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DEVELOPMENT AND LICENSE AGREEMENT BY AND BETWEEN BIOCRYST PHARMACEUTICALS, INC. AND MUNDIPHARMA INTERNATIONAL HOLDINGS LIMITED

Development Agreement

DEVELOPMENT AND LICENSE AGREEMENT BY AND BETWEEN BIOCRYST PHARMACEUTICALS, INC. 
AND MUNDIPHARMA INTERNATIONAL HOLDINGS LIMITED | Document Parties: BIOCRYST PHARMACEUTICALS INC | MUNDIPHARMA INTERNATIONAL HOLDINGS LIMITED You are currently viewing:
This Development Agreement involves

BIOCRYST PHARMACEUTICALS INC | MUNDIPHARMA INTERNATIONAL HOLDINGS LIMITED

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Title: DEVELOPMENT AND LICENSE AGREEMENT BY AND BETWEEN BIOCRYST PHARMACEUTICALS, INC. AND MUNDIPHARMA INTERNATIONAL HOLDINGS LIMITED
Date: 5/2/2006
Industry: Biotechnology and Drugs     Law Firm: Proskauer Rose LLP    

DEVELOPMENT AND LICENSE AGREEMENT BY AND BETWEEN BIOCRYST PHARMACEUTICALS, INC. 
AND MUNDIPHARMA INTERNATIONAL HOLDINGS LIMITED, Parties: biocryst pharmaceuticals inc , mundipharma international holdings limited
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Exhibit 10.2

NOTE: THIS DOCUMENT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST PURSUANT TO RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. PORTIONS OF THIS DOCUMENT FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED HAVE BEEN REDACTED AND ARE MARKED HEREIN BY “***”. SUCH REDACTED INFORMATION HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO THE CONFIDENTIAL TREATMENT REQUEST.

DEVELOPMENT AND LICENSE AGREEMENT

BY AND BETWEEN

BIOCRYST PHARMACEUTICALS, INC.

AND

MUNDIPHARMA INTERNATIONAL HOLDINGS LIMITED

 


 

TABLE OF CONTENTS

 

 

 

 

 

 

 

PAGE

ARTICLE 1 - DEFINITIONS

 

 

1

 

ARTICLE 2 - GRANT

 

 

9

 

2.1 License Grants

 

 

9

 

2.2 BioCryst Retained Rights

 

 

9

 

2.3 BCX-4208

 

 

10

 

2.4 New Compounds

 

 

10

 

2.5 New Indications for the Licensed Products

 

 

10

 

ARTICLE 3 - GOVERNANCE

 

 

10

 

3.2 Committee Membership

 

 

12

 

3.3 Committee Co-Chairs

 

 

12

 

3.4 Committee Meetings

 

 

13

 

3.5 Decision Making

 

 

13

 

ARTICLE 4 - DEVELOPMENT, COMMERCIALIZATION AND COOPERATION

 

 

13

 

4.1 BioCryst Trials Plan

 

 

13

 

4.2 Mundipharma Trials Plan

 

 

13

 

4.3 Development Costs

 

 

13

 

4.4 Registration of Licensed Products

 

 

15

 

4.5 Sequencing of Registration

 

 

15

 

4.6 Out-of-Pocket Development Costs

 

 

15

 

4.7 Commercialization

 

 

16

 

4.8 Promotion

 

 

17

 

4.9 Costs of Commercialization

 

 

17

 

4.10 BioCryst’s Rights Outside the Territory

 

 

17

 

4.11 Report of Results, Data and Information

 

 

17

 

4.12 Interactions with Government Agencies

 

 

18

 

4.13 Additional Information

 

 

20

 

4.14 Parties’ Rights in Communications

 

 

20

 

ARTICLE 5 - UNDERTAKINGS OF BIOCRYST AND MUNDIPHARMA

 

 

20

 

5.1 Non-Use and Non-Disclosure

 

 

20

 

5.2 Authorized Disclosure

 

 

20

 

5.3 Technical Assistance

 

 

21

 

5.4 Manufacturing

 

 

21

 

5.5 Maintenance of License

 

 

21

 

5.6 Guarantees; Opinions

 

 

21

 

ARTICLE 6 - SIGNING FEE — PAYMENTS — ROYALTIES

 

 

21

 

6.1 Signing Fee

 

 

21

 

6.2 Payments

 

 

22

 

6.3 Royalties Payable by Mundipharma

 

 

22

 

6.4 Royalty Reports

 

 

23

 

6.5 Records

 

 

23

 

6.6 Audit

 

 

23

 

6.7 Foreign Currency Conversion

 

 

23

 

6.8 Nature of Payments

 

 

24

 

6.9 Payments to Third Parties

 

 

24

 

ARTICLE 7 - TRADEMARK AND DOMAIN NAMES

 

 

24

 

7.1 Use of Trademark and BioCryst Logo

 

 

24

 

7.2 Right to Use Trademark

 

 

24

 

7.3 New Territory

 

 

25

 

7.4 Secondary Marks

 

 

25

 

7.5 Obligation to Enter into Trademark License

 

 

25

 

 


 

TABLE OF CONTENTS
(continued)

 

 

 

 

 

 

 

PAGE

7.6 New Trademarks

 

 

25

 

7.7 Property in Trademark and Payment of Fees

 

 

25

 

7.8 Domain Names

 

 

25

 

7.9 Infringement

 

 

26

 

7.10 Step-In

 

 

26

 

ARTICLE 8 - LITIGATION, PATENT PROSECUTION AND ROYALTY OFFSET

 

 

26

 

8.1 Litigation

 

 

26

 

8.2 Patent Prosecution

 

 

27

 

8.3 Registration of Patent License

 

 

28

 

8.4 Royalty Offset

 

 

28

 

ARTICLE 9 - REPRESENTATIONS AND WARRANTIES

 

 

28

 

9.1 BioCryst’s Representations and Warranties

 

 

28

 

9.2 Mundipharma’s Representations and Warranties

 

 

30

 

ARTICLE 10 - INDEMNITY AND PRODUCT LIABILITY

 

 

31

 

10.1 Indemnification and Defense by Mundipharma

 

 

31

 

10.2 Indemnification and Defense by BioCryst

 

 

32

 

10.3 Defense Procedures

 

 

32

 

10.4 Insurance

 

 

32

 

10.5 Survival

 

 

32

 

10.6 Disclaimer of Liability for Consequential Damages

 

 

32

 

ARTICLE 11 - TERM AND TERMINATION

 

 

33

 

11.1 Term

 

 

33

 

11.2 Termination by Parties

 

 

33

 

11.3 Rights and Obligations of Parties upon Term Expiration or Termination

 

 

34

 

ARTICLE 12 - DISPUTE RESOLUTION AND GOVERNING LAW

 

 

36

 

12.1 Disputes

 

 

36

 

12.2 Dispute Resolution

 

 

36

 

12.3 Governing Law

 

 

37

 

ARTICLE 13 - MISCELLANEOUS

 

 

37

 

13.1 BioCryst Sublicensees

 

 

37

 

13.2 Covenants

 

 

37

 

13.3 Non-Compete

 

 

37

 

13.4 Delay of payment

 

 

37

 

13.5 Assignment

 

 

37

 

13.6 Pre-Existing Third Party License

 

 

37

 

13.7 Press releases and external communications

 

 

38

 

13.8 Use of Name

 

 

38

 

13.9 Notices

 

 

39

 

13.10 Effect of Waiver

 

 

39

 

13.11 Effect of Partial Invalidity

 

 

39

 

13.12 Force Majeure

 

 

40

 

13.13 Entire Agreement; Amendment

 

 

40

 

13.14 Status of Parties

 

 

40

 

13.15 Further Assurances

 

 

40

 

13.16 Performance by Associates

 

 

40

 

13.17 Intellectual Property

 

 

40

 

13.18 Counterparts; Facsimile Signature

 

 

40

 

 


 

LICENSE AND DEVELOPMENT AGREEMENT

     This License and Development Agreement is made as of February 1, 2006 (the “ Effective Date ”) by and between BioCryst Pharmaceuticals, Inc., a company organized and existing under the laws of Delaware having offices at 2190 Parkway Lake Drive, Birmingham, Alabama 35244 (“ BioCryst ”) and Mundipharma International Holdings Limited, a Bermudan company, having offices at Mundipharma House, 14 Par-la-Ville Road, Hamilton, Bermuda HMJX (“ Mundipharma ”) (hereinafter, each of BioCryst and Mundipharma a “ Party ” and, collectively, the “ Parties ”).

W I T N E S S E T H :

      WHEREAS , BioCryst owns or controls patents and know-how related to a series of proprietary compounds which act as PNP Inhibitors (as defined below), including the compound known as BCX-1777.

      WHEREAS , Mundipharma has expertise in the discovery, development, manufacture and sale of pharmaceutical products.

      WHEREAS , Mundipharma wishes to obtain, and BioCryst wishes to grant, in the Territory only, rights and licenses under certain patents, know-how and trademarks owned or controlled by BioCryst.

      NOW, THEREFORE , in consideration of the mutual promises and covenants contained in this Agreement, the parties agree as follows:

ARTICLE 1 — DEFINITIONS

     As used in this Agreement, the following terms shall have the following meanings:

      1.1Associate ” of a Party means any person, firm, trust, corporation or other entity or combination thereof which directly or indirectly (a) controls said Party, (b) is controlled by said Party, or (c) is under common control with said Party; the terms “control” and “controlled” meaning direct or indirect ownership (including pursuant to any option, warrant or other arrangement or understanding) of fifty percent (50%) or more, including ownership by trusts with substantially the same beneficial interests, of the voting rights, shares or other equity interests of such person, firm, trust, corporation or other entity or combination thereof or the power to direct the management of such person, firm, trust, corporation or other entity or combination thereof.

      1.2Autoimmune Indications ” means all indications that involve pathogenic consequences, including tissue injury, produced by autoantibodies or autoreactive T lymphocytes interacting with self epitopes, i.e. autoantigens. Autoimmune Indications shall include, without limitation, asthma, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, juvenile rheumatoid arthritis, polymyositis, ankylosing spondylitis, Type I diabetes, sarcoidosis, Sjogrens syndrome, chronic active non-pathogenic hepatitis, non-infectious uveitis (Behcet’s), aplastic anemia, hemolytic anemia, idiopathic thrombocytopenia purpura, vasculitis, Hashimoto’s thyroiditis, atopic dermatitis, regional non-pathogenic enteritis (including ulcerative colitis, Crohn’s disease and inflammatory bowel disease), Kawasaki’s disease, post-infectious encephalitis, myasthenia gravis, multiple sclerosis, alopecia and tropic spastic paraparesis.

      1.3B-cell Acute Lymphoblastic Leukemia/lymphoma ” or “ B-ALL ” means a disease in which certain cells of the B lymphocytes or B-cells are malignant, and have populated the bone marrow.

      1.4B-CLL ” means B-type chronic lymphocytic leukemia.

      1.5B-NHL ” means a Non-Hodgkin’s lymphoma in which the malignant cells have characteristics predominantly of the ‘B’ lineage.

 


 

      1.6BCX-4208 ” means the PNP Inhibitor known as BCX-4208 having the following chemical structure ***.

      1.7BioCryst Know-How ” means all knowledge and proprietary information, including know-how, trade secrets, data, technology and scientific and technical information now or hereafter during the Term owned, developed or controlled by BioCryst or any of its Associates, which relate to the Compound or the Licensed Products, including but not limited to: (a) medical, clinical, toxicological or other scientific data, and (b) processes and analytical methodology useful in the Development, testing, analysis, manufacture or packaging of the Compound or the Licensed Products, but specifically excluding all of BioCryst’s or its Associates’ Independent Data.

      1.8BioCryst Patents ” means those patents and patent applications set forth on Schedule 1.8, and all patents and patent applications that claim priority to any of the foregoing or which claim the manufacture, use or sale of the Compound or Licensed Products in the Territory, which patent applications and patents are owned or controlled by BioCryst or its Associates, or as to which BioCryst or any of its Associates have a license with rights to sublicense, during the Term, and any extensions, supplementary protection certificates, continuations, continuations-in-part, divisions, reissues, re-examinations, additions, substitutions, confirmations, registrations, or re-validations of or to any of the foregoing.

      1.9BioCryst Trials ” means, collectively, the following ongoing or planned clinical trials of the Licensed Products sponsored or to be sponsored and funded by BioCryst (subject to sharing of Out-of-Pocket Development Costs as provided in Section 4.3.1) with a sufficient number of patients and designed to demonstrate statistical significance:

 

 

***

 

 

 

 

 

 

***

 

 

 

 

 

 

***

 

 

 

 

 

 

***

 

 

 

 

 

 

***; and

 

 

 

 

 

 

***

      1.10 “BioCryst Trials Plan” is defined in Section 4.1.

      1.11Business Day ” means a day that is not a Saturday, Sunday or a day on which banking institutions in New York, New York or London, England, are authorized by Legal Requirements to remain closed.

      1.12Cancerous State ” means a state in which cells exhibit aberrant and uncontrolled proliferation that are believed to be malignant.

      1.13Claims ” means any and all losses, liabilities, costs and expenses (including attorneys’ fees and expenses), debts and other obligations arising out of or resulting from claims, judgments, damages of any kind whatsoever (including but not limited to compensatory, exemplary and punitive damages), arbitral awards, and amounts paid in settlement of claims, judgments, legal (including but not limited to judicial, arbitral and administrative) proceedings and the like, which claims, judgments, damages, awards, settlements, legal proceedings and the like which arise out of or are connected or related in any way whatsoever to the design or clinical investigation or research or testing or labeling or manufacturing or packaging or marketing or sale or distribution of the Compound or Licensed Products, including (but not limited to) physical injury, death or product liability and similar Third Party claims.

 


 

      1.14Commercialization ” means, with respect to the Licensed Products, any and all processes and activities conducted to permit, establish, promote and maintain sales for the Licensed Products, including negotiating and obtaining Pricing Approvals, manufacturing, offering for sale, detailing, commercializing (including launch), promoting, storing, transporting, supporting, distributing, and importing the Licensed Products, and all Phase IV and post-marketing studies and tests of such Licensed Products, but in all cases excluding Development. “Commercialize” and “Commercializing” shall have their correlative meanings.

      1.15Commercially Reasonable Efforts ” means a level of resources, efforts and urgency to Develop and/or Commercialize the Licensed Products applied by a Party that is consistent with such Party’s practices in diligently and actively pursuing the development and/or commercialization of its other pharmaceutical products at a similar stage of product life, and having similar safety, efficacy and commercial potential. It is understood that such resources, efforts and urgency may change from time to time during the Term based upon changing safety, efficacy, scientific, business and commercial considerations.

      1.16Compound ” means the PNP Inhibitor known as BCX-1777 as claimed in the BioCryst Patents having the following chemical structure

 

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