COLLABORATIVE RESEARCH AND LICENSING AGREEMENT

DEFINITIONS

“Affiliate”:

means (i) any corporation or business entity of which more than fifty percent (50%) of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by a Party; (ii) any corporation or business entity which, directly or indirectly, owns, controls or holds more than fifty percent (50%) (or the maximum ownership interest permitted by law) of the securities or other ownership interests representing the equity, voting stock or general partnership interest of a Party or (iii) any corporation or business entity of which a Party has the right to acquire, directly or indirectly, at least fifty percent (50%) of the securities or other ownership interests representing the equity, voting stock or general partnership interest thereof.

“Analysis Databases”:

means the databases held at CTU containing data from the Centres Databases to be used in the main analysis of the Phase III Clinical Trial;

“Analysis Plan”:

means the plan agreed by the Trial Steering Committee (which will be amended from time to time as required) indicating the minimum analyses to be carried out relating to the Phase III Clinical Trial for preparation of the Main Master File;

“Background”:

means in respect of each party, the Intellectual Property Rights owned and/or Controlled by that party at the Commencement Date and all Intellectual Property Rights which that party may subsequently develop, acquire, own and/or have licensed to it which arise outside and independently of the Programme and which they are free to utilise in accordance with this Agreement;

“the Centres”:

means the clinical and non-clinical centres participating in the Programme as detailed in Schedule 4 to this Agreement, as amended from time to time by decision of the Programme Management Board or the Programme Liaison Group;

“Centres Databases”:

means all the data which are entered onto computer from the various sources of Trial Data at the Centres;

“CFR”:

means the United States Code of Federal Regulations;

“Commencement Date”:

means the date of this Agreement;

“Control”:

means the possession of the ability to grant a license as provided for herein without violating the terms of any agreement with any third party.

“Confidential Information”:

means in relation to each party any information relating to such party’s Background, business methods, suppliers, finances, ideas, strategies, concepts, methodologies, inventions, processes, specifications, marketing plans, formulae and/or products;

“CTU”:

means the UK MRC Clinical Trials Unit located in London.

“Current Good Manufacturing Practice”:

means current Good Manufacturing Practices to the extent applicable to Product (i) as defined in Parts 210 and 211 of Title 21 of the CFR, as may be amended from time to time, or any successor thereto, and (ii) as required by applicable guidelines in countries other than the United States.

“DFID”:

means H M Government’s Department for International Development;

“Draft First Full Report”:

means the draft report based on the Main Master File describing the main objectives of the Phase III Clinical Trial and the outcomes and intended for publication, prepared by a writing group appointed by the Trial Steering Committee;

“Draft Supplementary Reports”:

means any draft reports based on any Supplementary Master Files intended for publication subsequent to publication of the First Full Report, prepared by a writing group appointed by the Trial Steering Committee;

“FDA”

means the United States Food and Drug Administration and any successor agency having substantially the same function;

“Field”:

means the field of prevention of HIV infection in humans;

“First Full Report”:

means the final published report based on the Main Master File describing the main objectives of the Phase III Clinical Trial and the outcomes;

“the Grant”:

means MRC Grant number G0100137 entitled ‘Vaginal microbicides for the prevention of HIV transmission’ (appended at Schedule 1 to this Agreement;

“the Grant Holders”:

means Dr Sheena McCormack of the MRC Clinical Trials Unit and Dr Charles Lacey of Imperial College London;

“Independent Data Monitoring Committee”:

means the committee responsible for reviewing the accrued safety and efficacy data during the Phase III Clinical Trial, monitoring the overall progress of the trial, and providing advice on the conduct of the Phase III Clinical Trial to the Trial Steering Committee;

“IND”:

means Indevus’ investigational new drug application (as defined in 21 CFR Section 312.3) number 56962, and any amendments thereto, as filed with the FDA;

“Intellectual Property Rights”:

means any patent, copyright, design rights, trademark, Know-How, any rights in respect of any Confidential Information or other industrial and/or intellectual property right (whether registered or unregistered) subsisting

throughout the world and any application and/or right to apply for any of such rights that are necessary or useful for the development, manufacture or commercialization of the Product;

“Investigator”:

means the person at each Centre responsible for the conduct of the Programme at that Centre;

“Investigators’ Brochure”:

means the brochure relating to the Product (and matching placebo) and their use, storage and handling, to be supplied by Indevus to MRC under this Agreement;

“Know-How”:

means any confidential know-how, methodologies, formulae, processes, data and/or expertise (including but not limited to any relating to manufacture, production, storage, handling and/or use of Products) that are necessary or useful for the development, manufacture or commercialization of the Product;

“Main Master File”:

means a full set of analyses on which the Draft First Full Report and First Full Report for publication shall be based and prepared pursuant to the agreed Analysis Plan and shall include the Protocol and any additional definitions;

“MRC’s authorised representative”:

means Ian Viney of MRC Centre London, Stephenson House, 158-160 North Gower Street, London NW1 2ND; Tel: +44 (0)20 7670 4625; Fax : +44 (0)20 7670 4690;

“Net Sales”:

means the gross amount invoiced by Indevus from sales of Product to Third Parties outside the Territory commencing upon the date of first commercial sale outside the Territory after deducting the following:

(a)      credits, allowances, recalls, samples, discounts and rebates to, and chargebacks from the account of, Third Party customers or on account of returned or rejected Product, including allowance for breakage or spoilage;

(b)      freight, postage, shipping and insurance costs;

(c)      trade discounts, cash discounts, quantity discounts, rebates and retroactive price reductions;

(d)      sales, value-added, excise and other taxes incurred in connection with the sale of Product and customs duties, custom broker charges and other surcharges and governmental charges incurred in connection with the exportation or importation of Product;

(e)      rebates, chargebacks or similar payments or credits granted to managed health care organizations, wholesalers, distributors, buying groups, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations, or other institutions or health care organizations or to any governmental or regulatory authority in respect of any state, provincial, local or federal Medicare, Medicaid or

similar programs in any country, their agencies and purchasers and reimbursers; and

(f)       bad debt expense.

Sales or other transfers by Indevus, its Affiliates or sublicensees in the Territory shall be excluded from the computation of Net Sales and no payments will be payable on such sales or transfers. Sales or other transfers between Indevus and its Affiliates shall also be excluded from the computation of Net Sales and no payments will be payable on such sales or transfers except where such Affiliates are end users, but Net Sales shall include the subsequent sales by such Affiliates to Third Parties outside the Territory.

“Phase III Clinical Trial”:

means the Phase III Clinical Trial included in the Programme, the Protocol of which is appended as Schedule 6;

“the Product”:

means PRO 2000 gel and any other Indevus products derived from or incorporating PRO 2000 to the extent that such products are used in the Phase III Clinical Trial;

“the Programme”:

means the Microbicides Development Programme based on the Grant;

“the Programme Liaison Group”:

means the body responsible for the overall co-ordination of the Programme on a day to day basis, overseeing finances and administration;

“the Programme Management Board”:

means the body responsible for the overall management of the Programme;

“Protocol”:

means the Phase III Clinical Trial protocol entitled ‘An international multicentre, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 0.5% and 2% PRO 2000/5 gels for the prevention of vaginally acquired HIV infection’, appended as Schedule 6 to this Agreement;

“Royalty Term”:

means ten (10) years commencing from the date of first commercial sale of Product outside the Territory with respect to sales by Indevus;

“SAE”:

means any serious adverse event as defined in the Phase III Clinical Trial Protocol, including but not limited to death, serious injury, serious adverse reaction and/or any other effect materially adverse to human health and in any event shall have the meaning of Serious Adverse Drug Experience set forth in the ICH Harmonised Tripartite Guideline for Good Clinical Practice;

“Summary of Main Initial Findings”:

means a written report comprising a summary of the main findings of the Phase III Clinical Trial and the main conclusions supported by the initial analysis of the Trial Data pursuant to the Analysis Plan and intended for early release pending the preparation of the First Full Report;

“Supplementary Master File”:

means a set of analyses on which any Draft Supplementary Reports for publication from the Trial Steering Committee shall be based and prepared pursuant to the agreed Analysis Plan;

“Territory”:

means those countries defined from time to time by the World Bank as having “low-income economies” (or a mutually acceptable equivalent list of countries, if such World Bank lists are discontinued) together with additional countries as agreed between the Parties, as listed in Schedule 5 , provided, however, that if countries that are not listed on Schedule 5 are subsequently defined as having “low-income economies”, the inclusion of such additional countries in the Territory shall be subject to the mutual agreement of Indevus and MRC. The term “Territory” shall permanently include those countries in Africa in which any of the clinical Centres participating in the Programme are situated, regardless of those countries’ status on the World Bank list referred to above;

“Trial Data”:

means case record forms and related material (including copies of correspondence, hospital and clinic notes and discharge summaries, relevant information from telephone conversations and site visits) on individual participants received from the Centres and laboratory results obtained from the laboratories participating in the Phase III Clinical Trial. All such data will be anonymous;

“Trial Management Group”:

means the body charged with the general management of the activities relating to the Phase III Clinical Trial.

“Trial Steering Committee”:

means the committee to be established prior to the Phase III Clinical Trial to review progress of the trial.