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EXHIBIT 10.1




INVESTMENT AND SHAREHOLDERS’ AGREEMENT

Spepharm Holding B.V.




by and among





	1.	 	TVM Life Science Ventures VI L.P., c/o M&C Corporate Services Ltd., P.O. Box 309, Ugland
House, South Church Street, Grand Cayman, Cayman Islands





 - hereinafter referred to as “TVM LP” -





	2.	 	TVM Life Science Ventures VI GmbH & Co. KG, Maximilianstr. 35 c, D-80539 Munich, Germany





 - hereinafter referred to as “TVM KG” -





	3.	 	Life Sciences Opportunities Fund (Institutional) II, L.P., 126 East 56 th Street, 28 th
Floor, New York, NY 10022, U.S.A.





 - hereinafter referred to as “LSOFI” -





	4.	 	Life Sciences Opportunities Fund II, L.P., 126 East 56 th Street, 28 th Floor, New York, NY
10022, U.S.A.





 - hereinafter referred to as “LSOF” -





	5.	 	ARCADE SARL, 40 Rue des Mathurins, 75008 Paris, France





 - hereinafter referred to as “ARCADE” -




 - TVM LP, TVM KG, LSOFI, LSOF and ARCADE hereinafter referred to as “Investors” -




as well as





	6.	 	Valera Pharmaceuticals Inc., 7 Clarke Drive, Cranbury, NJ, USA 08512-3617





 - hereinafter referred to as “Valera” -




 -  Valera and the Investors as well as other future shareholders of Spepharm Holding
B.V., which may accede to this 

Shareholders Agreement, hereinafter referred to as
“Shareholders” -




and





	7.	 	Jean-François Labbé, 27 Allée des Bocages, 78110 Le Vésinet, France





 - hereinafter referred to as “JFLAB” -




as well as, upon its incorporation and accession hereto,





	8.	 	Spepharm Holding B.V., c/o Mr Wim van Bree, Heinsiuslaan 43, 3818 JG Amersfoort, The
Netherlands




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 - hereinafter referred to as the “Company” -.



All of the above stated parties — as well as any third party that accedes to this Investment and
Shareholders’ Agreement (“this Agreement”) in the future as of such accession — hereinafter: the
“Parties”.




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Recitals




Sec. 1 Foundation of Spepharm and Loan Commitment by LSOFI and LSOF




Sec. 2 First Capital Increase




Sec. 3 Second Capital Increase




Sec. 4 General Obligations with regard to Capital Increases / Syndication




Sec. 5 Default on Investment Obligation




Sec. 6 Valera’s Covenant to obtain Shire Waiver/Licence




Sec. 7 Other Covenants




Sec. 8 Intellectual Property Rights




Sec. 9 Transfer of Shares / Notification




Sec. 10 Rights of First Refusal




Sec. 11 Tag-Along Rights




Sec. 12 Drag-Along Rights




Sec. 13 Restrictions of Transfer




Sec. 14 Share Transfers and Share Issuance under Accession to this Agreement




Sec. 15 Transfers to Affiliated Companies and Funds




Sec. 16 Stock Incentive Scheme




Sec. 17 Supervisory Board




Sec. 18 Information




Sec. 19 Refinancing by KfW




Sec. 20 Effective Date / Succession of Rights




Sec. 21 Delivery Addresses and Authorised Recipients




Sec. 22 Amendments to and Cancellation of this Agreement




Sec. 23 Miscellaneous




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Recitals



Valera and the Investors intend to jointly create, incorporate and finance a Dutch B.V. under
the name of Spepharm Holding B.V. with its registered office in Amsterdam to serve as the parent
company of a European specialty pharmaceutical group of companies with the vision to become one of
the leading suppliers of specialty urology and endocrinology products to the European market place.
For this purpose and in order to regulate the legal relationship among themselves as future
shareholders of the Company, Valera and the Investors enter into the following agreement, which
they expect the Company to accede to in due course:




Sec. 1

Foundation of Spepharm and Loan Commitment by LSOFI and LSOF





	(1)	 	Immediately after signing this Agreement, the Investors and Valera shall set up a new B.V.
under Dutch law to be named Spepharm Holding B.V. (the “Company”), and shall provide all
information necessary to apply to the ministry of justice for its consent to the Company’s
incorporation. The Investors and Valera shall be entitled and obliged to subscribe for the
Company’s initial shares and make payments in the following amounts (with the term “cost”
referring to Sec. 23 (4) below):





	 	 	 	 	 	 	 	 	 
	 	 	 	 	Payment in EUR
	 	 	Shares	 	Nominal	 	Premium	 	Total
	TVM LP
	 	181,700	 	1,817	 	668,396 - cost	 	670,213 - cost
	 
	 	 	 	 	 	 	 	 
	TVM KG
	 	655,400	 	6,554	 	2,410,935 - cost	 	2,417,489 - cost
	 
	 	 	 	 	 	 	 	 
	LSOFI
	 	469,900	 	4,699	 	1,728,561 - cost	 	1,733,260 - cost
	 
	 	 	 	 	 	 	 	 
	LSOF
	 	84,100	 	841	 	309,368 - cost	 	310,209 - cost
	 
	 	 	 	 	 	 	 	 
	ARCADE
	 	88,100	 	881	 	324,082 - cost	 	324,963 - cost
	 
	 	 	 	 	 	 	 	 
	Valera
	 	367,492	 	3,674.92	 	—	 	3,674.92







The payments of the nominal amounts shall be effected to the Company’s bank account and the
payments of the premium shall be effected to a notary’s third party account, in each case
immediately upon the consent to the Company’s incorporation by the ministry of justice having
been granted. Without delay upon the receipt of all payments set forth above on the Company’s
bank account and on the notary’s third party account, respectively, the notarial deed for
incorporation of the Company shall be executed.




	(2)	 	The Shareholders shall adopt articles of association for the Company in the form set out in
Appendix 1.2.






	(3)	 	JFLAB shall become the Company’s initial director. Immediately after the foundation deed of
the Company has been executed, JFLAB shall offer to the Company the conclusion of a service
agreement at terms and conditions as set forth in Appendix 1.3.






	(4)	 	The Shareholders shall appoint Messrs. David Tierney, James Gale, Hubert Birner and Bernd
Seibel as members of the Company’s initial supervisory board. The Parties shall, to the extent
legally permissible and respecting the independence of the supervisory board and its members,
use their best efforts and all the influence they have to the effect that the supervisory
board adopts the Rules of Procedure for the Management as set forth in Appendix 1.4
immediately upon their appointment.




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	(5)	 	LSOFI and LSOF undertake to grant to the Company, immediately upon the Company’s
incorporation, short term loans in the amount of EUR 890,568 and EUR 159,432, respectively, at
the terms and conditions set forth in the draft loan agreement as attached hereto as Appendix
1.5.





Sec. 2




First Capital Increase





	(1)	 	If the Company requires additional funds, it shall inform the Shareholders accordingly in
writing. Each Investor shall, within six weeks as of receipt of such information, notify the
Company and the Shareholders whether such Investor supports the additional funding. If
Investors, who hold (together) a Qualified Investor Majority (as defined in Sec. 23 (1)
below), notify the Company and the Shareholders within such six weeks period of their support
of the additional funding, the Company shall without delay call for a written shareholders
resolution of an increase of the Company’s share capital from EUR 18,466.92 by up to EUR
25,536.83 to up to EUR 44,003.75 by issuing new shares in the Company (the “First Capital
Increase”) to Valera and the Investors. All Shareholders shall participate in, and vote in
favour of, the resolution on the First Capital Increase, waiving all requirements as to the
form and time period for calling such shareholders resolution.






	(2)	 	The Investors shall then each be entitled and obliged to subscribe for the Company’s new
            shares from the First Capital Increase and make payments in the following amounts (with the
term “cost” referring to Sec. 23 (4) below):





	 	 	 	 	 	 	 	 	 
	 	 	 	 	Payment in EUR
	 	 	Shares	 	Nominal	 	Premium	 	Total
	TVM LP
	 	86,000	 	860	 	316,357 - cost	 	317,217 – cost
	 
	 	 	 	 	 	 	 	 
	TVM KG
	 	310,400	 	3,104	 	1,141,828 - cost	 	1,144,932 – cost
	 
	 	 	 	 	 	 	 	 
	LSOFI
	 	576,300	 	5,763	 	2,119,960 - cost	 	2,125,723 – cost
	 
	 	 	 	 	 	 	 	 
	LSOF
	 	103,200	 	1,032	 	379,629 - cost	 	380,661 – cost
	 
	 	 	 	 	 	 	 	 
	ARCADE
	 	88,100	 	881	 	—	 	881







provided, that one or more third party investors (or any of the Investors) agree to subscribe
for new shares from the First Capital Increase and make payments in the following amounts:



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	 	 	 	 	 	 	Payment in EUR
	 	 	Shares	 	Nominal	 	Premium	 	Total
	Third party investor(s)

	 	 	881,500	 	 	 	8.815	 	 	3,242,660 — cost
	 	3,251,475 – cost







The payments set forth above in this Sec. 2 (2) shall be effected, within one week after the
resolution on the First Capital Increase has been taken, to a notary’s third party account,
instructing the notary to pay these amounts to the Company upon the execution of the notarial
deed on the First Capital Increase and issuance of the new shares as set forth in the above
table.




	(3)	 	Immediately upon payment of all of the above stated amounts, but in any event after the lapse
of four weeks as of the Shareholders’ resolution on the First Capital Increase, the Company
shall inform Valera on the extent to which the First Capital Increase has been subscribed and
paid pursuant to Sec. 2 (2), and shall offer to issue to Valera 19.9% of the entire new shares
from the First Capital Increase (i.e., the aggregate amount of the new shares subscribed and
paid for pursuant to Sec. 2 (2) plus the shares to be allotted to Valera pursuant to this Sec.
2 (3) so that following such issuance Valera would own 19.9%, or – in case of Sec. 6 (2) –
19.4%, of the outstanding shares of the Company) at a price that equals such shares’ nominal
amount. Valera shall subscribe and pay for those shares within one week as of receipt of such
offer, or the offer shall lapse. Valera’s payment shall be made to the same notary’s third
party account as used for the purpose of Sec. 2 (2), equally instructing the notary to pay
these amounts to the Company upon the execution of the notarial deed on the First Capital
Increase and issuance of the respective new shares to Valera.






	(4)	 	In addition to the payment set forth to be made to the Company by ARCADE in the table in Sec.
2 (2), ARCADE hereby commits towards the Shareholders, but without obliging itself towards the
Company, and provided that the Company has not filed for insolvency or has become obliged to
file for insolvency prior to such payment, to make an additional payment of EUR 324,082 minus
cost (see Sec. 23 (4) below) into the Company’s capital reserves at the latest immediately
prior to any of the following events: (i) a Trade Sale (as defined in Sec. 12 (1) below); (ii)
an initial public offering of shares of the Company; (iii) the liquidation of the Company (but
not in the context of an insolvency); and (iv) any transfer of any shares by ARCADE except for
share transfers under Sec. 15 (1) if the acquirer assumes this payment obligation. Nothing in
this Sec. 2 (4) shall be interpreted to grant to the Company any right or claim to the
additional payment by ARCADE.





Sec. 3




Second Capital Increase





	(1)	 	If after implementation of the First Capital Increase the Company requires additional
funds, it shall inform the Shareholders accordingly in writing. Each Investor shall, within
six weeks as of receipt of such information, notify the Company and the Shareholders whether
such Investor supports the additional funding. If Investors, who hold (together) a Qualified
Investor Majority (as defined in Sec. 23 (1) below), notify the Company and the Shareholders
within such six weeks period of their support of the additional funding, the Company shall
without delay call for a written shareholders resolution of a further increase of the
Company’s share capital by up to EUR 23,691.64 by issuing new shares in the Company (the
“Second Capital Increase”) to Valera and the Investors. All Shareholders shall participate in,
and vote in favour of, the resolution on the Second Capital Increase, waiving all requirements
as to the form and time period for calling such shareholders resolution.






	(2)	 	The Investors shall then each be entitled and obliged to subscribe for the Company’s new
shares from the Second Capital Increase and make payments in the following amounts:




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	 	 	 	 	Payment in EUR
	 	 	Shares	 	Nominal	 	Premium	 	Total
	TVM LP
	 	144,200	 	1,442	 	530,450	 	531,892
	 
	 	 	 	 	 	 	 	 
	TVM KG
	 	520,100	 	5,201	 	1,913,225	 	1,918,426
	 
	 	 	 	 	 	 	 	 
	LSOFI
	 	563,400	 	5,634	 	2,072,507	 	2,078,141
	 
	 	 	 	 	 	 	 	 
	LSOF
	 	100,900	 	1,009	 	371,168	 	372,177
	 
	 	 	 	 	 	 	 	 
	ARCADE
	 	95,000	 	950	 	—	 	950
	 
	 	 	 	 	 	 	 	 
	Third party investor(s)
	 	474,100	 	4.741	 	1,744,011	 	1,748,752







Such payments shall be effected, within one week after the resolution on the Second
Capital Increase has been taken, to a notary’s third party account, instructing the notary to
pay these amounts to the Company upon the execution of the notarial deed on the Second
Capital Increase and issuance of the new shares as set forth in the above table.




	(3)	 	Immediately upon payment of all of the above stated amounts, but in any event after the lapse
of four weeks as of the Shareholders’ resolution on the Second Capital Increase, the Company
shall inform Valera on the extent to which the Second Capital Increase has been subscribed and
paid pursuant to Sec. 3 (2), and shall offer to issue to Valera 19.9%, or – in case of Sec. 6
(2) – 19.4%, of the entire new shares from the Second Capital Increase (i.e., the aggregate
amount of the new shares subscribed and paid for pursuant to Sec. 3 (2) plus the shares to be
allotted to Valera pursuant to this Sec. 3 (3) so that following such issuance Valera would
own 19.9%, or – in case of Sec. 6 (2) – 19.4%, of the outstanding shares of the Company,
provided that Valera has fully subscribed to the shares offered to Valera pursuant to Sec. 2
(3)) at a price that equals such shares’ nominal amount. Valera shall subscribe and pay for
those shares within one week as of receipt of such offer, or the offer shall lapse. Valera’s
payment shall be made to the same notary’s third party account as used for the purpose of Sec.
3 (2), equally instructing the notary to pay these amounts to the Company upon the execution
of the notarial deed on the Second Capital Increase and issuance of the respective new shares
to Valera.






	(4)	 	In addition to the payment set forth to be made to the Company by ARCADE in the table in Sec.
3 (2), ARCADE hereby commits towards the Shareholders, but without obliging itself towards the
Company, and provided that the Company has not filed for insolvency or has become obliged to
file for insolvency prior to such payment, to make an additional payment of EUR 349,464 (on
top of the additional payment under Sec. 2 (2) above) into the Company’s capital reserves at
the latest immediately prior to any of the following events: (i) a Trade Sale (as defined in
Sec. 12 (1) below); (ii) an initial public offering of shares of the Company; (iii) the
liquidation of the Company (but not in the context of an insolvency); and (iv) any transfer of
any shares by ARCADE except for share transfers under Sec. 15 (1) if the acquirer assumes this
payment obligation. Nothing in this Sec. 3 (4) shall be interpreted to grant to the Company
any right or claim to the additional payment by ARCADE.





Sec. 4


General Obligations with regard to Capital Increases / Syndication





	(1)	 	To the extent necessary to implement Secs. 2 and 3, the Shareholders shall waive their
statutory subscription rights for the First and Second Capital Increase.




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	(2)	 	The Parties shall make any and all statements and undertake any and all actions necessary or
appropriate, including the co-operation with the execution of any relevant notarial deeds, to
implement the aforesaid resolutions set out in Secs. 1 to 3 as soon as reasonably practicable.






	(3)	 	Each of the Investors listed on the cover page of this Agreement shall be entitled to
transfer and assign its rights and obligations to subscribe and pay for shares from the First
and Second Capital Increase to a third party, provided that such third party (i) meets the
approval of Shareholders who hold (together) a majority of the shares held by all Shareholders
at the time of the approval, and (ii) accedes to this Agreement as an Investor by a
syndication and accession agreement as set forth in draft form as Appendix 4.3a hereto, which
shall be accepted on behalf of all Parties by the respective Investor who transfers and
assigns its rights and obligations. The same requirements shall apply to the third party
investor or third party investors envisaged in Secs. 2(2) and 3(2) to invest in the First and
Second Capital Increase, except that in such case, such third party investor shall accede to
this Agreement as an Investor by an accession agreement as set forth in draft form as Appendix
4.3b, which shall be accepted on behalf of all Parties by any of the Investors.





Sec. 5

Default on Investment Obligation





	(1)	 	If an Investor fails (i) to subscribe for shares from the First or Second Capital
Increase, or (ii) to make any of the payments under Sec. 2 (2) and 3 (2), in each case within
the time period provided for with regard to such subscription or payment in the respective
Sections above plus a grace period of one additional week (“Default”), such Investor’s right
to acquire shares from the respective First or Second Capital Increase shall lapse. In
addition, such Investor (the “Defaulting Investor”) shall be obliged to transfer 50% of the
shares held by such Investor at that time to the other Shareholders (who shall be entitled to
acquire such shares pro rata to their shareholdings) for an aggregate consideration of EUR 1,
such amount to be pro rated among the Shareholders receiving such transferred shares. The
share transfer shall be implemented without delay upon the lapse of the respective applicable
time period plus the grace period of one week, and the Defaulting Investor shall, in
particular, provide all co-operation needed for the execution of the notarial deed of the
share transfer. Secs. 9 – 11 of this Agreement shall not apply to such share transfer. The
Company shall immediately inform all Shareholders of such lapse of time and failure to
subscribe or make payments.






	(2)	 	Each Investor hereby assigns, subject to the condition precedent that he commits a Default,
all of the Relevant Claims (as defined hereinafter) to all other Shareholders (at the time of
Default) pro rata to their shareholdings at the time of Default. The Relevant Claims are 50%
of all claims of the Defaulting Investor for dividends, liquidation proceeds, trade sale
proceeds and redemption compensation with respect to all of the shares held by him at the time
of Default, provided, however, that such claims arise or become payable in the time period
between the Default and the share transfer pursuant to Sec. 5 (1).





Sec. 6




Valera’s Covenant to obtain Shire Waiver/Licence





	(1)	 	Valera hereby undertakes to obtain from Shire US Inc. a license to the Development Data
for the development, manufacture, use, supply and sale of the Licensed Product in Ireland
(each capitalised term as defined in the Termination Agreement, License Back and Option dated
21 December 2001 between Hydro Med Sciences, Inc. (n/k/a Valera Pharmaceuticals, Inc.) and
Shire US Inc.).






	(2)	 	If Valera fails to obtain from Shire such license by the lapse of six months as of the date
of incorporation of the Company, Valera shall transfer to the Company without consideration
such number of Valera’s shares which represent 0.5% of the entire outstanding shares of the
Company at that time. All Parties shall in such event, without delay upon the lapse of six




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	 	 	months after the incorporation of the Company, take all steps, measures and resolutions
necessary to implement such share transfer, including – but not limited to – the shareholders
resolution on the Company’s acquisition of such shares and the Company’s consent to such
share transfer. Secs. 9 – 11 shall not apply to such share transfer.





Sec. 7




Other Covenants





	(1)	 	Valera and the Investors shall ensure that immediately upon the Company’s incorporation
the Company will accede to this Agreement by signing it.






	(2)	 	Valera hereby offers to the Company or any of its subsidiaries the conclusion of the Licence
and Distribution Agreement set out in Appendix 7.2, and all Parties shall ensure that the
Company or its appropriate subsidiary without delay accepts such offer and enters into said
Distribution and Licence Agreement upon the Company’s or the appropriate subsidiary’s
incorporation.






	(3)	 	It is the parties’ joint intention that the Company sets up subsidiaries and a structure as
set out in Appendix 7.3 as amended from time to time by the Company’s management with the
approval of the Company’s supervisory board. The Parties shall make any and all statements and
undertake any and all actions necessary or appropriate to implement the aforesaid structure as
soon as reasonably practicable, provided, however, that no Shareholder shall be obliged under
this Sec. 7.3 to accept or enter into any financial obligations other than expressly provided
for in this Agreement. The Parties agree to procure that the articles of association or
similar instruments of any future subsidiaries of the Company will be established in such a
manner that they will provide that prior approval of the respective subsidiary’s shareholders
meeting shall be required for those resolutions or actions by such subsidiary’s management for
which, if such resolution or action was to be taken by the management of the Company, the
management would require the consent of the Company’s supervisory board, thus ensuring that
any such resolution or action ultimately requires the consent of the supervisory board of the
Company.






	(4)	 	All Parties shall ensure that the Company without delay upon its incorporation issues the
Management Rights Letter attached in draft form as Appendix 7.4 hereto to TVM LP as well as to
TVM KG. By signing and acceding to this Agreement, the Company undertakes to issue such
Management Right Letters without delay.





Sec. 8




Intellectual Property Rights





	(1)	 	The parties agree that JFLAB does not have any rights in or relating to intellectual
property rights (including, without limitation, any inventions, patents, copyrights and other
industrial property rights, especially with a view to software and related materials or rights
for remuneration) (hereinafter collectively referred to as the “IP Rights”) in the field of
speciality urology and endocrinology products (the “Field”). For the avoidance of doubt, JFLAB
hereby offers to transfer to the Company or the appropriate subsidiary, to the extent legally
possible, any and all IP Rights owned by him in the Field without any additional compensation.
Where such transfer is not possible for any legal reasons, JFLAB herewith offers to grant to
the Company or the appropriate subsidiary an exclusive and irrevocable licence to use such IP
Rights for all currently known uses without any fee or other consideration being payable. The
offered grant of licence is as broad as legally possible and shall specifically, without
limitation, be unlimited (in respect of duration, territorial scope and scope of the rights
concerned), exclusive, transferable and shall include the right to modify the IP Rights and to
grant sub-licences to third parties. The licence shall also include the permanent or temporary
reproduction of the work results by any means and in any form, in part or in whole, the
loading, displaying, running, transmission or storage of the work results, the translation,




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	 	 	adaptation, arrangement and any other alteration of the work results and the reproduction of
the results thereof, without prejudice to the rights of the person who alters the work
results, any form of distribution to the public, including the rental, of the original work
results or of copies thereof, and the right to make available to the public the work results
by any means.






	(2)	 	Where the above transfer of rights and the grant of licences requires any further deeds, acts
or declarations, JFLAB agrees to give and make any such deeds, acts and declarations
forthwith. Any costs accruing in this context shall be borne by the Company or the appropriate
subsidiary.






	(3)	 	At the request of the Company or the appropriate subsidiary, JFLAB shall demonstrate and
explain all IP Rights, know-how and any knowledge or work results in the Field to an expert
named by the Company or the appropriate subsidiary and answer all questions such expert may
have. JFLAB shall make available to the Company or the appropriate subsidiary all of his
documentation on IP Rights, know-how and any knowledge or work results in the Field.





Sec. 9

Transfer of Shares / Notification





	(1)	 	In the event that a Shareholder intends to transfer all or part of his shares in the
Company to any third person (including other Shareholders) with or without consideration, or
to enter into any commercially equivalent transaction (the “Selling Shareholder”), the Selling
Shareholder shall be obliged to notify the other Shareholders of such intent in writing (the
“Notification”) with a copy to the chairman of the Company’s supervisory board.





(2)   The Notification of the Selling Shareholder shall contain the following information:




	 	a)	 	name / firm name and address / registered office of the Selling Shareholder;
	 
	 	b)	 	name / firm name and address / registered office of the prospective purchaser;
	 
	 	c)	 	description of business of the prospective purchaser;
	 
	 	d)	 	purchase price or other consideration for the proposed transfer, if any;
	 
	 	e)	 	due date for payment of the purchase price and / or other consideration, if any;
	 
	 	f)	 	number of shares to be transferred;
	 
	 	g)	 	representations and warranties as well as indemnities to be given and covenants
to be assumed by each party to the proposed transfer.






	(3)	 	If, however, the Selling Shareholder intends to transfer shares for consideration other than
cash, the Selling Shareholder shall, for the purpose of the right of first refusal under Sec.
10, indicate in the Notification the value of any non-cash consideration in cash according to
the consideration’s fair market value. In the event that another Shareholder has reasonable
doubt as to the accuracy of the consideration’s value, such Shareholder (the “Objecting
Shareholder”) shall inform the Selling Shareholder accordingly in writing within two weeks as
of the receipt of the Notification, indicating the value which the Objecting Shareholder
believes to be accurate, with a copy of such information to all other Shareholders. If the
Objecting Shareholder and the Selling Shareholder do not agree within a period of one week on
the value of the non-cash consideration or on an expert to ultimately determine the non-cash
consideration’s fair market value, such value shall be ultimately determined by an auditor
nominated by the chairman of the Dutch Institute for Chartered Accountants (Nederlands
Instituut voor Register Accountants – NIVRA -) (the agreed expert or auditor nominated by
NIVRA hereinafter: the “Expert”). Such determination by the Expert shall be finally binding
for the purpose of the right of first refusal under Sec. 10. The Selling Shareholder shall
notify in writing all other Shareholders of the so determined fair market value of the
non-cash consideration immediately upon its determination with a copy to the chairman of the
Company’s supervisory board, and the Notification shall be deemed accordingly amended with
regard to the purchase price / consideration, and received by the other Shareholders only




40









 






	 	 	upon receipt of the notification on the non-cash consideration’s fair market value as
determined by the Expert. The cost of the Expert’s determination of the non-cash
consideration’s fair market value shall be borne by the Objecting Shareholder, if the
determined value is closer to the Selling Shareholder’s indication of value in the
Notification, and by the Selling Shareholder if the determined value is closer to the
Objecting Shareholder’s indication of value.





Sec. 10

Rights of First Refusal





	(1)	 	In the event that a Shareholder intends to sell his present or future shares in the
Company for consideration (purchase / swap / contribution against shareholder’s rights, etc.)
the Shareholders (other than the Selling Shareholder) shall have a right of first refusal as
set forth in the following provisions to acquire the shares, which the Selling Shareholder
intends to sell, at the terms and conditions set forth in the Notification pursuant to Sec. 9
(2) and (3).






	(2)	 	Within 30 days of receipt of the Notification, each Shareholder (other than the Selling
Shareholder), who wishes to exercise a right of first refusal, shall state in writing to the
Selling Shareholder the maximum number of shares (the “Acquisition Limit”) he is willing to
acquire at the terms and conditions set forth in the Notification pursuant to Sec. 9 (2) and
(3) (hereinafter: the “Purchase Statement”) with a copy to the chairman of the Company’s
supervisory board. Such statement shall be binding in accordance with Sec. 10 (3), (4) and (5)
below.






	(3)	 	If the aggregate number of shares that all Shareholders (other than the Selling Shareholder)
have stated to be willing to acquire within the aforesaid 30-day-period falls short of the
aggregate number of shares which the Selling Shareholder intends to sell pursuant to the
Notification, the Selling Shareholder shall inform all other Shareholders accordingly, and no
right of first refusal shall apply at all. The Selling Shareholder, subject to the
Shareholders’ Tag-Along Rights pursuant to Sec. 11 and the provisions of Sec. 14, shall be
entitled to sell his shares, but only in strict accordance with the Notification, within two
months upon the lapse of the aforesaid 30-days-period. The purchase agreement between the
Selling Shareholder and the purchaser shall be submitted to the chairman of the Company’s
supervisory board for review immediately.






	(4)	 	If the Shareholders (other than the Selling Shareholder) within the 30-day-period set forth
in Sec. 10 (2) state to be willing to acquire in aggregate all of, or even more than, the
shares which the Selling Shareholder intends to sell pursuant to the Notification, the
Shareholders, who have issued a Purchase Statement, shall have (and shall be deemed to have
exercised by way of their Purchase Statements) a right of first refusal with regard to all of
the shares, which the Selling Shareholder intends to sell. Such right of first refusal shall
vest with its holders (and be deemed to be exercised by way of the Purchase Statements) — up
to each holder’s Acquisition Limit — pro rata to their shareholdings (including common shares,
if any) inter se if and to the extent that more than one Shareholder have issued Purchase
Statements.






	(5)	 	If a right of first refusal applies pursuant to Sec. 10 (4), the Selling Shareholder shall be
obliged vis-à-vis each holder of such right of first refusal, and each holder of such right of
first refusal shall be obliged vis-à-vis the Selling Shareholder, to sell/purchase and
transfer shares in accordance with (i) the terms and conditions set forth in the Notification
pursuant to Sec. 9 (2) and (3), and (ii) the respective Purchase Statement pursuant to Sec. 10
(2) above and allocation pursuant to Sec. 10 (4) above.





Sec. 11

Tag-Along Rights





	(1)	 	The Shareholders shall be entitled to request from any Selling Shareholder, to the extent
that the latter is entitled under Sec. 10 (3) to sell shares to the purchaser named in the
Notification and provided that the purchaser is not one of the Shareholders, to co-sell shares
held by the Shareholders (other than the Selling Shareholder) to the purchaser named in the
Notification at




41









 






	 	 	the same terms and conditions as stated therein (the “Tag-Along Right”). Each Shareholder
(other than the Selling Shareholder) may (i) request the co-sale of shares and (ii) state to
be willing to acquire shares of the Selling Shareholder under his right of first refusal
pursuant to Sec. 10 at the same time to the effect that the co-sale shall occur if no rights
of first refusal apply pursuant to Sec. 10 (3). No co-sale rights shall apply with regard to
a sale and transfer of shares in exercise of the right of first refusal pursuant to Sec. 10.






	(2)	 	The Tag-Along Right shall be exercised within the 30-days-periods under Sec. 10 (2) by
written declaration to the Selling Shareholder with a copy to the chairman of the Company’s
supervisory board, stating the number of shares which the respective Shareholder wishes to be
co-sold. If the respective Shareholder considers the purchaser named in the Notification a
competitor of the Company or a company affiliated with such competitor, and on this basis
asserts Sec.11 (4) below to apply, he shall state this, too, in the written declaration
(“Assertion of Competition”).






	(3)	 	In the event that the purchaser named in the Notification is not willing to purchase all of
the shares that the Selling Shareholder and the Shareholders wish to be sold, the Selling
Shareholder shall not be entitled to sell shares to the purchaser unless (and subject to Sec.
11 (4) below) shares of the Shareholders who have requested the co-sale of shares pursuant to
Sec. 11 (2) are being sold to the purchaser pro rata (i.e., the same percentage of the
respective shareholdings — prior to the sale — of the Selling Shareholder and the
Shareholders, who have requested a co-sale, are being sold).






	(4)	 	The provisions of Sec. 11 (3) notwithstanding, the Selling Shareholder shall not be entitled
to sell shares to the purchaser without all of the shares that the Shareholders requested to
be co-sold being equally sold, if the purchaser named in the Notification is a competitor of
the Company or a company affiliated with such competitor, or if, as a result of the share
sale, the purchaser (and, if applicable, all companies affiliated with the purchaser) would
hold more than 50% of the Company’s share capital. Subject only to a final and binding court
decision, an Assertion of Competition shall be binding on all parties for the purposes of this
Sec. 11 (4).





Sec. 12

Drag-Along Rights





	(1)	 	Investors, who hold (together) a Qualified Investor Majority (as defined in Sec. 23 (1)
below), are entitled to demand from all Shareholders (i) to sell their shares to one or more
third parties (other than companies affiliated to, or private equity or venture capital funds
regularly managed or advised — with regard to its investment activities — by any of the
Shareholders or their affiliated companies, or managed or advised — with regard to its
investment activities — by the same manager or advisor that regularly manages or advises any
of the Shareholders) or to transfer their shares in the course of a merger, a contribution or
a similar transaction (such sale of shares or transfer of shares in the course of a merger, a
contribution or a similar transaction hereinafter: “Trade Sale”) or (ii) to participate in and
support the sale of more than 50% of the tangible and intangible assets of the Company
(calculated at fair market values) (such sale of assets hereinafter: “Asset Deal”).






	(2)	 	The person to be authorised to negotiate the terms and conditions of a Trade Sale pursuant to
Sec. 12 (1)(i) or an Asset Deal pursuant to Sec. 12 (1)(ii) with a third party (the
“Negotiator”) shall be equally determined by Investors, who hold (together) a Qualified
Investor Majority (as defined in Sec. 23 (1) below). Herewith, all of the Shareholders
instruct the Negotiator to negotiate all terms and conditions with the prospective purchaser
on their behalf. No Party shall be obliged to pay any fees to the Negotiator (unless otherwise
agreed), or to make any other payments to the Negotiator with regard to the negotiation of the
Trade Sale or the Asset Deal, other than a customary fee for the Negotiator that will be
deducted from the proceeds of a completed Trade Sale or the Asset Deal which had been
negotiated by the Negotiator. The authorisation (Beauftragung) shall be valid during the term
of this Agreement and shall continue to be valid even after a Shareholder’s death. The
Negotiator shall keep the Shareholders informed about the negotiations of the Trade Sale or
the Asset Deal and shall act in the interest of all Shareholders. The Negotiator shall in
particular ensure that the Shareholders’ interest in achieving a high price as consideration
and reasonable representations, warranties, indemnities and covenants for the Trade Sale or
the Asset Deal be




42









 






	 	 	duly considered.






	(3)	 	The Negotiator shall without undue delay submit a draft shareholders’ sales offer negotiated
with a third party purchaser (hereinafter: the “Final Draft Offer”) to the Shareholders and
the chairman of the Company’s supervisory board. Upon the receipt of the Final Draft Offer and
a written approval thereof by Investors, who hold (together) a Qualified Investor Majority (as
defined in Sec. 23 (1) below) (the “Investors’ Approval of the Offer”), the Company through
the chairman of its supervisory board shall immediately inform the Shareholders in writing and
submit the Final Draft Offer to them.






	(4)	 	In the event that the Final Draft Offer meets the following requirements, all Shareholders
shall submit, within two weeks after receiving the Final Draft Offer and the information on
the Investors’ Approval of the Offer, a duly signed and binding sales offer in accordance with
the Final Draft Offer to the Negotiator for passing it on to the purchaser:






	 	a)	 	95% or more of the Company’s shares shall be included in the Trade Sale or more
than 50% of the tangible and intangible assets of the Company shall be included in the
Asset Deal; the term to accept the offer shall not exceed four weeks, and the Trade Sale
or Asset Deal shall become unconditionally effective or ineffective no later than three
months after the acceptance of the offer;
	 
	 	b)	 	the consideration to be paid shall be in cash or shall be a divisible non-cash
consideration (e.g. shares) and shall, in case of a Trade Sale, be distributed among the
Shareholders in proportion to their respective participation in the Company’s share
capital at the time of the Trade Sale or, if Sec. 5 (2) above applies, in the proportion
set forth therein;
	 
	 	c)	 	up to the amount that tax accrues as a result of the sale, the consideration to
be paid to the Shareholders shall fall due and be liquid to an extent that enables the
Shareholders to timely pay any accrued tax;
	 
	 	d)	 	(i) the liability of each Shareholder with regard to representations, warranties,
indemnities and covenants granted to the purchaser in connection with the Trade Sale or
the Asset Deal, and any other obligations or liabilities in this regard shall be as
customarily agreed in such transactions and shall for each Party be limited in the
aggregate at maximum to the consideration received by such Party pursuant to lit. (b),
(ii) the representations, warranties and indemnities in the event of a Trade Sale shall
for all Shareholders who have not held a management position in the Company within the
last 12 months prior to the conclusion of the agreement on the Trade Sale or Asset Sale
be limited exclusively to representations and warranties regarding the existence and
unrestricted legal title to the shares (including the non-existence of third party
rights in the shares), full payment of the share capital attributable to them (including
non-repayment), and their unrestricted transferability, which representations and
warranties are only to be given by the Shareholders with respect to the shares sold by
the respective Shareholder, and (iii) the Shareholders are only severally liable.






	 	 	If these requirements are met, the Shareholders shall, furthermore, immediately submit all
declarations and undertake all measures, which the implementation of the Trade Sale or the
Asset Deal requires, in particular but not limited to shareholders’ resolutions or filings
for court or administrative clearances, permissions or authorisations.






	(5)	 	Sec. 9 to 11 and 14 shall not apply to any Trade Sale entered into pursuant to this Sec. 12,
except that Valera shall be entitled to exercise a right of first refusal upon receipt of the
Final Draft Offer and the information on the Investors’ Approval of the Offer by submitting to
the Negotiator within two weeks from such receipt a duly signed and binding offer to purchase
and acquire the shares in the Company at the terms and conditions set forth in the Final Draft
Offer. This right of first refusal of Valera shall, however, not apply (i) if the Investors,
who exercise their right to demand a Trade Sale pursuant to Sec. 12 (1) through (4) have
requested from Valera- prior to such demand — an offer from Valera for Valera’s purchase of
the entire shares of the Company (the “Valera Offer”), with such offer to be granted within
three months as of the request by the Investors (the “Valera Offer Period”) and with an
acceptance period of at least six months, and (ii) unless Valera has made a Valera Offer
within the Valera Offer Period and the purchase price of the Valera Offer exceeds the purchase
price of the




43









 






	 	 	Final Draft Offer. Notwithstanding the foregoing, if Valera has made an offer to acquire
either all shares held by all Shareholders other than Valera or all assets of the Company,
then for a period of nine months after the date of such offer, neither the Shareholders nor
the Company shall engage in a Trade Sale or Asset Deal at an aggregate purchase price that is
less than the aggregate purchase price offered by Valera.






	(6)	 	Upon an Asset Deal pursuant to this Sec. 12, Investors, who hold (together) a Qualified
Investor Majority (as defined in Sec. 23 (1) below), shall be entitled, within a time period
of six months as of the implementation of the Asset Deal, to request from all Shareholders to
resolve the dissolution and liquidation of the Company without undue delay.





Sec. 13

Restrictions of Transfer





	(1)	 	The Company’s shares shall be registered in the shareholders’ names. In order to ensure
that shares are solely transferred in compliance with this Agreement, the transferability of
the shares in the Company shall be restricted and any transfer shall require the Company’s
previous consent. The Company’s consent shall be required for the transfer of shares in the
Company irrespective of whether a share certificate has been issued.






	(2)	 	This Sec. 13 as well as Secs. 9, 10, 11 and 14 shall apply mutatis mutandis to any transfer
by JFLAB of any shares in ARCADE (which is currently owned 50.6% by JFLAB), as well as to any
other measure which entails that JFLAB does no longer exercise control over ARCADE.






	(3)	 	The Company shall be obliged to grant its consent to the transfer of shares if the transfer
is in compliance with the provisions of this Agreement; otherwise, the Company shall not
consent to the transfer of shares. The Company’s consent shall be decided upon by the
Company’s supervisory board.





Sec. 14

Share Transfers and Share Issuance under Accession to this Agreement



Shares in the Company shall in no event – except as expressly provided otherwise in this
Agreement – be transferred or issued to an acquirer, who is not yet a Party to this Agreement,
unless the acquirer has previously signed and acceded to this Agreement as Party hereto. Sec. 20
(3) and (4) apply. Sec. 9 – 11 remain unaffected.




Sec. 15




Transfers to Affiliated Companies and Funds





	(1)	 	Sec. 9 – 11 shall not apply to any transfers of shares with or without consideration by
any Shareholder to affiliated companies and/or to other private equity or venture capital
funds (in whatever legal form, e.g., companies, partnerships or other entities; hereinafter:
“Funds”) regularly managed or advised — with regard to their investment activities — by such
Shareholder, by an affiliated company of such Shareholder or by the same manager or advisor
that regularly manages or advises — with regard to its investment activities — such
Shareholder. With reference to Sec. 19, Sec. 9 – 11 shall equally not apply to any transfers
of shares by TVM KG, TVM LP or any of their permitted transferees under the preceding sentence
to KfW or an affiliated company of KfW, provided that this exemption from Sec. 9 – 11 shall be
limited to the transfer of such number of shares that corresponds to the portion of TVM KG’s
and TVM LP’s investment, which is refinanced by KfW, and shall in no event extend to more than
20% of all of the shares in the Company held by TVM KG, TVM LP and their permitted transferees
under the preceding sentence immediately prior to such share transfer.




44









 












	(2)	 	Sec. 15 (1) shall in no event apply to the transfer of shares to a portfolio company of the
respective Shareholder.





Sec. 16

Stock Incentive Scheme





	(1)	 	The Parties agree that a Stock Incentive Scheme shall be implemented at the Company for
the purpose of granting to the management of the Company, its employees and / or its
supervisory board members, advisors, or similar beneficiaries in aggregate options to shares
in the Company or economically comparable rights (one or the other hereinafter: “Option
Rights”) up to an aggregate amount equivalent to 10% of the aggregate (fully diluted) number
of outstanding shares of the Company, including the shares reserved under the Stock Incentive
Scheme. As a general rule, the Option Rights shall be subject to a vesting over three or four
years, and the specific terms as well as the allocation of the Option Rights shall be subject
to the approval of the Company’s supervisory board.






	(2)	 	The Parties further agree that from the overall amount of Option Rights to be granted
pursuant to Sec. 16 (1), Option Rights to an aggregate amount equivalent to 1.5% of the
aggregate (fully diluted) number of outstanding shares of the Company shall be reserved for
members of the Company’s supervisory board. Sec. 17 (4) lit. c) shall not apply in this
respect.
	 
	 	 	(1)





Sec. 17

Supervisory Board





	(1)	 	The Company’s supervisory board shall consist of five members. The Shareholders shall
exercise their voting rights at elections of the supervisory board as follows:






	 	a)	 	one member of the supervisory board (and a respective substitute member) shall be
appointed as nominated by Valera;
	 
	 	b)	 	one member of the supervisory board (and a respective substitute member) shall be
appointed as nominated jointly by TVM LP and TVM KG;
	 
	 	c)	 	one member of the supervisory board (and a respective substitute member) shall be
appointed as nominated jointly by LSOFI and LSOF;
	 
	 	d)	 	one member of the supervisory board (and a respective substitute member) shall be
appointed as nominated by simple majority of the Investors.






	 	 	A further member of the supervisory board (as well as the respective substitute member) shall
be elected by the Shareholders’ meeting of the Company with simple majority, provided,
however, that this candidate (as well as the substitute member) shall be an independent
member and industry expert with proven success, network and regulatory and/or marketing
expertise in global pharmaceutical industry. Nominations and appointments of supervisory
board members shall not exceed the time period from the date of such nomination/appointment
to the ordinary annual shareholders meeting of the calendar year following the year of
nomination and appointment.






	(2)	 	The nomination rights set forth above shall apply mutatis mutandis with regard to the removal
of members of the supervisory board. Retiring members of the supervisory board shall be
replaced pursuant to the provisions set forth in Sec. 17 (1) above. Any nomination right set
forth in Sec. 17 (1) litt. a) through c) shall expire if and when the shareholding of the
respective holder of such nomination right (and any of its permitted transferees under Sec. 15
(1) above) falls below 10% of the entire outstanding shares of the Company, except that
Valera’s nomination right pursuant to Sec. 17 (1) lit. a) shall not expire as long as Valera’s
shareholding amounts to at least 5% of the entire outstanding shares of the Company and 50% or
more of the entire net sales of the Company and its subsidiaries within the respective last
calendar quarter (from time to time) have been




45









 






	 	 	made by the Company and its subsidiaries with products supplied by Valera.






	(3)	 	Each of the Shareholders undertakes individually for himself vis-à-vis each other Shareholder
to vote in any Shareholders’ meeting of the Company resolving on the election of members of
the supervisory board in favour of the candidates nominated pursuant to Sec. 19 (1) above.






	(4)	 	The Parties shall, to the extent legally permissible and respecting the independence of the
supervisory board and its members, use their best efforts and all influence they have to the
effect that






	 	a)	 	the Company’s supervisory board shall hold meetings at least quarterly at the
Company’s registered seat or at any other place which the majority of the Company’s
supervisory board deems from time to time appropriate;
	 
	 	b)	 	the members of the supervisory board and of the management board shall be granted
a Directors’ and Officers’ liability insurance at the Company’s costs with a sufficient
coverage, but at least in the amount of EUR 1,000,000.00 per insured event, provided
that such insurance is available for the Company at reasonable conditions;
	 
	 	c)	 	only the independent industry experts nominated as members of the supervisory
board under Sec. 17 (1) above shall be granted by the Shareholders’ meeting an
appropriate cash remuneration for their services as members of the supervisory board;
Sec. 16 (2) remains unaffected;
	 
	 	d)	 	the transactions and measures listed in the rules of procedure for the Company’s
management board, as attached as Appendix 1.4 hereto shall be subject to supervisory
board approval requiring the consent of each of the three supervisory board members
nominated pursuant to Sec. 17 (1) litt. b), c) and d).






	 	 	Any reasonable disbursements of members of the supervisory board in connection with
board meetings, especially travel expenses shall be refunded by the Company.





Sec. 18

Information





	(1)	 	To the extent legally permissible, and with the consent of all Shareholders hereto being
hereby granted, the Company shall be obliged to forward the following information to each
Shareholder:






	 	a)	 	audited annual financial statements within 90 days after the end of the
respective fiscal year;
	 
	 	b)	 	annual business plan and budget including in particular without limitation
planned balance sheet, planned profit and loss statement and planned cash flow statement
for the forthcoming business year no later than 30 calendar days before the beginning of
each business year;
	 
	 	c)	 	monthly written reports on business operations no later than 21 calendar days
after the end of each month including unaudited financial statements (profit and loss
statements, balance sheets and statement of cash flows, plan versus actual budget,
liquidity status, number of employees) along with key operating parameters as well as
management discussion and analysis of all relevant details.






	(2)	 	All Shareholders shall keep secret and not disclose any confidential information concerning
the Company. Exempt from this confidentiality covenant, however, is the passing on of
information to the Shareholders’ shareholders, partners or investors (as the case may be) who
are under a duty to keep such information confidential, as well as any disclosure of
information required by law, by any stock exchange, by court or administrative order, or by
any regulatory authority, to which any of the Parties may be subject. All Shareholders also
shall abide by all confidentiality requirements of any agreements entered into by the Company,
including the License and Distribution Agreement between the Company and Valera.




46









 











Sec. 19

Refinancing by KfW



(2) TVM KG’s Investment into the Company is partly refinanced by Kreditanstalt für
Wiederaufbau (“KfW”). The Parties acknowledge that such investment is subject to certain
restrictions and agree to be bound by the provisions set forth in Appendix 19a hereto. Furthermore,
the Parties acknowledge that TVM KG requires the internal approval by KfW in case of any amendments
to this Agreement. The Company, upon its incorporation, shall without delay sign the KfW Rights
Letter as attached hereto in draft form as Appendix 19b.




Sec. 20

Effective Date / Succession of Rights





	(1)	 	This Agreement shall become effective upon its being signed by Valera and the Investors,
and shall remain in effect until terminated in writing by Shareholders holding (together) 75%
(or more) of the shares in the Company held by all Shareholders at the time of termination
with effect for all Parties, except that its provisions in Secs. 9 — 23 shall lapse and become
ineffective at an earlier date, if and when the shares in the Company or substituting
securities are first listed on a domestic or foreign stock exchange with the consent of
Shareholders who hold (together), at the time of the consent, at least 60% of the shares in
the Company held by all of the Shareholders from time to time, or upon the implementation of a
Trade Sale, irrespective whether effected by exercising Drag-Along Rights pursuant to Sec. 12
above or not. To the extent legally permissible, any termination of this Agreement by a Party
hereto is excluded. This Agreement shall apply to all shares held from time to time by any of
the Parties hereto. Any provisions herein relating to the transfer of shares in the Company
(in particular, but not limited to, rights of first refusal, tag-along rights, drag-along
rights) shall accordingly apply to any rights to acquire shares, e.g., share options,
warrants, subscription rights etc.






	(2)	 	This Agreement shall be binding upon the Parties irrespective of whether the Company and all
of its shareholders have become a Party hereto, and it shall continue to be binding even if
one or several Parties cease to be shareholders of the Company. If a Party to this Agreement
other than the Company and JFLAB transfers all of its shares and rights to shares in the
Company, such Party shall cease to be Party to this Agreement with effect for the future (but
not affecting any rights and obligations that have at this point of time already arisen
hereunder).






	(3)	 	This Agreement shall be binding upon all Parties that may accede to it in the future.
Herewith, the Parties irrevocably offer to future shareholders the accession to this
Shareholders’ Agreement; this shall in particular apply to persons who exercise option rights
granted under the Company’s employee incentive scheme and to persons or entities that acquire
shares in accordance with this Agreement. Herewith, the Shareholders irrevocably authorise the
Company to receive and accept respective declarations of accession from any third party future
shareholder.






	(4)	 	In the event that shares in the Company are transferred, the new shareholder shall, except if
expressly provided otherwise in this Agreement, enter into all of the rights and obligations
of the transferring shareholder under this Agreement. The separate transfer of rights and
obligations from or in connection with this Agreement shall – except as stated in the
preceding sentence and unless stated otherwise in this Agreement – be excluded.





Sec. 21

Delivery Addresses and Authorised Recipients





	(1)	 	Each Shareholder shall at any time maintain a mailing address and fax number, and keep at
all times the Company and the other Shareholders informed thereof. As of the date of this
Agreement, the Parties may direct any and all communication, in particular any and all
notifications, statements, declarations, demands and information to be issued in connection
with this Agreement or the shareholding in the Company to any other Party hereof to the
persons and addresses (and such




47









 






	 	 	communication, notifications, statements, declarations, demands and information shall be
deemed received if delivered to the persons and addresses) as stated in Appendix 21.1. The
Persons listed in Appendix 21.1 also shall be deemed to be authorised to issue any and all
notifications, statements, declarations, demands and information to be issued in connection
with this Agreement or the shareholding in the Company to any other Party hereof.






	(2)	 	In case of a change of address of any Party hereto, such Party shall immediately inform all
other Parties of such change of address in writing, with such change of address taking effect
for the purposes of Sec. 21 (1) two weeks upon receipt of such information by the other
Parties.






	(3)	 	Any communication, notification, statement, declaration, demand and information that is
required under this Agreement to be made in writing shall suffice to be sent by telecopy.





Sec. 22

Amendments to and Cancellation of this Agreement





	(1)	 	This Agreement may be amended or cancelled with effect for the future (but not affecting
any rights and obligations that have at this point of time already arisen hereunder) by way of
an agreement among Shareholders holding (together) 75% (or more) of the shares in the Company
held by all Shareholders at the time of such agreement with effect for all Parties
(hereinafter: a “Majority Amendment”), provided, however, that no amendments to this Agreement
shall be made to the disadvantage of a specifically named Shareholder (instead of all
Shareholders or any other group of Shareholders defined under this Agreement, e.g., the
Investors) without such Shareholder’s consent; and provided, further, that the provisions of
Sec. 17(1)(a)-(c) shall not be amended without the consent of the party named in such
subsection. In addition, if obligations or covenants of the Company shall be created, the
Company’s consent shall be required.






	(2)	 	In order for any Majority Amendment to become effective, (i) a copy of the respective
agreement pursuant to Sec. 22 (1) above must be sent by registered mail to every Shareholder,
who has not signed such agreement, and (ii) a copy of the respective agreement together with
copies of the mail registration certificates to all other Shareholders must be sent to the
Company. Upon receipt of such documents by the Company, the Majority Amendment shall become
effective, and the Company shall accordingly inform all Shareholders in writing without undue
delay, enclosing a copy of the respective agreement pursuant to Sec. 22 (1). If a Shareholder
believes, for whatever reason, that this Agreement has not been validly amended to the effect
as set forth in the information received by the Company, he shall notify the Company thereof
in writing within three weeks as of the receipt of the information. Otherwise the
Shareholder’s consent to the amendment as set forth in the information by the Company shall be
deemed granted.






	(3)	 	In case of a Majority Amendment, the requirement of any amendments to this Agreement to be in
writing (Sec. 23 (7) below) is met if the agreement among Shareholders holding (together) 75%
(or more) of the shares in the Company held by all Shareholders at the time of such agreement
is in written form.






	(4)	 	Investors, who hold (together) a Qualified Investor Majority (as defined in Sec. 23 (1)
below), shall have the right to determine the terms and conditions of further financing rounds
of the Company, and to request from all other Shareholders and the Company to consent to such
terms and conditions and make all declarations and take all actions required (except for
entering into financial obligations) to implement such financing rounds, provided that all
Shareholders shall be granted the right to invest pro rata in each further financing round and
that the terms and conditions of such financing rounds shall not be more onerous on some
investing Shareholder than on others. The terms and conditions of further financing rounds to
be determined by Investors holding a Qualified Investor Majority (as defined in Sec. 23 (1)
below) may, in particular, include (but shall not be limited to):






	 	a)	 	the introduction and issuance of shares of preferred stock, carrying preference
rights like a liquidation and exit proceeds preference, a dividend preference, drag
along, tag along and first refusal rights superior to the respective




48









 






	 	 	 	rights of shares of common stock, IPO demand rights and a right to anti dilution
protection;
	 
	 	b)	 	the conversion of any investor’s shares of preferred stock into common stock, and
loss of preference rights, in case such investor does not invest pro rata to other
existing investors from time to time in the then following financing rounds (“pay to
play”).





Sec. 23

Miscellaneous





	(1)	 	The term “affiliated company” or “company affiliated with ...” shall, for the purposes of
this Agreement, be understood to be any group company (groepsmaatschappij) as defined in
article 2:24b of the Dutch Civil Code. The term “Qualified Investor Majority” shall, for the
purposes of this Agreement, be understood as 60% (or more) of all of the shares held by all of
the Investors in the Company from time to time; this term shall not imply a requirement to
hold a meeting or have a formal vote among the Investors.






	(2)	 	The liability of the Investors for any and all obligations under this Agreement shall not be
jointly in nature, but severally only. This applies, in particular for (but not limited to)
the payment and subscription obligations under Secs. 1, 2 and 3 of this Agreement.






	(3)	 	The Parties shall ensure that the Company arranges for Key-Man-Insurance for JFLAB in the
amount of EUR 1,000,000 payable in favor of the Company.






	(4)	 	The Parties shall each bear their own costs incurred in connection with this Agreement,
provided, however, that the Investors shall be entitled to deduct from their premium payments
in the context of the foundation of the Company and of the First Capital Increase the costs
incurred in the context of this transaction for legal and tax advice. The Parties agree that
the Company shall bear, to the extent legally admissible, any costs and fees of registration
and the notary in connection with its foundation and the capital increases provided for in
this Agreement.






	(5)	 	In the event that provisions of this Agreement contradict provisions of the Company’s
articles of association (Satzung), this Agreement shall prevail to the extent legally
permissible. The Parties acknowledge and agree that the arrangements included in this
Agreement which relate in any way to the transfer of shares, are different from the transfer
restriction clauses in the articles of association of the Company. This deviation, however, is
expressly agreed and accepted by the Parties in their mutual contractual relations as
established through this Agreement. The Parties hereby agree to act in accordance with the
provisions of this Agreement and to co-operate in the effectuation of any transaction in
accordance with the provisions of this Agreement, including co-operation with the execution of
any additional documents, waivers, resolutions and/or notarial deeds necessary or relevant for
such transaction. In particular, each of the Parties agrees to waive any rights under the
articles of association of the Company to the extent such waiver is necessary to procure that
the provisions of this Agreement may be applied in such manner as is described herein.






	(6)	 	The Parties shall maintain confidentiality about the content of this Agreement and its
execution; provided that Valera may disclose the existence of this Agreement and its contents,
and file this Agreement with applicable regulatory authorities, as required by law. The
exemptions provided for in Sec. 18 (2) shall apply accordingly. Valera and the Investors shall
agree on the content, timing and format of any press release in connection with the conclusion
and implementation of this Agreement.






	(7)	 	Any amendments to this Agreement, including amendments to or waivers of this form
requirement, must be in written form in order to be effective.






	(8)	 	In the event that a provision of this Agreement is or becomes partly or entirely invalid or
if this Agreement contains a gap or omission, the validity of the remaining provisions of this
Agreement shall not be affected thereby. The Parties shall be obliged to replace the partly or
entirely invalid provision with a valid provision, which the Parties would have agreed on, had




49









 






	 	 	they been aware of the invalidity of the respective provision. The same shall apply in the
event that this Agreement contains a gap or omission.






	(9)	 	This Agreement shall be governed by Dutch law under exclusion of its rules of conflict of
laws. To the extent legally permissible, the place of jurisdiction and place of performance
shall be Amsterdam.




50









 











                    , this 17 July 2006




	 	 	 
	/s/ B. Seibel

	 	/s/ B. Seibel
	 
	 	 
	 

	 	 
	 
	 	 
	TVM Life Science Ventures VI L.P.

	 	TVM Life Science Ventures VI GmbH & Co. KG
	 
	 	 
	/s/ James Gale

	 	/s/ James Gale
	 

	 	 
	 
	 	 
	Life Sciences Opportunities Fund
(Instititutional) II, L.P.

	 	Life Sciences Opportunities Fund II, L.P.
	 
	 	 
	/s/ Jean-Francois Labbé

	 	David S. Tierney
	 

	 	 
	 
	 	 
	ARCADE SARL

	 	Valera Pharmaceuticals Inc.
	 
	 	 
	 

	 	26.06 2006
	 
	 	 
	/s/ Jean-Francois Labbé

	 	/s/ Jean-Francois Labbé
	 

	 	 
	 
	 	 
	Jean-François Labbé

	 	Spepharm Holding B.V.





(3)




	 	 	 
	List of Appendices
	 	 
	 
	 	 
	Appendix 1.2:

	 	Articles of Association of the Company
	 
	 	 
	Appendix 1.3:

	 	Terms of Service Agreement of JFLAB
	 
	 	 
	Appendix 1.4:

	 	Rules of Procedure for the Management
	 
	 	 
	Appendix 1.5:

	 	Draft Loan Agreement
	 
	 	 
	Appendix 4.3a/b:

	 	Accession Forms for Third Party Investor(s) (First and/or Second Capital Increase)
	 
	 	 
	Appendix 7.2:

	 	Distribution and Licence Agreement
	 
	 	 
	Appendix 7.3:

	 	Group Structure
	 
	 	 
	Appendix 7.4:

	 	Management Rights Letter
	 
	 	 
	Appendix 19a/b:

	 	KfW Provisions / KfW Rights Letter
	 
	 	 
	Appendix 21.1:

	 	Delivery Addresses and Authorised Recipients






51