to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
Regulatory Authority regarding such Product. Upon the transfer of an IND with
respect to a Product pursuant to Section 4.6(b), Exelixis shall notify the
applicable Regulatory Authorities in writing that it is transferring such INDs
for the applicable Product to Sanofi-Aventis, and Sanofi-Aventis would notify
the applicable Regulatory Authorities in writing that it is accepting such INDs
and all responsibilities associated therewith (including without limitation, the
responsibility for reporting adverse events), other than any ongoing activities
of Exelixis relating to ongoing Exelixis Clinical Trials (if applicable).
5.2 Other Regulatory Matters.
(a) Pharmacovigilance. Sanofi-Aventis shall be responsible for the management of
all pharmacovigilance and all reports required by the Regulatory Authorities in
order to obtain and maintain any Regulatory Approvals granted for the Products
in the Territory, including, without limitation, adverse drug experience
reports. The Parties agree to negotiate and execute a definitive safety data
exchange agreement (the "SDEA") within [ * ] of the Effective Date of this
Agreement, or within another time period as mutually agreed by the Parties,
which will describe the responsibilities and procedures to be followed by the
Parties with regard to all regulatory reporting for the Products under this
Agreement.
(b) Pricing and Reimbursement Approvals. Sanofi-Aventis and its Affiliates shall
have sole responsibility in the conduct of all pricing and reimbursement
approval proceedings relating to each Product.
(c) Rights of Reference. Sanofi-Aventis shall have the right to cross reference,
file or incorporate by reference any regulatory filing or drug master file (as
defined in the Code of Federal Regulations) (and any data contained therein) for
any Product (including all Approvals) in order to support regulatory filings
that Sanofi-Aventis is permitted to make under this Agreement for any such
Product and to enable Sanofi-Aventis to fulfill its obligations under this
Agreement to Develop, Manufacture (anywhere in the world), or Commercialize any
such Product.
5.3 Recalls. Any decision to initiate a recall or withdrawal of a Product shall
be made by Sanofi-Aventis. In the event of any recall or withdrawal,
Sanofi-Aventis shall take any and all necessary action to implement such recall
or withdrawal in accordance with applicable law, with assistance from Exelixis
as reasonably requested by Sanofi-Aventis. The costs of any such recall or
withdrawal shall be borne solely by Sanofi-Aventis [ * ].
6. COMMERCIALIZATION; SANOFI-AVENTIS RESPONSIBILITIES
6.1 Scope. Sanofi-Aventis shall have sole control and responsibility for, and
bear all costs and expenses associated with, the Commercialization of all
Licensed Compounds and/or Products. In connection with the foregoing,
Sanofi-Aventis shall be solely responsible for defining the marketing strategy
and promotional policy for the Products and, subject to Section 6.2, for
creating all packaging and promotional materials for the Products. Subject to
Section 6.2, Sanofi-Aventis shall own all right, title and interest in and to
any and all such promotional materials, including all applicable copyrights,
trademarks, program names and domain names relating to the Products.
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[ * ] = Certain