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Process Development Agreement

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Title:

Process Development Agreement

Entities:

Genentech, Inc.; ImmunoGen, Inc.; Millennium Pharmaceuticals Inc.

Date:

2006

Size:

Preview shows 18KB of 81KB total

Price:

$48

ID:

#2450535

► Licensing ► Development ► Process Development Agreements
► Biotech & Drugs ► Pharmaceutical Preparations

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PROCESS DEVELOPMENT AGREEMENT

THIS PROCESS DEVELOPMENT AGREEMENT (this Agreement) is entered into as of the 3rd day of May, 2006 (Effective Date), by and between Genentech, Inc., a Delaware corporation with an office at 1 DNA Way, South San Francisco, California 94080-4990 (Genentech), and ImmunoGen, Inc., a Massachusetts corporation with corporate headquarters at 128 Sidney Street, Cambridge, MA 02139 (ImmunoGen). In this Agreement, Genentech and ImmunoGen each may be referred to individually as a Party and together as the Parties.

BACKGROUND

A. Genentech and ImmunoGen are parties to the following agreements: that certain License Agreement dated as of May 2, 2000, and amendments thereto (the License Agreement); that certain Heads of Agreement, dated as of May 2, 2000, as amended (as so amended, the Heads of Agreement); that certain Process Development Heads of Agreement, dated as of June 29, 2001, and amendments thereto, including that certain Amendment No.1 dated November 15, 2002 (the PD Heads of Agreement); that certain Manufacturing and Supply Agreement dated as of January 11, 2005, and amendments thereto (the Clinical Supply Agreement); that certain Development Agreement dated as of June 1, 2004, and amendments thereto (the Development Agreement); and the Quality Services Agreement dated as of June 30, 2005 (the Quality Services Agreement) (the License Agreement, the Heads of Agreement, the PD Heads of Agreement, the Clinical Supply Agreement, the Development Agreement and the Quality Services Agreement, collectively the Existing Agreements).

B. ImmunoGen will develop a commercial-scale process for manufacturing the HER2 ADC, and Genentech will assist and compensate ImmunoGen, all as set forth in this Agreement.

AGREEMENT

In consideration of the mutual promises and covenants hereinafter set forth herein, and other consideration, the Parties agree as follows:

1. Defined Terms. The following capitalized terms used in this Agreement have the meanings indicated below:

1.1 Conjugation Process means a commercial-scale and commercial-grade process for manufacturing HER2 ADC by conjugating its component parts, which is to be developed under this Agreement.

1.2 Dedicated Equipment means the capital equipment identified on the Project Document as Dedicated Equipment.

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

1.3 Genentech Materials means (i) a proprietary Genentech anti-HER2 antibody identified on the Project Document, and (ii) any other items identified on the Project Document as Genentech Materials or delivered by Genentech under Section 2.6.

1.4 HER2 ADC means a pharmaceutical product consisting of the following, in the form of a conjugate: (i) a proprietary Genentech anti-HER2 antibody referred to as trastuzumab, (ii[***] [***] (a linker moiety referred to as [***]), and (iii) a cytotoxic maytansinoid compound referred to as DM1.

1.5 Project Document means the attachments or appendices to this Agreement, which describe the Services, set forth the Requirements, and include other information, terms and conditions relevant to performance of the Services, as those attachments or appendices may be amended and updated under Section 2.1.

1.6 Project Materials means any materials - other than Genentech Materials - used for manufacturing an HER2 ADC and otherwise performing the Services, including SMCC and DM1.

1.7 Requirements means any specifications or requirements for any of the following: the Dedicated Equipment, the Genentech Materials, the Project Materials, the Services, or the Conjugation Process.

1.8 Services means the process development work to be performed by ImmunoGen under this Agreement, as further described on the Project Document, including delivery of the documents embodying the Conjugation Process.

2. Services.

2.1 Project Document. The Project Document is intended to describe the Services and any other relevant terms and conditions for performance of the Services under this Agreement. The Project Document attached to this Agreement as of the Effective Date is preliminary; the Parties shall work in good faith to update and expand that preliminary Project Document, consistent with the preliminary Project Document and the terms and conditions of this Agreement, so that a final Project Document is complete within [***] ([***]) days after the Effective Date. The preliminary Project Document is incorporated into and forms an integral part of this Agreement; updated or amended Project Documents will become part of this Agreement upon execution by both Parties. In the event of a conflict between the terms in the main body of this Agreement and any terms of the Project Document, the main body of this Agreement controls.

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