that Sanofi-Aventis continue such internal ongoing stability studies after [**]
days following the Effective Date, Lexicon will reimburse Sanofi-Aventis for all
such costs, including reasonable costs for internal full-time employees (FTE)
costs at the FTE Rate.
10.
REGULATORY.
a.
Regulatory Matters. Sanofi-Aventis and Lexicon will use Commercially Reasonable
Efforts to transfer control and ownership of all Regulatory Documentation to
Lexicon within [**] days of the Settlement Date. Without limiting the foregoing,
Sanofi-Aventis shall (i) transfer or assign sponsorship of the INDs and Drug
Approval Application in the United States, and Regulatory Approval for T1DM in
the European Union, and other regulatory filings, relating to Terminated
Product, and (ii) provide copies of other regulatory documents that are
necessary for Lexicon to assume control and sponsorship, and maintain the
regulatory files. All Regulatory Documentation constituting INDs or Drug
Approval Applications (either finalized, or if in draft form, the most recent
version of the draft) shall be provided in native format documents, if
applicable. Pending and after such transfer, Sanofi-Aventis will cooperate with
Lexicon in such transition and other activities as may be reasonably necessary
to enable Lexicon to communicate and make submissions to regulatory authorities
related to the Terminated Product in the United States and European Union, and
will make appropriate personnel reasonably available to assist Lexicon in such
activities.
b.
PV Quality System and Database. Sanofi-Aventis and Lexicon will use Commercially
Reasonable Efforts and work together in good faith to transfer the global safety
database, and related patient safety oversight and governance files, to Lexicon
within [**] days following the Settlement Date; provided, that if the Parties
are unable to complete such
transfer within such [**]-day period, Sanofi-Aventis will continue to retain
responsibility for maintaining the global safety database and related files for
up to an additional [**] days, subject to the cost-transfer provision of
sub-Paragraph (g) of this Section. Sanofi-Aventis will provide Lexicon with
information reasonably necessary for Lexicon to comply with its
pharmacovigilance responsibilities, including, as applicable, any Adverse Events
or other adverse drug experiences, in each case in the form reasonably requested
by Lexicon. Subject to all other terms in this Paragraph, Sanofi-Aventis will
retain responsibility for maintaining the global safety database and related
files until such transfer is complete, but in no event beyond [**] days
following the Settlement Date. For clarity, following transfer of the global
safety database, Sanofi-Aventis shall have no further obligations relating to
pharmacovigilance responsibilities.
c.
Regulatory Authority Inspections. Pending and after the transfer of regulatory
documentation contemplated above, at Lexicon's request, Sanofi-Aventis will
reasonably assist Lexicon with respect to any Regulatory Authority inspection
that relates to any Development or Manufacturing activity conducted by or on
behalf of Sanofi-Aventis under the License Agreement and will permit a
reasonable number of Lexicon representatives to be present during such
inspection. Lexicon will reimburse Sanofi-Aventis for all reasonable costs with
respect to all such requested assistance, including reasonable costs for
internal full-time employees (FTE) costs at the FTE Rate.
d.
Simultaneous Transfer. The Parties agree