LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT

1.

DEFINITIONS

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.

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.

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.

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.

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

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.

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;

(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.

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.

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.

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.

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

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.

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

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

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

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

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

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.

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.

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

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

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 (2 ^nd ) 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;

(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

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.

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.

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 (2 ^nd ) 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

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 Auth