at [ * ], all agreements entered into by [ *
] with any [ * ] regarding the [ * ] or [ * ] of [ * ]. If an agreement that is
described in subsection [ * ] is not assignable, then Exelixis shall use
Diligent Efforts to amend the agreement to permit assignment.
6.
REGULATORY
6.1.Regulatory Responsibility.
(a)
Subject to Section 3.2 and Section 6.1(b), Sanofi-Aventis shall, during
the Term, have [ * ] discretion, control and responsibility for the preparation,
drafting, submission and filing, in its own name and at its own cost, of all
DAAs, documents, dossiers, etc., for Regulatory Approvals for the Products.
Subject to Section 6.1(b), Sanofi-Aventis shall have [ * ] responsibility for
interacting with any Regulatory Authority regarding any issues, DAAs or any
Regulatory Approval, and Exelixis shall provide its reasonable assistance to
Sanofi-Aventis (at Sanofi-Aventis' expense), whenever Sanofi-Aventis seeks such
assistance, to answer questions on the Products from any Regulatory Authority.
Additionally, in the event Sanofi-Aventis must communicate with or respond to a
Regulatory Authority within a very limited amount of time and needs the
assistance of Exelixis for such interaction with the Regulatory Authority,
Exelixis will use its Diligent Efforts to assist Sanofi-Aventis within the
required time frame (at Sanofi-Aventis' expense). Furthermore, subject to
Section 6.1(b) and to applicable laws and regulations, Sanofi-Aventis shall own
all Regulatory Approvals, submissions and dossiers that it files as well as the
Regulatory Approvals that are granted during the Term, including supporting
documentation and information.
(b)
Pending the [ * ] of [ * ] by [ * ] with respect to a [ * ] pursuant to [
* ], Exelixis shall remain the primary contact of Regulatory Authorities for
regulatory activities regarding such Product, on behalf of Sanofi-Aventis.
However, Sanofi-Aventis shall have the right to review and approve in advance
any communication with any Regulatory Authority regarding such Product. Upon the
[ * ] of [ * ] with respect to a [ * ] pursuant to [ * ], Exelixis shall notify
the applicable Regulatory Authorities in writing that it is [ * ] for the
applicable Product to Sanofi-Aventis, and Sanofi-Aventis would notify the
applicable Regulatory Authorities in writing that it is [ * ] 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).
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[ * ] = Certain confidential information contained in this document, marked by
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.
6.2.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