Pursuant to
17 CFR 240.24b-2, confidential information has been omitted in
places marked “* * *” and has been filed separately
with the Securities and Exchange Commission pursuant to a
Confidential Treatment Application filed with the
Commission.
FIRST AMENDMENT
TO
LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This First
Amendment (this “ Amendment ”) to the License,
Development and Commercialization Agreement between BioCryst
Pharmaceuticals, Inc. (“ BioCryst ”) and
Shionogi & Co., Ltd. (“ Shionogi ”), dated
as of February 28, 2007 (the “ Agreement
”), shall be effective as of September 30, 2008 (the “
First Amendment Date ”).
WHEREAS, pursuant
to Section 17.14 of the Agreement, the Agreement may be
amended in writing by BioCryst and Shionogi; and
WHEREAS, BioCryst
and Shionogi desire to amend the Agreement to expand the Territory
to Taiwan (defined below) and to provide rights for Shionogi to
perform a Phase III Clinical Trial in Hong Kong (defined below),
which is outside the Territory.
NOW, THEREFORE, in
consideration of the mutual covenants and promises contained herein
and in the Agreement, BioCryst and Shionogi, intending to be
legally bound hereby, amend, update and supplement the Agreement as
follows:
1. Amendment
of the Agreement . The parties hereby agree to amend the
Agreement, effective as of the First Amendment Date as
follows:
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a.
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Definitions . The following definitions shall be
added to Section 1.1 of the Agreement, as follows:
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(fff)
“ Hong Kong ” means the Hong Kong Special
Administrative Region of the People’s Republic of
China.
(ggg)
“ 2008 Trial ” means the Phase III
Clinical Trial described in Section 5.1(a), below.
(hhh)
“ Taiwan ” means the territories
of Taiwan, Republic of China.
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b.
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Territory . Section 1.1(bbb) of the
Agreement is hereby amended and restated in its entirety as:
““ Territory ” means Japan and
Taiwan”.
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c.
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References to Japan
. The following
references to “Japan” or “Japanese” are
hereby amended and restated in their entirety as
follows:
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1(h)
“ cGMPs ” means the United States
then-current good manufacturing practices and the equivalent
standards of the Governmental Entities in the Territory.
Pursuant to
17 CFR 240.24b-2, confidential information has been omitted in
places marked “* * *” and has been filed separately
with the Securities and Exchange Commission pursuant to a
Confidential Treatment Application filed with the
Commission.
1(aa)
“ IND ” means an Investigation of a New
Drug Filing (or the Japanese or Taiwanese equivalent) with a
Regulatory Authority in the Territory for purposes of obtaining
permission to initiate human clinical testing in such
jurisdiction.
1(oo)
“ NDA ” means a New Drug
Application (or the Japanese or Taiwanese equivalent), including
all supplements and amendments thereto, for the approval of the
Licensed Product as a new drug by the MHLW or applicable Regulatory
Authority in the Territory.
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d.
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Section 2.1
. Section 2.1 is
hereby amended and restated in its entirety as:
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License Grant; Reservation of Rights; Right to Conduct 2008
Trial in Hong Kong .
(a) Solely to the
extent necessary for Shionogi to perform its obligations hereunder
in accordance with the terms of this Agreement, and subject to all
of the rights retained hereunder, BioCryst hereby grants Shionogi a
personal, non-sublicensable, non-transferable, non-assignable right
and license under the BioCryst Patents and BioCryst Know-How, to
(i) exclusively Develop Licensed Products solely in the Field
and in the Territory, and (ii) exclusively Commercialize
Licensed Products solely in the Field and in the Territory. The
foregoing license grant shall be deemed to extend to
Shionogi’s Affiliate, Taiwan Shionogi & CO., Ltd.
(“Shionogi Taiwan”) solely with respect to activities
in Taiwan. Other than as explicitly set forth in this
Section 2.1, no other licenses to the BioCryst Intellectual
Property Rights or otherwise (including but not limited to all
rights in BioCryst Intellectual Property Rights outside the Field
and outside the Territory) are granted in this Agreement.
*** .
(b) In connection
with the 2008 Trial, and only for such purpose, BioCryst hereby
grants Shionogi the limited, nonexclusive right to conduct the 2008
Trial in Hong Kong. For the purposes of clarity, it is understood
and agreed that the foregoing right set forth in this
Section 2.1(b) is granted in furtherance of Shionogi’s
rights in the Territory, is subject in all respects to all of the
terms and conditions set forth in this Agreement including the
license grant and retained rights, including in
Sections 2.1(a) and 2.3, and does not include any further
rights to Develop or Commercialize in Hong Kong. All rights granted
under this Section 2.1(b) shall terminate upon the completion
of the 2008 Trial.
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e.
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Section 2.2
. Section 2.2 is
hereby amended and restated in its entirety as:
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f.
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Section 3.5(f)
. The following is
hereby added as a new Section 3.5(f):
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(f) BioCryst will be obligated to supply
Licensed Product and Compound to Shionogi pursuant to this
Section 3.5 (and otherwise under this Agreement) only in
Japan, and not in any other location, including Taiwan, unless
otherwise agreed to in writing by the Parties.
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g.
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Section 3.6
. The following is
hereby added to the end of Section 3.6:
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2
Pursuant to
17 CFR 240.24b-2, confidential information has been omitted in
places marked “* * *” and has been filed separately
with the Securities and Exchange Commission pursuant to a
Confidential Treatment Application filed with the
Commission.
BioCryst will
be obligated to supply Compound to Shionogi pursuant to this
Section 3.6 (and otherwise under this Agreement) only in
Japan, and not in any other location, including Taiwan, unless
otherwise agreed to in writing by the Parties.
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h.
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Section 5.1
. The following is
hereby added at the end of the exis
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