EXHIBIT 10.136

 

CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THISDOCUMENT HAVE
BEEN REDACTED AND HAVE BEEN FILED SEPARATELY WITH THE U.S. SECURITIES AND
EXCHANGE COMMISSION

 

Execution copy 30.01.04

 

AGREEMENT

 

This Agreement is made as of this 22nd day of January of 2004 by and between
FERRER INTERNACIONAL S.A., at Gran Via Carlos III, 94, 08028 Barcelona, Spain
(hereinafter referred to as “Ferrer”), and INDEVUS PHARMACEUTICALS INC.,
(formerly INTERNEURON PHARMACEUTICALS INC.) a corporation having offices at 99
Hayden Avenue, Suite 200, Lexington, MA 02421 (hereinafter referred to as
“Indevus”). All terms not defined herein are used herein as defined in the LA.

 

  A. WHEREAS, Indevus and Ferrer entered into a LA (hereinafter referred to as
“LA”) on January 13th 1993, relating to the licensing of the Preparation in the
Territory;

 

  B. WHEREAS, Indevus submitted an IND number [*] (the “IND”) relating to the
Preparation.

 

  C. WHEREAS, Ferrer desires (i) to seek agreement with Indevus to terminate the
LA, (ii) the assistance of Indevus in the transfer of the Data (as hereinafter
defined) and the IND (iii) the exclusive use of the New Patents, (iv) the
co-operation and assistance of Indevus in the future with respect to certain
technical and regulatory matters relating to the Preparation, and (v) to recover
and assume responsibility, directly or indirectly through a sublicensee, for
marketing the Preparation in the Territory;

 

D. WHEREAS, Indevus desires to enter into this Agreement with Ferrer to effect
the foregoing objectives;

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[*] CONFIDENTIAL TREATMENT REQUESTED

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  E. WHEREAS, both Parties understand and agree that Indevus has not marketed or
sold the Preparation in the Territory during the term of the LA and that Indevus
shall have no right to so market or sell the Preparation under the terms of this
Agreement.

 

NOW, THEREFORE, the Parties agree as follows:

 

  1. Ferrer and Indevus agree to terminate the LA on the terms and conditions
hereinafter contained.

 

  2. Articles 6, 7, 23, 26 and 27 of the LA as well as the Addendum to the LA
signed between the Parties on January 15th 1993, shall survive termination.
Unless otherwise expressly provided herein, all of the other provisions of the
LA shall terminate and be of no further force and effect.

 

  3. In accordance with Article 23 of the LA, Ferrer is not compelled to
indemnify Indevus.. All rights recovered by or transferred to Ferrer or its
designee, as a consequence of the termination of the LA, shall be free of
encumbrances and/or any obligation that Indevus might have acquired with third
parties.

 

  4. Notwithstanding the above, as the sole consideration for the agreement by
Indevus to (i) terminate the LA and the recovery by Ferrer of all rights on the
Compound and the Preparation; (ii) assist Ferrer in the transfer of the Data and
the IND; (iii) assist Ferrer in the future with respect to certain technical and
regulatory matters relating to the Preparation (iv) recognize in favor of Ferrer
the exclusive rights of use and exploitation of U.S. Patents and Patent
applications listed in Schedule A (hereinafter jointly referred to as the “New
Patents”), all of which is agreed to and acknowledged by Ferrer, the Parties
agree as follows:

 

  a) FERRER, its associates, its licensees, and its distributors have an
exclusive right to freely use and dispose of the New Patents in the countries of
the Territory. As a compensation of the aforementioned exclusive right granted
to FERRER, or by FERRER for the license or distribution agreements to third
parties following

 

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execution of this Agreement which relate to the Compound and/or the Preparation,
FERRER shall grant to INDEVUS the right to receive, separately for each one of
the countries of the Territory during the while the New Patents remain in force
and also as long as pending (the “Term”), the following payments, when
applicable:

 

1) In the event that the program is partnered and/or commercialized in the
Territory without additional Phase III clinical data (i.e. pivotal clinical
trial data acceptable to FDA conducted after the effective date of this
Agreement):

 

(i) Ferrer would pay Indevus 50% of all up-front and milestone payments received
by Ferrer from third parties in the Territory, and

 

(ii) Ferrer would pay Indevus royalties of [*]% of the net sales of the Compound
or the Preparation sold by Ferrer, its associates, its licensees, or its
distributors, in the Territory

 

2) In the event that the program is partnered and/or commercialized in the
Territory with additional Phase III clinical data (i.e. pivotal clinical trial
data acceptable to FDA conducted after the effective date of this Agreement)
required prior to approval:

 

(i) Ferrer would pay Indevus 50% of all up-front and milestone payments received
by Ferrer from third parties in the Territory, and

 

(ii) Ferrer would pay Indevus royalties of [*]% of the net sales of the Compound
or the Preparation sold by Ferrer, its associates, its licensees, or its
distributors, in the Territory;

 

(iii)Once the amounts paid by Ferrer to Indevus as a result of this paragraphs
(2) have reached the cumulative total amount of [*]million $US, then INDEVUS
only remaining right will consist in receiving, when applicable, for each one of
the countries of the Territory during the Term a royalty of [*] percent ([*]%)
of the net sales of the Compound or the Preparation sold by Ferrer, its
associates, its licensees, or its distributors in the Territory.

 

 

Notwithstanding Section 4 (a) (2) above, if, under the circumstances described
in Section 4 (a) (2) above only, Ferrer would be unable to obtain an agreement
with a third party in the Territory which will allow

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[*] CONFIDENTIAL TREATMENT REQUESTED

 

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Ferrer to obtain from said third party the [*]% royalty on net sales included in
the LA, then the Parties agree to negotiate in good faith an adjustment of their
respective royalties with the aim of reaching a reasonable and equitable share
of the royalties to be received from the third party by both Indevus and Ferrer.

 

Ferrer will pay any and all royalties owed to third parties by Ferrer in respect
of the manufacture, use or sale of the Preparation or Compound, if any. All
payments to be made under this Agreement shall be make in United States dollars
in the United States to a bank account designated by Indevus. The royalties due
under this Section shall be paid quarterly, within thirty (30) days following
each calendar quarter in which such royalties are earned. Ferrer shall keep
accurate books and accounts of record in connection with the manufacture, use
and/or sale by or for it of the Preparation hereunder. Indevus, at its expense,
through a internationally recognized certified public accounting firm accepted
by Ferrer, shall have the right to access such books and records exclusively and
directly related to and for the sole purpose of verifying the royalty
statements; such access shall be conducted after reasonable prior notice by
Indevus to Ferrer.

 

b) FERRER and INDEVUS shall give notice to the other Party of any infringement
or claim by a third party related to the New Patents of which FERRER or INDEVUS
have knowledge.

 

c) With respect to the rights and obligations of the Parties regarding the use
by Ferrer of the New Patents outside the Territory, the provisions of the
Addendum to the License Agreement shall continue to control. Ferrer agrees to
furnish to Indevus within 30 days after (i) execution of this Agreement and (ii)
the end of each calendar year thereafter, a written report detailing the use of
such New Patents and an accounting of any royalties or other payments received
by Ferrer in respect of such New Patents. Indevus or its designated
representatives shall have a right to audit such reports on an annual basis on
reasonable notice to Ferrer.

 

  5. a) From the date of the signature of this Agreement (“Effective Date”) and
until final regulatory approval (“Approval”) is received for the regulatory
submissions in the

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[*] CONFIDENTIAL TREATMENT REQUESTED

 

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Territory (the “Approval Date”), Indevus shall continue to use reasonable
efforts to assist Ferrer or its designee to directly or indirectly manage the
process of obtaining Approval from the United States Food and Drug
Administration (and/or all agencies under its direct control or any successor
organization) (the “FDA”) permitting the marketing of the Preparation under the
regulatory submissions.

 

Indevus shall provide copies to Ferrer or its designee of all documents, data or
other correspondence received from or proposed to be submitted to the FDA (or
any other regulatory authority) with respect to the Preparation.

 

b) Throughout the regulatory process until the Approval Date, each of Indevus
and Ferrer shall designate a contact person responsible for jointly coordinating
the efforts and interaction of the Parties relating to the regulatory process.
The initial contact persons for the Parties shall be:

 

  (i) For Indevus:

Indevus Pharmaceuticals, Inc.

99 Hayden Avenue, Suite 200

Lexington, MA 02421

Attention: Glenn Cooper, Chairman, President & Chief Executive Officer

 

  (ii) For Ferrer:

Gran Via Carlos III, 94 entlo

08023 Barcelona

Spain

Attention: Mr. Jorge Ramentol, Director General

With a copy to the attention of: Dr. Carlos De Lecea, VP International &
Business Development

 

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  6. Immediately after the Effective Date, Indevus shall take all necessary
steps, including providing all reasonable assistance, executing and delivering
all necessary documents and making all filings with any regulatory authority
necessary to transfer, convey and assign, free of charge, the ownership of any
applications submitted by Indevus to any U.S. regulatory authorities
(“Regulatory Applications”) to Ferrer or its designee.

 

  7. Indevus shall take all necessary steps, including providing all reasonable
assistance, executing and delivering all necessary documents and making all
filings with any regulatory authority necessary to transfer, convey and assign
to Ferrer or its designee, free of charge, all of Indevus’s right title and
interest, if any, in or to the Trademark application and the goodwill (if any)
represented by such trademark (the “Trademark Application”).

 

  8. Indevus shall promptly, but in no event later than 45 business days after
the Effective Date, transfer, assign and convey free of charge to Ferrer, or its
designee, the Original Data, the Additional Data, the Development Work, the Test
Results and all other documents, works or studies referring to the Preparation
and/or the Compound, as well as all available new information referring to the
Preparation and/or the Compound (such items referred to collectively as the
“Data”).

 

  9. Indevus acknowledge and agree that, as of the Effective Date, they shall
have no further rights in or to any Data, and shall have no right to use or to
retain copies or duplicates of such items in any form after the Effective Date
except for one copy to be kept in the Legal Department of Indevus for archival
purposes.

 

  10. Indevus shall keep confidential the Original Data, the Additional Data,
the Development Work and the Test Results, for a period of ten (10) years
following execution of this Agreement.

 

  11. a) Ferrer and Indevus each agree that all information considered
confidential and proprietary by the disclosing party (“Confidential
Information”) communicated to one

 

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of them by the other (or otherwise obtained by the receiving party), including
the existence of and terms of this Agreement, will be received in strict
confidence. The receiving party shall not disclose any Confidential Information
to any third party without the prior written approval of the disclosing party.
The receiving party shall properly safeguard the Confidential Information with
at least the same degree of care that the receiving party uses to protect its
own similar categories of confidential and proprietary information, but no less
than a reasonable degree of care under the circumstances. The receiving party
shall not make any copies of confidential information received from the
disclosing party except as necessary for its employees with a need to know (and
who are subject to a written confidentiality obligation at least as strict as
that contained in this Agreement). Any copies of Confidential Information that
are made shall be identified as belonging to the disclosing party and marked
“confidential,” “proprietary,” or with a similar legend. “Confidential
Information” shall not be deemed to include information which (i) is already
known to the receiving party and not subject to any confidentiality restrictions
at the time it is obtained from the disclosing party, (ii) is or becomes
publicly known through no wrongful act of the receiving party, or (iii) is
rightfully received by the receiving party from a third party without
restriction on further disclosure.

 

b) All notices to third parties and all other publicity and public announcements
concerning the transactions contemplated by this Agreement shall require the
prior written consent of the Party not proposing to generate such publicity,
which consent shall not be unreasonably withheld; provided that Indevus shall be
permitted to disclose the information with respect to this Agreement which
Indevus reasonably believes is required to be disclosed in order to comply with
the periodic reporting requirements of the Securities Exchange Act of 1934 (the
“Act”).

 

  12. Indevus shall refrain from manufacturing and commercializing the
Preparation following execution of this Agreement, and Indevus shall in no event
be entitled to make use of any Data after the Approval Date. This restriction
shall supersede and replace all restrictions on competition by either of the
Original Licensees contained in the LA.

 

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  13. Indevus hereby represents, warrants, and covenants that (i) IND No. [*] is
the only regulatory application submitted by them relating to the Preparation
and the Compound; (ii) all Regulatory Applications and related materials (to the
extent necessary for properly carrying out the Regulatory Process) have been
filed with the FDA and have been maintained in accordance with applicable law;
(iii) there are no outstanding encumbrances, liens, or agreements, either
written, oral, or implied, in connection with the Regulatory Applications, the
Trademark Application, the Original Data, the Additional Data, the Development
Work, or the Test Results; and (iv) Indevus has not filed any patent
applications relating to the Compound or the Preparation other than those
included in Schedule A of this Agreement.

 

  14. Indevus hereby represents, warrants and covenants that, to its best
knowledge, as of the date submitted to the FDA and as of the date transferred,
conveyed and assigned to Ferrer or its designee, the IND contains no material
misrepresentations or omissions.

 

  15. (a) Effective upon the date of this Agreement, Ferrer hereby agrees to
indemnify, save, defend and hold Indevus and its agents and employees harmless
from and against any and all suits, claims, actions, or demands by a third party
for damages, liabilities, expenses and/or loss, including reasonable legal
expense and attorneys’ fees (collectively, “Losses”), resulting directly from
(i) the manufacture, use, development, handling, storage, marketing, sale or
other disposition of the Compound or the Preparation by Ferrer, its Affiliates
or sublicensees, or (ii) Ferrer’s breach in any material respect of any of its
representations, warranties or obligations set forth in this Agreement or
Ferrer’s negligence or willful misconduct; except to the extent such Losses
result from the negligence or willful misconduct of Indevus, its agents or
employees or to the extent Indevus is obligated to indemnify Ferrer for such
Losses as provided in Section 15(b).

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[*] CONFIDENTIAL TREATMENT REQUESTED

 

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(b) Notwithstanding the provisions of Article 7 of the LA which shall survive
termination of the LA, Indevus hereby further agrees to indemnify, save, defend
and hold Ferrer and its agents and employees harmless from and against any and
all Losses resulting directly from (i) Indevus’ breach in any material respect
of any of its representations, warranties or obligations set forth in this
Agreement, (ii) Indevus’ negligence or willful misconduct, except to the extent
such Losses result from the negligence or willful misconduct of Ferrer, its
agents or employees, or to the extent Ferrer is obligated to indemnify Indevus
for such Losses as provided in Section 15(a).

 

(c) In the event that a Party (the “Indemnified Party”) is seeking
indemnification under this Section 15, it shall inform the other Party (the
“Indemnifying Party”) of a claim as soon as reasonably practicable after it
receives notice of the claim, shall permit the Indemnifying Party, at its sole
expense, to assume direction and control of the defense of the claim (including
the right to settle the claim solely for monetary consideration), and shall
cooperate as requested (at the expense of the Indemnifying Party) in the defense
and settlement of the claim. The Indemnified Party shall not voluntarily make
any payment or incur any expense in connection with any claim or suit without
the consent of the Indemnifying Party.

 

  16. All disputes arising under this Agreement shall be governed by and
interpreted under Articles 26 and 27 of the LA.

 

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IN WITNESS WHEREOF, the Parties, through their authorized representatives, have
executed this Agreement.

 

FERRER INTERNACIONAL, S.A.

By:

 

/S/ Carlos De Lecca

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Name:

 

Carlos De Lecca

Title:

 

VP International & Business Development

Date:

 

30th January 2004

INDEVUS PHARMACEUTICALS, INC.

By:

 

/S/ Glenn L. Cooper

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Name:

 

Glenn L. Cooper

Title:

 

CEO

Date

 

1/30/04

 

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SCHEDULE A

 

New Patents

 

US [*]

Method of [*]

Granted: [*]

 

US [*]

Method of [*]

Granted: [*]

 

US [*]

Reduction of [*]

Granted: [*]

 

US [*]

[*], process and use

Issued: [*]

 

US [*]

Method of treating [*]

Filed: [*]

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[*] CONFIDENTIAL TREATMENT REQUESTED

 

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