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Exclusive License Agreement

 

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Title:

Exclusive License Agreement

Entities:

First Busey Corp.

Date:

2007

Size:

Preview shows 37KB of 142KB total

Price:

$72

ID:

#2721220

 

 

► Licensing ► Licenses ► Exclusive License Agreements
► Financial ► Regional Banks

 

 

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January 4th, 2007
EXCLUSIVE LICENSE AGREEMENT
BETWEEN
ELI LILLY AND COMPANY
AND
PROSIDION LIMITED

 


 

CONTENTS
             
Article Number       Page Number  
 
           
 
           
ARTICLE 1     1  
DEFINITIONS     1  
1.1
  DEFINITIONS     1  
1.2
  FURTHER DEFINITIONS     12  
ARTICLE 2     12  
PURPOSE AND SCOPE OF THE LICENSE     12  
2.1
  PURPOSE OF THE LICENSE     12  
2.2
  LICENSE GRANT     13  
2.3
  SUBLICENSES     13  
2.4
  PROSIDION KNOW-HOW     13  
2.5
  COVENANT NOT TO SUE     14  
ARTICLE 3     14  
ROLE AND RESPONSIBILITIES OF LILLY     14  
3.1
  SCOPE OF LILLYS RESPONSIBILITIES     14  
3.2
  REGULATORY ACTIVITIES     14  
3.3
  DILIGENCE OBLIGATIONS     15  
3.4
  THIRD PARTY OBLIGATIONS     16  
3.5
  NON-COMPETE     16  
ARTICLE 4     17  
ROLE AND RESPONSIBILITIES OF PROSIDION     17  
4.1
  TECHNICAL INFORMATION PROVISION     17  
4.2
  REASONABLE TECHNICAL ASSISTANCE AND CO-OPERATION FOR TRANSITIONAL PURPOSES     17  
4.3
  MATERIALS PROVISION     17  
4.4
  NO ONGOING RESPONSIBILITY BEYOND TRANSITIONAL PURPOSES     18  
ARTICLE 5 INFORMATION REPORTING     18  
5.1
  INFORMATION REPORTING     18  
ARTICLE 6 PAYMENTS AND FINANCIAL REPORTING     19  
6.1
  UPFRONT PAYMENTS     19  
6.2
  MILESTONE PAYMENTS     19  
6.3
  ROYALTIES     20  
ARTICLE 7 CONFIDENTIALITY AND PUBLICATION     23  
7.1
  OBLIGATIONS     23  
7.2
  AUTHORIZED DISCLOSURES OF CONFIDENTIAL INFORMATION     23  
7.3
  DISCLOSURES LEGALLY REQUIRED OR NECESSARY     23  
7.4
  DISCLOSURE OF THE TERMS OF THE AGREEMENT     24  
7.5
  PUBLICATIONS     25  
ARTICLE 8 REPRESENTATIONS, WARRANTIES AND DISCLAIMERS     25  
8.1
  CORPORATE EXISTENCE AND AUTHORITY     25  
8.2
  AUTHORIZED EXECUTION; BINDING OBLIGATION     25  
8.3
  NO CONFLICTS     26  

ii


 

             
Article Number       Page Number  
 
           
 
           
8.4
  ALL CONSENTS AND APPROVALS OBTAINED     26  
8.5
  EXISTING PATENTS IN THE TERRITORY     26  
8.6
  KNOW-HOW     27  
8.7
  DISCLAIMER OF IMPLIED WARRANTIES     27  
8.8
  LIMITATION OF LIABILITY     27  
8.9
  GUARANTEE OF PERFORMANCE OF AFFILIATES     27  
8.10
  NOT DEBARRED     28  
8.11
  LITIGATION     28  
ARTICLE 9 MUTUAL INDEMNIFICATION     28  
9.1
  INDEMNIFICATION OBLIGATIONS     28  
9.2
  INDEMNIFICATION PROCEDURES     29  
9.3
  INDEMNIFICATION PAYMENT ADJUSTMENTS     30  
9.4
  INDEMNIFICATION PAYMENT     30  
9.5
  INSURANCE     30  
9.6
  SURVIVAL     32  
ARTICLE 10 INTELLECTUAL PROPERTY     32  
10.1
  LILLY IMPROVEMENTS     32  
10.2
  PATENT EXPENSES     32  
10.3
  FILING, PROSECUTION AND MAINTENANCE OF PATENTS     32  
10.4
  INTERFERENCE, OPPOSITION, REEXAMINATION AND REISSUE     33  
10.5
  ENFORCEMENT     33  
10.6
  THIRD PARTY PATENTS     34  
10.7
  CERTIFICATION UNDER DRUG PRICE COMPETITION AND PATENT RESTORATION ACT     34  
10.8
  PATENT TERM RESTORATION     35  
10.9
  PATENT MARKING     35  
ARTICLE 11 TERM AND TERMINATION     35  
11.1
  TERM     35  
11.2
  TERMINATION     35  
11.3
  TERMINATION FOR LILLY NON-COMPLIANCE WITH DILIGENCE OBLIGATIONS     36  
11.4
  TERMINATION AT WILL OF THE LILLY GKA PROGRAM BY LILLY     36  
11.5
  EFFECT OF TERMINATION; SURVIVING OBLIGATIONS     36  
11.6
  NON-EXCLUSIVE RIGHTS     38  
11.7
  RIGHTS IN BANKRUPTCY     38  
ARTICLE 12 DISPUTE RESOLUTION     38  
12.1
  DISPUTES     38  
12.2
  DISPUTE RESOLUTION PROCEDURES     38  
ARTICLE 13 MISCELLANEOUS     41  
13.1
  FORCE MAJEURE     41  
13.2
  ASSIGNMENT     41  
13.3
  CHANGE OF CONTROL     41  
13.4
  FURTHER ASSURANCES     41  
13.5
  SEVERABILITY     41  
13.6
  NOTICES     42  
13.7
  APPLICABLE LAW     42  

iii


 

             
Article Number       Page Number  
 
           
 
           
13.8
  ENTIRE AGREEMENT     44  
13.9
  HEADINGS     44  
13.10
  INDEPENDENT CONTRACTORS     44  
13.11
  WAIVER     44  
13.12
  NO THIRD PARTY BENEFICIARIES     44  
13.13
  COUNTERPARTS     44  
13.14
  WAIVER OF RULE OF CONSTRUCTION     45  
SCHEDULE 1.1.20     46  
SCHEDULE 1.1.26     47  
SCHEDULE 1.1.58     48  
SCHEDULE 1.1.70     49  
SCHEDULE 4.3     50  
SCHEDULE 8.5     51  
APPENDIX 1     52  

iv


 

EXCLUSIVE LICENSE AGREEMENT
     THIS EXCLUSIVE LICENSE AGREEMENT (the Agreement) is made and is effective as of January 4th, 2007 (the Effective Date) by and between:
     (i) Eli Lilly and Company, a corporation organized and existing under the laws of the State of Indiana, whose principal place of business is Lilly Corporate Center, Indianapolis, Indiana, 46285, United States of America (Lilly);
and
     (ii) Prosidion Limited, a company registered in England and Wales under registered number 4600121 with its registered offices at Windrush Court, Watlington Road, Oxford OX4 6LT, United Kingdom (together with its parent company OSI Pharmaceuticals, Inc. (OSI) and its Affiliates, Prosidion).
     Prosidion and Lilly are sometimes referred to herein individually as a Party and collectively as the Parties.
RECITALS
     A. Prosidion is engaged in the research and development of pharmaceutical products and is currently engaged in the research and development of the Prosidion GKA Program (as hereinafter defined).
     B. Lilly is engaged in the research, development, manufacture and marketing of pharmaceutical products and is interested in further research and development in the GKA (as hereinafter defined) area.
     C. Prosidion desires to grant to Lilly exclusive license rights in the further research and development of the Prosidion GKA Program and clinical development and marketing of Product(s) (as hereinafter defined), and Lilly desires to receive such rights, subject to and in accordance with the terms in this Agreement.
     NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the Parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
     1.1 DEFINITIONS
     When used and capitalized in this Agreement (other than the headings of the Articles and Sections), including the foregoing recitals, the following terms shall have the meanings assigned to them in this Article and include the plural as well as the singular.

1


 

     1.1.1 Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a Product and which may or may not have a causal relationship with administration of such Product.
     1.1.2 Affiliate means any Person that directly (or indirectly through one or more intermediaries) controls, is controlled by, or is under common control with, a Party. For purposes of this definition only, the terms controls, controlled, and control mean: (i) the direct or indirect ability or power to direct or cause the direction of the management and policies of an entity or otherwise direct the affairs of such entity, whether through ownership of equity, voting securities or beneficial interest, by contract, or otherwise; or (ii) the ownership, directly or indirectly, of at least fifty percent (50%) of the voting securities (or other comparable ownership interest for an entity other than a corporation) of a Party.
     1.1.3 API or Active Pharmaceutical Ingredient means the active pharmaceutical ingredient of PSN010 or GKA Back-ups in bulk form, which, if appropriately formulated and finished, would constitute Product.
     1.1.4 Applicable Laws means all applicable statutes, ordinances, regulations, rules or orders of any kind whatsoever of any Governmental Authority, including, without limitation, the Regulatory Laws, Prescription Drug Marketing Act, Generic Drug Enforcement Act of 1992 (21 U.S.C. Section 335a et seq.), and Anti-Kickback Statute (42 U.S.C. Section 1320a-7b et seq.), all as amended from time to time.
     1.1.5 Calendar Quarter means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
     1.1.6 Calendar Year means each successive period of twelve (12) months commencing on January 1 and ending on December 31.
     1.1.7 cGCP means the then current good clinical practices as defined in U.S. Regulations 21 CFR Sections 50, 54, 56, 312 and 314, (or in the case of foreign jurisdictions, comparable regulatory standards), and in any successor regulation, including those procedures expressed or implied in the Regulatory Materials with respect to any Product(s) provided to Regulatory Authorities.
     1.1.8 cGLP means the then current good laboratory practice standards promulgated or endorsed by the FDA (or in the case of foreign jurisdictions, comparable regulatory standards), including those procedures expressed or implied in the Regulatory Materials with respect to any Product(s) provided to Regulatory Authorities.
     1.1.9 cGMP or GMP means the then current good manufacturing practices for pharmaceuticals as described in regulations promulgated by Regulatory Authorities as applicable to the Manufacture of Product(s), as such regulations are in effect at the time of Manufacturing Product(s).
     1.1.10 Change Of Control means, with respect to either Party, any of the following events: (i) the acquisition by any entity of beneficial ownership (as defined in Rule 13d-3 under the United States Securities and Exchange Act of 1934, as amended) directly or indirectly, of fifty percent (50%) or more of the shares of such Partys capital stock, the holders of which have general voting power under ordinary circumstances to elect at least a majority of such Partys board of directors or equivalent body (the Board of Directors) (the Voting Stock); (ii) the approval by the shareholders of such Party of a merger, share exchange, reorganization, consolidation or similar transaction of such Party (a Transaction), if any party to the Transaction is an entity, other than a Transaction which would result in the beneficial owners of Voting Stock of such Party immediately prior thereto continuing to

 

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