that for purposes of continuity and to
ensure regulatory compliance, Sanofi-Aventis, to the extent practicable, will
transfer information set forth in the "Regulatory Matters" and "PV Quality
System and Database" paragraphs above simultaneously to Lexicon, and Lexicon
will undertake reasonable efforts to accommodate the simultaneous transfer.
e.
No Launch Before Transfer. Lexicon represents that it does not intend to, and
hereby agrees that it will not commercially launch the Terminated Products
before the completion of transfers contemplated in the "Regulatory Matters" and
"PV Quality System and Database" paragraphs above.
f.
Mutual Cooperation. Lexicon and Sanofi-Aventis will use Commercially Reasonable
Efforts to complete and execute all documentation and respond to regulator
inquiries in order to effect the transfer of the Regulatory Documentation and
patient safety databases under this provision. Pending and after such transfer,
Sanofi-Aventis will cooperate with Lexicon in such transition and other
activities and shall provide such regulatory support as may be reasonably
necessary to assist Lexicon to prepare and submit initial filings for the
regulatory approval of the Terminated Product for T2DM in the United States and
European Union currently planned for the first half of 2020 and to respond to
inquiries or information requests from Regulatory Authorities with respect
thereto, and will make appropriate personnel reasonably available to assist
Lexicon in such activities; provided, that Sanofi shall not be obligated to
provide such regulatory assistance or cooperation beyond [**] days following the
Settlement Date except to the extent Lexicon is not reasonably able to
appropriately respond to such Regulatory Authority inquiries or information
requests without such assistance or cooperation from Sanofi-Aventis, in which
case, the Parties agree that Sanofi-Aventis's obligation to cooperate after [**]
days following the Settlement Date shall be limited to answering specific
questions via teleconference.
g.
Ongoing Regulatory and Ethical Responsibility Costs. To the extent
Sanofi-Aventis continues maintenance of regulatory files (including activities
as may be reasonably necessary to assist Lexicon to communicate and make
submissions to regulatory
authorities related to the Terminated Product in the United States and European
Union) after [**] days following the Settlement Date, Lexicon will reimburse
Sanofi-Aventis for all reasonable costs relating to such continued maintenance,
including reasonable costs for internal full-time employees (FTE) costs at the
FTE Rate; provided, that the foregoing obligation is subject to Sanofi-Aventis'
exercise of Commercially Reasonable Efforts to promptly carry out its
obligations with respect to the transfer of control and ownership of such
regulatory files.
11.
QUALITY. Sanofi-Aventis will use Commercially Reasonable Efforts to
transfer to Lexicon quality assurance ("QA") information including copies of
audit plans and audit certificates, comprehensive information relating to
product specific observations and remediation efforts, and lists of all
Regulatory Authority inspections relating to its QA activities with respect to
Terminated Product within [**] days of the Settlement Date. Lexicon may request
additional QA information and Sanofi-Aventis agrees to cooperate and provide
additional QA information that is reasonably requested and necessary for the
purpose of Lexicon's assumption of responsibilities for the Terminated Product.
Pending and after such