Research And Development, License And Supply Agreement

EXHIBIT 10.25

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. CONFIDENTIAL

RESEARCH AND DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT

THIS LICENSE AND SUPPLY AGREEMENT (the " Agreement" ) is made and entered into as of the 22 nd day of SEPT, 2005 (the " Effective Date" ) by and between Eiffel Technologies Limited ACN 072 178 977 of 3 Innovation Road North Ryde NSW 2113 Australia (" EIFFEL" ), and MAP Pharmaceuticals, Inc. of 2400 Bayshore Parkway, Suite 200, Mountain View, California, 94043 USA, a Delaware corporation, (" MAP" ). EIFFEL and MAP are sometimes referred to herein individually as a " Party" and collectively as the " Parties" .

RECITALS

WHEREAS , EIFFEL is engaged in the research and development of engineered particles to enhance the therapeutic performance of compounds for inhalation therapy by pulmonary or nasal delivery using its proprietary supercritical fluid particle formation technology, including but not limited to the aerosol solvent extraction system (the " ASES Technology" );

WHEREAS , MAP is engaged in the research and development of proprietary drug delivery systems for inhalation therapy by pulmonary or nasal delivery, including devices and formulations suitable for those devices;

WHEREAS , MAP and EIFFEL entered into a Confidentiality Deed dated February 23, 2004, a Confidentiality Agreement dated February 9, 2005 (the Confidentiality Deed and Confidentiality Agreement collectively referred to as the " Non-Disclosure Agreements" ), a Feasibility Study Deed dated 18 November, 2004 for the development of a budesonide formoterol combination particle, (the " Combination Feasibility Study" ) and a second Feasibility Study Deed dated February 20, 2005 for the development of a budesonide particle (the " Budesonide Feasibility Study" ) whereby MAP provided certain instructions and funding for the development of engineered particles of pharmaceutical compounds for administration by inhalation;

WHEREAS, MAP and EIFFEL desire to define the terms and conditions under which EIFFEL will develop Product Intermediates and assist in the supply of such Product Intermediates for the use in Products; and WHEREAS , MAP desires to obtain and EIFFEL is willing to grant to MAP, a license under the EIFFEL Intellectual Property in the Fields to develop, manufacture, market and sell, offer for sale, import and export Products on the terms and conditions provided in this Agreement;

AGREEMENT NOW, THEREFORE , in consideration of the foregoing and the covenants and promises contained in this Agreement, the Parties agree as follows:


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PART I: DEFINITIONS 1.1. Definitions. As used herein, the following terms shall have the following meanings: " Affiliate" shall mean a corporation, partnership, trust or other entity that directly, or indirectly through one or more intermediates, controls, is controlled by or is under common control with a Party to this Agreement. For such purposes, " control," " controlled by" and " under common control with" shall mean the possession of the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of voting stock or partnership interest, by contract or otherwise. In the case of a corporation, the direct or indirect ownership of more than fifty percent (50%) of its outstanding voting shares or the ability otherwise to elect a majority of the board of directors or other managing authority of the entity shall in any event be deemed to confer control, it being understood that the direct or indirect ownership of a lesser percentage of such shares shall not necessarily preclude the existence of control.

" Beta-agonist" shall mean any [ * ] beta-agonist or any [ * ] beta agonist as those terms may be further defined from time to time in a generally accepted pharmacology textbook. " Commercial Launch" shall mean on a country-by-country basis, the first sale of a Product to a Third Party following Regulatory Approval of the Product in such country.

" Compound" shall mean (i) any beta-agonist in combination with any steroid; (ii) any steroid; and (iii) insulin, as well as any salts, isomorphs, polymorphs, cogeners or isomers of the preceding. Initial specifications for each Compound will be agreed to by the parties and after such agreement shall be attached hereto as Exhibit 1 and considered an original part of this Agreement.

" Confidential Information" has the meaning set forth in Section 13.

" Compulsory License" shall mean a compulsory license under the EIFFEL Intellectual Property obtained by a Third Party through the order, decree, or grant of a competent governmental authority, authorizing such Third Party to manufacture, use, sell, offer for sale or import a Product in a particular country. " Control" shall mean the ability to grant a license or sublicense as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.

" Development Milestones" shall mean the development milestones in relation to each Field as set out in Exhibit 8.

" DMF" shall mean Drug Master File maintained with the FDA and the equivalent thereof, if any, in jurisdictions outside the United States.


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[ * ] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

" EIFFEL Developed Technology" shall mean improvements to the EIFFEL Know-How and EIFFEL Patents conceived, created, developed or otherwise invented or acquired solely by an employee or agent of EIFFEL or one of its Affiliates or a Third Party (under contract with EIFFEL or one of its Affiliates) as a direct result of fulfilling obligations or exercising rights, including the sharing of Confidential Information, under this Agreement or any other agreement between the Parties.

" EIFFEL Intellectual Property" shall mean the EIFFEL Know-How, the EIFFEL Patents and the EIFFEL Developed Technology. EIFFEL Intellectual Property excludes (a) technologies solely relating to: the Compound, Formulation, or the Product; and (b) products, processes, methods, technologies and other inventions in the public domain or that are owned or made by Third Parties (other than on behalf of EIFFEL or its Affiliates) and not Controlled by EIFFEL or its Affiliates.

" EIFFEL Know-How" shall mean any and all rights owned, licensed or controlled by EIFFEL as of the Effective Date to any scientific, pharmaceutical or technical information, data, discovery, invention (whether patentable or not), know-how, substances, techniques, processes, systems, formulations, designs and expertise relating to the production or manufacture of Product Intermediate which is not generally known to the public. It is expressly acknowledged by the Parties that the EIFFEL Know-How shall not include any MAP Know-How. " EIFFEL Patents" shall mean any and all rights under the Patent Applications and/or Patents as set forth in Exhibit 2 and Exhibit 2a as of the Effective Date and as amended from time to time, and any foreign counterparts thereof and all divisionals, continuations, continuations-in-part, any foreign counterparts thereof and all patents issuing on any of the foregoing, and any foreign counterparts thereof, together with all registrations, reissues, re-examinations, supplemental protection certificates, or extensions thereof, and any foreign counterparts thereof . In the event any additional EIFFEL Patent or Patent Application is necessary or useful to allow MAP to practice the rights granted to it by EIFFEL herein, EIFFEL shall include such Patent or Patent Application in Exhibit 2 or Exhibit 2a, as applicable. " EMEA" shall mean the European Medicines Evaluation Agency, or any successor thereto, which coordinates the scientific review of human pharmaceutical products under the centralized licensing procedure in the European Union.

" FDA" shall mean the United States Food and Drug Administration, or any successor thereto, having the administrative authority to regulate the marketing of human pharmaceutical products or biological therapeutic products, delivery systems and devices in the United States.

" Field" shall mean the administration of a Product by inhalation as follows: (i) for a Product containing any Beta-agonists and any steroid, the Field shall be limited to administration via pulmonary delivery; (ii) for a Product containing a steroid as the sole active ingredient, the Field shall include administration by pulmonary or nasal delivery; and (iii) for any Product containing Insulin as the sole active ingredient, the Field shall include administration by pulmonary or nasal delivery . The parties may add additional fields to the definition of Field as the parties may mutually agree from time to time, under the terms of this Agreement.


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[ * ] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

" Formulation" shall mean a composition of Product Intermediate suitable for administration by inhalation via pulmonary or nasal delivery, as applicable. A Formulation may comprise a mixture, blend or solution of the Product Intermediate combined with excipients and/or adjuvants or neat Product Intermediate and a single Product Intermediate may be covered by more than one Formulation . Specifications for each Formulation will be developed by MAP and after such development shall be attached hereto as Exhibit 3 and considered an original part of this Agreement.

" GCP" shall mean the then-current standards, practices and procedures set forth in the guidelines entitled in " Good Clinical Practice: Consolidated Guideline," including related regulatory requirements imposed by the FDA, any successor agency and as applicable the equivalent thereof in jurisdictions outside the United States. " GMP" shall mean the good manufacturing practices which are then-current regulations set forth in 21 C.F.R. Parts 210 211, 820 and 21 C.F.R. Subchapter C (Drugs), Quality System Regulations and the requirements thereunder imposed by the FDA and, as applicable, the equivalent regulations and requirements in jurisdictions outside the United States. " Head Room Zero" shall mean with respect to EIFFEL a determination made by EIFFEL that the forecasted cash outflow of Eiffel for the next [ * ] exceeds forecasted available cash resources.

" In-Market" shall mean the sale of a Product in the Territory by MAP or an Affiliate of MAP, or where applicable, by a sublicensee, to an unaffiliated Third Party, such as a wholesaler, distributor, managed care organization, hospital or pharmacy and shall exclude bona fide sales of a Product by one MAP Affiliate to another MAP Affiliate or to a sublicensee in the regular course of business as carried out on or after the Effective Date.

" Information" shall mean formulas, practices, procedures, processes, methods, knowledge, know-how, trade secrets, skill, experience, documents, apparatus, results, clinical and regulatory strategies, test data, including pharmacological, toxicological and clinical test data, analytical and quality control data, manufacturing data and descriptions, patent and legal data, market data, financial data or descriptions, devices, assays, chemical formulations, specifications, compositions of matter, product samples and other samples, physical, chemical and biological materials and compounds, and the like, whether or not patentable. " Insolvency Event" shall mean the occurrence of any one or more of the following events in relation to any person: (a) an application is made to a court for an order, or an order is made, that it be wound up, declared bankrupt or that a provisional liquidator or receiver or receiver and manager be appointed;

(b) a liquidator or provisional liquidator is appointed;

(c) an Administrator (as defined in section 9 of the Corporations Act 2001 (Cth) or a Controller (as defined in section 9 of the Corporations Act) is appointed to any of its assets;


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[ * ] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (d) it enters into an arrangement or composition with one or more of its creditors, or an assignment for the benefit of one or more of its creditors, in each case other than to carry out a reconstruction or amalgamation while solvent;

(e) it proposes a winding up, dissolution or reorganisation, moratorium, deed of company arrangement or other administration involving one or more of its creditors;

(f) it is insolvent as disclosed in its accounts or otherwise, states that it is insolvent, is presumed to be insolvent under an applicable law (including under section 459C(2) or section 585 of the Corporations Act)) or otherwise is, or states that it is, unable to pay all its debts as and when they become due and payable;

(g) it becomes, or states that it is, an Insolvent under Administration (as defined in section 9 of the Corporations Act) or action is taken which could result in that event;

(h) an order is made, a resolution is passed, or any other action taken, in each case which is preparatory to or could result in any of the matters referred to in paragraphs (a) (g) inclusive;

(i) it is taken to have failed to comply with a statutory demand as a result of section 459F(1) of the Corporations Act; (j) a notice is issued under sections 601AA or 601AB of the Corporations Act;

(k) a writ of execution is levied against it or its property;

(l) any step is taken by a mortgagee to enter into possession of or dispose of the whole or any part of the person' s assets or business; (m) it ceases to carry on business or threatens to do so; or

(n) anything occurs under the law of any jurisdiction which has a substantially similar effect to any of the above paragraphs of this definition. " Insulin" shall mean the full length insulin molecule or any fragment thereof. " JDC" shall mean the Joint Development Committee as set out in Section 2.5(b).

" Laws" shall mean any local, state or federal rule, regulation, statute or law in any jurisdiction relevant to the activities undertaken pursuant to this Agreement or applicable to either of the Parties with respect to any matters set forth herein. " MAP Developed Technology" shall mean improvements to the MAP Know-How and MAP Patents conceived, created, developed or otherwise invented or acquired solely by an employee or agent of MAP or one of its Affiliates or a Third Party (under contract with MAP or one of its Affiliates) as a direct result of fulfilling obligations or exercising rights, including the sharing of Confidential Information, under this Agreement or any other agreement between the Parties.

" MAP Intellectual Property" shall mean the MAP Know-How, the MAP Patents and the MAP Developed Technology. MAP Intellectual Property excludes (a) technologies solely relating to: production or manufacture of Product Intermediate; and (b)

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[ * ] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

products, processes, methods, technologies and other inventions in the public domain or that are owned or made by Third Parties (other than on behalf of MAP or its Affiliates) and not Controlled by MAP or its Affiliates.

" MAP Know-How" shall mean any and all rights owned, licensed or controlled by MAP as of the Effective Date to any scientific, pharmaceutical or technical information, data, discovery, invention (whether patentable or not), know-how, substances, techniques, processes, systems, formulations, designs and expertise relating to the Compounds, Formulations, Products and delivery devices in the Field which is not generally known to the public. It is expressly acknowledged by the Parties that the MAP Know-How shall not include any EIFFEL Know-How or the MAP Patents.

" MAP Patents" shall mean any and all rights under the Patent Applications and/or Patents owned by MAP as of the Effective Date and as amended from time to time, and any foreign counterparts thereof and all divisionals, continuations, continuations-in-part, any foreign counterparts thereof and all patents issuing on any of the foregoing, and any foreign counterparts thereof, together with all registrations, reissues, re-examinations, supplemental protection certificates, or extensions thereof, and any foreign counterparts thereof. The MAP Patents do not include the MAP Know-How.

" Net Sales" shall mean the aggregate gross In-Market sales amounts billed for each Product, in accordance with generally accepted accounting principles, less the following deductions relating to such sales, provided that all such deductions shall be commercially reasonable and consistent with standard industry practices and are actually paid:

(i) trade, quantity and cash discounts or rebates actually allowed and taken; (ii) any adjustments on account of price adjustments, billing errors, rejected goods, damaged goods and returns;

(iii) charge-backs granted or given to wholesalers and other distributors; (iv) payments or rebates paid in connection with sales of a Product to any governmental or regulatory authority in respect of any state or federal Medicare, Medicaid or similar programs;

(v) freight and insurance charges for industry standard freight, insurance or other transportation costs not charged to the customer; and

(vi) any sales tax, use tax, tariffs, duties, excise or other governmental charges incurred in connection with exportation or importation, but only if directly imposed and with reference to particular sales, if applicable and provided such payments are detailed and made available in a manner which allows for tax credits under US-Australia tax treaties to be claimed. Any tax based on income is specifically excluded from this definition and will not be a deduction from gross In-Market sales to arrive at Net Sales.

In the event that MAP, its Affiliates or Sublicensees receives non-monetary compensation for the sale of a Product, then Net Sales shall also include the fair market value of such compensation.


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[ * ] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

" NDA" shall mean (a) the single application or set of applications for the Product and/or pre-market approval to make and sell commercially both a Formulation, which is, or was processed using, the Product Intermediate, filed by MAP or its sublicensee with the FDA or any successor agency having the administrative authority to regulate the approval for marketing of new human pharmaceuticals or biological therapeutic products, delivery systems and devices in the United States and (b) any related registrations with or notifications to the FDA. " Product Intermediate(s)" shall mean particles of the Compounds that have been engineered using EIFFEL Intellectual Property. Specifications for each Product Intermediate shall be agreed to by the Parties and after such agreement shall be attached hereto as Exhibit 5 and considered an original part of this Agreement. " Patent" shall mean (i) letters patent and utility models including any extension, substitution, registration, confirmation, reissue, re-examination, renewal, or foreign corresponding rights thereof and (ii) to the extent rights are granted by a governmental authority thereunder, a Patent Application. " Patent Application" shall mean an application for letters patent, including without limitation a continuation application, a continued prosecution application, a continuation in-part application or, divisional application, or foreign equivalents thereof.

" Product" shall mean the Formulation comprising the Product Intermediate and, to the extent required to effect delivery to a patient, a delivery device for use in the Field. " Regulatory Approval" shall mean (a) in the United States, approval by the FDA of an NDA or other applicable filing and satisfaction of any related applicable FDA registration and notification requirements (if any) and (b) in any country other than the United States, e.g., Europe, approval by regulatory authorities having jurisdiction over such country, e.g., EMEA, of a single application or set of applications comparable to an NDA or other applicable filing, e.g., MAA, and satisfaction of any related applicable regulatory and notification requirements, if any, together with any other approval necessary to make and sell pharmaceuticals commercially in such country.

" Regulatory Health Authority" shall mean the FDA or any successor agency in the United States, and the equivalent regulatory authorities in other jurisdictions of the Territory, e.g., EMEA.

" Territory" shall mean worldwide.

" Third Party" shall mean any person or entity other than MAP, EIFFEL, a sublicensee of MAP or an Affiliate of any of them.

" Third Party Patents" shall mean any and all rights under the Patent Applications and/or Patents set forth in Exhibit 2A which EIFFEL has the exclusive license to use and sublicense for all fields of use as of the Effective Date and as amended from time to time, and any foreign counterparts thereof and all divisionals, continuations, continuations-in-part, any foreign counterparts thereof and all patents issuing on any of the foregoing, and any foreign counterparts thereof, together with all registrations, reissues, re-examinations,


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[ * ] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

supplemental protection certificates, or extensions thereof, and any foreign counterparts thereof. " Third Party Patents License Agreement" shall mean the license agreement entered into by and between The University of Sydney and Unisearch Limited as licensors and EIFFEL as licensee, dated April 18, 2001.

" Valid Claim" shall mean a claim of an issued and unexpired patent or an allowed claim in a pending patent application within EIFFEL Intellectual Property which has not been (i) revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which is unappealable, or is unappealed within the time allowed for appeal, (ii) disclaimed or abandoned, or (iii) admitted to be invalid or unenforceable through reissue, disclaimer, or otherwise. " WP" means the work plan developed by the Parties in relation to the research and development collaboration in accordance with Section 2.8.

1.2. Interpretation . In this Agreement: (a) the singular includes the plural and vice versa, the masculine includes the feminine and vice versa and references to natural persons include corporate bodies, partnerships and vice versa;

(b) any reference to a Section or Exhibit, unless otherwise specifically provided, shall be respectively to a Section or Exhibit of this Agreement;

(c) the headings of this Agreement are for ease of reference only and shall not affect its construction or interpretation;

(d) the expressions " include" , " includes" and " including" shall be construed without limitation. PART II: RESEARCH AND DEVELOPMENT COLLABORATION 2. Product and Manufacturing Development . 2.1. General Background . As part of its responsibilities under this Agreement: (a) EIFFEL shall develop the Product Intermediate and manufacture non-GMP preclinical and clinical supplies of Product Intermediate under a WP developed under Section 2.8 and pursuant to the terms of this Agreement, and transfer such manufacturing process to a Third Party as mutually agreed by MAP and Eiffel. For the avoidance of doubt, it is not EIFFEL' s obligation under this Agreement to provide preclinical or clinical supplies of the Product Intermediates in accordance with GMP requirements but rather EIFFEL' s obligation to transfer the manufacturing process for such GMP Product Intermediates to such Third Party as set forth in this Agreement. For the avoidance of doubt, while the capital expenditures for the transfer of the manufacturing process for such Product Intermediates is assumed to be minimal as such Third Party is expected to have the basic infrastructure required to implement such manufacturing process, the Parties agree to negotiate a mechanisms to address any unforeseen capital expenditures that should arise in


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[ * ] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

relation to the transfer of such manufacturing process. MAP and EIFFEL agree to cover their own human resource and travel costs not included in a WP associated with the transfer of any such manufacturing process to a Third Party.

2.2. Responsibilities of Eiffel .

EIFFEL has sole responsibility, unless otherwise set forth in this Agreement, for developing the process for producing the Product Intermediates. Specifically, EIFFEL' s responsibilities include but are not limited to:

(a) developing a scalable process for manufacturing the Product Intermediates as set forth in Exhibit 6 hereto; (b) providing arrangements, including tasks relating to process development, technical transfer and project management, for the manufacture by a Third Party mutually acceptable to Eiffel and MAP under a pre-commercial manufacturing and supply agreement, the Product Intermediate for regulatory and toxicology studies, preclinical studies and Phase I and II clinical trials according to a schedule mutually agreed by the Parties

(c) to the extent that EIFFEL has the appropriate skills, cooperating with MAP in its regulatory filings, including sending an appropriate representative as needed to meetings with the FDA or other appropriate Regulatory Health Authority as requested by MAP, and at the cost of MAP,

(d) providing arrangements, including tasks relating to process development, technical transfer and project management, for the manufacture by a Third Party mutually acceptable to Eiffel and MAP under a commercial manufacturing and supply agreement, the Product Intermediate according to a schedule mutually agreeable to the Parties.

2.3. Default by Eiffel .

(a) In the event that EIFFEL

(i) becomes subject to an Insolvency Event; or

(ii) MAP terminates the Agreement as set forth under section 15.4,

EIFFEL expressly acknowledges and agrees that MAP will have the right to exercise its rights related to Products under this Agreement, including, but not limited to, carrying out such development work related to Products on its own account or through a third party and that the license granted pursuant to Section 4.1 shall, at the option of MAP, survive such default by EIFFEL, subject to the payment obligations of MAP as set forth in Section 7.2 and Section 7.3. In addition, if MAP becomes entitled to exercise its rights under this clause 2.3(a)(i) at any time during this Agreement, MAP shall exercise its rights as a secured creditor, and the full amount of the loan as described in Section 7.1 of this Agreement is immediately due and repayable by EIFFEL to MAP. Furthermore, EIFFEL, or its receiver, liquidator or administrator, will provide all reasonable assistance to MAP, including providing prompt access upon request to all documents, materials, tools, methodologies,


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[ * ] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

EIFFEL Intellectual Property and any other information reasonably necessary to enable MAP or MAP' s appointed third party to exercise its rights related to Products under this Agreement and execute its rights as set forth in this Agreement, including, but not limited to, carrying out such development work related to Products. (b) As partial consideration for the financial obligations of MAP to EIFFEL under this Agreement and the financial and other obligations of EIFFEL to MAP as set forth i ...