Document:

Technology Transfer Agreement

 Exhibit 10.11 
 ***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. 

Technology Transfer Agreement 
 between 
 Merck KGaA (“Merck”),

Frankfurter Strasse 250, 64271 Darmstadt
 and 
 Nitec Pharma AG (“Nitec Pharma”) 

Switzerland 

Preamble 
 Merck has been
marketing corticoids (Fortecortin, Decortin, Decortin H, Solu Decortin H) successfully – primarily in Germany – for many years. In order to support the corticoid business Merck started developing Prednison Night Time Release in 1998, which
is a novel galenic formulation using the active agent prednison. For the treatment of rheumatoid arthritis (“RA”) the Project (as defined hereinafter) has not yet entered phase 3 of clinical testing. 

Merck due to limited resources and its focus on other business areas is unable to develop the Project until it is ready for marketing or to obtain a
legal pharmaceutical licence for the Project. Merck therefore internally has decided to discontinue the Project. 
 It now appears that Nitec
Pharma may be able to resume the Project at its own cost and risk, see it through phase III clinical testing and obtain a license to market the Merchandise (as defined below) in Germany, Austria and other countries. 

In light of this development Merck is willing to transfer the Project to Nitec Pharma by turning over to Nitec Pharma all know-how acquired within the
framework of and in connection with the Project and all pertinent industrial property rights. In particular Merck is willing to grant Nitec Pharma access to all data, which have accrued within the framework of the Project development and which are
still to accrue pending the conclusion of the successful “Mutual Recognition Procedure”. 
 As provided herein Nitec Pharma is willing
to undertake to use all of its Commercially Reasonable Efforts (as defined below) to continue the clinical and technical development of the Project on its own, in particular using its own financial resources and at its own company risk and to obtain
legal pharmaceutical approvals for relevant markets that have been identified by Nitec Pharma as promising markets and to confirm that Merck shall, under the terms specified in greater detail in section 6 hereof retain the right to market the
Merchandise on an exclusive or non-exclusive basis in Germany and Austria and that such right shall only pass to Nitec Pharma as set forth in section 6 hereof. 
 For this purpose the parties stipulate as follows: 

	1.	Definitions 

 “Technology Transfer
Agreement” or “TTA” refers to this Agreement between Merck and Nitec Pharma. 
 “Clinical
Development” refers to the implementation of all clinical trials aimed at obtaining licences to market the Merchandise in Germany, Austria and other countries. 
 “Commercially Reasonable Efforts” means those efforts and resources that Nitec Pharma would use were it developing, manufacturing, promoting and detailing the Active Agents as its own
pharmaceutical products but taking into account clinical development results (including all safety, efficacy and cost issues), product labeling, regulatory review and approval issues, market potential, past performance, market potential, economic
return, the general regulatory environment and competitive market conditions in the therapeutic area, all as measured by the facts and circumstances at the time such efforts are due. 
 “Technical Development” refers to the implementation of all technical activities aimed at obtaining licences to market the Merchandise in Germany, Austria and other countries. 

“Approval” refers to the date on which an approval to market the Merchandise is granted in Germany and/or Austria. 

“Launch” refers to the day on which the Merchandise is brought onto the market in Germany and/or Austria. 

“Access to Data” refers to access to all data within Merck or affiliated enterprises of Merck within the meaning of § 15 of the
German Stock Corporation Act (“Merck Group”) concerning the Project as well as concerning the Project periphery (e.g. Decortin, Decortin H), which are required or useful within the framework of Nitec Pharma’s activities
described in this Agreement. 
 “Initial Application” is the date on which the first application for a legal pharmaceutical
licence for the Project is filed in a country, which is a member of the European Union. 
 “Ex-factory Price” is the list price
of the product without discounts by Merck Group to each independent customer. 
 “Production Costs” are all costs incurred by
Nitec Pharma in the complete provision of Merchandise to one of Merck’s supply depots. 
 “Patents” refer to all of Merck
Group’s patents and/or applications and utility models with respect to the Project. 
 “Project” refers to the galenic
formulation containing Active Agents and which releases the latter in a delayed manner as more specifically described in Annex I. 

“Merchandise” refers to the primary and secondary project packed and released for marketing. 

“Bulk-Ware” refers to the galenic formulation approved for marketing, which still needs to undergo primary and secondary packing.

  

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 “Packing Instruments” comprises primary and secondary packing for Merchandise. 

“Rheumatoid Arthritis” refers to the indication for which Nitec Pharma initially endeavours to obtain Approval. 

“Active Agents” refer to Prednison, Prednisolon and Methylprednisolon. 
 “Skye Pharma” shall mean Skye Pharma AG with its head office in Muttenz, Switzerland, is the company, which has participated in the development of the Project from the technical aspect
and which is meant to undertake production of the bulk-ware at its Lyon production site. 
 “Jagotec” shall mean Jagotec AG, a
Swiss corporation having its head office at Eptingerstr. 51 in CH-6052 Hergiswil, Switzerland. 
 “Option Area” are the
national territories of Germany and Austria. 
  

	2.	Third Party Contracts 

  

	2.1.	Merck, subject only to the restriction set forth specifically in section 6 hereof, hereby assigns to Nitec Pharma the agreement attached hereto as Appendix 2.1
“Skye/Jagotec DLA”) between Merck and SkyePharma/Jagotec concerning the development and production of the Project, on the precondition that SkyePharma /Jagotec shall give its required consent thereto. For the purpose of said
assignment, Merck shall continue the agreement until then. 

  

	2.2.	The content of the agreement with SkyePharma/Jagotec is known to Nitec Pharma. All documents pertaining thereto, including correspondence concerning the agreement
as well as other documents, which are useful for the implementation and interpretation thereof, shall be delivered to Nitec Pharma following the signing hereof. 

 

	3.	Transfer of Rights and Know-How 

  

	3.1.	Merck hereby sells, assigns and promises to otherwise transfer to and Nitec Pharma hereby purchases, accepts assignment and promises to accept delivery and/or transfer
of the entire know-how obtained within the framework of the development of the Project to date, including all clinical test and stability patterns, experimental charges and all (also electronic) documents, including the correspondence to date
(“Know-How”). Upon conclusion hereof the Know-How becomes the property of Nitec Pharma and shall be transferred promptly to Nitec Pharma after the signature of this Agreement to the extent that such transfer requires action beyond
the signature of this Agreement. Insofar as it is set out in documents, on data carriers or represented in another manner (“Represented Know-How”), Merck shall store the Know-How in safe keeping for Nitec Pharma pending delivery
thereof to the latter. In addition, Merck shall grant Nitec Pharma access to all of its know-how obtained with respect to the Active Agent. 

  

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	3.2.	Nitec Pharma shall assemble the Represented Know-How by 31st December 2004 at the latest at Merck’s premises, submit such know-how for Merck’s approval,
and Merck shall thereupon deliver the same to Nitec Pharma promptly. 

  

	3.3.	If the results of the development work performed hitherto are protected by copyrights or other industrial property rights, said rights are hereby assigned to Nitec
Pharma and Nitec Pharma accepts such assignment. In the same manner, and subject to the condition precedent of the conferral of the required approval pursuant to section 13.4 of the Skye/Jagotec DLA, all of the industrial property rights acquired by
Merck from Skye Pharma or from Jagotec on the basis of the Skye/Jagotec DLA within the framework of or in connection with the Skye/Jagotec DLA, are hereby assigned to Nitec Pharma and Nitec Pharma accepts such assignment. 

 

	3.4.	The purchase price for such Know-How, Represented Know-How and the property rights as defined hereinabove shall be [...***...]. Payment shall become due upon
signature of this Agreement. 

  

	3.5.	Should an assignment pursuant to section 3.1 and 3.3 hereof be impossible for legal reasons, Nitec Pharma is hereby granted [...***...] a worldwide, exclusive,
unlimited and unrestricted perpetual license to use these property rights (with the right to sublicense but subject to the following sentence). Said right of use shall not be transferable in connection with marketing and distributing Merchandise in
the Option Area, but shall be transformed into a transferable right of use for such purpose as soon as Nitec Pharma becomes entitled to market and distribute or have marketed and distributed Merchandise in the Option Area in accordance with the
provisions set forth in sec. 6 hereof. 

  

	3.6.	Should the results of the development performed hitherto contain inventions or ideas capable of being protected, Nitec Pharma shall be entitled hereupon to apply for
relevant protections in its own name and at its own costs – and where required by law, by naming the inventors pursuant to the statutory provisions in force from time to time - in any countries. 

 

	3.7.	Should it be reasonably necessary or beneficial for the development and production of the Project to allow access to know-how and/or copyrights and/or industrial
property rights from outside the development of the Project, whether owned or licensed or otherwise available to Merck or any other company within the Merck Group, Merck hereby grants Nitec Pharma and undertakes to use its best efforts to procure
that Nitec Pharma is granted by any other company within the Merck Group a non-exclusive, [...***...] license to use such know-how and/or copyrights and/or industrial property rights. The right to transfer such right shall be limited to
affiliates of Nitec Pharma within the meaning of § 15 German Stock Corporation Act. Transfers to any other persons shall be limited to the following purposes: 

 

	 	•	 	 Clinical development in RA and other indications 

  

	 	•	 	 Technical development and production, 

  

	 	•	 	 obtaining and maintaining the Approval in the Option Area and in other countries 

 

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	 	•	 	 marketing and distributing Merchandise and for contractual / licensing negotiations with other interested pharmaceutical companies and the subsequent
award of licences, insofar as section 6 does not contradict this. 

 Irrespective of the above limitations, the
transfer of rights obtained pursuant to this section 3.7 shall always be permitted to the extent necessary for fulfilment of Nitec Pharma’s obligations to grant industrial property rights resulting from the Skye/Jagotec DLA, which is to be
assigned to Nitec Pharma, in particular from section 5.3 (b) of the Skye/Jagotec DLA, as such agreement is amended from time to time between Nitec Pharma and Skye/Jagotec. 

 

	3.8.	Insofar as it is reasonably necessary or useful in connection with the Project, Merck allows Nitec Pharma to make a reference or cross-reference with regard to any
approvals obtained by Merck. 

  

	3.9.	Merck warrants to Nitec Pharma (a) with regard to the Know-How and Represented Know-How and other objects sold or transferred hereunder, that these are free of
third party rights and that at the date of transfer no circumstances exist that would enable third parties to establish such rights to the assigned rights and other objects without Nitec Pharma’s consent, (b) there is no pending, nor has
there been overtly threatened any legal action, suit, proceeding, arbitration, summons or subpoena relating to the transactions contemplated by this Agreement or the Project or Merchandise or Know-How; and (c) Merck is the owner of the Know-How
and, to Merck’s knowledge, no use of the Know-How or the Licensed Know-How will infringe the rights of, or result in any liability to, any member of the Merck Group or to any third person. 

 

	3.10.	Except as expressly provided herein, no warranty is made regarding the completeness or the suitability for a specific purpose (e.g. the Project) of the Know-How and/or
Represented Know-How sold under section 3.1. 

  

	4.	Continuation of the Project by Nitec Pharma 

  

	4.1.	Nitec Pharma shall use its Commercially Reasonable Efforts to continue to develop the Project at its own cost following the conclusion of this Technology Transfer
Agreement and of a financing agreement with a third party until respective Approval is obtained in the first country within the Option Area. Exceptions hereto are regulated by section 5.1. 

 

	4.2.	Nitec Pharma shall be the owner of all approvals. 

  

	4.3.	In the case of joint regulatory activities Nitec Pharma shall bear external costs, if these have been initiated and/or approved by Nitec Pharma.

  

	4.4.	Nitec Pharma shall involve Merck in the activities of the clinical trials for the Project in such a manner that Nitec Pharma’s trials can be used as pre-marketing
activity for the subsequent launch in the Option Area. 

  

	4.5.	Nitec Pharma shall, following prior consultation with Merck, utilize the trial report specified in section 5.1 upon delivery, and publish parts thereof.

  

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	4.6.	Nitec Pharma grants Merck the option of co-publication. Any mention of Merck involvement in a publication requires Merck’s prior approval.

  

	5.	Support of Nitec Pharma by Merck following the assignment of Rights and Know-How 

 

	5.1.	Since Nitec Pharma will not have a GxP system at its disposal following its establishment, Merck declares its willingness to support Nitec Pharma in the following
manner [...***...] (unless specifically set forth otherwise below), in order to minimise the delay until Approval is granted: 

  

	 	-	 	 Merck shall appear as sponsor of the trial under the appellation EMR 62215-003 

 

	 	-	 	 Merck shall conclude the contract with CRO for the implementation of the said trial, [...***...] 

 

	 	-	 	 Costs of such trial (CRO and test centres) shall be pre-financed by Merck up to [...***...]. For the pre-financed costs Merck shall issue a bill
to Nitec Pharma without a mark-up on a [...***...]. Payment shall be effected in each case within [...***...] after receipt of invoice. Costs, occurring after the pre-financed period, shall be budgeted in advance on a quarterly basis.
Such budgeted costs shall be paid by Nitec Pharma to Merck latest on [...***...] of the first month following each quarter for which the amounts have been budgeted for. Any deviations from the estimated to the actual costs shall be compensated
by Merck to Nitec Pharma or by Nitec Pharma to Merck, as the case may be, by the next quarterly payment, respectively up to the end of the phase III trial. 

 

	 	-	 	 Merck shall provide an experienced clinician until the end of the first Phase 3 trial (expected to take place in Q2 of 2006).

  

	 	-	 	 Conclusion of a patients’ insurance for the EMR 62215-003 trial by Merck 

 

	 	-	 	 Utilising all GxP processes of Merck for the fulfilment of pertinent EU Directives (2003/84/EU “Principles and Guidelines of Good Manufacturing
Practice for Human Medicinal Products and for Test Compounds Designed for Use on Humans”, Annex 13, Directive 2001/20/EU “Application of Good Clinical Practice in the Case of the Performance of Clinical Tests with Human Medicinal
Products”) 

  

	 	-	 	 Merck shall prepare a trial report and provide the latter to Nitec Pharma for its unlimited and exclusive use, whereby Merck shall remain entitled to
use same within the framework of the marketing activities in the countries concerning which Merck has concluded a licensing agreement with Nitec Pharma providing for the marketing products by Merck 

 

	 	-	 	 The publication of intermediate results and any lectures on this topic during and after the conclusion of the aforementioned trial shall only be
permitted with the approval of both parties, insofar as Merck is mentioned in the publication. 

  

	5.2.	 During the period following the transfer of rights and Know-How pursuant to section 3, and pending the successful conclusion of the mutual recognition
procedure, Merck shall [...***...] grant Nitec Pharma Access to Data and access to all documents and all know-how stored electronically or in paper form in MEDISI, which could be reasonably necessary or useful for obtaining Approval for the
Project. The parties in balance of their mutual interest shall agree on the type of access to be granted. Merck shall, in particular, support Nitec Pharma with the information in its possession, such as e.g. competition and market research data.
Access to data under this section shall include data pertaining to Decortin, which shall be mentioned 

 

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as a reference product in the licence, and Decortin H. The access relates primarily to data on technical development, production, quality control, quality assurance, regulatory affairs, clinical
development, market research results, contact addresses of all pertinent clinics for rheumatology and of established rheumatologists as well as access to data banks in Merck’s possession which are of indication relevance (e.g. Datamonitor, IMS,
Decision Resources). Access and receipt are subject to the confidentiality provisions hereof. 

  

	5.3.	Insofar as information is potentially relevant for obtaining the Approval for the Project, especially, but not limited to, information with regard to Decortin and
Decortin H, Merck shall forward such information promptly and without charge to Nitec Pharma. Nitec Pharma shall utilise this information, as far as possible, for the purposes of obtaining such Approval. Merck shall keep Nitec Pharma continuously
informed of the respective status of a licence for Decortin and Decortin H. This relates to all markets in which Merck distributes the Active Agent. 

  

	5.4.	Merck shall maintain complete and accurate records of the expenses subject to reimbursement in this section 5. Such records shall be available for inspection, during
reasonable business hours and upon reasonable notice, for the period of [...***...] after expense increment for examination at such place or places where such records are customarily kept, at Nitec Pharma’s expense (subject to the
rest of this paragraph 5.4). and not more often than once each calendar year, by an internationally recognised accounting firm (the “Accountant”), selected and employed by Nitec Pharma and acceptable to Merck, but solely for the purpose of
verifying for Nitec Pharma the correctness of the expenses. The Accountant may be required by Merck to enter into a reasonably acceptable confidentiality agreement, and in no event shall the Accountant disclose to Nitec Pharma any information, other
than such information as is specified and the amount of any overpayment or underpayment of expenses. The report of the Accountant regarding such expenses reports expenses shall be binding on the parties, other than in the case of manifest error.
Nitec Pharma shall bear the cost of any such inspection; provided that if the inspection shows an overpayment of expenses of more than [...***...], then Merck shall promptly reimburse Nitec Pharma for all costs incurred in connection with such
inspection. Merck shall, within twenty (20) calendar days of its receipt of the report of the Accountant, pay to Nitec Pharma the amount of any overpayment, plus interest calculated at [...***...] per annum. 

 

	6.	Marketing and Distribution in the Option Area, Rights to Information, Precedence in Negotiations 

The right to distribute and market the Project in Germany and Austria for Merchandise containing the Active Agent as the sole active ingredient shall only
transfer to Nitec Pharma upon occurrence of the events as further detailed in this section 6. 
  

	6.1.	Nitec Pharma shall pursue the Approval of the Project in Germany and Austria in its own name. Merck shall support Nitec Pharma to the extent deemed necessary by Merck
within the framework of the Approval procedure. In the case of an inspection within the framework of the conferral of the Approval, in Germany or other countries, Merck shall provide the resources necessary for a successful approval
[...***...]. Nitec Pharma shall, upon request, inform Merck at any time of the status of the approval procedure. 

  

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	6.2.	Nitec Pharma shall notify Merck in writing without delay of the Initial Application for the Project. Upon receipt of said notification Merck shall inform Nitec Pharma
in writing whether or not Merck intends to exercise its right to market and distribute or to have marketed or distributed Merchandise delivered by Nitec Pharma in the Option Area under the terms specified in greater detail herein pursuant to section
6.4 (“Merck Option”). 

  

	6.3.	 The Merck Option shall lapse in the event that Nitec Pharma has not received any written notice by Merck within [...***...]
 following receipt by Merck of the notification by Nitec Pharma per section 6.2 above, stating that Merck will make use of such option (“Option Exercise”). During these [...***...] Merck has the possibility of reviewing its
interest in marketing the Project. For this purpose Nitec Pharma shall provide Merck in due time with appropriate documents (e.g. the results of the phase 3 trial, approval file, etc.) and Merck shall draw up a statistically valid pricing study of a
type that is customary in this market and make same available to Nitec Pharma at its own cost and in due time. This obligation shall cease to apply if objective reasons make this trial appear irrelevant. 

 

	6.4.	In the event that Merck exercises the Merck Option, Merck and Nitec Pharma shall, at the request of either party, negotiate and conclude a purchase and licensing
agreement (including jointly concluded forecasts and ex-factory prices and/or floor-prices/price corridors) containing terms customary in the market within 90 days following Option Exercise, whereby it is agreed 

 

	 	a)	that [...***...] shall be made to Nitec Pharma under the purchase and licensing agreement 

 

	 	b)	that under the agreement Nitec Pharma shall deliver to Merck Merchandise and samples under the following conditions: [...***...] 

 

	 	c)	In case any of the Parties should be liable to withhold taxes on any payments such withholding taxes may be deducted. 

 

	6.5.	Should Merck exercise the Merck Option, Merck shall 

  

	 	•	 	 launch the Project in Germany and/or Austria no later than [...***...] following Approval, price approval or other official approvals, insofar as
these constitute a precondition for launching a product and market the Project in its own name. 

  

	 	•	 	 display, at Nitec Pharma’s request, Nitec Pharma’s name and logo on the packaging and package inserts, undertake all commercially significant
and necessary marketing activities, in order to meet the forecasts, which were fixed promptly after the exercise of the Merck Option. If, after [...***...] following the Launch, the sales goals defined therein have been attained at a rate less
than [...***...] section 6.7 below shall apply, unless the shortfall from the minimum sales requirement is due to reasons for which Merck is not responsible. Nitec Pharma shall support Merck

  

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in meeting the forecasts by ensuring that the phase 3 trial is implemented in at least 10 trial centres in Germany. 

 

	 	•	 	 within the first three (3) years following the Launch of the Project, refrain from launching any other project with a comparable operating mechanism on
the RA indication. 

  

	6.6.	Should Merck make use of the Option Exercise and should the agreement specified in section 6.4 fail to be concluded within [...***...] specified therein or within
an agreed extended deadline, because the parties cannot find agreement on detailing terms, than the parties shall within [...***...] as of the lapse of such [...***...] period or the agreed upon extension period submit all relevant
information to an independent professional project evaluator mutually acceptable to the parties and shall request that such evaluator proposes within another [...***...] as of accepting the office of evaluator equitable terms for an agreement
as set forth in section 6.4. If Merck does not conclude the license agreement within [...***...] as of both parties receiving the proposal of the evaluator, then the right to distribute and market the Project in Germany and/or Austria, as the
case may be, automatically transfers to Nitec Pharma upon the expiry of such 30 days period. 

  

	6.7.	Should Merck be in breach of one of the aforementioned provisions in section 6.5 and should said breach, following a written notice to Merck, fail to be remedied
promptly, but in no event later than within [...***...] as of such notice to Merck, then with effect as per the expiry of such [...***...] period the exclusive licence of the Merck Option transformes into a non-exclusive licence without
minimum sales and Merck grants to Nitec Pharma the royalty free, semi-exclusive right to market either directly or indirectly the Project in the Option Area, 

 

	6.8.	Irrespective of the lapse of the Merck Option, Nitec Pharma shall, in any case, advise Merck [...***...] before the conclusion of a licence agreement for any
country of the Option Area, of the fact that the conclusion of an agreement is being planned, so that Merck, for its part, has the opportunity within this period of submitting a bid for such a licence. Conditions offered to a third party shall in no
event be more favourable for the third party than those offered to Merck prior to the expiry or the waiver by Merck of the Merck Option taking into consideration all relevant aspects. Nitec Pharma shall be free to conclude a licence agreement for
the Option Area with a third party after the said [...***...] have expired unless Merck prior to such expiry provides Nitec Pharma with a new bid and Merck’s new bid for Germany and/or Austria is at least equivalent in value to the best
bid submitted by a third party prior to such expiry. In the event Merck’s bid for Germany and/or Austria shall be at least equivalent in value to the best bid submitted by such third party, then Nitec Pharma shall conclude the licence agreement
exclusively with Merck. 

  

	7.	Marketing and Distribution of Merchandise outside of the Option Area 

 The exclusive right to distribute and market the Project outside the Option Area resides with Nitec Pharma. 

  

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 In all countries outside of the Option Area with the exception of the U.S.A., Canada and
Japan Nitec Pharma shall offer Merck the conclusion of a licence agreement for marketing the Project following the commencement of the EMR 62215-003 trial for the Project. If the parties are unable within [...***...]
 to conclude in good faith such licence agreement, then Nitec Pharma shall be free to conclude a licence agreement to that effect with third parties. The said time limit shall cease to apply as soon Merck states that it has no interest in concluding
a licence. 
  

	8.	Further Developments, further Indications 

  

	8.1.	Nitec Pharma shall offer Merck any product improvements or further developments in the RA Indication for the sole purpose of marketing these in the Option Area and
shall not conclude pertinent contracts with third parties for [...***...] following such an offer. For Germany and Austria the said offer shall be made at market conditions on an exclusive basis. Further details shall be mutually agreed upon
between the parties. Following the expiry of the time limit, Nitec Pharma shall be free to conclude a licence agreement with third parties with respect to product improvements or further developments, including the Project itself. The said time
limit shall cease to apply as soon as Merck states that it has no interest in concluding a licence. 

  

	8.2.	Should the Project become applicable for other indications (e.g. asthma), Nitec Pharma shall advise Merck thereof before the commencement of phase III trials and offer
a marketing licence, which shall be on an exclusive basis for the countries in which Merck has an exclusive licence for the RA indication and non-exclusive in the countries in which Merck has a non-exclusive licence for the RA indication. Details of
such a licence agreement shall be negotiated between the parties at the proper time. In this connection the terms and conditions specified in section 6.4. are not binding, but shall be negotiated in good faith. If the parties are unable within
[...***...] of the commencement of phase III trials to agree in good faith on such marketing license, Nitec Pharma shall be free to conclude a licence agreement to that effect with third parties. The said time limit shall cease to apply as
soon as Merck states that it has no interest in concluding a licence. 

  

	9.	Confidentiality 

  

	9.1.	Except as required by applicable law or legal process or in connection with the customary submissions to regulatory authorities, the publication by Nitec Pharma of
results of clinical studies and presentations at conferences, the parties undertake with respect to all information put at their disposal or obtained by them in another manner in connection with the preparation hereof during the term hereof and for
10 years subsequently thereto 

  

	 	a)	to treat said information in a strictly confidential manner, 

  

	 	b)	to use it exclusively for the purpose of implementing this Agreement and 

  

	 	c)	to grant access thereto only to those employees, advisers (tax advisers, lawyers, management consultants), and sublicensees who are involved in the object of this
Agreement. 

  

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	9.2.	The parties undertake to obligate in writing all persons as per 9.1.c) who are given access to information - insofar as same are not subject to a duty of secrecy by
virtue of professional rules - to maintain confidentiality pursuant to this Agreement. In doing so, the parties shall, within the framework of legally permissible acts, ensure that their employees’ duty of confidentiality shall also apply where
the employees terminate their employment during the term hereof. 

  

	9.3.	The duty of confidentiality shall not apply to such information concerning which it can be proved that 

 

	 	•	 	 it was already publicly known at the time of the signing hereof and/or at the time it was transmitted to third parties or 

 

	 	•	 	 it was already known to the receiving party or 

  

	 	•	 	 it was independently obtained by employees of the receiving party, who did not themselves have any access to the transmitted information or

  

	 	•	 	 it was lawfully obtained by a third party or 

  

	 	•	 	 it is not subject to [a duty of] confidentiality on the basis of a written declaration of the disclosing party. 

 

	10.	Term of Agreement, Discontinuation of the Project by Nitec Pharma (partial), Denial of Approval 

 

	10.1.	The validity of this Agreement is dependent on the effective assignment of the Skye/Jagotec DLA attached hereto as Appendix 2.1 to Nitec Pharma. This Agreement shall
run for an indefinite period. The Agreement can be terminated by either party by giving [...***...] months notice of termination, which shall take effect at the end of a contractual calendar year, but no earlier than the expiry of the year
[...***...]. The right to terminate this agreement with immediate effect in case of a severe breach is reserved. In the event of any termination hereunder, Articles 3, 9 and this Article 10 shall survive without limitation.

  

	10.2.	Should Nitec Pharma be unsuccessful in finding one or more investors to acquire an interest in Nitec Pharma against a contribution of equity capital and/or by providing
outside capital within [...***...] days following the conclusion of this Technology Transfer Agreement, Nitec Pharma shall reassign to Merck without delay all the rights transferred by Merck to Nitec Pharma hereunder against repayment of the
proved business expenses and other costs, which have been incurred up to the reassignment date by the founders of Nitec Pharma in connection with the Project. However, the amount shall not exceed EUR [...***...]. 

 

	10.3.	If Nitec Pharma does obtain the support of an investor described in section 10.2 above, but finally discontinues pursuit of the Project at a later point in time, Nitec
Pharma shall invite Merck to acquire the Project, including all further developments and improvements at the market value that shall have been achieved by that time less the amount described in section 10.4. The market value is either (i) the
value for which it can be proved that a third party is willing to acquire the Project or (ii) the value of the Project determined under the terms of section 10.5, whichever value is the higher. 

 

	10.4.	The amount to be deducted pursuant to section 10.3 sentence 1 shall be 

  

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	 	•	 	 in the case of a reassignment following the commencement and prior to the conclusion of phase III of the trial (verification of effectiveness) the sum
invested by Merck into the Project prior to the date of the transfer of the Project from Merck to Nitec Pharma (“Merck Investment”), less the costs of phase III of the trial incurred by Nitec Pharma or reimbursed to Merck by
Nitec Pharma up to the date of reassignment, 

  

	 	•	 	 in the case of a reassignment following the conclusion of phase III of the trial: zero 

 

	10.5.	In case of discontinuation of the Project as per 10.3 and irrespective of the Project being reassigned to Merck or transferred to a third party, Merck shall in any case
be reimbursed promptly upon such discontinuation for the costs disbursed by Merck within the framework of the EMR 62215-003 study for Nitec Pharma, insofar as said costs have not already been repaid. 

 

	10.6.	The parties can mutually stipulate the market value pursuant to section 10.3 (ii) and the Merck Investment. Should the parties be unable to so agree, this issue
shall be adjudged with binding effect by a panel consisting of three experts, whereby Merck and Nitec Pharma shall each appoint one expert and both appointed experts shall then agree upon the identity of the third expert. The findings of the experts
shall only be subject to review by the state courts on the grounds of an obvious mistake within the meaning of § 319 (1) German Civil Code). Should the experts be unable to agree upon a value, the average sum contained in the experts’
opinions shall be deemed to be the market value. In the case of transfers to a third party Merck shall be reimbursed for the aforementioned amounts, insofar as said amounts have not already been repaid. 

 

	10.7.	The costs of a reassignment shall be borne by Merck. 

  

	11.	Miscellaneous 

  

	11.1.	Changes, amendments or alterations must be made in writing in order to be effective. This applies also to a waiver of such requirement of written form. Fax or email
transmissions do not satisfy the requirement of the written form. 

  

	11.2.	For disputes arising out of or in connection with the stipulations set forth in sections 6.3, 6.4, 6.6, 6.7 and sections 10.3. and 10.4 the procedure as described in
section 10.6 shall apply. 

  

	11.3.	The jurisdictional venue for all disputes arising hereunder shall be Nitec Pharma’s last domestic principal place of business or, where no domestic principal place
of business has been established, Frankfurt am Main. 

  

	11.4.	All business and legal relations between the parties shall be exclusively governed by the law of the Federal Republic of Germany, excluding Private International Law
and excluding the United Nations Convention on Contracts for the International Sale of Goods (CISG). 

  

 12 

	11.5.	If any provision of this Agreement were to be or become fully or partly invalid or unenforceable for any reason whatever, or to violate any applicable law, the same
shall be considered divisible as to such provision and such provision shall be deemed deleted herefrom, and the remainder hereof shall be valid and binding as if such provision were not included herein. The parties hereto shall then, if necessary,
negotiate for an appropriate amendment of this Agreement. 

  

					
	 Bard, August 2, 2004
	 		 	Darmstadt, July 14, 2004
	Place, Date	 		 	
		 		 	ppa.
			
	 /s/ Dr. Hubertus Ludwig
	 		 	 /s/ Rosemarie Schiemer

	Nitec Pharma AG	 		 	Merck KGaA
	 represented by: Dr. Hubertus Ludwig
    (Verwaltungsrat)
	 		 	represented by: Rosemarie Schiemer
			
		 		 	I.V.
		 		 	 /s/ Christiane Kaltenschnee

		 		 	Merck KGaA
		 		 	represented by: Christiane Kaltenschnee

  

 13Transfer, License and Supply Agreement dated December 19, 2006

 Exhibit 10.12 
 ***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 Pharma GmbH 

Alsfelder Straße 17, 
 64289 Darmstadt, Germany 
 (“Merck”), 

and 

Nitec Pharma AG 
 Röschenzerstr. 9, 
 4153 Reinach, Switzerland 

(“Nitec AG”) 
 and 
 Nitec GmbH 

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

Nitec AG and Nitec German 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 Frankfürter 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 Germany via Merck; 

  

	4.	Whereas, Nitec AG, through Nitec Germany, has applied for the MARKETING AUTHORIZATION for the PRODUCT in Germany with the competent authority thereby becoming a
Marketing Authorization Holder (“MAH”), as defined in § 4 subp. 18 Arzneimittelgesetz (“AMG”); 

  

	5.	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; 

  

	6.	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 whereas, Nitec will not make use of more than one Duplicate in the TERRITORY and only to the extent as provided for in Art. 5.8 of this AGREEMENT; 

 

	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. 

 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. 

“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 brought onto the market in the TERRITORY. 

 

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 “MARKETING AUTHORIZATION” shall mean the authorization and related documents granted by the
German competent authority, the Bundesinstitut für Arzneimittel and Medizinprodukte (“BfArM”) 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.

 “SPECIFICATIONS” means the specifications for PRODUCT (including shelf life), attached hereto, incorporated in and made part
of this AGREEMENT as Appendix 1. 
 “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. 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 Germany. 
 “TRADEMARK” shall mean “Lodotra”, Swiss Registration No. 535 303. If this TRADEMARK should be rejected by the BfArM 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. 
 Article 2- Transfer and License 
  

	2.1	Subject to the terms and conditions of this AGREEMENT, Nitec AG hereby undertakes 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

  

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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, 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, Launch 
  

	4.1	Merck shall make all declarations and filings to maintain the MARKETING AUTHORIZATION. 

 

	4.2	The PRODUCT, subject to Nitec AG’s ability to deliver the PRODUCT, shall be launched within [...***...] after the MARKETING AUTHORIZATION has been
transferred by Nitec Germany to Merck. 

  

	4.3	 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 

  

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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. 

 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.

 In any event, but subject to Section 4.2, Merck will launch the PRODUCT in the TERRITORY no later than
[...***...] following transfer of the MARKETING AUTHORIZATION to Merck by Nitec Germany hereunder, price approval and other official approvals, to the extent that these approvals are a condition for so launching PRODUCT. 

 

	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 shall be subject to Article 12. 

 If within [...***...] 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 [...***...] 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. 
 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 [...***...] days following each calendar quarter, Merck shall send to Nitec a copy of the Merck’s internal sales report covering the
preceding quarter. 

  

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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’s exclusive remedy shall be the right to make use of the Duplicate Authorization, as defined in
No. 6 of the Preamble effective as of the end of the [...***...] period and to introduce or to have introduced a product in the TERRITORY under such duplicate authorization. In such a case, the continuation of this AGREEMENT shall not be
subject to any ANNUAL MINIMUM SALES. 

  

	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. 

 Article 6- Ex factory Price 

 

	6.1	Merck shall draw up a statistically valid pricing study of a type that is customary in this market at its own cost in due time based on the clinical Phase Ill study
results and make same available to Nitec free of charge. 

  

	6.2	The EX FACTORY PRICES will be discussed by the Parties sufficiently in advance of the LAUNCH based on the above described pricing study and fürther relevant
criteria, it being understood that the prices shall be set by Merck. The EX FACTORY PRICE will be discussed by the Parties upon either Party’s written request at any time in light of the then current market situation without limiting
Merck’s right to set the price. 

  

	6.3	 In case of reductions of the price imposed by the Health Insurance Institutions and to be paid by the ultimate customer or to be reimbursed by the
Health 

  

 ***Confidential Treatment Requested 

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Insurance in accordance with the Sozialgesetzbuch Tell V (SGB V) or the possibility of such price reductions Merck will use its reasonable best efforts to convince the Institut für
QuaRät and Wirtschaftlichkeit im Gesundheitswesen (IQWIG) (§ 139a SGBV) (or any other similar institution) about the additional benefit of the PRODUCT compared to standard prednisone tablets to avoid any reference price (Festbetrag) or
other price reduction. 

 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	The minimum purchase order, irrespective of the dosage for the tablets, shall be [...***...], divided into [...***...]. Purchase orders in excess of such
[...***...] shall be the multiple of [...***...] tablets. Merck and Merck Gesellschaft mbH, Austria may internally combine purchase orders for PRODUCT to reach the amounts mentioned in this section 7.2. 

 

	7.3	The PRODUCT will be delivered in accordance with Appendix 1. 

  

	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 18 months. 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	At least [...***...] months in advance of the requested delivery date of the PRODUCT, Merck shall submit to Nitec AG a written purchase order for the desired
quantities of the PRODUCTS. Such purchase order shall be firm and binding upon Merck when accepted by Nitec AG, Nitec shall not be entitled to decline any orders which are up to [...***...] of the respective forecast and shall use its
reasonable commercial efforts to fulfill orders above [...***...]. Each order placed by Merck will bear the exact quantity (including pack-size and dose strengths) ordered in accordance with section 7.2, the delivery date and the address at
which the PRODUCT must be sent. When shorter delivery times could be achieved, Nitec AG shall promptly inform Merck hereof. 

  

	7.7	 Merck shall maintain a minimum inventory level of the PRODUCT corresponding to at least [...***...] sales calculated on the basis of the

  

 ***Confidential Treatment Requested 

7/22 

	 	 
actual sales forecast or otherwise agreed upon by the Parties provided that Nitec AG supplies to Merck the PRODUCT in accordance with this AGREEMENT. 

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. Nitec assures that the third party manufacturer at any time complies with the requirements of the Betriebsverordnung
für pharmazeutische Unternehmer (PharmBetrV) 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. 

  

	8.2	The provisions contained in § 377 Handelsgesetzbuch shall not be applicable. Merck shall, however, inspect PRODUCT 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.

  

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	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, with the Heilmittelwerbegesetz (“HWG”), with the PharmBetrV and with the
Betriebsverordnung für Arzneimittelgroßhandelsbetriebe. 

  

	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 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	Merck shall inform Nitec AG of any requirements for changes of the packaging, labelling, 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: 

 

	11.1	Nitec AG shall secure that Nitec Germany files a variation notice with the BfArM relating to the transfer of the MARKETING AUTHORIZATION to Merck in accordance with
§ 29 subp. 1 AMG and informs Merck of that notification by copy. 

  

	11.2	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. 

  

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	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.

 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 limitation in Section 13.4, Nitec AG will indemnify Merck and its Affiliates (and their respective officers, directors
and employees) from and 
  

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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. 

  

	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

  

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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. If both Parties are marketing authorisation
holders in the TERRITORY they will agree on appropriate measurements in order to avoid double reporting to competent authorities. 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 (Stufenplanbeauftragte) of each party pursuant to § 63 a AMG. 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 fürnished by a Party to the other Party in the English language. 

 

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

  

	14.6	Nitec agrees that the obligations contained in this Article 14 may be performed by Merck KGaA. Fürther details will be set forth in the Safety Data Exchange
AGREEMENT between Nitec AG and Merck KGaA to be concluded in due course. Merck agrees that the obligations of Nitec may be performed by a third party selected by Nitec. 

 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”. 

  

***Confidential Treatment Requested 
 12/22 

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

 

	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 transfer the MARKETING AUTHORIZATION for the PRODUCT 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. 

  

***Confidential Treatment Requested 
 13/22 

 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 (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. 

 

 ***Confidential Treatment Requested 

14/22 

	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 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. 

 

 15/22 

 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 19.12.2006	 		 	Darmstadt, den 19.12.2006
			
	Nitec Pharma AG	 		 	Merck Pharma GmbH
			
	 /s/ Dr. Hubertus Ludwig
	 		 	 /s/ Rosemarie Schiemer

	(Dr. Hubertus Ludwig)	 		 	(Rosemarie Schiemer)
			
	Mannhein, den 19.12.06	 		 	
			
	Nitec Pharma GmbH	 		 	
			
	 /s/ Jochen Mattis
	 		 	
	(Jochen Mattis)	 		 	

 Appendix 1    Specifications and Supply Conditions 

Appendix 2    Target Sales 
  

 16/22 

  
 Transfer, License and Supply
Agreement 
 Appendix 1 
 (1) Composition of the medicinal products 
 Lodotra 1mg 

 

									
	 Component
	 	 Per Tablet Formula
	 	 Percentage Formula
	 	 Function
	 	 Quality Standard

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

  

***Confidential Treatment Requested 
 17/22 

  
 Lodotra 2mg 

 

									
	 Component
	 	 Per Tablet Formula
	 	 Percentage Formula
	 	 Formula
	 	 Quality Standard

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

  

***Confidential Treatment Requested 
 18/22 

 Lodotra 5mg 
  

									
	 Component
	 	 Per Tablet Formula
	 	 Percentage Formula
	 	 Formula
	 	 Quality Standard

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

 [...***...] 

  

***Confidential Treatment Requested 
 19/22 

  
 [...***...] 

 

							
	 Test
	 	 Specifications on
release

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

  

***Confidential Treatment Requested 
 20/22 

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

 ***Confidential Treatment Requested 

21/22 

 [...***...] 
 Appendix 2 
 [...***...] 

[...***...] 

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

 [...***...] 
  

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

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

 [...***...] 

[...***...] 

[...***...] 
  

 ***Confidential Treatment Requested 

22/22

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"}]]