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.
LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
BIOCRYST PHARMACEUTICALS,
INC.
Dated as of February 28,
2007
LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
This LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT (this “
Agreement ”) is entered into as of
February 28, 2007 by and between BIOCRYST PHARMACEUTICALS,
INC., a corporation organized and existing under the laws of the
State of Delaware having offices at 2190 Parkway Lake Drive,
Birmingham, Alabama 35244 (“ BioCryst ”),
and SHIONOGI & CO., LTD., a corporation organized and existing
under the laws of the Japan having offices at 1-8, Doshomachi
3-chome, Chuo-ku, Osaka 541-0045, Japan (“
Shionogi ”). BioCryst and Shionogi are each
referred to herein by name or individually as a “
Party ” or collectively as the “
Parties .”
WHEREAS, BioCryst owns or controls patents, know-how and
other intellectual property related to a compound known as
Peramivir.
WHEREAS, Shionogi has expertise in the discovery,
development, manufacture and sale of pharmaceutical products in the
Territory (as defined below).
WHEREAS, Shionogi wishes to obtain, and BioCryst wishes
to grant, in the Territory only, rights and licenses under certain
of BioCryst’s patents, know-how and trademarks to Shionogi so
that Shionogi can obtain the necessary regulatory approvals to sell
Licensed Products (as defined below) in the Territory.
NOW, THEREFORE, in consideration of the premises and mutual
covenants herein below, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties hereby agree as follows:
1.1 Defined Terms. As used in this Agreement,
the following terms shall have the meanings indicated:
(a) " Affiliate ” means
any corporation or other entity which is directly or indirectly
controlling, controlled by or under common control of a Party, for
so long as such control exists. For the purposes of this
Section 1.1(a), “control” means direct or indirect
ownership of fifty percent (50%) or more (or, if less than fifty
percent (50%), the maximum ownership interest permitted by
applicable Law) of the voting rights, shares or other equity or
income interest of a Party.
(b) " BioCryst Know-How
” means Know-How owned, developed or controlled by, or
licensed to, BioCryst.
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(c) " BioCryst Intellectual Property
Rights ” means all Intellectual Property Rights owned
or controlled by BioCryst, including but not limited to BioCryst
Know-How, the BioCryst Marks, and BioCryst Patents.
(d) " BioCryst Logo ”
means the company logo of BioCryst in a form provided, and approved
in writing, by BioCryst from time to time.
(e) " BioCryst Marks ”
means the BioCryst Logo and any trademark, trade name or logo
approved by BioCryst for use in connection with the
Commercialization of the Licensed Product (whether or not owned by
BioCryst).
(f) " BioCryst Patents
” means those Patents owned, licensed or controlled by
BioCryst which are filed in the Territory and which relate to the
manufacture, use or sale of Licensed Products and/or Compound,
which are set forth on Schedule 1.1(f).
(g) " Budget ” means,
individually, the applicable budget set forth in the Development
Plan or Commercialization plan.
(h) " cGMPs ” means the
United States then-current good manufacturing practices and the
equivalent standards of the Japanese government.
(i) " Change of Control
” means, with respect to a Party, any of the following
events: (i) any corporation or other entity is or becomes the
“beneficial owner” (as such term is used in sections
12(d) and 13(d) of the Securities Exchange Act of 1934, as amended,
except that a corporation or other entity shall be deemed to have
“beneficial ownership” of all shares that any such
corporation or other entity has the right to acquire, whether such
right may be exercised immediately or only after the passage of
time), of a majority of the total voting power represented by all
classes of capital stock then outstanding of such Party normally
entitled to vote in elections of directors of the Party;
(ii) such Party consolidates with or merges into another
corporation or entity, or any corporation or entity consolidates
with or merges into such Party, other than (A) a merger or
consolidation which would result in the voting securities of such
Party outstanding immediately prior to such merger or consolidation
continuing to represent (either by remaining outstanding or by
being converted into voting securities of the surviving entity or
any parent thereof) a majority of the combined voting power of the
voting securities of such Party or such surviving entity or any
parent thereof outstanding immediately after such merger or
consolidation, or (B) a merger or consolidation effected to
implement a recapitalization of such Party (or similar transaction)
in which no corporation or other entity becomes the beneficial
owner, directly or indirectly, of voting securities of such Party
representing a majority of the combined voting power of such
Party’s then outstanding securities; or (iii) such Party
conveys, transfers or leases all or substantially all of its assets
to any corporation or other entity other than a wholly-owned
subsidiary of such Party in one or more related
transactions.
(j) “
COGS ” or “ Cost of Goods
Sold ” means, ***.
(k) “
Combination Product ” means ***.
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(l) " Commercialization
” means, with respect to Licensed Product, any and all
processes and activities conducted to establish and maintain sales
for such Licensed Product, including offering for sale, detailing,
selling (including launch), marketing (including education and
advertising activities), promoting, manufacturing Licensed Product
from Compound, but not manufacturing Compound itself), storing,
transporting, supporting, distributing, and importing such product,
but shall exclude development and manufacturing of Compound.
“Commercialize” and “Commercializing” shall
have their correlative meanings.
(m) " Compound ” means
the chemical compound known as “ Peramivir
” having the following chemical structure:
(1S,2S,3R,4R)-3-[(1S)-1-(acetylamino)-2-ethylbutyl]
-4-[(aminoiminomethyl)amino]-2-hydroxy-cyclopentanecarboxylic acid,
trihydrate
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