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.
4.6 Technology and Regulatory Transfer of Licensed Compounds. Exelixis shall
disclose or transfer to Sanofi-Aventis the Information and documents described
in subsections 4.6(a) - (b) below:
(a) Within [ * ] after the Effective Date Exelixis shall disclose (and provide
copies, as applicable) to Sanofi-Aventis any Information, including but not
limited to any preclinical data, clinical data, assays, protocols, procedures
and any other information in Exelixis' possession or Control, not previously
disclosed to Sanofi-Aventis, and [ * ] to continue or initiate pre-clinical or
clinical Development, or in seeking Regulatory Approval of Products.
(b) Exelixis shall transfer, [ * ] to Sanofi-Aventis, [ * ] (except as described
below) and upon [ * ] prior written notice to Exelixis: (i) [ * ]; (ii) any
agreements [ * ] all or some of the agreements [ * ], and Exelixis shall not be
required to transfer, [ * ] the items described in [ * ] that are [ * ] for
Exelixis to conduct such Exelixis Clinical Trials until such delegation of
authority ceases.
5. REGULATORY
5.1 Regulatory Responsibility.
(a) Subject to Section 5.1(b) and Section 6.3, Sanofi-Aventis shall, during the
Term, have [ * ] 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 in the
jurisdictions where Sanofi-Aventis determines[ * ] it is commercially reasonable
to do so. Subject to Section 5.1(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 5.1(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 transfer of an IND held by Exelixis with respect to a Product
pursuant to Section 4.6(b), 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
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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