EXHIBIT 10.208

EXECUTION COPY

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

LICENSE, SUPPLY

AND DISTRIBUTION AGREEMENT

by and between

INDEVUS PHARMACEUTICALS, INC.

and

ORION CORPORATION

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Table of Contents

 

          Page

1.

   DEFINITIONS    2

2.

   RIGHTS GRANTED; RETAINED RIGHTS; NON-COMPETITION; SUBLICENSES    10

3.

   DEVELOPMENT, EXCHANGE OF INFORMATION AND LICENSED PRODUCT REGISTRATION    12

4.

   OVERSIGHT COMMITTEE    20

5.

   FORECASTING AND ORDERING    21

6.

   SUPPLY OF BULK DRUG PRODUCT AND INSERTION TOOLS    24

7.

   UP-FRONT AND MILESTONE PAYMENTS    27

8.

   SUPPLY PRICE AND PAYMENTS    30

9.

   QUALITY OF BULK DRUG PRODUCT    31

10.

   MARKETING    34

11.

   PATENTS    38

12.

   PRODUCT RECALL    41

13.

   BACKUP MANUFACTURING RIGHTS    42

14.

   FORCE MAJEURE    43

15.

   TERM, EXPIRATION AND TERMINATION    44

16.

   REPRESENTATIONS AND WARRANTIES, INDEMNIFICATION AND LIABILITY; INSURANCE   
47

17.

   CONFIDENTIALITY    50

18.

   STATEMENTS TO PUBLIC    50

19.

   PUBLICATIONS    51

20.

   INDEPENDENT CONTRACTORS    51

21.

   NON-WAIVER    51

22.

   ASSIGNMENT    52

23.

   GOVERNING LAW    52

24.

   DISPUTE RESOLUTION    53

25.

   ENTIRE AGREEMENT    53

26.

   SEVERABILITY    53

27.

   AMENDMENTS    54

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28.

   NOTICES    54

29.

   COUNTERPARTS    55

30.

   SCHEDULES    55

31.

   HEADINGS    55

 

ii

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This License, Supply and Distribution Agreement

executed and entered into as of this      day of April, 2008

(hereinafter referred to as “Date of Agreement”)

by and between

Indevus Pharmaceuticals, Inc.

a company duly organised under the laws of the State of Delaware, United States
of America,

and having its principal place of business at

33 Hayden Avenue, Lexington, MA 02421, United States of America

(hereinafter referred to as “Indevus”),

and

Orion Corporation

a company duly organised under the laws of Finland,

(Business Identity Code FI 19992126),

and having its principal place of business at Orionintie 1, FI-02200 Espoo,
Finland,

(hereinafter referred to as “Orion”),(Orion and Indevus also individually
referred to as “Party”,

and collectively as “Parties”)

WITNESSETH

WHEREAS, Orion is engaged, directly and through its Affiliates and Marketing
Distributors (as defined herein) in the business of developing, producing and
selling pharmaceutical products;

WHEREAS, Orion is interested in commercializing Licensed Product for the Initial
Indication in the Territory (each as defined herein) and obtaining from Indevus
an exclusive license under the Indevus Proprietary Rights (as defined herein)
therefor, and Indevus is willing to grant such license to Orion, all on the
terms and conditions of this Agreement; and

WHEREAS, Orion desires to purchase Bulk Drug Product and Insertion Tools (each
as defined herein) from Indevus and Indevus desires to supply Bulk Drug Product
and Insertion Tools to Orion, for use in the Initial Indication in the
Territory, subject to and on the terms and conditions of this Agreement.

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NOW, THEREFORE, Orion and Indevus, in consideration of the premises and of the
mutual agreements, covenants and conditions hereinafter set forth, and for other
good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, agree as follows:

 

1. DEFINITIONS

Unless specifically set forth to the contrary herein, for purposes of this
Agreement, the following terms, where used in the singular or plural, shall have
the respective meanings set forth below:

 

  1.1 “Additional Development” means any development relating to Licensed
Product, other than Registration Studies or development relating to an Initial
Indication Improvement, including development of Additional Indications and/or
Improvements to any Additional Indications, subject to and in accordance with
the provisions of Section 3.1.3.

 

  1.2 “Additional Indication” means any indication for Licensed Product in the
Territory, other than the Initial Indication, for which the Parties have agreed
to pursue Additional Development.

 

  1.3 “Affiliate(s)” means any entity controlling, controlled by or in common
control with a Party hereto, as applicable. For purposes of this definition,
“control” shall mean ownership or control, directly or indirectly, of more than
fifty percent (50%) of the voting stock, equity share capital or other equity
ownership interest.

 

  1.4 “Agreement” means this License, Supply and Distribution Agreement together
with all Schedules attached hereto, as may be amended from time to time in
accordance with the terms and conditions contained herein.

 

  1.5 “Agreement Term” has the meaning set forth in Section 15.1.

 

  1.6 “Batch” means a specific quantity of Bulk Drug Product that is produced
during the same cycle of manufacture. As of the Date of Agreement, one Batch of
Bulk Drug Product consists of approximately [***], provided that (a) the number
of vials in the first [***] Batches and in [***] Batch per year thereafter will
be reduced to reflect stability testing by Indevus in accordance with
Section 9.5, and (b) except as set forth in the foregoing clause or as otherwise
agreed to by the Parties, [***] Batch will not exceed [***] and will not be less
than [***].

 

  1.7 “Business Day” means any day that is not a Saturday or a Sunday or a day
on which the New York Stock Exchange is closed or a day that is a bank holiday
in Finland.

 

  1.8 “Bulk Drug Product” means [***], (a) in bulk form, prior to being in
finished, labelled and packaged form, and (b) otherwise identical to the [***]
comprising the VANTAS® product manufactured for use in the United States, except
that if otherwise defined in Marketing Authorizations in the Territory or
otherwise requested by Orion in Purchase Orders submitted in accordance with
this Agreement, [***] may be marked with the Indevus production lot number.

 

  1.9 “Calendar Quarter” means for each Calendar Year, each of the three
(3) month periods ending March 31, June 30, September 30 and December 31;
provided, however, that (a) the first Calendar Quarter of any particular period
shall extend from the commencement of such period to the end of the first
complete Calendar Quarter thereafter; and (b) the last Calendar Quarter shall
end upon the expiration or termination of this Agreement.

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

2

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  1.10 “Calendar Year” means (a) for the first Calendar Year of the Agreement
Term, the period beginning on the Date of Agreement and ending on December 31,
2008, (b) for each Calendar Year of the Agreement Term thereafter, each
successive period beginning on January 1 and ending twelve (12) consecutive
calendar months later on December 31, and (c) for the last Calendar Year of the
Agreement Term, the period beginning on January 1 of the Calendar Year in which
the Agreement terminates or expires and ending on the effective date of
expiration or termination of this Agreement.

 

  1.11 “CFR” means the United States Code of Federal Regulations.

 

  1.12 “Claim” shall mean a claim, suit, action or proceedings brought by a
Third Party against a Party.

 

  1.13 “CMC Information” means the chemistry, manufacturing and control
information filed by Indevus from time to time with the FDA with respect to
Licensed Product in the Field.

 

  1.14 “Commercially Reasonable Efforts” means, with respect to a Party, the
efforts and resources equivalent to the level that the Party devotes to its
other products of similar commercial potential and a similar stage of
commercialization, development or product life.

 

  1.15 “Competing Product” means any pharmaceutical composition containing
Compound or any other [***] other than (a) the product marketed by Orion on the
Date of Agreement and set forth on Schedule 1.15; (b) a Licensed Product
introduced in the Territory in the Field by Orion or any Affiliate of Orion in
accordance with the terms of this Agreement; or (c) a product deemed to be added
to Schedule 1.15 in accordance with Section 2.5, subject to the provisions of
Section 10.1.2(c).

 

  1.16 “Compound” means [***].

 

  1.17 “Current Good Manufacturing Practices” or the letters “GMP” or “cGMP”
means current good manufacturing practice and standards as provided for (and as
amended from time to time), in (a) the Current Good Manufacturing Practice
Regulations of the U.S. Code of Federal Regulations Title 21 (21 CFR Parts 210
and 211) in relation to the production of pharmaceutical intermediates and
active pharmaceutical ingredients, as interpreted by applicable ICH Harmonised
Tripartite Guideline [Q7] Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients, and (b) European Community Directive 2003/94/EC
(Principles and guidelines of good manufacturing practice in respect of
medicinal products for human use and investigational medicinal products for
human use).

 

  1.18 “Data” means any and all research data, pharmacology data, preclinical
data, clinical data, safety data and/or all other documentation that are
necessary or useful for the development or commercialization of Licensed Product
in the Field and that are submitted or required to be submitted to the FDA or
any Regulatory Authority in the Territory with respect to Licensed Product in
the Field, but excluding any DMFs.

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

3

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  1.19 “DMF” means a Drug Master File as defined in CFR Title 21 part 314,
section 420, including all supplements and amendments thereto.

 

  1.20 “Facility” means Indevus’ facility located in Cranbury, New Jersey,
United States, or any other facility that is identified in the NDA to
manufacture Bulk Drug Product or the Insertion Tools.

 

  1.21 “FDA” means the United States Food and Drug Administration and any
successor agency having substantially the same functions.

 

  1.22 “Field” means human pharmaceutical use of Licensed Product for the
Initial Indication and/or, if applicable, any Additional Indication.

 

  1.23 “Final Packaging” shall mean the packaging and labelling of Bulk Drug
Product to produce finished product, including the primary packaging, secondary
packaging, insertion of package inserts necessary for sale of Licensed Product
for the Initial Indication in each country in the Territory to the ultimate
consumer, storage of the finished product until release for shipment, tertiary
packaging of finished product in a form suitable for shipping and transportation
of finished product under the specified conditions to Orion’s designated
destinations.

 

  1.24 “First Commercial Sale” means the date of the first commercial sale of
Licensed Product for the Initial Indication in the Territory by Orion or its
Affiliates or Marketing Distributors.

 

  1.25 “Improvements” means any and all developments, improvements,
modifications, enhancements or adaptations, such as in the formulation,
preparation, presentation, means of delivery, administration, or dosage, whether
or not patented or patentable, of Licensed Product for the Initial Indication,
which are invented or otherwise come into existence during the Agreement Term
and/or which are derived from the research, development and commercialisation of
the Licensed Product during the Agreement Term for the Initial Indication, in
each case subject to and in accordance with the terms of Section 3.

 

  1.26 “Indevus Know-How” means any and all unpatented information and Data,
materials, inventions, Improvements and know how concerning Licensed Product,
including the NDA, (a) that are necessary, applicable and/or useful for the
development, use and/or commercialization of Licensed Product for the Initial
Indication, (b) that are owned or controlled by Indevus or its Affiliates or
that are generated, developed, discovered, invented or made by or on behalf of
Indevus or its Affiliates during the Agreement Term, and (c) as to which Indevus
has the right to license or sublicense in the Territory. Notwithstanding any
other provision of this Agreement, Indevus Know-How shall not include data,
materials, inventions, improvements, regulatory applications or approvals,
and/or know how relating to Indevus’ product known as Supprelin®-LA.

 

4

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  1.27 “Indevus MAAs” means the existing Marketing Authorizations and Marketing
Authorization Applications in the Territory, including the Variations, owned or
submitted by Indevus with any Regulatory Authority in the Territory as of the
Date of Agreement with respect to Licensed Product for the Initial Indication in
the Territory.

 

  1.28 “Indevus Patent Rights” means any Patents listed on Schedule 1.28 and any
Patents in any country in the Territory (a) that are as of the Date of Agreement
or at any time during the Agreement Term become owned or controlled by Indevus;
(b) that are necessary, applicable and/or useful for the development, use or
commercialization of Licensed Product for the Initial Indication in any country
in the Territory; and (c) as to which Indevus has the right to license or
sublicense in the Territory.

 

  1.29 “Indevus Proprietary Rights” means Indevus Patent Rights and Indevus
Know-How.

 

  1.30 “Initial Indication” means the use of Licensed Product for the palliative
treatment of advanced prostate cancer.

 

  1.31 “Initial Indication Improvement” has the meaning set forth in
Section 3.1.2 (d).

 

  1.32 “Insertion Tools” means the tools used to insert the Licensed Product
implant into a human body, supplied in bulk form and otherwise identical to the
insertion tools used in the VANTAS® product manufactured for use in the United
States except that if required by Regulatory Authorities in the Territory and
requested by Orion, the Insertion Tools shall be provided with [***]

 

  1.33 “Joint Inventions” shall have the meaning set forth in Section 11.5.3.

 

  1.34 “Launch Period” means the period commencing on the Date of Agreement and
expiring on [***].

 

  1.35 “LHRH” means luteinizing hormone-releasing hormone.

 

  1.36 “Licensed Product” means the twelve (12) month hydrogel implant
containing fifty [***]of Compound as the active pharmaceutical ingredient and
the related Insertion Tool referenced in the NDA and sold as of the Date of
Agreement in the United States under the trademark VANTAS® and as referenced in
the Marketing Authorization for VANTAS® in Europe, as it stands following the
Mutual Recognition Procedure [***], including (a) all modified or improved
versions of VANTAS® that would improve the safety or effectiveness of VANTAS®
for use in the Initial Indication; and (b) any other product that the Parties
agree, pursuant to the terms and conditions of Section 3, shall be a Licensed
Product. Notwithstanding any provision of this Agreement, in no event shall
Licensed Product include or be deemed to include the product known as
Supprelin®-LA or any adaptations, modifications, line extensions or other
improvements thereto.

 

  1.37 “Losses” means any and all damages, awards, deficiencies, settlement
amounts, defaults, assessments, fines, dues, penalties (including penalties
imposed by any governmental authority), costs, fees, liabilities, obligations,
taxes, liens, losses, and expenses (including court costs, interest and
reasonable fees of attorneys, accountants and other experts) awarded or
otherwise paid or required to be paid to Third Parties in connection with any
Claims.

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

5

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  1.38 “Major European Countries” means United Kingdom, France, Germany, Italy,
Spain, Finland, Denmark, Norway, and Sweden.

 

  1.39 “Marketing Authorisation” means, with respect to a particular country in
the Territory, all marketing and other authorisations and approvals (including
any required Marketing Authorisation Certificate) by the applicable Regulatory
Authority in such country permitting Licensed Product to be marketed in the
Field in such country including, if applicable, pricing approvals necessary to
obtain reimbursement from a governmental authority.

 

  1.40 “MAA” or “Marketing Authorisation Application” means a marketing
authorization application for obtaining Marketing Authorization in the
Territory, including all supporting documentation and Data included in or
submitted with such application.

 

  1.41 “Marketing Distributor” means a Third Party to whom Orion or its
Affiliate has granted a right to distribute, market, sell and promote Licensed
Product in any country in the Territory.

 

  1.42 “Minimum Requirement” means, with respect to each Calendar Year set forth
on Schedule 1.42, the number of units of Bulk Drug Product listed in Schedule
1.42 corresponding to such Calendar Year.

 

  1.43 “Minimum Requirements Period” shall mean the period commencing on January
1, 2009 and expiring on [***].

 

  1.44 “Mutual Recognition Procedure” shall mean the mutual recognition
procedure for marketing authorization in accordance with Directive
No. 2001/83/EC of November 6, 2001 or any successor regulations and/or
directives.

 

  1.45 “NDA” means the new drug application for marketing authorization of
Licensed Product for the Initial Indication in the United States, owned by
Indevus as of the Date of Agreement (No. 21,732), together with all amendments,
supplements and updates thereto.

 

  1.46 “Net Sales” means the gross amount invoiced by Orion, its Affiliates or
Marketing Distributors on all sales of the Licensed Product in the Field to
Third Parties in the Territory, less the following deductions actually allowed
or taken: (a) returns and/or credits for returns, (b) sales tax, value added
tax, goods and services tax or any other tax that may be imposed on the sale of
such Licensed Product, (c) promotional, cash, trade or volume discounts
including those resulting from governmental or managed care contracts, and
(d) freight, transport and delivery (including insurance).

 

  1.47

“Orion Know-how” means all unpatented information and Data, materials,
inventions, Improvements and know how, including MAAs and Marketing
Authorisations, concerning Licensed Product (i) that are necessary or useful for
the development and/or

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

6

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commercialization of Licensed Product in the Field, (ii) that are generated,
developed, discovered, invented or made by or on behalf of Orion or any of its
Affiliates during the Agreement Term, (iii) that are owned by or become in
Orion’s possession or control during the Agreement Term, and (iv) as to which
Orion has or obtains the right to license or sublicense to Indevus.

 

  1.48 “New EU Member” has the meaning set forth in Section 2.1.

 

  1.49 “Non-Compete Period” has the meaning set forth in Section 2.5.

 

  1.50 “Orion Patent Rights” means any Patents that (i) become during the
Agreement Term owned or controlled by Orion or any of its Affiliates and
(ii) relate to Licensed Product in the Field in the Territory or claim any
Improvement or Additional Indication in the Field made by Orion, including
Orion’s interest in any Patents in Joint Inventions; provided, however, that
“Orion Patent Rights” shall not include Patents owned or controlled by Orion
prior to the Date of Agreement.

 

  1.51 “Oversight Committee” means the committee described in Section 4.

 

  1.52 “Pack”, “Packed”, or “Packing” means the operations which comprise the
packing and packaging of Bulk Drug Product and Insertion Tools, solely for the
purpose of storage and shipment of Bulk Drug Product and Insertion Tools in
accordance with cGMP, as generally described on Schedule 1.52.

 

  1.53 “Patents” means any patents, patent applications, certificates of
invention, or applications for certificates of invention and any supplemental
protection certificates, together with any extensions, registrations,
confirmations, reissues, substitutions, divisions, continuations or
continuations-in-part, reexaminations or renewals thereof.

 

  1.54 “Pharmacovigilance Agreement” means the agreement executed by the Parties
on the Date of Agreement in the form attached as Exhibit 1.54.

 

  1.55 “Population Council Agreement” means the Termination of Agreement dated
September 12, 1990, signed on September 26, 1997 by The Population Council, Inc.
(“The Council”) and on October 1, 1997 by GP Strategies Corporation, the
successor to National Patent Development Corporation, as amended on November 29,
2001 and on August 31, 2004 by The Council and Valera Pharmaceuticals, Inc, a
predecessor of Indevus, as previously provided to Orion and as such agreement
may be amended from time to time during the Agreement Term.

 

  1.56 “Producer Price Index” means the Producer Price Index, Pharmaceutical
Preparations (Series ID 325412325412) as published by the U.S. Department of
Labor, Bureau of Labor Statistics.

 

  1.57 “Proprietary Information” means any and all scientific, clinical,
regulatory, marketing, financial and commercial information or Data, whether
communicated in writing, orally or by any other means, which is owned and/or
under the protection of one Party and is being provided by that Party to the
other Party in connection with this Agreement.

 

7

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  1.58 “Registration Studies” has the meaning set forth in Section 3.1.2.

 

  1.59 “Regulatory Authority” means any governmental regulatory authority,
agency, commission, official or other instrumentality of any federal, state,
county, city or other political subdivision, domestic or foreign, in the
Territory that performs a function for such political subdivision similar to the
function performed by the FDA for the United States with regard to the approval,
licensing, registration or authorization to develop, test, manufacture, package,
market, distribute, use, store, import, transport or sell Licensed Product in
the Field in the Territory or with respect to the approval of pricing or
reimbursement for such product.

 

  1.60 “Sales Critical Product Event” means the occurrence of any of the
following, to the extent not caused by any act or omission on the part of, and
outside the reasonable control of, Orion, its Affiliates or Marketing
Distributors:

 

  (a) any materially adverse change (equivalent to an FDA-mandated addition of a
“Black Box” warning) mandated by Regulatory Authorities in any of the Major
European Countries on the product labelling of Licensed Product for the Initial
Indication that is unique to such product among the class of LHRH agonists for
the Initial Indication;

 

  (b) any recall or withdrawal of Licensed Product for the Initial Indication
mandated by Regulatory Authorities in any of the Major European Countries;

 

  (c) the receipt by Orion of a written Claim asserting a product liability
Claim or that the manufacture, use, sale, offer for sale or importation of
Licensed Product for the Initial Indication in any country of the Territory
infringes a Third Party Patent relating to the Bulk Drug Product and/or
Insertion Tools or the manufacture thereof or a Third Party trademark, as a
result of which Orion withdraws Licensed Product from the market in any of the
countries in the Territory within sixty (60) days from receipt of such Claim; or
a determination by a court of competent jurisdiction in an unappealed or
unappealable decision that a patent or other intellectual property right owned
by a Third Party is infringed by the manufacture, use, sale, offer for sale or
importation of Licensed Product for the Initial Indication in the Territory, and
enjoining such manufacture, use, sale, offer for sale, or importation;

 

  (d) either (i) any significant (at least [***] delay in obtaining Regulatory
Approval of Licensed Product for the Initial Indication in any of the Major
European Countries that is not caused by an act of or failure to act by Orion,
or (ii) an Indevus decision, in accordance with Section 3.1.2(b), that a
Registration Study not be conducted, which decision would result in the
inability to obtain Regulatory Approval of Licensed Product for the Initial
Indication in any of the Major European Countries;

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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  (e) in any Calendar Year, LHRH analogs for the Initial Indication have a
combined market size (in euros) in the Major European Countries of [***] or less
of their combined market size (in euros) for the immediately preceding Calendar
Year; and

 

  (f) failure of Indevus to supply [***] in any Calendar Year at least [***] of
the quantities of Batches of Bulk Drug Product and/or Insertion Tools included
in the Firm Commitment portion of the Initial Forecast or Rolling Forecast, as
applicable, which failure to supply is uncured for at least [***].

 

  1.61 “Supply Price” means the applicable supply price for Bulk Drug Product
and Insertion Tools as set forth on Schedule 8.1, and subject to the provisions
of Section 8.1.

 

  1.62 “Territory” means all of the following: European Union: Austria, Belgium,
Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden
and the United Kingdom; and New European Union candidate countries: Croatia, the
Republic of Macedonia and Turkey; and Other Countries: Switzerland, Norway,
Russia, Ukraine.

 

  1.63 “Test Samples” means the specific quantity of units per Batch of Bulk
Drug Product and Insertion Tools, as applicable, that are required by Regulatory
Authorities in the Territory to be tested to ensure conformance of such Batch
with applicable specifications for release.

 

  1.64 “Third Party(ies)” means a person or entity who or which is neither a
Party nor an Affiliate of a Party.

 

  1.65 “Trademark” means the VANTAS® trademark and/or any other trademarks that
are selected for Licensed Product in the Field in any country in the Territory
pursuant to Section 10.6, including any applications to register trademarks, or
other registrations or applications related to trademarks, common-law trademarks
and rights, service marks, logos, trade names, all rights arising from the use
of or existing in connection with domain names, and all goodwill associated with
the foregoing, if not otherwise defined in this Agreement, and all registrations
and applications for registration of any of the foregoing.

 

  1.66 “Variations” shall have the meaning set forth in Section 3.3.1.

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”. References to Articles, Sections, subsections, and clauses
are to the same with all their subparts as they appear in this Agreement.
“Herein” means anywhere in this Agreement. “Hereunder” and “hereto” means under
or pursuant to any provision of this Agreement.

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

9

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2. RIGHTS GRANTED; RETAINED RIGHTS; NON-COMPETITION; SUBLICENSES

 

  2.1 License Grant. Subject to the terms and conditions of this Agreement,
Indevus hereby grants Orion during the Agreement Term:

 

  2.1.1 an exclusive right and license in the Field under the Indevus
Proprietary Rights solely to import, use, promote, market, offer for sale,
distribute and sell Licensed Product into and throughout the Territory and to
use the Trademark on and in connection with the marketing, sale and promotion of
Licensed Product for the Initial Indication in the Territory; and

 

  2.1.2 a co-exclusive (with Indevus and not any Third Party) right and license
under the Indevus Proprietary Rights to develop Licensed Product for the Initial
Indication in the Territory in accordance with Section 3.1.

Orion, its Affiliates, sublicensees and Marketing Distributors will not supply
or distribute Licensed Product to any customer outside the Territory. In the
event a country that is not in the European Union as of the Date of Agreement
subsequently becomes part of the European Union (a “New EU Member”) but is not
in the Territory, Orion, its Affiliates, sublicensees and Marketing Distributors
will not conduct active sales of Licensed Product to any customer in such New EU
Member.

 

  2.2 Sublicense under Population Council Agreement. The licenses granted to
Orion under Section 2.1 include exclusive sublicenses by Indevus in the Field in
the Territory of Indevus’ rights under the Population Council Agreements to use,
import, offer for sale, and sell Licensed Product in the Field for use in the
Territory. Indevus represents and warrants that the execution and delivery of
this Agreement and the performance of Indevus’ obligations hereunder do not
conflict with or violate the Population Council Agreement. Orion acknowledges
that it is a sublicensee under the Population Council Agreement to the extent
stated in the first sentence of this Section 2.2 and agrees not to act
inconsistently with the terms of the Population Council Agreement to the extent
they are applicable to the sublicenses granted to Orion hereunder and, in
particular, to comply as if specifically applicable to Orion, with Sections
5(e), 6, and 9 of the Population Council Agreement. Provided that Orion is in
compliance with its reporting and reasonably undisputed payment obligations
under this Agreement, Indevus shall pay any amounts that Indevus shall owe to
The Council under the Population Council Agreements by virtue of this Agreement.

 

  2.3 Reserved Rights. All rights not specifically granted to Orion herein are
reserved and retained by Indevus, including all rights under the Indevus
Proprietary Rights outside the Field and outside the Territory, and all rights
to the product known as Supprelin®-LA. Nothing in this Agreement shall be deemed
to constitute the grant of any license or other right to either Party, to or in
respect of any product, patent, trademark, Proprietary Information, trade secret
or other data or any other intellectual property of the other Party, except as
expressly set forth herein.

 

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  2.4 Sublicenses, Marketing Distributors and Subcontractors. Orion shall have
the right to grant sublicenses to an Orion Affiliate under any of the rights or
licenses granted to it by Indevus under this Agreement as set forth in this
Section 2.4. Orion shall advise Indevus at least [***] in advance of any
proposed sublicense and give due consideration to Indevus’ comments with respect
thereto. Any sublicense shall be subject to the terms and conditions of this
Agreement, including the provisions relating to payments. Orion shall be
responsible to Indevus for any non-performance by any sublicensee of Orion’s
obligations under this Agreement that are assumed by the sublicensee and, at
Indevus’ option, any such sublicense between Orion and such sublicensee shall
terminate upon notice by Indevus to Orion in the event the sublicensee
subsequently (such as by divestiture) becomes an entity that is no longer an
Affiliate of Orion. Orion shall also have the right to use Marketing
Distributors for purposes of promoting, marketing, selling and/or distributing
the Licensed Product in the Territory, provided that Orion shall remain
responsible for its commitments and obligations under this Agreement despite
such use. No later than thirty (30) days after entering into any agreement with
any sublicensee or Marketing Distributor as contemplated hereunder, Orion shall
provide Indevus with a full copy of such agreement.

Orion shall have the right to use subcontractors to render services (e.g.,
regulatory services) in relation to this Agreement, provided that Orion shall
remain responsible for all obligations, responsibilities and commitments under
this Agreement notwithstanding such use.

 

  2.5 No Competing Product.

 

  2.5.1 Subject to the terms of this Section 2.5, Orion will not (and will
ensure that its Affiliates and Marketing Distributors that are not wholesalers
do not) at any time during the Non-Compete Period directly or indirectly, in any
country in the Territory, market, import, offer for sale, sell or distribute,
any Competing Product, nor cause any Competing Product to be marketed, imported,
offered for sale or sold or distributed on its own behalf. The Non-Compete
Period shall mean (a) in European Union countries of the Territory (which, for
purposes of this Section 2.5.1, shall include any New EU Member), the period
expiring on the [***] of First Commercial Sale in the European Union countries,
and (b) for all other countries in the Territory, (i) the Agreement Term or
(ii) the maximum period legally possible in accordance with a country’s
mandatory competition laws, on a country-by-country basis, whichever is shorter.
In the event that, after expiration of the Non-Compete Period in any country in
the European Union, Orion directly or indirectly, markets, imports, offers for
sale, sells or distributes in any country in the European Union, any Competing
Product, Orion shall provide Indevus with written notice of such Competing
Product and of Orion’s activities with respect thereto and, upon Indevus’
receipt of such written notice, such Competing Product shall be deemed to be
added to Schedule 1.15 with respect to the European Union and shall be subject
to the provisions of Section 10.1.2(c).

 

  2.5.2

Notwithstanding the provisions of Section 2.5.1, in the event that during the
Non-Compete Period, Orion purchases a Third Party or is purchased by, or takes

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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control of or becomes controlled by a Third Party, which has commercialized (and
is continuing to sell), directly or indirectly, a Competing Product in a country
in the Territory, then Orion or such Third Party shall, within [***] after such
event either (a) cease marketing, or cause its applicable Affiliate to cease
marketing, the Competing Product in that country; or (b) divest, or cause its
applicable Affiliate to divest, the Competing Product in that country.

 

  2.6 Grant-back Right. During the Agreement Term, Orion hereby grants Indevus
the irrevocable, royalty-free and fully paid-up right and exclusive license
under any Orion Know-How and Orion Patent Rights generated by Orion during the
Agreement Term in the course of Orion’s performance of its obligations hereunder
and not otherwise owned by Indevus, solely to develop, manufacture, exploit,
import, use, offer for sale and sell Licensed Product in the Field outside the
Territory.

 

  2.7 Resale Price. The Parties acknowledge that Orion is, and shall at all
times remain, free to set its resale price for the Licensed Product in the
Territory. However, if Orion, its Affiliates or Marketing Distributors sell
Licensed Product to a customer who also purchases other products from any such
entity, Orion agrees not to (and agrees to require its Affiliates and their
Marketing Distributors not to) deal with Licensed Product in a manner that is
intended to disadvantage Licensed Product to the benefit of other products
offered for sale by Orion, its Affiliates or their Marketing Distributors to
such customer.

 

  2.8 Representation and Warranty. Indevus warrants and represents that
(a) Indevus has provided Orion with access to all material Data in Indevus’
possession and control regarding Licensed Product for the Initial Indication,
and (b) there are no pending or, to Indevus’ knowledge, threatened, actions,
suits, investigations, claims, judgments or proceedings relating to the Indevus
Patent Rights in the Territory and Indevus is not aware of any patent not
included in the Indevus Patent Rights that is infringed by the manufacture, use
or sale of Licensed Product for the Initial Indication in the Territory. Orion
represents and warrants that it has utilized its own scientific, marketing and
distribution expertise and experience to analyze and evaluate both the
scientific and commercial value of the Licensed Product for the Initial
Indication.

 

3. DEVELOPMENT, EXCHANGE OF INFORMATION AND LICENSED PRODUCT REGISTRATION

 

  3.1 Development.

 

  3.1.1 General. Except as otherwise set forth herein, from and after the Date
of Agreement, development of Licensed Product in the Field in the Territory
shall be under the general review of the Oversight Committee and the activities
expected to be undertaken in the course of such development are set forth
generally in this Agreement. Orion agrees to perform development activities as
contemplated in this Agreement, if any, in compliance in all material respects
with applicable laws, regulations and guidelines.

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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  3.1.2 Development for Initial Indication: Registration Studies and
Improvements.

 

  (a) Except as otherwise set forth herein, Orion shall be responsible for
conducting, and shall bear all costs associated with, any and all development,
including any preclinical or clinical studies of Licensed Product and any
post-approval or Phase IV studies, required by any Regulatory Authority in the
Territory as a condition to or in connection with Marketing Authorization of
Licensed Product for the Initial Indication in the Territory (the “Registration
Studies”).

 

  (b) Notwithstanding the foregoing, Orion will submit to the Oversight
Committee (or, if the Oversight Committee has been disbanded, to a designated
representative of Indevus) in advance all draft study protocols for the
performance of proposed Registration Studies. Orion shall have the right to make
all decisions with respect to such Registration Studies, except that if Indevus
reasonably believes a proposed Registration Study would have an impact on
Licensed Product outside the Initial Indication or outside the Territory,
Indevus shall have the right to make all decisions with respect to such
Registration Study, subject to the provisions of Section 1.60(d).

 

  (c) Upon the written request of Orion, (a) during the [***] period from the
Date of Agreement or (b) until the last Marketing Authorization in the Territory
has been received, whichever (a) or (b) is later, Indevus shall provide
reasonable assistance in connection with Registration Studies undertaken by
Orion in accordance with this Agreement and with obtaining Marketing
Authorisations in the Territory, provided Orion reimburses Indevus for all
documented [***] associated with providing such assistance, and such assistance
is provided at times and places mutually agreed upon between the Parties. After
such period, Indevus shall not be obligated to, but may if requested by Orion,
elect to continue to provide such assistance on terms that are agreed between
the Parties.

 

  (d)

Either Party may at any time submit to the Oversight Committee a written
proposal for development of an Improvement for the Initial Indication (an
“Initial Indication Improvement”). Such proposal shall contain, at a minimum,
commercially reasonable information supporting the rationale for such
development from a scientific, regulatory and commercial standpoint, as well as
an estimated developmental critical path and an estimate of the time, cost and
economic or other benefit of such efforts. In considering whether to recommend
approval of such proposal for an Initial Indication Improvement, the Oversight
Committee shall evaluate whether the proposed program for such Improvement
(i) has scientific and technical merit and is likely to result in the approval
at least by the FDA and Regulatory Authorities in the Major European Countries
of such Initial Indication Improvement, (ii) is advisable to address safety or
efficacy issues, (iii) whether the commercial return

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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from sales of Licensed Product resulting from such Initial Indication
Improvement in the Territory that may result from such proposed Improvement can
reasonably be expected to offset the cost of development within a reasonable
period of time, and (iv) any other factors relevant to a determination as to
whether to pursue such Initial Indication Improvement.

 

  (e) If development of any such Initial Indication Improvement is approved by
the Oversight Committee, the Oversight Committee shall promptly determine a
development plan and budget for such development including the estimated cost
and scope of work necessary for obtaining any required approval by the FDA in
the United States and/or approval by Regulatory Authorities in the Territory.
Upon receipt of such plan and budget, the Parties shall promptly meet to
negotiate in good faith and determine (i) mutually acceptable terms for
conducting, administering and funding such development taking into consideration
the provisions of subsections 3.1.2(f) and 3.1.2(g) below; (ii) a possible new
supply price for the supply of Bulk Drug Product and/or Insertion Tools
associated with clinical development and commercial use of any product
incorporating or resulting from such Improvement; and (iii) such other material
terms relating to the development and commercialization of any product
incorporating or resulting from such Improvement as may be negotiated between
the Parties.

 

  (f) Notwithstanding any provision of this Agreement, Indevus and Orion each
shall have unilateral discretion to determine if it wants to participate in the
funding of development of any Initial Indication Improvement; provided, however,
that (i) if the Parties cannot reach mutually acceptable terms for the funding
of any such development then Indevus (but not Orion) may exclusively develop
and/or commercialize any product resulting from such development and any such
product shall not be deemed a Licensed Product or otherwise included in the
license granted to Orion under this Agreement, subject to the provisions of
subsection 3.1.2(g); and (ii) Orion’s share of development costs for an Initial
Indication Improvement, if Orion has decided to participate in the funding,
shall be calculated based on the Territory’s [***] for Licensed Product for the
Initial Indication.

 

  (g)

In the event that (i) any development relating to an Initial Indication
Improvement is presented to the Oversight Committee; (ii) Orion does not elect
to participate in the funding of such development within [***] days after such
proposal is presented to the Oversight Committee; and (iii) Indevus funds such
development, then as soon as reasonably practicable after additional material
information or data supporting the proof of concept for the Initial Indication
Improvement is available, Indevus shall submit such data to Orion and Orion
shall have a subsequent option to participate in and/or reimburse Indevus for
Orion’s

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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share of the funding of such development and to obtain rights under this
Agreement in the Territory to any product incorporating such Initial Indication
Improvement or resulting from such development on terms and conditions to be
negotiated in good faith by the Parties within [***] days after providing such
additional information or data or until a mutually agreed extension of said
deadline. Such terms shall include provisions for financial compensation to
Indevus, if any, which may include (i) participation in and/or reimbursement of
development expenses associated with development of such Initial Indication
Improvement; (ii) a new supply price for the supply of Bulk Drug Product and/or
Insertion Tools associated with clinical development and commercial use of the
Initial Indication Improvement and (iii) such other material terms relating to
the development and commercialization of any product incorporating or resulting
from such Initial Indication Improvement as may be negotiated between the
Parties.

 

  3.1.3 Additional Development.

 

  (a) Either Party may at any time submit to the Oversight Committee a written
proposal for Additional Development. Such proposal shall contain, at a minimum,
commercially reasonable information supporting the rationale for such
development from a scientific, regulatory and commercial standpoint, as well as
an estimated developmental critical path and an estimate of the time, cost and
economic or other benefit of such efforts. In considering whether to recommend
approval of such proposal for Additional Development, the Oversight Committee
shall evaluate factors whether the proposed program (i) relates to an Additional
Indication or an Improvement to an Additional indication; (ii) has scientific
and technical merit and is likely to result in the approval at least by the FDA
and Regulatory Authorities in the Major European Countries of such Improvement
to Additional Indication or Additional Indication, (iii) is advisable to address
safety or efficacy issues, (iv) whether the commercial return from sales of
Licensed Product in the Field in the Territory that may result from such
proposed Additional Development can reasonably be expected to offset the cost of
development within a reasonable period of time, and (v) any other factors
relevant to a determination as to whether to pursue such Additional Development.

 

  (b)

If any such Additional Development is approved by the Oversight Committee, the
Oversight Committee shall promptly determine a development plan and budget for
such development including the estimated cost and scope of work necessary for
obtaining any required approval by the FDA in the United States and/or approval
by Regulatory Authorities in the Territory. Upon receipt of such plan and
budget, the Parties shall promptly meet to determine whether the Parties can
reach mutually acceptable terms for (i) conducting, administering and funding

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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such development (taking into consideration the provisions of the following
subsections 3.1.3 (c) and (d)); (ii) if such Additional Development relates to
an Additional Indication, and Orion desires to obtain rights under this
Agreement in the Territory to any product resulting therefrom or for use in such
Additional Indication, financial compensation to Indevus, if any, which may
include milestone payments associated with the development and commercialization
of any product for an Additional Indication; (iii) a new supply price for the
supply of Bulk Drug Product and/or Insertion Tools associated with clinical
development and commercial use of any product incorporating or resulting from
such Additional Development; and/or (iv) such other financial and other material
terms relating to the development and commercialization of any product
incorporating or resulting from such Additional Development as may be negotiated
between the Parties.

 

  (c) Notwithstanding any provision of this Agreement, Indevus and Orion each
shall have unilateral discretion to determine if it wants to participate in the
funding of any Additional Development; provided, however, that (i) if the
Parties cannot reach mutually acceptable terms for the funding of any such
Additional Development then Indevus (but not Orion) may exclusively so develop
and/or commercialize any product resulting from such development and, unless
such product incorporates an Improvement to an Additional Indication that has
previously been agreed by the Parties to be a Licensed Product, any such product
shall not be deemed a Licensed Product or otherwise included in the license
granted to Orion under this Agreement, and such indication shall not be deemed
an Additional Indication, subject to the provisions of subsection 3.1.3(d); and
(ii) Orion’s share of development costs for any Additional Development, if Orion
has decided to participate in the funding, shall be calculated based on the
Territory’s [***] of Licensed Product for the Additional Indication.

 

  (d)

In the event that (i) any Additional Development is presented to the Oversight
Committee; (ii) Orion does not elect to participate in the funding of such
Additional Development within [***] days after such proposal is presented to the
Oversight Committee; and (iii) Indevus funds such development, then as soon as
reasonably practicable after additional material information or data supporting
the proof of concept for the Additional Development is available, Indevus shall
submit such data to Orion and Orion shall have a subsequent option to
participate in the funding of and obtain rights under this Agreement in the
Territory to any product resulting from such Additional Development on terms and
conditions to be negotiated in good faith by the Parties within [***] days after
providing such additional information or data or until a mutually agreed
extension of said deadline. Such terms shall include provisions for financial
compensation to Indevus, if any, which may include

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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participation in and/or reimbursement of development expenses, milestone
payments associated with the development and commercialization of any such
product for an Additional Indication, a new supply price for the supply of such
product, and/or such other financial and other material terms relating to the
development and commercialization of any product.

 

  3.2 Exchange of Information

 

  3.2.1 Within thirty (30) days from the Date of Agreement, Indevus shall
disclose to Orion in writing (either in electronic format or hard copies), all
Indevus Proprietary Rights not previously available or made available to Orion,
as of the Date of Agreement. If at any time during the Agreement Term, any
additional Indevus Proprietary Rights are acquired by Indevus, Indevus shall
promptly upon such acquisition disclose and provide to Orion in writing (in
electronic format or hard copies) any such additional Indevus Proprietary
Rights. If at any time during the Agreement Term, any Orion Patent Rights or
Orion Know How are acquired by Orion, Orion shall promptly upon such acquisition
disclose and provide to Indevus in writing (either in electronic format or hard
copies), any such Orion Patent Rights or Orion Know How.

 

  3.2.2 Each Party shall permit the other Party to access, and shall provide the
other Party on a timely basis with the right to cross-reference and use in
exercising its rights and performing its obligations hereunder with respect to
Licensed Product in the Field, the NDA and the MAAs, as applicable, as well as
such Party’s Data. At the request of the other Party and to the extent legally
permitted and in accordance with the terms of this Agreement, each Party shall
notify the FDA and the appropriate Regulatory Authorities, as applicable, of the
other Party’s right to reference such regulatory filings in regulatory
submissions filed by the other Party in accordance with this Agreement.

 

  3.2.3 Each Party shall share with the other Party any Data or written
communications from any Regulatory Authority (including with respect to
marketing and promotional materials) generated or obtained by such Party during
the Agreement Term in the course of developing or relevant to Licensed Product
for the Initial Indication, any Additional Development or otherwise performing
its activities hereunder. Such sharing by each Party shall take place as soon as
reasonably practicable after such Data become available, but in no event shall a
final study report for a clinical study involving Licensed Product for the
Initial Indication be provided later than [***] months after data base lock for
such study, and provided further that any disclosure of Data to be shared is not
restricted by any Third Party contractual obligations preventing such disclosure
by a Party to the other. Each of Indevus and Orion agrees that it will use
Commercially Reasonable Efforts to avoid subjecting itself to such restrictions
that would prevent such disclosures.

 

  3.2.4

Without limiting the generality of the foregoing, Indevus shall use Commercially
Reasonable Efforts to provide Orion, in response to a written request therefor

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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from Orion, with additional documentation, information and Data that is
(a) included in Indevus Know-How, not previously provided to Orion, and in
Indevus’ possession and control as of the date of Orion’s request; and
(b) reasonably believed by Orion to be required in order to obtain or maintain
Marketing Authorisation for use of Licensed Product for the Initial Indication
in the Territory. Indevus shall use Commercially Reasonable Efforts to provide
such documentation, information and Data within [***] days of Orion’s written
request, provided the nature of such documentation, information and Data can
reasonably be expected to be provided within such [***] day period and, if not,
Indevus shall use Commercially Reasonable Efforts to provide such documentation,
information and Data as soon thereafter as reasonably practicable. For the
avoidance of doubt, Indevus shall have no obligation to conduct or fund, and
Orion shall be responsible for conducting and funding any clinical trials or
other development activities required and intended for use in obtaining
Marketing Authorisations in the Territory, subject to and in accordance with
this Agreement.

 

  3.2.5 With respect to adverse drug experiences reports relating to Licensed
Product in the Field, the Parties are simultaneously entering into the
Pharmacovigilance Agreement to provide operating procedures for the exchange of
safety information between the Parties sufficient to enable each Party to comply
with its legal obligations to report to the appropriate Regulatory Authorities
in the countries in which Licensed Product is being developed or commercialized
by such Party, in accordance with the appropriate laws and regulations of the
relevant countries and authorities.

 

  3.3 Licensed Product Registration and Regulatory Matters

 

  3.3.1 Assignment of Indevus MAAs. The Parties acknowledge that prior to the
Date of Agreement, Indevus has submitted variations to the Indevus MAAs as
described on Schedule 3.3 (the “Variations”), primarily intended to harmonize
the manufacturing process. Within thirty (30) days from the Date of Agreement,
Indevus shall submit to the applicable Regulatory Authorities in the Territory
an authorization to transfer to Orion ownership of the Indevus MAAs. Orion shall
cooperate with such transfer, including by executing and submitting on a timely
basis any required information or documentation requested by any Regulatory
Authority in the Territory in connection with such transfer of ownership and
acknowledging Orion’s commitment to assume ownership of Marketing Authorisations
and MAAs in the Territory. Orion shall assume such ownership and the related
obligations thereof effective upon such transfer.

 

  3.3.2 Ownership of Regulatory Filings.

 

  (a)

Upon the effectiveness of the transfer to Orion of ownership of the Indevus
MAAs, the Indevus MAAs, as well as any other Marketing Authorisations obtained
by Orion during the Agreement Term, shall during the Agreement Term and
thereafter, unless the provisions of Section 15.9.2 are applicable, be owned by
and in the name of Orion.

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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Except as otherwise specifically set forth in this Agreement, from and after the
effectiveness of such transfer, Orion shall have sole legal and financial
responsibility for (i) the preparation, filing and prosecution and maintenance
of all Marketing Authorisations, MAAs, and any other submissions, filings and/or
other regulatory applications (including for any Final Packaging and for any
promotional materials) and any additional required reports (including reporting
of adverse drug experiences) and documentation, required to obtain, prosecute
and maintain Marketing Authorisations for Licensed Product for the Initial
Indication in the Territory, (ii) all interactions with Regulatory Authorities
in the Territory regarding such Marketing Authorizations and MAAs, and (iii) the
timely payment of all associated fees, charges and other payments.

 

  (b) Orion shall use Commercially Reasonable Efforts to submit, prosecute,
obtain and maintain, as applicable, MAAs and Marketing Authorisations in the
Territory as soon as reasonably practicable. Orion shall notify a designated
person at Indevus promptly after the submission and filing of any MAA, the
receipt of any Marketing Authorizations, with respect to any material changes or
material problems that may arise in connection with its MAAs or Marketing
Authorisations in the Territory, and of the First Commercial Sale in the
Territory.

 

  3.3.3 CMC Information and DMFs. Notwithstanding the provisions of this
Section 3.3, with respect to any updated CMC Information required to be
submitted to any Regulatory Authority in the Territory, to the extent required,
Indevus shall prepare and deliver to Orion any additional reports required to
update such CMC Information. Within fifteen (15) Business Days after receiving
such reports from Indevus, Orion shall submit with the appropriate Regulatory
Authorities any variations or other amendment or supplement as required to the
Marketing Authorisations or MAAs in the Territory, provided that all relevant
information and reports to do the submission have been provided to Orion by
Indevus. Orion shall provide Indevus as soon as practicable with a copy of any
comments received by Orion from any Regulatory Authority in the Territory
relating to updated CMC Information and Indevus shall reasonably cooperate with
Orion to provide a response to such comments as soon as reasonably practicable
and within timelines set by the Regulatory Authorities. Indevus shall be
responsible for ensuring that its Third Party manufacturers file in the
Territory any required DMFs relating to Compound and provide the right to
reference in the MAAs any such DMFs.

 

  3.3.4 Neither Party gives any warranty nor makes no representation, express or
implied, to the other Party that any Regulatory Authority will accept any MAA or
any variation thereto or that Marketing Authorisation of the Licensed Product
for the Initial Indication, including the Variations, will be granted in the
Territory, or that any Regulatory Authority will not require further data,
documentation and/or information, or further studies or trials with respect to
the Licensed Product for the Initial Indication as a pre-requisite for granting
or maintaining the Marketing Authorisation or otherwise.

 

19

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4. OVERSIGHT COMMITTEE

 

  4.1 Members. As of the Date of Agreement, the Parties shall establish an
oversight committee (“Oversight Committee”) to function as a forum for the
Parties to inform and consult with one another concerning progress of the
development and commercialization of Licensed Product in the Territory and as
the initial forum to render decisions thereto. The Oversight Committee shall
include two (2) representatives of each Party from the appropriate departments.
The initial members of the Oversight Committee as of the Effective Date are set
forth on Schedule 4.1. Either Party may replace any or all of its
representatives on the Oversight Committee at any time upon written notice to
the other Party. A Party may designate a substitute to temporarily attend and
perform the functions of such Party’s designated representative at any meeting
of the Oversight Committee. The Oversight Committee shall initially be chaired
by a representative of Indevus; for each subsequent one-year period,
representatives of the Parties shall alternate as the chairperson of the
Oversight Committee. The chairperson shall appoint a secretary of the Oversight
Committee, who shall be a representative of the other Party.

 

  4.2 Role and Responsibilities. In particular, the Oversight Committee shall
perform the following functions:

 

  4.2.1 Oversee the development of Licensed Product in the Field in the
Territory (including any Registration Studies), including review of draft study
protocols for the performance of Registration Studies by Orion;

 

  4.2.2 Review commercialization activities with respect to Licensed Product in
the Field in the Territory, excluding any matters concerning pricing;

 

  4.2.3 Monitor regulatory strategy and communications in the Territory;

 

  4.2.4 Evaluate Phase IV Clinical Trials;

 

  4.2.5 Evaluate Additional Development including opportunities for Additional
Indications with respect to Licensed Product; and

 

  4.2.6 Have such other responsibilities as may be assigned to the Oversight
Committee pursuant to this Agreement or as may be mutually agreed upon by the
Parties from time to time.

 

  4.3

Meetings. The Oversight Committee shall meet at least twice annually, unless
otherwise agreed and may be called by either Party with not less than ten
(10) Business Days notice to the other unless such notice is waived. Such
meetings shall alternate between Indevus and Orion locations or such other
location as may be mutually agreed upon by the Parties and be held at such times
as are mutually agreed upon by the Oversight Committee. The Oversight Committee
may be convened, polled or consulted

 

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from time to time by means of telecommunication or correspondence. Each Party
will disclose to the other proposed agenda items reasonably in advance of each
meeting of the Oversight Committee. The meetings of the Oversight Committee
shall be documented in written minutes to be approved by both Parties. Each
Party shall bear its own costs for participation in the Oversight Committee. Any
Proprietary Information disclosed in any meeting of the Oversight Committee by a
Party shall remain Proprietary Information of such Party, subject to the terms
and conditions of this Agreement.

 

  4.4 Decision Making. For the avoidance of doubt, the Parties understand and
agree, that all decisions concerning pricing of Licensed Product in the Field in
the Territory shall be made solely by Orion. The Oversight Committee may make
decisions with respect to the matters defined in Section 4.2. The Oversight
Committee shall use its good faith efforts to resolve by consensus any issue
before it. The Oversight Committee shall give consideration to the views,
position and recommendations of each Party on any issue that has been brought
before the Oversight Committee. If the Oversight Committee shall arrive at a
consensus on any issue, such consensus shall be binding upon the Parties. All
decisions of the Oversight Committee shall be made by unanimous vote or written
consent, as indicated by all members signing the written minutes, with Orion
representatives collectively having one (1) vote and Indevus representatives
collectively having one (1) vote in all decisions. If the Oversight Committee
cannot reach consensus on a matter brought to its attention, then any Oversight
Committee member may submit the issue to a representative of each Party at the
executive officer level for resolution. The executive officers shall attempt in
good faith to resolve any issue presented to them by the Oversight Committee. In
the event that the executive officers cannot resolve the issue within twenty
(20) Business Days after the issue has been brought to their attention[***]

 

  4.5 Disbanding of Oversight Committee. The Parties shall have the right to
disband the Oversight Committee upon mutual agreement. Additionally, to the
extent the Oversight Committee is not disbanded pursuant to the preceding
sentence, the Oversight Committee shall be automatically disbanded effective on
the fifth anniversary of the Date of Agreement unless the Parties mutually agree
to extend such period prior to the expiration of such five year period.

 

  4.6 No Amendment. The Oversight Committee shall have only the powers assigned
to it in this Article 4. All activities conducted by the Oversight Committee
shall be consistent with and subject to the provisions of this Agreement, and
the Oversight Committee shall not have any power to take any action that
conflicts with the terms of this Agreement or to amend, modify or waive
compliance with this Agreement.

 

5. FORECASTING AND ORDERING

 

  5.1

Initial Forecasts. At least [***] months prior to the estimated initial launch
date of Licensed Product for the Initial Indication in the Territory (the
“Launch Date”) or within [***] days after the Effective Date, whichever is
later, Orion shall furnish to Indevus a written forecast of its estimated
requirements for Bulk Drug Product for the

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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eight (8) Calendar Quarters (broken down by Calendar Quarter) commencing with
the Calendar Quarter in which the Launch Date is estimated to occur (even if
such Calendar Quarter is less than a complete Calendar Quarter) (the “Initial
Forecast”). On June 30, 2008, Orion shall provide Indevus with an updated
Initial Forecast.

 

 

5.2

Rolling Forecasts. Commencing on September 30, 2008, and thereafter on a
quarterly basis not later than the last Business Day of each Calendar Quarter
during the Agreement Term, Orion shall provide Indevus with an updated forecast
(the “Rolling Forecast”) of its estimated requirements of Bulk Drug Product for
the [***] Calendar Quarters commencing at the beginning of the second
(2nd) complete Calendar Quarter that commences after the date of such forecast,
broken down by Calendar Quarter. Each Initial Forecast and Rolling Forecast
provided during the Launch Period is referred to as a “Launch Period Forecast”.

 

  5.3 Firm Commitment. The (a) [***] of each Launch Period Forecast, and
(b) [***] of any Rolling Forecast that is not a Launch Period Forecast, shall
constitute a firm order for the quantities of Bulk Drug Product and a binding
commitment to submit Purchase Orders for the quantities of Bulk Drug Product
specified therein (“Firm Commitment”). Except as set forth in Section 5.4 and
Section 5.5, the following [***] Calendar Quarters of a Launch Period Forecast
and the following [***] Calendar Quarters of any Rolling Forecast that is not a
Launch Period Forecast shall be non-binding, good faith estimates for planning
purposes only and shall not constitute binding commitments by Orion to purchase
Bulk Drug Product. The minimum size of a Firm Commitment (consisting of one
delivery) shall be one Batch of Bulk Drug Product and all quantities of Bulk
Drug Product shall be forecasted in multiples of full Batch quantities. The
number of Insertion Tools deemed to be included in the Firm Commitment shall be
determined in accordance with the last sentence of Section 5.6.2.

 

  5.4 Subject to the provisions of Section 5.5, each Rolling Forecast provided
by Orion shall supersede any previous Rolling Forecast solely with respect to
Calendar Quarters which were not previously part of the Firm Commitment portion
of the Rolling Forecast, provided, however, that if Orion fails to timely
provide a Rolling Forecast, the most recently provided Initial Forecast or
Rolling Forecast, as applicable (including with respect to the Firm Commitment
portion), shall be deemed resubmitted for the then-current Calendar Quarter. If
any such resubmitted Rolling Forecast does not cover the Calendar Quarter then
in question, the last Calendar Quarter of the resubmitted Rolling Forecast shall
apply to the then-current Calendar Quarter(s).

 

  5.5 Variation of Initial Forecasts and Rolling Forecasts. Except as may
otherwise be mutually agreed between the Parties, with every quarterly update of
an Initial Forecast or Rolling Forecast, Orion may:

 

  5.5.1 with respect to Initial Forecasts:

 

  (a) not increase or decrease the forecast for the first Calendar Quarter (Q1)
of any updated Initial Forecast from the first Initial Forecast provided under
Section 5.1;

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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  (b) increase the forecast for the second Calendar Quarter (Q2) of any updated
Initial Forecast from the first Initial Forecast provided under Section 5.1 by
[***]; and

 

  (c) increase or decrease the forecast for the respective Calendar Quarters
[***] of any updated Initial Forecast by not more than [***] from the amount
forecasted for such Calendar Quarter in the first Initial Forecast provided
under Section 5.1;

 

  5.5.2 with respect to Launch Period Forecasts other than Initial Forecasts:

 

  (a) increase the forecast for the [***] Calendar Quarter [***] of the Launch
Period Forecast as that Calendar Quarter rolls from [***]; and

 

  (b) increase or decrease the forecast for the respective Calendar Quarters
[***] of the Launch Period Forecast by not more than [***] from the amount
forecasted for such Calendar Quarter in the preceding Launch Period Forecast;

 

  5.5.3 with respect to Rolling Forecasts that are not Launch Period Forecasts:

 

  (a) increase the forecast for the [***] of the Rolling Forecast as that
Calendar Quarter rolls from [***]; and

 

  (b) increase or decrease the forecast for the respective Calendar Quarters
[***] of the Rolling Forecast by not more than [***] from the amount forecasted
for such Calendar Quarter in the preceding Launch Period Forecast.

 

  5.6 Purchase Orders.

 

  5.6.1 At least [***] days before the requested delivery dates of Bulk Drug
Product and Insertion Tools, and not more often than on a monthly basis (and
provided on the last Business Day of a month), Orion shall provide Indevus with
a firm, binding, non-cancelable purchase order on the standard purchase order
forms of Orion for the aggregate number of Batches of Bulk Drug Product
specified in the applicable Firm Commitment portion of the Rolling Forecast,
designating for each Batch the number of units of Bulk Drug Product and the
number of units of Insertion Tools required as Test Samples of each and
specifying the requested delivery dates for each Batch (“Purchase Order”).

 

  5.6.2

Each Purchase Order covering any Firm Commitment portion of a Rolling Forecast
shall be for the full Batch quantities of Bulk Drug Product constituting the
Firm Commitment portion of the applicable Rolling Forecast and shall conform to
the terms of this Agreement. Indevus will confirm receipt and accept or reject
each such Purchase Order within ten (10) Business Days from the receipt thereof.
Assuming Indevus accepts a Purchase Order, Indevus shall fulfil the Firm
Commitment portion of the Purchase Order by delivering the number of Batches

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

23

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of Bulk Drug Product ordered on the requested delivery date in accordance with
Section 6.2. In fulfilling Purchase Orders hereunder, Indevus shall also supply
Orion with the number of Insertion Tools at least equal to (a) the number of
units of Bulk Drug Product per Batch that were not designated in the applicable
Purchase Order as Test Samples, plus (b) the number of units of Insertion Tools
that were designated in such Purchase Order as Test Samples.

 

  5.6.3 Indevus may reject a Purchase Order, in whole or in part, if: (a) the
delivery date is less than [***] days from the date of Indevus’ receipt of such
Purchase Order; or (b) the volume under the Purchase Order and all other
accepted Purchase Orders covering the applicable Calendar Quarter exceeds the
Firm Commitment set forth in Orion’s then-current Rolling Forecast for such
Calendar Quarter. Notwithstanding the foregoing, Indevus shall use Commercially
Reasonable Efforts to satisfy that portion of any Purchase Order that exceeds
the Firm Commitment with respect to such Calendar Quarter by one Batch (“Excess
Portion”) subject to Indevus’ other supply commitments, the availability of
Compound, and manufacturing and equipment capacity. Within ten (10) Business
Days of Indevus’ receipt of any Purchase Order that includes any Excess Portion,
Indevus shall confirm the extent to which it can supply such Excess Portion on
the delivery date requested in the Purchase Order or, if unable to so supply the
Excess Portion by such delivery date, the earliest delivery date(s) on which it
can supply such Excess Portion, provided, however, that Indevus’ failure to so
deliver the Excess Portion shall not be a breach of this Agreement.

 

6. SUPPLY OF BULK DRUG PRODUCT AND INSERTION TOOLS

 

  6.1 Subject to the terms and conditions of this Agreement, during the
Agreement Term, Indevus (or its designees) shall have the exclusive right to
supply Orion with quantities of Bulk Drug Product and Insertion Tools requested
by Orion in Purchase Orders in accordance with this Agreement for use in the
Initial Indication in the Territory, and Orion shall purchase from Indevus all
requirements of Orion, its Affiliates, sublicensees and Marketing Distributors
of Bulk Drug Product and Insertion Tools, at the applicable Supply Price. The
Parties acknowledge and agree that Indevus obtains Compound, the Insertion Tools
and other components of the Bulk Drug Product through contractual arrangements
with Third Party manufacturers and shall continue to have the right to
subcontract with Third Parties for the performance of its obligations hereunder,
provided, that Indevus shall remain responsible for its commitments and
obligations under this Agreement despite such use.

Without prejudice to any rights or remedies available to Orion under law or this
Agreement, Indevus agrees upon first knowledge thereof to notify Orion of any
actual or anticipated delay in any delivery of Bulk Drug Product and/or
Insertion Tools.

 

  6.2 Indevus undertakes during the term of this Agreement to supply such
quantities of Bulk Drug Product and Insertion Tools that are subject to a Firm
Commitment portion of a Rolling Forecast and Purchase Order covering such Firm
Commitment submitted pursuant to Section 5.6, by the delivery date specified in
such Purchase Order, provided such delivery date is at least [***] days from the
date of the applicable Purchase Order.

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

24

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  6.3 All shipments of Bulk Drug Product and Insertion Tools to Orion shall be
by a carrier selected by Orion, [***] made part of this Agreement by reference)
Indevus’ Cranbury, NJ, USA Facility, provided that Indevus shall be responsible
for loading the Bulk Drug Product and Insertion Tools at such Facility, at which
time and place title and risk of loss shall pass to Orion. If Orion does not
timely indicate in writing its selection of a carrier to Indevus, Indevus shall
be entitled to select an appropriate carrier. No general terms and conditions of
either Party that are inconsistent with the terms of this Agreement shall apply
to supply of Bulk Drug Product and Insertion Tools hereunder.

 

  6.4 Indevus will provide shipment preparation and Packing of Bulk Drug Product
and Insertion Tools in accordance with cGMP and as generally described on
Schedule 1.52. Indevus shall be responsible for obtaining, at its sole cost and
expense, all materials necessary for Packing Bulk Drug Product and Insertion
Tools in accordance with cGMP. It is agreed that all costs and expenses for
Packing materials shall be deemed included in the Supply Price.

 

  6.5 Shipping Costs. If Indevus pays any of the shipping costs on behalf of
Orion, then Indevus shall invoice such shipping costs to Orion and Orion shall
pay such documented costs in accordance with the provisions of Sections 8.2 and
8.3.

 

  6.6 Failure to Take Delivery. Orion shall provide Indevus with not less than
[***] prior written notice, or as close thereto as reasonably possible, if it
will not take delivery of any Bulk Drug Product and Insertion Tools at the
Facility on the scheduled delivery date. Notwithstanding the foregoing, if Orion
or its designee fails to take delivery of any Bulk Drug Product and Insertion
Tools at the Facility within [***] Business Days from the scheduled delivery
date, Orion shall be invoiced on the last day of each month for administration
and storage costs. For all such undelivered Bulk Drug Product and Insertion
Tools, Orion agrees that: (a) Orion has made a fixed commitment to purchase such
Bulk Drug Product and Insertion Tools, (b) risk of ownership for such Bulk Drug
Product and Insertion Tools passes to Orion, (c) such Bulk Drug Product and
Insertion Tools shall be on a bill and hold basis for legitimate business
purposes, (d) Indevus shall have the right to ship the Bulk Drug Product and
Insertion Tools to Orion within [***] months after the scheduled delivery date,
and (e) Orion will be responsible for the Supply Price for such Bulk Drug
Product and any shipping costs incurred by Indevus.

 

 

6.7

Inventory. In order to secure the availability and timely delivery of the Bulk
Drug Product and Insertion Tools to Orion, commencing during the second
(2nd) Calendar Quarter of the first Rolling Forecast in which such Calendar
Quarter occurs after the launch date of Licensed Product for the Initial
Indication in the Major European Countries, Indevus undertakes to use
Commercially Reasonable Efforts to keep at all times, at its sole cost, expense
and responsibility, in its premises inventory of Bulk Drug Product and Insertion
Tools in accordance with this Section 6.7. The quantities of Bulk Drug Product
and Insertion Tools to be held as inventory by Indevus shall correspond to

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

25

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the quantities of Bulk Drug Product and Insertion Tools forecasted for the [***]
of each Rolling Forecast that is submitted by Orion to Indevus immediately prior
to the then current Rolling Forecast. Unless and until Marketing Authorisation
in the Territory is obtained for [***] month dating with respect to Bulk Drug
Product (a) such inventory shall not be required to meet the shelf life
requirements set forth in Section 6.8 (but shall be as long as reasonably
possible under the circumstances); and (b) such inventory shall be included in
the Firm Commitment portion of the Rolling Forecast (and be shipped in
fulfilment of the corresponding Purchase Order), as the second Calendar Quarter
rolls to the first Calendar Quarter in the updated Rolling Forecast. For the
avoidance of doubt, the Parties expressly agree that the costs and expenses
incurred by the Indevus as result of keeping such inventory shall be deemed
already included in the Supply Price.

 

  6.8 All Bulk Drug Product and Insertion Tools supplied by Indevus hereunder
shall (a) be manufactured at the Facility or, if applicable, the Subcontracting
Manufacturer and (b) except Bulk Drug Product that constituted inventory held in
accordance with Section 6.7, have a remaining shelf life of at least [***] of
the total shelf life .

 

  6.9 Change Management.

 

  6.9.1 Change Required by Indevus. If Indevus wishes or is required by the FDA
to make a change to the specifications of the Bulk Drug Product or Insertion
Tools, the manufacturing process, or the Facility, in each case which may have
an impact on the Marketing Authorizations in any countries of the Territory (“US
Change Request”), Indevus shall provide Orion the necessary information in a
mutually agreed upon format for Orion’s annual report and Orion will submit such
information to the appropriate Regulatory Authorities in the Territory along
with any other necessary regulatory filings. Orion shall be responsible for any
related filings required by any Regulatory Authority in the Territory and
Indevus will reasonably assist Orion to meet the respective governmental and/or
regulatory requirements which, in Indevus’ judgment, must be fulfilled before
implementation of the respective change.

 

  6.9.2 Change Required by Orion. If a Regulatory Authority in the Major
European Countries requires a change to the specifications, the manufacturing
process, the Facility or any other aspects with respect to the Bulk Drug Product
(“Territory Change Request”), Orion shall submit to Indevus in writing and in
English details of the requested change. Indevus shall review such Territory
Change Request and provide Orion with a summary of its likely effect on Indevus’
production systems, the capital equipment and/or costs necessary to implement
such a change as well as any impact on the Supply Price, if any. If Indevus
believes that meetings should be held with a Regulatory Authority in the
Territory regarding the basis of such Territory Change Request, Orion will not
unreasonably withhold its consent to do so and Indevus will be included in all
such meetings. Indevus will use Commercially Reasonable Efforts to implement the
Territory Change Request.

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

26

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  6.9.3 Costs. [***] shall bear all costs arising from and associated with
implementing a US Change Request, except to the extent any such costs would
otherwise have been incurred by [***] in connection with its commercialization
of Licensed Product in the Field in the Territory hereunder, and [***] shall
bear all costs arising from and associated with implementing a Territory Change
Request except such changes that are primarily intended to benefit the Facility
or the manufacturing process.

 

  6.10 Facility Inspection. During the Agreement Term, Orion is entitled upon
prior written notice, not more than once per Calendar Year, to visit Indevus,
its Affiliates or Third Party manufacturer of Compound and carry out in a
reasonable manner audits of the Facility in which the Bulk Drug Product is
manufactured to verify compliance with cGMP and with Indevus’ obligations under
this Agreement. Such visits shall be arranged during normal working hours within
two (2) weeks from the date of Orion’s notice. For purposes of such audits,
Indevus undertakes to co-operate in good faith with Orion and provide Orion with
such manufacturing and quality control records relating to the Bulk Drug Product
and/or Insertion Tools, which Orion may reasonably request to verify such
compliance. Orion shall indemnify and hold harmless Indevus for any action or
activity of such representatives while on Indevus’ premises in accordance with
this Agreement, except to the extent resulting from Indevus’ negligence or
willful misconduct. In the event of a safety or health or other emergency
related to the Product, Indevus shall use Commercially Reasonable Efforts, in
good faith and commensurate with the urgency of the circumstances, to allow
Orion to initiate any inspection under this Section 6.10 (which shall be in
addition to any annual inspection referred to in the first sentence of this
Section 6.10) upon forty-eight (48) hours notice during regular business hours.
Indevus shall use Commercially Reasonable Efforts to permit Orion to have the
same rights, subject to the same obligations, set forth in this Section 6.10
with respect to the Facility in which the Insertion Tools are manufactured.

 

  6.11 Packaging and Labeling. Orion shall be solely responsible for Final
Packaging, at its own cost and expense, and for ensuring that all Final
Packaging, labels and labelling, including the package make-up, package inserts
and other elements relating to packaging, labels and labelling, as well as all
promotional materials, comply with all applicable laws and regulations in the
Territory. Orion will establish, update as necessary and implement processes and
procedures designed to ensure that all Licensed Product used or sold in the
Territory are labeled and packaged in accordance with the applicable Marketing
Authorisations and laws and regulations of each country or other jurisdiction in
the Territory, and shall bear all costs relating thereto. Without limiting the
generality of the foregoing, Orion shall, at its own cost and expense, conduct
readability testing of the patient information leaflet in accordance with
applicable laws and regulations.

 

7. UP-FRONT AND MILESTONE PAYMENTS

As consideration to Indevus for the rights granted to Orion hereunder, Orion
shall make the following payments to Indevus:

 

  7.1 Up-front Payment. Orion shall pay Indevus an up-front, non-refundable and
non-creditable payment of US$7,000,000 on the Date of Agreement by wire transfer
of immediately available funds.

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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  7.2 Milestone Payments. Orion shall pay Indevus the following non-refundable
and non-creditable milestone payments, contingent upon occurrence of the
specified event, and payable the first time such milestone is achieved, with
respect to Licensed Product for the Initial Indication:

 

  7.2.1 US$2,800,000 upon Marketing Authorization in all of the following
countries (a) the [***]; provided, however, that in the event Marketing
Authorization is obtained in some, but not all of the foregoing
jurisdictions/countries, Orion shall pay Indevus US$560,000 upon receipt of
Marketing Authorization in each of the jurisdictions/countries listed in
(a) through (e) of this subsection 7.2.1. For the avoidance of a doubt, the
Parties understand and agree that (A) [***] shall be interpreted as one country
for purposes of determining whether Marketing Authorization has been obtained in
such country/jurisdiction in accordance with the foregoing clause of this
Section 7.2.1; and (B) in the event that Marketing Authorization is obtained in
any of [***], Orion shall pay Indevus US$186,667 for each of such countries in
which such Marketing Authorization is obtained;

 

  7.2.2 US$2,800,000 upon the first achievement of annual Net Sales in the
Territory of [***];

 

  7.2.3 US$2,800,000 upon the first achievement of annual Net Sales in the
Territory of [***];

 

  7.2.4 US$2,800,000 upon the first achievement of annual Net Sales in the
Territory of [***]; and

 

  7.2.5 US$2,800,000 upon the first achievement of annual Net Sales in the
Territory of [***].

Orion shall notify Indevus in writing of the achievement of the milestones set
forth in Section 7.2.1 within ten (10) Business Days after the achievement
thereof and of the achievement of any of the milestones relating to Net Sales
within ten (10) Business Days after Orion’s determination of the achievement
thereof, but in any event not later than thirty (30) days after the end of the
Calendar Quarter in which such Net Sales milestone(s) are achieved. Not later
than within five (5) Business Days from the date of such notice, Orion shall
make the applicable milestone payment to Indevus by wire transfer of immediately
available funds. The Parties acknowledge and agree that achievement of any of
the milestones set forth above relating to Net Sales (and, accordingly, payment
of the applicable milestone payment) may occur during the same Calendar Year as
achievement of

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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any other milestone relating to Net Sales (and payment of such applicable
milestone payment). Notwithstanding the termination or expiration of this
Agreement, any Net Sales by Orion permitted under this Agreement after the
effective date of such termination or expiration shall continue to be included
in Net Sales for the purposes of determining the achievement of the milestones
set forth above relating to Net Sales.

 

  7.3 Indevus shall receive the full amount of the up-front payment required by
Section 7.1 and the milestone payments required by Section 7.2, without any
deduction for taxes (including withholding taxes), duties or other amounts
assessed thereon.

 

  7.4 Reports. Commencing with respect to the Calendar Quarter in which the
First Commercial Sale of Licensed Product occurs and ending with respect to the
last Calendar Quarter in which there were Net Sales in the Territory, Orion
shall furnish to Indevus a written report for each Calendar Quarter showing
(a) gross sales and Net Sales of Licensed Product in the Territory, broken down
by country, during such Calendar Quarter (including a detailing of all
deductions taken in the calculation of Net Sales) in each country’s currency,
and (b) the applicable exchange rate to convert from each country’s currency to
United States Dollars. The conversion to United States Dollars shall be
calculated on a monthly basis using the arithmetic averages of the closing
conversion rates on the first and last Business Day of such month in the
Calendar Quarter, as published by The Wall Street Journal, Eastern edition (if
available), or any other publication as agreed to by the Parties. Reports under
this Section 7.4 shall be due on the twentieth (20th) day following the close of
each Calendar Quarter. Orion shall keep complete and accurate records in
sufficient detail to properly reflect gross sales and Net Sales.

 

  7.5 Audits. Upon the written request of Indevus, Orion shall permit an
independent certified public accounting firm of nationally recognized standing
selected by Indevus and reasonably acceptable to Orion, to have access during
normal business hours at times mutually convenient to the Parties and upon
reasonable notice to Orion to such of the records of Orion as may be reasonably
necessary to verify the accuracy of the reports provided under Section 7.4 for
any Calendar Year (or portion thereof) ending not more than [***] prior to the
date of such request. The accounting firm shall disclose to Indevus only whether
the reports are correct or incorrect, the specific details concerning any
discrepancies (including the accuracy of the calculation of Net Sales, and the
resulting effect of such calculations on any amounts payable by Orion under this
Agreement) and such other information that should properly be contained in a
report required under this Agreement.

 

  7.5.1 If such accounting firm concludes that additional payments were owed
during such period, Orion shall pay the additional payments, together with
interest thereon as set forth in Section 8.3, within ten (10) Business Days of
the date Indevus delivers to Orion such accounting firm’s written report so
concluding. The fees charged by such accounting firm shall be paid by Indevus;
provided, however, that if an error in favor of Indevus in the payment of a
milestone payment is discovered of more than [***] as a result of Orion’s errors
in calculating Net Sales (including if a payment should have been but was not
paid), then the fees and expenses of the accounting firm shall be paid by Orion.

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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  7.5.2 Indevus shall treat all financial information subject to review under
this Section 7.5 in accordance with the confidentiality provisions of this
Agreement, subject to The Council’s related rights under the Population Council
Agreement.

 

  7.5.3 Orion acknowledges and agrees that it has been provided with a copy of
the Population Council Agreement, and agrees to comply with, and to enable
Indevus to comply with, the provisions of Section 5(e) of the Population Council
Agreement with respect to the audit and other rights of The Council to verify
the information required to be provided by Indevus to The Council under the
Population Council Agreement.

 

8. SUPPLY PRICE AND PAYMENTS

 

  8.1 The initial Supply Prices for all Bulk Drug Product and Insertion Tools
supplied hereunder are as set forth on Schedule 8.1, and are subject to the
following:

 

  8.1.1 For purposes of calculating the applicable Supply Price, only the
quantities of Bulk Drug Product (and not the quantities of Insertion Tools)
purchased hereunder shall be used.

 

  8.1.2 With respect to units of each Batch of Bulk Drug Product purchased
hereunder that are required by the Marketing Authorisations to be used as Test
Samples and are not used for commercial sale, the Supply Price for such units of
Bulk Drug Product shall be [***] per unit.

 

  8.1.3 The Supply Prices shall be fixed until the end of the Calendar Year
ending December 31, 2008; thereafter, on January 1 of each Calendar Year, the
Supply Prices may be adjusted on an annual basis, to reflect the total actual
percentage change in the Producer Price Index since the most recent price
adjustment, or in the case of an initial adjustment, since the Date of
Agreement. Indevus shall provide Orion with a written notice of any such
adjustment to the Supply Prices for a particular Calendar Year by not later than
January 31 of such Calendar Year, if any.

 

  8.2

Invoices. Unless otherwise agreed by the Parties, Orion shall be invoiced at the
applicable Supply Price at the time of or promptly after shipment by Indevus.
For invoices during any particular Calendar Year, the Supply Price shall be
calculated on a cumulative basis based on the quantities of Bulk Drug Product
shipped during that Calendar Year up to and including Bulk Drug Product
purchased under the Purchase Order for which the calculation is being made,
provided, however, that within sixty (60) days after the end of each Calendar
Year, Indevus shall calculate the actual Supply Price for such Calendar Year
based on a calculation of the total quantities of Bulk Drug Product purchased
for that Calendar Year and the applicable Supply Price for such quantities of
Bulk Drug Product in accordance with Schedule 8.1 and Indevus shall, at its
option, either refund to Orion within ten (10) Business Days after such
reconciliation

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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or credit against future purchases of Bulk Drug Product any amounts due Orion
for any excess payment of the Supply Price. To the extent applicable, any
documented shipping costs incurred by Indevus shall be included in the invoice
in addition to the Supply Price.

 

  8.3 Payments. Orion shall pay the Supply Price (and, if applicable, any
shipping costs) within sixty (60) days from the date of Indevus’ invoice. All
payments required by this Agreement shall be made in United States dollars. In
the event of any late payment of any payment due hereunder, the amount of the
late payment shall bear interest at the Prime Rate commencing on the date such
payment is due until such date as the payment is made. “Prime Rate” for purposes
of this Section 8.3 shall mean the prime rate of Citibank, N.A. in New York, New
York as published in the Wall Street Journal computed on a daily basis and shall
change when and as the Prime Rate changes.

 

  8.4 Taxes. Any and all payments by Orion to or for the account of Orion under
this Agreement shall be made without deduction for any and all present or future
taxes, duties, levies, imposts, deductions, charges or withholdings imposed,
assessed, levied or collected by any taxing authority within the Territory (the
“Taxes”), if any; provided that, if Orion shall be required by law to deduct any
Taxes from any such payments: (a) the sum payable to Indevus shall be increased
as necessary so that after making all required deductions (including deductions
applicable to additional sums payable under this Section) Indevus receives an
amount equal to the sum it would have received had no such deductions been made;
(b) Orion shall make such deductions; (c) Orion shall pay the full amount
deducted to the relevant taxation authority or other authority in accordance
with applicable law; and (d) Orion shall furnish to Indevus the original, or a
certified copy, of a receipt evidencing payment thereof.

 

9. QUALITY OF BULK DRUG PRODUCT

 

  9.1 Indevus represents and warrants that (i) all Bulk Drug Product and
Insertion Tools supplied to Orion shall have been manufactured in conformance
with cGMPs and Indevus’ testing criteria with respect to the Bulk Drug Product
as set forth in Schedule 9.1 (the “Indevus Testing”) and (ii) the Indevus
Testing shall be consistent with the testing requirements of the Marketing
Authorisations (the “Agreed Quality”), provided, however, that the Parties agree
and acknowledge that (a) the Indevus Testing shall not constitute the full
testing requirements of the Marketing Authorisations and (b) Orion (and not
Indevus) shall be responsible for release and acceptance of the Bulk Drug
Product and Insertion Tools supplied hereunder for the Territory, Final
Packaging of the Licensed Product for the Territory and final quality control of
the packed, Final Packaging of the Licensed Product for the Territory; and
(iii) the Bulk Drug Product and Insertion Tools, when delivered to the carrier,
shall conform to all covenants and obligations of Indevus contained in this
Agreement.

 

  9.2

THE LIMITED WARRANTIES SET FORTH IN SECTION 9.1 ARE IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY,
WARRANTY OF NON-INFRINGEMENT AND ANY WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE. EXCEPT

 

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FOR THE WARRANTIES EXPRESSED IN SECTION 9.1, INDEVUS MAKES NO OTHER WARRANTY,
EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE MANUFACTURING OR THE BULK DRUG
PRODUCT AND INSERTION TOOLS.

 

  9.3 To the extent required under applicable laws and regulations, the Parties
shall enter into a separate quality assurance agreement reflecting the Parties’
respective obligations (the “Quality Agreement”), such agreement to be entered
into prior to the first delivery of Bulk Drug Product and Insertion Tools under
this Agreement.

 

  9.4 Indevus shall for each Batch of Bulk Drug Product and Insertion Tools
supplied furnish Orion with a certificate of analysis and such other information
and documentation as may be agreed to between the Parties in the Quality
Agreement, based on the level of testing as may be agreed between the Parties.

 

  9.5 Stability Testing. Indevus shall conduct, at its cost, post-registration
stability studies on the first [***] Bulk Drug Product Batches, and continuing
stability studies during the period of the manufacture pursuant to this
Agreement, as may be required from time to time under applicable laws,
regulations and guidelines, including cGMP.

 

  9.6 Acceptance and Release. Orion shall be responsible for the release and
acceptance of all Bulk Drug Product and Insertion Tools supplied hereunder in
accordance with the provisions of this Section 9.6.

 

  9.6.1 Inspection, Testing and Notice. Upon receipt by Orion of Bulk Drug
Product and/or Insertion Tools from Indevus, Orion shall (a) within thirty
(30) days, inspect such Bulk Drug Product and/or Insertion Tools for damages,
shortage and, as far as reasonably practicable, any other reasonably discernible
defects, and (b) within fifty (50) days, perform (or have performed) such
quality control testing on the Bulk Drug Product and/or Insertion Tools as is
required to be performed by Orion under the Quality Agreement and in order to
determine whether the Bulk Drug Product and/or Insertion Tools conforms to the
Agreed Quality. Orion shall notify Indevus of (a) any such damages, shortage and
other reasonably discernible defects discovered by Orion promptly following
Orion’s discovery thereof, but in any event within such thirty (30) day period,
and (b) any non-conformance with the Agreed Quality discovered by Orion promptly
following Orion’s discovery thereof, but in any event within such fifty (50) day
period. Failure to deliver notice of acceptance or rejection of the Bulk Drug
Product and/or Insertion Tools within the applicable periods shall be deemed to
be acceptance of such Bulk Drug Product and/or Insertion Tools. In the case of
Bulk Drug Product or Insertion Tools with latent defects, Orion shall notify
Indevus of any such latent defects discovered by Orion promptly, but in any
event within thirty (30) days following Orion’s discovery thereof.

 

  9.6.2

Defective Products. Any claims by Orion regarding such Bulk Drug Product and/or
Insertion Tools shall specify in reasonable detail the nature and basis for the
claim and cite relevant Indevus’ Batch control numbers or other information to
enable specific identification of Bulk Drug Product and/or Insertion Tools

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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involved. Orion shall also provide Indevus with an opportunity to inspect and
test such Bulk Drug Product and/or Insertion Tools. Indevus agrees to review any
written claim made by Orion regarding the quality of the Bulk Drug Product
and/or Insertion Tools and provide Orion with the results of such review within
thirty (30) days after Indevus’ receipt of such written claim and, if
applicable, inspection and testing of such Bulk Drug Product and/or Insertion
Tools. If such review and testing by Indevus confirms that a claimed quantity of
Bulk Drug Product and/or Insertion Tools is damaged, non-conforming or otherwise
defective, Orion shall have the right to reject such batch of Bulk Drug Product
and/or Insertion Tools, and shall at Indevus’ expense dispose of or deliver such
quantity involved to such destination as Indevus shall direct in writing,
provided that such directions are in compliance with applicable environmental
laws and regulations. In such event, Indevus shall at Orion’s option, either
(a) make a replacement delivery of conforming Bulk Drug Product and/or Insertion
Tools free of charge as soon as reasonably practicable, provided that if
sufficient quantities of Bulk Drug Product are then held in inventory in
accordance with Section 6.7, such replacement delivery shall be made within
thirty (30) days from the receipt of Orion’s notice (provided that in such
event, the quantities of inventory of Bulk Drug Product required to be held for
the applicable Calendar Quarter by Indevus under Section 6.7 shall be reduced by
the quantities delivered in the replacement delivery hereunder), or (b) credit
Orion’s account in the amount of any Supply Price payments already made for such
non-conforming Bulk Drug Product and/or Insertion Tools.

 

  9.6.3

Disputed Claims. If the Parties hereto fail to agree as to whether a delivered
quantity of Bulk Drug Product and/or Insertion Tools is damaged, non-conforming,
or otherwise defective, then the Parties agree to have the Batch in dispute
tested and further analysed by an independent testing laboratory in the European
Union selected by agreement between the Parties, or lacking such agreement,
appointed by the Finnish Central Chamber of Commerce. Should said laboratory’s
testing determine that delivered Bulk Drug Product and/or Insertion Tools is
damaged, non-conforming, or otherwise defective or does not comply with the
Agreed Quality, then their decision shall be deemed final as to any dispute over
Bulk Drug Product and/or Insertion Tools quality and in such case Indevus shall
bear all costs for the independent laboratory testing, and then Orion shall have
the right to reject such batch of Bulk Drug Product and/or Insertion Tools. In
such event, Indevus shall at Orion’s option, either (a) make a replacement
delivery of conforming Bulk Drug Product and/or Insertion Tools free of charge
as soon as reasonably practicable, provided that if sufficient quantities are
then held in inventory in accordance with Section 6.7, such replacement delivery
shall be made within thirty (30) days after the receipt of Orion’s notice
(provided that in such event, the quantities of inventory required to be held
for the applicable Calendar Quarter by Indevus under Section 6.7 shall be
reduced by the quantities delivered in the replacement delivery hereunder) or
(b) credit Orion’s account with the amount of any Supply Price payments already
made for such non-conforming Bulk Drug Product and/or Insertion Tools. Orion
shall dispose of or deliver such non-conforming quantity at Indevus’ expense in

 

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such way and to such destination as Indevus shall in writing direct provided
that such directions are in compliance with applicable environmental laws and
regulations. However, if said quantity of Bulk Drug Product and/or Insertion
Tools is determined by said independent laboratory not to be damaged,
non-conforming, otherwise defective or not in compliance with the Agreed
Quality, then Orion shall bear all costs of the independent laboratory testing
and disposal of such products.

 

10. MARKETING

 

  10.1 Marketing, Distribution and Sales.

 

  10.1.1 Orion agrees to use Commercially Reasonable Efforts to promote, market,
distribute and sell the Licensed Product for the Initial Indication in the
Territory under the Trademark.

 

  10.1.2 Orion shall:

 

  (a) launch Licensed Product for the Initial Indication in the Major European
Countries within [***] after Marketing Authorization has been obtained in any of
the Major European Countries and a tender has been won by Orion, in cases of
tender business countries of the Major European Countries, provided, that if
Orion is unable to launch by such date because Indevus failed to supply on the
requested delivery date Bulk Drug Product and Insertion Tools that were subject
to a Firm Commitment portion of a Rolling Forecast and Purchase Order submitted
hereunder, such period shall be extended by the period of time equal to the
period of the supply delay. For the avoidance of a doubt Parties understand and
agree that if the Marketing Authorizations in some of the Major European
Countries have been granted prior to the Date of Agreement, then Orion shall
launch Licensed Product for the Initial Indication in such countries within
[***] from the Date of Agreement and a tender has been won by Orion, in cases of
a tender business country;

 

  (b) submit an MAA with respect to Licensed Product for the Initial Indication
in the countries and jurisdictions not subject to the MRP within [***] after the
Date of Agreement, if commercially feasible, provided, that if Orion is unable
to submit an MAA by such date because Indevus failed to provide Orion with
required and requested Data in accordance with Section 3.2, such period shall be
extended by the period of time equal to the period of the delay in providing
such Data;

 

  (c) expend, in connection with launch and marketing of Licensed Product in the
Territory, such amounts as are commercially reasonable in connection with the
marketing and promotion of Licensed Product in the

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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Field in the applicable countries, with the objective of promoting the
therapeutic profile and benefits of Licensed Product in a commercially
beneficial manner and, in any event, not less than the amounts spent by Orion in
the corresponding countries with respect to the marketing and promotion of the
product listed on, and any product deemed under Section 2.5 to be added to,
Schedule 1.15; and

 

  (d) provide Indevus with an annual written report and confer with Indevus at
least half-yearly (if not at an Oversight Committee meeting) to summarize and
update the status of Orion’s regulatory and commercialization efforts and
activities with respect to Licensed Product in the Territory.

 

  10.2 Marketing Plans. Orion agrees to prepare and provide Indevus with an
annual marketing plan for the Territory for the following Calendar Year by
December 1 of each year. Indevus shall provide Orion with a copy of its annual
marketing plan for the United States for the following Calendar Year by the end
of September of each year.

 

  10.3 Licensed Product Training. At such times and dates as shall be mutually
agreed by the Parties, Indevus shall provide, for up to three (3) Business Days
at Indevus’ offices in the United States, access to a reasonable number of
Indevus’ sales training and marketing personnel to assist and advise key Orion
marketing and medical personnel (Global Brand Manager, Medical Marketing
Advisor, MRP phase I regional Marketing Representatives (UK, Germany,
Scandinavia) as to the marketing and promotion of Licensed Product for the
Initial Indication in the United States, including medical/scientific/marketing
profiling of Licensed Product for the Initial Indication (US marketing plan),
training concept, market and key medical advisor feedback, and sales process,
provided that Orion shall be responsible for all its travel and other costs
relating thereto.

 

  10.4 Marketing Materials.

Within thirty (30) days from the Date of Agreement, Indevus shall provide Orion
with names of its key medical advisors with respect to the Initial Indication in
US and in the Territory.

During the Agreement Term, Indevus shall provide Orion as reasonably requested
by Orion, with copies of all market research conducted by Indevus with respect
to Licensed Product for the Initial Indication in the United States, Licensed
Product scientific/ marketing slide sets, marketing materials (including detail
aids) and training materials, in written form (either electronic or hard copies)
All of materials and information shall constitute Indevus’ Proprietary
Information.

 

  10.5 Minimum Requirements.

 

  10.5.1

Subject to the provisions of Section 10.5.2, during each Calendar Year set forth
on Schedule 1.42 (each, a “Requirement Year”) Orion shall submit Purchase Orders
for at least the number of units of Bulk Drug Product set forth on

 

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Schedule 1.42 with respect to the applicable Calendar Year. If Orion does not
satisfy such Minimum Requirement during any Requirement Year, [***] (the
“Payment Date”), Orion shall pay Indevus an amount (the “Minimum Requirement
Payment”) [***] subject to the provisions of Section 10.5.2 and 10.5.3.

 

  10.5.2 Notwithstanding the provisions of Section 10.5.1, in the event of a
Sales Critical Product Event in any Requirement Year, Orion shall notify Indevus
in writing of such Sales Critical Product Event within twenty (20) Business Days
of its knowledge thereof and the Parties shall thereafter within sixty (60) days
negotiate in good faith to determine whether any adjustment, suspension, or
termination of the Minimum Requirement obligation for such Requirement Year (or
any future Requirement Years) should be effected, based on an analysis of
relevant factors at that time, including the nature and timing of the Sales
Critical Product Event and the significance and expected duration of the impact
of the Sales Critical Product Event on Licensed Product for the Initial
Indication in the Territory; provided, however, that in the event of a Sales
Critical Product Event specified in Section 1.60(b) or 1.60(f), the Minimum
Requirement shall be suspended for the duration of the applicable Sales Critical
Product Event, and provided, further, that in the event of a Sales Critical
Product Event specified in Section 1.60(b), the amount of the suspension of the
Minimum Requirement during the duration of such Sales Critical Product Event
shall be calculated based on [***] that are subject to such recall or withdrawal
of Licensed Product.

 

  10.5.3 If, (a) as a result of the negotiations provided for in Section 10.5.2,
the Parties agree prior to the Payment Date for a particular Requirement Year to
adjust the Minimum Requirement for such Requirement Year, or (b) an automatic
suspension is required by Section 10.5.2, the payment required to be made by
Orion on the Payment Date for such Requirement Year shall give effect to the
revised or suspended Minimum Requirement. If, as a result of the negotiations
provided for in Section 10.5.2, the Parties are unable to reach agreement prior
to the Payment Date for a particular Requirement Year as to whether there should
be an adjustment to the Minimum Requirement for such Requirement Year, or as to
the amount of any such adjustment, the payment required to be made by Orion on
the Payment Date for the applicable Requirement Year shall be the payment that
is provided for under Section 10.5.1; provided, however, that if as a result of
any subsequent resolution of the disputed issue, whether between the Parties or
as a result of the dispute resolution provisions of this Agreement, the Minimum
Requirement for such Requirement Year is reduced, Indevus shall credit Orion
with the amount of any excess payment made by Orion under Section 10.5.1 within
ten (10) Business Days from an agreement or a resolution of the issue.

 

  10.6 Trademarks.

 

  10.6.1

Indevus hereby grants to Orion an exclusive right and license to use the
Trademark during the Agreement Term in connection with the marketing, sale,

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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advertising and promotion of Licensed Product in the Field in the Territory.
Orion will use Commercially Reasonable Efforts to use the Trademark “VANTAS®” on
and in connection with the commercialization of Licensed Product for the Initial
Indication in the Territory. However, if it is determined that it is not
possible, or if the Parties mutually determine that it is not advisable or
desirable, to use the Trademark “VANTAS®” in connection with the
commercialization of Licensed Product for the Initial Indication in any country
in the Territory, the Parties shall mutually agree on an alternate appropriate
trademark for adoption in the Territory that is possible, advisable and
desirable and, if selected, such alternate trademark shall, for purposes of this
Agreement, be deemed the Trademark.

 

  10.6.2 Indevus shall be responsible for the registration and maintenance of
the Trademark which Orion employs in connection with the commercialization of
Licensed Product in the Field in the Territory. Indevus shall own and control
the Trademark and bear all relevant costs relating thereto. If necessary to
permit Orion to use the Trademark, Indevus shall make application to register
Orion as a permitted user or registered user of the Trademark.

 

  10.6.3 Orion recognizes the ownership by Indevus of any proprietary Indevus
name or Trademark furnished by Indevus for use in connection with the marketing,
sale or distribution of Licensed Product. Except for the rights specifically
granted to it under this Agreement, neither Orion nor any of its Affiliates or
Marketing Distributors shall, either while this Agreement is in effect, or at
any time thereafter, register, use or challenge or assist others to challenge
the Trademark or attempt to obtain any right in or to any such name or
trademarks with respect to any product confusingly similar to Licensed Product
as defined in this Agreement or any other goods and products, notwithstanding
that such goods or products have a different use or are dissimilar to Licensed
Product as defined in this Agreement. Neither Party shall commercialize or
permit another to commercialize in the Territory, any product (other than, under
this Agreement, Licensed Product in the Field) under the Trademark or any
confusingly similar trademark.

 

  10.6.4 Subject to compliance with applicable laws and regulations, (a) Orion
shall not modify or alter the Trademark or do anything which might reasonably be
expected to damage the Trademark and (b) Orion shall use the Trademark only as
agreed upon with Indevus in writing.

 

  10.6.5

Orion shall promptly notify Indevus of any actual, alleged or threatened
infringement of the Trademark or of any unfair trade practices, trade dress
limitation, passing off of counterfeit goods, or similar offenses known to
Orion. Indevus shall have the first right to determine in its discretion whether
to and to what extent to institute, prosecute and/or defend any action or
proceedings involving or affecting any rights relating to the Trademark in the
Territory. Upon Indevus’ reasonable request, Orion shall cooperate with and
assist Indevus, at Indevus’ cost, in any of Indevus’ enforcement efforts with
respect to the Trademark in the Territory. If Indevus determines not to take
action against any actual or suspected infringement of the Trademark in the
Territory within sixty

 

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(60) days after having become aware of such infringement, then Orion shall have
the right, but not the obligation, to bring or assume control of any action
against the allegedly infringing Third Party as Orion determines in its sole
discretion. In the event that Orion brings or assumes control of any such
action, then Indevus agrees to reasonably assist Orion in connection therewith.
However, Orion may not enter into a settlement with such Third Party without the
prior written consent of Indevus, which consent may not be unreasonably withheld
or delayed. Any damages or other monetary awards recovered pursuant to this
Section 10.6.5 shall be allocated first to the costs and expenses of the Party
bringing or maintaining the defense of such suit, then to the costs and
expenses, if any, of the other Party. In the event that Indevus brings such
action, [***] of any amounts remaining shall be payable to Indevus and the
remaining [***] to Orion; in the event that Orion brings such action, [***] of
any amounts remaining shall be payable to Orion and the remaining [***] to
Indevus.

 

  10.6.6 Except for the licenses granted by Indevus to Orion under this
Agreement, Orion shall not acquire any right, title, or interest in any
trademark, trade name, logo or trade dress of Indevus by reason of this
Agreement. Orion acknowledges that all use of any of Indevus’ trade names,
trademarks and logos and all of the goodwill associated therewith shall inure
solely to Indevus’ benefit.

 

  10.7 Domain Names. Except as set forth in this Section 10.7, Indevus shall be
responsible for the registration, hosting, maintenance, costs and defense of the
Domain Names. For the avoidance of doubt, Indevus is allowed to register in its
own name, to host on its own servers, maintain and defend the Domain Names and
use them for websites. Notwithstanding the foregoing, Orion shall have the right
at all times to host a website based in the Territory, and to control the
content of such website, using the Domain Name, in connection with the
marketing, sale, advertising and promotion of Licensed Product for the Initial
Indication in the Territory. The Parties shall coordinate its activities under
this Section 10.7 to ensure regulatory compliance by each Party.

 

11. PATENTS

 

  11.1 Filing, Prosecution and Maintenance of Patents. As between the Parties,
(a) Indevus shall retain sole ownership of the Indevus Patent Rights and the
Indevus Know-How and (b) Indevus shall have the sole right to file, prosecute
and maintain the Indevus Patent Rights. Indevus has the obligation to maintain
the Indevus Patent Rights in the Territory as long as possible in accordance
with applicable laws during the Agreement Term. Indevus shall keep Orion
reasonably informed of all material matters relating to the filing, prosecution
and maintenance of the Indevus Patent Rights in the Territory and shall timely
inform Orion of any Patent included in the Indevus Patent Rights issuing or
granting from a patent application filed hereunder.

 

  11.2

Patent Office Proceedings. Each Party shall inform the other Party of any
request for, filing, or declaration of any proceeding before a patent office
seeking to protest, oppose, cancel, reexamine, declare an interference
proceeding, initiate a conflicts proceeding, or analogous process involving a
patent application or patent included in the Indevus

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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Patent Rights of which it becomes aware in the Territory. Each Party thereafter
shall cooperate with the other with respect to any such patent office proceeding
by providing the other with reasonable information or assistance.

 

  11.3 Third Party Infringement of Indevus Patent Rights.

 

  11.3.1 Each Party shall promptly give the other Party notice of any
infringement or suspected infringement of any Patent included in the Indevus
Patent Rights by a Third Party in the Territory that comes to such Party’s
attention. The Parties will thereafter consult and cooperate fully to determine
a course of action, including, without limitation, the commencement of legal
action by any Party.

 

  11.3.2 Absent a mutual agreement, Indevus shall have the first right, but not
the obligation, to commence any form of action or take any such preliminary
steps, as are necessary to terminate or prevent such infringement, to initiate
and prosecute such legal action at its own expense, and/or to control the
defense of any declaratory judgment action relating to the Indevus Patent Rights
in the Territory. Indevus shall provide Orion with notice of any such action it
commences and apprise Orion of any significant developments in the proceedings.
Orion shall reasonably cooperate with Indevus, at Indevus’ cost, including the
joining of suit if necessary or desirable and executing all documents reasonably
necessary for Indevus to prosecute, defend and maintain such action.

 

  11.3.3 Indevus shall promptly inform Orion if Indevus elects not to exercise
such first right, and Orion thereafter shall have the right, but not the
obligation, either to initiate and prosecute such action or to control the
defense of such declaratory judgment action. If Orion elects to do so, the cost
of any course of action, including the costs of any legal action commenced or
any declaratory judgment action defended, shall be borne solely by Orion,
subject to the right to recover such costs pursuant to Section 11.3.5.

 

  11.3.4 For any such legal action or defense, in the event that any Party is
unable to initiate, prosecute, or defend such action solely in its own name, the
other Party will join such action voluntarily and will execute all documents
necessary for the Party to prosecute, defend and maintain such action. The
Parties will cooperate with each other in the planning and execution of any such
action and will provide each other with any information or assistance that
either reasonably may request.

 

  11.3.5 Any recovery obtained by Orion or Indevus (whether by settlement or
otherwise) shall be shared as follows:

 

  (a) the Party that initiated and prosecuted, or maintained the defense of, the
action shall recoup all of its costs and expenses (including attorneys’ fees)
incurred in connection with the action;

 

  (b) the other Party then shall, to the extent possible, recover its costs and
expenses (including attorneys’ fees) incurred in connection with the action;

 

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  (c) if Indevus initiated and prosecuted, or maintained the defense of, the
action, the amount of any recovery remaining shall be allocated [***] percent to
Indevus and [***] to Orion; and

 

  (d) if Orion initiated and prosecuted, or maintained the defense of, the
action, the amount of any recovery remaining shall be allocated [***] percent to
Orion and [***] to Indevus.

 

  11.4 Patent Marking. Orion shall mark, and shall require its Affiliates and
their respective Marketing Distributors to mark, all Licensed Product sold or
distributed pursuant to this Agreement, if applicable, in accordance with the
applicable patent statutes or regulations in the country or countries of
manufacture and/or sale thereof.

 

  11.5 Ownership of New Inventions. During the Agreement Term, except as
otherwise provided in and subject to the terms of this Agreement, the following
shall be applicable:

 

  11.5.1 As between the Parties, Indevus shall own and retain all rights, title
and interest in all inventions, Improvements, discoveries and know-how covering
Licensed Product, including any Indevus Know-How, which are made, conceived,
reduced to practice or generated during the Agreement Term solely by Indevus’
employees, agents, or other persons acting under its authority, subject to the
license granted to Orion under this Agreement in the Field with respect to
Licensed Product in the Territory, and shall have the sole right, at its option
and expense, to file, prosecute and maintain any patent application or patent
claiming such invention.

 

  11.5.2 As between the Parties, Orion shall own and retain all rights, title
and interest in all inventions, Improvements, discoveries and know-how covering
Licensed Product, including any Orion Know-How, which are made, conceived,
reduced to practice or generated during the Agreement Term solely by Orion’
employees, agents, or other persons acting under its authority, subject to a
grant-back license, as defined in Section 2.6, to Indevus under such Orion
Patent Rights and Know-How outside the Territory, and shall have the sole right,
at its option and expense, to file, prosecute and maintain any patent
application or patent claiming such invention.

 

  11.5.3 As between the Parties, they shall each, as to their respective
territories, have full rights, title and interest in all inventions,
Improvements, discoveries and know-how covering Licensed Product in the Field,
which are jointly made, conceived, reduced to practice or generated during the
Agreement Term by employees or agents of both of them (“Joint Inventions”).
Indevus shall have the sole right, at its option and expense, to file, prosecute
and maintain any patent application or patent claiming a Joint Invention.

 

  11.5.4 The terms of Sections 11.5.1, 11.5.2 and 11.5.3 shall apply regardless
of whether the development activity resulting in the invention was conducted
directly by a Party or by a Third Party (e.g., a contract research organization)
on behalf of such Party in accordance with the terms of this Agreement.

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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  11.6 Rights in Bankruptcy. All rights and licenses granted under or pursuant
to this Agreement by Indevus are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of the United States Bankruptcy Code, licenses of a
right to “intellectual property” as defined under Section 101 of the United
States Bankruptcy Code. Orion, as licensee of such rights under this Agreement
shall retain and may fully exercise all of its rights and elections under the
United States Bankruptcy Code in the event of the commencement of a bankruptcy
proceeding by or against Indevus under the United States Bankruptcy Code,
including, but not limited to, in the event Indevus rejects this Agreement under
Section 365 of the United States Bankruptcy Code, the right to treat this
Agreement or any agreement supplementary to this Agreement as terminated or to
retain its rights under this Agreement or any agreement supplementary to this
Agreement. In the event that Orion elects to retain its rights under this
Agreement or any agreement supplementary to this Agreement, Indevus shall
provide to Orion all intellectual property and all embodiments of such
intellectual property within the possession or control of Indevus.

 

12. PRODUCT RECALL

 

  12.1 Each Party shall promptly inform the other Party of any notification of
any action by, or notification or other information which it receives (directly
or indirectly) from any Regulatory Authority, which (a) raises any concerns
regarding the safety or efficacy of the Licensed Product in the Field, or
(b) indicates a reasonable likelihood for a recall or market withdrawal of the
Licensed Product in the Field.

 

  12.2 In the event that (a) any Regulatory Authority issues a recall or takes
similar action (a “Recall”) in connection with the Licensed Product sold or
distributed by Orion in the Territory, or (b) a court of competent jurisdiction
orders such a Recall, then Orion shall inform Indevus of such Recall, the
Parties shall consult with each other with respect thereto and Orion shall
consider in good faith any comments or suggestions of Indevus, provided,
however, that nothing herein shall prohibit Orion from initiating or conducting
any Recall that it reasonably believes is required in the Territory.

 

  12.3 In the event Orion believes there is a possible safety risk with respect
to Licensed Product and, as a result thereof, wishes to cease distribution
and/or sales of the Licensed Product in the Territory, it shall inform Indevus
of its belief and provide such information with respect thereto as Indevus shall
request, and the Parties shall in good faith consider the matter and each others
views with respect thereto.

 

  12.4

Except as set forth above, Orion shall have responsibility for and shall make
all decisions relating to conducting any Recall mandated by any Regulatory
Authority related to Licensed Product in the Field in the Territory and Orion
shall undertake such actions in a manner designed to minimize any harm to the
marketability of Licensed Product or the reputation of the Parties. At Orion’s
request, to the extent a Recall or

 

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market withdrawal implicates Bulk Drug Product and/or Insertion Tools supplied
by Indevus to Orion, Indevus shall provide reasonable assistance in conducting
such Recall or market withdrawal including providing pertinent manufacturing
records that Orion may reasonably request to assist in effecting such action. In
any event, Orion shall keep Indevus informed with respect to the status of any
Recall or market withdrawal in the Territory and Indevus shall have the right to
participate, upon its request, in any statements relating to any such Recall or
market withdrawal to the extent feasible under the circumstances.

 

  12.5 Except as expressly otherwise provided in this Article 12, Orion shall
bear all costs of a Recall, marketing withdrawal or other corrective action with
respect to Licensed Product in the Field in the Territory. Notwithstanding the
foregoing, Indevus shall bear such costs if such Recall, market withdrawal or
other corrective action (a) is attributable to the fault of Indevus; (b) results
from the negligence, recklessness or intentional misconduct on the part of
Indevus or any of its Affiliates or subcontractors (and not from the negligence,
recklessness or omission or intentional misconduct on the part of Orion or any
of its Affiliates, sublicensees or Marketing Distributors) or breach of this
Agreement by Indevus or its Affiliates or subcontractors (and not from breach of
this Agreement by Orion or any of its Affiliates, sublicensees or Marketing
Distributors); or (c) is attributable to the failure of Bulk Drug Product and/
Insertion Tools supplied by Indevus to comply with the Agreed Quality.

 

13. BACKUP MANUFACTURING RIGHTS

 

  13.1 Appointment of Subcontracting Manufacturer. Indevus reserves for itself
the manufacturing rights and know-how in relation to the Licensed Product, but
hereby agrees at any time at Orion’s request, to appoint a qualified
subcontracting manufacturer (the “Subcontracting Manufacturer”) mutually agreed
upon by Orion and Indevus as a back-up manufacturer of the Bulk Drug Product
and/or Insertion Tools, provided that, except as specifically set forth in
Section 13.3, Orion shall be responsible for and shall pay for all costs
(including Indevus’ costs associated with the technology transfer set forth in
Section 13.2) associated with establishing, contracting with, qualifying and
funding the ongoing operations of such Subcontractor Manufacturer, including the
costs of obtaining and maintaining licenses, permits, certifications and
approvals, regardless of whether Orion is authorized to purchase Bulk Drug
Product and/or Insertion Tools from such Subcontract Manufacturer. Indevus
agrees not to unreasonably withhold its consent to the appointment of such
Subcontracting Manufacturer in accordance with the terms of this Article 13,
provided that Orion shall not be authorized to purchase Bulk Drug Product and/or
Insertion Tools from such Subcontract Manufacturer without Indevus’ prior
written consent except in the event of and during the period of an Inability to
Supply and in any event not unless and until all actions required to have such
facility approved by applicable Regulatory Authorities in the Territory shall
have been taken.

 

  13.2

Technology Transfer. Indevus shall deposit with or provide the Subcontracting
Manufacturer with access to all instructions, software, specifications, data,
technology, documentation and materials necessary to manufacture and test of the
Bulk Drug

 

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Product and/or Insertion Tools in accordance with the terms of this Agreement.
Indevus’ agreement with such Subcontracting Manufacturer must bind the
Subcontracting Manufacturer to the same standards and provisions as applicable
to the Bulk Drug Product and Insertion Tools supply and manufacturing under and
subject to this Agreement. Prior to appointing such Subcontracting Manufacturer
Orion shall have a right to review the terms and conditions of Indevus’
agreement with such Subcontracting Manufacturer.

 

  13.3 Inability to Supply. Should Indevus for any reason at any time during the
Agreement Term not be able or fail to supply Orion, or determine that it will
not be able to supply Orion, with any Bulk Drug Product and/or Insertion Tools
for a period [***] (an “Inability to Supply”), Orion shall have the right to
request that Indevus use Commercially Reasonable Efforts to transfer the
manufacture of the Bulk Drug Product and/or Insertion Tools to the
Subcontracting Manufacturer that has been established and qualified in the NDA
and/or the Marketing Authorisations and in accordance with the terms of this
Agreement as a manufacturer of Bulk Drug Product and Insertion Tools, as soon as
reasonably practicable, for the duration of the period of the Inability to
Supply. In such event, the out-of-pocket, documented costs incurred by Orion
pursuant to Section 13.1 shall be offset against the Supply Price payable by
Orion hereunder.

 

  13.4 To facilitate timely supplies of the Bulk Drug Product and Insertion
Tools and, as the case may be, an orderly transfer of the manufacturing know-how
concerning the Bulk Drug Product and/or Insertion Tools, Indevus, at the request
of Orion, undertakes to maintain at its expense a safety stock of the Bulk Drug
Product and Insertion Tools for commercial purposes, as set forth in
Section 6.7.

 

14. FORCE MAJEURE

 

  14.1 Non-performance by a Party of an obligation pursuant to this Agreement or
delay in performing same shall not constitute a breach of this Agreement during
the period of time when such non-performance or delay is due to force majeure,
i.e. any future event or condition, which (a) is caused by or results from
causes beyond the reasonable control, and without the fault of the Party
affected thereby, and (b) was not known by such Party at the time this Agreement
was entered into, including fire, flood, embargo, war, acts of war (whether war
be declared or not), terrorism, insurrection, riot, civil commotion, strike,
lockout or other labor disturbance, failure of public utilities or common
carriers, or act of God (“Force Majeure”), provided that the Party so prevented
from fulfilling its obligations due to Force Majeure has forthwith, and in any
event at the latest on the [***] after the commencement of Force Majeure,
informed the other Party of the Force Majeure and a bona fide estimate of the
duration thereof. The Parties shall discuss in good faith what, if any,
modification of the terms of this Agreement may be required in order to arrive
at an equitable solution in light of any Force Majeure that continues for at
least [***]

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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15. TERM, EXPIRATION AND TERMINATION

 

  15.1 Agreement Term. This Agreement shall become effective on the Date of
Agreement and, except as hereinafter provided for in this Section 15, shall
continue in effect for a period expiring and terminating fifteen (15) years from
the Date of Agreement (“Initial Period”), to be automatically renewed for one
(1) year periods (each, a “Renewal Period”) at a time, subject to the right of
either Party to terminate this Agreement at any time effective at the end of the
Initial Period or any subsequent Renewal Period thereafter with at least six
(6) months prior written notice to the other (the Initial Period and any Renewal
Period are referred to as the “Agreement Term”).

 

  15.2 Termination by either Party for Cause. Either Party may terminate this
Agreement by notice to the other Party at any time during the Agreement Term as
follows:

 

  15.2.1 If a Party breaches any of its material obligations under this
Agreement (the “Defaulting Party”), the other Party (the “Non-Defaulting Party”)
may give written notice of such breach to the Defaulting Party, specifying the
nature of the breach and requesting a cure. If the Defaulting Party has not
cured such breach within (a) thirty (30) days after notice of such breach is
provided by the Non-Defaulting Party to the Defaulting Party, in case such
breach is a non-payment of any undisputed amount due under this Agreement (which
shall be deemed a breach of a material obligation), and (b) sixty (60) days
after notice of such breach is provided by the non-Defaulting Party to the
Defaulting Party for other cases of breach. The Non-Defaulting Party shall have
the right to terminate this Agreement effective at the end of the (x) thirty
(30) day period in case the breach is a non-payment of any undisputed amount due
under this Agreement if the Defaulting Party has not cured such breach during
such thirty (30) day period, or (y) sixty (60) day period for other cases of
breach unless the Defaulting Party cures such breach during such sixty (60) day
period, in which case the Agreement may not be terminated.

 

  15.2.2 If the other Party is adjudged bankrupt, applies for judicial or
extra-judicial settlement with its creditors, makes an assignment for the
benefit of its creditors, voluntarily files for bankruptcy or has a receiver or
trustee or the like in bankruptcy appointed by reason of its insolvency, or in
the event an involuntary bankruptcy action is filed against the other Party, or
if the other Party becomes the subject of liquidation or dissolution
proceedings, such right to terminate shall only become effective if the Party
consents to the involuntary proceeding or such proceeding is not dismissed
within ninety (90) days after the filing thereof.

 

  15.3 In the event in Orion’s reasonable judgment the use of Licensed Product
for the Initial Indication poses a potential serious risk to public health or
there exists a significant concern regarding a patient safety issue that would
adversely impact the long term viability of the Licensed Product for the Initial
Indication, Orion shall have the right to terminate this Agreement, upon sixty
(60) days prior written notice thereof to Indevus, provided, however, that prior
to giving such notice, Orion discusses and justifies its belief and the reasons
therefor at a meeting of the Oversight Committee.

 

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  15.4 Indevus will have the right to terminate this Agreement in its entirety
or with respect to the affected countries, by written notice to Orion in the
event Orion or any of its Affiliates, sublicensees or Marketing Distributors
commences any legal proceeding seeking to challenge or otherwise dispute the
validity or ownership of any of the Indevus Patent Rights or any of the claims
therein, or knowingly assists any Third Party to do any of the foregoing, which
termination shall be effective on the date set forth in such notice.

 

  15.5 In the event Net Sales in the Territory for [***] consecutive Calendar
Years or for[***] Calendar Years out of [***] consecutive Calendar Years, in
each case commencing during the Calendar Year ending December 31, 2009, do not
include the minimum number of units of Licensed Product sufficient to satisfy
the applicable Minimum Requirements for each of such Calendar Years, then Orion
shall have the right to terminate this Agreement in its entirety by giving at
least [***] prior written notice to Indevus.

 

  15.6 Upon the effective date of expiration or termination of this Agreement
pursuant to any provision in this Agreement, Orion shall notify Indevus of the
amount of Licensed Product Orion, its Affiliates and their Marketing
Distributors then have on hand and shall have the right to sell in the Territory
(except with respect to any country in the Territory in which Licensed Product
has been withdrawn or there is no Marketing Authorization), its remaining stock
of Licensed Product for the Initial Indication for a period ending upon the
earlier of: (a) Orion’s, its Affiliates’ and their Marketing Distributors’ sale
of all such Licensed Product in their possession on the date of termination of
this Agreement, or (b) six (6) months after such termination, and the terms and
conditions of this Agreement shall apply, as applicable to such Licensed Product
so sold. Indevus hereby grants a non-exclusive license to Orion solely as
reasonably necessary to sell such Licensed Product for the Initial Indication in
the Territory, subject to payment of all related amounts due under this
Agreement. Any remaining quantities of Licensed Product not sold during this
period shall be destroyed by Orion at Orion’s cost.

 

  15.7

Except as expressly set forth herein, the rights to terminate as set forth
herein shall be in addition to all other rights and remedies available under
this Agreement, at law, or in equity, or otherwise. Termination or expiration of
this Agreement, for whatever reason, shall be without prejudice to any rights,
claims or obligations of either Party which have accrued prior to, or become due
at the date of such expiration or termination. Payments of amounts owing to
Indevus or Orion under this Agreement as of its expiration or termination shall
be due and payable either (a) to the extent such amounts can be calculated and a
fixed sum determined at the time of expiration or termination of this Agreement,
within ten (10) Business Days after the date of such expiration or termination,
or (b) to the extent such amounts cannot be calculated and a fixed sum
determined at the time of expiration or termination of this Agreement, ten
(10) Business Days after the date in which such amounts can be calculated and a
fixed sum determined. In the event that any of the milestones linked to Net
Sales are achieved during the Calendar Year in which expiration or termination
of this Agreement occurs, but after the effective date of such expiration or
termination, or during the non-exclusive

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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license period referred to in Section 15.6, Indevus shall be entitled to the
applicable milestone payment, if achieved by Orion, based on the portion of such
Calendar Year completed prior to the effective date of such expiration or
termination or the expiration of such non-exclusive license period, as
applicable.

 

  15.8 Survival. In addition to any other provisions of this Agreement which by
their terms continue after the termination or expiration of this Agreement,
Articles 15 through 18, 20 through 25 and 28 shall survive and continue in full
force and effect notwithstanding such termination or expiration in accordance
with their respective terms. In addition, any other provision required to
interpret and enforce the Parties’ rights and obligations under this Agreement
shall also survive, but only to the extent required for the full observation and
performance of this Agreement.

 

  15.9 Effect of Expiration or Termination

 

  15.9.1 In the event of any termination of this Agreement the following shall
be applicable: (a) all licenses granted hereunder with respect to the Indevus
Proprietary Rights and the Trademark shall immediately cease except as provided
in Section 15.6; and (b) Orion shall promptly transfer and return to Indevus
copies of all Indevus Proprietary Rights and all relevant records and materials
in Orion’s possession or control containing Proprietary Information of Indevus
(provided that Orion may keep one copy of such Proprietary Information of
Indevus for archival purposes only).

 

  15.9.2 In the event of termination of this Agreement by Orion under [***] at
Indevus’ request, Orion shall at Indevus’ request, (a) transfer to Indevus
ownership of, and assign to Indevus all of its right, title and interest in and
to, any MAAs, Marketing Authorizations and any other regulatory filings owned or
controlled by Orion or its Affiliates and relating to Licensed Product in the
Territory; (b) assign to Indevus any Orion Patent Rights, provided that if any
Orion Patent Rights include claims that cover products in addition to the
Licensed Product, in lieu of assignment of such Orion Patent Rights Orion shall
grant Indevus an exclusive royalty-free fully paid-up license to and under such
Orion Patent Rights to the extent reasonably necessary for Indevus’ development
and commercialization of Licensed Product; and (c) grant Indevus a sole
royalty-free, fully paid-up license under any Orion Know-How, to the extent
reasonably necessary for Indevus’ development and commercialization of the
Licensed Product. In addition to any other payment obligations provided for
hereunder, Orion shall pay Indevus not later than the effective date of such
termination, the then current Supply Price for all Bulk Drug Product and
Insertion Tools that were subject to a Firm Commitment portion of a Rolling
Forecast or Purchase Order provided by Orion hereunder and/or that constitute
inventory held in accordance with Section 6.7.

 

  15.9.3

In the event of termination of this Agreement by Orion under [***] Orion, if
requested by Indevus, shall grant Indevus an non-exclusive worldwide license to
and under any Orion Patent Rights and Orion Know-How, including any MAAs,
Marketing Authorizations and any other regulatory filings owned or controlled by

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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Orion or its Affiliates and relating to Licensed Product in the Territory, to
the extent necessary for Indevus’ development and commercialization of the
Compound and Licensed Product subject to the immediately following sentence. Any
such license will include a commercially reasonable transfer price payment or
royalty for use of Orion Patent Rights and Orion Know-How, royalty for use of
the Trademark that was used by Orion in the Territory in the event Indevus
elects to use the same Trademark in connection with the commercialization of
Licensed Product for the Initial Indication in the Territory, or other terms to
be negotiated in good faith between the Parties based on an analysis of factors
relevant at that time, including the Parties’ relative contribution to the
development of Licensed Product, the stage of development and commercialisation
of Licensed Product in the Territory and the nature and timing of the breach, if
any, or other event leading to termination of this Agreement.

 

  15.9.4 During the [***] period immediately following such termination, Orion
shall use Commercially Reasonable Efforts, if so requested by Indevus, at
Indevus’ cost, to cooperate with Indevus to provide for an orderly transition to
Indevus or its designee(s) of the development, regulatory and commercialization
activities being performed by Orion hereunder with respect to Licensed Product
in the Territory.

 

16. REPRESENTATIONS AND WARRANTIES, INDEMNIFICATION AND LIABILITY; INSURANCE

 

  16.1 General Representations. Each Party hereby represents and warrants to the
other Party as of the Date of Agreement as follows:

 

  16.1.1 Such Party is a corporation duly organized, validly existing and in
good standing under the laws of the jurisdiction in which it is incorporated;

 

  16.1.2 Such Party has the corporate power and authority and the legal right to
enter into this Agreement and to perform its obligations hereunder and the
execution, delivery and performance by such party of this Agreement have been
duly authorized by all necessary corporate action;

 

  16.1.3 This Agreement has been duly executed and delivered on behalf of such
Party, and constitutes a legal, valid, binding obligation, enforceable against
such Party in accordance with its terms, except as enforceability may be limited
by any applicable bankruptcy, insolvency, reorganization, moratorium or similar
law affecting creditor’s rights generally;

 

  16.1.4 All necessary consents, approvals and authorizations of all
governmental authorities and other persons required to be obtained by such Party
in connection with this Agreement have been obtained; and

 

  16.1.5 The execution and delivery of this Agreement and the performance of
such Party’s obligations hereunder do not conflict with or violate any
requirement of applicable laws or regulations or any judgment, injunction,
decree, determination or award presently in effect having applicability to it.

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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  16.2 Liability; Indemnification.

 

  16.2.1 In no event shall either Party be liable for or have any obligation to
compensate or indemnify the other Party, its Affiliates, officers and directors,
for any indirect or consequential damages claimed by such other Party, its
Affiliates, officers or directors other than in connection with their respective
indemnification obligations set forth in this Section 16.2, including the loss
of opportunity, loss of use, or loss of revenue or profit, in connection with or
arising out of this Agreement or breach thereof.

 

  16.2.2 Indevus agrees to indemnify Orion, its officers, directors and
Affiliates and hold it harmless from and against all Losses incurred by Orion
arising out of, attributable to or resulting from any Claims to the extent such
Claims arise out of (a) Indevus’ willful or criminal wrongdoing, or recklessness
in performing its material obligations under, or material breach of, this
Agreement; or (b) Bulk Drug Product and/or Insertion Tools that are not in
compliance with the Agreed Quality at the time when they are available for
Orion; (c) the infringement of any Third Party intellectual property right
arising from the manufacture, use, sale, offer for sale, or importation of Bulk
Drug Product and/or Insertion Tools; or (d) research or development of the
Licensed Product conducted by Indevus, its Affiliates or by a Third Party on
Indevus’ behalf, including pre-clinical and clinical trials; provided, however,
that Indevus shall not be obligated under this Section 16.2.2 to the extent any
Claim arises out of (i) any wilful or criminal wrongdoing, or negligent act or
omission, or breach of any of Orion’s relevant obligations or representations or
warranties under this Agreement by Orion, its Affiliates, sublicensees or
Marketing Distributors; or (ii) any Bulk Drug Product or Insertion Tools that
have been adulterated or otherwise mistreated by Orion.

 

  16.2.3 Orion agrees to indemnify Indevus, its officers, directors and
Affiliates and hold it harmless from and against all Losses incurred by Indevus
arising out of, attributable to or resulting from any Claims to the extent such
Claims arise out of (a) the Final Packaging of Bulk Drug Product and Insertion
Tools; (b) research, development, testing, use, marketing, sale or other
disposition of the Bulk Drug Product or Licensed Product by Orion, its
Affiliates, sublicensees or Marketing Distributors or by any other Third Party
on Orion’s behalf in the Territory; or (c) Orion’s willful or criminal
wrongdoing or recklessness in performing its material obligations under, or
material breach of, this Agreement; provided, however, that Orion shall not be
obligated under this Section 16.2.3 to the extent any Claim arises out of any
wilful or criminal wrongdoing, or negligent act or omission, or breach of any of
Indevus’ relevant obligations or representations and warranties under this
Agreement by Indevus, its Affiliates or its subcontractors.

 

  16.2.4 In the event that negligence, recklessness or willful misconduct of
both Indevus and Orion is determined to have contributed to any such Claims,
Indevus and Orion will each indemnify and hold harmless the other with respect
to that portion of the Claims determined to be attributable to its respective
negligence, recklessness or willful misconduct or breach of this Agreement.

 

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  16.2.5 With respect to any indemnification under this Agreement, the following
shall be applicable:

 

  (a) The indemnified Party shall notify the indemnifying Party promptly in
writing of any claim which may give rise to an obligation on the part of the
indemnifying Party hereunder; provided, however, that failure to provide prompt
notice shall not relieve any Party of the duty to defend or indemnify unless
such failure materially prejudices the defense of any matter.

 

  (b) The indemnifying Party shall be allowed to timely undertake the sole
control of the defence of any such action and claim, including all negotiations
for the settlement, or compromise of such claim or action at its sole expense;
provided, however, that an indemnifying party shall not, without the written
consent of the other Party, which shall not be unreasonably withheld, as part of
any settlement or compromise (i) admit to liability on the part of the other
Party; (ii) agree to an injunction against the other Party; or (iii) settle any
matter in a manner that separately apportions fault to the other Party.

 

  (c) The indemnified Party shall at the expense of the indemnifying Party
render reasonable assistance, information, co-operation and authority to permit
the indemnifying Party to defend such action; provided, however, that an
indemnified Party shall not, except at its own cost, voluntarily make any
payment or incur any expense with respect to any Claim without the prior written
consent of the indemnifying Party, which the indemnifying Party shall not be
required to give.

 

  16.3 Insurance. Each Party shall maintain during the Agreement Term and for a
period of five (5) years after any expiration of termination of this Agreement
Commercial General Liability Insurance, (including Products Liability,
Contractual Liability, Bodily Injury, Property Damage and Personal Injury) to
cover its indemnification obligations under this Section 16, with minimum limits
of [***] in the aggregate, which may be self-insured. Within ten (10) days after
the Date of Agreement and thereafter periodically upon request, each Party shall
furnish the other with a certificate of insurance evidencing that such insurance
coverage is in force. During the Agreement Term, each Party shall provide
reasonable prior written notice to the other Party if such insurance is reduced
below the minimum limits as set forth in this Section 16.3 (other than by
payment of Claims) or is expired or cancelled, unless outside of the control of
the Party. In all cases prompt notification to the other Party of any such
reduction, cancellation or expiration of the insurance is required. Upon request
each Party shall provide Certificates of Insurance to the other Party evidencing
the coverage specified herein.

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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17. CONFIDENTIALITY

 

  17.1 Non-Disclosure and Non-Use Obligations. Each Party shall keep (and shall
require that its Affiliates and, in the case of Orion, its Marketing
Distributors keep) in confidence all Proprietary Information of the other Party,
and may not disclose to any Third Party, other than to Marketing Distributors
and subcontractors who are subject to a confidentiality agreement with
provisions comparable to those set forth herein or use such Proprietary
Information for any other purposes than those set forth in this Agreement
without the prior written consent of the Party that disclosed the Proprietary
Information to the other Party. The confidentiality obligations shall, however
not be applied to the extent that such Proprietary Information, (a) is or
becomes generally available or otherwise public through no fault of the
receiving Party, or (b) was received from a Third Party, as documented by
business records, without any obligation of confidentiality, or (c) was in the
possession of the receiving Party prior to receipt of same from the other Party
without any obligation of confidentiality related thereto, (d) has been
independently developed, as documented by research and development records,
without using Proprietary Information received from the other Party, or (e) is
required to be disclosed by law, applicable Regulatory Authority or court order,
provided that notice is promptly delivered to the non-disclosing Party in order
to provide an opportunity to challenge or limit the disclosure.

 

  17.2 Return of Proprietary Information. Each Party shall promptly upon
termination of this Agreement cease using Proprietary Information received from
the other Party and, unless the Parties separately agree on destruction of such
material and information, return the material and information in question
including all copies thereof within thirty (30) days; provided the Party may
keep one copy of such material and information for archival purposes only.

 

  17.3 Survival. The rights and obligations under this Section 17 shall survive
the termination or expiration of this Agreement for whatsoever reason and shall
remain in effect for a period of [***] from the termination or expiration of
this Agreement.

 

18. STATEMENTS TO PUBLIC

 

  18.1

Except as required by law, neither Orion nor Indevus shall make or procure or
permit the making of any press release or other announcement or statement to the
public with respect to this Agreement except as set forth herein. It is
understood that either Party may make disclosure of this Agreement and the terms
hereof in any filings required by the United States Securities and Exchange
Commission, other governmental authority or securities exchange, may file this
Agreement as an exhibit to any filing with any such agency or authority, or
securities exchange, and may distribute any such filing in the ordinary course
of its business. Each Party agrees to provide to the other Party a copy of any
such public announcement as soon as reasonably practicable under the
circumstances prior to its scheduled release. Each Party shall have the right to
expeditiously (but in any event within two (2) Business Days of receipt) review
any press release, announcement or other public disclosure regarding this
Agreement or the subject matter of this Agreement, provided, however, that such
right of review shall

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

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only apply for the first time that specific information is to be disclosed, and
shall not apply to the subsequent disclosure of substantially similar
information that has previously been disclosed unless there have been material
changes in the disclosure since the date of the previous disclosure.

 

19. PUBLICATIONS

 

  19.1 Each Party acknowledges the other Party’s interest in publishing its
results related to Licensed Product to obtain recognition within the scientific
community and to advance the state of scientific knowledge. Each Party also
recognizes the mutual interest in obtaining valid patent protection and in
protecting business interests and trade secret information. Accordingly, Orion
shall not submit for written or oral publication any manuscript, abstract or the
like relating to Licensed Product without the prior review of Indevus. If Orion
proposes to submit any such publication, it shall deliver the proposed
publication or an outline of the oral disclosure at least thirty (30) Business
Days prior to planned submission or presentation. At the request of Indevus, the
submission of such publication may be delayed such that any issues of patent
protection may be addressed. In the absence of any such request, upon expiration
of the applicable period referred to in this Section 19.1, Orion shall be free
to proceed with the publication or presentation. If Indevus requests
modifications to the publication, Orion shall edit such publication to prevent
disclosure of trade secret or proprietary business information prior to
submission of the publication or presentation, if reasonably possible. The
contribution of each Party, if any, shall be noted in all publications or
presentations by acknowledgment or co-authorship, whichever is appropriate.

 

20. INDEPENDENT CONTRACTORS

 

  20.1 The status of Orion and Indevus under the business arrangement
established by this Agreement is that of independent contractors. It is
expressly agreed that for tax, legal or other purposes (a) this Agreement or any
portion of this Agreement shall not be considered to be a partnership agreement,
and (b) the relationship between the two Parties shall not constitute a
partnership, joint venture or agency. Neither Party has any authority whatsoever
to act as an agent or representative of the other, nor has either any authority
or power to contract for, or create or assume any obligation or liability in the
other’s name or on behalf of the other or otherwise bind the other in any way
for any purpose, nor shall either Party hereto represent to any third parties it
possesses any such authority to bind the other Party.

 

21. NON-WAIVER

 

  21.1 The failure by either Party at any time to enforce any of the terms,
provisions or conditions of this Agreement or to exercise any right hereunder
shall not constitute or be construed to constitute a waiver of the same or
affect that Party’s rights thereafter to enforce or exercise the same. No waiver
of any term, provision or condition of this Agreement shall be effective unless
it is in writing and signed by a duly authorised person on behalf of the
waiving.

 

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22. ASSIGNMENT

 

  22.1 This Agreement may not be assigned or otherwise transferred without the
prior written consent of the other Party; provided, however, that:

 

  22.1.1 Indevus may assign this Agreement to an Affiliate or in connection with
the transfer or sale of its business or all or substantially all of its assets
relating to Licensed Product or in the event of a merger, consolidation, change
in control or similar corporate transaction with respect to Indevus, without
such consent; and

 

  22.1.2 Orion may assign this Agreement to any Affiliate of Orion or in
connection with the transfer or sale of Orion’s business or all or substantially
all of Orion’s assets as a whole or in the event of a merger, consolidation,
change in control or similar corporate transaction with respect to Orion (any of
the foregoing, a “Corporate Transaction”), without such consent; provided,
however, that:

 

  (a) such consent shall be required in connection with the transfer or sale of
all or substantially all of Orion’s assets relating to Licensed Product, except
where such transfer or sale would constitute a transfer or sale of all or
substantially all of Orion’s assets as a whole and would constitute a Corporate
Transaction; and

 

  (b) in the event Orion or any of its Affiliates (i) signs a definitive
agreement with respect to a Corporate Transaction by operation of which Orion or
any of its Affiliates would (A) acquire a product (a “Divestiture Causing
Product”) which causes any regulatory authority or government agency to require
the divestiture of either the Divestiture Causing Product or Licensed Product;
or (B) be acquired by or merge with a Third Party who has a Divestiture Causing
Product, or (ii) as a result of any other event or transaction or series of
events or transactions, engages in a Corporate Transaction that results in the
common ownership or control of both Licensed Product and a Divesture Causing
Product; then Orion or its Affiliate (or the other Party to the Corporate
Transaction) shall divest the Divesture Causing Product, provided that any
divestiture of Licensed Product will result in the automatic termination of this
Agreement.

 

  22.2 This Agreement shall be binding upon, inure to the benefit of and be
enforceable by and against the successors and permitted assigns of the Parties.
Any assignment not in accordance with this Agreement shall be void.

 

23. GOVERNING LAW

 

  23.1 The Agreement shall be governed by and construed in accordance with the
laws of the United States of America and State of New York without reference to
any rules of conflict of laws. It is specifically agreed that the United Nations
Convention on Contracts for the International Sale of Goods is not applicable to
this Agreement.

 

52

--------------------------------------------------------------------------------

24. DISPUTE RESOLUTION

 

  24.1 Any and all disputes, controversies or claims of any sort arising from
this Agreement (a “Dispute”) not otherwise addressed herein shall first be
discussed by the Parties hereto, who shall try to settle the dispute among
themselves. Should they fail to agree within a maximum of ninety (90) days of a
written request by either Party, any such Dispute shall be referred, by written
notice from either Party to the other, to the Chief Executive Officer of each
Party. Such Chief Executive Officers shall negotiate in good faith to achieve a
resolution of the Dispute referred to them within a maximum of twenty
(20) Business Days after such notice is received by the Party to whom the notice
was sent. If the Chief Executive Officers are unable to settle the Dispute
between themselves within a maximum of twenty (20) Business Days, either of
them, or both jointly, shall so report to the Parties in writing.

 

  24.2 All Disputes not resolved in accordance with the prior paragraph shall be
finally and exclusively settled under the Rules of Arbitration of the
International Chamber of Commerce by three (3) arbitrators appointed in
accordance with said Rules, except where modified herein.

 

  24.3 Each such arbitrator shall have prior experience in the biotechnology or
pharmaceutical industry: one arbitrator shall be appointed by each of Indevus
and Orion and the third arbitrator, who shall be the Chairman of the tribunal,
shall be appointed by the two Party-appointed arbitrators (the three arbitrators
are referred to herein as the “Board of Arbitration”). The place of arbitration
shall be London, United Kingdom. The Board of Arbitration shall have the
authority to grant specific performance. Any award so rendered shall be final
and binding and judgment upon the award so rendered may be entered in any court
having jurisdiction or application may be made to such court for judicial
acceptance of any award and an order of enforcement, as the case may be. Any
such arbitration shall be conducted in the English language.

 

25. ENTIRE AGREEMENT

 

  25.1 This Agreement, together with all Schedules hereto, represents the full
and complete understanding and agreement of the Parties pertaining to the
subject matter hereof and prevails over all statements, clauses or conditions
which may be contained in any other form or document. All express or implied
agreements and understandings, either oral or written, made on or before the
Date of Agreement, including any offering letters or term sheets, are expressly
superseded by this Agreement.

 

26. SEVERABILITY

 

  26.1

In case one or more of the provisions contained in this Agreement shall, for any
reason, be held invalid, illegal or unenforceable in any respect, such
invalidity, illegality or unenforceability shall not affect any other provision
of this Agreement, unless the absence of the invalidated provision(s) adversely
affect the substantive rights of a Party, but this Agreement shall be construed
by limiting such invalid, illegal or unenforceable provision, or if such is not
possible, by deleting such invalid, illegal or unenforceable

 

53

--------------------------------------------------------------------------------

 

provision from this Agreement; provided that in such event, the Parties shall
replace the invalid, illegal or unenforceable provision(s) with valid, legal and
enforceable provision(s) which are agreed to by the Parties and, insofar as
practical, implement the purposes of this Agreement.

 

27. AMENDMENTS

 

  27.1 No modifications and amendments to this Agreement shall be valid unless
made in writing and signed by duly authorised representatives of both Parties.

 

28. NOTICES

 

  28.1 Notices provided hereunder to be given by either Party to the other shall
be in writing and shall be sent by fax (and promptly confirmed by personal
delivery, registered or certified mail or overnight courier), or delivered by
recognised overnight delivery service or sent by government mail service
(certified or registered air mail) to the following respective addresses or to
such other addresses as the Parties may hereafter communicate to each other in
writing:

If to Orion:

Orion Corporation

Attn: President

Orionintie 1

02200 Espoo

Tel. +358 10 426 3000

Fax. +358 10 426 4323

If to Indevus:

Indevus Pharmaceuticals, Inc.

33 Hayden Avenue

Lexington, MA 02421, United States of America

Attention: Chief Executive Officer

Fax No.: 781-862-3859

All Purchase Orders to be sent to:

Indevus Pharmaceuticals, Inc.

8 Clarke Drive

Cranbury, NJ 08512

Attention: Customer Service

Fax No.: 609-409-1654

The notices shall be deemed to have been received as follows: (a) telefaxes, on
the day following the day of transmission; (b) upon confirmed delivery by
nationally-recognized overnight courier if so delivered (c) registered or
certified air-mail, on the third (3rd) day after mailing; and (d) notices
delivered in any other form, on the day when delivered at the address of the
recipient.

 

54

--------------------------------------------------------------------------------

29. COUNTERPARTS.

 

  29.1 The Agreement 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. Signatures to the Agreement transmitted by fax, by email in
“portable document format” (“.pdf”) or by any other electronic means intended to
preserve the original graphic and pictorial appearance of the Agreement shall
have the same effect as physical delivery of the paper document bearing original
signature.

 

30. SCHEDULES

 

  30.1 The following schedules are attached to and constitute an integral part
of this Agreement.

 

Schedule 1.15    Exclusion from Competing Product Schedule 1.28    Indevus
Patent Rights Schedule 1.42    Minimum Requirements Schedule 1.52    Packing of
Bulk Drug Product Exhibit 1.54    Form of Pharmacovigilance Agreement
Schedule 3.3    Variations to Indevus MAAs Schedule 4.1    Oversight Committee
Members Schedule 8.1    Supply Price Schedule 9.1    Indevus Testing

 

31. HEADINGS

 

  31.1 All section headings in this Agreement are for convenience only and shall
not in any way affect the meaning or interpretation of the Agreement.

 

55

--------------------------------------------------------------------------------

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
in duplicate, as of the day and year first above written, by their duly
authorised representatives.

SIGNATURES

 

Orion Corporation     Indevus Pharmaceuticals, Inc. By:  

 

    By:  

 

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

 

      Name:         Title:        

--------------------------------------------------------------------------------

SCHEDULE 1.15

To the License, Supply and Distribution Agreement between Indevus
Pharmaceuticals,

Inc. and Orion Corporation dated April 2, 2008

EXCLUSION FROM COMPETING PRODUCT

[***]

 

*** CONFIDENTIAL TREATMENT REQUESTED

--------------------------------------------------------------------------------

SCHEDULE 1.28

To the License, Supply and Distribution Agreement between Indevus
Pharmaceuticals,

Inc. and Orion Corporation dated April 2, 2008

INDEVUS PATENT RIGHTS

[***]

 

*** CONFIDENTIAL TREATMENT REQUESTED

--------------------------------------------------------------------------------

SCHEDULE 1.42

To the License, Supply and Distribution Agreement between Indevus
Pharmaceuticals,

Inc. and Orion Corporation dated April 2, 2008

MINIMUM REQUIREMENTS

Minimum Annual Units of Bulk Drug Product per Calendar Year:

 

Year

   Units

[***]

  

 

*** CONFIDENTIAL TREATMENT REQUESTED

--------------------------------------------------------------------------------

SCHEDULE 1.52

To the License, Supply and Distribution Agreement between Indevus
Pharmaceuticals,

Inc. and Orion Corporation dated April 2, 2008

PACKING OF BULK DRUG PRODUCT

Packaging of Vantas Bulk Drug Product for EU Shipment

The primary packaging of Vantas is defined in the MAA and is part of the
manufacturing process. The Vantas implant is sealed inside a [***] and is
sterile.

Indevus proposes using the [***] to ship product in bulk to Europe. A diagram of
the system is set forth on the next page of this Schedule.

The bulk drug shipment will be placed inside a [***] designed for maintaining
product temperature in the range [***], either summer of winter. Each [***]
container will hold approximately 300 implant vials. (Note; the exact number of
vials per shipping container will depend on results of a shipping study that
will be completed by 4/30/2008).

Each vial will be stored horizontally in a clear molded plastic tray which in
turn will be placed inside product box (see diagram attached) in multiple
layers. Each tray, box and container will be labeled with the lot number and
product name. Each [***] container will contain vials from a single lot only.
Multiple containers will be required to ship a single lot of Vantas.

Indevus will qualify the [***] for use with Vantas prior to the initial shipment
to Orion. The [***] is intended for single use by Indevus. Empty the [***]
weighs approximately 56 Kg.

The implantation device will be packaged in double-wall corrugated cardboard
shippers with an inside plastic liner. There are [***] devices in each shipper.
This is the standard size that Indevus has qualified for bulk shipments.

[***]

 

*** CONFIDENTIAL TREATMENT REQUESTED

--------------------------------------------------------------------------------

EXHIBIT 1.54

To the License, Supply and Distribution Agreement between Indevus
Pharmaceuticals,

Inc. and Orion Corporation dated April 2, 2008

FORM OF PHARMACOVIGILANCE AGREEMENT

--------------------------------------------------------------------------------

PHARMACOVIGILANCE

DATA EXCHANGE

AGREEMENT

between

Orion Corporation

and

Indevus Pharmaceuticals, Inc.

--------------------------------------------------------------------------------

PROCEDURE FOR THE EXCHANGE OF PHARMACOVIGILANCE DATA

 

1 Scope

This document describes the procedures and time frames and defines the
responsibilities which the Parties, Orion Corporation (ORION) and Indevus
Pharmaceuticals, Inc. (INDEVUS) shall adopt to ensure compliance with the
regulatory requirements for pharmacovigilance, and to satisfy business interest
of ORION and INDEVUS with regard to safety issues of the Products.

This agreement is considered as an integral part of the License and Distribution
Agreement between ORION and INDEVUS and is attached to the agreement concerned
as Exhibit 1.54. This Pharmcovigilance Data Exchange Agreement shall become
effective on the date signed by both parties and shall remain in effect until
termination or expiration of the aforementioned licensing agreement.

The communication language of the data exchange shall be English.

 

2 Definitions

The definitions of terms used in this agreement are in accordance with ICH
guidelines (www.ich.org). Key definitions are

 

  2.1 Adverse Event (AE)

Any untoward medical occurrence in humans receiving medicinal product which does
not necessarily have to have a positive causal relationship with this treatment.

 

  2.2 Adverse Drug Reaction (ADR)

A response to a drug which is noxious and unintended and which occurs at doses
normally used in man for prophylaxis, diagnosis, therapy of disease or for
modification of a physiological function.

In addition all cases of drug-drug interaction, pregnancy (with or without
outcome), lack of efficacy, overdose, drug abuse and misuse, drug
maladministration or accidental exposure and dispensing errors are defined as
adverse events (“AEs”) even if no clinical event has been reported. For all
clinical trial serious adverse events (“SAEs”) the above conditions must be
associated with a clinical event fulfilling SAE criteria.

--------------------------------------------------------------------------------

  2.3 Serious Adverse Event (SAE) / Serious ADR

Any event which is fatal, life-threatening, persistantly or significantly
disabling/incapacitating, congenital anomaly/birth defect or which results in or
prolongs hospitalisation, or is any medically significant event, e.g. an
intervention to prevent one of the above outcomes, is considered serious.

Life threatening is defined as any adverse drug experience that places the
patient, in the view of the initial reporter, at immediate risk of death from
the adverse drug experience as it occurred, i.e., it does not include an adverse
drug experience that, had it occurred in a more severe form, might have caused
death.

In addition, any suspected transmission via a medicinal product of an infectious
agent is considered a serious adverse reaction.

 

3 Products and Territory

The Products: Licensed Product as defined in the License and Distribution
Agreement.

The Territory: As defined in the License and Distribution agreement.

 

4 World-wide Safety Database

INDEVUS shall be responsible for the maintenance and consistency of a complete
safety database for spontaneous (including literature) AE reports as well as
clnical study SAE reports concerning the Product. ORION shall keep a secondary
safety database for all reports from its territory and any other reports it
receives. Duplicate reports within the INDEVUS and ORION databases shall be
identified, notified to the other Party and deleted from the databases of both
Parties.

BOTH PARTIES shall be responsible for forwarding all reports received from their
Territory to each other within timeframes defined in Section 5 to enable the
entry of such reports into the corresponding databases.

 

5 Data Exchange of Individual Case Safety Reports

 

  5.1 General

Exchange of individual AE and SAE reports shall be between the central
pharmacovigilance units of INDEVUS and ORION, Indevus Pharmaceuticals Drug
Safety and Orion Pharma Drug Safety (“DS”), which shall collect and distribute
the data in their own safety networks according to their own Standard Operating
Procedures (“SOPs”).

--------------------------------------------------------------------------------

  5.2 Reports from Spontaneous Sources

The individual reports to be exchanged need to fulfil the minimum criteria:

 

  •  

An identifiable source

 

  •  

The Product as a suspected drug

 

  •  

Suspected ADR and

 

  •  

Patient, identified by sex, age (or date of birth) or initials. It is agreed
that in the instance that a specific patient is known to the reporter, but
identification is not provided, it will be considered as an identifiable
patient.

In general, the principle of the implied positive causality shall be applied to
all spontaneously reported AEs.

 

  5.2.1 Serious ADRs

From ORION to INDEVUS:

ORION shall forward CIOMS I reports of all fatal and life-threatening
spontaneous ADRs including reports from literature to INDEVUS as soon as
possible but no later than within [***] calendar days after receipt.

All other serious spontaneous reports, including reports from literature, are to
be sent to INDEVUS no later than [***] calendar days after received by ORION

From INDEVUS to ORION:

INDEVUS shall forward CIOMS I reports of all fatal and life-threatening
spontaneous ADRs, including reports from literature, originating from any other
territory to ORION as soon as possible but no later than within [***] calendar
days after receipt.

All other serious spontaneous reports, including reports from literature, are to
be sent to ORION no later than [***] calendar days after received by INDEVUS

 

*** CONFIDENTIAL TREATMENT REQUESTED

--------------------------------------------------------------------------------

  5.2.2 Non-serious ADRs

From ORION to INDEVUS:

ORION shall forward CIOMS I reports of non-serious ADRs, including reports from
literature, originating from the territory to INDEVUS as soon as possible but no
later than within [***] calendar days after receipt.

From INDEVUS to ORION:

All appropriate reports of non-serious ADRs, including reports from literature
from outside the Orion Territory shall be provided by INDEVUS to ORION no later
than [***] calendar days after received by INDEVUS.

 

  5.3 Reports from Clinical Trials

From clinical studies sponsored by INDEVUS or ORION, the investigator shall
report all SAEs to the respective company according to the procedures in each
company’s particular study protocol. INDEVUS or ORION shall exchange information
of SAEs originating from clinical studies sponsored by INDEVUS or ORION,
respectively, by fax or e-mail within the timelines below. The reports shall be
forwarded on completed CIOMS I forms.

 

  •  

Fatal/life-threatening related reports [***] calendar days

 

  •  

Other serious, related reports [***] calendar days

 

  •  

Not-related SAEs, within [***] calendar days following the date it was reported
to the company.

 

  •  

Reports of non-serious AEs from clinical studies are outside the scope of this
agreement.

If study specific reporting is considered necessary by both Parties, it shall be
agreed separately by the Parties in due time before finalisation of the study
protocol.

 

  5.4 Reports from Literature

INDEVUS shall have the primary responsibility for reviewing the world-wide
scientific literature. ORION shall assist by notifying INDEVUS of literature
reports brought to its knowledge in particular from the Territory within
timeframes defined above, see 5.2.1 and 5.2.2.

 

*** CONFIDENTIAL TREATMENT REQUESTED

--------------------------------------------------------------------------------

  5.5 Follow-up Information

The Party notified first of an AE/ADR is responsible for obtaining follow-up
information required for a proper assessment of the AE/ADR. Should INDEVUS or
ORION have questions regarding an individual report received from the other
Party, these shall be communicated to the other to request the information.

In addition, INDEVUS shall promptly follow-up any AEs under special monitoring
to ensure they are fully documented as required in EU Risk Management Plan.

Follow-up data shall be exchanged as initial data.

 

6 Reconciliation

The receiver of AE reports, INDEVUS or ORION, shall confirm the receipt within
two working days. Without confirmation, the sender shall resend the reports on
the next working day.

 

7 Assessment of Individual Reports

Each Party shall be responsible for its own processing and assessment of the
reported AEs when entering the report into its database according to their
internal SOPs.

In the event that there is a difference in seriousness or causality assessments
of a case received from either Party and entered into a database, discussion
between the Parties shall take place and every effort by both Parties shall be
made to reach an agreement in the assessments to allow timely reporting. Any
resultant action must be communicated between the Parties. In the event that a
mutual agreement can not be reached, both Parties will act according to their
own assessments.

 

  7.1 Spontaneous reports

In general, the principle of the implied positive causality shall be applied to
all spontaneously reported AEs. Each Party shall assess each of the
expectedness, labelling and listedness issues for each report as appropriate and
according to their internal SOPs.

--------------------------------------------------------------------------------

  7.2 Reports from clinical studies

The assessment of causality of the Product with respect to the SAE occurring in
a clinical study shall be made by the responsible investigator and the sponsor
of the clinical study according to the procedure in the study protocol and the
sponsor’s applicable guideline/SOP, respectively. For clinical study reports the
causality scales of the Parties are attached in Appendix 2.

Assessment of labelling (expectedness) shall be made by the sponsor according to
its applicable guideline/SOP using a common Investigator’s Brochure and/or Core
Data Sheet and approved national labelling.

 

8 Periodic Reports

 

  8.1 Periodic Reports outside the Territory to any other Authority

INDEVUS shall be responsible for preparing local Periodic Reports according to
the FDA 21 CFR Part 314.80 The periodicity of Periodic Report shall be based on
the FDA Approval Date of the Product and shall be prepared on annual basis. Each
Party shall contact the other if a change in Periodic Report periodicity is
considered necessary.

INDEVUS shall provide final Periodic Reports in addition to CIOMs Line Listings
as necessary to ORION.

INDEVUS or its other partners shall be responsible for preparing Periodic Safety
Reports to any other authority outside the Orion Territory. INDEVUS shall
provide a copy of the final report to ORION upon release.

 

  8.2 Periodic Safety Update Reports in the Territory

ORION shall be responsible for preparing Periodic Safety Update Reports (PSURs)
in the Territory according to the ICH E2C Guideline as adopted by the European
Union Committee for Proprietary Medicinal Products Pharmacovigilance Working
Party.

INDEVUS is responsible for providing ORION with the necessary information for
the PSUR as defined in the above CPMP Guidelines and as needed by ORION for the
preparation of PSURs. INDEVUS shall provide this information as soon as possible
and at least within 3 weeks of the data lock point (the last day of that PSUR
period, or “DLP”). This information shall include at least the following:

 

  •  

Up to date Marketing Authorisation status

--------------------------------------------------------------------------------

  •  

Update of regulatory authority or Marketing Authorisation Holder actions taken
for safety reasons

 

  •  

Patient exposure in clinical studies conducted by INDEVUS during the PSUR period

 

  •  

Short discussion of all INDEVUS’ completed studies (non-clinical, clinical and
epidemiological), studies specifically planned or in progress and published
studies addressing safety issues or yielding safety information with potential
impact on Product information.

In case INDEVUS transfers rights outside the Territory to any other Party than
ORION, INDEVUS shall ensure that the above data shall be provided to ORION
according to same principles.

ORION shall prompt INDEVUS approximately two weeks prior to the DLP to compile
and submit such data to ORION.

ORION shall be responsible for appropriate RA submissions (expedited individual
adverse event reports and PSURs) in the Territory.

 

9 Product Labelling

Orion shall be responsible for maintaining the local Summary of Product
Characteristics (SPCs) for the Product in the Territory. Orion shall inform
INDEVUS of any planned changes related to safety information in the SPC prior to
implementation with sufficient time for INDEVUS to review and comment on the
proposed changes. Orion shall have the right to make decisions on the changes in
the Territory.

INDEVUS or its other partners shall be responsible for maintaining the labeling
outside the Territory. INDEVUS shall inform ORION of any planned changes related
to safety information in the labeling prior to implementation with sufficient
time for ORION to review and comment on the proposed changes. INDEVUS shall have
the sole right to make all decisions on the changes outside the Territory.

--------------------------------------------------------------------------------

10 Risk Management

ORION is responsible for the maintenance and implementation of the Risk
Management Plan (RMP) in the Territory as required by the Regulatory Authorities
in the Territory. INDEVUS shall support ORION and provide all applicable data
outside the Territory to ensure proper safety surveillance of the Product and
completion of actions required in the EU RMP.

Should INDEVUS decide to maintain its own RMP outside the Territory, INDEVUS
shall distribute the document to ORION for comments. Risk Minimisation and other
risk management activities in INDEVUS RMP having a potential impact on the RMP
in the Territory shall be discussed together to reach a mutual agreement on the
need of such activities.

All the above shall be discussed in the Safety Committee (Section 14). ORION
shall make all the decisions on the content of the RMP in the Territory.

 

11 Submission to Regulatory Authorities (RAs)

ORION shall be responsible for appropriate RA submissions in the Territory.

 

12 Regulatory Authority Requests for Additional Safety Information

 

  12.1 Additional Safety Information to an Individual Report

The Party receiving an individual ADR report first shall be responsible for
obtaining the requested information from the reporter.

 

  12.2 Additional Safety Information of More General Nature

Responses to all pharmacovigilance-related requests from the Regulatory
Authorities shall be the responsibility of the Party to which the questions are
addressed.

Each Party shall provide the other with a copy of the pharmacovigilance related
or risk-benefit assessment request as well as any documentation pertaining to
the request, within [***] calendar days of receipt, as well as a copy of the
response to the request at the time of submission.

Co-ordination of the response to an additional safety information request is the
responsibility of the Party who received the request. The response will be based
on the database of the Party who received the

 

 

*** CONFIDENTIAL TREATMENT REQUESTED

--------------------------------------------------------------------------------

request, or whenever needed based on the nature of the request, on the
world-wide safety database. When needed, both Parties are responsible for
providing AE-data analyses from their clinical studies as required.

 

13 Signal detection

INDEVUS is responsible for detection and evaluation of safety signals. ORION
shall assist by notifying INDEVUS promptly if any potential safety signals are
identified by ORION.

Both Parties shall notify the other in writing of any potential safety signals
identified and discuss and agree upon any proposed actions, including safety
changes in the relevant labelling reference documents.

Both Parties shall identify the representatives needed to evaluate and agree on
the necessary actions.

 

14 Meetings/Safety Committee

The Parties shall meet to discuss pharmacovigilance issues and/or changes to
this Agreement at the reasonable request of either of the Parties.

Two-Party safety committee shall have a regular meeting on safety issues which
may occur by teleconference or a meeting in a mutually acceptable location.

Additionally, the Parties agree that they will deliver safety data concerning
the Product to the other Parties’ internal safety evaluation meetings upon a
reasonable request to do so by either of the other Parties (e.g. once a year
and/ or when a reasonable amount of new safety data has been gathered). The
safety data to be submitted to the other Parties can include e.g. clinical study
statuses; clinical study SAE, AE and laboratory data; decisions made by Data
Monitoring Committees (DMCs); post-marketing data; overall safety conclusions
etc. The format and the contents of the data to be delivered will be agreed upon
by the Parties on a case by case basis, but the Parties hereto are in agreement
that they will deliver the safety data reasonably requested by either of the
other Parties, as provided herein. Any request for safety data by a Party will
be made at least 1 month before the data is to be supplied to the other Parties.

 

15 Auditing

ORION or INDEVUS may perform a product specific pharmacovigilance audit at the
other party, if announced at a minimum 2 weeks in advance.

--------------------------------------------------------------------------------

16 Contact Persons

Contact persons of the Parties are presented in Appendix 1. Contact information
may be changed by written notice to the other party without amendment.

--------------------------------------------------------------------------------

This agreement for pharmacovigilance data exchange has been agreed upon and
adopted by ORION and INDEVUS and shall be in force immediately upon signing.

 

ORION     INDEVUS Date:  

 

    Date:  

 

 

   

 

p.p. Reijo Salonen

Senior Vice President Research & Development

   

James E. Shipley, M.D.

Senior Vice President Clinical Development & Medical Affairs

Date:  

 

    Date:  

 

 

   

 

p.p. Inge-Britt Linden

Director

Global Regulatory Affairs

   

Cynthia C. Abell, R.T.(R)(MR)

Senior Manager

Drug Safety

Date:  

 

     

 

     

Jukka Pesonen

Director

Drug Safety

   

--------------------------------------------------------------------------------

APPENDIX 1 CONTACT INFORMATION

 

ORION CORPORATION DRUG SAFETY         Name:   [***]         Phone:   [***]
        Fax:   [***]         E-mail:   [***]         Address:   Orion
Corporation   Orionintie 1, P.O. Box 65   FI-02101 Espoo, Finland

Individual reports/transmission and pharmacovigilance related inquiries

 

        Fax:   [***]         E-mail:   [***]         Address:   Orion
Corporation   Orionintie 1, P.O. Box 65   FI-02101 Espoo, Finland

 

INDEVUS PHARMACEUTICALS DRUG SAFETY         Name:   [***]         Phone:   [***]
        Telefax:   [***]         E-mail:   [***]         Address:   Indevus
Pharmaceuticals, Inc.   8 Clarke Drive   Cranbury, NJ 08512

 

*** CONFIDENTIAL TREATMENT REQUESTED

--------------------------------------------------------------------------------

APPENDIX 2 CAUSALITY SCALES FOR SAES FROM CLINICAL STUDIES

 

ORION

  

INDEVUS

Category/Definition

  

For

Reporting

  

Category/Definition

  

For

Reporting

Related

The temporal relationship of the AE/SAE onset to the administration of the
investigational product makes a causal relationship possible, and other drugs,
therapeutic interventions or underlying conditions do not provide a sufficient
explanation for the AE/SAE.

  

Related=

Associated

  

Related

The temporal relationship of the AE/SAE onset to the administration of the
investigational product makes a causal relationship possible, and other drugs,
therapeutic interventions or underlying conditions do not provide a sufficient
explanation for the AE/SAE.

  

Related=

Associated

Not Related

The temporal relationship of the AE/SAE onset to the administration of the
investigational product makes a causal relationship unlikely, or other drugs,
therapeutic interventions or underlying conditions provide a sufficient
explanation for the AE/SAE.

  

Unrelated=

Not

associated

  

Not Related

The temporal relationship of the AE/SAE onset to the administration of the
investigational product makes a causal relationship unlikely, or other drugs,
therapeutic interventions or underlying conditions provide a sufficient
explanation for the AE/SAE.

  

Unrelated=

Not

associated

Unknown by reporter.

Safety Officer will assess the causality (Related or Not Related) and the report
will be processed accordingly. The investigator will be queried to provide the
causality assessment.

  

Related /

Unrelated

  

Unknown by reporter.

Safety Officer will assess the causality (Related or Not Related) and the report
will be processed accordingly. The investigator will be queried to provide the
causality assessment.

  

Related /

Unrelated

--------------------------------------------------------------------------------

SCHEDULE 3.3

To the License, Supply and Distribution Agreement between Indevus
Pharmaceuticals, Inc.

and Orion Corporation dated April 2, 2008

VARIATIONS TO INDEVUS MAAs

 

1. Variations

[***]

 

2. Timelines

[***]

 

3. All variations filed by 20 February 2008

[***]

 

*** CONFIDENTIAL TREATMENT REQUESTED

--------------------------------------------------------------------------------

SCHEDULE 4.1

To the License, Supply and Distribution Agreement between Indevus
Pharmaceuticals, Inc.

and Orion Corporation dated April 2, 2008

OVERSIGHT COMMITTEE MEMBERS

Representatives of Orion:

[***]

Representatives of Indevus:

[***]

 

*** CONFIDENTIAL TREATMENT REQUESTED

--------------------------------------------------------------------------------

SCHEDULE 8.1

To the License, Supply and Distribution Agreement between Indevus
Pharmaceuticals, Inc.

and Orion Corporation dated April 2, 2008

SUPPLY PRICES

[***]

 

* Subject to the provisions of Section 8.1.

 

*** CONFIDENTIAL TREATMENT REQUESTED

--------------------------------------------------------------------------------

SCHEDULE 9.1

To the License, Supply and Distribution Agreement between Indevus
Pharmaceuticals, Inc.

and Orion Corporation dated April 2, 2008

INDEVUS TESTING

[***]

 

*** CONFIDENTIAL TREATMENT REQUESTED