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Title: |
Co-Development Agreement |
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Entities: |
AmSouth Bank; Bioenvision Inc.; Chase Manhattan Bank; ILEX Oncology, Inc. |
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Date: |
2002 |
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Size: |
Preview shows 13KB of 241KB total |
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Price: |
$99 |
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ID: |
#285962 |
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CO-DEVELOPMENT AGREEMENT
BETWEEN
BIOENVISION
AND
ILEX ONCOLOGY
{PAGE}
TABLE OF CONTENTS
CO-DEVELOPMENT AGREEMENT ............................................... 1
WITNESSETH ............................................................. 1
1. DEFINITIONS ....................................................... 1
2. CO-DEVELOPMENT PROGRAM ............................................ 3
3. CO-DEVELOPMENT FUNDING ............................................ 6
4. INCOME AND ROYALTY PAYMENTS ....................................... 9
5. SRI MILESTONE PAYMENTS ............................................ 11
6. MARKETING ......................................................... 12
7. SUBLICENSING ...................................................... 13
8. PAYMENTS AND REPORTS .............................................. 14
9. RECORDS ........................................................... 15
10. MANUFACTURE ....................................................... 16
11. OWNERSHIP OF THE TECHNOLOGY, TECHNICAL ............................ 16
INFORMATION AND IMPROVEMENTS
12. PATENT PROSECUTION ................................................ 17
13. INFRINGEMENT BY THIRD PARTY ....................................... 17
14. REVOCATION PROCEEDINGS ............................................ 18
15. INFRINGEMENT OF THIRD PARTY RIGHTS ................................ 19
16. REPRESENTATIONS ................................................... 19
17. DISCLAIMER ........................................................ 21
18. INDEMNIFICATION ................................................... 21
i
{PAGE}
19. INSURANCE ......................................................... 23
20. TERM AND TERMINATION .............................................. 23
21. CONFIDENTIALITY; PUBLICATION; PUBLICITY ........................... 26
22. DISPUTE RESOLUTION ................................................ 28
23. ASSIGNABILITY ..................................................... 30
24. REFORM ............................................................ 30
25. WAIVER AND ALTERATION ............................................. 30
26. MARKING ........................................................... 31
27. IMPLEMENTATION .................................................... 31
28. GOVERNING LAW ..................................................... 31
29. EXPORTATION OF TECHNICAL INFORMATION .............................. 31
30. HEADINGS .......................................................... 31
31. PARTIES INDEPENDENT ............................................... 32
32. COUNTERPARTS ...................................................... 32
33. FORCE MAJEURE ..................................................... 32
34. SURVIVAL OF OBLIGATIONS ........................................... 32
35. NOTICE ............................................................ 33
APPENDIX I - PATENTS AND PATENT APPLICATIONS ...................... 35
APPENDIX II- CO-DEVELOPMENT AGREEMENT ............................. 36
BETWEEN BIOENVISION AND SRI
APPENDIX III - SLOAN-KETTERING INSTITUTE FOR
CANCER RESEARCH AGREEMENT
ii
{PAGE}
CO-DEVELOPMENT AGREEMENT
THIS AGREEMENT (the "Agreement") is entered into and effective this 12th day of
March, 2001, by and between Bioenvision, Inc. having its principal place of
business at One Rockefeller Plaza, New York, NY 10020, herein called
"Bioenvision", and Ilex Oncology, Inc. having its principal place of business at
4545 Horizon Hill Blvd, San Antonio, Texas 78229-2263, herein called "Ilex".
WITNESSETH
WHEREAS, Bioenvision has commercial rights that were licensed from Southern
research Institute ("SRI") relating to the development and uses of a
2'-fluoro-2-halo substituted purine nucleoside, herein referred to as
"Clofarabine", which has been shown to be effective in vitro and in vivo against
hematologic malignancies; and
WHEREAS, Bioenvision recognizes that Ilex has expertise in the development of
new drugs for clinical use, and
WHEREAS, Bioenvision recognizes that the development program for Clofarabine
will be expedited by the expertise of Ilex, and
WHEREAS, Bioenvision has expertise and strategic relationships which may
facilitate the development and marketing of Clofarabine outside of the United
States and Canada;
NOW THEREFORE, in consideration of the mutual agreements and covenants herein
contained and intending to be legally bound thereby, the parties agree as
follows:
1. DEFINITIONS
As used herein the following terms shall have the meanings set forth below:
1.1 Affiliate means any corporation, firm, partnership or other entity that
controls, is controlled by, or is under common control with a party
hereto. For purposes of this Agreement, "control" means the ownership,
whether direct or indirect, of fifty (50%) percent or more of the
equity having the power to vote or otherwise direct the affairs of the
entity.
1.2 Bioenvision means Bioenvision, Inc. and joint ventures, subsidiaries,
or other business entities controlled directly or indirectly by
Bioenvision or in which Bioenvision owns at least a majority interest.
1.3 Clofarabine means 2-ch1oro-9-(2-deoxy-2-fluoro-[Beta]-D-
arabinofuranosyl)-9H-purin-6-amine.
1
{PAGE}
1.4 Co-Development Program means the joint clinical development of the
Technology by Bioenvision and Ilex.
1.5 Confidential Information has the meaning set forth in Article 21.1.
1.6 Damages has the meaning set forth in Article 18.1.
1.7 Field means, and is limited to, the practice of the Patent, Invention
and Technical Information for use in the treatment of human cancer. For
purposes of this Agreement, "cancer" shall mean any malignant tumor
arising from or situated in either the hematological cell lines or
solid organs or tissues within the human body. The cancer may be
primary or secondary in origin."
1.8 Ilex means Ilex Oncology, Inc. and joint ventures, subsidiaries, or
other business entities controlled directly or indirectly by Ilex or in
which Ilex owns at least a majority interest.
1.9 Improvement or Improvements means those unencumbered technology
advances in the formulation, manufacture or structure of Clofarabine or
any Product made by or on behalf of Management during the term of this
Agreement that are either within the scope of and would constitute an
infringement of the Patent claims or use Technical Information and are
within the Field.
1.10 Indemnified Party has the meaning set forth in Article 18.3.
1.11 Indemnifying Party has the meaning set forth in Article 18.3.
1.12 Invention or Inventions means (i) applications of the Technology or
(ii) applications necessary for use of the Technology and claimed in
any Patent, solely in the Field.
1.13 Management means the team established pursuant to Section 2.2, which
shall be responsible for co-ordination and supervision of the
Co-Development Program.
1.14 Net Sales Revenue means the gross amount recognized by a party or its
Affiliates or sublicensees for the sale of Clofarabine or other
Product(s) through normal distribution channels (as determined by
generally accepted accounting principles and industry practices), less
any deductions for value added taxes incurred, and not recovered by
such party or the equivalent, or trade discounts, or returns, or such
deductions that may be made from the sale price in the Territory.
1.15 Patent or Patents means the patents and/or patent applications, set
forth in Appendix I, covering the Invention or Improvement as defined
above, patents to be issued pursuant thereto, and all divisionals,
continuations, continuations-in-part, reissues, substitutions, and
extensions thereof, and any patent issuing on a patent application
filed after the Effective Date of this Agreement which is included in
the grant of license hereunder and any foreign counterparts of the
foregoing. Appendix I lists the owner of each such Patent.
2
{PAGE}
1.16 Product(s) means Clofarabine . which was licensed by Bioenvision from
SRI and as set out in the SRI Agreement (as hereinafter defined), and
includes other related purine nucleosides within the scope of the
patent rights licensed in the aforementioned license.
1.17 Providing Party has the meaning set forth in Article 21.1.
1.18 Representatives has the meaning set forth in Article 21.1.
1.19 Technical Information means unencumbered published or unpublished
confidential and proprietary information in the nature of research and
development information, knowledge and technical data, together with
trade secrets relating to the Products, including any inventions in the
possession of and belonging solely to Ilex or Bioenvision on or prior
to the Effective Date of this Agreement and which Ilex or Bioenvision,
acting in good faith, believe to be useful in carrying out the
co-development program, including that which comes into the possession
of Ilex or Bioenvision during the term of this Agreement as a result of
activities carried out under this Agreement.
1.20 Technology means the patented and unpatented, patentable and
unpatentable proprietary Technical Information related to the Products
for use in the Field which is owned or possessed by Bioenvision with
rights to sublicense and is made available to Ilex pursuant to this
Agreement.
1.21 Territory means worldwide, with the exception of Japan and Southeast
Asia (as defined in the Agreement between SRI and Bioenvision -
Appendix II).
1.22 SRI Agreement means, collectively, the Co-Development Agreement between
Bioenvision and SRI dated August 31, 1998 (Appendix II to this
Agreement) and the accompanying inter-institutional agreement between
SRI and Sloan-Kettering Institute for Cancer Research ("MSK") (Appendix
III to this Agreement), in each case, as amended (if amended).
2. CO-DEVELOPMENT PROGRAM
2.1 The parties to this Agreement hereby agree to jointly co-develop
Clofarabine for commercialization according to the terms of this
Agreement. This Agreement supersedes all other written or verbal
agreements, express or implied, between Ilex and Bioenvision relating
to the subject matter hereof. Ilex shall be responsible for conducting
all clinical trials and the filing and prosecution of all applications
with applicable USA and Canadian regulatory authorities and all
regulatory filings in the USA and Canada shall be in the name of Ilex.
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