to provide comments thereon, which comments Licensor must
consider and address if provided to Licensor at least fifteen (15) days before
such action is due. Should Licensor decide that it does not desire to Handle a
Licensor Patent in the Territory, it shall advise sanofi-aventis thereof no less
than forty-five (45) days prior to the date when the Licensor Patent would
become abandoned. At the written request of sanofi-aventis, Licensor shall then,
at no cost to Licensor, assign to sanofi-aventis such Licensor Patent and
sanofi-aventis may thereafter Handle the same in sanofi-aventis' name, at
sanofi-aventis' sole cost and expense, to the extent that sanofi-aventis desires
to do so.
9.2
Infringement -
(a)
Each Party shall promptly provide written notice to the other Party during the
Agreement Term of any known infringement or suspected infringement of any
Licensor Patents by a Third Party.
(i)
[***]
(ii)
[***]
(b)
A Party that elects to bring and control an infringement action pursuant to this
Section 9.2 shall provide prompt written notice to the other Party of any such
suit commenced or action taken by such Party.
(c)
Upon written request, the Party bringing suit or taking action ("Initiating
Party") shall keep the other Party informed of the status of any such suit or
action and shall provide the other Party with copies of all substantive
documents communications filed in such suit or action. [***].
12
[Confidential treatment has been requested as to certain portions of this
document. Each such portion, which has been omitted herein and replaced with a
series of three asterisks in brackets [***], has been filed separately with the
Securities and Exchange Commission.]
(d)
[***]
(e)
[***]
(f)
[***]
ARTICLE 10
REGULATORY MATTERS
10.1
Regulatory Approval - Licensor shall diligently prepare and file the
applications for Regulatory Approval required to manufacture, have manufactured
or Commercialize the Product in the Territory. Licensor hereby acknowledges and
agrees that sanofi-aventis shall have the right to review and comment on the
initial filing made to the governing Authority seeking Regulatory Approval of
the Product in the Territory. Once the Product is approved for sale in the
Territory, sanofi-aventis or its Affiliates shall compile and submit all
regulatory filings' documentation, and be responsible for interactions with
regulatory agencies, for the Product in the Territory. Additionally,
sanofi-aventis or its Affiliates shall be responsible for the preparation,
filing and maintenance of any applications for Regulatory approval in the
Territory for Product Improvement.
10.2
[***]
10.3
Maintenance of Regulatory filings - Save and except for any filing specifically
defined as being made by the Licensor, once Regulatory Approval is obtained on
Product, sanofi-aventis shall have responsibility to maintain such regulatory
filings with the governing Authority.
10.4
Pharmacovigilance - Both Parties jointly designate Licensor as responsible for
maintaining, for the Product and the Product Improvement, the global
pharmacovigilance database containing Pharmacovigilance Data.
Sanofi-aventis shall be responsible for providing Licensor with the full
pharmacovigilance data collected in the Territory. Sanofi-aventis will handle
all Pharmacovigilance data from within the Territory