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AMENDMENT NO. 3 TO COOPERATIVE DEVELOPMENT AGREEMENT

Development Agreement

AMENDMENT NO. 3 TO COOPERATIVE DEVELOPMENT AGREEMENT | Document Parties: ALTUS PHARMACEUTICALS INC | AMANO ENZYME INC You are currently viewing:
This Development Agreement involves

ALTUS PHARMACEUTICALS INC | AMANO ENZYME INC

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Title: AMENDMENT NO. 3 TO COOPERATIVE DEVELOPMENT AGREEMENT
Governing Law: Delaware     Date: 11/7/2007
Industry: Biotechnology and Drugs     Sector: Healthcare

AMENDMENT NO. 3 TO COOPERATIVE DEVELOPMENT AGREEMENT, Parties: altus pharmaceuticals inc , amano enzyme inc
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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.

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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

 
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