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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

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	 	 	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

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	 	 	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.

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	(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.

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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

51exv10w2

 

EXHIBIT 10.2

LICENSE AND DISTRIBUTION AGREEMENT

THIS LICENSE AND DISTRIBUTION AGREEMENT is entered into as of the 27 day of September 2006, by and
between VALERA PHARMACEUTICALS, INC., a corporation incorporated under the laws of the state of
Delaware with its principal place of business located at 7 Clarke Drive, Cranbury, New Jersey
08512-3617 USA (“Valera”), and SPEPHARM HOLDINGB.V., a corporation incorporated under the laws of
the Netherlands with its principal place ofbusiness located in Amsterdam, the Netherlands
(“Spepharm”).

BACKGROUND

WHEREAS, Spepharm has been organized for the purpose of serving as a distributor of specialty
pharmaceutical products throughout Europe;

WHEREAS, Valera has developed and is the sole owner of certain patent rights and other intellectual
property relating to certain Products;

WHEREAS, Valera wishes to appoint Spepharm as the exclusive licensee and distributor of the
Products in the Territory (as defined below) for use in the same indications for which Valera owns
or controls an approval from the United States Food and Drug Administration or similar agency of a
foreign government, the whole in accordance with the terms and conditions set forth in this
Agreement;

WHEREAS, Spepharm desires Valera to supply Spepharm with the Products on an exclusive basis in the
Territory prior to Regulatory Approval (as defined below), and following receipt of Regulatory
Approval, for distribution and sale in the Territory for use in the indications described above,
the whole in accordance with the terms and conditions set forth in this Agreement.

TERMS

NOW, THEREFORE, in consideration of the respective covenants, agreements, representations,
warranties and indemnities contained in this Agreement and for other good and valuable
consideration, Spepharm and Valera hereby covenant and agree as follows:

Article 1 – Definitions and Interpretation

1.1 Definitions. For the purposes of this Agreement or any notice, consent, authorization
or other communication required or permitted to be given under this Agreement, the following
expressions shall have the following meanings, respectively, unless the context otherwise requires:

(a) “Affiliate” shall mean any Person which directly or indirectly controls, is
controlled by, or is under common control with another Person; provided that “control” shall mean
ownership as to more than fifty percent (50%) of the outstanding voting equity securities of
another Person or the power to direct decisions of another Person including, without limitation,
the power to direct management and policies of another Person, whether by reason of ownership, by
contract or otherwise.

(b) “Agreement” shall mean this License and Distribution Agreement, as amended from time
to time.

(c) “Business Day” shall mean any day other than a Saturday, Sunday or other day on which
the branches of the Federal Reserve Bank with jurisdiction over the then-current principal place of
business of Valera are not open for business.

(d) “Calendar Month” shall mean each calendar month of each year during the term of this
Agreement.

(e) “Calendar Quarter” shall mean the periods from January 1st to March
31st, April 1st to June 30th, July 1st to September
30th and October 1st to December 31st in a given year.

(f) “Calendar Year” shall mean the period from January 1st to December
31st in a given year.

(g) “CMC information” shall mean the chemistry, manufacturing, and control information
filed by Valera from time to time with the FDA with respect to a Product.

52

 

(h) “Commercial Sale” means any sale or distribution of a Productby Spepharm or its
Affiliates or sublicensees to a Third Party, other than distribution in connection with clinical
trials of a Product conducted by Spepharm. For the avoidance of doubt, the sale or distribution of
a Product between or among any of Spepharm or its Affiliates or sublicensees shall not be
considered a Commercial Sale.

(i) “Competing Product” shall be as defined in Section 3.5.

(j) “Confidential Information” shall be as defined in Section 12.1.

(k) “Development Plan” shall have the meaning set forth in Section 2.3.

(l) “Dollar” and the symbol “$” shall mean lawful money of the United States.

(m) “Effective Date” shall mean the date first written above.

(n) “Event of Force Majeure” shall have the meaning set forth in Section 14.1.

(o) “FDA” means the United States Food and Drug Administration and any successor thereto.

(p) “Forecast” shall be as defined in Section 6.3.

(q) “GMPs” shall mean then-current Good Manufacturing Practices as required under the
rules and regulations of the FDA.

(r) “Governmental Body” shall mean (i) any national, federal, provincial, state,
municipal or other government or body with jurisdiction over all or any part of the Territory, (ii)
any subdivision, ministry, department, secretariat, bureau, agency, commission, board,
instrumentality or authority of any of the foregoing governments or bodies, (iii) any
quasigovernmental or private body exercising any regulatory, expropriation or taxing authority
under or for the account of any of the foregoing governments or bodies, or (iv) any domestic or
foreign judicial, quasi-judicial, arbitration or administrative court, grand jury, tribunal,
commission, board or panel of any of the foregoing governments or bodies.

(s) “Implant” means Valera’s proprietary histrelin implants currently marketed or to be
marketed in the United States under the trademark Vantas® or Supprelin®.

(t) “Implantation Device” means the TROCAR device that is used to insert an Implant into
a human body.

(u) “Improvements” shall mean any re-formulations, lineextensions or other advances in,
or modifications or improvements to, a Product for use in an Indication.

(v) “Indemnified Party” shall be as defined in Section 10.3.

(w) “Indemnifying Party” shall be as defined in Section 10.3.

(x) “Indication” shall mean an indication for which an Implant is approved for marketing
and sale, the approval of which issued by the FDA or similar agency of a foreign government. As of
the Effective Date, the only indication for which an Implant has been approved for marketing and
sale in the United States is the treatment of hormone responsive prostate cancer.

(y) “Labels” shall mean (i) all labels and other written, printed, or graphic matter upon
the Product or any packaging, container or wrapper utilized with the Product, in each case when
sold for use in the United States and (ii) any written material accompanying the Product, including
without limitation, any package inserts, in each case when sold for use in theUnited States.

(z) “Laws” shall mean:

(i) all constitutions, treaties, laws, statutes, codes, ordinances, orders, decrees,
rules, regulations, and municipal by-laws, whether domestic, foreign or international, including
any such constitutions, etc. of any Governmental Body;

(ii) all judgments, orders, writs, injunctions, decisions, rulings, decrees and awards of
any Governmental Body; and

53

 

(iii) all policies, practices and guidelines of any Governmental Body, in each case
binding on or affecting the Party or Person referred to in the context in which such word is used;
and “Law” shall mean any one of them.

(aa) “Losses” shall mean liabilities, damages, costs or expenses, including reasonable
fees and expenses of attorneys and other professionals, as well as court costs.

(bb) “Marketing Approval Application” shall mean an application or registration filed
with a Regulatory Authority seeking the approval to market, distribute and sell the Product for an
Indication in the jurisdiction controlled by such Regulatory Authority.

(cc) “Marketing Plan” shall have the meaning set forth in Section
3.9.

(dd) “Material Breach” shall mean any breach of the terms of this Agreement of such a
nature as to have a material effect on the non-breaching Party.

(ee) “Minimum Net Sales” shall mean for a specified Calendar

Year the Minimum Unit Quantities (as defined in Schedule 1) of the Products as set forth in
Schedule 1, multiplied by the Average Net Selling Price for the respective Calendar Year. The
Average Net Selling Price shall be calculated by dividing the Net Sales of the relevant Calendar
Year by the number of Units sold in such Calendar Year. The Minimum Unit Quantities set forth in
Schedule 1 are based on assumed dates for Regulatory Approvals as set forth in Schedule 1. If
Regulatory Approvals are not granted by the specified dates, the parties shall negotiate in good
faith an adjustment of the Minimum Unit Quantities for purposes of determining Minimum Net Sales,
unless such delay is caused by Spepharm. The parties shall also be obligated to negotiate in good
faith an adjustment of the Minimum Unit Quantities for purposes of determining Minimum Net Sales,
if (i) the launch of a Product is delayed because Spepharm cannot use the trademark Vantas® or
Supprelin®, as applicable, or a reasonable alternative trademark provided by Valera in reasonable
time prior to such launch, in any country of the Territory or (ii) following the launch of the
respective Product, Spepharm’s use of the trademark Vantas® or Supprelin®, or any alternative
trademark that may have been used by Spepharm for such Product at the time of launch, as
applicable, is contested by a third party in any country of the Territory and as a result Spepharm
cannot use such trademark in such country.

(ff) “Net Sales” shall mean the gross amount invoiced by Spepharm or its Affiliates or
sublicensees with respect to the Commercial Sale of the Products in the Territory, less the
aggregate of: (i) customers’ returns for Products that fail to comply with the warranties set forth
in Section 8.1; (ii) amounts paid for freight, transport and delivery, including insurance, for
shipping from Spepharm’s or its Affiliates’ or sublicensees’ or their respective designees’
facilities to a customer (but only to the extent of the actual cost of such freight, transport and
delivery charges); (iii) any sales tax, value added tax, goods and services tax or any other tax
that may be imposed on the sale of the Product, which taxes are included in gross amount invoiced
by Spepharm and its Affiliates or sublicensees; (iv) amounts actually repaid or credited for
retroactive price reductions; and (v) rebates, including those paid or payable pursuant to
governmental regulations or agreements with governmental entities.

(gg) “Parties” shall mean Spepharm and Valera, collectively.

(hh) “Party” shall mean either Valera or Spepharm, as the context requires.

(ii) “Person” shall mean an individual, corporation, limited liability company,
co-operative, partnership, organization or any similar entity.

(jj) “Plan” shall be as defined in Section 2.3.

(kk) “Product” shall mean all dosage strengths and forms of either of the Implants in
final finished form along with the Implantation Device, together with all Labels and any and all
Improvements.

(ll) “Promotional Materials” shall mean all promotional materials, detail aids and
pieces, journal ads, films, artwork and graphics, and any other marketing literature and
information relating to the marketing, distribution or sale of a Product for use in an Indication

outside of the Territory.

(mm) “Purchase Order” shall be as defined in Section 6.1.

(nn) “Purpose” shall be as defined in Section 12.2.

54

 

(oo) “Regulatory Approval” shall mean, with respect to a particular country in the
Territory and an Indication, the approval by all Regulatory Authorities of the Marketing Approval
Application and the receipt by Spepharm of the other approvals, licenses, registrations and
authorizations of all Regulatory Authorities necessary for the marketing, distribution and sale of
a Product in such Territory for use in such Indication and necessary for patients to obtain
reimbursement of such Product from national health insurance.

(pp) “Regulatory Authority” shall mean each and every Governmental Body from which
approvals are required for the marketing, distribution or sale of a Product in a country in the
Territory.

(qq) “Royalty Amount” shall be as defined in Section 7.1.

(rr) “Specifications” shall mean the specifications for a Product approved by the
Regulatory Authority for use in the relevant Indication.

(ss) “Spepharm Releasees” shall be as defined in Section 10.2.

(tt) “Term” shall mean the time period from the Effective Date until the expiration or
earlier termination of this Agreement.

(uu) “Territory” shall mean the European Union (including countries that accede to the
European Union after the date of this Agreement if Valera has not already granted distribution
rights for a Product in such country at the time of the accession), Norway and

Switzerland.

(vv) “Third Party” means any Person other than a Party or an Affiliate of a Party.

(ww) “Trademarks” shall mean, subject to Article 4, all trademarks and trade names and
trade dresses (whether registered or not) owned by Valera or its Affiliates and approved by Valera
for use in the marketing, distribution and sale of a Product in a country in the Territory for use
in a particular Indication.

(xx) “Transfer Price” shall be as defined in Section 7.2.

(yy) “Valera Releasees” shall be as defined in Section 10.1.

(zz) “Warranty Period” shall be as defined in Section 8.4.

1.2 Interpretation. The division of this Agreement into Articles and the insertion of
headings are for convenience of reference only and shall not affect the interpretation of this
Agreement. In this Agreement, words importing the singular number only shall include the plural and
vice versa and words importing gender shall include all genders.

Article 2  — Product Development and Regulatory Approval

2.1 Regulatory Approval. Valera shall assign to Spepharm all Marketing Approval
Applications and any Regulatory Approval held by Valera with respect to such Products in the
Territory. Valera shall submit all necessary paperwork to all Regulatory Authorities to
request assignment to Spepharm of all Marketing Approval Applications Regulatory Approval held by
Valera with respect to such Products in the Territory. In accordance with the terms and subject to
the conditions herein specified, Spepharm shall, at its own expense, apply for each Regulatory
Approval for each Product in each country of the Territory for use in each Indication. Spepharm
hereby agrees to use commercially reasonable efforts in applying for each such Regulatory Approval,
which shall be held in the name of Spepharm or an Affiliate of Spepharm. Valera’s only obligations
in regards to the Regulatory Approval effort shall be for Valera to: (a) provide to Spepharm the
information and data required by Section 2.2; (b) make personnel available for telephone calls with
Spepharm and Regulatory Authorities as Valera determines in its sole discretion; and (c) supplying,
at Spepharm’s expense based on Valera’s cost of production, a reasonable quantity of the Product
for use in clinical trials as set forth in this Agreement, including
any Product necessary for any required stability testing. If Spepharm desires or requires more
assistance or resources from Valera in relation to the Regulatory Approval effort, it may request
such resources and Valera will determine in its sole discretion whether it will provide such
resources and the cost to Spepharm of providing such resources. Spepharm shall not use any
Development Data in Ireland unless and until Valera has obtained 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.).

55

 

2.2 Furnishing Data. Valera shall supply Spepharm with all data and information in its
possession or control as is necessary for the purpose of obtaining and maintaining Regulatory
Approval for each Product in each country of the Territory for use in each Indication, including
clinical and non-clinical study data, results and reports (including toxicology reports) and/or CMC
information including, where required, a reasonable number of samples for actual testing by
Regulatory Authorities. Without limiting the generality of the foregoing and to the extent legally
permitted, Valera shall provide Spepharm with access to and the right to cross-reference existing
regulatory filings for each Product submitted by it and/or its Affiliates or designated nominees in
any jurisdiction outside of the Territory. At the request of Spepharm and to the extent legally
permitted, Valera shall notify the Regulatory Authority in each country of the Territory of
Spepharm’s right to reference any such regulatory filings in any application filed by Spepharm in
accordance with the terms of this Agreement.

2.3 Development and Regulatory Approval Plans. Within sixty (60) Business Days after the
Effective Date, Spepharm shall prepare a plan outlining all pre-clinical, clinical and regulatory
activities that are necessary for receiving Regulatory Approval for the use of the Product in the
prostate cancer Indication in each country of the Territory and estimated time schedules for the
completion of all such activities (the “Plan”). Generally, the Plan shall allocate responsibility
for pre-clinical and clinical activities and regulatory activities in each country of the Territory
(including development and approval of Territory-specific labeling for the Product) to

Spepharm and shall not allocate any responsibility to Valera other than provision of the data and
information required by Article 2 and the supply of the Product. The Plan shall be subject to the
review and approval of Valera, which will not be unreasonably withheld or delayed. As new
Indications become available during the Term, Spepharm shall develop a Plan for receiving
Regulatory Approval from each Regulatory Authority in the Territory for such Product for use in
such Indication no later than sixty (60) Business Days after Valera notifies Spepharm of the
approval of the Product for marketing, sale and use in the United States in such Indication. Each
such Plan shall be subject to the review and approval of Valera, which approval shall not be
unreasonably withheld or delayed.

2.4 Clinical Trial Data. All clinical and/or marketing data developed by the Parties
during the Term shall remain the property of the Party developing such data, and any data to which
both Parties have contributed to or on which both Parties have worked shall remain the property of
both jointly and severally worldwide; provided that Valera shall have a perpetual, irrevocable,
royalty-free, fully paid-up license to copy, disclose and use in any manner any and all clinical
and/or marketing data developed in the course of such trials and not otherwise owned by Valera. The
Parties agree that they will promptly share with one another all information and reports regarding
the results of any trials.

2.5 Phase IV Clinical Studies. Spepharm shall have the exclusive right (but not the
obligation) to conduct Phase IV clinical trials relating to the use of the Product in each
Indication in each country of the Territory, but only with the prior written consent of Valera,
which consent shall not be unreasonably withheld or delayed.

2.6 Maintaining Regulatory Approval. Spepharm undertakes to use commercially reasonable
efforts to maintain each Regulatory Approval for each Product for use in each Indication in each
country of the Territory. All reasonable direct out-of-pocket expenses incurred by Spepharm and/or
Valera in maintaining the registrations in the Territory shall be borne or reimbursed by Spepharm.

2.7 Copies of Correspondence. Copies of all pertinent correspondence related to the
promotion, sale and use of each Product for use in each Indication to and from all Regulatory
Authorities and all submissions, or pertinent excerpts thereof, to the Regulatory Authorities
connected to each Product for use in each Indication will be furnished by the corresponding Party
to the other Party in a timely manner.

2.8 Unit Prices. Spepharm shall, at its own expense, make all submissions and filings to
each Government Body and all other Third Parties necessary or desirable to establish unit prices
for each Product for use in each Indication in each country of the Territory.

Article 3  — Exclusive Distribution; Promotion and Sales

3.1 Appointment of Distributor. Subject to the terms and conditions of this Agreement,
Valera hereby appoints Spepharm during the Term, and Spepharm hereby accepts its appointment, as
the exclusive distributor of the Products in each country of the Territory for use in each
Indication.

3.2 Exclusive Supply. During the Term, Valera shall not supply any of the Products for
distribution or sale in any country of the Territory to any Person other than Spepharm, it being
understood between the Parties that Valera shall not directly or indirectly sell, or otherwise make
available, any of the Products in any country of the Territory other than through Spepharm in
accordance with the terms of this Agreement. Valera shall refer to Spepharm all orders or inquiries
received by it from sources in any country of the Territory in connection with any of the Products
for use in any Indication.

56

 

3.3 Reservation of Rights. In no event shall this Agreement be construed to prevent
Valera from directly or indirectly: (a) manufacturing, using, marketing, promoting, distributing
and selling any Product outside the Territory for use in any indication; or (b) entering into and
performing agreements with third parties regarding the foregoing.

3.4 Sales within each Country of the Territory. Spepharm shall not, and Spepharm shall
cause its Affiliates and sublicensees not to, directly or indirectly, without the prior written
consent of Valera, sell the Product outside the Territory, or knowingly sell any Product to any
Person within any country of the Territory for resale or use outside of the Territory.

3.5 Competing Product. For a period of five (5) years from the date of this Agreement,
Spepharm shall not, and shall cause its Affiliates and sublicensees not to, directly or indirectly,
jointly or in conjunction with any other Person, whether as principal, agent, shareholder,
employee, independent contractor, or in any other manner whatsoever, develop, market, distribute or
sell in any country of the Territory any products that contain the same active ingredient as that
which is contained in any Product, any products similar to or competitive with any Product, or any
products that are used in any Indication (each, a “Competing Product”) without Valera’s prior

written consent.

3.6 Subcontracting. The Parties acknowledge and agree that, subject to prior written
notification to and acceptance from the appropriate Regulatory Authority, each Party shall have the
right, at its sole expense, to subcontract with Third Parties or Affiliates for the performance of
its obligations hereunder, upon prior written approval of the other Party where the subcontractor
is a Third Party (which approval shall not be unreasonably withheld or delayed); provided, however,
that the subcontracting Party shall remain responsible to the other Party for (a) assuring that
each subcontractor complies with all applicable provisions of this Agreement and all

applicable Laws and (b) fulfilling all of its obligations hereunder; and provided further that
Spepharm shall have no right to approve or disapprove of any contract manufacturer or contract
packager engaged by Valera. In the event that any subcontracting by Valera would have a material
impact on Spepharm’s responsibilities to the appropriate Regulatory Authority and to the extent
reasonably possible, Valera will inform Spepharm at least six (6) months prior to arranging for any
such subcontracting.

3.7 Product Promotion. Spepharm shall employ reasonable efforts to market, distribute and
sell each Product in each country of the Territory for use in its relevant Indication and shall
bear all costs and expenses incurred in connection with such efforts. The Parties agree to meet at
either Party’s reasonable request, but at least once every six months during the Term, in order to
review and discuss marketing, distribution and sales issues.

3.8 Promotional Materials. Valera shall provide Spepharm, at no additional cost, with
samples of all Promotional Materials owned by Valera to market the Product for use in each
Indication outside of the Territory; provided that Spepharm reimburses Valera for all additional
advertising agency costs, if any, associated with supplying any artwork and graphics. Valera hereby
grants to Spepharm the right to use such Promotional Materials to translate such Promotional
Materials and, subject to Article 4, to modify any artwork and graphics for its purpose.

3.9 Marketing Plan. Commencing in the year in which Spepharm submits a Marketing Approval
Application to a Regulatory Authority within a particular country for a particular Indication,
Spepharm shall prepare, develop and submit to Valera an annual marketing plan in relation to use of
such Product for such Indication in such country (each, a “Marketing Plan”) for Valera’s review by
no later than the 15th of February of each year during the Term for the then-current Calendar Year.
The Marketing Plan will outline plans for the promotion and sale of such Product in such country
for such Indication, and will also include recommendations for
Product pricing, reimbursement status and activities, positioning, and a description of the
promotional programs, if any, planned for the relevant Calendar Year. Valera, acting in good faith,
shall have thirty (30) Business Days from the date of receipt to review each Marketing Plan and
suggest commercially reasonable changes. Spepharm shall make commercially reasonable efforts to
include any changes in the Marketing Plan suggested by Valera and shall advise, in writing, within
fifteen (15) Business Days which changes it has incorporated together with an explanation as to any
changes that were suggested by Valera but not incorporated. In the event that Valera does not
respond to Spepharm within thirty (30) Business Days of the receipt of a Marketing Plan, such
Marketing Plan will be deemed to be acceptable to Valera. Notwithstanding anything else contained
herein to the contrary, at the request of either Party, the Parties shall meet semi-annually to
review proposed marketing plans for the Products.

3.10 Sublicensing. Spepharm may sublicense the distribution rights granted pursuant to
Section 3.1; provided that (a) Spepharm enters into a written agreement with the sublicensee that
binds the sublicensee to non-economic terms and conditions substantially similar to the
non-economic terms and conditions of this Agreement applicable to Spepharm; and (b) prior to
entering into such sublicense agreement, Spepharm provides Valera with a full copy of the proposed
agreement; and provided, further, that sublicensing to any entity other than an Affiliate of
Spepharm shall require prior written consent of Valera, which consent shall not be unreasonably
withheld. Valera’s consent is deemed reasonably withheld if the potential sublicensee is a direct
competitor of Valera. Sublicensing shall not relieve Spepharm of any of its obligations under this
Agreement. Spepharm shall be liable for any sublicensee’s failure to perform any term or condition
of this Agreement as if Spepharm itself breached the applicable term or condition of this
Agreement.

57

 

Article 4  — Branding; Trademarks

4.1 License Grant; Branding. Subject to the terms and conditions of this Agreement,
Valera hereby grants Spepharm an exclusive license to use the Trademarks in connection with the
marketing, distribution, and sale of the Products in each country of the Territory for use in the
applicable Indication. The Products shall bear a product name owned by Valera, which product name
shall, if possible, be the same as the product name used in the United States (but may vary by
Indication), as well as certain other trademarks of Valera and trademarks of Spepharm (other than a
product name of Spepharm) and use the trade dress identified by Valera from time to time and
approved by Spepharm; provided, however, that all packaging shall, to the extent legally feasible,
ensure that the distinctiveness of the trademarks of each party is maintained and include a tag
line that indicates the ownership of each Party’s trademarks.

4.2 Obligations and Conditions. No Promotional Materials bearing the Trademarks may be
used without Valera’s prior written approval, which consent shall not be unreasonably withheld or
delayed but shall be conditioned upon maintaining the distinctiveness of the trademarks of each
Party and including a tag line that indicates Valera’s ownership of the Trademarks. It is agreed by
the Parties that in the event that Valera does not respond to Spepharm’s submission of the new
Promotional Materials or labeling within ten (10) Business Days, consent shall be deemed to be
granted.

4.3 Spepharm’s Trademarks. Spepharm hereby, for itself and on behalf of its Affiliates,
grants Valera the right to affix Spepharm’s and its Affiliates’ trademarks, trade names, logos and
trade dress on labeling of the Products.

4.4 Changes. Each Party may discontinue, alter or add new trademarks to be used in
connection with the labeling and marketing of the Products in each country of the Territory for use
in an Indication; provided that: (a) the foregoing shall not be deemed to allow Spepharm to use or
place a product name owned by Spepharm or licensed by Spepharm from a Third Party on any Product;
and (b) each Party may use up any packaging, labeling or Promotional Materials that it has at the
time of the discontinuance, alteration or addition, either in stock or in process.

4.5 No Other Rights; Allocation of Goodwill. Except for the licenses granted by each of
Valera and Spepharm to the other under this Agreement, neither Party shall acquire any right,
title, or interest in any trademark, trade name, logo or trade dress of the other

Party by reason of this Agreement. Each of Spepharm and Valera shall be responsible for
registering, as necessary, its own trademarks, trade names, logos and trade dress. Spepharm
acknowledges that all use of any of Valera’s trade names, trademarks, trade dress and logos and all
of the goodwill associated therewith shall inure solely to Valera’s benefit. Likewise, Valera
acknowledges that all use of any of Spepharm’s trademarks, trade dress, trade names, and logos, and
all of the goodwill associated therewith shall inure solely to Spepharm’s benefit.

4.6 Confusingly Similar Marks. Spepharm shall not authorize or undertake any use of any
mark that is confusingly similar to the Trademarks in each country of the Territory.

4.7 Effect of Termination. Upon termination of this Agreement both parties shall
immediately cease all use of the other party’s trademarks, trade names, logos and trade dress,
except as set forth in Article 4.

Article 5 – Manufacture and Supply

5.1 Manufacturing. Valera shall, directly or through an Affiliate or Third Party designee
(including contract manufacturers and contract packagers), have the sole right and responsibility
for manufacturing the Products in such quantities as, in Valera’s opinion, are required to fill all
orders and for maintaining such inventory levels of raw materials and packaging components as are
required to meet Spepharm’s then-current forecast for the Products (as delivered pursuant to
Section 6.3.

5.2 Labeling. Valera shall supply the Products to Spepharm in unlabeled packaging in
bulk. Spepharm shall be responsible for the labeling and packaging necessary to comply with all
Regulatory Approvals and bear all costs related to the same. From time to time, and in any event
promptly following Valera’s request, Spepharm shall notify Valera of all labeling and packaging
activities undertaken by or on behalf of Spepharm to comply with all Regulatory Approvals in the
Territory.

5.3 Failure to Supply. In the event that Valera or its Affiliates are unable to supply a
Product in specified quality or in quantities sufficient to meet forecast demand for a successive
period of ninety (90) Business Days, then Valera shall indemnify Spepharm for all

damages (including lost profits) resulting from such failure based on the difference between
Spepharm’s Forecast Net Sales and its actual Net Sales for a period not to exceed eighteen months
from the date of Valera’s initial failure to supply.

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5.4 Documentation and Certificate of Analysis. Valera shall provide Spepharm with
required supporting documentation for the manufacture and packaging of Product in a form suitable
for Spepharm’s submission to the Regulatory Authorities. A certificate of analysis and full set of
batch manufacturing records shall be delivered with each batch of Product delivered to Spepharm.

5.5 Improvements; New Formulation. Valera shall furnish Spepharm with all information
pertinent to the marketing, sale and promotion of a Product relating to any Improvements, which
Valera may make from time to time to the Product, or to any new formulation of the Product. To the
extent reasonably possible, Valera shall provide Spepharm with six (6) months prior written notice
of any anticipated Improvements or new formulations.

5.6 Shelf Life. Each unit of a Product will have a remaining shelf life of at least
eighteen (18) months at the time of shipment to Spepharm.

5.7 Compliance with Laws; Instructions. Spepharm shall comply with all applicable Laws in
relation to the handling, storage, distribution and sale of each Product in each country of the
Territory as well as Valera’s then-current instructions relating to handling, storage and shipment
of each Product.

Article 6 – Forecasts/Ordering/Return/Insurance

6.1 Ordering. Spepharm may order units of Product by issuing binding purchase orders
(each, a “Purchase Order”) to Valera pursuant to the terms of this Agreement. Each Purchase Order
shall state the quantity and type of Product to be purchased, delivery date(s) and routing
instructions, destination or destinations; provided that, with respect to each Purchase Order,
Spepharm shall be required to order Product in the quantity increments set forth on Schedule 6.1.
No different or additional terms or conditions on any purchase order, acknowledgment or other
transmittal, whether a standard business form or otherwise, utilized by Spepharm or Valera in
connection with the sale of Product shall be construed or deemed to be an amendment of or
supplement to this Agreement or otherwise binding on either Spepharm or Valera.

6.2 Acceptance or Rejection of Purchase Orders. Valera shall indicate its acceptance or
rejection of each Purchase Order within ten (10) Business Days after receipt; provided that Valera
may reject a Purchase Order, in whole or in part, only if: (a) the Purchase Order fails to comply
with the terms and conditions of this Agreement; (b) the delivery date is less than one hundred
fifty (150) days from the date of Valera’s receipt of such Purchase Order; or (c) if the volume
under the Purchase Order and all other accepted Purchase Orders covering the applicable monthly
period exceeds the volume set forth in Spepharm’s then-current forecast (delivered pursuant to
Section 6.3) by more than twenty five (25%) during the first two (2) years after the effective date
of this Agreement and by more than fifteen (15%) thereafter). If requested by Spepharm following
Spepharm’s receipt of Valera’s rejection notice under clause (c) above, Valera will use
commercially reasonable efforts to deliver the excess volume of the Product specified in the
rejected Purchase Order, but Valera’s failure to so deliver the excess volume shall not be a breach
of this Agreement. In no event shall Valera be liable to any third party for Valera’s failure to
deliver the Product to Spepharm by any delivery due date set forth in any Purchase Order.

6.3 Forecasts. Spepharm shall provide Valera a non-binding twelve (12) month rolling
forecast (the “Forecast”) of Spepharm’s estimated requirements of each Product. The Forecast shall
be reviewed and updated by Spepharm no later than thirty (30) days before the start of each
calendar quarter during the Term. Each such Forecast shall reflect a good faith attempt by Spepharm
to estimate quantity requirements of each Product, based on anticipated demand therefor.

6.4 Shipment. Valera will use diligent efforts to ship Product ordered by Spepharm within
one hundred and fifty (150) days after its acceptance of Spepharm’s purchase order. Product will be
shipped EXW (Incoterms 2000) Valera’s or its Third Party designee’s facilities. Valera shall ensure
that Product is suitably packed for shipment in standard containers and organize the shipping on
behalf and at Spepharm’s costs.

6.5 Delivery. To the extent possible, Spepharm shall verify counts and identify any
damages to Valera within five (5) Business Days of receipt.

6.6 Return. Spepharm shall have no right to return any Product shipped pursuant to a
valid Purchase Order other than pursuant to the provisions set forth in Section 8.4.

6.7 Valera’s Product Liability Insurance. Valera agrees to maintain product liability
insurance consistent with its normal business practices to cover risks related to Product and, upon
Spepharm’s request from time to time, to provide Spepharm with certificates of insurance attesting
to the existence of such insurance. Valera shall name Spepharm as an additional insured under the
foregoing insurance policy.

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6.8 Spepharm’s Product Liability Insurance. Spepharm agrees to maintain product liability
insurance to cover risks related to its activities (or activities undertaken on its behalf) with
respect to the labeling, packaging, storage, marketing, sales, and distribution of
Product in each country of the Territory with a limit of liability of at least $[20,000,000] in the
aggregate. Upon request by Valera, Spepharm will provide Valera with a certificate of insurance
attesting to the existence of such insurance. Spepharm shall name Valera as an additional insured
under the foregoing insurance policy. Spepharm will cause its sublicensees to comply with this
Section 6.8 for the respective country sublicensed as if the sublicensee were Spepharm.

6.9 Insurance Notification. Each Party agrees, upon request, to advise the other Party of
the status of the insurance required by this Agreement and of any change in such status. It is
understood and agreed that furnishing of such insurance coverage will not relieve either Party of
their obligations under this Agreement.

Article 7 – Pricing and Payment Terms

7.1 Pricing. Spepharm shall pay Valera for Valera’s supply and Spepharm’s distribution of
the Products under this Agreement an aggregate amount equal to forty percent (40%) of Net Sales
(the “Royalty Amount”) in accordance with the procedures set forth in this Article 7.

7.2 Transfer Price Payment. With each shipment of Product, Valera shall invoice Spepharm
an amount (the “Transfer Price”) equal to (a) the price per unit for each Product as set forth on
Schedule 7.2 multiplied by (b) the quantity of such Product shipped to Spepharm. Within sixty (60)
days after the date of each such invoice, Spepharm shall pay to Valera the
Transfer Price indicated in such invoice.

7.3 Monthly Report; Annual Report. Within fifteen (15) days following the end of each
Calendar Month, Spepharm shall render a written report to Valera segregated by each Product, and by
Spepharm, each Affiliate and each sublicensee, setting forth the following

information and calculations for such Calendar Month: (a) each component making up Net Sales for
the Calendar Month and the calculation of Net Sales; (b) the actual number of each Product sold
(net of returns) for the Calendar Month; and (c) the calculation of the Royalty Amount for such
Calendar Month. No later than sixty (60) days after the conclusion of each Calendar Year, Spepharm
shall supply to Valera a report certified by its chief financial officer showing the quantity and
sales prices for such Calendar Year in respect of sales of the Products by Spepharm and its
Affiliates and sublicensees.

7.4 Royalty Payment. Within thirty (30) days following the end of each Calendar Quarter,
Spepharm shall pay to Valera an amount equal to the difference between (a) the aggregate Royalty
Amount for such Calendar Quarter minus (b) the aggregate Transfer Prices paid by Spepharm during
such Calendar Quarter. In connection with each such payment, Spepharm shall deliver a written
report to Valera setting forth the calculation of such payment.

7.5 Failure to Achieve Minimum Net Sales.

(a) If Spepharm fails to achieve the Minimum Net Sales in a given Calendar Year with
respect to a Product, then Spepharm shall pay to Valera an amount equal to (i) the difference
between Minimum Net Sales for such Product for such Calendar Year minus the actual amount of Net
Sales of the Product for such Calendar Year multiplied by (ii) forty percent (40%), the result to
be reduced by the aggregate Transfer Prices paid by Spepharm during such Calendar Year to the
extent such Transfer Prices have not been taken into account for the purposes of determining the
Royalty Payment pursuant to Section 7.4.

(b) Notwithstanding Section 7.5(a), Spepharm may notify Valera no later than forty-five
(45) days after the completion of the Calendar Year that it will not pay the amounts required by
Section 7.5(a) for the just completed Calendar Year, in which case: (a) Spepharm shall be relieved
from its obligation to pay the amount required by Section 7.5(a) for such Calendar Year; but (b)
Valera shall have the right either (i) to convert all of the exclusive rights granted to Spepharm
in this Agreement with respect to such Product into non-exclusive rights effective as of the date
of Spepharm’s notice to Valera or such later date as Valera may specify or (ii) to terminate this
Agreement with respect to such Product effective as of the date of Spepharm’s notice to Valera or
such later date as Valera may specify. If Spepharm does not send a notice permitted by this Section
7.5(b) or does so after the period specified in this Section 7.5(b), Spepharm shall not be relieved
of its obligations under Section 7.5(a) and failure to pay such obligation shall be considered a
Material Breach.

7.6 Payment Terms. Spepharm shall pay all amounts due under this Agreement by wire
transfer in Dollars to such bank as Valera may direct from time to time. Overdue amounts shall bear
interest at a rate equal to the lower of 1% per month or the highest rate
permitted by law from the due date until the date paid. All expenses incurred in making such
transfers shall be borne by Spepharm. To the extent that Net Sales includes amounts collected by
Spepharm in currency other than Dollars, such amounts shall be converted to

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Dollars using the average exchange ratio as set forth in the Wall Street Journal during the thirty
(30) day period ending on the last day of the relevant Calendar Month.

7.7 Records. Spepharm shall, and shall cause its Affiliates and sublicensees to, record
all sales of Product and keep full and true books of account and other records in accordance with
the requirements of generally accepted accounting principles, consistently applied, and other good
business practice so that details of sales for Product, the calculation of Net Sales and payment
obligations in respect thereof may be properly ascertained.

7.8 Audit. Spepharm agrees to permit, and shall cause its Affiliates and sublicensees to
permit, at the request of Valera and at Valera’s expense, an independent accounting firm selected
by Valera to have access, upon reasonable notice, during ordinary business hours and no more
frequently than once in any Calendar Year, to such books of account and other records as may be
necessary to confirm the calculation of Net Sales. If such independent certified public accountant
shall determine that an amount is due and owing by one Party to the other, then the owing Party
shall promptly pay the amount due and owing; provided that if the Party owing the
amount is Spepharm and such amount is five percent (5%) or more of the total amount that should
have been paid under this Agreement in respect of the audited period, then Spepharm shall also
reimburse Valera for the cost of the audit.

Article 8  — Product Warranties

8.1 Limited Warranty for the Products. Valera warrants to Spepharm that: (a) each unit of
Product will be manufactured and packaged in accordance with GMPs; (b) each unit of Product, when
delivered to the carrier, will conform to the Specifications, and (c)
each unit of Product shall be free from defects in materials, workmanship and packaging that would
render such Product unusable at the time of delivery to the carrier .

8.2 Disclaimer. THE EXPRESS LIMITED WARRANTY FOR THE PRODUCTS SET FORTH IN SECTION 8.1
AND THE ADDITIONAL REPRESENTATIONS AND WARRANTIES SET FORTH IN SECTION 9.1 ARE IN LIEU OF ALL OTHER
REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED. VALERA HEREBY DISCLAIMS ANY AND ALL
OTHER REPRESENTATIONS AND WARRANTIES OF ANY KIND, EXPRESSED OR IMPLIED, WHETHER ARISING FROM A
COURSE OF DEALING OR USAGE OF TRADE, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.

8.3 Warranty Claim Procedure. Unless otherwise agreed by Valera, to make a warranty
claim, Spepharm shall at Spepharm’s expense return the allegedly defective unit(s) of Product(s),
or a representative sample thereof, together with a description of the alleged defect. Valera
shall, promptly after receipt and as required, inspect the alleged defective Product(s). If such
inspection results reasonably confirm that the unit(s) of Product(s) do not conform with the
warranties set forth in Section 8.1 and the non-conformance did not arise from misuse, mishandling,
storage in a manner inconsistent with Valera’s directions, neglect, modification or unusual
physical or chemical stress after delivery to the carrier, Spepharm shall return any remaining
Product(s) in Spepharm’s inventory with the same defect at Valera’s expense, and the sole and
exclusive warranty remedies set forth in Section 8.4 shall apply. If such test results fail to
confirm the Products’ non-conformance to the warranties set forth in Section 8.1, or if the parties
fail to otherwise resolve the dispute, the parties shall submit unit(s) of the Product(s), or a
representative sample thereof, along with a reference batch which has previously been shown by
Spepharm to conform to the warranties set forth in Section 8.1, to a mutually acceptable
independent laboratory along with mutually agreeable interrogatories to be answered by such
laboratory. The determination of the Products’ conformance or non-conformance to the warranties set
forth in Section 8.1 shall be binding upon the Parties. If the laboratory determines that the
Products conform to the warranties set forth in Section 8.1, Spepharm shall pay all independent
laboratory and shipping costs incurred by Valera, and if such laboratory confirms that the Products
do not conform with the warranties set forth in Section 8.1, Valera shall pay all independent
laboratory costs and the sole and exclusive warranty remedies set forth in Section 8.4 shall apply.

8.4 Spepharm’s Warranty Remedies. Spepharm must make a claim for breach of any warranties
set forth in Section 8.1 no later than one (1) year after shipment of the unit of Product to
Spepharm claimed to be defective (the “Warranty Period”). Valera shall replace, at Valera’s
expense, or at Spepharm’s option, refund or credit the Transfer Price for, any units of Product
that do not comply with Valera’s limited warranty set forth in Section 8.1 and reported to Valera
during the Warranty Period (and confirmed or determined to be defective pursuant to Section 8.3).
Valera’s obligation to replace defective Product or to refund or credit the purchase price paid for
such Product pursuant to this Section 8.4 shall not apply to any Product that has been subjected to
misuse, mishandling, storage in a manner inconsistent with Valera’s directions, neglect,
modification or unusual physical or chemical stress after delivery to the carrier. Other than with
respect to third party claims for which Valera must indemnify Spepharm pursuant to Section 10.2,
this Section 8.4 states Spepharm’s sole and exclusive remedy for failure of any the Products to
comply with the limited warranties set forth in Section 8.1.

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Article 9 – Representations and Additional Warranties

9.1 Representations and Warranties of Valera. Valera hereby makes the following
representations and warranties to Spepharm and does so in full understanding and acknowledgement
that Spepharm is relying on such representations and warranties in entering into this Agreement,
notwithstanding any due diligence investigation done or information obtained by Spepharm prior to
the Effective Date:

(a) Status. Valera is a corporation organized and existing under the Laws of the State of
Delaware, U.S.A. No action has been taken by the directors, officers or shareholders of Valera to
dissolve the corporation. Valera has the corporate power and authority to
enter into this Agreement and to perform all its obligations under this Agreement.

(b) All Necessary Proceedings. The execution and delivery by Valera of this Agreement,
the performance by Valera of all the terms and conditions thereof to be performed by it and the
consummation of the transactions contemplated hereby have been duly authorized by all necessary
corporate actions of Valera, and no other act or approval of any Person is required to authorize
such execution, delivery, and performance.

(c) No Violation. The execution, delivery and performance of this Agreement by Valera:
(i) does not violate or conflict with any provision of Law or any provision of its certificate of
incorporation or bylaws; and (ii) does not and will not, with or without the passage of time or the
giving of notice, result in the breach of, or constitute a default, cause the acceleration of
performance, or require any consent under, or result in the creation of any lien, charge or
encumbrance upon any of its property or assets pursuant to any material instrument or agreement to
which it is a party or by which it or its properties is bound. Without limiting the generality of
the foregoing, Valera has not made any written or oral agreement or undertaking with any other
Person regarding the rights to promote, distribute or sell any of the Products or to seek
Regulatory Approval for any of the Products in any country of the Territory.

(d) Third Party Claims. As of the Effective Date, there is no outstanding or, to Valera’s
knowledge, threatened claim or allegation that the marketing, distribution or sale of any of the
Products or use of the Trademarks in accordance with this Agreement infringe upon any rights of a
Third Party in each country of the Territory.

(e) Right to Grant Licenses. Valera is the sole and exclusive owner of all intellectual
property needed to market, distribute and sell the Products in each country of the Territory in
accordance with this Agreement, provided that Valera does not warrant that it has the right use the
Trademarks in the Territory. Valera has filed a Community Trade Mark application in the European
Union for each of the trademarks Vantas® and Supprelin®. Valera has the full right, power and
authority to grant the rights granted to Spepharm under this Agreement.

(f) Regulatory Approval. As of the Effective Date of this Agreement, Valera is not aware
of any facts that would reasonably lead it to conclude that any of Products will be unable to
receive Regulatory Approval in any country of the Territory.

9.2 Representations and Warranties of Spepharm. Spepharm hereby makes the following
representations and warranties to Valera and does so in full understanding and acknowledgement that
Valera is relying on its said representations and warranties in entering into this Agreement,
notwithstanding any due diligence investigation done or information obtained by Valera prior to the
Effective Date:

(a) Status. Spepharm is a vennootschap met beperkte aansprakelijkheid_] organized and
existing under the Laws of the Netherlands. No action has been taken by the directors, officers or
shareholders of Spepharm to dissolve Spepharm. Spepharm has the power and authority to enter into
the present Agreement.

(b) All Necessary Proceedings. The execution and delivery by Spepharm of this Agreement,
the performance by Spepharm of all the terms and conditions thereof to be performed by it and the
consummation of the transactions contemplated hereby have been duly authorized by all necessary
actions of Spepharm, and no other act or approval of any Person is required to authorize such
execution, delivery, and performance.

(c) No Violation. The execution, delivery and performance of this Agreement by Spepharm:
(i) does not violate or conflict with any provision of Law or any provision of its articles of
association; and (ii) does not and will not, with or without the passage of time or the giving of
notice, result in the breach of, or constitute a default, cause the acceleration of performance, or
require any consent under, or result in the creation of any lien, charge or encumbrance upon any of
its property or assets pursuant to any material instrument or agreement to which it is a party or
by which it or its properties is bound.

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Article 10 – Indemnification

10.1 By Spepharm. Spepharm shall indemnify Valera, its Affiliates and their respective
directors, officers, shareholders, employees or agents (collectively, the “Valera Releasees”), and
hold them harmless from and against any and all Losses (including personal)injury, death or
property damage) arising from any and all Third Party claims against the Valera Releasees: (a)
relating to the marketing, distribution or sale of the Products in each country of the Territory;
(b) of any nature whatsoever relating to any processing or repackaging of Product after delivery to
the carrier in accordance with Section 6.4; or (c) caused by a breach or misstatement by
Spepharm of its representations and warranties under this Agreement; except, in each case, to the
extent such Third Party claims result from the fault, negligence or willful misconduct of the
Valera Releasees or their material failure to comply with the terms of this Agreement. Spepharm
shall not be liable under this Section 10.1 in the event that the Valera Releasees admit or settle
any such claim without the prior written consent of Spepharm, which consent shall not be
unreasonably withheld, conditioned, delayed or denied.

10.2 By Valera. Valera shall indemnify Spepharm, its Affiliates and their respective
directors, officers, shareholders, employees or agents (collectively, the “Spepharm Releasees”),
and hold them harmless from and against any and all Losses (including personal)
injury, death or property damage) arising from any and all Third Party claims against the Spepharm
Releasees: (a) that the manufacture, use or sale of Product in accordance with this Agreement
infringes the intellectual property rights of a third party in each country of the Territory; (b)
of any nature whatsoever relating to the manufacture of Product; or (c) caused by a breach or
misstatement by Valera of its representations and warranties in Section 9.1; except, in each case,
to the extent such Third Party claims result from the fault or negligence of the Spepharm
Releasees, or their material failure to comply with the terms of this Agreement. Valera shall not
be liable under this Section 10.2 in the event that the Spepharm Releasees admit or settle any such
claim without the
prior written consent of Valera, which consent shall not be unreasonably withheld, delayed or
denied.

10.3 Indemnification Procedure. A Party seeking indemnification (the “Indemnified Party”)
shall notify, in writing, the other Party (the “Indemnifying Party”) within fifteen (15) Business
Days after the assertion of any claim or discovery of any fact upon which the
Indemnified Party intends to base a claim for indemnification. An Indemnified Party’s failure to so
notify the Indemnifying Party shall not, however, relieve such Indemnifying Party from any
liability under this Agreement to the Indemnified Party with respect to such claim except to the
extent that such Indemnifying Party suffers or otherwise incurs additional liquidated or other
readily quantifiable damages as a result of being denied, during the period of delay in notice, the
opportunity to remedy or otherwise mitigate the event or activity giving rise to the claim for
indemnification or the damages therefrom or is materially prejudiced in the defense of the claims
giving rise to the right to indemnification.

10.4 Defending Claims. The Indemnifying Party, while reserving the right to contest its
obligations to indemnify the Indemnified Party under this Agreement, shall be responsible for the
defense of any claim, demand, lawsuit or other proceeding in connection with
which the Indemnified Party claims indemnification hereunder. To the extent legally possible, the
Indemnified Party shall have the right, at its expense, to participate jointly with the
Indemnifying Party in the defense of any such claim, demand, lawsuit or other proceeding, but with
respect to any issue involved in such claim, demand, lawsuit or other proceeding with respect to
which the Indemnifying Party has acknowledged its obligation hereunder, the Indemnifying Party
shall have the right to select counsel, settle, try or otherwise dispose of or handle such claim,
demand, lawsuit or other proceeding on such terms as the Indemnifying Party shall deem appropriate,
subject to any reasonable written objection of the Indemnified Party.

Article 11 – Intellectual Property Matters

11.1 Intellectual Property Infringement.

(a) Without limiting the obligations and requirements of Sections 10.1 through 10.4, each
Party will notify the other Party if it receives any notice that the activities engaged in under
this Agreement infringe or may infringe any Third Party’s intellectual property rights. If Spepharm
establishes to Valera’s reasonable satisfaction that license(s) under such Third Party’s
intellectual property rights is or are necessary or advisable for purposes of enabling Spepharm to
market, use or sell Product in a country of the Territory, Valera and Spepharm shall cooperate to
obtain such license(s) for the benefit of Valera and Spepharm, in accordance with the following
provisions of this Section 11.1:

(i) Valera shall be primarily responsible for obtaining any such third party license. The
matter shall be deemed resolved if Valera is granted a license, whether royalty-free or
royalty-bearing, under the relevant intellectual property rights that would make Spepharm’s, its
Affiliates’ and sublicensees’ past and continued marketing, use or sale of such Product in such
country of the Territory for use in the applicable Indication non-infringing with respect to such
Third Party’s intellectual property rights.

(ii) In the event that Valera is unable to resolve the matter in accordance with Section
11.1(a)(i) in spite of good faith efforts and/or upon terms that are commercially reasonable to
Valera, then Spepharm shall be entitled to negotiate a license in favor of Spepharm under such
Third Party’s intellectual property rights; provided that Spepharm shall not enter into such
license without the prior written consent of Valera, such consent not to be unreasonably withheld
or delayed. In the event that such license requires Spepharm to pay

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the Third Party royalties or other payments, Spepharm may deduct such royalties or other payments
from the amounts due to Valera under Section 7.2.

(iii) Should any claim or suit that a Product infringes any Third Party’s intellectual
property rights in a country of the Territory be upheld by a final, nonappealable order of a court
such that Spepharm is prevented from marketing, using and selling such Product in such country of
the Territory and no license that permits Spepharm to market, use and sell such Product in such
country of the Territory in accordance with this Agreement is obtained by either Valera or Spepharm
pursuant to Sections 11.1(a)(i) and 11.1(a)(ii), Valera shall repurchase from Spepharm, at cost,
all of the Product currently in Spepharm’s stock for use in such country that have not been sold
and, if commercially reasonable to Valera, change such Product so as to make it non-infringing. If
changing such Product so as to make it non-infringing is not commercially reasonable to Valera,
Valera may terminate this Agreement effective upon giving
Spepharm notice of termination without any liability to Spepharm other than a liability pursuant to
Section 10.2.

11.2 Third Party Infringement.

(a) In the event that either Party determines that a Third Party(other than a permitted
licensee, transferee or distributor of either Party) is making, using, or selling a product or
process that may infringe any of the intellectual property relating to a Product, including later
issued and acquired patents covering a Product, or any uses or processes pertaining thereto, it
will promptly notify the other Party in writing.

(b) Valera shall be responsible for, in its sole discretion, obtaining a discontinuance
of any infringement or bringing suit against a Third Party infringer relating to a Product.
Notwithstanding anything contained herein to the contrary, Valera shall have the right, but
not the obligation, to bring such a suit. Valera shall bear all the expenses of any such suit
brought by it. Spepharm agrees to be named as a co-plaintiff if Valera brings suit and shall
cooperate with Valera (which shall include providing any necessary assistance and executing any
necessary documents, with any reasonable, receipted out-of-pocket expenses being reimbursed to
Spepharm by Valera to the extent such expenses were previously approved in writing by Valera), and
shall have the right to consult with Valera and to participate in and be represented by independent
counsel in such litigation at its own expense. Except as otherwise specifically provided herein,
Valera shall have control over any such suit, and decisions as to settlement, methods and/or terms
and conditions for resolving the suit shall be made by Valera (after consultation with Spepharm,
should Spepharm be joined as a party to such suit).

(c) In the event that Spepharm can reasonably demonstrate that a Third Party is
infringing a patent covering a Product and Valera does not elect to institute an action against
such Third Party, and provided that Spepharm can reasonably demonstrate that such infringement is
materially impairing its ability to meet the applicable Minimum Net Sales amount, then Valera and
Spepharm shall negotiate in good faith to adjust the applicable Minimum Net Sales amount
accordingly.

11.3 Patent Prosecution and Maintenance.

(a) Valera shall be responsible for and shall control the preparation, filing,
prosecution, grant and maintenance of all patents owned by Valera covering a Product. Valera shall
prepare, file, prosecute and maintain such patents in good faith consistent with its
customary patent policy and its reasonable business judgment, and shall consider in good faith the
interests of Spepharm in so doing; provided that in no event shall Valera be required to maintain
any such patents in any country in which Spepharm has not sold any Product within 180 days after
Spepharm has received Regulatory Approval for such Product in such country. Valera shall be
responsible for payment of all costs and expenses related to such filings, prosecution and
maintenance, unless relieved of same hereunder.

(b) Valera shall give notice to Spepharm of any decision to cease prosecution and/or
maintenance, or not to proceed with an extension, of any patent owned by Valera covering a Product
and, in such case, shall permit Spepharm at Spepharm’s sole discretion, to continue prosecution or
maintenance or proceed with the extension at Spepharm’s own expense. If Spepharm selects to
continue prosecution or maintenance or to proceed with the extension, Valera shall execute such
documents and perform such acts at Spepharm’s expense as may be reasonably necessary to permit
Spepharm to continue such prosecution and maintenance or to
proceed with the extension. Notwithstanding anything to the contrary, Valera shall maintain
ownership in all such patents. Any reasonable out-of-pocket expenses incurred by Spepharm in
connection with such prosecution, maintenance or extension shall be deducted from the payment
obligations of Spepharm under Article 7 of this Agreement .

Article 12 – Confidentiality

12.1 Confidential Information. For the purposes of this Agreement, “Confidential
Information” means all verbal, written, electronically transmitted and/or machine reproduced
information, chemical structures, data, documents, methods and intellectual property of or relating
to the business of either Party or its Affiliates, already provided or disclosed by it or its
Affiliates to the other Party, or which will be provided to the other Party under this Agreement,
and all materials, data, results, reports and other documents

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generated by or on behalf of the other Party containing or regarding such information, data,
documents, methods and intellectual property.

12.2 Obligations. During the Term, each Party may supply to the other Party such
Confidential Information as is considered useful solely for the purpose of enabling the other Party
to perform its obligations hereunder (the “Purpose”). The other Party shall not use or allow the
use of the Confidential Information for any purpose other than the Purpose or to enforce its rights
under this Agreement

12.3 Exceptions. Neither Party shall have any obligation of non-disclosure or non-use
hereunder with respect to any Confidential Information which: (a) at the time of
disclosure to the other Party is already available or known to the public; (b) disclosure
to the other Party becomes available or known to the public through no breach of this Agreement;

(c) is already lawfully in the possession of the other Party at the time disclosure
hereunder was made and such possession is documented by written evidence and not subject to any
obligation of non-disclosure or non-use; or

(d) is received from a Third Party having the right to disclose same and who is not bound
by obligations of non-disclosure and/or non-use.

12.4 Compelled Disclosure. If a Party shall become compelled by any requirement of law or
pursuant to any legal, regulatory or investigatory proceeding before any court, tribunal or other
governmental entity, agency or commission to disclose Confidential Information of the other Party,
such Party shall give the other Party prompt written notice of its receipt of the order or notice
requiring the disclosure so that the other Party may seek a protective order or other remedy to
protect the confidentiality of the Confidential Information and/or waive the compelled Party’s
obligations under this Article 12. If such protective order, other remedy or waiver is not
obtained or granted by the time the compelled Party is required to comply, the compelled Party may
furnish only that portion of the Confidential Information of the disclosing Party that it is
compelled to disclose and no more.

12.5 Unauthorized Use. In case either Party becomes aware or has knowledge of any
unauthorized use or disclosure of Confidential Information, it shall promptly notify the other
Party of such unauthorized use or disclosure and, thereafter, shall take all reasonable steps to
assist the other Party in attempting to minimize any potential or actual damages or losses
resulting from such unauthorized use or disclosure.

12.6 Return of Documents. Each Party, upon receipt of a written request from the other
Party following the expiration or termination of this Agreement, shall promptly return to the other
Party all Confidential Information of such other Party, including all reproductions and copies
thereof together with all internal material and documents generated by it containing Confidential
Information or references thereto or from which references the substance of the Confidential
Information can be implied or understood and shall delete all references thereto stored
electronically.

12.7 Ownership Rights. Each Party agrees that it shall not claim to have any rights,
title or ownership in the Confidential Information of the other Party or any discoveries or
inventions based on or derived from the Confidential Information, and that rights, title and
ownership in the Confidential Information or any discoveries or inventions based on or derived from
said Confidential Information shall, as between the Parties, rest in the disclosing Party. Each
party agrees to promptly disclose to the disclosing Party any discoveries or inventions based on or
derived from the Confidential Information. Each Party further agrees to assign (and does hereby
assign) to the disclosing Party, the sole and exclusive ownership in all such discoveries and
inventions and to sign all documents and do all things required to give effect thereto.

12.8 Term. The provisions of this Article 12 shall survive the expiration or termination
of the Agreement until all of the Confidential Information has fallen within one of the exceptions
set forth in Section 12.3.

Article 13 – Term and Termination

13.1 Term. This Agreement shall commence upon the Effective Date and shall continue for a
period of ten (10) years from the Effective Date, unless sooner terminated as provided elsewhere in
this Agreement.

13.2 Termination. This Agreement may be terminated:

(a) By a Party if the other Party commits a Material Breach and (i) fails to remedy the
breach within thirty (30) Business Days of being required by the first Party to do so; or (ii)
where remedy of the breach is not reasonably possible within thirty (30) Business Days, fails to
propose a plan within twenty (20) Business Days which, in the opinion of the first Party acting
reasonably, is capable of providing a remedy of the breach within ninety (90) Business Days.
(b) If either Party shall commence as debtor any proceedings

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under any bankruptcy, insolvency, readjustment of debt, dissolution or liquidation Law or any such
proceeding shall be commenced against either Party, or any trustee or receiver shall be appointed
therefor, and either Party shall by any act or failure to act indicate approval of or consent to,
or acquiescence in such proceedings or in the appointment of any such trustee or receiver; or if
any
such proceedings brought against either Party shall be approved by any court and shall remain
undismissed for thirty (30) Business Days after its levy, then in any such case, the Party not
involved in such proceedings shall have the option to terminate this Agreement in its entirety by
written notice of such termination to the Party involved in such proceedings and upon the giving of
such notice this Agreement shall immediately terminate.

(c) By either Party, upon at least thirty (30) days prior written notice to the other
Party, if, as a result of an Event of Force Majeure, the other Party is unable to fully perform its
obligations hereunder for a period of one hundred fifty (150) consecutive days; provided that if
the required performance is met during the thirty (30) day period, this Agreement shall continue in
full force and effect as if the notice had not been given.

(d) By a Party, on a country-by-country, Product-by-Product and Indication-by-Indication
basis, if the Regulatory Authority for such country has finally denied Regulatory Approval (or any
material part thereof) for such Product with respect to such Indication.

(e) By Valera, on a Product-by-Product basis, in accordance with Section 7.3.

(f) By Valera, on a country-by-country, Product-by-Product and Indication-by-Indication
basis, if Spepharm fails to file all Marketing Approval Applications necessary to allow the
marketing and sale of a Product in the given country for use in the given Indication within thirty
(30) days after the deadline stated in the Plan for such country for the filing of all such
Marketing Approval Applications for such Product for such Indication;

(g) By Spepharm, on a Product-by-Product basis, in the event that Valera or its
Affiliates are unable to supply a Product in specified quality or in quantities sufficient to meet
forecast demand for a successive period of ninety (90) Business Days where Valera, upon
request of Spepharm, fails to propose a plan within twenty (20) Business Days following such
request which, in the opinion of Spepharm acting reasonably, is capable of providing a resumption
of supply within ninety (90) Business Days following such request. If Spepharm terminates the
Agreement pursuant to this Section 13.2(g), then Spepharm shall not be entitled to indemnification
from Valera under Section 5.3 for damages resulting from such
failure after the date of termination.

13.3 Partial Termination. In the event that any termination of this Agreement is limited
to one (1) or more, but not all forms or dosages of a Product, or to a country or Indication, then
the effects of such termination shall only apply to the affected form(s),
dosage(s), country (ies) or Indication(s), but shall not affect in any way the validity of this
Agreement with respect to any other form, dosage, country or Indication.

13.4 Remedies Not Limited. The termination of this Agreement by either Party shall not
limit remedies that may be otherwise available.

13.5 Survival. Expiration or termination of this Agreement for any reason shall not
relieve either party for any breach of this Agreement occurring prior to the expiration or
termination of this Agreement. Article 1, Article 7 (with respect to Products sold during the Term
only), Article 8, Article 10, Article 12 and Article 15 and Sections 3.3, 3.5, 4.5, 4.6, 4.7, 9,
10, 12, 13.4, 13.5, 13.6 and 13.7 shall survive expiration or termination of this Agreement for any
reason in accordance with their respective terms.

13.6 Post-Termination. Unless Valera terminates this Agreement pursuant to Section 13.2
(a) or (b) during the six (6) month period following the expiration or termination of this
Agreement, Spepharm may sell out its stock on hand of the Product. All applicable provisions of
this Agreement shall survive termination as necessary to give effect to this Section 13.6.

13.7 Other Consequences of Termination. Upon termination or expiration of this Agreement
(whether in whole or in part), Spepharm shall within thirty (30) days from the date of receipt of a
request from Valera submit all necessary paperwork to all Regulatory Authorities to request
assignment to Valera or designee of all Marketing Approval Applications and all related
registrations and product numbers for the relevant Products and any other Regulatory Approval held
with respect to such Products (in each case whether in Spepharm’s name or the name of any Affiliate
of Spepharm); provided that if this Agreement is only terminated as to a particular country or
Indication, then only the assignment of all Marketing Approval Applications and all related
registrations and product numbers for such Product and any other Regulatory Approval held with
respect to the Product (in each case whether in Spepharm’s name or the name of any Affiliate of
Spepharm) for such country or Indication shall be required.

Article 14 – Force Majeure

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14.1 Definition. For the purposes of this Agreement, an “Event of Force Majeure” means
any one or more of the following: (a) acts of God;

(b) expropriation, confiscation or requisitioning of facilities, compliance with any Law
not presently existing, or change in the interpretation of any presently existing Law which affects
to a degree not presently existing the supply, availability, export or use of the Product,
materials or labour;

(c) acts or inaction on the part of any Governmental Body or Person purporting to act
therefor;

(d) embargoes, or acts of war or the public enemy, whether war be declared or not;

(e) strikes, public disorder, insurrection, rebellion, riots or violent demonstrations;

(f) floods, earthquakes, lightning, hail, inclement weather conditions or other natural
calamities; and

(g) any circumstances whether or not of the class or kind specifically named above not
within the reasonable control of a Party and which, despite the exercise of reasonable diligence,
such Party is unable to prevent, avoid or remove including demand

that exceeds Valera’s supply of the Product.

14.2 Procedure. If any Party wishes to invoke an Event of Force Majeure, then it shall
(i) promptly following the commencement of such Event of Force Majeure notify the other Parties of
the occurrence of such Event of Force Majeure, the reasonably estimated date and time on which it
commenced and the nature of the Event of Force Majeure, and (ii) as soon as reasonably practicable
thereafter, submit to the other Parties proof of the Event of Force Majeure.

14.3 Suspension of Obligations. If one of the Parties is unable to perform any
obligations under this Agreement because of an Event of Force Majeure, then such Party shall be
excused from performance of such obligations until the Event of Force Majeure terminates and the
obligations of such Party, which cannot be met due to the Event of Force Majeure, shall be
suspended during the pendency of the Event of Force Majeure; provided that such Party uses all
reasonable efforts to attempt to prevent, avoid or remove the Event of Force Majeure within the
shortest possible delay. Nevertheless, an Event of Force Majeure has no effect on the obligation to
pay a sum of money owing for the purchase of the Product.

14.4 Resolution. If either Party is excused from performance under this Agreement because
of an Event of Force Majeure, then the Parties agree to promptly meet and to work in good faith
together in an attempt to find appropriate solutions and to shorten the duration of the Event of
Force Majeure, to the extent reasonably feasible.

Article 15 – Miscellaneous

15.1 Limitations Of Liability. EXCEPT IN RESPECT OF A PARTY’S INDEMNIFICATION OBLIGATIONS
UNDER THIS AGREEMENT OR SPEPHARM’S PAYMENT OBLIGATIONS UNDER SECTION 7 OF THIS AGREEMENT, IN NO
EVENT SHALL A PARTY’S LIABILITY TO THE OTHER PARTYFOR DAMAGES UNDER OR IN RESPECT OF THIS AGREEMENT
EXCEED, IN THE AGGREGATE, THE GREATER OF THE TOTAL AMOUNT PAID TO VALERA UNDER THIS AGREEMENT
DURING THE TWELVE (12) MONTHS PRECEDING THE EVENT GIVING RISE TO THE DAMAGE OR 5,000,000 USD,
WHETHER SUCH DAMAGES ARISE IN TORT, CONTRACT OR OTHERWISE. IN ADDITION, EXCEPT FOR VALERA’S
LIABILITY PURSUANT TO SECTION 5.3, IN NO EVENT SHALL A PARTY BE LIABLE FOR ANY SPECIAL, INCIDENTAL,
CONSEQUENTIAL OR INDIRECT DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY. THIS LIMITATION
WILL APPLY EVEN IF THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

15.2 Notices. Any notice or other communication required or permitted to be given
hereunder shall be in writing and shall be delivered in person, transmitted by facsimile or sent by
internationally-recognized overnight courier mail, charges prepaid, addressed as follows: to
Valera:

Valera Pharmaceuticals, Inc.

7 Clarke Drive,

Cranbury, New Jersey

08512-3617 USA

Attention: President

Telephone: 609-235-3000

Facsimile: 609-409-1650

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To Spepharm:

Spepharm Holding .B.V

Attention: Jean-Francois

Labbé

Telephone:

Facsimile:

Any such notice or other communication shall be deemed to have been given and received on the day
on which it was delivered or successfully transmitted (or, if such day is not a Business Day, on
the next following Business Day) or, if sent by nationally-recognized overnight courier, on the
date on which it was received or first-attempted delivery. Either Party may change its address for
service from time to time by giving notice thereof to the other Party in accordance with this
Section 15.2.

15.3 Amendments. No amendment or waiver shall be binding on either Party unless in
writing and consented to in writing by such Party. No waiver of any provision of this Agreement
shall constitute a waiver of any other provision, nor shall any
waiver constitute a continuing waiver unless otherwise expressly provided.

15.4 Arbitration. In the event of any controversy or claims arriving out of or in
relation to any provision of this Agreement or the breach thereof, the parties shall first make
reasonable efforts to settle the problem among themselves. Any disputes arising out of or in
connection with this agreement shall finally be settled under the rules of the International
Chamber of Commerce by one or more arbitrators appointed in accordance with such rules. The
language of arbitration shall be English. The place of arbitration shall be London, England.
Notwithstanding the foregoing, a party may seek injunctive and other equitable relief in any court
of competent jurisdiction. The prevailing party’s reasonable attorneys’ and accountants’ fees,
expenses and disbursements) shall be borne by the party against whom judgment is rendered.

15.5 Assignment. The rights and obligations under this Agreement may not be assigned by
Spepharm (except to an Affiliate) without the prior written consent of Valera, which consent shall
not be unreasonably withheld or delayed. Valera may assign its rights and obligations under this
Agreement in its sole discretion, provided that any such assignment by Valera without Spepharm’s
prior written consent shall not relieve Valera of its obligations to Spepharm under this Agreement.

15.6 Further Assurances. Each Party will, from time to time subsequent to the date
hereof, at the request and expense of any other Party, execute and deliver all such documents and
do all such other acts and things as that other Party, acting reasonably, may from

time to time request be executed or done in order to better evidence, perfect or effectuate any
provision of this Agreement or any of the respective obligations intended to be created hereby or
thereby.

15.7 Publicity. Neither Party shall issue any press release or other public announcement
relating to existence or terms of this Agreement without the prior written consent of the other
Party (which consent shall not be unreasonably withheld or delayed), except where such
announcements are required by law or regulation, in which event the Parties will use all reasonable
efforts to consult with each other and cooperate with respect to the wording of any such
announcement. The Parties shall cooperate in issuing an initial public release with respect to the
signing of this Agreement, either separately or as a joint release.

15.8 Counterparts. This Agreement may be executed in counterparts, each of which shall
constitute an original and all of which taken together shall constitute one and the same instrument
in effect as of the date first above mentioned.

15.9 Governing Law. This Agreement shall be governed by and interpreted in accordance
with Laws of the State of New York, U.S.A., regardless of the conflict of law doctrines of any
jurisdiction including New York.

15.10 Language. The Parties confirm that it is their wish that this Agreement as well as
all other documents relating to this Agreement, including notices, have been and shall be drawn up
in the English language only.

15.11 Entire Agreement. This Agreement constitutes the entire agreement between the
Parties with respect to the subject matter of this Agreement and supersedes all prior and
contemporaneous agreements, understandings, letters of intent, negotiations and discussions,
whether written or oral. There are no conditions, covenants, agreements, representations,
warranties or other provisions, express or implied, collateral, statutory or otherwise, relating to
the subject matter of this Agreement, except as provided in this Agreement.

(signature page follows)

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IN WITNESS WHEREOF, this Agreement has been executed by the Parties on the date
first set forth above.

VALERA PHARMACEUTICALS,
INC.

By: /s/ David S. Tierney

David S. Tierney, CEO

Date: September 28, 2006

SPEPHARM HOLDING B.V.

By: Jean-Francois Labbé

Name: Jean-Francois Labbé

Title: Director

Date: Sept. 27, 2006

69

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