AMENDED AND RESTATED LICENSE AND DEVELOPMENT AGREEMENT

Exhibit 10.2

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “***”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

AMENDED AND RESTATED

LICENSE AND DEVELOPMENT AGREEMENT

THIS AMENDED AND RESTATED LICENSE AND DEVELOPMENT AGREEMENT (this “ Agreement ”), dated as of July 31, 2007 (the “ Execution Date ”), is entered into by and between NOVADEL PHARMA, INC. , a Delaware corporation (“ NovaDel ”), and HANA BIOSCIENCES, INC . , a Delaware corporation (the “ Licensee ”). NovaDel and Licensee each may be referred to herein individually as a “ Party ,” or collectively as the “ Parties .”

WHEREAS, NovaDel has certain proprietary rights and intellectual property (including to certain patents) with respect to lingual sprays for the metered delivery of pharmaceutical products to humans (the “ Technology ”); and

WHEREAS , pursuant to that certain License and Development Agreement by and between NovaDel and Licensee, effective as of October 26, 2004 (the “ Effective Date ”), as amended by that certain Amendment No. 1 To License and Development Agreement dated August 3, 2005, as amended by that certain Amendment No. 2 To License and Development Agreement dated May 15, 2006, and as amended by that certain Amendment No. 3 To License and Development Agreement dated December 22, 2006, (collectively, the “ Initial Agreement ”), Licensee obtained from NovaDel, and NovaDel granted to Licensee, an exclusive, restricted, sublicensable license to develop and commercialize a pharmaceutical product containing ondansetron as an active ingredient that will be administered only to humans using the Technology; and

WHEREAS , the Parties desire to amend and restate the Initial Agreement in its entirety upon the terms and conditions as set forth herein in connection with the PAR Sublicense Agreement.

NOW, THEREFORE, in consideration of the foregoing premises, the mutual promises and covenants of the Parties contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as follows:

ARTICLE 1              

DEFINITIONS

For the purposes of this Agreement, the following words and phrases shall have the following meanings, unless otherwise specifically provided herein:

1.2           “ Affiliate ” shall mean, with respect to any Entity, any other Entity that directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Entity. For purposes of this Section 1.2 only, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” shall mean (a) the

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possession, directly or indirectly, of the power to direct the management or policies of an Entity, whether through the ownership of voting securities, by contract or otherwise, or (b) the ownership, directly or indirectly, of at least fifty percent (50%) of the voting securities or other ownership interest of an Entity.

1.6           “ Applicable Law ” shall mean the applicable laws, rules, regulations, guidelines and requirements of the Regulatory Authorities, in the Territory.

1.9           “ Commercially Reasonable Efforts ” shall mean, with respect to the development or commercialization of a Licensed Product, efforts and resources commonly used in the research-based pharmaceutical industry for a product of similar commercial potential at a similar stage in its lifecycle, taking into consideration its safety and efficacy, its cost to develop, the competitiveness of alternative products, its proprietary position, the likelihood of regulatory approval, its profitability, and all other relevant factors. Commercially Reasonable Efforts shall be determined on a market-by-market basis for each Licensed Product without regard to the particular circumstances of a Party, including any other product opportunities of such Party.

1.11         “ Common Technical Document ” shall have the meaning set forth in the International Conference on Harmonization of the Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline M4, Organization of the Common Technical Document , as revised on January 13, 2004.

1.12         “ Control ” shall mean, with respect to any item of Information and Inventions, Patents or other intellectual property right, possession of the ability, whether directly or indirectly, and whether by ownership, license or otherwise, to assign, or grant a license, sublicense or other right to or under, such item, Patent or right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.

1.14         “Development Activities” shall mean the activities performed by the Parties under the Development Plan pursuant to Article 3.

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1.20         “ Entity ” shall mean any individual, sole proprietorship, corporation, limited liability company, association, joint venture, partnership, limited partnership, limited liability partnership, trust, university, business, government or political subdivision thereof, including an agency, or any other organization that possesses independent legal standing.

1.21         “Exploit” shall mean to make, have made, import, use, sell, or offer for sale, including to research, develop, register, modify, improve, manufacture, have manufactured, store, have used, export, transport, distribute, promote, market or have sold or otherwise dispose of a Licensed Product or Licensed Process.

1.22         “ Exploitation ” shall mean the making, having made, importation, use, sale, offering for sale of a licensed product or process, including the research, development, registration, modification, improvement, manufacture, storage, optimization, import, export, transport, distribution, promotion, marketing, sale or other disposition of a Licensed Product or Licensed Process.

1.23         “ Extraterritorial Licensees ” shall mean NovaDel’s Affiliates and licensees outside of the Territory.

1.24         “ FDA ” shall mean the United States Food and Drug Administration, or any successor agency responsible for the evaluation and approval of pharmaceutical products.

1.25         “ GAAP ” shall mean Generally Accepted Accounting Principles as consistently applied.

1.26         “ Improvement ” shall mean any modification, variation or revision to an apparatus, method, product or technology, or any discovery, technology, device, process or formulation related to an apparatus, method, product or technology, whether or not patented or patentable, including any enhancement in the manufacture or steps or processes thereof, ingredients, preparation, presentation, formulation, means of delivery, packaging or dosage of an apparatus, method, product or technology, any discovery or development of any new or expanded indications for an apparatus, method, product or technology, or any discovery or development that improves the stability, safety or efficacy of an apparatus, method, product or technology, in each case, to the extent related to the Licensed Process, Licensed Product or Licensed Technology.

1.27         “ IND ” shall mean an investigational new drug application filed with the FDA for approval to commence human clinical trials, and its equivalent in other countries or regulatory jurisdictions in the Territory.

1.28         “Indemnification Claim Notice” shall have the meaning set forth in Section 10.3.1.

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1.30         “ Initial Commercial Sale ” shall mean the first sale for use or consumption by the general public of the Licensed Product by Licensee or its Affiliates or Sublicensee in the Territory following Regulatory Approval of the Licensed Product. Sales for clinical studies, compassionate use, named patient programs, sales under a treatment IND, test marketing, any nonregistrational studies, or any similar instance where the Licensed Product is supplied without charge shall not constitute an Initial Commercial Sale.

1.33         “ Information and Inventions ” shall mean all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including pre-clinical and clinical trial results, manufacturing procedures and test procedures and techniques, (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed, and all Improvements, whether to the foregoing or otherwise, and other discoveries, developments, inventions, and other intellectual property (whether or not confidential, proprietary, patented or patentable), in each case, to the extent related to the Licensed Process, Licensed Product or Licensed Technology.

1.34         “ Knowledge ” shall mean the good faith understanding of the vice presidents, senior vice presidents, executive vice presidents, president or chief executive officer of the respective Party of the facts and information then in their possession without any duty to conduct any investigation with respect to such facts and information.

1.35         “ Licensed Process ” shall mean the proprietary lingual spray technology for the delivery of pharmaceutical compounds through the mucosal membrane of the mouth in humans using an aerosol or pump spray device that is under the Control of NovaDel as of the Effective Date and any Improvements thereto that are conceived and reduced to practice by NovaDel in the course of performing the Development Activities.

1.36         “ Licensed Product ” shall mean any dosage of pharmaceutical composition or preparation in finished form labeled and packaged for sale by prescription, over-the-counter or any other method only for human application that contains, as the sole ingredient, the Designated Compound delivered by means of the Licensed Process.

1.37         “ Licensed Technology ” shall mean the NovaDel Patents, the NovaDel Know-How and the Drug Master File, collectively, but only with respect to the Exploitation of the Licensed Product.

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1.41         “ NDA ” shall mean a New Drug Application filed pursuant to the requirements of the FDA, as more fully defined in 21 C.F.R. § 314.5 et seq ., and any equivalent application required by any Regulatory Authority for the marketing, sale or use of the Licensed Product in the Territory for human application.

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1.44         “ NovaDel Know-How ” shall mean all Information and Inventions Controlled by NovaDel or an Affiliate of NovaDel as of the Effective Date or, from time to time, during the Term that (a) (i) are necessary for the use of the Licensed Process to Exploit the Licensed Product or (ii) relate to Improvements to the Licensed Product or Licensed Process that are conceived and/or reduced to practice in the course of Exploiting the Licensed Product or Licensed Process, and (b) are not generally known, but excluding any Information and Inventions to the extent claimed by any NovaDel Patents.

1.45         “ NovaDel Patents ” shall mean the Patents that NovaDel Controls (a) as of the Effective Date that are listed on Exhibit A hereto and (b) from time to time during the Term that claim (i) the Licensed Process, (b) the Licensed Product, (c) NovaDel Know-How, or (d) any Improvements that are conceived and/or reduced to practice in the course of Exploiting the Licensed Product or Licensed Process.

1.50         “ Patents ” shall mean any of the following: (a) United States patents; (b) United States patent applications (both provisional and non-provisional), PCT patent applications, and divisionals, continuations and claims of continuation-in-part applications which shall be directed to subject matter specifically described in such United States and/or PCT patent applications, and the resulting patents (whether such divisionals, continuations or continuation-in-part applications are based upon a United States patent, United States patent application or PCT application); (c) any patents resulting from reissues or reexaminations of the United States patents described in (a) and (b) above; (d) foreign patents; (e) foreign patent applications and, to the extent applicable, divisionals, continuations and claims of continuation-in-part applications which shall be directed to subject matter specifically described in such foreign patent applications, and the resulting patents (whether such divisionals, continuations or continuation-in-part applications are based upon a foreign patent application or a foreign patent); and (f) any foreign patents, resulting from foreign procedures similar to United States reissues and reexaminations, of the foreign patents and applications described in (d) and (e) above.

1.51         “ Regulatory Approval ” shall mean approval by the FDA to market the Licensed Product in the United States, or equivalent Regulatory Authority in Canada to market the Licensed Product in Canada, including the issuance by the FDA or such other Regulatory Authority of an action letter indicating the approval of the NDA and the manufacturing processes and facilities for commercial supplies of the Licensed Product.

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1.52         “ Regulatory Authority ” shall mean any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Licensed Technology or the Licensed Product in the Territory.

1.53         “ Regulatory Documentation ” shall mean all applications, registrations, licenses, authorizations and approvals (including all Regulatory Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all supporting documents and all clinical studies and tests, relating to any Licensed Product, and all data contained in any of the foregoing, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.

1.54          “ Sublicensee ” shall mean any Third Party to which Licensee grants a sublicense pursuant to Section 2.4 under the licenses granted to Licensee by NovaDel under Section 2.1.

1.58         “ Third Party ” shall mean any Entity other than NovaDel, Licensee and their respective Affiliates.

1.60         “ Trademark ” shall include any word, name, symbol, color, designation or device or any combination thereof, including any trademark, trade dress, brand mark, trade name, brand name, logo or business symbol.

1.61         “ Valid Claim ” shall mean, with respect to a particular country, a claim of a Patent in such country that (a) has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken or has been taken within the time allowed for appeal, and (b) has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise in such country, except if a claim, or the subject matter thereof, of a pending patent application shall not have issued within four (4) years after the filing date from which such claim, or subject matter thereof, takes priority, such claim shall not constitute a valid claim for purposes of this agreement unless and until such claims shall issue.

ARTICLE 2              

GRANT OF RIGHTS

2.1            License Grants to Licensee. Subject to Section 2.3 and the other terms and conditions of this Agreement, NovaDel hereby grants to Licensee and Licensee accepts, a non-transferable (except as provided in Article 12), sublicenseable (only as provided in Section 2.4), royalty-bearing, exclusive right and license under the Licensed Technology to Exploit the

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Licensed Product in the Territory, to the full end of the Term for which the Licensed Technology is licensed, unless sooner terminated as herein after provided.

2.2            License Grant to NovaDel. Licensee hereby grants to NovaDel a limited, royalty-free, non-exclusive right and license in the Territory in and to the Licensed Technology to the extent necessary to perform its Development Activities under Article 3.

2.3            Retained Rights. NovaDel retains all right, title and interest, including the right to grant licenses to Third Parties, in and to the Licensed Technology. Licensee shall have no rights, express or implied, with respect to the Licensed Technology, except as expressly set forth in Section 2.1, and Licensee covenants to NovaDel that none of Licensee, its Affiliates or Sublicensees shall use the Licensed Technology, directly or indirectly, for any purpose other than for administration of the Designated Compound in connection with the Exploitation of Licensed Product hereunder. Notwithstanding anything in this Agreement to the contrary, NovaDel does hereby retain, without any duty of accounting or otherwise to Licensee or a Sublicensee, as applicable,:

2.3.1        The right to enter into collaborations or other agreements with, and to grant licenses and other rights under the NovaDel Patents and NovaDel Know-How to Third Parties to Exploit products containing compounds other than the Designated Compound and to use the Licensed Process in connection therewith; and

2.3.2        The right to independently Exploit products containing compounds other than the Designated Compound and to use the Licensed Process in connection therewith; and

2.3.3        An irrevocable, non-exclusive, royalty-free right to use the Licensed Technology (including the Licensed Process) with respect to the Designated Compound, for its internal, non-commercial research and development activities; and

2.3.4        The rights for all other territories other than the Territory and non-human uses of the Designated Compound.

2.4            Sublicenses. Licensee shall have the right to grant sublicenses under the grants in Section 2.1 to Third Parties pursuant to a separate written agreement, subject to the following requirements and conditions:

2.4.1        Licensee must obtain NovaDel’s prior written consent in respect of each such sublicense, such consent not to be unreasonably withheld but in no case will exceed thirty (30) days. Except to the extent the Parties otherwise agree pursuant to the terms of a particular sublicense granted under this Section 2.4, any sublicense agreement must be fully consistent with the terms and conditions of this Agreement, and provide that Sublicensee will indemnify NovaDel and its Affiliates to the extent provided in Article 10.

2.4.2        Within five (5) days after execution or receipt thereof, as applicable, Licensee shall provide NovaDel with a full and complete copy of each sublicense agreement granted hereunder and shall deliver copies of all reports (including relating to royalties and other payments) received by Licensee from such Sublicensees.

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2.4.3        Termination of this Agreement by NovaDel pursuant to Section 8.3 with respect to Licensee shall not terminate any sublicense granted by Licensee pursuant to this Section 2.4 with respect to a Sublicensee, provided that (a) such Sublicensee is not in breach of any provision of this Agreement or the applicable sublicense agreement, (b) such Sublicensee shall perform all obligations of Licensee under this Agreement, (c) NovaDel shall have all rights with respect to any and all Sublicensees as it had hereunder with respect to Licensee prior to termination of this Agreement with respect to Licensee, and (d) Licensee shall include in any sublicense a provision in which said Sublicensee acknowledges its obligations to NovaDel hereunder and the rights of NovaDel to terminate such sublicense agreement for a breach of such sublicense agreement by such Sublicensee. The failure of Licensee to include in a sublicense the provisions referenced in clause (d) shall render the affected sublicense void.

ARTICLE 3              

DEVELOPMENT AND COMMERCIALIZATION ACTIVITIES

3.1            Development and Commercialization . Licensee or its Sublicensee shall have the sole right and obligation to develop and commercialize the Licensed Product in the Territory. NovaDel shall perform or cause to be performed, on behalf of Licensee, certain Development Activities in accordance with this Article 3. Except as set forth herein or in an applicable sublicense, Licensee shall be solely responsible for all costs and expenses in connection with all development and commercialization activities, including the Development Activities performed by NovaDel on behalf of Licensee.

3.2            Development Activities. Except as the Parties otherwise agree pursuant to the terms of a sublicense agreement:

3.2.1        Election Upon Termination of Par Sublicense. If that certain Product Development and Commercialization Sublicense Agreement by and between Licensee, NovaDel and PAR Pharmaceutical, Inc. (“ PAR ”), dated as of the Execution Date (the “ PAR Sublicense Agreement ”) is terminated, Licensee shall notify NovaDel within sixty (60) days following such termination of Licensee’s election to undertake further development of Licensed Product. Within sixty (60) days following delivery of such notice to NovaDel, Licensee will adopt and provide to NovaDel a development plan describing its strategy and principal activities in seeking Regulatory Approval and commercializing the Licensed Product in accordance with the terms of this Agreement (the “ Development Plan ”). If Licensee fails to notify NovaDel within the sixty (60) day period of its election to undertake further development, fails to provide NovaDel within the sixty (60) day period a Development Plan, or elects not to continue development of Licensed Product, this Agreement shall terminate in accordance with the provisions of Section 8.4

3.2.2        General . Under the direction and supervision of the Development Committee, NovaDel and Licensee each shall perform, or cause to be performed, its respective Development Activities in accordance with the Development Plan and corresponding development budget (the “ Development Budget ”). Notwithstanding the foregoing, the Parties acknowledge and agree that there can be no assurances that the objectives of the Development Activities can be achieved, or that they can be achieved in the manner or in the time set forth in the Development Plan. Although outcomes cannot be guaranteed, each Party shall use Commercially Reasonable Efforts to perform or cause to be performed its respective

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Development Activities in good scientific manner, and in material compliance with Applicable Law. In addition, and without limiting Licensee’s obligations under this Section 3.2.2, Licensee or its Sublicensee shall file the NDA with the FDA on or before the last day of the thirty-second (32nd) month after the Execution Date (the “ Anticipated Filing Date ”); provided, however, that Licensee or its Sublicensee may extend the Anticipated Filing Date by four (4) months by delivering, at any time after the second (2nd) anniversary of the Execution Date, written notice of such extension to NovaDel. The Anticipated Filing Date, as extended, may thereafter be extended only upon the mutual agreement of Licensee or its Sublicensee and NovaDel.

3.2.3        Reports. Within thirty (30) days after the end of each calendar quarter in which Development Activities are performed, each Party shall provide to the Development Committee a written progress report, which shall describe the Development Activities it has performed, or cause to be performed, during such calendar quarter, evaluate the work performed in relation to the goals of the Development Plan and in relation to the Development Budget, and provide such other information as may be required by the Development Plan or reasonably requested by the Development Committee with respect to the Development Activities. Minutes from periodic project team meetings or other meetings between the Parties can serve as a substitute for the required progress reports outlined in this Section 3.2.3.

3.2.4        Development Plan and Budget. The Development Committee shall review the Development Plans and the Development Budgets at least quarterly and shall have the right to make such modifications or updates to the Development Plans or Development Budgets that it deems appropriate. The Parties acknowledge and agree that the amounts set forth in the Development Budgets are estimates and, given the unpredictability of the Development Activities, there can be no assurances that the Development Activities can be completed within the Development Budgets, provided, however, that the Parties agree to use their Commercially Reasonable Efforts to adhere to the Development Budgets not to exceed the amounts set forth in such Development Budgets without written approval of the Development Committee.

3.3            Development Committee. Except as the Parties otherwise agree pursuant to the terms of a sublicense agreement:

3.3.1        Formation and Authority of Development Committee. NovaDel and Licensee shall establish a development committee (the “ Development Committee ”), which shall oversee the Development Activities performed by the Parties, review and approve the Development Budget and approve any changes to the Development Plan and Development Budget. Each Party shall appoint an equal number of representatives with the requisite experience and seniority to enable them to make decisions on behalf of the Parties with respect to the Development Activities. From time to time, each Party may substitute its representatives on written notice to the other Party.

3.3.2        Procedural Rules of Development Committee. The Development Committee shall meet monthly, or as otherwise agreed to by the Parties. The Development Committee shall adopt such standing rules as shall be necessary for its work. A quorum of the Development Committee shall exist whenever there is present at a meeting at least one representative appointed by each Party. Members of the Development Committee may attend a meeting either in person or by telephone, video conference or similar means in which each

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participant can hear what is said by the other participants. Representation by proxy shall not be allowed. The Development Committee shall take action by unanimous consent of NovaDel and Licensee, with each such Party having a single vote, irrespective of the number of representatives actually in attendance at a meeting, or by a written resolution signed by the designated representatives of each of NovaDel and Licensee.

3.3.3        Dispute Resolution. If the Development Committee cannot, or does not, reach agreement on an issue, then either Party shall have the right to refer such issue to the Chief Executive Officers of the Parties who shall confer on the resolution of the issue. Any final decision mutually agreed to by the Chief Executive Officers of the Parties shall be in writing and shall be conclusive and binding on the Parties. If such officers are not able to agree on the resolution of an issue within twenty (20) days after such issue was first referred to them, either Party shall have the right to refer such dispute to arbitration pursuant to Article 9.

3.3.4        Limitations on Authority of Development Committee. Each Party to this Agreement shall retain the rights, powers, and discretion granted to it under this Agreement, and no such rights, powers, or discretion shall be delegated to or vested in the Development Committee unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing. The Development Committee shall not have the power to amend or modify this Agreement, which may only be amended or modified as provided in Section 16.4.

3.4            Regulatory Approvals. Except as the Parties otherwise agree pursuant to the terms of a sublicense, all INDs, NDAs and other filings, applications or requests pursuant to or in connection with the Regulatory Approvals required under the Development Plan shall be made in the name of Licensee; provided, however, that Licensee shall consult with NovaDel with respect to the preparation and submission of any such filings, applications or requests in connection with Regulatory Approvals.

3.4.1        Licensee will be the primary contact for Chemistry, Manufacturing and Control (“ CMC ”) matters in all relevant regulatory applications except to regulatory bodies outside the United States and Canada. Licensee will keep NovaDel reasonably informed of all such communications, if any, between Licensee and the Regulatory Authorities in the United States and Canada.

3.4.2        NovaDel and NovaDel’s Extraterritorial Licensees shall have a perpetual, royalty-free, irrevocable, worldwide right to use and reference the Regulatory Documentation with respect to the Licensed Product and any data included or referenced therein for all purposes. Licensee agrees to utilize the Common Technical Document format for its marketing applications in order to facilitate any subsequent submissions filed by NovaDel or its Extraterritorial Licensee’s outside of the Territory. Licensee shall keep NovaDel reasonably informed as to the communications, if any, between Licensee and the Regulatory Authorities.

3.4.3        Licensee agrees to keep the Common Technical Document, except for those sections in the Summary Basis of Approval and available through the Freedom of Information Act, strictly confidential in accordance with Article 15.

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3.5            Regulatory Records. NovaDel and Licensee each shall maintain, or cause to be maintained, records of its respective Development Activities in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development Activities, and which shall be retained by such Party for at least five (5) years after the termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records; provided, however, that neither Party shall have the right to conduct more than one such inspection in any twelve (12)-month period.

3.6            Development Expenses. Except as the Parties otherwise agree pursuant to the terms of a sublicense:

3.6.1        Licensee’s Obligation. In consideration of NovaDel’s performance of its Development Activities, Licensee shall reimburse NovaDel for the reasonable and documented costs and expenses incurred by NovaDel in performing such activities in accordance with the Development Budget (as may be amended in accordance with Section 3.2.4). Licensee shall bear all costs and expenses incurred by or on behalf of Licensee in connection with the performance of its Development Activities.

3.6.2        Invoices and Payments. Within thirty (30) days after the end of each month in which Development Activities are performed, NovaDel shall invoice Licensee for any costs and expenses incurred by NovaDel or its Affiliates in such month. Each invoice shall be payable to NovaDel within thirty (30) days after invoice date.

3.6.3        Books and Records. Each Party shall maintain complete and accurate books, records and accounts that, in reasonable detail, fairly reflect any reimbursable costs and expenses incurred by it or its Affiliates in performance of the Development Activities in conformity with GAAP. Each Party shall retain such books, records and accounts until the later of (a) three (3) years after the end of the period to which such books, records and accounts pertain, and (b) the expiration of the applicable tax statute of limitations (or any extensions thereof), or for such longer period as may be required by Applicable Law. Each Party shall have the right to have its certified public accountant, who shall be reasonably acceptable to NovaDel and Licensee, as applicable, audit the books and financial records of the other Party and their respective Affiliates relating to its Development Activities during one or more calendar quarters; provided, however, that Licensee shall not have the right to audit a calendar quarter more than two (2) years after the end of such quarter, to conduct more than one such audit in any twelve-month period, or to audit any calendar quarter more than once; and provided further that each Party shall bear the cost of such audit unless the audit reveals a variance of more than five percent (5%) from the reported results, in which case audited Party shall bear the cost of the audit. The results of such accounting firm shall be final, absent manifest error.

3.7            Cooperation. Each Party shall cooperate with any and all reasonable requests for assistance from the other Party with respect to the Development Activities, including by making its employees, consultants and other scientific staff available upon reasonable notice during

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normal business hours at their respective places of employment to consult with such other Party on issues arising in connection with the performance of such Development Activities.

3.8            Development and Use of Trademarks. Licensee shall have the sole right to determine the Trademarks to be used with respect to the Exploitation of the Licensed Product in the Territory, provided that the product labeling and promotional materials disclose that the Licensed Product are delivered using the Licensed Process.

3.9            Diligence Obligations. Following receipt of Regulatory Approval of the Licensed Product by the FDA, Licensee (or its Sublicensees) shall use Commercially Reasonable Efforts to Exploit the Licensed Product in the United States. Licensee shall have the right, but not the obligation, to Exploit the Licensed Product in Canada. In addition, Licensee directly or through a Sublicensee will consummate the Initial Commercial Sale in the United States within nine (9) months after receipt of Regulatory Approval from the FDA for the Licensed Product. Licensee (or its Sublicensee if there is a sublicense agreement) shall have responsibility for all advertising, marketing, promotion, distribution, selling and other commercialization activities, including developing strategies and tactics related to such activities for the Licensed Product. Licensee (or its Sublicensee if a there is a sublicense agreement) shall, at all times during the Term of this Agreement, use efforts, including but not limited to appropriate promotional campaigns and materials, and qualified commercial personnel, consistent with those typically used in the pharmaceutical industry and equal to those committed to products of similar size and expected value to seek to commercialize the Licensed Product in the Territory after receipt of Regulatory Approval for those formulations and indications for which Licensee (or its Sublicensee if a there is a sublicense agreement) is commercializing the Licensed Product. Should Licensee (or its Sublicensee if a there is a sublicense agreement) fail to meet the above ‘standard’, the Parties will discuss Licensee’s (or its Sublicensee’s if a there is a sublicense agreement) continued commitment to commercialize the Licensed Product and the termination of this Agreement or sublicense agreement, if applicable.

3.10         Manufacturing. Except as the Parties otherwise agree pursuant to the terms of an applicable sublicense:

3.10.1      Subject to the other provisions of this Section 3.10.1, Licensee shall be solely responsible for the manufacture of the Licensed Product, both for clinical development and following receipt of Regulatory Approval of the Licensed Product; provided that Licensee may contract with a Third Party to perform such manufacturing services. Licensee shall share all data and other information relating to the manufacturing process and shall consult with NovaDel with respect thereto. Without limiting the generality of the foregoing, NovaDel shall have the opportunity to review, prior to execution, all agreements with Third Parties relating to the manufacture of the Licensed Product. Any disputes between NovaDel and Licensee relating to the manufacture of the Licensed Product shall be resolved in the manner set forth in Section 3.3.3 hereof. NovaDel and its Extraterritorial Licensees retain the right to purchase product from said Third Party, if applicable, at the same costs as Licensee with the exception of an increase of cost due to a modification to the packaging/labeling by NovaDel or any Extraterritorial Licensee.

3.10.2      Licensee agrees that, at all times during the performance of the Development Activities, it, or its designee, will act in accordance with all Applicable Laws.

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3.10.3      To the extent Licensee contracts with a Third Party to manufacture the Licensed Product, such Third Party shall agree in writing to be bound by the obligations of confidentiality and non-use at least equivalent in scope to those set forth in Article 15 of this Agreement.

3.10.4      NovaDel and its Extraterritorial Licensees may purchase Licensed Product under Section 3.10.1 in the identical packaging and labeling as Licensee purchases such Licensed Product for sale in the United States, subject to the requirement by NovaDel and Sublicensees to have such Licensed Product uniquely identified by a separate batch record identification or other indicia sufficient to distinguish sales by NovaDel, or its Extraterritorial Licensees, from those of Licensee.

3.10.5      Licensee shall use Commercially Reasonable Efforts to obtain any required licenses, permissions needed and documentation (e.g., Certificate of Pharmaceutical Product) in order for NovaDel and its Extraterritorial Licensees to buy and export Licensed Product from the United States. NovaDel shall reimburse all reasonable expenses incurred by Licensee for obtaining such licenses or permissions within thirty (30) days of an Extraterritorial Licensee’s receipt of an invoice from Licensee itemizing such expenses.

3.10.6      NovaDel warrants, covenants and agrees that any license agreement that NovaDel enters into with an Extraterritorial Licensee regarding Licensed Product that are subject to this Agreement shall contain an indemnity clause requiring the Extraterritorial Licensee to indemnify Licensee and its Affiliates against any and all claims, proceedings, demands, liability and expenses of any kind, including legal expenses and attorneys’ fees (collectively, “ Claims ”), arising out of or in connection with the manufacture, sale, use, consumption, advertisement or other disposition of Licensed Product by the Extraterritorial Licensee, its Affiliates or any end user, or arising from any violation of law, negligence, willful or reckless misconduct, or from any breach of any material obligation of such Extraterritorial Licensee under its agreement with NovaDel, other than Claims resulting from the gross negligence or willful misconduct of Licensee; provided, however, that in no event shall the scope of the indemnification to Licensee be any less than the scope of the Extraterritorial Licensee’s indemnification obligations to NovaDel.

ARTICLE 4              

ROYALTIES AND OTHER CONSIDERATION

4.1            Royalties. As consideration for the rights, privileges and licenses granted hereunder and the Development Activities performed by NovaDel pursuant to Article 3, Licensee shall make the following payments to NovaDel:

4.1.1        Licensee shall pay to NovaDel royalties as follows: (i) [***] percent ( [***] %) of up to the first $ [***] of Net Sales by Licensee or any Affiliate or Sublicensee of Licensee of the Licensed Product during each calendar year in the Territory plus (ii) [***] percent ( [***] %) of Net Sales greater than $ [***] and up to $ [***] by Licensee or any Affiliate or Sublicensee of Licensee of the Licensed Product during each calendar year in the Territory

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plus (iii) [***] percent ( [***] %) of Net Sales greater than $ [***] by Licensee or any Affiliate or Sublicensee of Licensee of the Licensed Product during each calendar year in the Territory (see Exhibit B for schedule of royalty calculation).

4.1.2        The conversion rate for payments under Section 4.1.1, as it pertains to sales in Canada, shall be calculated by using the conversion rate on the last day of the calendar quarter for which the sales apply. The conversion rate to be used will be taken from the currency converter at www.oanda.com . Canadian dollar sales will be converted into U.S. dollars and then the royalty rates outlined in Section 4.1.1 will apply.

4.1.3        Notwithstanding anything to the contrary contained herein, any and all royalties to be received by Licensee pursuant to the PAR Sublicense Agreement shall be paid to a lock-box account. Accordingly, the Parties agree that, within thirty (30) days after the Execution Date, the Parties and the Sublicensee will take such actions reasonably requested by NovaDel, and enter into documentation in form and substance reasonably satisfactory to NovaDel (including, without limitation, a security agreement, lockbox agreement and irrevocable payment instructions), in order to (i) grant to NovaDel a first priority, perfected security interest in all of Licensee’s right, title and interest under the Par Sublicense Agreement (including without limitation its right to receive payments of the sublicense fees and other amounts payable by Par thereunder) and in and to any lockbox account(s) to which royalty payments thereunder may be made, (ii) perfect NovaDel’s security interest in such lockbox account(s) and provide for remittances therefrom in accordance with the terms in this Agreement and (iii) irrevocably instruct PAR to make all royalty payments under the PAR Sublicense Agreement directly to such lockbox account(s).

4.2            Royalty Term. Except as the Parties otherwise agree pursuant to the terms of an applicable sublicense, Licensee’s royalty obligations under Section 4.1.1 shall terminate, on a country-by-country basis, with respect to the Licensed Product upon the later of (a) the expiration or invalidation in such country of the last NovaDel Patent that includes at least one Valid Claim covering the Licensed Product in such country and (b) the twentieth (20th) anniversary of the Execution Date; provided, however, if (i) the last NovaDel Patent that includes at least one Valid Claim covering the Licensed Product in such country expires or is invalidated prior to the twentieth (20th) anniversary of the Execution Date and (ii) and no regulatory exclusivity with respect to such Licensed Product exists in such country (whether as a result of expiration of the exclusivity period or otherwise), then the royalty obligations under Section 4.1.1 in such country shall be reduced in accordance with the terms of Section 4.6.

4.3            Royalty Payments. Royalties under Section 4.1.1 shall be payable to NovaDel on a calendar quarterly basis, within forty-five (45) days after the end of each calendar quarter. Licensee will submit to NovaDel documentation to support the total amount of funds spent by the Licensee on pharmaceutical development and clinical studies for the Licensed Product. Licensee will submit along with payment to NovaDel, a quarterly royalty statement in a format mutually agreed by both Parties. Along with the statement will be all supporting documentation comprising of a statement of net sales for the period and copies of actual paid invoices covering clinical supplies, consultants, clinical studies, investigator fees, document preparation, regulatory fees and other direct fees related to development of the Licensed Product,

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4.4            Licensee Fee & Equity. Simultaneously with the execution of the Initial Agreement, Licensee issued and sold to NovaDel 73,121 shares of its common stock (the “ Licensee Shares ”) totaling a value of $500,000. Upon execution of this Agreement, NovaDel will transfer and assign to Licensee all of its right, title and interest in and to the Licensee Shares and Licensee will redeem the Licensee Shares. Such transfer and assignment by NovaDel will be evidenced by a duly executed stock power or other form of assignment and shall be accompanied by the original certificate representing the Licensee Shares.

4.5.1        Licensee has paid, and NovaDel hereby acknowledges receipt of, the Milestone Payments in the total sum of $ [***] , as described in Sections 4.5.1, 4.5.2 and 4.5.3 of the Initial Agreement.

4.5.2        Licensee shall pay to NovaDel the additional sum of $ [***] within ten (10) Business Days from the date on which the NDA for