MEIJI SEIKA KAISHA,
LTD. INTERNATIONAL
HEADQUARTERS, PHARMACEUTICALS
4-16, Kyobashi 2 chome, Chuo-ku,
Tokyo, 104-8002
Japan TELEPHONE:(03)3272
6511 FAX: (03)3281 • 4058 (03)3278-6551
JOINT DEVELOPMENT
AGREEMENT
This Agreement
is made as of this 11th day of February, 2008 by and
between:
Meiji Seika
Kaisha, Ltd., a company organized and existing under the laws of
Japan and having its principal place of business at 4-16, Kyobashi
2-chome, Chuo-ku, Tokyo 104-8002 Japan (hereinafter referred to as
“Meiji Seika”), and
Cornerstone
Biopharm Inc., a corporation organized and existing under the laws
of the State of Nevada and having its principal office at 2000
Regency Parkway, Suite 255 Cary, North Carolina, 27518 USA
(hereinafter referred to as “Cornerstone”).
WHEREAS, Meiji
Seika and Cornerstone entered into the License and Supply Agreement
dated October 12, 2006 regarding Cefditoren Pivoxil as amended by
the Amendment No. 1 dated July 27, 2007 (“License
Agreement”); and
WHEREAS, Meiji
Seika and Cornerstone concluded a letter agreement dated
July 27, 2007 (“Letter Agreement”) regarding the
development of the Once-Daily Product and the Pediatric Product
(respectively defined below); and
WHEREAS, Meiji
Seika and Cornerstone entered into a letter agreement dated
January 11, 2008 to confirm the mechanism and allocation of
expenses for formulation of [***] tablet and [***] study as a part
of the development of the Once-Daily Product and scale up
manufacture of [***] as a part of the development of the Pediatric
Product (“Formulation Agreement”); and
WHEREAS, Meiji
Seika and Cornerstone discussed the mechanism and allocation of
expenses for the remaining part of the development of the
Once-Daily Product and the Pediatric Product.
[***]
Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.
MEIJI SEIKA KAISHA,
LTD. INTERNATIONAL
HEADQUARTERS, PHARMACEUTICALS
4-16, Kyobashi 2 chome, Chuo-ku,
Tokyo, 104-8002
Japan TELEPHONE:(03)3272
6511 FAX: (03)3281 • 4058 (03)3278-6551
NOW, THEREFORE,
in consideration of the mutual obligations and promises as set
forth herein, the parties do hereby agree as follows:
For the purpose
of this Agreement, the following terms shall have the following
meanings:
|
(1)
|
|
The
capitalized terms not defined herein shall have the meanings
ascribed to them in the License Agreement.
|
|
(2)
|
|
The
term “Development” shall mean the development of the
Once-Daily Product and the Pediatric Product in the Territory to be
conducted in accordance with the Development Plan.
|
|
(3)
|
|
The
term “Development Plan” shall mean the plan and
schedule for the development of the Once-Daily Product and the
Pediatric Product in the Territory as described in the Annex A
attached hereto and any amendment thereto which may be mutually
agreed in writing between both parties.
|
|
(4)
|
|
The
term “Effective Date” shall mean the date of this
Agreement first written above.
|
|
|
|
|
|
(5)
|
|
The
term “Once-Daily Product” shall mean a once-daily
dosage form of the Product.
|
|
|
|
|
|
(6)
|
|
The
term “Pediatric Product” shall mean a pediatric form of
the Product.
|
|
(1)
|
|
Subject to the terms and conditions
set forth in this Agreement, Meiji Seika hereby grants Cornerstone
an exclusive right to conduct the Development.
|
MEIJI SEIKA KAISHA,
LTD. INTERNATIONAL
HEADQUARTERS, PHARMACEUTICALS
4-16, Kyobashi 2 chome, Chuo-ku,
Tokyo, 104-8002
Japan TELEPHONE:(03)3272
6511 FAX: (03)3281 • 4058 (03)3278-6551
|
(2)
|
|
Meiji Seika and Cornerstone agree
that the Development has been started and is to be proceeded with
according to the Development Plan. Cornerstone shall, with full
consultation with Meiji Seika, be in charge of the project
management for the Development, including but not limited to filing
a submission of the Once-Daily Product and the Pediatric Product to
the health authorities in the Territory for obtaining the Product
Registrations. Specific mechanism and the decision making
process/method to proceed with the Development shall be discussed
separately by Meiji Seika and Cornerstone. The important decision
such as continuance or discontinuance of the Development and
amendment of the Development Plan shall be made jointly and
unanimously between Meiji Seika and Cornerstone. If either party
foresees a possible risk including occurrence of serious events
which would make it impossible or impracticable to pursue the
Development from a reasonable pharmaceutical point of view, such a
party may, with full consultation with the other party, terminate
this Agreement upon thirty (30) day’s written
notice.
|
|
(3)
|
|
Any
and all data and results generated from the Development hereunder
shall be the property jointly owned by Meiji Seika and Cornerstone
and both party shall have the right to access and use such data and
results solely for the purpose of this Agreement and shall not use
such data and results for any other purpose, provided that
(a) Meiji Seika has the right to use such data and results in
order to obtain the product registrations of and to commercialize
both the Once-Daily Product and the Pediatric Product outside the
Territory, and (b) notwithstanding the confidentiality
obligations set forth in Article 7, Meiji Seika may disclose
such data and results to its licensees and potential licensees
outside the Territory with the binder of confidentiality
obligations not less stringent than those set forth in
Article 7 and to the health authorities outside the Territory
for such purpose.
|
|
(4)
|
|
The
total expenses of the Development except for the expenses agreed to
be allocated by Formulation Agreement shall be borne by
Cornerstone.
|
Article 3 — Inclusion in the License
Agreement
|
