EXHIBIT 10.160

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

Execution Copy

AMENDMENT AND AGREEMENT

THIS AMENDMENT AND AGREEMENT (“Amendment”) is made as of November 3, 2006
(“Amendment Effective Date”) by and between Indevus Pharmaceuticals, Inc., a
corporation organized and existing under the laws of the State of Delaware and
having its principal office at 33 Hayden Avenue, Lexington, MA 02421, United
States (“Indevus”), and Madaus GmbH, a successor to Madaus AG, a company with
limited liability organized and existing under the laws of Germany and having
its principal office at Colonia-Allee 15, 51067 Cologne, Germany (“Madaus”).
Indevus and Madaus are collectively referred to herein as the “Parties”.

W I T N E S S E T H:

WHEREAS, on November 26, 1999, Madaus and Indevus entered into a license
agreement granting Indevus an exclusive license under the Madaus Know-How in the
Territory, on the terms and conditions set forth therein, as amended in
Amendment No. 1 thereto mutually executed by the Parties on January 19, 2004
(the “Agreement”);

WHEREAS, the Parties agree that certain provisions of the Agreement should be
amended to reflect the current intentions of the Parties with respect to such
license, and that it is in their mutual best interests to resolve and compromise
amicably any actual or potential disputes and to avoid future disputes arising
under the Agreement, and to provide for certain additional agreements between
the Parties; and

WHEREAS, contemporaneously with this Amendment, the Parties are entering into
the License and Supply Agreement (as defined herein).

NOW, THEREFORE, in consideration of the premises contained herein, and for other
good and valuable consideration, the adequacy and receipt of which are hereby
acknowledged, the Parties hereto intending to be legally bound agree as follows:

1. Definitions and References.

Except as set forth herein, capitalized terms not otherwise defined or amended
in this Amendment shall have the meaning ascribed to them in the Agreement.
Where words and phrases are used herein in the singular, such usage is intended
to include the plural forms where appropriate to the context, and vice versa.
The words “including”, “includes” and “such as” are used in their non-limiting
sense and have the same meaning as “including without limitation” and “including
but not limited to”. Except as otherwise indicated, references to Articles or

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Sections are to the same with all their subparts as they appear in the
Agreement. References to Paragraphs are to the numbered paragraphs with all
their subparts as they appear in this Amendment.

2. Amendments to the Agreement. The Agreement is hereby amended as of the
Amendment Effective Date as set forth in this Paragraph 2 of this Amendment:

(a) The following new Sections are hereby added to Article 1 of the Agreement:

“1.27 “Additional Payment” shall have the meaning set forth in Section 3.7.

1.28 “Amendment” shall mean the Amendment and Agreement by and between Madaus
and Indevus dated November 3, 2006.

1.29 “Compound Supply Agreement” shall mean the Compound Supply Agreement by and
between Madaus and Indevus dated November 3, 2006.

1.30 “Excluded Licensed Product” shall have the meaning set forth in Paragraph
2(f) of the Amendment.

1.31 “Joint Territory” shall mean Canada, Japan, Korea and China.

1.32 “License and Supply Agreement” shall mean that certain License and Supply
Agreement between Madaus and Indevus effective as of November 3 , 2006.

1.33 “Madaus Territory” shall mean worldwide, excluding the Territory and the
Joint Territory.

1.34 “SANCTURA®” shall mean the 20 mg. dosage oral formulation of Compound
marketed on the Amendment Effective Date in the Territory under the tradename
SANCTURA® for twice-daily administration for the treatment of overactive bladder
with symptoms of urge urinary incontinence, urgency and/or urinary frequency.

1.35 “SANCTURA XR™” shall mean a controlled or extended-release oral formulation
of Compound which is intended to be administered once a day, for the treatment
of overactive bladder and/or urinary incontinence.

1.36 “Supply Agreement” shall mean the Supply Agreement by and between Madaus
and Indevus dated as of December 16, 2002.”

(b) The following sentence is added to the end of Section 1.17 of the Agreement:
“Any product (other than an Excluded Licensed Product) which contains Compound
as at least one active ingredient shall also be a “Licensed Product.” The
following sentence is added to the end of Section 1.20 of the Agreement: “The
First Commercial Sale of SANCTURA® occurred on August 23, 2004.”

 

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(c) The last two sentences of Section 2.2 of the Agreement are hereby amended
and restated to read in their entirety as follows:

“Indevus hereby grants to Madaus the right to use Indevus’ clinical and
preclinical data relating to Compound or Licensed Product (other than a Licensed
Product that (i) is a pulmonary inhalation product, or (ii) is an oral liquid
formulation intended for pediatric or elderly use in overactive bladder,
incontinence or detrusor instability) for Madaus’ own regulatory filings
relating to the development and marketing of Compound or such Licensed Product
or both outside the Territory. In addition, it is agreed and understood that
after the applicable Distribution Period, Madaus shall have the right to make,
have made, use, and sell Compound and/or Licensed Product (other than a Licensed
Product that (i) is a pulmonary inhalation product, or (ii) is an oral liquid
formulation intended for pediatric or elderly use in overactive bladder,
incontinence or detrusor instability) in the Territory, by itself or through an
Affiliate, using Indevus’ clinical and preclinical data relating to Compound or
such Licensed Product in regard to Indevus’ regulatory filing.”

(d) Madaus hereby waives and terminates any and all rights to consent to any
sublicensee of Licensed Product. In accordance with the foregoing,
Section 2.3(a) of the Agreement is hereby amended and restated in its entirety
to read as follows:

“(a) Indevus shall have the right to issue sublicenses to Third Parties to make,
have made, use, develop, import, offer for sale, sell or have sold the Licensed
Product in the Territory as long as Indevus has rights thereto under this
Agreement provided, however, that Indevus shall remain responsible for the
performance by the sublicensee of any of Indevus’ obligations to Madaus under
this Agreement.”

(e) The Parties acknowledge that (i) SANCTURA® is, and assuming First Commercial
Sale of SANCTURA XR™, SANCTURA XR™ will be, a Licensed Product; (ii) it is
possible that there may be additional Licensed Products during the term of the
Agreement; and (iii) each Licensed Product has its own First Commercial Sale
date and Distribution Period.

(f) Madaus hereby waives and terminates any and all rights to manufacture and/or
supply (i) SANCTURA XR™; (ii) any Licensed Product that (A) is a pulmonary
inhalation product or (B) is in an oral liquid formulation intended for
pediatric or elderly use in overactive bladder, incontinence or detrusor
instability; and/or (iii) with respect to any Licensed Product sold after
November 12, 2007, Compound (each of the Licensed Products set forth in (i),
(ii) and (iii), an “Excluded Licensed Product”). In consideration thereof,
Indevus agrees to make the payments to Madaus set forth in Section 3.7(b)(ii) of
the Agreement (as amended by this Amendment). Section 3.7 of the Agreement is
hereby amended and restated in its entirety to read as follows:

 

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“3.7 Manufacturing.

(a) Licensed Products other than Excluded Licensed Products.

(i) Subject to the terms and conditions of this Section 3.7, Indevus accepts
Madaus as exclusive manufacturer during the respective Distribution Periods of
(A) SANCTURA® (also subject to the terms and conditions of the Supply
Agreement), and (B) any other Licensed Product that is not an Excluded Licensed
Product; provided that Madaus’ manufacturing facility is in compliance with cGMP
and all other regulatory requirements in the Territory including successful
regulatory inspection of any such facility.

(ii) Indevus reserves the right to appoint a second source supplier of a
Licensed Product subject to Section 3.7 (a) if Madaus fails after reasonable
prior written notice (a) to meet the regulatory requirements with respect to
production of such Licensed Product or (b) is unable to deliver such Licensed
Product in quantities which satisfy Indevus’ reasonable commercial requirements
for that Licensed Product. If Indevus appoints a second source supplier pursuant
to the immediately preceding sentence, Madaus has the right to receive an
adequate royalty, not to exceed [*] of net sales, for giving such a
manufacturing license relying on Madaus Know-How. With respect to any such
Licensed Product manufactured by any such second source supplier and sold by
Indevus or its designees prior to November 12, 2007, such Licensed Product will
be manufactured using Compound supplied by Madaus and purchased by Indevus
pursuant to the Compound Supply Agreement, provided that the Parties acknowledge
and agree that the price for such Compound is not expected to exceed [*]

(b) SANCTURA XR™.

(i) Subject to Section 3.7(c), Indevus or its designees shall have the exclusive
right to manufacture and supply SANCTURA XR™ for use in the Territory, the
Madaus Territory and the Joint Territory, whether as bulk drug product or as
finished product.

(ii) Indevus shall pay Madaus an amount equal to [*] capsules of SANCTURA XR™
sold in the Territory through [*] (the “Additional Payment”). The payment of the
Additional Payment shall be subject to the following:

(A) No Additional Payment shall accrue on the disposition of SANCTURA XR™ by
Indevus, its Affiliates or sublicensees as samples (promotion or otherwise), for
development, testing, clinical trials or as donations (for example, to
non-profit institutions or government agencies for non-commercial purposes);

(B) The Additional Payment shall be reduced by the amount, if any, by which the
cost to Indevus of obtaining Compound from Madaus pursuant to Section 3.7(c) and
the Compound Supply Agreement exceeds the cost at which a Third Party supplier
has agreed to supply Indevus with Compound;

(C) The Additional Payment shall be payable in accordance with the provisions of
Section 5.3;

(D) No Additional Payment shall be payable with respect to any period after the
first Calendar Quarter in which generic formulations of SANCTURA XR™ achieve a
market share of [*] or greater of the total prescriptions for SANCTURA XR™ in
the Territory (as so shown by IMS (or IMS equivalent) data for such
prescriptions in that Calendar Quarter);

 

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[*] CONFIDENTIAL TREATMENT REQUESTED

 

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(E) If, during any portion of any Renewal Supply Term that expires prior to the
expiration of the Manufacturing Payment Term, Indevus’ Manufacturing Costs
exceed the Manufacturing Costs Cap, then the Additional Payment shall be reduced
by the amount by which Indevus’ Manufacturing Costs exceed the Manufacturing
Costs Cap. With the exception of the term “Additional Payment”, all capitalized
terms used in this subsection (E) shall have the respective meanings ascribed to
them in the License and Supply Agreement (which definitions are incorporated by
reference herein); and

(F) Sales of SANCTURA XR™ capsules between Indevus and its Affiliates or
licensees or sublicensees, or among such Affiliates and licensees or
sublicensees, shall not be considered sales of SANCTURA XR™ capsules for
purposes of calculating the Additional Payment, but in such cases the Additional
Payment shall be calculated based on the number of SANCTURA XR™ capsules sold by
such Affiliates or licensees or sublicensees to Third Parties who are not an
Indevus licensee or sublicensee.

(c) Compound. Subject to the terms and conditions of the Compound Supply
Agreement, Indevus or its designees will use Compound supplied by Madaus and
obtained by Madaus from [*] or its Affiliates or successors in connection with
the manufacture of SANCTURA XR™ that is sold by Indevus or its designees prior
to November 12, 2007.”

(g) Section 5.3 of the Agreement is hereby amended and restated in its entirety
to read as follows:

“5.3 Reports; Payment of Royalties and Additional Payment. Following the First
Commercial Sale of a Licensed Product and during the term of the Agreement for
so long as royalty payments or Additional Payments are due, Indevus shall
furnish to Madaus a quarterly written report for the Calendar Quarter (a
“Section 5.3 Report”) showing, as applicable, (a) the sales of all Licensed
Products subject to royalty payments (i.e. not SANCTURA XR™, which is covered in
(b)) sold by Indevus, its Affiliates and its sublicensees in the Territory
during the Calendar Quarter (and a reconciliation of gross sales to Net Sales)
and the royalties payable under this Agreement; and (b) the number of capsules
of SANCTURA XR™ sold in the Territory during the Calendar Quarter by Indevus,
its Affiliates and its licensees or sublicensees subject to an Additional
Payment payable under this Agreement and a calculation of the Additional Payment
payable under this Agreement. Section 5.3 Reports shall be due on the [*]
following the close of each Calendar Quarter, subject to an extension in
accordance with the terms of a sublicensing agreement, but in no event longer
than an additional [*] for a total of [*] following the close of each Calendar
Quarter. Royalties and Additional Payments shown to have accrued by each
Section 5.3 Report, if any, shall be due and payable on the date such report is
due. Indevus shall keep complete and accurate records in sufficient detail to
enable the royalties and the Additional Payment payable hereunder to be
determined.

 

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[*] CONFIDENTIAL TREATMENT REQUESTED

 

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Indevus recognizes that Madaus has an interest in Indevus’ audit rights under
Indevus’ agreements with sublicensees of Licensed Product to the extent that
reports provided to Indevus by such sublicensees cover financial information
that is required to be contained in a Section 5.3 Report. Accordingly, if
Indevus exercises any such audit rights with respect to a specified period, it
shall (a) use an independent certified public accounting firm of recognized
standing; (b) notify Madaus in writing not later than [*] Business Days prior to
the anticipated exercise of such planned exercise and of the name of the
accounting firm (and, as soon as known to Indevus, the name of the individual(s)
at such firm conducting such audit); (c) request, on behalf of Madaus, that such
firm also review, to the extent consistent with contractual rights and
restrictions existing on the Amendment Effective Date, the information necessary
to verify any financial information that is required to be contained in
Section 5.3 Reports for the corresponding period; and (d) provide Madaus a copy
of the portions of the results of any such audit that cover financial
information contained in a Section 5.3 Report, subject to Madaus’ agreement to
the confidentiality obligations contained in Indevus’ agreement with such
sublicensee with respect to such audit.

Indevus shall not enter into a sublicense with respect to a Licensed Product
that is inconsistent with the foregoing sentence and, promptly after entering
into any sublicense with respect to Licensed Product after the Amendment
Effective Date, Indevus shall inform Madaus of Indevus’ audit rights under such
sublicense agreement.

Subject to contractual rights and restrictions existing on the Amendment
Effective Date, in the event that Indevus has not exercised such audit rights
with respect to a specified period within thirty (30) days prior to the
expiration thereof, Madaus shall have the right to request (by providing written
notice of such request that is received by Indevus not later than five
(5) Business Days prior to the expiration thereof), that Indevus exercise such
audit rights on Madaus’ behalf and at Madaus’ cost, in order to request relevant
information necessary to verify any financial information contained in
Section 5.3 Reports for the corresponding period. If so requested by Madaus,
Indevus shall to the extent consistent with contractual rights and restrictions
existing on the Amendment Effective Date, (a) exercise such audit right, (b) use
good faith efforts to provide Madaus with direct contact to the accounting firm
conducting such audit and (c) provide Madaus with a copy of the portions of the
results of any such audit that cover financial information that should be
contained in a Section 5.3 Report, subject to Madaus’ agreement to the
confidentiality obligations contained in Indevus’ agreement with such
sublicensee with respect to such audit. If as a result of any audit requested by
Madaus under this paragraph, an error in favor of Madaus in the payment of
Additional Payments of [*] of the Additional Payments due hereunder for the
period being reviewed is discovered, then the fees and expenses of the
accounting firm shall be reimbursed by Indevus.”

3. Mutual Releases.

(a) Release by Indevus. Indevus, on its own behalf and on behalf of its
Affiliates, predecessors, successors, and assigns and all others claiming by or
through any of the foregoing (collectively, the “Indevus Parties”), hereby
releases and forever discharges Madaus,

 

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[*] CONFIDENTIAL TREATMENT REQUESTED

 

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its Affiliates and their respective assigns, attorneys, agents, legal
representatives, officers, directors, employees, predecessors, successors,
distributors, manufacturers and Affiliates (collectively, the “Madaus
Releasees”) from any and all claims, causes of action, actions, duties, rights,
damages, liabilities, losses, and obligations of every kind and manner
whatsoever, in law or in equity, judicial or administrative, civil or criminal,
whether or not now known, claimed or asserted, which any Indevus Party now has,
had at any time or may in the future claim to have, against any of the Madaus
Releasees based on, arising out of or related to the Agreement or the Supply
Agreement and arising from or relating to any actions, omissions, or events
prior to the Amendment Effective Date, provided, however, that the foregoing
release shall not include, and Indevus shall retain, all claims, causes of
action, actions, duties, rights, damages, liabilities, losses, or obligations
(a) arising out of or under this Amendment, or (b) that are outstanding payment
and/or supply or delivery obligations that have accrued under the Agreement or
the Supply Agreement in the ordinary course of business (i) during the Calendar
Quarter ended September 30, 2006 or (ii) commencing October 1, 2006 through the
Amendment Effective Date.

(b) Release by Madaus. Madaus, on its own behalf and on behalf of its
Affiliates, predecessors, successors, and assigns and all others claiming by or
through any of the foregoing (collectively, the “Madaus Parties”) hereby
releases and forever discharges the Indevus Parties and their respective
assigns, attorneys, agents, legal representatives, officers, directors,
employees, predecessors, successors, distributors, manufacturers and Affiliates
(collectively, the “Indevus Releasees”) from any and all claims, causes of
action, actions, duties, rights, damages, liabilities, losses, and obligations
of every kind and manner whatsoever, in law or in equity, judicial or
administrative, civil or criminal, whether or not now known, claimed or
asserted, which any Madaus Party now has, had at any time or may in the future
claim to have, against any of the Indevus Releasees based on, arising out of or
related to the Agreement or the Supply Agreement and arising from any actions,
omissions, or events prior to the Amendment Effective Date, provided, however,
that the foregoing release shall not include, and Madaus shall retain, all
claims, causes of action, actions, duties, rights, damages, liabilities, losses,
or obligations (a) arising out of or under this Amendment, or (b) that are
outstanding payment and/or supply or delivery obligations that have accrued in
the ordinary course of business under the Agreement or the Supply Agreement
(i) during the Calendar Quarter ended September 30, 2006 or (ii) commencing
October 1, 2006 through the Amendment Effective Date.

4. Representations and Warranties. Each Party hereby represents and warrants to
the other Party that:

(a) Such Party has the requisite corporate power and authority to execute and
deliver this Amendment and to grant the releases and perform its other
obligations hereunder; the execution, delivery and performance of this Amendment
have been duly and validly authorized and no other corporate proceedings are
necessary to authorize this Amendment or the performance hereof or thereof by
such Party; and

(b) This Amendment has been duly and validly executed and delivered by such
Party and, assuming due execution and delivery by the other Party, constitute
the valid and binding obligations of such Party, enforceable against such Party
in accordance with its terms.

 

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5. Other.

(a) From and after the Amendment Effective Date all references to the Agreement
shall mean the Agreement as amended by this Amendment. Except as expressly
amended by this Amendment, all of the provisions of the Agreement shall remain
in full force and effect.

(b) This Amendment may be executed in two or more counterparts, each of which
shall be deemed an original but all of which together shall constitute one and
the same instrument.

(c) This Amendment shall be governed by and construed in accordance with the
laws of the State of Delaware without reference to any rules of conflict of
laws.

(d) All notices, requests and other communications hereunder shall be in writing
and shall be personally delivered or sent by facsimile transmission (and
promptly confirmed by personal delivery, registered or certified mail or
overnight courier) or by registered or certified mail, return receipt requested,
postage prepaid, or sent by internationally-recognized overnight courier, in
each case to the respective address specified below, or such other address as
may be specified in writing to the other party hereto:

if to Indevus to:

INDEVUS PHARMACEUTICALS, INC.

33 Hayden Avenue

Lexington, MA 02421

Attention: Chief Executive Officer

Fax No.: 781-862-3859

if to Madaus to:

MADAUS GmbH

Colonia-Allee 15

51067 Cologne, Germany

Attention: Geschaeftsfuehrung

Fax No.: 011 49 221 8998 759

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IN WITNESS WHEREOF, the Parties have executed this Amendment as of the date
first set forth above.

 

Indevus Pharmaceuticals, Inc. By:  

/s/ Glenn L. Cooper, M.D.

Name:   Glenn L. Cooper, M.D. Title:   Chairman and Chief Executive Officer
Madaus GmbH By:  

/s/ Dr. Kurt N. Gebhart

Name:   Dr. Kurt N. Gebhart Title:   Geschaeftsfuehrer By:  

/s/ Dr. Ing. Freddy Santermans

Name:   Dr. Ing. Freddy Santermans Title:   Geschaeftsfuehrer

 

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