Exhibit 10-3

 

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.

 

PRODUCT DEVELOPMENT AND

COMMERCIALIZATION SUBLICENSE AGREEMENT

This Development and Commercialization Sublicense Agreement (this “Agreement”) is made and entered into this 31st day of July, 2007 (the “Effective Date”), by and among HANA Biosciences, Inc., a Delaware corporation (“HANA”), PAR Pharmaceutical, Inc., a Delaware corporation (“PAR”), and NovaDel Pharma, Inc., a Delaware corporation (“NovaDel”).

WHEREAS, HANA has exclusive, restricted sublicensable rights under a license from NovaDel , the owner of certain patents, intellectual property and know-how relating to lingual sprays for the metered delivery of pharmaceutical products to humans;

WHEREAS, HANA has commenced the development of a pharmaceutical product containing ondansetron as an active ingredient that will be administered to humans using the Licensed Technology (as defined below) on terms and conditions set forth herein;

WHEREAS, HANA desires to sublicense to PAR the Licensed Technology, and PAR desires to accept such sublicense on the terms and conditions set forth herein; and

WHEREAS, simultaneously with the execution of this Agreement, the Parties are entering into that certain Subscription Agreement that provides, on the terms and subject to the conditions set forth therein, for a purchase by PAR of the common stock of HANA in an amount up to $5,000,000.

NOW, THEREFORE, in consideration of the mutual covenants and promises contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, HANA, PAR and NovaDel agree as follows:

ARTICLE 1

DEFINITIONS

For 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 Person, any other Person that directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Person. For purposes of this Section 1.1 only, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” shall mean (a) the possession, directly or indirectly, of the power to direct the management or policies of an Person, whether through the ownership of voting securities, by contract or otherwise, or (b) the

 

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ownership, directly or indirectly, of at least fifty percent (50%) of the voting securities or other ownership interest of a Person

 

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

1.7          CGMP means the regulatory requirements for current good manufacturing practices promulgated by the FDA under the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, particularly 21 C.F.R. Section 210 et seq., and 21 C.F.R. Sections 600-610, as the same may be amended from time to time.

1.8          Commercialization means the marketing, promotion, advertising, selling and/or distribution of the Licensed Product in the Territory after Regulatory Approval therefor has been obtained; and the term “Commercialize” has a corresponding meaning.

1.9          Commercially Reasonable Efforts shall mean, with respect to the development or commercialization of the 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.

1.10       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, Patent Rights 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.

 

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1.17       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.

1.18       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.

1.19       FDA means The Food and Drug Administration of the United States Department of Health and Human Services, or any successor agency(ies) thereof performing similar functions.

1.23       HANA Know-How shall mean all Information and Inventions Controlled by HANA or an Affiliate of HANA at any time during the Term that (a) are necessary for the use of the Licensed Process to Exploit the Licensed Product, and (b) are not generally known.

1.24       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.

1.25       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.

 

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1.28       Information And Invention 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.

1.30       Initial Commercial Sale means the first sale for use or consumption by the general public of the Licensed Product by PAR or its Affiliates 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.

1.31       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 of the NovaDel-Hana License and any Improvements thereto that are conceived and reduced to practice by NovaDel in the course of performing its obligations under the NovaDel-Hana License.

1.32       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 active ingredient, the Designated Compound delivered by means of the Licensed Process.

1.33       Licensed Technology shall mean the NovaDel Patent Rights, the NovaDel Know-How and Improvements thereof, and the Drug Master File, collectively, but only with respect to the Exploitation of the Licensed Product.

1.34       Licensed Trademark shall mean “ZENSANA” owned by HANA as evidenced by U.S. Trademark Application Serial No. 78,710,181.

1.37       NDA means a New Drug Application as defined in the United States Federal Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder as amended from time to time 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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1.40       NovaDel-Hana License means that certain License and Development Agreement originally dated October 26, 2004, by and between NovaDel and HANA, as amended and restated effective as of July 31, 2007.

1.42       NovaDel Know-How shall mean all Information and Inventions Controlled by NovaDel or an Affiliate of NovaDel as of the effective date of the NovaDel-Hana License 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 License Process, and (b) are not generally known, but excluding any Information and Inventions to the extent claimed by any NovaDel Patents.

1.43       NovaDel Patents shall mean the Patent Rights that NovaDel Controls (a) as of the effective date of the NovaDel-Hana License that are listed on Exhibit A hereto and (b) from time to time during the Term that claim (i) the Licensed Process, (ii) the Licensed Product, (iii) NovaDel Know-How, or (iv) any Improvements that are conceived and/or reduced to practice in the course of Exploiting the Licensed Product or License Process.

1.47       Patent Rights means 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.

 

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1.48       Person means an individual, partnership, joint venture, association, corporation, limited liability company and any other form of business organization, government, regulatory or governmental agency, commission, department or instrumentality.

1.49       Product Liability Claim means a Third Party’s assertion of a strict liability claim of actual personal injury or death as a result of the use of the Licensed Product during the Term.

1.51       Regulatory Approval means 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.

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 the 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.

1.57       Third Party means any Person other than PAR, NovaDel, HANA and their respective Affiliates.

1.59       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.

1.60       Valid Claim shall mean, with respect to a particular country, a claim of a Patent Right 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

 

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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

SCOPE OF THE COLLABORATION

2.1          Objectives The Parties agree, pursuant and subject to the terms of this Agreement, that HANA intends to assign to PAR, and PAR intends to assume, all of HANA’s rights and obligations to develop and obtain Regulatory Approval for the Licensed Product in the Territory and to commercialize the Licensed Product in the Territory.

2.2          Diligence Obligations PAR shall use Commercially Reasonable Efforts in accordance with the terms and conditions of this Agreement, including the Development Plan, to (a) develop and commercialize the Licensed Product in the entire Territory; (b) file the NDA with the FDA in PAR’s name and obtain Regulatory Approval(s) with respect to the Licensed Product in the Territory; and (c) Exploit the Licensed Product in the Territory.

2.3          Outsourcing of MARQIBO Development HANA holds the exclusive license and patent rights for the commercialization of Sphingosomal Vincristine sulfate liposome for the therapeutic treatment of patients with leukemia, lymphoma and solid tumors currently being developed under the trade name “MARQIBO.” In the event that HANA in its sole discretion, elects to grant a Third Party a right to manufacture and sell such product, HANA will inform PAR and, if PAR so requests, HANA will allow PAR to submit a proposal for HANA’s consideration prior to entering into negotiations with any other Third Party to manufacture and sell the product.

2.4          Co-Promotion of ZENSANA Within ninety (90) days following PAR’s submission of an NDA for the Licensed Product, HANA may submit a proposal for PAR’s consideration with respect to the Parties’ joint promotion and commercialization of such Licensed Product; provided, however, that any determination whether to jointly promote and commercialize the Licensed Product with HANA will be in PAR’s sole discretion and if PAR determines to jointly promote with HANA, then PAR and HANA will negotiate in good faith an agreement that provides for the rights and obligations in respect thereof.

ARTICLE 3

GRANT OF RIGHTS

3.1          License Grant Subject to Section 3.3 and the other terms and conditions of this Agreement, HANA hereby grants to PAR and its Affiliates and PAR accepts:

3.1.1      A non-transferable (except as provided in Section 11.3.2), nonsublicenseable (except as set forth in this Section 3.1 and Section 3.2), royalty-bearing, exclusive sublicense under the Licensed Technology to Exploit the 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; provided, however, that PAR shall have the right to (i) utilize Third Parties to manufacture the Licensed Product in the Territory, and (ii) use, have

 

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used, manufacture or have manufactured the Licensed Product outside of the Territory solely for purposes of the distribution and sale of the Licensed Product inside the Territory. PAR shall be entitled to use a Third Party contract sales organization to market the Licensed Product in the Territory; provided, that the employees of such Third Party contract sales organization that are utilized to market the Licensed Product are trained and managed by PAR and carry only PAR’s products.

3.1.2      In the event that PAR elects to use the Licensed Trademark in connection with the Exploitation of the Licensed Product in the Territory pursuant to Section 5.4, then a non-transferable (except as provided in Article 12), nonsublicenseable, royalty-bearing, non-exclusive right and license under the Licensed Trademark will be granted for the sole purpose of using the Licensed Trademark to market, distribute and sell the Licensed Product in the Territory, to the full end of the Term for which the Licensed Product is licensed, unless sooner terminated as herein after provided.

3.1.3      PAR shall not sell, distribute or transfer the Licensed Product to any Person that, to PAR’s knowledge or should reasonably know, is using or intends to use the Licensed Product outside of the Territory or is selling or transferring, or intends to sell or transfer, the Licensed Product to a Person who is using or intends to use such Licensed Product outside of the Territory.

3.1.4      PAR agrees that during the Term it will use the Licensed Technology only as explicitly provided and in accordance with the term and conditions of this Agreement. PAR expressly acknowledges and agrees that the only licenses granted under this Agreement are the licenses expressly granted under this Agreement and that there shall be no implied license or license by estoppel.

3.2          License Grant to NovaDel. In the event that NovaDel and PAR agree pursuant to Section 4.1 that NovaDel is to perform certain development activities under the Development Plan, PAR hereby grants to NovaDel a limited, royalty-free, co-exclusive right and license in the Territory in and to the Licensed Technology to the extent necessary to perform such development activities.

3.3          Retained Rights PAR acknowledges that NovaDel retains all right, title and interest, including the right to grant licenses to Third Parties, in and to the Licensed Technology. PAR shall have no rights, express or implied, with respect to the Licensed Technology except as expressly set forth in Section 3.1, and PAR covenants to HANA and NovaDel that none of PAR or its Affiliates 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, PAR acknowledges that NovaDel retains, without any duty of accounting or otherwise to PAR:

3.3.1      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

 

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

3.3.3      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

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

3.4.1      HANA covenants and agrees that, from and after the Effective Date until the termination of this Agreement, neither it nor any of its Affiliates shall seek to develop (directly or indirectly) any lingual spray technology for the delivery of anti-emetic pharmaceutical compounds.

3.4.2      Promptly after the Effective Date, each of NovaDel and HANA shall at its cost and expense, use good faith reasonable efforts to disclose to PAR in writing, or via mutually acceptable electronic media, copies or reproductions of all HANA Know-How and NovaDel Know-How, not previously disclosed to PAR, reasonably necessary in order to enable PAR to exploit its rights granted under this Article 3. In addition, during the Term, each of HANA and NovaDel shall promptly disclose to PAR in writing, or via mutually acceptable electronic media, on an ongoing basis, copies or reproductions of all new HANA Know-How and NovaDel Know-How that is reasonably necessary to market, sell or have sold the Licensed Product. Such HANA Know-How and NovaDel Know-How and other information shall be automatically deemed to be within the scope of the licenses granted herein without payment of any additional compensation.

3.5.1      Subject to the other provisions of this Section 3.5.1, PAR 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 PAR may contract with a Third Party to perform such manufacturing services. PAR 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; provided, however, that PAR shall have the ultimate decision making authority in the event of any dispute between NovaDel and PAR relating to the terms of any such manufacturing agreement (or the choice of such Third Party manufacturer). NovaDel and its Extraterritorial Licensees (as defined in the NovaDel-Hana License) retain the right to purchase product from said Third Party, if applicable, at the same costs as PAR with the exception of an increase of cost due to a modification to the packaging/labeling by NovaDel or any Extraterritorial Licensee.

3.5.2      PAR 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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3.5.3  To the extent PAR 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 9 of this Agreement.

3.5.4      PAR shall not object to permitting any Third Party manufacturer from selling NovaDel and its Extraterritorial Licensees Licensed Product under Section 3.5.1 in the identical packaging and labeling as PAR 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 PAR.

3.5.5      PAR 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 PAR for obtaining such licenses or permissions within thirty (30) days of an Extraterritorial Licensee’s receipt of an invoice from PAR itemizing such expenses

3.5.6      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 PAR 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 PAR; provided, however, that in no event shall the scope of the indemnification to PAR be any less than the scope of the Extraterritorial Licensee’s indemnification obligations to NovaDel.

ARTICLE 4

DEVELOPMENT PROGRAM

4.1.1      Within sixty (60) days after the Effective Date, PAR will adopt a development plan, and provide such development plan to NovaDel, describing its strategy and principal activities in seeking Regulatory Approval for the Licensed Product and commercializing the Licensed Product in accordance with the terms of this Agreement (the “Development Plan”), which may be amended by PAR in its commercially reasonable discretion. PAR will use its Commercially Reasonable Efforts to execute the Development Plan. Subject to the Development Plan and the other terms and conditions contained in this Agreement, PAR shall have control over and responsibility for executing all aspects of the Development Plan, including planning, strategy, administrative management, and fiscal control; provided, however, that PAR shall include the Development Committee in such efforts in a consultative capacity. In

 

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the event that PAR desires, PAR may request NovaDel to conduct certain development activities, and, if NovaDel agrees, NovaDel and PAR shall negotiate in good faith the scope of such development activities to be undertaken by NovaDel, appropriate amendments to the Development Plan and the amounts to be paid to NovaDel for the provision of such development activities; provided that it is understood that PAR shall not be entitled to amend the Development Plan to include the performance of any activities by NovaDel without the prior written consent of NovaDel.

4.1.2      PAR and NovaDel shall establish a development committee (the “Development Committee”), which shall confer at least on an annual basis to coordinate PAR’s and NovaDel’s performance of their respective responsibilities under this Agreement. PAR and NovaDel each shall appoint an equal number of representatives with the requisite experience and seniority to enable them to make decisions on behalf of the Parties. From time to time, PAR and NovaDel each may substitute its representatives on written notice to the other. The Development Committee shall not have the power to amend or modify the Development Plan, which may only be amended or modified as provided in Section 4.1.1.

4.1.3      By no later than November 1 of each calendar year during the Term, PAR shall prepare and deliver to NovaDel an updated Development Plan for the following calendar year. NovaDel shall have the right to comment on the Development Plan (including the initial Development Plan delivered pursuant to Section 4.1.1), and PAR shall consider such comments in good faith; provided that nothing contained herein is intended to limit PAR’s sole discretion with respect to the development of the Licensed Product in the Territory.

.4.2.1     Subject to the terms of the Development Plan, in the Territory, PAR shall (a) use its Commercially Reasonable Efforts to conduct required clinical trials of the Licensed Product and obtain Regulatory Approval, and (b) be responsible for all activities related to the toxicology, formulation, process development, quality assurance/quality control, and regulatory affairs for the Licensed Product and (c) include HANA and NovaDel in such efforts in a consultative capacity; provided, however, that, as and to the extent requested by PAR and agreed to by NovaDel pursuant to Section 4.1.1, NovaDel may collaborate with PAR in executing the Development Plan; provided further, however, for purposes of clarity, neither HANA nor NovaDel shall have the right to direct or control PAR’s conduct of such activities.

4.2.2      Subject to the terms of the Development Plan, PAR shall use its Commercially Reasonable Efforts to prepare any required application(s) for Regulatory Approval, including the filing of the NDA with the FDA in PAR’s name, and shall have responsibility for: (a) all clinical data and reports related to Licensed Product studies, including clinical trials for the Licensed Product; and (b) all NDAs and other Regulatory Approvals for the Licensed Product in the Territory. PAR shall inform HANA and NovaDel of all communications with the FDA, and shall provide copies of all FDA submissions and other written communication with the FDA as soon as reasonably practicable. The Parties shall cooperate in good faith with respect to all such submissions and meetings with the FDA relating to regulatory approval of the Licensed Product. In addition, and without limiting PAR’s obligations under Section 2.2 or this Section 4.2.2, PAR shall file the NDA with the FDA on or before the last day of the thirty-

 

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second (32nd) month after the Effective Date (the “Anticipated Filing Date”); provided, however, that PAR may extend the Anticipated Filing Date by four (4) months by delivering, at any time after the second (2nd) anniversary of the Effective Date, written notice of such extension to NovaDel. The Anticipated Filing Date, as extended, may thereafter be extended only upon the mutual agreement of PAR and NovaDel.

4.2.3      PAR shall, and shall cause its Affiliates to, promptly disclose to NovaDel all Regulatory Documentation and all other Information and Inventions in the possession or Control of PAR or its Affiliates that relate to the Exploitation of the Licensed Product. NovaDel and NovaDel’s Extraterritorial Licensees shall have a perpetual, royalty-free, irrevocable, worldwide right to use and reference the Regulatory Documentation and any data included or referenced therein for all purposes. PAR 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 Licensees outside of the Territory.

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

4.2.5      PAR 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 9.

4.3          Development Program Reporting. PAR shall provide HANA and NovaDel at least quarterly with updates regarding the progress of the Development Program and Regulatory Approval process, including all planned and ongoing clinical trials for the Licensed Product, planned and ongoing formulation and stability studies, interaction with Regulatory Authorities, planned and ongoing promotional advertising and other marketing efforts, rolling forecasts of projected sales of each Licensed Product for the upcoming twelve (12) months, and also shall advise HANA and NovaDel of any unforeseen material problems or delays encountered since the date of its last such report and any other information reasonably requested by HANA or NovaDel with respect to the development activities related to the Licensed Product undertaken by PAR in such calendar quarter.

4.4          Development Costs PAR shall be solely responsible for all costs and expenses incurred by it after the Effective Date relating to the development of the Licensed Products for Exploitation in the Territory, including costs and expenses, if any, incurred by NovaDel at in accordance with Section 4.1.1.

4.5          Regulatory Records PAR shall maintain records of its 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 development activities, and which shall be retained by PAR for at least five (5) years after the termination of this Agreement, or for such longer period as may be required by Applicable Law. NovaDel shall have the right, during normal business

 

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hours and upon reasonable notice, to inspect and copy any such records; provided, however, that NovaDel shall not have the right to conduct more than one such inspection in any twelve (12)-month period.

ARTICLE 5

COMMERCIALIZATION OBLIGATIONS

5.1          Regulatory Compliance. All Commercialization activities in respect of the Licensed Product in the Territory shall be conducted by PAR in compliance with Applicable Laws and the Regulatory Approval in the country of sale.

5.2          Labeling and Patent Marking. The Licensed Product shall be packaged by PAR and labeled in a manner consistent with the requirements of the Regulatory Authorities and all Applicable Laws in the country in which it will be sold, and where legally permissible, shall identify any applicable Patent Rights consistent with any patent marking requirements.

5.3          Commercialization Efforts. Following receipt of Regulatory Approval of the Licensed Product by the FDA, PAR shall use Commercially Reasonable Efforts to Exploit the Licensed Product in the United States. PAR shall have the right to Exploit the Licensed Product in Canada; provided, however, that if PAR does not use Commercially Reasonable Efforts to Commercialize the Licensed Product in Canada within one hundred eighty (180) days following Regulatory Approval by Health Canada, then HANA may Commercialize the Licensed Product in Canada, provided further, that, in such case, PAR shall be entitled to a royalty of [***] percent ([***]%) of the Net Sales in Canada. In addition, and without limiting PAR’s obligations under Section 2.2 or this Section 5.3, PAR shall 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. PAR 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. PAR shall, at all times during the Term after receipt of Regulatory Approval, 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 for those formulations and indications for which PAR is commercializing the Licensed Product. Should PAR fail to meet the above ‘standard’, the NovaDel and PAR will discuss PAR’s continued commitment to commercialize the Licensed Product and the termination of this Agreement.

5.4          Trademarks. PAR shall have the right and obligation to determine the trademark and any other related logos, trade names, and similar source identifiers that are created or selected for use to be used on and with the Licensed Product, including the whether to use the Licensed Trademark (collectively, the “Product Trademarks”). With the exception of the Licensed Trademark, the Product Trademarks shall not include any trademarks, logos, trade names or similar source identifiers that are owned or licensed by HANA or NovaDel as of the Effective Date.

 

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ARTICLE 6

ROYALTIES AND OTHER CONSIDERATIONS

6.1          License Fee and Equity. Simultaneously with the execution of this Agreement, PAR shall purchase Five Million Dollars ($5,000,000) worth of shares of newly issued HANA common stock at a price per share that reflects a twenty-five percent premium to the then current market price of HANA’s common stock pursuant to the terms and conditions of that certain Stock Purchase Agreement between the Parties of even date herewith (the “Subscription Agreement”). The number of shares of HANA’s common stock issued to PAR will be determined by dividing the sum of Five Million Dollars ($5,000,000) by one hundred twenty-five percent (125%) of the weighted average closing price per share of HANA’s common stock on the NASDAQ Global Market during the ten (10) business days prior to the Effective Date. PAR represents that it is acquiring the shares of common stock of HANA for investment purposes only and covenants that it will not sell, transfer or otherwise dispose of any such shares until the earliest of: (a) the one (1) year anniversary of the Effective Date, (b) the filing of an NDA for the Licensed Product, and (c) the termination of this Agreement. PAR shall pay HANA for such shares by wire transfer of immediately available funds upon execution and delivery of this Agreement (the “Lock-Up Period”). Following the expiration of the Lock-Up Period, the Investor further agrees that, without the prior written consent of the Company, it will not sell more than fifty percent (50%) of the aggregate number of Shares purchased hereunder in any ninety (90) day period until the first anniversary of the end of the Lock-Up Period, at which time this further restriction shall no longer be applicable.

6.2          Milestone Payments. In addition to the preceding amounts, PAR shall also pay milestone payments to HANA as follows:

6.2.1      [***] Dollars ($[***]) within ten (10) days following PAR’s receipt of Regulatory Approval from the FDA of the NDA for the Licensed Product; plus

6.2.2      If Net Sales during a specified fiscal year equal at least $[***] in the Territory, then PAR will pay to HANA [***] Dollars ($[***]) within 60 days following the end of such year; plus

6.2.3      If Net Sales during a specified fiscal year equal at least $[***] in the Territory, then PAR will pay to HANA [***] Dollars ($[***]) within 60 days following the end of such year; plus

6.2.4      If cumulative Net Sales of the Licensed Product reaches [***] Dollars ($[***]) within five (5) years following Regulatory Approval by the FDA of the NDA, then PAR will pay to HANA [***] Dollars ($[***]) within 60 days after obtaining such Net Sales threshold; plus

6.2.5      If cumulative Net Sales of the Licensed Product reaches [***] Dollars ($[***]) within five (5) years following Regulatory Approval by the FDA of the NDA, then PAR will pay to HANA [***] Dollars ($[***]) within 60 days after obtaining such Net Sales threshold.

 

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6.3          Royalty Payments. In addition to the milestone payments described above, PAR shall pay to HANA royalty payments based on Net Sales of the Licensed Product as follows:

6.3.1      PAR shall pay to HANA amounts due to NovaDel as royalties under the NovaDel-Hana License as follows:

6.3.1.1  [***] percent ([***]%) of up to the first $[***] of Net Sales by PAR or any Affiliate during each fiscal year in the Territory; plus

6.3.1.2  [***] percent ([***]%) of Net Sales greater than $[***] and up to $[***] by PAR or any Affiliate during each fiscal year in the Territory; plus

6.3.1.3  [***] percent ([***]%) of Net Sales greater than $[***] by PAR or any Affiliate during each fiscal year in the Territory.

6.3.2      After cumulative Net Sales exceed [***] Dollars ($[***]) within five (5) years following Regulatory Approval by the FDA of the NDA, PAR shall pay to HANA royalty payments based on Net Sales equal to [***] percent ([***]%) of Net Sales in excess of [***] Dollars ($[***]) per Contract Year (in addition to the [***] percent ([***]