EXHIBIT 10.1
CERTAIN CONFIDENTIAL INFORMATION INDICATED BY "[***]" HAS BEEN OMITTED FROM THE
FILED COPY OF THIS EXHIBIT BECAUSE
IT IS BOTH (I) NOT MATERIAL AND (II) WOULD
BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED
EXECUTION VERSION
LICENSE AGREEMENT
between
SANOFI
and
ACER
Dated as of December 21, 2018
--------------------------------------------------------------------------------
EXECUTION VERSION
TABLE OF CONTENTS
Article 1 DEFINITIONS
2
Article 2 GRANT OF RIGHTS
12
Article 3 DEVELOPMENT AND REGULATORY
14
Article 4 COMMERCIALIZATION
15
Article 5 MANUFACTURE AND SUPPLY
19
Article 6 PAYMENTS
20
Article 7 INTELLECTUAL PROPERTY
25
Article 8 PHARMACOVIGILANCE AND SAFETY
26
Article 9 CONFIDENTIALITY AND NON-DISCLOSURE
26
Article 10 REPRESENTATIONS AND WARRANTIES
29
Article 11 INDEMNITY
30
Article 12 TERM AND TERMINATION
33
Article 13 MISCELLANEOUS
37
Schedules
Schedule 1.49
Licensed Know-How
Schedule 1.90
Sanofi Corporate Names
Schedule 3.1.2
Development Plan
Page 1 of 49
--------------------------------------------------------------------------------
LICENSE AGREEMENT
This License Agreement (this "Agreement") is made and entered into as of
December 21, 2018 (the "Effective Date") by and between Sanofi, a French
corporation ("Sanofi") and Acer Therapeutics Inc., a Delaware corporation
("Acer"). Sanofi and Acer are sometimes referred to herein individually as a
"Party" and collectively as the "Parties."
RECITALS
WHEREAS, Sanofi controls certain intellectual property rights with respect to
the Licensed Compound (as defined herein) and Licensed Products (as defined
herein) in the Territory (as defined herein); and
WHEREAS, Sanofi wishes to grant to Acer, and Acer wishes to take, a license
under such intellectual property rights to Develop (as defined herein) and
Commercialize (as defined herein) Licensed Products in the Territory, in each
case in accordance with the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the premises and the mutual promises and
conditions hereinafter set forth, and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties, intending
to be legally bound, do hereby agree as follows:
Article 1
DEFINITIONS
Unless otherwise specifically provided herein, the following terms shall have
the following meanings:
1.1"Acceptance" means with regard to any Drug Approval Application (a) the date
upon which Acer, its Affiliate or Sublicensee, as the case may be, receives
written notice of acceptance of such Drug Approval Application for substantive
review from the Regulatory Authority having jurisdiction for such Drug Approval
Application, provided that such Regulatory Authority issues such notice as part
of its standard practice, or (b) for those Regulatory Authorities that do not
issue notice of acceptance referred to in part (a), the date on which Acer, its
Affiliate or Sublicensee, as the case may be, files or submits the Drug Approval
Application.
1.2"Acer Indemnitees" has the meaning set forth in Section 11.2.
1.3"Affiliate" means, with respect to a Party, any Person that, directly or
indirectly, through one or more intermediaries, controls, is controlled by or is
under common control with such Party. For purposes of this definition, "control"
and, with correlative meanings, the terms "controlled by" and "under common
control with" means (a) the possession, directly or indirectly, of the power to