STRATEGIC ALLIANCE AGREEMENT

EXHIBIT 10.1


CONFIDENTIAL


CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.


STRATEGIC ALLIANCE AGREEMENT


BETWEEN


BIONUMERIK PHARMACEUTICALS, INC.


AND


ASTA MEDICA AKTIENGESELLSCHAFT


18TH OF JANUARY, 2001
TABLE OF CONTENTS RECITALS ................................................................................................ 1


1. DEFINITIONS .......................................................................................... 1
1.1 Affiliate(s)................................................................................. 2
1.2 Alliance Steering Committee.................................................................. 2
1.3 ASTA Medica Improvements..................................................................... 2
1.4 ASTA Medica Know-How......................................................................... 2
1.5 ASTA Medica Patent Rights.................................................................... 2
1.6 BioNumerik Improvements...................................................................... 2
1.7 BioNumerik Know-How.......................................................................... 3
1.8 BioNumerik Patent Rights..................................................................... 3
1.9 BNP7787...................................................................................... 3
1.10 Budget....................................................................................... 3
1.11 Competitor................................................................................... 4
1.12 Confidential Information..................................................................... 4
1.13 Costs........................................................................................ 4
1.14 Development Plan............................................................................. 4
1.15 Fiscal Year.................................................................................. 4
1.16 Government Regulatory Approvals.............................................................. 4
1.17 Gross Profits................................................................................ 4
1.18 Gross Sales.................................................................................. 4
1.19 Improvements................................................................................. 5
1.20 Know-How..................................................................................... 5
1.21 Parties...................................................................................... 5
1.22 Patents...................................................................................... 5
1.23 Patent Rights................................................................................ 5
1.24 Product(s)................................................................................... 5
1.25 Product Trademark............................................................................ 6
1.26 Supply Agreement............................................................................. 6
1.27 Territory.................................................................................... 6
1.28 Trademarks................................................................................... 6 2. GRANT OF RIGHTS ...................................................................................... 6
2.1 Research and Development License............................................................. 6
2.2 License to Market, Sell and Distribute....................................................... 6
2.3 Sublicenses.................................................................................. 7
2.4 Canada Right of First Offer.................................................................. 7
2.5 Retention of Rights.......................................................................... 7
2.6 Provision of Know-How........................................................................ 8
2.7 Distribution................................................................................. 8
3. MANAGEMENT OF RELATIONSHIP................................................................... 8
3.1 Steering Committee........................................................................... 8
3.2 Project Team................................................................................. 9
3.3 Additional Teams and Assistance.............................................................. 10
3.4 Cooperation.................................................................................. 10
3.5 Voting and Dispute Resolution................................................................ 10
3.6 Costs of Maintenance and Operation........................................................... 10
4. DEVELOPMENT PLAN AND COSTS................................................................... 11
4.1 Development Costs............................................................................ 11
4.2 Government Approvals and Clinical Trials..................................................... 11


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4.3 Development Plan and Budget.................................................................. 12
4.4 Promotional Materials involving BioNumerik and Labeling...................................... 13 5. LICENSE FEES AND ROYALTIES ........................................................................... 13
5.1 License Fees................................................................................. 13
5.2 Royalties.................................................................................... 13
5.3 Expiration of Royalty Obligations............................................................ 14
5.4 Inclusion of Sublicense Fees................................................................. 14
5.5 Sales Forecast and Payment................................................................... 14
5.6 Forecast Adjustment.......................................................................... 15 6.INFORMATION SHARING .................................................................................. 15
6.1 Sharing of Information....................................................................... 15
6.2 BioNumerik Information....................................................................... 16
6.3 Additional Information Sharing............................................................... 16 7. MANUFACTURING ........................................................................................ 17
7.1 Manufacturing Rights......................................................................... 17
7.2 Non-Exclusive Manufacturing Option for Territory............................................. 17
7.3 Pre-Commercial Manufacturing................................................................. 18
7.4 Commercial Supply Agreement.................................................................. 18
7.5 No Infringing Manufacture or Supply.......................................................... 19 8. DILIGENCE ............................................................................................ 19
8.1 General Diligence Efforts.................................................................... 19
8.2 Target Development and Commercialization Plan................................................ 19 9.PATENT MATTERS ....................................................................................... 20
9.1 BioNumerik Patent Maintenance................................................................ 20
9.2 ASTA Medica Patent Maintenance and Assistance................................................ 21
9.3 BioNumerik Patent Representations............................................................ 21
9.4 ASTA Medica Patent Representations........................................................... 21
9.5 Enforcement of Patents and Proprietary Rights................................................ 22 10.TRADEMARKS AND TRADEMARK RIGHTS ...................................................................... 23
10.1 Registration, Maintenance and Ownership...................................................... 23 11.IMPROVEMENTS ......................................................................................... 24
11.1 BioNumerik Improvements Included............................................................. 24
11.2 ASTA Medica Improvement Grantbacks........................................................... 25
11.3 Joint Improvements........................................................................... 25
11.4 Sublicenses.................................................................................. 25 12.CONFIDENTIALITY ...................................................................................... 26
12.1 Confidential and Proprietary Information..................................................... 26
12.2 Matters not Included as Confidential Information............................................. 26
12.3 Survival of Confidentiality.................................................................. 27 13.PAYMENTS, RECORDS AND ACCOUNTING ..................................................................... 27
13.1 Means of Payment............................................................................. 27
13.2 Currency..................................................................................... 27
13.3 Access to Records............................................................................ 28
13.4 Taxes and Required Withholdings.............................................................. 28 14.DURATION AND TERMINATION OF AGREEMENT ................................................................ 28
14.1 Duration..................................................................................... 28
14.2 Termination.................................................................................. 29
14.3 Effect of Expiration or Termination.......................................................... 31
14.4 Termination for BioNumerik's Breach, Change in Control or Bankruptcy......................... 31
14.5 Termination for ASTA Medica's Breach, Change in Control or Bankruptcy........................ 32


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14.6 Termination Due to Cessation of Regulatory Authorization or Lack of Patent Coverage.......... 32
14.7 Sale of Inventory............................................................................ 33
14.8 Country Specific Termination of Rights....................................................... 33 15.BIONUMERIK REPRESENTATIONS & WARRANTIES .............................................................. 33
15.1 Due Organization and Authority............................................................... 33
15.2 Safety of Product(s)......................................................................... 34
15.3 Warranties on Quality of the Know-How........................................................ 34
15.4 Governmental Agencies and Product Documentation.............................................. 34
15.5 Circumstances and Acts....................................................................... 34 16.ASTA MEDICA REPRESENTATIONS AND WARRANTIES ........................................................... 35
16.1 Due Organization and Authority............................................................... 35
16.2 Right to Accept License; Due Diligence....................................................... 35
16.3 Governmental Agencies........................................................................ 35
16.4 Circumstances and Acts....................................................................... 35 17.INDEMNIFICATION ...................................................................................... 35
17.1 Indemnification by BioNumerik................................................................ 35
17.2 Indemnification by ASTA Medica............................................................... 36
17.3 Mechanics.................................................................................... 36
17.4 Insurance Coverage........................................................................... 36 18.RELATION OF THE PARTIES .............................................................................. 37 19.ASSIGNMENTS .......................................................................................... 37
19.1 Assignment Restrictions...................................................................... 37
19.2 Sale of Business............................................................................. 38
19.3 [**]
19.4 Assignment to Affiliates..................................................................... 38 20.MISCELLANEOUS ........................................................................................ 39
20.1 Regulatory Communications.................................................................... 39
20.2 Adverse Effects.............................................................................. 39
20.3 Market Analysis and Marketing Reports........................................................ 39
20.4 Notice/Reports............................................................................... 40
20.5 Severability................................................................................ 40
20.6 Counterparts................................................................................. 40
20.7 Warranty Disclaimer.......................................................................... 41
20.8 Force Majeure................................................................................ 41
20.9 Arbitration.................................................................................. 41
20.10 Export Controls.............................................................................. 42
20.11 Construction / Jurisdiction / Official Language.............................................. 42 21.USE OF NAMES ......................................................................................... 42 22.ENTIRE AGREEMENT ..................................................................................... 43 23.CAPTIONS ............................................................................................. 43


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[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
STRATEGIC ALLIANCE AGREEMENT


THIS AGREEMENT ("Agreement") is made and entered into effective as of the 18th day of January, 2001, between ASTA Medica Aktiengesellschaft, a German corporation with its office located at An der Pikardie 10, D-01277 Dresden, Germany (hereinafter referred to as "ASTA Medica") and BioNumerik Pharmaceuticals, Inc., a Texas corporation, with its office located at 8122 Datapoint Drive, Suite 1250, San Antonio, Texas 78229, U.S.A. (hereinafter referred to as "BioNumerik").


RECITALS:


WHEREAS, BioNumerik is the owner of certain inventions, trade secrets, know-how and rights relating to a certain medicinal toxicity protecting and mitigating agent and related compounds denoted as "BNP7787", and has been issued and has applied for certain patent and trademark rights with respect to BNP7787 and has developed BNP7787 for the treatment and mitigation of various clinically important toxicities.


WHEREAS, BioNumerik and ASTA Medica wish to further the development of BNP7787 for the prevention, treatment and mitigation of various medical treatment-associated toxicities that are associated with drug administration and other treatments in designated territories of the world.


NOW, THEREFORE, in consideration of the financial terms set forth herein and of the other terms, conditions and agreements contained herein, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, BioNumerik and ASTA Medica hereby agree as follows:


1. DEFINITIONS. When used in this Agreement, each of the following defined terms shall have the meanings set forth in this Section. There are other terms defined in this Agreement parenthetically, and such terms shall have the meanings apparent from the context in which such terms are parenthetically defined.


1.1 "Affiliate(s)" means, with respect to each Party, any organization, company, firm, or other entity that controls, is controlled by, or is under common control with said Party. A company shall be deemed to have control of another if it owns directly or indirectly a majority of the voting shares of or is


1 entitled directly or indirectly to appoint a majority of the directors or other managing body of the other company.


1.2 "Alliance Steering Committee" means the Alliance Steering Committee described in Section 3 hereof.


1.3 "ASTA Medica Improvements" means any and all inventions, developments, discoveries, and improvements useful in the development, manufacture or sale of the Product(s), including, without limitation, formulae, compounds, specifications, designs, chemical and physical data, clinical data, information concerning synthesis, processes, formulations, applications, toxicity, operations, regulatory affairs and marketing, that are developed by or for ASTA Medica subsequent to the date of the Confidentiality Agreement between BioNumerik and ASTA Medica dated as of December 12, 1998 (the "BioNumerik Confidentiality Agreement") and during the term of this Agreement, subject in all cases to any restrictions that may exist on the ability of ASTA Medica to license such inventions, developments, discoveries or improvements to BioNumerik in accordance with Sections 11 and 14 of this Agreement.


1.4 "ASTA Medica Know-How" means all data and information owned by ASTA Medica and useful in the development, manufacture or sale of the Product(s), including, without limitation, formulae, specifications, designs, chemical and physical data, clinical data, information concerning synthesis, processes, formulations, manufacture of the Active Pharmaceutical Ingredient (API) for the Product(s), applications, administration to patients, clinical protocols, toxicity, operations, regulatory affairs and marketing, that have been developed by or for ASTA Medica on or before the date of the BioNumerik Confidentiality Agreement, subject in all cases to any restrictions that may exist on the ability of ASTA Medica to use and license such know-how in accordance with the terms of this Agreement.


1.5 "ASTA Medica Patent Rights" means all patents or patent applications (excluding the BioNumerik Patent Rights) owned or controlled by ASTA Medica relating to ASTA Medica Know-How, ASTA Medica Improvements or other matters that are useful in the development, manufacture or sale of the Product(s) or that bear some tangible relationship to the Product(s).


1.6 "BioNumerik Improvements" means any and all inventions, developments, discoveries and improvements useful in the development, manufacture or sale of the Product(s), including, without limitation, formulae, compounds, specifications, designs, chemical and physical data, clinical data,


2 information concerning synthesis, processes, formulations, applications, toxicity, operations, regulatory affairs and marketing, that are developed by or for BioNumerik subsequent to the date of this Agreement and during the term of this Agreement, subject in all cases to any restrictions that may exist on the ability of BioNumerik to license such inventions, developments, discoveries or improvements to ASTA Medica in accordance with the terms of this Agreement.


1.7 "BioNumerik Know-How" means all data and information owned by BioNumerik and useful in the development, manufacture or sale of the Product(s), including, without limitation, formulae, specifications, designs, chemical and physical data, clinical data, information concerning synthesis, processes, formulations, manufacture of the API for the Product(s), applications, administration to patients, clinical protocols, toxicity, operations, regulatory affairs and marketing, that have been developed by or for BioNumerik on or before the date of this Agreement, subject in all cases to any restrictions that may exist on the ability of BioNumerik to license such know-how to ASTA Medica in accordance with the terms of this Agreement.


1.8 "BioNumerik Patent Rights" means all patents and patent applications and utility models and utility model applications (also known as "gebrauchsmuster"), including any addition, continuation, continuation-in-part, or division thereof or any substitute application therefore; any patent issued with respect to such patent application; any reissuance, re-examination or extension, including Supplementary Protection Certificates, of any such patent, in each case which patent or patent application bears some tangible relationship to the Product(s) and in which BioNumerik has an ownership or control during the term of this Agreement. BioNumerik Patent Rights shall include but not be limited to those patent applications listed on Attachment A hereto. For purposes of this Agreement, "gebrauchsmuster" shall mean the protection of technical inventions as defined in the current German Gebrauchsmuster Law or a legal institutes comparable to the "Gebrauchsmuster" within the Territory in a state other than Germany where applicable.


1.9 "BNP7787" means the compounds described on Attachment B hereto.


1.10 "Budget" means the annual budget approved from time to time by the Alliance Steering Committee pursuant to Section 4.


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1.11 "Competitor" of a Party shall mean a company or organization engaged in the business of discovering, developing, manufacturing and/or selling any products or services that compete with any of the Product(s) or any of the other material products that such Party is then developing, manufacturing, selling or having sold.


1.12 "Confidential Information" means all information that is of a confidential and proprietary nature, including without limitation, trade secrets, inventions and unpatented Know-How and Improvements and related technology, and any and all material information either of the Parties hereto may acquire concerning the financial, business and marketing goals and plans of the other, including the terms of this Agreement and (a) what has been disclosed by BioNumerik to ASTA Medica under the existing BioNumerik Confidentiality Agreement, and (b) what has been disclosed by ASTA Medica to BioNumerik under the existing Confidentiality Agreement (the "ASTA Medica Confidentiality Agreement") dated as of September 28, 2000, between ASTA Medica and BioNumerik.


1.13 "Costs" means [**].


1.14 "Development Plan" means the plan for the development and commercialization of the Product(s) approved from time to time by the Alliance Steering Committee pursuant to Section 4.


1.15 "Fiscal Year" means ASTA Medica's fiscal year commencing on January 1 and ending on December 31 of each year.


1.16 "Government Regulatory Approvals" means all government approvals, health registrations and/or permits required for manufacture, sale, and distribution of Product(s) in the Territory.


1.17 "Gross Profits" means [**].


1.18 "Gross Sales" means [**].


[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.


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1.19 "Improvements" means the BioNumerik Improvements and the ASTA Medica Improvements.


1.20 "Know-How" means the BioNumerik Know-How and the ASTA Medica Know-How.


1.21 "Parties" means ASTA Medica and BioNumerik, or if used in the singular, ASTA Medica or BioNumerik.


1.22 "Patents" means those patents that embody the Patent Rights in the Territory.


1.23 "Patent Rights" means the BioNumerik Patent Rights and the ASTA Medica Patent Rights.


1.24 "Product(s)" means any pharmaceutical preparation, composition, product, method of administration or treatment use, or formulation for administration that contains BNP7787, a related thiol or disulfide, metabolites or another related cytoprotective agent.


[**] None of BioNumerik's other agents in discovery or development (including, but not limited to, karenitecin, MDAM, and preclinical candidates) are included in this Agreement. [**]


1.25 "Product Trademark" means the main (global) trademark for the Product(s) in the Territory.


1.26 "Supply Agreement" has the meaning set forth in Section 7 hereof.


1.27 "Territory" shall mean worldwide, except for the United States of America (and its possessions and territories), Canada (and its possessions and territories), and Japan (and its possessions and territories).


[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.


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1.28 "Trademarks" means (i) the brand name(s) selected and owned either by BioNumerik alone or by ASTA Medica to be used for or in connection with the Product(s) in the Territory (including the Product Trademark, alternative trademarks to the Product Trademark) and all associated logos, and (ii) the general reference trade name selected by BioNumerik for BNP7787 and Product(s).


2. GRANT OF RIGHTS.


2.1 Research and Development License. Subject to the terms of this Agreement, BioNumerik h ...