS, if not attributable to Nitec as per clause 13.2. Upon filing of any such
claim, Nitec shall immediately notify Merck and the third full paragraph of section 13.2 shall apply mutatis mutandis. 

  

					
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	13.4	Subject to mandatory law, neither party shall be liable or responsible for any exemplary, punitive, special, indirect, consequential 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. 

 Article 14 - Exchange of Information and Pharmacovigilance 
  

	14.1.	The Parties shall keep each other informed on all matters related to the PRODUCT and on any information received from any source concerning adverse drug reactions
coming to either Party’s knowledge with regard to the PRODUCT. 

  

	14.2	Merck is responsible for fulfilling the documentation and reporting obligations in accordance with the legal requirements. Independently of any national reporting
requirements, the Parties hereto shall in relation to the PRODUCT report to each other all serious adverse events from clinical trials with a reasonable suspicion of causal relationship to the administered PRODUCT and all serious spontaneously
reported suspected adverse drug reactions. 

  

	14.3	In any case where a change in the risk-benefit-ratio becomes evident or risk minimizing steps due to adverse drug reactions seem to be necessary (e.g. change of the
label, PRODUCT information, special information/warnings to the medical profession, patients, authorities or recall of the PRODUCT), the Parties hereto will inform each other without delay and harmonise further measures as appropriate. Such exchange
of information is realised through direct contacts between the appropriately qualified persons responsible for pharmacovigilance of each party. Therefore, both Parties undertake to inform each other on any change in the responsible persons, the
address, telephone and fax-numbers. 

  

	14.4	Any information on drug safety issues as pointed out above shall be furnished by a Party to the other Party in the English language. 

 

	14.5	Nitec GmbH will be responsible for preparing the periodic safety update reports and will maintain the respective EU database in accordance with the law and shall
provide copies of same to Merck. 

  

	14.6	Merck agrees that the obligations of Nitec may be performed by a third party selected by Nitec. Further details will be set forth in the Safety Data Exchange AGREEMENT
between Nitec and Merck to be concluded in due course. 

  

					
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 Article 15 - Non Competition

 Within the first three (3) years following the LAUNCH of the PRODUCT, Merck shall refrain from launching oral glucocorticoids in the
indication “rheumatoid arthritis”. 
 Article 16 - Term and Termination 

 

	16.1	Term 

 This AGREEMENT
shall take effect as of the signature by all parties and, unless otherwise terminated as provided in this AGREEMENT, shall remain in full force and effect for a period of 10 (ten) years as of the LAUNCH. 

Thereafter, the AGREEMENT will be automatically renewed for successive periods of [...***...] until terminated by either Party
giving 12 (twelve) months prior written notice to the other Party. 
  

	16.2	Termination 

Notwithstanding other rights to terminate this AGREEMENT pursuant to Art. 16.1, this AGREEMENT may be terminated with immediate effect in
accordance with the following provisions: 
  

	 	a)	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, should the other
Party file a petition of any type as to its bankruptcy, be declared a bankrupt, become insolvent, make an assignment for the benefit of creditors, go into liquidation or receivership; 

 

	 	b)	Either Party may terminate this AGREEMENT by giving notice in writing to the other Party should an event of force majeure as provided in Article 17.4 continue for more
than [...***...] months; 

  

	 	c)	Either Party may terminate this AGREEMENT by giving notice in writing to the other Party stating that this AGREEMENT might terminate under this Article 16.2., if the
other Party (i) commits a material breach of any condition herein contained, and does not within [...***...] days from receipt of written notice by the other Party of such breach remedy the same, if capable of remedy, or offer full
compensation therefore; or (ii) if the other Party repetitiously commits a breach of any condition contained herein, and the aggregate of such repetitious breach represents a material breach of this AGREEMENT. 

 

	 	d)	In any event, should the application for the YELLOW BOX fail to succeed or should the PRODUCT be removed from the YELLOW BOX later and moved to the NO BOX
(non-reimbursable products but in case of individual authorization an a case by case basis), then the parties shall meet and shall discuss the issue in good faith. Failing agreement within [...***...] on a joint course of action, either party
may terminate this agreement. 

  

***Confidential Treatment Requested 
  

					
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	 	e)	Should the Hauptverband require a 7 tablets/pack and should Nitec not elect to deliver such pack, then the parties shall meet and shall discuss the issue in good faith.
Failing agreement on a joint course of action, either party may terminate this agreement. 

  

	16.3	Rights and Obligations on Expiration and Termination 

 In the event of termination or expiration of this AGREEMENT for any reason, the Parties shall have the following rights and obligations: 

 

	 	a)	Merck shall without undue delay take any measures necessary to transfer the MARKETING AUTHORIZATION for the PRODUCT and all documentation relating thereto to Nitec
Germany or to a third party designated by Nitec Germany. 

  

	 	b)	All of Merck’s rights under or related to the TRADEMARK automatically end upon termination of this AGREEMENT. 

Termination 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; 
  

	16.4	Both Parties’ obligations pursuant to secrecy in Article 12 shall survive termination of this AGREEMENT; 

 

	16.5	In case of termination or expiration of this AGREEMENT, Merck will discontinue to distribute, to market and to sell the PRODUCT, if not stated otherwise in this
AGREEMENT. 

  

	16.6	In the event of termination of this AGREEMENT, Nitec AG may repurchase stocks of PRODUCT held by Merck at the prices Merck has bought the PRODUCT from Nitec AG, if
Nitec AG so chooses. Otherwise Merck 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 Merck’ responsibility and costs, a proof of which shall be submitted to Nitec AG. 

 Article 17 - Miscellaneous 
  

	17.1	Notices. 

 All notices,
demands and communications required to be made under this AGREEMENT shall be in writing and delivered personally or sent by telefax and confirmed by airmail letter to the addresses shown above. Notice shall be deemed delivered on the date of
delivery when delivered personally or on the third business day after the day on which they were sent by telefax or fourteen 

 

 ***Confidential Treatment Requested 

 

					
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(14) days after being mailed by airmail letter, which provides for a signed receipt upon delivery. 
  

	17.2	Headings. 

 It is agreed
by the Parties hereto, that the headings of the clauses herein have been included for convenience only and do not form any part of the AGREEMENT. 
  

	17.3	Severability. 

 In the
event that any provision of this AGREEMENT is held by a court of competent jurisdiction to be unenforceable because it is invalid or in conflict with any law of any relevant jurisdiction, the Parties shall replace any Article or part of an Article
found to be invalid or unenforceable by alternative provisions which shall be as similar as possible in their conditions with regard to their spirit and commercial effect. The validity of the remaining provisions shall not be affected. 

 

	17.4	Force Majeure. 

 In the
event that the performance of this AGREEMENT or of any obligation hereunder, other than payment of money as herein provided, by either Party is prevented, restricted or interfered with by reasons of any cause not within the control of the respective
Party, and which could not by reasonable diligence have been avoided by such Party, the Party so effected, upon giving prompt notice to the other Party as to the nature and probable duration of such event, shall be excused from such performance to
the extent and for the duration of such prevention, restriction or interference, provided that the Party so affected shall use its best efforts to avoid or remove such cause of non-performance and shall fulfil and continue performance hereunder with
the utmost dispatch whenever and to the extent such cause or causes are removed. 
  

	17.5	Assignment. 

 Merck and
Nitec may assign its rights and obligations under this AGREEMENT, in whole or in part, to any AFFILIATE upon prior written consent from Nitec or Merck respectively, which consent shall not be unreasonably withheld or delayed, provided that in each
case the transferring party agrees to be fully responsible for the receiving AFFILIATE’S performance of this AGREEMENT. 
  

	17.6	Hardship. 

 Should the
effects of this AGREEMENT resulting from future unforeseen events and developments lead to an unjust hardship for either Party and which hardship does not correspond with the intention of the Parties in good faith, the Parties shall without delay
enter into negotiations to see in what way the conditions of the AGREEMENT can be made to suit altered circumstances. 
  

	17.7	Waiver. 

 If any Party
should at any time refrain from enforcing its rights arising from a breach or default by the other Party of any of the provisions of this 
  

					
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AGREEMENT, such waiver shall not be construed as a continuing waiver regarding that breach or default or other breaches or defaults of the same or other provisions of this AGREEMENT. 

 

	17.8	Conflicting Agreements. 

In the event any provisions contained in the TTA shall conflict with the provisions contained in this AGREEMENT, this AGREEMENT shall
prevail. 
  

	17.9	Written Form. 

 No waiver,
alteration or modification of any of the provisions hereof shall be binding unless made in writing and signed by duly authorized officers of the Parties. Any waiver of this written form requirement shall be in writing. 

Article 18 - Governing Law 
 This
AGREEMENT shall be governed by and interpreted in accordance with the laws of Germany without its provisions on the conflict of laws and without the UN Convention on the international Sale of Goods (CISG) and the rules incorporating this convention
into German law. 
  

					
	Reinach, den 26/3/09	 		  	Wien, den 10/03/2009
			
	Nitec Pharma AG	 		  	Merck GesmbH
			
	 /s/ Dr. Anders Härfstrand
	 		  	 /s/ Andreas Peilowich

	(Dr. Anders Härfstrand)	 		  	(Andreas Peilowich)
			
	 Mannhein, den 25/03/09
  

Nitec Pharma GmbH
	 		  	
			
	 /s/ Achim Schäffler
	 		  	
	(Achim Schäffler)	 		  	

 Appendix 1    Target Sales 
 Appendix 2     Design for Lodotra Trademark 
  

					
		  	17/20	  	

 Transfer, Licence and Supply Agreement 

Appendix 1 

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

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

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

[...***...] 

[...***...] 

[...***...] 

[...***...] 

[...***...] 
  

 ***Confidential Treatment Requested 

 

					
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 [...***...] 
  

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

 [...***...] 

[...***...] 

[...***...] 
  

 ***Confidential Treatment Requested 

 

					
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 Appendix 2 
 Design of Lodotra Trademark 
 [...***...] 

 

 ***Confidential Treatment Requested 

 

					
		  	20/20Manufacturing and Supply Agreement, dated March 24, 2009

 Exhibit 10.16 
 ***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 MEDICAL COMPANY 
  

 
 MANUFACTURING
AND SUPPLY AGREEMENT 
  
  

 

 MANUFACTURING AND SUPPLY AGREEMENT 

THIS AGREEMENT is made the 26th 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 (“Nitec”); and 

  

	(2)	MUNDIPHARMA MEDICAL COMPANY a partnership organised in accordance with the laws of Bermuda with Registered No. EC – 16260 and with its registered office at
Canon’s Court, 22 Victoria Street, Hamilton, HM 12 Bermuda (“Mundipharma”). 

 RECITALS

  

	(A)	Nitec is able to procure the manufacture of the Products (as hereinafter defined) and supply the same. 

 

	(B)	Nitec has appointed Mundipharma’s Associate, Mundipharma International Corporation Limited (“MICL”), as its exclusive distributor and licensee of the
Products in the Territory pursuant to a Distribution Agreement between Nitec and MICL of even date herewith (the “Distribution Agreement”); 

  

	(C)	MICL wishes Nitec to procure the manufacture of the Products and supply the same and has designated Mundipharma to purchase the Products from Nitec for distribution in
accordance with the Distribution Agreement. 

 NOW IT IS HEREBY AGREED as follows: 

 

	1	Definitions 

 In this
Agreement, in addition to the terms listed in the Recitals, the following terms shall have the following meanings:- 
  

 Page 1 of 25 

			
		
	“Associate”	  	means 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 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;
		
	“Average Net Selling Price”	  	means the aggregate Net Sales for a country in the Territory divided by the aggregate number of units of the Finished Product sold in the same period in that country by MICL, its
Associates or sub-licensees, less those rejected, returned and recalled in a manner consistent with Mundipharma or its Associates’ customary policy;
		
	“Calendar Quarter”	  	means a calendar quarter ending on
31st March, 30th June, 30th September and 31st December in any calendar year;
		
	“cGMP”	  	means the Rules Governing Medicinal Products in the European Union, Volume 4, Medicinal Products for Human and Veterinary Use Good Manufacturing Practices and Commission
Directive 91/356/EEC of 13 June 1991, as amended from time to time;
		
	“Commencement Date”	  	means the date of execution of this Agreement;

  

 Page 2 of 25 

			
		
	“Delivery Address”	  	means the following address for delivery of the Finished Products: Alloga (Nederland) BV, De Amert 603, 5462 GH Veghel, Nederland;
		
	“Distribution Agreement”	  	has the meaning set out in the Recital B hereto;
		
	“Finished Products”	  	means all packaged Products ready to be distributed under the trade mark LodotraTM or such other trade mark determined by the parties under the Distribution
Agreement;
		
	“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 related Nitec intellectual
Property (as defined below), which shall include (without limitation) all dosage strengths and line extensions to the Product and any improvement thereof;
		
	“Intellectual Property”	  	means 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;
		
	“Launch”	  	means for each country of the Territory when MICL launches the Product in that country in the Territory under the Distribution Agreement.

  
 Page 3
of 25 

			
		
	 “Manufacturing” and
 “Manufacture”
	  	 means the totality of the following operations:
  

(a) purchasing, supply and storage of active ingredients, excipients and packaging materials;

 
 (b) checks performed on the active
ingredients, excipients, packaging materials, semi-finished or Finished Products and their release;
  

(c) production operations performed from the active ingredients and excipient stage to the semi-finished
product stage;
  

(d) packaging, packing and labelling of semi-finished products, to produce the Finished Product;

 
 (e) analysis and release of batches of
Finished Product and delivery of these batches, accompanied by certificates of compliance signed by a qualified person in the EU;
  

(f) management and archiving of files relating to batches of each of the Products, and retention of samples
for the period provided for in current laws and regulations;

		
	“Manufacturing Premises”	  	means the facilities located at SkyePharma SAS, ZA de Chesnes Quest, 55 rue du Montmurier, BP 4538291 Saint-Quentin-Fallavier where the Third Party Manufacturer shall manufacture
bulk tablets of the Product or any other site approved by the Regulatory Authorities for the Manufacture of the Product;

  
 Page 4
of 25 

			
		
	“Net Sales”	  	 means the gross amount invoiced by MICL, its Associates or sub-licensees for sales of the Finished 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 MICL or
Mundiphaima on account of lack of sufficient remaining shelf life); and

		
		  	 (e)     amounts repaid, discounted or credited by reason of (i) retroactive price reductions,
discounts, or rebates, which are, in any case, imposed on MICL or its Associates or sub-licensees 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 MICL by written records or (ii) retroactive price reductions, discounts or rebates (not specified in an invoice) granted to

 

 Page 5 of 25 

			
		  	 a third party without the authority to impose such price reductions, discounts or rebates to the extent these are either pre-agreed with Nitec or
do not exceed [...***...] of the gross invoice
price.

		
		  	The transfer of the Finished Product by MICL to an Associate or sub-licensee will not be deemed a sale;
		
	“Nitec Intellectual Property”	  	means any and all Intellectual Property relating to the Product and/or corticosteroids owned by, licensed to or under the control of Nitec including (without limitation) the
Intellectual Property licensed from SkyePharma plc and/or Jagotec AG regarding GeoClock Technology and its use with corticosteroids, the patent applications [...***...] (and any patents, divisional patents, supplementary protection
certificates and extensions granted in relation to such 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;
		
	“Packaging Premises”	  	means the facilities located at Catalent Solutions Germany Schorndorf GmbH, Steinbeisstraße 1-2, D 73614 Schorndorf, Germany where the Third-Party Packager shall package
the Products or any other site approved by the Regulatory Authorities for the packaging of the Product;

  

***Confidential Treatment Requested 
 Page 6 of 25 

			
		
	“Product”	  	means the modified release formulation of prednisone 1mg, 2mg, 5mg in all pack presentations and including Improvements;
		
	“Registrations”	  	means any marketing authorisations granted under the relevant legislation in the Territory for the Manufacture, distribution and sale of the Finished Products;
		
	“Regulatory Authority”	  	means 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;
		
	“Sales Forecast”	  	means the sales forecast for the Product for each country or group of countries in the Territory as set out in Table 1 of Schedule 2;
		
	“Specification”	  	means the specification for the Finished Products given in the Technical Agreement;
		
	“Technical Agreement”	  	means the technical agreement to be entered into between Nitec Pharma GmbH and Mundipharma or its Associate within ninety (90) days as of the date of this
Agreement;
		
	“Territory”	  	means the countries listed in Schedule 1;
		
	“Testing Premises”	  	means the facilities located at Phast Gmbh Kardinal-Wendel-Str. 16 D-66424 Homburg/Saar, Germany where the Third Party Tester shall test the Product or any
other

  
 Page 7
of 25 

			
		  	site approved by the Regulatory Authorities for the testing of the Product;
		
	“Third-Party Manufacturer”	  	means Jagotec AG or any other party appointed and approved by the Regulatory Authorities for the Manufacture of the Product;
		
	“Third-Party Packager”	  	means Catalent Solutions Germany Schorndorf GmbH or any other party approved by the Regulatory Authorities for the packaging of the Product;
		
	“Third-Party Service Providers”	  	means the Third-Party Manufacturer, the Third-Party Packager and the Third-Party Tester;
		
	“Third-Party Tester”	  	means Phast GmbH or any other party approved by the Regulatory Authorities for the testing of the Product.

 

	2	Interpretation 

  

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

 

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

 

	3	Duration 

  

	3.1	This Agreement shall take effect on the Commencement Date and subject as hereinafter provided shall continue in force for so long as the Distribution Agreement remains
in effect and shall terminate on the date on which the Distribution Agreement terminates or expires. 

  

 Page 8 of 25 

	4	Manufacture and Supply 

  

	4.1	Nitec shall procure that the Third-Party Manufacturer shall Manufacture the Products at the Manufacturing Premises and shall procure that the Third-Party Packager shall
package the Products at the Packaging Premises and shall procure that the Third-Party Tester shall test the Products at the Testing Premises and Nitec shall supply the Finished Products to Mundipharma, all in accordance with the Specification, the
terms and conditions of this Agreement and the Technical Agreement. 

  

	4.2	 Nitec shall fully exercise all of its rights under its agreements with the Third-Party Service Providers to cause the Third Party Manufacturer and the
Third Party Packager at all times to take reasonable precautions in order to ensure that Nitec is able to satisfy Mundipharma’s estimated requirements of the Finished Products for the next [...***...] (as shown in the Firm Forecast pursuant to
Clause 5). Without prejudice to Clause 4.3 below, Nitec shall promptly notify and keep Mundipharma informed about any manufacturing, packaging, testing or supply problems that may affect Nitec’s ability to fulfill Mundipharma’s orders for
the Finished Products in a timely manner and use commercially reasonable efforts to resolve or work around such problems as soon as possible. 

  

	4.3	As soon as is reasonably practicable, Nitec shall identify, evaluate and select an organization capable of providing services identical in nature, scope and quality to
the services provided by the Third-Party Manufacturer (the “Alternative Third-Party Manufacturer”) and shall submit that Alternative Third-Party Manufacturer to the Regulatory Authorities for their approval. If the Alternative
Third-Party Manufacturer selected by Nitec is not approved by the Regulatory Authorities, Nitec shall use all reasonable endeavours to select an alternative manufacturer acceptable to the Regulatory Authorities as soon as reasonably practicable.
Following approval from the relevant authorities, Nitec shall enter into a legally-binding agreement with the Alternative Third-Party Manufacturer requiring the Alternative Third-Party Manufacturer to supply such services to Nitec upon reasonable
notice. 

  

	4.4	 Nitec shall provide the Alternative Third-Party Manufacturer with (or procure that the Alternative Third Party Manufacturer be provided with) any and
all information, data, 

  

 ***Confidential Treatment Requested 

Page 9 of 25 

	 	 
licences (including intellectual property licences), permissions, authorizations, resources, materials and a press-coater in advance as required by the Alternative Third-Party Manufacturer to
provide the services under Clause 4.3. 

  

	4.5	In the event that Nitec (having complied with Clause 4.4) or its designee is unable or expects to be unable to supply the Products in accordance with this Agreement
owing to the failure of the Third-Party Manufacturer to supply its services to Nitec for any reason, Nitec shall procure the provision of equivalent services from the Alternative Third-Party Manufacturer so as to enable Nitec to supply the Finished
Products in accordance with this Agreement. Following Nitec’s procurement of equivalent services from the Alternative Third-Party Manufacturer, that Alternative Third-Party Manufacturer shall be deemed the Third-Party Manufacturer for the
purposes of Clauses 4.1 and 4.2 above and Nitec shall enter into good-faith discussions with Mundipharma during which the parties shall endeavour to agree on appropriate additional measures to be made in order to secure the continued and successful
Manufacture and supply of the Product. Unless the parties agree alternative measures within a reasonable period of time, Nitec shall re-execute its obligations under Clauses 4.3 and 4.4 above in order to secure a new Alternative Third-Party
Manufacturer. 

  

	4.6	In the event that changes are requested or required to be made to the packaging for the Products, the following provisions shall apply: 

 

	 	4.6.1	Nitec shall use all of its contractual rights to cause the Third-Party Packager to use reasonable efforts to use up its existing stocks of packaging materials as
expeditiously as possible to minimize any write-offs of surplus packaging materials. 

  

	 	4.6.2	If Mundipharma requests packaging changes and the timescale for implementation of the changes is such that the Third-Party Packager will not be able, despite its
reasonable efforts, to use up its existing stocks of packaging materials before implementing the changes, Mundipharma shall reimburse Nitec for any costs it reasonably incurs as a result of the surplus packaging materials being required to be
written off by the Third-Party Packager. 

  

	 	4.6.3	 Subject to Clause 4.6.4, if packaging changes are required by the action or 

 

 Page 10 of 25 

	 	 
pronouncement of a governmental or Regulatory Authority in the Territory, the parties shall bear equally the cost of writing off any surplus packaging materials. 

 

	 	4.6.4	Any and all fees (including, without limitation, fees imposed by a governmental or Regulatory Authority in the Territory) incurred by either party owing to a change in
the packaging of the Finished Product directly or indirectly requested or required by a party to this Agreement shall be paid solely by that party. For the purposes of this clause, Nitec shall also be liable of any fees incurred owing to a change in
packaging directly or indirectly requested or required by a licensee of Nitec. 

  

	4.7	Should Mundipharma wish Nitec to make use of a Mundipharma packaging site such that Mundipharma be the Third-Party Packager for the purposes of this Agreement,
Mundipharma shall so notify Nitec and the parties shall enter into good faith negotiations to agree the terms of such collaboration. 

  

	5	Estimates and Orders 

  

	5.1	 Within a reasonable period of time prior to the first Launch of the Product in the Territory, Mundipharma shall provide Nitec with an estimate of
Mundipharma’s requirement for delivery of the Finished Products for the following [...***...] and shall [...***...] prior to each Calendar Quarter thereafter during the term of this Agreement provide a new
[...***...] for the next period. The [...***...] shall be set out on a quarterly basis, such quarters being [...***...] estimating Mundipharma’s requirements of Product in the Territory, which forecasts shall be used by Nitec
for planning purposes. 

 The estimates for the first [...***...] of the [...***...] shall
be firm (the “Firm Forecast”) and the estimates for the remaining [...***...] of such forecast shall be tentative (the “Tentative Forecast”). 

The submission of each [...***...] shall oblige Mundipharma to place a binding order for the quantity of Product set forth in Q1 in
accordance with Clause 5.2. In 
  

 ***Confidential Treatment Requested 

Page 11 of 25 

 
each
[...***...]
 (other than the very first such forecast submitted under this Agreement), the quantity of Product set forth in Q1 shall be (i) within [...***...] of the quantities of the Product set out in Q2 in the [...***...] immediately
preceding the most recent [...***...] and (ii) within [...***...] of the quantities set out in Q3 in the [...***...] immediately preceding the [...***...] referred to in (i). 

This Clause 5.1 reflects the current terms of Nitec’s agreement with the Third Party Service Providers. if Nitec is able to modify
the terms of its agreement with the Third Party Service Providers (and/or the Alternative Third Party Manufacturer, if applicable), the relevant time periods in this Clause 5.1 shall be shortened by an equivalent amount. 

 

	5.2	Mundipharma shall submit written orders seven (7) days prior to each Calendar Quarter in the amount of the Firm Forecast and, following written confirmation from
Nitec, Nitec shall deliver such quantities of the Finished Products to Mundipharma by the date(s) specified in such orders, which shall be within [...***...] after placement of the binding order. If Mundipharma should require additional
quantities of Finished Products upon short notice, Nitec shall use its reasonable endeavours to meet such requirements. 

  

	6	Prices and Payment 

  

	6.1	Mundipharma shall purchase the Finished Products exclusively from Nitec at a unit price of [...***...] of the Average Net Selling Price of the relevant strength
of the Finished Products for the relevant country for the first [...***...] following first Launch of the Product in that country and at a price of [...***...] of the Average Net Selling Price of the relevant strength of Finished
Products for the relevant country from [...***...] after first Launch of the Product in that country subject always to a minimum price of [...***...] per tablet (the “Payment Price”), inclusive of all packaging and
materials, insurance, import taxes and transport costs for delivery to the Delivery Address. Such prices are exclusive of Value Added Tax which, if applicable, shall be paid at the prevailing rate. 

 

	6.2	 The Average Net Selling Prices used to calculate the supply prices pursuant to Clause 6.1 for supplies of Product in each country for the initial
period up until the first reconciliation 

  

 ***Confidential Treatment Requested 

Page 12 of 25 

	 	 
pursuant to Clause 6.3 following Launch in that country shall be based upon Mundipharma’s reasonable estimate of the Average Net Selling Prices for the first six (6) months following
Launch in that country. For the following six (6) months and all six (6) month periods thereafter supply prices shall be calculated pursuant to Clause 6.1 based on the actual Average Net Selling Prices from the preceding six (6) month
(or shorter initial) period for that country determined in accordance with Clause 6.3. 

  

	6.3	Within three (3) months of the end of the six (6) month period following first Launch of the Products in the Territory, and within three (3) months of
every six (6) month period thereafter Mundipharma and its Associates shall calculate the actual Average Net Selling Prices for each and every country in the Territory in which the Product is Launched during all or part of the preceding six
(6) months. Once the actual Average Net Selling Prices have been so calculated, Mundipharma shall notify the same to Nitec accompanied by documentation allowing Nitec to verify the calculation of the Average Net Selling Price. Mundipharma shall
also calculate and notify to Nitec the supply prices it would have paid had the actual Average Net Selling Prices been used to calculate the supply prices in the preceding six (6) month period. Nitec shall then reimburse to Mundipharma any
amounts actually paid by it in excess of the amounts it would have paid if the actual Average Net Selling Prices had been used to calculate the supply prices and Mundipharma shall pay to Nitec any shortfall in the amounts actually paid by
Mundipharma versus the amounts it would have paid if the Average Net Selling Prices had been used to calculate the supply prices. 

  

	6.4	 Payment against invoices submitted by Nitec for the Finished Products sold hereunder shall be made within [...***...]
 of the date of Nitec’s invoice. 

  

	6.5	 At the end of each successive twelve month period following the Launch of the Finished Product in a particular country (or group of countries) the Net
Sales attained in that country (or group of countries) in that period shall be compared with the Sales Forecast for that country (or group of countries) and for that period. If the Net Sales attained exceed the forecast sales for that particular
country (or group of countries) and for that period then Nitec shall promptly pay to Mundipharma a rebate equivalent [...***...] of the Net Sales attained in that country (or group of countries) in that period for every [...***...] that
such Net Sales exceed the forecast sales for that particular country (or group of countries) for that period provided that 

  

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the maximum rebate payable under this clause shall be [...***...] of the Net Sales attained. 

 

	7	Storage and Delivery Arrangements 

  

	7.1	Nitec shall use all of its contractual rights to cause the Third-Party Service Providers to safely and correctly store all raw materials, excipients, intermediate
products and preparations, and packaging material used in the Manufacture of the Finished Products whilst in the possession of the Third-Party Service Providers. Nitec shall sign (or will have signed) technical agreements with Third-Party Service
Providers and the Alternative Third-Party Manufacturer to assure appropriate storage under cGMP. 

  

	7.2	Nitec shall deliver the Finished Products DDP (INCOTERMS 2000) to the Delivery Address. After delivery Mundipharma shall be responsible for the appropriate storage and
shipment of Product and shall comply with the written shipment and storage conditions provided by Nitec in the Technical Agreement. 

  

	8	Manufacturing Processes 

  

	8.1	Nitec shall use all of its contractual rights to cause the Third-Party Service Providers at all times to operate in accordance with the criteria defined in the
Technical Agreement and in compliance with the Registrations and cGMP and all other relevant regulations and legislation. Nitec shall regularly audit the Third-Party Service providers and endeavour to ensure that they receive regular inspections by
the relevant Medicines Inspectorate to ensure that the Manufacturing processes are always in conformity with such requirements. 

  

	8.2	Any delivery of Finished Products to Mundipharma or its designee must first be inspected by the Third-Party Tester or Nitec and released by the Third-Party Tester or
Nitec’s Qualified Person (the “QP”), or a person acting on their authority in the capacity of person responsible for quality assurance. This QP shall draw up a written report certifying the conformity of the delivery to the conditions
specified in the Technical Agreement. Nitec shall use all of its contractual rights to ensure that the Third-Party Tester shall not, without the prior written consent of Nitec, assign the responsibility for inspection and release of the Finished
Products to a third party. 

  

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	8.3	The parties shall enter into the Technical Agreement as soon as practicable after the Commencement Date. 

 

	9	Quality of the Products, Inspection and Recalls 

  

	9.1	Nitec will use its reasonable endeavours to ensure that the Finished Products shall upon delivery to the Delivery Address be free of defects, of satisfactory quality
and fit for the purpose for which they are intended to be used. 

  

	9.2	Mundipharma shall inspect the Finished Products delivered within five (5) working days of receiving delivery and shall inform the party effecting the delivery
(with a copy to Nitec) within such five day period of any shortages or any defects visible on inspection. Should Mundipharma subsequently become aware of any latent defects, it shall inform Nitec within five (5) working days of becoming so
aware of the same. Failure to comply with the duty to inform Nitec of any defects (including latent defects) within the timeframes provided in this Clause 9.2 shall result in Mundipharma forfeiting its right to a replacement of the relevant
defective Finished Products under Clause 9.3 below. 

  

	9.3	In the event that any of the Finished Products are defective and Mundipharma informs Nitec within the timeframes provided in Clause 9.2, Nitec shall replace the
defective Finished Products free of charge. 

  

	9.4	The Finished Products shall have a minimum shelf life of at least [...***...] from the date of delivery to Mundipharma or its designee, such minimum shelf life to
be increased from time to time based on the latest shelf life for the Products approved by the applicable Regulatory Authorities in the Territory. 

  

	9.5	 In the event that a recall or a withdrawal of any of the Finished Products is required by any governmental or Regulatory Authority in the Territory, or
if a recall or withdrawal of any of the Finished Products or suspension of sales of any of the Finished Products is reasonably deemed advisable by Mundipharma, then such recall, withdrawal or suspension, as applicable, shall be implemented and
administered by Mundipharma (and/or its designee) in a 

  

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manner that is appropriate and reasonable under the circumstances and in conformity with any requests or orders of the applicable governmental or Regulatory Authority, as well as accepted trade
practices. For the avoidance of doubt: Mundipharma shall at all times and before taking any action — unless action is required to be taken immediately without consultation to avoid material damage — inform Nitec about the underlying facts,
the action Mundipharma intends to take as well the reasons for such actions and meet with the QP and/or Nitec’s management to discuss the most appropriate course of action. Details for such prior consultation shall be as set forth in the
Technical Agreement. 

  

	9.6	The party responsible for the circumstances giving rise to the recall, withdrawal or suspension shall pay the administrative costs and expenses for the same. If neither
party is at fault, both parties are at fault or fault cannot be determined, each party shall bear filly percent (50%) of the administrative costs and expenses; provided that nothing herein shall limit Nitec’s indemnification obligations
set forth in Clause 11. 

  

	10	Access and Right to Audit 

  

	10.1	Nitec shall procure that Mundipharma has access to Nitec, or whoever is responsible for the release of Product though its authorized qualified person, on reasonable
prior notice at all reasonable times during normal working hours to inspect its quality control systems for the purpose of ensuring compliance with the Registrations, cGMP and any other relevant legislation. Details are set forth in the Technical
Agreement. 

  

	10.2	Mundipharma shall procure that MICL shall maintain and procure the maintenance of accurate and up-to-date records and books of account showing all figures necessary to
calculate the Average Net Selling Price for the Product since the Product was first Launched in each and every country of the Territory including but not limited to the quantity, description and value of the Product supplied in each country of the
Territory during the previous six (6) years. 

  

	10.3	 Mundipharma shall during business hours, on no less than fourteen (14) days’ written notice from Nitec and not more than once in any Calendar
Year, procure that MICL makes available 

  

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for inspection the records and books referred to in Clause 10.2. Such inspection shall be undertaken by an independent auditor appointed by Nitec and reasonably acceptable to Mundipharma for the
sole purpose of verifying whether Mundipharma has calculated correctly the Average Net Selling Prices for the Product in each country of the Territory in which the Product has been Launched in accordance with Clauses 6.2 and 6.3.

  

	10.4	Nitec shall procure that any independent auditor shall maintain all information and materials received, directly or indirectly, by it from Mundipharma, MICL or their
Associates in strict confidence and shall not use or disclose the same to any third party save for the sole purpose of reporting the results of the audit. 

 

	11	Indemnity 

  

	11.1	 Nitec shall indemnify and hold harmless Mundipharma and its employees against legal liability for costs, claims and damages in respect of any death and
personal injury, damage or loss which may be caused by the use of the Finished Products to the extent that any such death or personal injury, damage or loss is due to negligence or fault on the part of Nitec, its Associates or their sub-contractors
or any of their respective employees. Nitec shall keep in force insurance to provide [...***...] cover in respect of the risks referred to in this clause. 

 

	11.2	Mundipharma shall indemnify and hold harmless Nitec and its employees against legal liability for costs, claims and damages in respect of any death and personal injury,
damage or loss which may be caused by Mundipharma’s activities under this Agreement other than the use of the Finished Products to the extent that any such death or personal injury, damage or loss is due to negligence on the part of Mundipharma
or its employees. Mundipharma shall keep in force insurance to provide [...***...] cover in respect of the risks referred to in this clause. 

  

	12	Confidentiality 

  

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	12.1	Mundipharma will keep any information provided to it by Nitec in relation to Nitec or to the Products secret and confidential and procure that any consultant, adviser
or Associate or other party to whom disclosure is made shall keep secret and confidential all such information save to the extent that the same: 

  

	 	(i)	is in the public domain at the time of the disclosure or after the disclosure enters into the public domain by publication or otherwise through no fault of Mundipharma
or its Associates; or 

  

	 	(ii)	has already become or subsequently becomes available to Mundipharma or its Associates from any legitimate source without obligation of confidentiality or non-use or is
disclosed to the Mundipharma or its Associates by a third party having lawful right to make such disclosure; or 

  

	 	(iii)	was legitimately known to Mundipharma or its Associates prior to disclosure by Nitec. 

 

	12.2	Nitec and Mundipharma shall regard this Agreement and any arrangement between the parties in relation thereto as confidential and shall not disclose the same to any
third party without the written consent of the other or as may be required by law. 

  

	13	Force Majeure 

  

	13.1	Neither party shall have any liability to the other in respect of any failure to carry out its obligations under this Agreement where such failure is due to an event of
“force majeure”. For the purpose of this clause an event of force majeure means an event which by its nature could not have been foreseen by the party in default or, if it could have been foreseen, was not avoidable by the taking of
reasonable commercial measures; and shall include but shall not be limited to acts of God, storms, flood, tempest, strikes or other industrial action (whether at the premises of the party in default or elsewhere), fire, riots, sabotage, war, civil
commotion or unrest, failure of essential supplies of raw materials, energy or otherwise, interference by civil or military authorities. 

  

 Page 18 of 25 

	13.2	 In the event of force majeure, the affected party shall keep the other party fully informed and shall use its best efforts to comply to the fullest
extent possible with its obligations pursuant to this Agreement and subject to the use of such best efforts the time for performance of the obligation(s) prevented by the force majeure event shall be extended by a period equivalent to that during
which performance is prevented, provided that if the event of force majeure shall continue for more than [...***...], the other party shall be entitled to terminate this Agreement and/or any order made pursuant to this Agreement.

  

	14	Assignment 

 Neither this
Agreement nor any rights or obligations under this Agreement 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 for the receiving party’s full and timely performance of its obligations under this Agreement as of the assignment. 

 

	15	Termination 

  

	15.1	Either party shall be entitled to terminate this Agreement by written notice to the other if: 

 

	 	(i)	that other party commits any continuing or material breach of any of the provisions of this Agreement and, in the case of such a breach (whether in respect of an
individual Product or generally) which is capable of remedy, fails to remedy the same within [...***...] of receipt of written notice giving full particulars of the breach and the action required to remedy such breach (and if such notice
relates to an individual Product or Finished Product then this Agreement shall be terminated in respect of that Product or Finished Product only); 

  

	 	(ii)	an encumbrancer takes possession or a receiver is appointed over any of the property or assets of that other party; 

 

	 	(iii)	that other party makes a voluntary arrangement with its creditors or becomes subject to an administration order; 

 

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	 	(iv)	that other party goes into liquidation (except for purposes of an amalgamation, reconstruction or other reorganisation and in such manner that Nitec resulting from the
reorganisation effectively agrees to be bound by or to assume the obligations imposed on that other party under this Agreement); 

  

	 	(v)	that other party ceases, or threatens to cease, to carry on business; or 

  

	 	(vi)	a like event to one referred to in (ii) to (v) above occurs in any jurisdiction in the Territory. 

 

	15.2	Termination shall operate without prejudice to the rights and obligations of either party in relation to the other which have accrued prior to the date on which the
term hereof expires and in the event of the termination of this Agreement if any order for Finished Products has already been despatched prior to the date of termination Mundipharma shall take delivery of and make payment for such Finished Products
as herein provided but if any order has not been despatched prior to such date Nitec shall not be bound to despatch it. 

  

	15.3	Upon the termination of this Agreement for any reason, subject as otherwise provided in this Agreement and to any rights or obligations which have accrued prior to
termination, neither party shall have any further obligation to the other under this Agreement provided however that the indemnity under Clause l l and the obligation of confidentiality in Clause 12.1 shall continue after termination.

  

	16	Notices 

 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. 
  

 Page 20 of 25 

	17	Choice of Law 

 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	General 

  

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

 

	19.2	This Agreement (and the other agreements referred to herein) contains the entire agreement between the parties with respect to the subject matter hereof and supersedes
all previous agreements and understandings between the parties with respect thereto. 

  

	19.3	Any variation of this Agreement shall be effective only if agreed in writing and signed by duly authorised representatives of the parties. 

 

	19.4	 The waiver of any right herein contained by either party shall not be construed as a waiver of

  

 Page 21 of 25 

	 	 
the same right at a future date or as a waiver of any other right herein contained. 

  

	19.5	Nothing in this Agreement is intended to nor shall it confer an enforceable benefit on any third party, except in respect of Associates of the parties as specifically
set out herein. 

  

	19.6	 All invoices to be issued by Nitec will be denominated in EURO (€) and any amounts 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 [...***...].
 

  

	19.20	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. 

  

	20	Invalidity and Severability 

  

	20.1	If any provision of this Agreement shall be found by any court or administrative body of competent jurisdiction to be invalid or unenforceable the invalidity or
unenforceability of such provision shall not affect the other provisions of this Agreement and all provisions not affected by such invalidity or unenforceability shall remain in full force and effect. 

 

	20.2	The parties hereby agree to attempt to substitute for any invalid or unenforceable provision a valid or enforceable provision which achieves to the greatest extent
possible the economic legal and commercial objectives of the invalid or unenforceable provisions. 

  

	21	Announcements 

 Unless
required by law or by any applicable regulation, neither of the parties hereto shall make any press statement or other public announcement in connection with this Agreement without the prior agreement of the other both as to the timing and text of
such statement or announcement. 
  

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 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
		  		 	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 MEDICAL COMPANY	  	 )
 )
	 	 Douglas Docherty
 GENERAL
MANAGER

		  		 	Print Name

  

 Page 23 of 25 

 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 24 of 25 

  
 SCHEDULE 2

 SALES FORECAST 
 Table 1 
 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	 
	 [...***...]
	  				  				  				  				  				  				  				  				  				  			

  
 Page 25
of 25

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