Exclusive License Agreement

EXHIBIT 10.61 January 4 th , 2007 EXCLUSIVE LICENSE AGREEMENT BETWEEN ELI LILLY AND COMPANY AND PROSIDION LIMITED


CONTENTS Article Number Page Number ARTICLE 1 1 DEFINITIONS 1 1.1 DEFINITIONS 1 1.2 FURTHER DEFINITIONS 12 ARTICLE 2 12 PURPOSE AND SCOPE OF THE LICENSE 12 2.1 PURPOSE OF THE LICENSE 12 2.2 LICENSE GRANT 13 2.3 SUBLICENSES 13 2.4 PROSIDION KNOW-HOW 13 2.5 COVENANT NOT TO SUE 14 ARTICLE 3 14 ROLE AND RESPONSIBILITIES OF LILLY 14 3.1 SCOPE OF LILLY' S RESPONSIBILITIES 14 3.2 REGULATORY ACTIVITIES 14 3.3 DILIGENCE OBLIGATIONS 15 3.4 THIRD PARTY OBLIGATIONS 16 3.5 NON-COMPETE 16 ARTICLE 4 17 ROLE AND RESPONSIBILITIES OF PROSIDION 17 4.1 TECHNICAL INFORMATION PROVISION 17 4.2 REASONABLE TECHNICAL ASSISTANCE AND CO-OPERATION FOR TRANSITIONAL PURPOSES 17 4.3 MATERIALS PROVISION 17 4.4 NO ONGOING RESPONSIBILITY BEYOND TRANSITIONAL PURPOSES 18 ARTICLE 5 INFORMATION REPORTING 18 5.1 INFORMATION REPORTING 18 ARTICLE 6 PAYMENTS AND FINANCIAL REPORTING 19 6.1 UPFRONT PAYMENTS 19 6.2 MILESTONE PAYMENTS 19 6.3 ROYALTIES 20 ARTICLE 7 CONFIDENTIALITY AND PUBLICATION 23 7.1 OBLIGATIONS 23 7.2 AUTHORIZED DISCLOSURES OF CONFIDENTIAL INFORMATION 23 7.3 DISCLOSURES LEGALLY REQUIRED OR NECESSARY 23 7.4 DISCLOSURE OF THE TERMS OF THE AGREEMENT 24 7.5 PUBLICATIONS 25 ARTICLE 8 REPRESENTATIONS, WARRANTIES AND DISCLAIMERS 25 8.1 CORPORATE EXISTENCE AND AUTHORITY 25 8.2 AUTHORIZED EXECUTION; BINDING OBLIGATION 25 8.3 NO CONFLICTS 26

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Article Number Page Number 8.4 ALL CONSENTS AND APPROVALS OBTAINED 26 8.5 EXISTING PATENTS IN THE TERRITORY 26 8.6 KNOW-HOW 27 8.7 DISCLAIMER OF IMPLIED WARRANTIES 27 8.8 LIMITATION OF LIABILITY 27 8.9 GUARANTEE OF PERFORMANCE OF AFFILIATES 27 8.10 NOT DEBARRED 28 8.11 LITIGATION 28 ARTICLE 9 MUTUAL INDEMNIFICATION 28 9.1 INDEMNIFICATION OBLIGATIONS 28 9.2 INDEMNIFICATION PROCEDURES 29 9.3 INDEMNIFICATION PAYMENT ADJUSTMENTS 30 9.4 INDEMNIFICATION PAYMENT 30 9.5 INSURANCE 30 9.6 SURVIVAL 32 ARTICLE 10 INTELLECTUAL PROPERTY 32 10.1 LILLY IMPROVEMENTS 32 10.2 PATENT EXPENSES 32 10.3 FILING, PROSECUTION AND MAINTENANCE OF PATENTS 32 10.4 INTERFERENCE, OPPOSITION, REEXAMINATION AND REISSUE 33 10.5 ENFORCEMENT 33 10.6 THIRD PARTY PATENTS 34 10.7 CERTIFICATION UNDER DRUG PRICE COMPETITION AND PATENT RESTORATION ACT 34 10.8 PATENT TERM RESTORATION 35 10.9 PATENT MARKING 35 ARTICLE 11 TERM AND TERMINATION 35 11.1 TERM 35 11.2 TERMINATION 35 11.3 TERMINATION FOR LILLY NON-COMPLIANCE WITH DILIGENCE OBLIGATIONS 36 11.4 TERMINATION AT WILL OF THE LILLY GKA PROGRAM BY LILLY 36 11.5 EFFECT OF TERMINATION; SURVIVING OBLIGATIONS 36 11.6 NON-EXCLUSIVE RIGHTS 38 11.7 RIGHTS IN BANKRUPTCY 38 ARTICLE 12 DISPUTE RESOLUTION 38 12.1 DISPUTES 38 12.2 DISPUTE RESOLUTION PROCEDURES 38 ARTICLE 13 MISCELLANEOUS 41 13.1 FORCE MAJEURE 41 13.2 ASSIGNMENT 41 13.3 CHANGE OF CONTROL 41 13.4 FURTHER ASSURANCES 41 13.5 SEVERABILITY 41 13.6 NOTICES 42 13.7 APPLICABLE LAW 42

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Article Number Page Number 13.8 ENTIRE AGREEMENT 44 13.9 HEADINGS 44 13.10 INDEPENDENT CONTRACTORS 44 13.11 WAIVER 44 13.12 NO THIRD PARTY BENEFICIARIES 44 13.13 COUNTERPARTS 44 13.14 WAIVER OF RULE OF CONSTRUCTION 45 SCHEDULE 1.1.20 46 SCHEDULE 1.1.26 47 SCHEDULE 1.1.58 48 SCHEDULE 1.1.70 49 SCHEDULE 4.3 50 SCHEDULE 8.5 51 APPENDIX 1 52

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EXCLUSIVE LICENSE AGREEMENT THIS EXCLUSIVE LICENSE AGREEMENT (the " Agreement" ) is made and is effective as of January 4 th , 2007 (the " Effective Date" ) by and between: (i) Eli Lilly and Company, a corporation organized and existing under the laws of the State of Indiana, whose principal place of business is Lilly Corporate Center, Indianapolis, Indiana, 46285, United States of America (" Lilly" ); and (ii) Prosidion Limited, a company registered in England and Wales under registered number 4600121 with its registered offices at Windrush Court, Watlington Road, Oxford OX4 6LT, United Kingdom (together with its parent company OSI Pharmaceuticals, Inc. (" OSI" ) and its Affiliates, " Prosidion" ). Prosidion and Lilly are sometimes referred to herein individually as a " Party" and collectively as the " Parties" . RECITALS A. Prosidion is engaged in the research and development of pharmaceutical products and is currently engaged in the research and development of the Prosidion GKA Program (as hereinafter defined). B. Lilly is engaged in the research, development, manufacture and marketing of pharmaceutical products and is interested in further research and development in the GKA (as hereinafter defined) area. C. Prosidion desires to grant to Lilly exclusive license rights in the further research and development of the Prosidion GKA Program and clinical development and marketing of Product(s) (as hereinafter defined), and Lilly desires to receive such rights, subject to and in accordance with the terms in this Agreement. NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the Parties hereby agree as follows: ARTICLE 1 DEFINITIONS 1.1 DEFINITIONS When used and capitalized in this Agreement (other than the headings of the Articles and Sections), including the foregoing recitals, the following terms shall have the meanings assigned to them in this Article and include the plural as well as the singular.

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1.1.1 " Adverse Event" means any untoward medical occurrence in a patient or clinical investigation subject administered a Product and which may or may not have a causal relationship with administration of such Product. 1.1.2 " Affiliate" means any Person that directly (or indirectly through one or more intermediaries) controls, is controlled by, or is under common control with, a Party. For purposes of this definition only, the terms " controls," " controlled," and " control" mean: (i) the direct or indirect ability or power to direct or cause the direction of the management and policies of an entity or otherwise direct the affairs of such entity, whether through ownership of equity, voting securities or beneficial interest, by contract, or otherwise; or (ii) the ownership, directly or indirectly, of at least fifty percent (50%) of the voting securities (or other comparable ownership interest for an entity other than a corporation) of a Party. 1.1.3 " API" or " Active Pharmaceutical Ingredient" means the active pharmaceutical ingredient of PSN010 or GKA Back-ups in bulk form, which, if appropriately formulated and finished, would constitute Product. 1.1.4 " Applicable Laws" means all applicable statutes, ordinances, regulations, rules or orders of any kind whatsoever of any Governmental Authority, including, without limitation, the Regulatory Laws, Prescription Drug Marketing Act, Generic Drug Enforcement Act of 1992 (21 U.S.C. Section 335a et seq.), and Anti-Kickback Statute (42 U.S.C. Section 1320a-7b et seq.), all as amended from time to time. 1.1.5 " Calendar Quarter" means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31. 1.1.6 " Calendar Year" means each successive period of twelve (12) months commencing on January 1 and ending on December 31. 1.1.7 " cGCP" means the then current good clinical practices as defined in U.S. Regulations 21 CFR Sections 50, 54, 56, 312 and 314, (or in the case of foreign jurisdictions, comparable regulatory standards), and in any successor regulation, including those procedures expressed or implied in the Regulatory Materials with respect to any Product(s) provided to Regulatory Authorities. 1.1.8 " cGLP" means the then current good laboratory practice standards promulgated or endorsed by the FDA (or in the case of foreign jurisdictions, comparable regulatory standards), including those procedures expressed or implied in the Regulatory Materials with respect to any Product(s) provided to Regulatory Authorities. 1.1.9 " cGMP" or " GMP" means the then current good manufacturing practices for pharmaceuticals as described in regulations promulgated by Regulatory Authorities as applicable to the Manufacture of Product(s), as such regulations are in effect at the time of Manufacturing Product(s). 1.1.10 " Change Of Control" means, with respect to either Party, any of the following events: (i) the acquisition by any entity of " beneficial ownership" (as defined in Rule 13d-3 under the United States Securities and Exchange Act of 1934, as amended) directly or indirectly, of fifty percent (50%) or more of the shares of such Party' s capital stock, the holders of which have general voting power under ordinary circumstances to elect at least a majority of such Party' s board of directors or equivalent body (the " Board of Directors" ) (the " Voting Stock" ); (ii) the approval by the shareholders of such Party of a merger, share exchange, reorganization, consolidation or similar transaction of such Party (a " Transaction" ), if any party to the Transaction is an entity, other than a Transaction which would result in the beneficial owners of Voting Stock of such Party immediately prior thereto continuing to

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beneficially own (either by such Voting Stock remaining outstanding or being converted into voting securities of the surviving entity) more than fifty percent (50%) of the Voting Stock of such Party or such surviving entity immediately after such Transaction; or (iii) approval by the shareholders of such Party of a complete liquidation of such Party or a sale or disposition of all or substantially all of the assets of such Party. 1.1.11 " Combination Product" means a product that includes PSN010 or a GKA Back-up in addition to at least one additional therapeutically effective active ingredient (whether coformulated or copackaged) which did not arise from the Lilly GKA Program. 1.1.12 " Commercialisation" means all activities undertaken by Lilly before and after Marketing Approval for the Lilly GKA Program or otherwise relating specifically to the marketing, sale and distribution of relevant Product(s) including, without limitation: (i) sales force detailing, advertising, education, planning, marketing, sales force training and distribution; (ii) scientific and medical affairs, including drug safety and regulatory affairs activities necessary per Lilly' s reasonable determination to maintain Marketing Approvals; (iii) Phase IIIB Trials and Post-Approval Trials; and (iv) the Manufacture of Product(s) intended for commercial sale, including, without limitation, formulation, bulk API and/or drug product production, fill/finish, distribution, manufacturing process improvement and quality assurance technical support. 1.1.13 " Commercially Reasonable Efforts" means that level of effort and application of expertise and resource, typical in the pharmaceutical industry in the research, development and commercialisation of a product or compound owned by a Third Party or resulting from its own research efforts, that is of similar market potential and at a similar stage in its development or product life, taking into account issues of safety and efficacy, product profile, difficulty in developing the product, competitiveness of the marketplace for resulting products, the patent position of the compound or product, the regulatory structure involved, the potential total profitability of the applicable products marketed or to be marketed, and other relevant factors affecting the cost, risk and timing of development and the total potential reward to be obtained if a product is commercialised . In determining whether Commercially Reasonable Efforts have been satisfied by Lilly, the fact that Lilly is required to comply with certain financial obligations hereunder to Prosidion shall not be a factor weighed (i.e., Lilly may not apply lesser resources or effort to Product(s) because it has a financial obligation hereunder to Prosidion with respect to sales of Product(s), than it would to a product of its own). 1.1.14 " Competing Product (s)" means any product other than PSN010 or a GKA Back-up: ** 1.1.15 " Confidential Information" means the Prosidion Confidential Information or the Lilly Confidential Information, as applicable. 1.1.16 " Control" or " Controlled" means with respect to any intellectual property right, that the Party owns or has a license to such intellectual property right and has the ability to grant access, a license, or a sublicense to such intellectual property right to the other Party as provided for in this Agreement without violating an agreement with a Third Party as of the time such Party would be first required under this Agreement to grant the other Party such access, license or sublicense; provided, however, that for rights acquired from Third Parties after the Effective Date, such access can be granted without additional cost. ** This portion has been redacted pursuant to a confidential treatment request.

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1.1.17 " Development" means the conduct of all activities that are reasonably required to obtain Marketing Approval of a Product, including, without limitation: (i) non-clinical studies (including, without limitation, pharmacology, toxicology and pharmacokinetics); (ii) regulatory affairs, project management, clinical operations, medical writing, bio-statistics, data management and drug safety, and clinical trials, in accordance with the cGLPs, cGCPs and cGMPs or other designated quality standards and Applicable Laws; (iii) all activities relating to developing the ability to Manufacture such Product, including, without limitation, formulation, stability/analytical, packaging, delivery technologies and devices, bulk API and/or drug product production, Manufacturing fill/finish, Manufacturing process development, and quality assurance technical support, clinical supplies distribution and quality control testing and release, until such time as Manufacturing of such Product intended for commercial sale commences; and (iv) any required post-Marketing Approval commitments. 1.1.18 " EMEA" means the European Medicines Evaluation Agency for the European Union, or a successor agency, which has jurisdiction over Marketing Approval of a pharmaceutical product or device in the European Union. 1.1.19 ** 1.1.20 " Existing Suppliers" means, in relation to Section 3.1 (e), any existing suppliers of goods and/or services to Prosidion at the Effective Date, as set forth in Schedule 1.1.20. 1.1.21 ** 1.1.22 " FD&C Act" means the U.S. Food, Drug and Cosmetic Act, as amended from time to time (21 U.S.C. Section 301 et seq.), together with any rules and regulations promulgated thereunder. 1.1.23 " FDA" means the U.S. Food and Drug Administration, or any successor federal agency in the U.S. having responsibility over U.S. Marketing Approvals. 1.1.24 " Field" means all indications for the treatment, prevention or diagnosis of conditions in humans or animals. 1.1.25 ** 1.1.26 " GKA Back-up(s)" means those back-up compounds to PSN010, within the Prosidion GKA Program that are set forth in Schedule 1.1.26 and/or are covered by a Valid Claim of a Prosidion Patent. 1.1.27 " Governmental Authority" means any court, tribunal, arbitrator, agency, commission, official or other instrumentality of any federal, state, or other political subdivision, or supranational body, domestic or foreign. 1.1.28 " IND" means an Investigational New Drug Application (together with all additions, deletions , and supplements thereto) filed with the FDA or other equivalent filing with any applicable Regulatory Authority outside the U.S., necessary to commence and conduct human clinical trials in a jurisdiction. ** This portion has been redacted pursuant to a confidential treatment request.

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1.1.29 " Information" means any information Controlled by Prosidion as of the Effective Date or by Lilly during the Term that is necessary for the Research and Development of the Lilly GKA Program and/or the Manufacture and Commercialisation of Product(s). Information may include, but is not limited to: (a) any and all inventions, know-how, developments, Lilly Improvements, materials, data, analyses, and the like, regardless of whether the information is stored or transmitted in oral, documentary, or electronic form; and (b) information relating to research and development plans, experiments, results, compounds, therapeutic leads, candidates and products, clinical and preclinical data, trade secrets and Manufacturing, marketing, financial, regulatory, and other business information and plans, and all scientific, clinical, regulatory, marketing, financial and commercial information or data; in each case, to the extent necessary for the Research and Development of the Lilly GKA Program and/or the Manufacture and Commercialisation of Product(s). 1.1.30 " License" shall have the meaning provided in Section 2.2. 1.1.31 " Lilly Confidential Information" means all information (scientific, clinical, regulatory, marketing, financial, commercial, or otherwise, including Lilly Know-How ) disclosed or provided by, or on behalf of, Lilly to Prosidion or Prosidion' s designees in connection with this Agreement whether disclosed or provided prior to, or after, the Effective Date and whether provided orally, visually, electronically, or in writing, except such information that Prosidion can show: (a) was, prior to the date of Lilly' s disclosure, known to it, as shown by competent written evidence, or already in the public domain; (b) became part of the public domain, after Lilly' s disclosure hereunder, through no breach of this Agreement by Prosidion or by any person or entity to whom Prosidion disclosed such information; (c) was subsequently disclosed to Prosidion, without any restrictions, by a person or entity having lawful possession of, and a legal right to disclose, such information; or (d) was developed by Prosidion without use, and independent, of Lilly Confidential Information, as shown by competent written evidence. 1.1.32 " Lilly GKA Program" means the Research, Development, Manufacture and Commercialisation conducted by Lilly during the Term regarding development candidate PSN010 and/or GKA Back-ups. The Lilly GKA Program does not include within its meaning Lilly' s research, development, manufacturing or commercialization efforts with respect to compounds other than PSN010 or GKA Back-ups. 1.1.33 " Lilly Improvement" means any findings, developments, discoveries, inventions, additions, modifications, enhancements, formulations, or changes to the composition of matter, or method of use of, a Product, or its Manufacture made by, or coming under Control of Lilly or any of its Affiliates or Sublicensees during the Term and developed in the course of the Lilly GKA Program and which are necessary in the Research and Development of the Lilly GKA Program and/or the Manufacture and Commercialisation of Product(s), including without limitation, new or improved methods of synthesis, manufacture, ingredients, preparation, presentation, means of delivery, dosage, formulation, or analysis, whether or not patentable. 1.1.34 " Lilly Know-How" means all Information that Lilly Controls as of the Effective Date or during the Term that arises from the Lilly GKA Program, including without limitation, any Lilly

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Improvements. Lilly Know-How does not include Lilly Patents or the information contained in a published Lilly Patent. 1.1.35 " Lilly Patents" means all Patents Controlled by Lilly as of the Effective Date or during the Term that arise from or are useful to the Lilly GKA Program, including without limitation, any such Patents claiming the composition of matter or the use of Product(s) or any Lilly Improvements. 1.1.36 " Lilly Rights" means Lilly Patents, Lilly Know-How and any Lilly Improvements. 1.1.37 " Major Market" means any of the following jurisdictions: ** 1.1.38 " Major Pharmaceutical Company" means any Third Party (which, for the avoidance of doubt, shall exclude OSI) which, during the immediately preceding fiscal year, ** Beginning with January 1, 2008, the market capitalization value described above shall be increased by five percent (5%) annually. 1.1.39 " Manufacture" or " Manufacturing" or " Manufactured" means all operations involved in the manufacturing, quality control testing (including in-process, release and stability testing, if applicable), releasing, packaging and shipping of Product(s). 1.1.40 " Marketing Approval" means the act of a Regulatory Authority necessary for the Manufacture, use, marketing and sale of a Product in the Field for one or more indications in a country or regulatory jurisdiction in the Territory, including, without limitation, the approval of an NDA by the FDA and EU Approval and satisfaction of all applicable regulatory and notification requirements. 1.1.41 " NDA" or " New Drug Application" means an application or set of applications (and any other required registrations, notifications, forms, amendments or supplements) for Marketing Approval for Product(s) and/or pre-market approval to make and sell commercially Product(s), filed with the FDA or with a Regulatory Authority anywhere in the Territory, including, without limitation, all documents, data and other information concerning a pharmaceutical product which are necessary for gaining Marketing Approval. 1.1.42 " Net Sales" means, with respect to Product(s), the gross amount invoiced by Lilly (including a Lilly Affiliate) or any Sublicensee to unrelated Third Parties, excluding any Sublicensee, for Product(s) in the Territory, less: (a) Trade, quantity and cash discounts allowed; (b) Commissions, discounts, refunds, rebates (including, but not limited to, wholesaler inventory management fees), chargebacks, retroactive price adjustments, and any other allowances which effectively reduce the net selling price; (c) Actual Product returns and allowances; (d) That portion of the sales value associated with drug delivery systems; (e) Any tax imposed on the production, sale, delivery or use of the Product, including, without limitation, sales, use, value added taxes or excise taxes; and ** This portion has been redacted pursuant to a confidential treatment request.

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(f) Any other similar and customary deductions. Such amounts shall be determined from the books and records of Lilly, its Affiliates or Sublicensees, maintained in accordance with U.S. Generally Accepted Accounting Principles (" U.S. GAAP" ) or, in the case of Sublicensees, such similar accounting principles, consistently applied. Lilly further agrees in determining such amounts, it and its Affiliates will use Lilly' s then current standard procedures and methodology, including Lilly' s then current standard exchange rate methodology for the translation of foreign currency sales into US dollars and, in the case of Sublicensees, such similar methodology, consistently applied. In the event that Product is sold as part of a Combination Product, the Net Sales of the Product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales of the Combination Product by the fraction, A / (A+B) where A is the weighted average sale price of the Product when sold separately in finished form, and B is the weighted average sale price of the other product(s) sold separately in finished form. In the event that the weighted average sale price of the Product can be determined but the weighted average sale price of the other product(s) cannot be determined, Net Sales for purposes of determining royalty payments shall be calculated by multiplying the Net Sales of the Combination Product by the fraction A / C where A is the weighted average sale price of the Product when sold separately in finished form and C is the weighted average sale price of the Combination Product. In the event that the weighted average sale price of the other product(s) can be determined but the weighted average sale price of the Product cannot be determined, Net Sales for purposes of determining royalty payments shall be calculated by multiplying the Net Sales of the Combination Product by the following formula: one (1) minus B / C where B is the weighted average sale price of the other product(s) when sold separately in finished form and C is the weighted average sale price of the Combination Product. In the event that the weighted average sale price of both the Product and the other product(s) in the Combination Product cannot be determined, the Net Sales of the Product shall be deemed to be equal to ** of the Net Sales of the Combination Product. The weighted average sale price for a Product, other product(s), or Combination Product shall be calculated once each Calendar Year and such price shall be used during all applicable royalty reporting periods for the entire following Calendar Year. When determining the weighted average sale price of a Product, other product(s), or Combination Product, the weighted average sale price shall be calculated by dividing the sales dollars (translated into U.S. dollars) by the units of active ingredient sold during the twelve (12) months (or the number of months sold in a partial calendar year) of the preceding Calendar Year for the respective Product, other product(s), or Combination Product. In the initial Calendar Year, a forecasted weighted average sale price will be used for the Product, other product(s), or Combination Product. Any over or under payment due to a difference between forecasted and actual weighted average sale prices will be paid or credited in the first royalty payment of the following Calendar Year. For the avoidance of doubt, excipients shall not be considered products for the purpose of this definition of Net Sales. Notwithstanding the above, the Parties agree that for the purposes of determining royalty payments, in no event shall the value of Net Sales of the Product, where the Product is sold as part of a ** This portion has been redacted pursuant to a confidential treatment request.

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Combination Product, be less than **. 1.1.43 " Patent" or " Patents" means: (a) patent applications (including provisional applications and applications for certificates of invention); (b) any patents issuing from such patent applications (including certificates of invention); (c) all patents and patent applications based on, corresponding to, or claiming the priority date(s) of any of the foregoing; (d) any reissues, substitutions, confirmations, registrations, validations, re-examinations, additions, continuations, continued prosecution applications, continuations-in-part, or divisions of or to any of the foregoing; and (e) term extensions, supplementary protection certificates and other governmental action beyond the original patent expiration date. 1.1.44 " Patent Expenses" means all costs and expenses incurred by a Party after the Effective Date for the preparation, filing, prosecution and maintenance of a Prosidion Patent including, without limitation, costs and expenses related to Patent defense (e.g., the conduct of any interference or opposition). 1.1.45 " Person" means a natural person, a corporation, a partnership, a trust, a joint venture, a limited liability company, any governmental authority or any other entity or organization. 1.1.46 " Phase I Trials" means human clinical trials conducted in healthy volunteers or patients anywhere in the world in accordance with cGCP intended to establish an initial safety profile and the pharmacokinetics and/or pharmacodynamics of Product(s). 1.1.47 ** 1.1.48 " Phase II Trials" means human clinical trials conducted in patients anywhere in the world with Product(s) in accordance with cGCP and intended to demonstrate efficacy and a level of safety in the particular indication tested, as well as to obtain a preliminary indication of the unit and/or daily dosage regimen required. 1.1.49 " Phase III Trials" means large scale human clinical trials conducted in patients anywhere in the world in accordance with cGCP and intended to demonstrate efficacy and a level of safety in the particular indication tested sufficient to obtain Marketing Approval of Product(s). Phase III Trials include " bridging studies" which allow submission in a target country of clinical data generated from Phase III studies completed in other countries to be submitted in lieu of repeating Phase III studies in the target country. 1.1.50 " Phase IIIB Trials" means Phase III Trials commenced before receipt of Marketing Approval in the jurisdiction where such trials are being conducted, but which are not required for receipt of Marketing Approval and are conducted primarily for the purpose of Product support (i.e., providing additional drug profile data). 1.1.51 " Post-Approval Trials" means all clinical trials which are conducted after Marketing Approval for Product(s) has been obtained from an appropriate Regulatory Authority comprising of trials conducted voluntarily by Lilly for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or r ...