SUPPLY AND OPTION AGREEMENT

Exhibit 10.1

SUPPLY AND OPTION AGREEMENT

          This SUPPLY AND OPTION AGREEMENT (“Agreement”), dated as of  January 28, 2005 (“Effective Date”), is made by and between BIOGENERIX AG, a corporation organized under the laws of the Federal Republic of Germany (“BioGeneriX”), and NEOSE TECHNOLOGIES, INC., a Delaware corporation (“Neose”).  BioGeneriX and Neose are sometimes referred to herein, individually, as a “party” and, collectively, as the “parties.”

BACKGROUND

          A.  Each of BioGeneriX and Neose possesses certain intellectual property rights relating to the development of next-generation ****** products.

          B.  Each of BioGeneriX and Neose has a development program relating to one or more ****** products.

          C.  Neose and BioGeneriX believe that a research program that applies certain intellectual property of Neose to ****** product under development by BioGeneriX will be in their mutual and individual best interests.

          NOW, THEREFORE, in consideration of the mutual covenants contained herein, and intending to be legally bound hereby, the parties agree as follows:

TERMS

1.           Supply of Protein .

             1.1      Supply .   BioGeneriX will deliver to Neose, free of charge, after the Effective Date, ****** (“******” or the “Protein”).  The Protein delivered will be accompanied by a certificate of analysis and any data on characterization.

             1.2      Use of Protein .  Neose will (i) not use the Protein delivered pursuant to this Agreement except in any research commenced by Neose to identify a lead  ****** candidate for development using any of its GlycoAdvance™ and GlycoPEGylation™ technologies (“Neose Technology”), (ii) only distribute the Protein delivered pursuant to this Agreement or any formulation of such Protein to third parties for the sole purpose of conducting such research and will not distribute the Protein delivered pursuant to this Agreement or any formulation of such Protein to any other third party without BioGeneriX’s prior written consent, and (iii)will not administer the Protein delivered pursuant to this Agreement or any formulation of such Protein to any human.

 

2.           Option Grant .

             2.1      Option .   Neose hereby grants to BioGenriX an exclusive option (the “Option”), exercisable any time after the date hereof and prior to April 28, 2005 (“Option Exercise Date”) to enter into a Research, License, and Option Agreement (“License Agreement”) with Neose, in the form attached hereto as Exhibit 2.1 , by written notice to Neose and payment to Neose in accordance with Section 3.2 below.

             2.2      Execution of License Agreement .   Upon exercise of the Option in accordance with Section 2.1, Neose and BioGeneriX will execute and deliver to the other the License Agreement.

3.           Payments .

             3.1      Upon Execution .   Simultaneously with the execution of this Agreement, BioGeneriX will pay to Neose $******.

             3.2      Upon Exercise .   Upon exercise of the Option and the execution by Neose of the License Agreement, BioGeneriX will pay to Neose $******.

             3.3      Payment Credit .   The payments made pursuant to this Section 3 will be credited toward the amount otherwise payable pursuant to Section 2.4.1 of the License Agreement.

4.           Research Period .   During the period commencing on the Effective Date and ending on the Option Exercise Date (“Research Period”), Neose may conduct research on the Protein using its GlycoAdvance and GlycoPEGylation technologies.  Any data and results (“Results”) generated by such research conducted by Neose during the Research Period will be disclosed to BioGeneriX.  In the event that BioGeneriX does not exercise the Option, it will own the Results, except to the extent that the Results relate to the Neose Technology.

5.          Public Announcement of Agreement.   Each party shall be entitled to announce the signing of this Agreement in substantially the form attached as Exhibit 5 , and, otherwise, with the prior written consent of the other party, which shall not be unreasonably withheld.  The parties acknowledge and agree that neither party may disclose the identity of the Protein except in compliance with 17.2.2 of the License Agreement.

6.           Miscellaneous .

             6.1      Notice .   Any notice, request or other communication required to be given pursuant to the provisions of this Agreement shall be in writing and shall be deemed to be given when delivered in person or three business days after being delivered to a recognized international courier service (e.g., Federal Express, DHL, UPS), charges prepaid, to the other party, addressed as follows:

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             6.2      Assignment .   This Agreement, and the rights and obligations hereunder, may not be assigned or transferred by any party without the prior written consent of the other party, which consent shall not be unreasonably withheld, except that either party may assign this Agreement to an Affiliate (as defined in the License Agreement) or in connection with the merger, consolidation or sale of all or substantially all of its assets.

             6.3      Entire Agreement . This Agreement, together with the Secrecy Agreement dated as of August 9, 2002, constitutes the entire agreement of the parties with regard to the subject matter hereof, and supersedes all previous written or oral representations, agreements and understandings between the parties with respect thereto. 

             6.4      No Modification .   This Agreement may be changed only in writing signed by the parties.

             6.5      Applicable Law .   This Agreement shall be governed by the laws of the Federal Republic of Germany without regard to provisions for conflicts of law. The UN Convention for International Sale of Goods shall be explicitly excluded.

             6.6      Counterparts .   This Agreement may be executed in two or more counterparts, each of which shall be deemed to be an original as against any party whose signature appears thereon, but all of which together shall constitute but one and the same instrument.

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          IN WITNESS WHEREOF, each party has caused this Agreement to be signed by its duly authorized representative(s) as of the date first above written.

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EXHIBIT 2.1

RESEARCH, LICENSE AND OPTION

AGREEMENT

between

BIOGENERIX AG

and

NEOSE TECHNOLOGIES, INC.

January __, 2005

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Table of Contents

 

 

RESEARCH, LICENSE AND OPTION AGREEMENT

          This RESEARCH, LICENSE AND OPTION AGREEMENT, dated as of  January __, 2005 (“Agreement”), is made by and between BIOGENERIX AG, a corporation organized under the laws of the Federal Republic of Germany (“BioGeneriX”), and NEOSE TECHNOLOGIES, INC., a Delaware corporation (“Neose”).  BioGeneriX and Neose are sometimes referred to herein, individually, as a “party” and, collectively, as the “parties.”

BACKGROUND

                       A.  Each of BioGeneriX and Neose possesses certain intellectual property rights relating to the development of next generation ******  products.

                       B.  Each of BioGeneriX and Neose has a development program relating to one or more ****** -based products.

                       C.  Neose and BioGeneriX believe that a research program that applies certain intellectual property of Neose to ****** product under development by BioGeneriX will be in their mutual and individual best interests.

                       NOW, THEREFORE, in consideration of the mutual covenants contained herein, and intending to be legally bound hereby, the parties agree as follows:

          1.           Definitions .  As used in this Agreement, the following capitalized terms shall have the meanings set forth below.

                       1.1      “Affiliate” means any individual or entity directly or indirectly controlling, controlled by or under common control with, a party to this Agreement.  Without limiting the foregoing, the direct or indirect ownership of over 50% of the outstanding voting securities of an entity, or the right to receive over 50% of the profits or earnings of an entity, shall be deemed to constitute control.

                       1.2      “BioGeneriX” means BioGeneriX and any Affiliate thereof.

                       1.3      “BioGeneriX Improvements ” means any Research Technology constituting Improvements made, conceived or reduced to practice solely by BioGeneriX except, in each case, for any Neose Improvements.

                       1.4      “BioGeneriX Technology” means any existing or future (i) Patent Rights owned or controlled by BioGeneriX in the Territory relating to the development or manufacture of ******, (ii) know-how, trade secrets, technical information, formulae, processes and data owned or controlled by BioGeneriX that relate to the composition, design, remodeling, development, manufacture or use of ******, (iii) the rights of BioGeneriX in and to any trademark designated for use with the Product anywhere in the Territory, whether pending, allowed or registered, and (iv) all rights of BioGeneriX in and to any Improvements related to ******; in each case, to the extent BioGeneriX has the right to license or sublicense any such right to Neose. 

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                       1.5      “BLA” means a Biologics License Application (or any successor application) filed with the FDA with respect to the Next Generation ******, or any comparable filing made with a regulatory authority outside the United States.

                       1.6      “Calendar Quarter” means each three-month period beginning on January 1, April 1, July 1 and October 1 of each year.

                       1.7      “******” means ******  produced in ******.

                       1.8      “CMO” means a third-party, if any, selected by BioGeneriX to ****** under a contract between such third-party and BioGeneriX, all in accordance with this Agreement.

                       1.9      “Confidential Information” has the meaning set forth in Section 13.

                       1.10      “Effective Date” means the date of execution of this Agreement by both parties.

                       1.11      “EMEA” means the European Agency for the Evaluation of Medicinal Products.

                       1.12      “******” ******  products.

                       1.13      “Exchange Act” means the U.S. Securities Exchange Act of 1934, as amended.

                       1.14      “FDA” means the U.S. Food and Drug Administration.

                       1.15      “Field” means any and all ******  indications.

                       1.16      “HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder.

                       1.17      “Improvements” means any and all developments, discoveries, inventions, additions, amendments, modifications, ideas, processes, methods, compositions, formulae, techniques, information and data, whether or not patentable, conceived, developed or reduced to practice, that improve or beneficially change, or enhance the economic and/or technical attributes of, any know-how or Patent Rights or any process, device or composition.

                       1.18      “******” means ******  produced in ******.

                       1.19      “Joint Improvements” means Improvements jointly owned by the parties, if any, as determined in accordance with Section 5.2.3.

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                       1.20      “Joint Project Team” means the team established pursuant to Section 3.4, or any successor group appointed by the parties.

                       1.21      “License” means the license to be granted to BioGeneriX as a result of the exercise of the Option by BioGeneriX.

                       1.22      “License Effective Date” means, with respect to the License, the later of (i) the date on which BioGeneriX exercises the Option and (ii) if notification is required to be made under the HSR Act in respect of such grant, the expiration or earlier termination of any notice and waiting period under the HSR Act.

                       1.23      “Neose” means Neose and any Affiliate thereof.

                       1.24      “Neose Improvements” means any and all Research Technology (i) constituting Improvements to the Patent Rights owned or controlled by Neose on the Effective Date; (ii) constituting Improvements to the Patent Rights acquired by Neose after the Effective Date and owned or controlled by Neose during the Research Term; (iii) constituting Improvements to know-how owned or controlled by Neose on the Effective Date; and any and all other Improvements made, conceived or reduced to practice using any of the Reagents or in connection with the development and/or manufacture of the Next Generation ******.

                       1.25      “******” ******.

                       1.26      “Neose Technology” means any existing or future (i) Patent Rights owned or controlled by Neose in the Territory relating to glycosylation design or remodeling of ****** made using any of Neose’s GlycoAdvance™, GlycoPEGylation™ and GlycoConjugation™ technologies, (ii) know-how, trade secrets, technical information, formulae, processes and data owned or controlled by Neose which relate to the composition, design, remodeling, development, manufacture or use of ******, (iii) the rights of Neose in and to GlycoAdvance™, GlycoPEGylation™ and GlycoConjugation™ and any other trademark, and (iv) all rights of Neose in and to any Improvements related to ******; in each case, to the extent Neose has the right to license or sublicense any such right to BioGeneriX. 

                       1.27      “Net Sales” means the invoiced price of the Product charged to an unaffiliated end user in the Territory (i.e., a third party whose use is intended to result in the consumption or destruction of the Product), net of returns and rejections, and after deducting, to the extent charged or credited to the purchaser and identified on the invoice or other documentation related to the sale, any sales or similar taxes, packaging charges, freight, insurance, trade and quantity discounts and allowances, rebates and commissions. 

                       1.28      “Next Generation ******” means a molecule remodeled under this Agreement ****** and Neose Technology, which molecule has ******.

                       1.29      “Option” means the option granted to BioGeneriX in Section 4.1.

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                       1.30      “Ownership Rights” means any and all right, title and interest under patent, copyright, trade secret and trademark law, or any other intellectual property or other law, in and to any know-how, Patent Rights or Improvements.

                       1.31      “Patent Rights” means any patents or patent applications, including all corresponding foreign patents and patent applications, all divisions, continuations, continuations-in-part, reissues, renewals, extensions or additions to any such patents and patent applications.

                       1.32      “Product” means the Next Generation ******, whether alone or in combination with another active ingredient, that is developed and commercialized by BioGeneriX.

                       1.33      “Reagents” means the enzymes, nucleotide sugars and sugar-PEGs used in the research-scale GlycoPEGylation process for the lead candidate recommended for preclinical development as set forth in the Research Deliverables.

                       1.34      “Reasonable Commercial Efforts” with respect to a party’s obligation under this Agreement will be deemed satisfied if the party exercises at least the same level of effort to perform such obligation as is customarily exercised by similarly situated parties developing or commercializing their own pharmaceutical products of like potential, with the party having such contractual obligation also having the burden of proof in the event of a dispute over its performance.

                       1.35      “Regulatory Approval” means any marketing authorization (including authorizations approving a BLA) required for a Product in the Territory.

                       1.36      “Research” means the work to be conducted in accordance with the Research Plan.

                       1.37      “Research Leader” means the person designated from time to time by BioGeneriX or Neose to manage its monitoring or performance of the Research, as provided in Section 3.1. 

                       1.39      “Research Deliverables” means the deliverables specified on Exhibit A hereto, as amended from time to time by agreement of the parties.

                       1.40      “Research Plan” means the plan for the Research and related timeline set forth as Exhibit B hereto, as amended from time to time by agreement of the parties.

                       1.41      “Research Technology” means the Patent Rights, know-how and Improvements created by either or both parties during the Research in furtherance of the Research Plan.

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                       1.42      “Research Term” means the period during which Neose performs the Research in accordance with the Research Plan, which period is expected to last  approximately twelve (12) months and shall end upon delivery of the Research Deliverables by Neose to BioGeneriX.

                       1.43      “Sublicense” means a sublicense of any or all of BioGeneriX’s rights under the Neose Technology.

                       1.44      “Sublicensee” means a sublicensee under a Sublicense.

                       1.45      “Territory” means the world.

                       1.46      “******” means the ****** molecule that is produced by or for, and under development by, BioGeneriX.

          2.           Purpose, Scope and Conduct of the Research

                       2.1      Purpose .  The purpose of the Research is to allow Neose to apply the Neose Technology to ****** supplied by BioGeneriX in order to identify a lead candidate Next Generation ******, which BioGeneriX may take into preclinical development. 

                       2.2      Scope and Duration .  The Research shall be conducted in accordance with the Research Plan and shall be completed upon delivery of the Research Deliverables to BioGeneriX.

                       2.3      Supply Obligations .  BioGeneriX promptly shall supply to Neose, without cost to Neose, such quantities of ****** as Neose may reasonably request to conduct the Research.  Neose shall supply any other materials necessary for the conduct of the Research.

                       2.4      Payment for Research .  BioGeneriX shall compensate Neose for performance of the Research by making the following payments to Neose:

                                   2.4.1     an upfront fee of US$******, payable upon the execution of this Agreement; and

                                   2.4.2     four quarterly payments of US$******, which quarterly payments shall not exceed US$****** in the aggregate, payable as follows:  the first three quarterly payments payable upon the last day of each of the first three Calendar Quarters ending during the Research Term, respectively, and the fourth quarterly payment payable upon delivery by Neose to BioGeneriX of a report summarizing the Research Deliverables. 

                       2.5      Exclusivity .  During the Research Term, the parties shall work exclusively with each other on the development of Next Generation ****** under the terms and conditions of this Agreement. The parties acknowledge and agree that, during the Research Term and otherwise:  (i) ******, which activities may be conducted ******, acting alone or with one or more third party collaborators or licensees; and (ii) ******.

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          3.           Management of the Research during the Research Term

                       3.1      Research Leaders .  The Research shall be performed by Neose and monitored by BioGeneriX.  Each party shall appoint a Research Leader to oversee the management of the Research, maintain communication with the Research Leader for the other party, and facilitate the efficient conduct of the Research.  The initial Research Leaders are:  (i) for BioGeneriX, _____________________; telephone number __________________; facsimile number: 011.49.621.875.56.33; email address: ______________); and (ii) for Neose, _______________ telephone number: ______________; facsimile number: 215-315-9100; email address: __________).  A party may designate a new Research Leader at any time, and from time to time, by notice to the other party.

                       3.2      Communications and Records .  It is anticipated that there will be multiple levels of communication relating to the Research among employees of BioGeneriX and employees of Neose.  Each Research Leader will be responsible for maintaining appropriate records of the deliberations and decisions relating to the Research.  A Research Leader may sign any notice or approval on behalf of the party that appointed the Research Leader, subject to any other signing requirements of such party and in conformity with this Agreement.  Until further notice, a party may rely on any notice or approval signed by the Research Leader for the other party. 

                       3.3      Establishment and Responsibilities of Joint Project Team . Promptly following the Effective Date, the parties will establish a Joint Project Team to monitor the activities of the Research Plan during the Research Term.  The Joint Project Team shall carry out the obligations assigned to it under this Agreement or by the Research Leaders, and shall make recommendations to the Research Leaders with respect to its activities.  In particular, from and after the Effective Date, the Joint Project Team shall be responsible for (i) monitoring the Research; (ii) communicating with the Research Leaders regarding the status of the Research; (iii) recommending to the Research Leaders any suggested changes to the Research Plan; (iv) communicating to the Research Leaders the completion of each of the Research Deliverables, and (v) such other activities as may be assigned to it by the Research Leaders.  If the Joint Project Team does not reach a decision on any matter for which it is responsible, the matter will be resolved in accordance with Section 19. 

                       3.4      Action by Joint Project Team .  The Joint Project Team shall consist of such number of members and alternate members as the parties may determine from time to time.  Each party shall appoint 50% of the permanent and alternate members of the Joint Project Team.  The members of the Joint Project Team shall include members of senior management of each party.  The members of the Joint Project Team representing a party and present at a meeting shall have one vote, collectively.  No action may be taken at a meeting of the Joint Project Team unless each party is represented by at least one member.  Any changes to the Research Plan may be made only by an amendment of this Agreement signed by each party.

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                       3.5      Changes to Joint Project Team .  Each party may remove and replace its representatives on the Joint Project Team at any time, without cause, upon written notice to the other party.  An alternate member designated by a party shall be entitled to participate in the absence of a permanent member designated by such party.  All references to “ members ” in this Agreement refer to the then permanent members of the Joint Project Team and any alternate member acting in the place of a permanent member. 

                       3.6      Meetings .  Regular meetings of the Joint Project Team shall be scheduled by the Research Leaders.  Special meetings of the Joint Project Team may be called by the Research Leaders or by any two or more members, at least one of whom represents each party.  Meetings may be in person or by teleconference or videoconference, and notice of meetings may be by email.  Each party will bear its own costs in connection with the coordination of the Research and the Joint Project Team.

                       3.7      No Waiver .  No action, nor any failure to act, by the Joint Project Team shall alter, amend, waive or otherwise affect the obligations of the parties under this Agreement.

                       3.8      Selection of Development Partner .  BioGeneriX shall have the sole right to select its partner for the development of the Product, which selection may be made at any time following the exercise of the Option in accordance with Section 4.1.

          4.           Option and Intellectual Property Grants

                       4.1      Option .  Neose hereby grants to BioGeneriX a sole and exclusive right and option to obtain an exclusive license under the Neose Technology to develop and commercialize the Product.  BioGeneriX may exercise the Option by providing written notice of exercise to Neose at any time from the Effective Date through the ninetieth day after the end of the Research Term.

                       4.2      Exclusive License .  Subject to the terms and conditions of this Agreement, Neose hereby grants to BioGeneriX, as of the License Effective Date an exclusive, royalty-bearing license (or sublicense) under the Neose Technology that is useful for the Product in the Field (i) to make, have made, use, sell, offer to sell and import the Product in the Field in the Territory and (ii) to make, have made and use Reagents in the Territory solely for the purpose of making and having made the Product.  The licenses granted pursuant to this Section 4.2 shall include a right to grant Sublicenses in accordance with Section 4.3. 

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                       4.3      Sublicense Rights .  Prior to the earlier of entering into a Sublicense or providing a proposed Sublicensee with Confidential Information of Neose, BioGeneriX shall give notice to Neose identifying, and seeking Neose’s approval of, the proposed Sublicensee, which approval shall not be unreasonably denied or delayed.  Without limiting the foregoing, Neose shall be entitled to condition its approval in any instance on the execution by the proposed Sublicensee of an agreement protecting the Confidential Information and intellectual property of Neose, which agreement shall be in form and substance reasonably acceptable to Neose.    

                       4.4      Liability .  BioGeneriX shall remain primarily liable to Neose for the performance by each Affiliate and Sublicensee in accordance with the terms and conditions of this Agreement that are applicable to an Affiliate or Sublicensee, as the case may be.

                       4.5      Reservation of Rights .  Neose hereby reserves to itself all right, title and interest in and to the Neose Technology not expressly granted in the License.  Without limiting the foregoing, in no event shall this Agreement be construed to prohibit Neose from engaging in any of the following activities:  (i) practicing the processes, methods and know-how of the Neose Technology in connection with the development and/or commercialization of ****** or outside the Field at any time; (ii) practicing the processes, methods and know-how of the Neose Technology in connection with the development of and/or commercialization of Next Generation ****** if BioGeneriX shall not have duly exercised the Option prior to the end of the Research Term; (iii) developing, making, using or selling proteins or Reagents, whether in conjunction with the Neose Technology or otherwise, for any use except in connection with the development of Next Generation ****** or outside the Field during the Research Term or the development and commercialization of the Product during the term of the License; or (iv) entering into and performing agreements with third parties regarding any of the foregoing, including, without  limitation, research agreements, development agreements and licensing agreements.

                       4.6      BioGeneriX Technology .  Subject to the terms and conditions of this Agreement and solely to the extent necessary to enable Neose to carry out its obligations under the Research Plan and in connection with any technical assistance provided at the request of BioGeneriX, BioGeneriX hereby grants to Neose, a non-exclusive, royalty-free, license under the BioGeneriX Technology to use the BioGeneriX Technology for the sole purpose of carrying out its obligations under the Research Plan and to perform any technical assistance requested by BioGeneriX. 

                       4.7      No Other Rights or Licenses .  Except for the rights and licenses expressly granted in this Agreement or granted upon the exercise of the Option, nothing in this Agreement shall be deemed to grant to either party, or to any third party, any other rights or licenses, including, without limitation, any implied licenses.

                       4.8      Technology Transfer .  Promptly following the License Effective Date, Neose shall use Reasonable Commercial Efforts to transfer to BioGeneriX the know-how owned or controlled by Neose that is useful in connection with the exercise by BioGeneriX of its rights under the License, to the extent that Neose has the right to transfer such know-how to BioGeneriX.

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          5.           Ownership of Intellectual Property

                       5.1      Intellectual Property Rights .  All Ownership Rights in and to the Neose Technology shall remain at all times with Neose.  All Ownership Rights in and  to the BioGeneriX Technology shall remain at all times with BioGeneriX, subject to the parties’ obligation to assign certain Ownership Rights to the other party under Sections 5.3 and 5.4.

                       5.2      Improvements

                                   5.2.1      Neose Improvements .  Any and all Neose Improvements shall be owned solely by Neose and shall be deemed to be part of the Neose Technology for the purposes of the Option and the License.  Except as provided in Section 5.4, any and all Research Technology constituting Improvements made, conceived or reduced to practice solely by Neose shall be owned by Neose.

                                   5.2.2      BioGeneriX Improvements .  Except for the Neose Improvements, any Research Technology constituting Improvements made, conceived or reduced to practice solely by BioGeneriX shall be owned by BioGeneriX.

                                   5.2.3      Joint Improvements .  Except as otherwise provided in Section 5.2.1 or 5.2.2, each of Neose and BioGeneriX shall own a one-half undivided interest in any Research Technology constituting Improvements made, conceived, or reduced to practice jointly by Neose and BioGeneriX, whether patentable or not, provided however, that a party shall lose its one-half undivided interest in any Patent Rights included in Joint Improvements with respect to which it does not fund patent prosecution and maintenance costs, as provided in Section 5.5.

                       5.3      Assignment by BioGeneriX .  To the extent that BioGeneriX may obtain or retain any Ownership Rights in any Neose Improvements, BioGeneriX hereby irrevocably assigns and transfers, and agrees to assign and transfer, to Neose any and all such Ownership Rights, in perpetuity or for the longest period otherwise permitted by law, without the necessity of further consideration, and Neose shall be entitled to receive and hold in its own name all such Ownership Rights.  With respect to any Ownership Rights that BioGeneriX is required to assign and transfer to Neose under this Section 5.3, at the request of Neose and at Neose’s expense, either before or after the termination of this Agreement, BioGeneriX shall assist Neose in acquiring and maintaining patent, copyright, trade secret and trademark protection upon, and confirming Neose’s title in and to, any such respective Ownership Rights, and BioGeneriX shall provide Neose appropriate documentation evidencing Ownership Rights to which Neose is entitled.  The assistance of BioGeneriX shall include, but shall not be limited to, signing all applications, and any other documents and instruments for patent, copyright and any other proprietary rights, providing executed license documents, cooperating in legal proceedings, and taking any other actions considered necessary or desirable by Neose.  For the purpose of facilitating the above assignments, BioGeneriX agrees that any and all employees and contractors employed or engaged by BioGeneriX and providing any service in connection with the Research, prior to providing such service, shall have agreed in writing to covenants consistent with the covenants of BioGeneriX set forth in this Section 5.3.

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                       5.4      Assignment by Neose .  To the extent that Neose may obtain or retain any Ownership Rights in any BioGeneriX Improvements, Neose hereby irrevocably assigns and transfers to BioGeneriX any and all such Ownership Rights, in perpetuity or for the longest period otherwise permitted by law, without the necessity of further consideration, and BioGeneriX shall be entitled to receive and hold in its own name all such Ownership Rights.   With respect to any Ownership Rights that Neose may assign and transfer to BioGeneriX under this Section 5.4, at the request and expense of BioGeneriX, either before or after termination of this Agreement, Neose shall assist BioGeneriX in acquiring and maintaining patent, copyright, trade secret and trademark protection upon, and confirming the title of BioGeneriX in and to, any such respective Ownership Rights.  Neose’s assistance shall include, but shall not be limited to, signing all applications, and any other documents and instruments for patent, copyright and any other proprietary rights, cooperating in legal proceedings, and taking any other actions considered necessary or desirable by BioGeneriX.  For the purpose of facilitating the above assignments, Neose agrees that any and all employees and contractors employed or engaged by Neose and providing any service in connection with the Research, prior to providing such service, shall have agreed in writing to covenants consistent with Neose’s covenants set forth in this Section 5.4.

                       5.5      Prosecution ad Maintenance of Patent Rights in Research Technology .  Each party shall have the right, in its sole discretion and at its sole expense, to prepare, file, prosecute and maintain all Patent Rights covering Research Technology that such party solely owns, as determined in accordance with Section 5.  With respect to Joint Improvements, the parties shall meet to determine whether patent protection is appropriate and, if so, in which countries, if any, patent applications claiming such joint inventions and discoveries should be filed.  The parties shall jointly file, prosecute, and maintain, such patent applications, with each party funding one-half of the costs thereof.  Either party may at any time, in its sole discretion, discontinue funding the preparation, prosecution or maintenance of any Patent Rights covering Joint Improvements, in which case the party discontinuing such support shall provide notice thereof to the other party.  The parties shall retain undivided equal interests in and to all Patent Rights covering Joint Improvements for as long as they are sharing the costs of prosecuting and maintaining such Patent Rights.  If a party discontinues funding the preparation, prosecution or maintenance of any Patent Rights covering Joint Improvements, the other party shall, thereafter, have sole rights in and to such Patent Rights.

                       5.6      Use and Sublicensing of Joint Improvements .  Subject to the exclusive Ownership Rights of the parties under this Section 5 and the funding obligations of the parties under Section 5.5, each party shall be entitled to use its rights to Joint Improvements, and to sublicense such rights, without any further consideration to the other party.

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          6.           Further Development of Next Generation ****** and Commercialization of the Product  

                       6.1      Responsibilities of BioGeneriX for Commercialization in EU .  From and after the License Effective Date, BioGeneriX shall use Reasonable Commercial Efforts during the term of the License to diligently (i) initiate preclinical development of Next Generation ******, (ii) pursue all approvals and obtain all licenses and permits necessary for the development of Next Generation ****** and commercialization of the Product in the EU; and (iii) market and sell the Product in the EU.  Such activities shall be the sole responsibility of BioGeneriX and shall be conducted at its sole cost and expense.  It is acknowledged and agreed that BioGeneriX may pursue such activities, and meet its obligations under this Section 6.1, with one or more partners.

                       6.2      Commercialization in the United States and Japan .  It is contemplated that BioGeneriX will pursue the development and commercialization of the Product in the United States, Japan and other countries in the Territory selected by BioGeneriX, with one or more partners.  With respect to each of the United States and Japan, if BioGeneriX (acting directly or through a partner) shall not have made the first commercial sale of the Product within one year after the later of ****** (or such other date as the parties shall mutually agree upon in writing) or the expiration of the last key blocking patent in such country, then the licenses granted to BioGeneriX under Section 4 with respect to such country shall be terminable by Neose upon 60 days’ notice, and the parties shall have the rights and obligations set forth in Section 21.1, to the extent applicable.        

                       6.3      Supply of Reagents .  From and after the License Effective Date, BioGeneriX shall use Reasonable Commercial Efforts during the term of the License to (i) to supply to Neose, upon commercially reasonable terms, such quantities as Neose may reasonably request of any Reagents that are being manufactured by or for BioGeneriX under the License, and (ii) upon the request of Neose, to provide to Neose the know-how owned or controlled by BioGeneriX and/or its CMO that is useful in connection with the commercial-scale production of such Reagents by or for Neose, to the extent that BioGeneriX and/or its CMO has the right to transfer such know-how to Neose.

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                       6.4      Technical Assistance .  Upon the reasonable request of BioGeneriX  at any time after the License Effective Date during the term of the License, Neose agrees to provide reasonable technical assistance to BioGeneriX (and/or its CMO) with respect to the further development of Next Generation ******, subject to reimbursement by  BioGeneriX for any such technical assistance based on Neose’s annual full-time-equivalent rate in effect at the time (which rate is now US$****** and shall be fixed, for the purp