Agreement.
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EXCHANGE ACT OF 1934, AS AMENDED.
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(c)
Sanofi shall not use or distribute in
connection with Promotion of the Product any materials bearing Vivus' name or
trademarks without Vivus' prior written approval. Notwithstanding the foregoing,
Sanofi shall be permitted to use the Vivus Trademarks in accordance with the
license granted in Section 2.1(b).
4.6
Compliance.
(a)
In performing its duties hereunder, Sanofi
shall and shall cause its Sales Force to: (i) Commercialize the Product in
conformity with its approved labeling; and (ii) comply with all Applicable Laws,
including all laws and regulations and other guidelines concerning the sale,
promotion, and advertising of prescription drug products that are applicable to
the Sanofi Territory.
(b)
Sanofi shall Commercialize the Product in a
professional, ethical and competent manner and shall ensure that the systems,
processes, and standard operating procedures being used by Sanofi or its
Affiliates in connection with the Commercialization of Product in the Sanofi
Territory (including procedures for collecting and reporting adverse events)
comply with Applicable Law and industry practice.
Without limiting the
generality of the foregoing, Sanofi shall ensure that each of its employees and
Sales Force representatives does not make any representation, statement,
warranty or guaranty with respect to the Product that is inconsistent with its
current labeling, that is deceptive or misleading, or that disparages the
Product or the good name, goodwill or reputation of Vivus or its Affiliates.
4.7
Re-Sale Price.
Sanofi shall be free to determine the
price(s) at which it sells Products in the Sanofi Territory, subject to any
pricing approvals or other requirements imposed by Applicable Law.
4.8
Commercialization Reports.
Sanofi shall keep Vivus
reasonably informed regarding the material progress and results of its
Commercialization activities and those of its Affiliates, sublicensees,
including providing the following:
(a)
On a *** basis during the Term, an email
reporting (i) the Net Sales of Products in the Sanofi Territory, on a
country-by-country basis, booked during the preceding calendar month and
(ii) the aggregate Net Sales in the Sanofi Territory during the ongoing calendar
year.
Within *** days after the end of each *** during the Term following
Product Launch, Sanofi shall provide to Vivus a written report summarizing
Sanofi's material Commercialization activities pursuant to this Agreement for
such *** and on a calendar year-to-date basis, including: (i) the number of
Details made; (ii) the total number of Sample Distributions delivered and/or
redeemed, and (iii) Information in Sanofi's possession regarding any direct mail
advertising, journal advertising and DTC advertising.
(b)
Any report submitted to Vivus by Sanofi
under this Agreement shall be in a reasonable format, as determined by Sanofi in
its discretion. Each such report shall be considered Sanofi's Confidential
Information.
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