brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
7. MANUFACTURING AND SUPPLY
7.1 Manufacturing Generally.
(a) Subject to Sections 7.1(b) and 7.2 and in accordance with Section 7.4, it is
the Parties' intention to transfer responsibility for the Manufacture of the
Licensed Compounds and the Products to Sanofi-Aventis within the shortest delay
possible following the Effective Date and Exelixis agrees to cooperate with
Sanofi-Aventis toward that goal.
(b) Notwithstanding the foregoing, Exelixis agrees that it shall retain
responsibility for the Manufacture and supply of all of the Clinical Supply
Requirements necessary for the Development of the Products in accordance with
Section 7.2, until and pending the actual transfer of the Manufacturing
responsibility to Sanofi-Aventis in accordance with Section 7.4.
7.2 Manufacture of Clinical Supply Requirements by Exelixis. Pending the
transfer to Sanofi-Aventis of the Manufacturing responsibility, Exelixis shall
Manufacture and supply, or arrange with a Third Party for the Manufacture and
supply of any Clinical Supply Requirements for the Development of the Products
until completion of the Manufacturing Technology transfer in accordance with
Section 7.4, and the Parties shall use Diligent Efforts to complete such
transfer before [ * ]. Any Exelixis Clinical Supply Costs incurred in connection
with the foregoing shall be borne solely by Sanofi-Aventis, including expenses
for Exelixis' transfer to Sanofi-Aventis of any Clinical Supply Requirements
that may exist as of the Execution Date and through the Effective Date, and that
will be invoiced at cost to Sanofi-Aventis [ * ]. Promptly after the Effective
Date, the Parties shall enter into a letter agreement, substantially in the form
of the letter described in Exhibit 7.2, containing the terms and conditions for
the quality responsibilities associated with Exelixis' provision of Clinical
Supply Requirements for the Development of the Product.
7.3 Manufacture of Commercial Quantities. Sanofi-Aventis shall Manufacture, or
arrange with Third Parties for the Manufacture of any Product (in bulk and
finished form) for Commercialization, and Sanofi-Aventis shall bear the costs of
such Manufacture. Sanofi-Aventis shall, at all times, have sole control and
responsibility for the manufacturing process development with respect to the
Products for Commercialization and expenses associated therewith.
7.4 Transfer of Manufacturing Technology.
(a) [ * ] after the Effective Date, Exelixis shall disclose (and provide copies,
as applicable) to either Sanofi-Aventis or a Third Party manufacturer designated
by Sanofi-Aventis [ * ] that is Controlled by Exelixis, required for the
Manufacture of the Licensed Compounds and Products and is [ * ] to enable
Sanofi-Aventis or such Third Party manufacturer (as appropriate) to Manufacture
such Products. Such Information shall include, without limitation, the
Information and documents set forth in Exhibit 7.4 hereof (the "Manufacturing
Technology"). The steps, planning and obligations of the Parties regarding the
transfer of the Manufacturing Technology for each Product (for both the active
pharmaceutical ingredient and the drug product) will be set forth in a
"Technology Transfer Master Plan API" and a