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
BIOCRYST
PHARMACEUTICALS, INC.
MUNDIPHARMA
INTERNATIONAL HOLDINGS LIMITED
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PAGE
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1
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9
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9
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2.2 BioCryst Retained Rights
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9
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10
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10
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2.5 New Indications for the Licensed
Products
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10
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10
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12
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12
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13
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13
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ARTICLE 4 - DEVELOPMENT, COMMERCIALIZATION AND
COOPERATION
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13
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13
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4.2 Mundipharma Trials Plan
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13
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13
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4.4 Registration of Licensed Products
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15
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4.5 Sequencing of Registration
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15
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4.6 Out-of-Pocket Development Costs
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15
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16
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17
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4.9 Costs of Commercialization
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17
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4.10 BioCryst’s Rights Outside the
Territory
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17
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4.11 Report of Results, Data and
Information
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17
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4.12 Interactions with Government
Agencies
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18
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4.13 Additional Information
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20
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4.14 Parties’ Rights in
Communications
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20
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ARTICLE 5 - UNDERTAKINGS OF BIOCRYST AND
MUNDIPHARMA
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20
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5.1 Non-Use and Non-Disclosure
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20
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5.2 Authorized Disclosure
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20
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21
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21
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5.5 Maintenance of License
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21
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21
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ARTICLE 6 - SIGNING FEE — PAYMENTS —
ROYALTIES
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21
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21
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22
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6.3 Royalties Payable by Mundipharma
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22
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23
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23
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23
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6.7 Foreign Currency Conversion
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23
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24
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6.9 Payments to Third Parties
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24
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ARTICLE 7 - TRADEMARK AND DOMAIN
NAMES
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24
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7.1 Use of Trademark and BioCryst
Logo
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24
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7.2 Right to Use Trademark
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24
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25
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25
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7.5 Obligation to Enter into Trademark
License
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25
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TABLE OF CONTENTS
(continued)
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PAGE
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25
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7.7 Property in Trademark and Payment of
Fees
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25
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25
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26
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26
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ARTICLE 8 - LITIGATION, PATENT PROSECUTION AND
ROYALTY OFFSET
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26
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26
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27
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8.3 Registration of Patent License
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28
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28
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ARTICLE 9 - REPRESENTATIONS AND
WARRANTIES
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28
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9.1 BioCryst’s Representations and
Warranties
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28
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9.2 Mundipharma’s Representations and
Warranties
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30
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ARTICLE 10 - INDEMNITY AND PRODUCT
LIABILITY
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31
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10.1 Indemnification and Defense by
Mundipharma
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31
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10.2 Indemnification and Defense by
BioCryst
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32
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32
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32
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32
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10.6 Disclaimer of Liability for Consequential
Damages
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32
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ARTICLE 11 - TERM AND TERMINATION
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33
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33
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11.2 Termination by Parties
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33
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11.3 Rights and Obligations of Parties upon Term
Expiration or Termination
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34
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ARTICLE 12 - DISPUTE RESOLUTION AND GOVERNING
LAW
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36
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36
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36
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37
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ARTICLE 13 - MISCELLANEOUS
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37
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13.1 BioCryst Sublicensees
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37
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37
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37
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37
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37
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13.6 Pre-Existing Third Party License
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37
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13.7 Press releases and external
communications
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38
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38
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39
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39
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13.11 Effect of Partial Invalidity
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39
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40
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13.13 Entire Agreement; Amendment
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40
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40
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40
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13.16 Performance by Associates
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40
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13.17 Intellectual Property
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40
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13.18 Counterparts; Facsimile
Signature
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40
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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
”).
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:
As used in this Agreement, the
following terms shall have the following meanings:
1.1 “ Associate
” 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.
1.2 “ Autoimmune
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.
1.3 “ B-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.
1.4 “ B-CLL
” means B-type chronic lymphocytic leukemia.
1.5 “ B-NHL
” means a Non-Hodgkin’s lymphoma in which the malignant
cells have characteristics predominantly of the ‘B’
lineage.
1.6 “ BCX-4208
” means the PNP Inhibitor known as BCX-4208 having the
following chemical structure ***.
1.7 “ BioCryst
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.
1.8 “ BioCryst
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.
1.9 “ BioCryst
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:
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***
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•
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***
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•
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***
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•
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***
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•
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***; and
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•
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***
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1.10 “BioCryst Trials
Plan” is defined in Section 4.1.
1.11 “ Business
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.
1.12 “ Cancerous
State ” means a state in which cells exhibit aberrant and
uncontrolled proliferation that are believed to be
malignant.
1.13 “ Claims
” 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.
1.14 “
Commercialization ” 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.
1.15 “ Commercially
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.
1.16 “ Compound
” means the PNP Inhibitor known as BCX-1777 as claimed in the
BioCryst Patents having the following chemical structure
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