EXHIBIT 10.2
Amendment No. 3 to Cooperative Development
Agreement
THIS
AMENDMENT, entered into as of 12 th day of July,
2007 (this “Amendment”) by and between ALTUS
PHARMACEUTICALS INC. , a corporation organized and existing under
the laws of the State of Delaware and having its principal place of
business at 125 Sidney Street, Cambridge, MA 02139, USA
(hereinafter called “ALTUS”), and AMANO ENZYME INC. , a
corporation organized and existing under the laws of Japan and
having its principal place of business at 1-2-7, Nishiki, Naka-ku,
Nagoya, Japan (hereinafter called “AMANO”), amends the
Cooperative Development Agreement dated as of November 8,
2002, by and between Altus and Amano (the “Agreement”).
Capitalized terms used in this Amendment and not defined in this
Amendment shall have the meanings ascribed to them in the
Agreement.
Background
WHEREAS,
ALTUS, through research and development, acquires and possesses
certain valuable technologies pertaining to certain pharmaceutical
products known as ALTU-237 (an orally-delivered crystalline
formulation of an oxalate-degrading enzyme designed by ALTUS for
the treatment of hyperoxalurias) and a method for manufacturing
such products and continues to develop scientific techniques
pertaining to the products, and owns and controls certain patent
rights and trademark rights in the products, and ?
WHEREAS,
AMANO has, over the years, demonstrated its expertise in
development, manufacturing and worldwide marketing of many kind of
enzymes for the commercial markets especially in food industry and
pharmaceutical industry, and has thereby established a reputation
of high regard in such markets, which reputation is believed by
ALTUS to be of great value to the possible success of the joint
development contemplated hereunder, and
WHEREAS,
AMANO desires to undertake manufacture of enzyme materials to be
used in the products of ALTUS,
WHEREAS,
ALTUS and AMANO desire to amend the Agreement to allow for,
cooperative development for the manufacture and supply of
oxalate-degrading enzymes (hereinafter called
“Materials”) by Amano for use by Altus in ALTU-237 in
certain non-clinical studies, and
WHEREAS,
ALTUS and AMANO propose to decide at the end of the Phase II
clinical trial process whether they will enter into a Phase III
clinical supply and commercial supply manufacturing
agreement.
NOW,
THEREFORE , Altus and Amano agree to cooperate per this
Amendment as follows:
1. The parties acknowledge that certain provisions of this
Amendment anticipate that, if the parties agree that Amano shall
act as the primary manufacturer of Materials following Phase II
Completion, the parties will enter into good faith negotiations for
a manufacturing agreement to
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Registrant’s application requesting confidential treatment
under Rule 24b-2 of the Exchange Act.
- 1 -
govern
the manufacture and supply of Materials for both the Phase III
clinical study and the commercial supply of ALTU-237 (the
“Manufacturing Agreement”). Notwithstanding such
provisions, the parties have agreed to proceed with the manufacture
and supply of Pre-Clinical Materials as set forth below in this
Amendment and to defer negotiation of the Manufacturing Agreement
until the terms of paragraph 2 below have been met.
2. The parties have reached agreement regarding Altus’
anticipated timing and needs for pre-clinical Materials and
Amano’s manufacturing capacity, resource availability and
capabilities for such materials. Both parties will work in good
faith to reach agreement regarding future clinical supply of
Materials and Amano’s manufacturing capacity, resource
availability and capabilities for such Materials. With respect to
Materials for commercial supply which Amano has sufficient capacity
and capabilities, and provided Amano has achieved successful
completion of the clinical supply, Amano and Altus shall make a
good faith election whether or not to negotiate the Manufacturing
Agreement on or about [***]. In the event the development of
ALTU-237 reasonably requires a decision for [**] supply at an
earlier date, Altus shall notify Amano and Amano shall notify Altus
of its interest in proceeding with negotiation of the Manufacturing
Agreement within thirty (30) days of such notice. If the
parties enter into the Manufacturing Agreement, Altus shall retain
the right to [******] a [****] for any such Material.
3. Amano shall supply GMP-compliant Materials and non-GMP
non-clinical Materials meeting the agreed upon Specifications at
the following prices (excluding shipping charges) [***] that meets
the requirements set forth in the quality agreements provided for
in Section 4 below:
Oxalate
[***] (non-GMP): US$[****] *1
Oxalate
[***] (GMP): US$[*****] *2
*1
[***]
*2
[****]
Collateral Condition
The necessary
equi