Exhibit 10.46

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

LICENSE AND COMMERCIALIZATION AGREEMENT

 

by and between

 

VIVUS, INC.

 

and

 

SANOFI

 

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CONFIDENTIAL

EXECUTION COPY

 

LICENSE AND COMMERCIALIZATION AGREEMENT

 

THIS LICENSE AND COMMERCIALIZATION AGREEMENT (the “Agreement”) is entered into
as of the 11th day of December, 2013 (the “Effective Date”) by and between
Vivus, Inc., a corporation with its principal office at 351 E. Evelyn Avenue,
California, 94041, United States of America (referred to herein as “Vivus”), and
Sanofi, a French corporation having a place of business at 54 rue la Boétie,
75008, Paris, France (referred to herein as “Sanofi”).  Vivus and Sanofi are
sometimes referred to herein individually as a “Party” and collectively as the
“Parties”.

 

RECITALS

 

Vivus owns or has a license to certain patent rights and other intellectual
property rights relating to a therapeutic drug known as avanafil.

 

Vivus has received regulatory approval for avanafil in the United States for the
treatment of male erectile dysfunction (under the trade name Stendra™) and has
filed for European regulatory approval for avanafil for the same indication
(under the trade name Spedra™).

 

Vivus desires to grant to Sanofi, and Sanofi desires to receive, an exclusive
license for the development, manufacture and commercialization of avanafil in
the Field (as hereinafter defined) in certain territories as defined herein.

 

NOW THEREFORE, in consideration of the foregoing premises and the mutual
promises, covenants and conditions contained in this Agreement, the Parties
agree as follows:

 

ARTICLE 1
DEFINITIONS

 

As used in this Agreement, the following initially capitalized terms, whether
used in the singular or plural form, shall have the meanings set forth in this
Article 1.

 

1.1                               “Action Date” means, with respect to a legal
action in connection with a Product Infringement, the date that is the earlier
of (a) *** following notice pursuant to Section 8.5(a) of a Product
Infringement, and (b) *** before the date after which a legal action would be
substantively limited or compromised with respect to the remedies available
against the alleged Third Party infringer.  Notwithstanding the foregoing, the
Action Date shall in no event be earlier than *** after notice pursuant to
Section 8.5(a) of a Product Infringement.

 

1.2                               “Affiliate” means, with respect to a
particular Party, any person, firm, trust, corporation, company, partnership, or
other entity or combination thereof that directly or indirectly controls, is
controlled by or is under common control with such Party.  For the

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

1

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purposes of this definition, the word “control” (including, with correlative
meaning, the terms “controlled by” or “under the common control with”) means
(a) ownership of fifty percent (50%) or more of the voting and equity rights of
such person, firm, trust, corporation, company, partnership or other entity or
combination thereof, or (b) the power to direct the management of such person,
firm, trust, corporation, company, partnership, or other entity or combination
thereof.

 

1.3                               “Alliance Managers” has the meaning set forth
in Section 3.1.

 

1.4                               “API” has the meaning set forth in
Section 6.1.

 

1.5                               “Applicable Law” means any and all laws,
statutes, ordinances, regulations, permits, orders, decrees, judgments,
directives, or rules of any kind whatsoever that are promulgated by a federal,
state, or other governmental authority, including, without limitation, any
regulations promulgated by any Regulatory Authority in the Sanofi Territory, all
as amended from time to time.

 

1.6                               “Anti-Bribery Laws” means any applicable
anti-bribery and good business ethics legislation, regulations and/or codes,
both national and foreign, including but not limited to, the United States
Foreign Corrupt Practices Act of 1977, the United Kingdom Bribery Act, and
national laws adopted and implemented pursuant to the Convention on Combating
Bribery of Foreign Public Officials in International Business Transactions.

 

1.7                               “Bankrupt Party” has the meaning set forth in
Section 12.7.

 

1.8                               “Business Day” means each day of the week
excluding Saturday, Sunday or a day on which banking institutions in New York,
New York or Paris, France, are closed.

 

1.9                               “Calendar Quarter” shall mean any consecutive
3-month period ending March 31, June 30, September 30 or December 31.

 

1.10                        “Calendar Year” shall mean a twelve (12) month
period commencing January 1.

 

1.11                        “Claim” means all investigations, claims, suits,
actions, cross-complaints, demands, rights, requests, causes of action, or
proceedings, whether at law, equity or otherwise, or whether sounding in tort,
contract, equity, strict liability or any statutory or common law cause of
action of any sort.

 

1.12                        “Commercialization” means the marketing, Promotion,
sale, offering for sale, importation and/or distribution of Product.
“Commercialize” has a correlative meaning.

 

1.13                        “Commercialization and Medical Affairs Plan” has the
meaning set forth in Section 4.3(a).

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

2

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1.14                        “Commercially Reasonable Efforts” means, with
respect to a Party’s obligations under this Agreement, the reasonable and good
faith efforts normally used by a similarly situated company in the
pharmaceutical industry for a product that is of similar market potential and at
a similar stage in its development or product life as the Product, which level
of effort is at least commensurate with the level of effort that such Party
would devote to its own internally discovered compounds or products that are of
similar market potential and at a similar stage of development or product life
as the Product.

 

1.15                        “Competing Product” means a PDE-5 Inhibitor other
than the Product.

 

1.16                        “Compound” means the compound identified by the
International Non-Proprietary Name avanafil and chemically known as
(S)-4-(3-Chloro-4-methoxybenzylamino)-2-(2-hydroxymethylpyrrolidin-1-yl)-N-pyrimidin-2-ylmethyl-5-pyrimidinecarboxyamide,
including any metabolites, polymorphs, salts, esters, free acid forms, free base
forms, pro-drug forms, racemates and all optically active forms thereof (each, a
“Compound” and collectively, the “Compounds”).

 

1.17                        “Confidential Information” means, with respect to a
Party, all proprietary Information of such Party that is disclosed to or
accessed by the other Party under this Agreement.

 

1.18                        “Control” means, with respect to any
material, Information, or intellectual property right, that a Party and/or its
Affiliates owns or has a license or right to such material, Information, or
intellectual property right and has the ability to grant to the other Party
access, a license, or a sublicense (as applicable) to such
material, Information, or intellectual property right on the terms and
conditions set forth herein without violating the terms of any then-existing
agreement or other arrangement with any Third Party.

 

1.19                        “Core Indication” means the treatment of male
erectile dysfunction.

 

1.20                        “Cover”, “Covered” or “Covering” means, with respect
to Vivus Patents, Sanofi Patents or Joint Patents that, but for a license
granted thereunder, the use, manufacture, import, or sale of a Product would
infringe a Valid Claim included in such Vivus Patents, Sanofi Patents or Joint
Patents, or in the case of Vivus Patents, Sanofi Patents or Joint Patents that
are patent applications, would infringe a claim in such patent applications if
it were to issue as a Valid Claim.

 

1.21                        “Detail” or “Detailing” means each separate
face-to-face contact by a professional sales representative with a physician or
other professional with authority to write prescriptions during which time the
promotional message involving the Product is presented and is a topic of
discussion.  When used as a verb, “Detail” shall mean to engage in a Detail.

 

1.22                        “Development” means all activities that relate to
obtaining, maintaining or expanding Regulatory Approval of Product.  This
includes (a) preclinical and clinical studies,

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

3

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including formulation and CMC activities on Product; (b) preparation,
submission, review, and development of data or information for the purpose of
submission to a Regulatory Authority to obtain, maintain and/or expand
Regulatory Approval of Product; and (c) post-Regulatory Approval product support
for Product (including laboratory and clinical efforts directed toward the
further understanding of the safety and efficacy of Product).  For clarity,
Development includes phase IV clinical trials and other post-Regulatory Approval
clinical trials of Product.  “Develop” and “Developed” have correlative
meanings.

 

1.23                        “EMA” means the European Medicines Agency or its
successor.

 

1.24                        “Existing Confidentiality Agreement” means the
Confidentiality Agreement entered into by the Parties, dated August 30, 2011.

 

1.25                        “Existing PDE-5 Inhibitor” means any of the generic
PDE-5 Inhibitors listed on Exhibit A hereto, each of which, as of the Effective
Date, is being developed or is planned to be registered by Sanofi or any of its
Affiliates for sale in the Sanofi Territory or is sold by Sanofi or any of its
Affiliates or sublicensees in the Sanofi Territory.

 

1.26                        “FDA” means the United States Food and Drug
Administration or its successor.

 

1.27                        “FD&C Act” means the United States Federal Food,
Drug and Cosmetic Act.

 

1.28                        “Federal Arbitration Act” has the meaning set forth
in Section 13.2.

 

1.29                        “Field” means any therapeutic use in humans.

 

1.30                        “Generic Product” means, with respect to the *** in
a given *** of the ***, a product *** in such *** by a Third Party (other than a
*** or any other Third Party *** such *** by, or otherwise in the *** of, ***)
that (a) contains the *** as the ***, or any *** of such *** (but no more ***
than is contained in the ***), and (b) is *** or *** in such *** pursuant to any
*** based solely on (A) (x) *** to a *** for such *** held by *** in such ***,
and/or (y) *** to other *** with respect to such *** generated by ***, and (B) a
*** of *** to such ***.  With respect to a *** that is *** as *** of a *** with
*** (collectively “the ***”), a Generic Product shall, for purposes of this
paragraph, *** as *** the same *** as *** in such ***, or any *** thereof, and
meet the conditions defined in (b) above.

 

1.31                        “IFRS” means the International Financial Reporting
System as adopted by the European Union, consistently applied by Sanofi.

 

1.32                        “IND” means an Investigational New Drug Application,
as defined in the FD&C Act, or a similar application filed with an applicable
Regulatory Authority outside of the United States such as a clinical trial
application (CTA) or a clinical trial exemption (CTX).

 

1.33                        “Indemnified Claim” has the meaning set forth in
Section 11.3.

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

4

--------------------------------------------------------------------------------

 

1.34                        “Indemnified Party” has the meaning set forth in
Section 11.3.

 

1.35                        “Indemnifying Party” has the meaning set forth in
Section 11.3.

 

1.36                        “Information” means any data, results, and
information of any type whatsoever, in any tangible or intangible form,
including know-how, trade secrets, practices, techniques, methods, processes,
procedures, inventions, developments, specifications, formulations, formulae,
software, algorithms, marketing reports, expertise, stability, technology, 
pharmacological, biological, chemical, biochemical, toxicological, and clinical
test data, analytical and quality control data, and stability data.

 

1.37                        “Invention” means any new or useful process,
machine, manufacture, use, method of use or composition of matter, whether
patentable or not.

 

1.38                        “Joint Invention” has the meaning set forth in
Section 8.1.

 

1.39                        “Joint Patent” has the meaning set forth in
Section 8.3(b).

 

1.40                        “Liquidated Damages” shall have the meaning set
forth in Section 6.2.

 

1.41                        “Losses” means (a) all damages (including
compensatory damages, monetary damages, statutory damages, punitive and
exemplary damages and any pre-judgment and post-judgment interest), judgments,
or settlements payable to Third Parties; and (b) all legal expenses (including
attorneys’ fees and disbursements, expert and witness fees, fees and costs
associated with any investigations, court costs and appeal bonds).

 

1.42                        “Major Market Countries” means ***.

 

1.43                        “Manufacture” or “Manufacturing” shall mean all
activities related to the production, manufacture, processing, filling,
finishing, packaging, labeling, inspection, receiving, holding and shipping of
the Product or any constituents (including without limitation the Product’s API)
or packaging materials with respect thereto, or any intermediate of any of the
foregoing (such as the Product in the form of bulk tablets), including process
and cost optimization, process qualification and validation, release, testing,
quality assurance and quality control.  When used as a verb, “Manufacture” shall
mean to engage in Manufacture.

 

1.44                        “Marketing Authorization Application” or “MAA” means
an application to the appropriate Regulatory Authority for approval to sell the
Product in any particular jurisdiction in the Sanofi Territory.

 

1.45                        “MTPC” means Mitsubishi Tanabe Pharma Corporation,
formerly known as Tanabe Seiyaku Co., Ltd..

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

5

--------------------------------------------------------------------------------

 

1.46                        “MTPC Agreement” means that certain Agreement
between Vivus and MTPC (as successor in interest to Tanabe Seiyaku Co., Ltd.),
effective as of December 28, 2000, as successively amended by Amendment N°1
dated January 9, 2004, Amendment N°2 dated August 1, 2012, Amendment N°3 dated
February 21, 2013 and excluding any further amendment that may be agreed between
Vivus and MTPC, their Affiliates and/or successors in interest.

 

1.47                        “MTPC Supply Obligations” has the meaning set forth
in Section 6.2.

 

1.48                        “NDA” means a New Drug Application, as defined in
the FD&C Act.

 

1.49                        “Net Sales” means the amount invoiced or otherwise
billed by Sanofi or its Affiliate or Sublicensee for sales or other commercial
disposition of the Product, in the Sanofi Territory, to a Third Party purchaser,
less the following, to the extent included in such billing or otherwise actually
allowed or incurred with respect to such sales: (a) discounts, including cash,
trade and quantity discounts, price reduction programs, retroactive price
adjustments with respect to sales of the Product, charge-back payments and
rebates granted to managed health care organizations or to federal, state and
local governments (or their respective agencies, purchasers and reimbursers) or
to trade customers, including but not limited to, wholesalers and chain and
pharmacy buying groups; (b) credits or allowances actually granted upon
rejections or returns of Product, including for recalls or damaged goods;
(c) freight, postage, shipping and insurance charges actually allowed or paid
for delivery of Product, to the extent billed; (d) customs duties, surcharges
and other governmental charges incurred in connection with the exportation or
importation of a Product; (e) bad debts relating to sales of Product that are
actually written off by Sanofi in accordance with IFRS, consistently applied,
during the applicable royalty calculation period; and (f) taxes, duties or other
governmental charges levied on, absorbed or otherwise imposed on sale of
Product, including value-added taxes, or other governmental charges otherwise
measured by the billing amount, when included in billing, as adjusted for
rebates and refunds, but specifically excluding taxes based on net income of the
seller; provided that all of the foregoing deductions are calculated in
accordance with IFRS. Such amounts shall be determined from the books and
records of Sanofi, its Affiliates or its Sublicensees, as the case may be,
maintained in accordance with Sanofi’s normal practices. Notwithstanding the
foregoing, in the event a Product is sold in combination or conjunction with one
or more active ingredients, so as to be a combination product (whether packaged
together and sold as one (1) stock keeping unit or in the same therapeutic
formulation), Net Sales of the Product shall be calculated by multiplying the
Net Sales of such combination product by a fraction, the numerator of which
shall be the fair market value of the Product as if sold separately (determined
in accordance with generally accepted accounting principles), and the
denominator of which shall be the aggregate fair market value of all the
proprietary active components of such combination product, including the
Product, as if sold separately.  In the event no such separate sales are made by
Sanofi, its Affiliates or Sublicensees, Net Sales of the combination product
shall be calculated in a manner to be negotiated and agreed upon by the Parties,
reasonably and in good faith, prior to any sale of such combination product,
which shall be based upon the respective estimated commercial values of the
proprietary active components of such combination product. Sanofi’s or any of
its

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

6

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Affiliate’s transfer of Product to an Affiliate or Sublicensee shall not result
in any Net Sales, unless such Product is consumed by such Affiliate or
Sublicensee in the course of its commercial activities.  Further, the
disposition of a Product for, or the use of Product in, pre-clinical or clinical
(Phase I — III) trials, other market-focused (Phase IV or V) trials, or
Regulatory Approvals or free samples shall not result in any Net Sales.

 

1.50                        “Patents” shall mean issued patents and patent
applications, including provisional applications, continuations,
continuations-in-part, continued prosecution applications, divisions,
substitutions, reissues, additions, renewals, reexaminations, extensions, term
restorations, confirmations, registrations, revalidations, revisions, priority
rights, requests for continued examination and supplementary protection
certificates granted in relation thereto, as well as utility models, innovation
patents, petty patents, patents of addition, inventor’s certificates, and
equivalents in any country or jurisdiction.

 

1.51                        “Payment” has the meaning set forth in Section 10.6

 

1.52                        “PDE-5 Inhibitor” means any product that operates as
a phosphodiesterase type-5 inhibitor.

 

1.53                        “Product” means any composition containing a
Compound as API, alone or in combination with one or more other active
ingredient(s), in all dosage strengths, whether packaged and labeled or in bulk
form, ***.

 

1.54                        “Product Infringement” has the meaning set forth in
Section 8.5(a).

 

1.55                        “Product Launch” means the first sale of Product by
Sanofi or its Affiliate or sublicensee after the Effective Date to an unrelated
Third Party in a bona fide arms-length transaction for use, consumption, or
commercial distribution in the Field in the Sanofi Territory, excluding any
transfer of Product for research, test marketing, clinical trial purposes,
compassionate use, or named patient arrangements, or for warehousing or staging
in advance of release of the Product for commercial sale.

 

1.56                        “Promotion” means those activities, including
advertising, Detailing, and distributing samples of a product, normally
undertaken by a pharmaceutical company that are aimed at legally marketing and
promoting, and encouraging the appropriate use of, a particular prescription
pharmaceutical product.  “Promote” and “Promotional” have correlative meanings.

 

1.57                        “Promotional Materials” means all training materials
and all written, printed, graphic, electronic, audio or video matter, including
journal advertisements, sales visual aids, leave items, formulary binders,
reprints, direct mail, direct-to-consumer (“DTC”) advertising, Internet postings
and broadcast advertisements, in each case created by Sanofi or on its behalf,
and used or intended for use in connection with any Promotion of the Product in
the Sanofi Territory under this Agreement.

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

7

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1.58                        “Prosecuting Party” has the meaning set forth in
Section 8.3(b).

 

1.59                        “PV Agreement” has the meaning set forth in
Section 5.5.

 

1.60                        “Regulatory Approval” means all approvals necessary
for the manufacture, marketing, importation and sale of the Product for one or
more indications in a country or regulatory jurisdiction, which may include
satisfaction of all applicable regulatory and notification requirements. For the
avoidance of doubt, Regulatory Approval includes any pricing approval that may
be required by Applicable Law.

 

1.61                        “Regulatory Authority” means, in a particular
country or regulatory jurisdiction, any applicable governmental authority
involved in granting Regulatory Approval.

 

1.62                        “Regulatory Materials” means regulatory
applications, submissions, notifications, registrations, and/or other filings
made to or with a Regulatory Authority that are necessary or reasonably
desirable in order to Develop, manufacture, market, sell or otherwise
Commercialize the Product in a particular country or regulatory jurisdiction,
along with any documents of Regulatory Approval issued by a Regulatory Authority
in a particular country or regulatory jurisdiction.  Regulatory Materials
include INDs and MAAs for the relevant country or regulatory jurisdiction.

 

1.63                        “Required Notice Date” has the meaning set forth in
Section 2.6(d).

 

1.64                        “Right of First Negotiation” has the meaning set
forth in Section 2.7.

 

1.65                        “Royalty Payment Term” has the meaning set forth in
Section 7.4 (b).

 

1.66                        “Sales Force” means Sanofi’s sales personnel that
Detail Product in the Sanofi Territory, including employees of, and contract
sales organizations engaged by, Sanofi who are qualified to do so pursuant to
the terms and conditions of this Agreement.

 

1.67                        “Sample Distribution” means the distribution to a
physician’s office of (a) a voucher for free Product or (b) free Product
packaged as a complimentary trial for use by patients in the Sanofi Territory
and in accordance with Applicable Law.

 

1.68                        “Sanofi API Supply Agreement” means that certain
Commercial Supply Agreement, between Vivus and Sanofi Chimie, effective as of
January 1, 2014.

 

1.69                        “Sanofi Background Technology” means Sanofi’s
intellectual property used by Sanofi or its Affiliates in exercising their
rights and/or performing their obligations hereunder or under the Technology
Transfer and Development Services Agreement, including any patented technology,
know-how, trade secrets that was in Sanofi’s possession prior to the disclosure
by Vivus of the Vivus Know-How or Vivus’ Confidential Information, is later
generated or acquired by Sanofi outside the scope of this Agreement,
independently from and without use of or

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

8

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reference to the Vivus Technology.

 

1.70                        “Sanofi Indemnitees” has the meaning set forth in
Section 10.1.

 

1.71                        “Sanofi Know-How” means all Information (excluding
any patents and patent applications) that is Controlled by Sanofi or any
Affiliate as of the Effective Date or during the Term and is necessary for the
Development of the Product in the Field, provided however that, as used in this
Agreement, the term “Sanofi Know-How” shall exclude the Sanofi Background
Technology and the Sanofi Severable Improvements. For clarity, Sanofi Know-How
shall also exclude the Vivus Know-How licensed to Sanofi hereunder.

 

1.72                        “Sanofi Manufacturing Territory” shall mean the
entire world except the Democratic People’s Republic of Korea (North Korea), the
Republic of Korea (South Korea), Singapore, Malaysia, Thailand, Vietnam and the
Philippines.

 

1.73                        “Sanofi Patents” means all Patents (a) that are
Controlled by Sanofi or any Affiliate as of the Effective Date or during the
Term and (b) that Cover the Product.  As used in this Agreement, the Sanofi
Patents do not include: (a) any Patent Covering the Sanofi Background Technology
and/or the Sanofi Severable Improvements; (b) the Vivus Patents licensed to
Sanofi hereunder and (c) Sanofi’s ownership interest in any Joint Patent.

 

1.74                        “Sanofi Product Manufacturing Agreement” means that
certain Manufacturing and Supply Agreement between Vivus and Sanofi Winthrop
Industrie that, as of the Effective Date, is being negotiated between the
Parties.

 

1.75                        “Sanofi Severable Improvements” means improvements
to the Manufacturing process(es) of the Product that are made by or on behalf of
Sanofi or its Affiliates and that are not Product-specific but can be used for
other products.

 

1.76                        “Sanofi Technology” means the Sanofi Patents and
Sanofi Know-How.

 

1.77                        “Sanofi Territory” means all the countries of
Africa, the Middle East-Turkey, and Eurasia, as detailed in Exhibit B.

 

1.78                        “Sanofi Territory Approvals” has the meaning set
forth in Section 4.1(a).

 

1.79                        “Sanofi Trademarks” has the meaning set forth in
Section 8.8.

 

1.80                        “SEC” means the United States Securities and
Exchange Commission or any successor.

 

1.81                        “Service Provider” shall mean any Third Party
service providers such as contract research organizations, clinical research
organizations, contract manufacturing organizations, consultants, subcontractors
or other independent contractors performing on behalf of a Party (or

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

9

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MTPC) such Party’s obligations under this Agreement (or in the case of MTPC,
MTPC’s obligations under the MTPC Agreement).

 

1.82                        “Sole Inventions” has the meaning set forth in
Section 8.1.

 

1.83                        “Technology Transfer and Development Services
Agreement” shall have the meaning set forth in Section 6.1.

 

1.84                        “Term” has the meaning set forth in Section 13.1.

 

1.85                        “Third Party” means any person, entity, or
organization other than Vivus, Sanofi or an Affiliate of either Party.

 

1.86                        “Trademarks” means trademarks and all registrations
or applications for registration thereof.

 

1.87                        “Valid Claim” means a claim of any examined and
issued patent that has not been revoked or held invalid or unenforceable by
final decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed for appeal, and
that is not admitted to be invalid or unenforceable through reissue, disclaimer
or otherwise.

 

1.88                        “***” shall have the meaning set forth in
Section 6.5.

 

1.89                        ***.

 

1.90                        “Vivus Indemnitees” has the meaning set forth in
Section 10.2.

 

1.91                        “Vivus Know-How” means all Information (excluding
any patents and patent applications) that (a) is Controlled as of the Effective
Date or during the Term by Vivus or its Affiliates and (b) is reasonably
necessary or useful for the Development, Manufacture, use, or Commercialization
of the Product in the Field.  Information within the Vivus Know-How shall
include data and reports arising out of any study performed as part of
post-approval commitments to the Regulatory Authorities in the Vivus Territory.
Notwithstanding the foregoing, the Vivus Know-How shall not include any
Information to the extent such Information relates specifically to active
pharmaceutical ingredients other than a Compound unless Sanofi exercises its
Right of First Negotiation pursuant to Section 2.7 with respect to a ***, in
which case the Vivus Know-How shall include Information (excluding any patents
and patent applications) that relates to the other active pharmaceutical
ingredients included in the *** and that otherwise satisfies the requirements
set forth in subsections (a) and (b) above.

 

1.92                        “Vivus License” has the meaning set forth in
Section 2.2(a).

 

1.93                        “Vivus Patents” means (a) the Patents that are
listed in Exhibit C; (b) any Patents Controlled by Vivus or its Affiliates as of
the Effective Date or during the Term (excluding

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

10

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Vivus’ ownership interest in any Joint Patent) Covering (x) the Development,
use, Manufacture and import of the Product in the Field and in the Sanofi
Territory (y) the Manufacture of the Product in the Field in the Sanofi
Manufacturing Territory.  Notwithstanding the foregoing, Vivus Patents shall
exclude any claim that specifically relate to the composition of matter, use or
manufacture of active pharmaceutical ingredients other than a Compound unless
Sanofi exercises the Right of First Negotiation pursuant to Section 2.7, in
which case the Vivus Patents shall include claims that relate to the composition
of matter, use or manufacture of the other active pharmaceutical ingredients
included in the *** and that otherwise satisfy the requirements set forth in
subsections (a) or (b) above.

 

1.94                        “Vivus Supply Agreement” has the meaning set forth
in Section 6.3.

 

1.95                        “Vivus Tablet Supply Obligations” shall have the
meaning set forth in Section 6.2.

 

1.96                        “Vivus Technology” means the Vivus Patents and Vivus
Know-How.

 

1.97                        “Vivus Territory” means all countries in the world
other than the countries of the Sanofi Territory.

 

1.98                        “Vivus Territory Regulatory Approval Holder” has the
meaning set forth in Section 5.1(a).

 

1.99                        “Vivus Trademarks” means the Trademarks “Stendra™”
and “Spedra™”, all designs and styles used by Vivus in the depiction of the
foregoing Trademark, and any copyrights therein, and all goodwill appurtenant to
any of the foregoing, in each case Controlled by Vivus as of the Effective Date
or during the Term, provided however that if the registration of any of the
Vivus Trademarks is refused by any Regulatory Authority or trademark office in
the Sanofi Territory and by mutual agreement of the Parties another Trademark
owned by or licensed to Vivus or its Affiliates is selected to be used by Sanofi
with respect to the Manufacture and Commercialization of the Product in the
Sanofi Territory, such other Trademark shall also be included in Vivus
Trademarks.

 

1.100                 “***” has the meaning set forth in Section 6.2.

 

ARTICLE 2
LICENSES

 

2.1                      Licenses to Sanofi.

 

(a)                                  License under Vivus Technology.  Subject to
the terms and conditions of this Agreement, Vivus hereby grants to Sanofi, under
the Vivus Technology: (i) an exclusive (even as to Vivus), royalty-bearing,
sublicensable license to Develop, have Developed, use,

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

11

--------------------------------------------------------------------------------

 

Commercialize the Product and to Manufacture or have Manufactured the Product
and API in the Field in the Sanofi Territory and (ii) a non-exclusive,
royalty-bearing, sublicensable license to Manufacture or have Manufactured the
Product and/or API in the Sanofi Manufacturing Territory.  For clarity, the
rights granted to Sanofi to Manufacture and have Manufactured Product are not
intended to, and shall not, limit or extend any Manufacturing rights granted to
Sanofi in the Sanofi API Supply Agreement or the Sanofi Product Manufacturing
Agreement.

 

(b)                                  License under Vivus Trademarks.  Subject to
the terms and conditions of this Agreement including the terms set forth in
Section 8.7, Vivus hereby grants to Sanofi an exclusive (even as to Vivus),
sublicensable (subject to Section 2.5) license to use the Vivus Trademarks
solely in connection with the Manufacture, Development, and Commercialization of
the Product in the Field within the scope of the licenses granted in
Section 2.1(a).  In recognition of Vivus’ desire to develop a consistent
worldwide brand for the Product, the foregoing license to the Vivus Trademarks
shall be subject to Sanofi’s compliance with Vivus’ quality control provisions,
as set-forth in Exhibit D to this Agreement, as may be amended from time to time
by mutual agreement of the Parties.

 

(c)                                   Vivus Retained Rights.  Notwithstanding
the rights granted to Sanofi in Section 2.1(a) and Section 2.1(b), Vivus retains
under the Vivus Technology (i) the right to conduct those responsibilities
assigned to Vivus under this Agreement and (ii) the right to conduct research,
Development, and Manufacturing activities in the Sanofi Territory (as well as
Manufacturing activities in the rest of the Sanofi Manufacturing Territory) in
support of the Regulatory Approvals or Commercialization of Products in the
Vivus Territory.  For clarity, these retained rights are subject to any
exclusive Manufacturing rights granted to Sanofi in the Sanofi API Supply
Agreement or the Sanofi Product Manufacturing Agreement.

 

2.2                               License Grant to Vivus.

 

(a)                                  Subject to the terms and conditions of this
Agreement, Sanofi hereby grants to Vivus a non-exclusive, royalty-free,
non-transferable (except in accordance with Section 15.5), sublicensable
(subject to Section 2.5) license under the Sanofi Technology solely to the
extent pertaining to the Product containing a Compound as its sole active
ingredient, and solely to the extent necessary to (i) fulfill its obligations
under this Agreement; and (ii) conduct Development and Manufacturing of Product
in the Sanofi Territory solely in support of the Regulatory Approval of Products
in the Core Indication in the Vivus Territory (the “Vivus License”).  Vivus
shall obtain from its licensees under the Vivus Technology outside the Sanofi
Territory a license grant, with a right to sublicense, of similar scope as the
Vivus License.  If Vivus is unable to obtain such a license grant from a
licensee, then as Sanofi’s sole remedy, the Vivus License shall cease to be
sublicensable to such licensee unless and until such license grant is obtained.

 

(b)                                  For the avoidance of doubt, the scope of
Vivus License shall not extend to: (i) any Product containing a Compound in
combination or association with one or more active ingredients and/or (ii) any
indication other than the Core Indication.  Upon Vivus’ request in

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

12

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writing, Sanofi may consider the grant to Vivus of a royalty bearing license
under the Sanofi Technology to Develop and Commercialize in the Vivus Territory:
(i) any Product Developed by Sanofi containing a Compound in combination or
association with one or more active ingredients and/or (ii) the Product in any
indication other than the Core Indication, subject to the good-faith
negotiations between the Parties of the terms and conditions applying to such
license.

 

2.3                               No Other Licenses.  Neither Party grants to
the other Party any rights, licenses or covenants in or to any intellectual
property, whether by implication, estoppel, or otherwise, other than the license
rights that are expressly granted under this Agreement.

 

2.4                      Sublicensing by Sanofi.  Sanofi acknowledges that the
licenses granted to Sanofi in Section 2.1 include sublicenses under the rights
licensed to Vivus under the MTPC Agreement and that Vivus is required to notify
and consult with MTPC with respect to the selection of sublicensees. 
Consequently, the licenses granted by Vivus to Sanofi in Section 2.1 may be
further sublicensed by Sanofi to a Third Party only with the prior written
consent of Vivus, which shall not be unreasonably withheld. Any agreement
granting a sublicense under the licenses granted by Vivus to Sanofi in
Section 2.1 shall be consistent with the terms of this Agreement and shall
include confidentiality and non-use obligations no less stringent than those set
forth in Article 12.  Notwithstanding the foregoing, Sanofi shall have the right
to sublicense all rights granted by Vivus to Sanofi pursuant to Section 2.1 to
any of its Affiliates, Service Providers or Third Party agents or distributors
in relation to the Development, Manufacture or Commercialization of the Product
without the prior consent of Vivus.

 

2.5                      Sublicensing by Vivus. The licenses granted by Sanofi
to Vivus in Section 2.2(a) may be freely sublicensed by Vivus to Vivus’
Affiliates or to any of Vivus’ licensees or sublicensees through one or multiple
tiers.

 

2.6                      Mutual Non-Compete.

 

(a)                                 Except for its activities with respect to
the Product under this Agreement and subject to the following subsections of
this Section 2.6, for a period of *** following the Effective Date (the
“Restricted Period”), each Party hereby covenants that neither it nor its
Affiliates or will, directly or indirectly, develop, commercialize, or
in-license any product that it knows to be a Competing Product in the Sanofi
Territory in the Field, provided however that ***. For clarity, the foregoing is
not intended to limit Vivus’ covenant set forth in last sentence of
Section 2.2(a).

 

(b)                                 Notwithstanding Section 2.6(a), if Vivus or
any of its Affiliates, *** that *** or *** to, a *** that does not ***, then
Vivus and/or its Affiliates (or the ***, as applicable) shall have the right to
*** provided that Vivus or its Affiliate (or the ***, as applicable)
(i) notifies Sanofi of such *** in writing no later than the Required Notice
Date (as defined below) *** (ii) does not use the *** or any ***(including, but
not limited to, the *** that qualifies as ***) in connection with the *** of
such ***.

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

13

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(c)                                  In the event that, ***, either Sanofi or
any of its Affiliates *** that *** or *** to a *** then Sanofi (or the ***, as
applicable) shall (x) notify Vivus of such *** in writing no later than the
Required Notice Date (as defined below); (y) not use any *** in connection with
the *** of such ***; and (z) *** one of the following *** under *** (and specify
which of the following it will *** in the notice provided pursuant to subsection
(x), which decision shall be final and binding):

 

(i)                       *** and notify Vivus in writing of such ***; provided
that such *** shall be ***; or

 

(ii)                    *** (in which case the notice delivered pursuant to
subsection (i) above shall be deemed to be a ***); or

 

(iii)                 *** such that neither Sanofi nor any Sanofi Affiliates
have *** with respect to such ***; provided such ***; and it being understood,
for the avoidance of doubt, that as of the *** Sanofi shall have ***, to *** any
***; or

 

(iv)                *** for purposes of ***.

 

(d)                                 As used herein, “Required Notice Date” means
the date that is ***; provided that the Required Notice Date shall in no event
be *** following the consummation of the transaction described in ***, as
applicable.

 

2.7                      Right of First Negotiation.

 

(a)                                 Right of First Negotiation Generally. In the
event Vivus or its Affiliates, either by themselves or as part of a
collaboration with any Third Party, develop a ***, Sanofi shall have a right of
first negotiation to obtain an exclusive license under any intellectual property
rights under the Control of Vivus or its Affiliates that are necessary and/or
useful to develop, and/or Manufacture, and/or Commercialize such *** (the “Right
of First Negotiation”). Sanofi may exercise the Right of First Negotiation at
any time during the development of any such ***, but in no event later than ***
after the receipt from Vivus of the report of *** for such Vivus Combination
(the “Option Period”). If Sanofi exercises the Right of First Negotiation during
the Option Period by providing written notice of such exercise to Vivus (the
“Sanofi ROFN Notice”), then for a period of *** after VIVUS receives the Sanofi
ROFN Notice (or such longer period as the Parties may mutually agree) (the
“Negotiation Period”), the Parties shall negotiate in good faith the
commercially reasonable terms under which ***.

 

(b)                                 Exercise of the Right of First Negotiation.
Sanofi shall have the right to exercise the Right of First Negotiation at any
time during the Option Period. Vivus (or its Affiliates) shall not enter into
any discussions with any Third Party with regard to the development and/or
Manufacturing and/or Commercialization of any *** during the Option Period
and/or, if applicable, the Negotiation Period. Vivus shall periodically report
to Sanofi on the progress of all ***, and, in any event, shall report to Sanofi
at ***, and provide Sanofi with the final

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

14

--------------------------------------------------------------------------------

 

development reports for such *** of development and, upon request, with all
***.  Until such time as Sanofi exercises the Right of First Negotiation, Vivus
and its Affiliates shall be free to continue development of such *** on their
own and at own expense. In the event Sanofi does not elect to exercise the Right
of First Negotiation during the Option Period, or Sanofi elects to exercise the
Right of First Negotiation, but the Parties fail to mutually agree on
commercially reasonable terms during the Negotiation Period, then, in each case,
after the Option Period or Negotiation Period (respectively), Vivus shall be
free to grant licenses to one or more Third Parties with respect to the
development, Manufacturing and Commercialization rights relating to the *** that
is the subject of the Right of First Negotiation, without any further
obligations to Sanofi; provided, however, that Vivus shall not enter into any
such license unless the terms thereof are, in the aggregate, less favorable to
Vivus than the last terms offered by Sanofi.

 

(d)                                 Mutual Agreement of the Parties.  In the
event Sanofi exercises its Right of First Negotiation and the Parties mutually
agree to commercially reasonable terms under which the definition of Product
hereunder would be expanded to include the applicable *** (as evidenced by a
written document signed by both Parties), this Agreement shall be amended to
incorporate such financial terms and conditions; the definition of Products
shall thereafter be deemed to include such ***; and the Agreement shall
otherwise remain unchanged and in full force and effect provided that the
definition of Vivus Patents shall be expanded by the inclusion by Vivus in
Exhibit C of any Patent(s) in respect to any such ***.

 

ARTICLE 3
ALLIANCE MANAGEMENT

 

3.1                      Appointment.  Each of the Parties shall appoint a
single individual to act as a single point of contact between the Parties (each,
an “Alliance Manager”) during the Term.  Each Party may change its designated
Alliance Manager from time to time upon written notice to the other Party.  Any
Alliance Manager may designate a substitute to temporarily perform the functions
of that Alliance Manager by written notice to the other Party.

 

3.2                      Responsibilities.  Each Alliance Manager: (i) will be
the point of first referral in all matters of conflict resolution; (ii) will
coordinate the relevant functional representatives of the Parties in developing
and executing strategies and plans for the Product in the Sanofi Territory in an
effort to ensure consistency and efficiency with similar efforts in the Vivus
Territory; (iii) will provide a single point of communication for seeking
consensus both internally within the respective Parties’ organizations and
between the Parties regarding key strategy and plan issues; (iv) will identify
and bring disputes to the attention of the Parties’ in a timely manner; and
(v) will plan and coordinate cooperative efforts and internal and external
communications.

 

3.3                      Meetings.  Upon the reasonable request of Sanofi, the
Alliance Managers shall organize ad hoc meetings with appropriate
representatives from each Party having expertise in

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

15

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the matter discussed, and, as may be needed or requested by Sanofi, Vivus will
seek the participation of representatives of Vivus’ licensees for the Product in
the Vivus Territory, to facilitate the coordination efforts set forth in
Section 3.2 above.

 

3.4                      Independence.  Subject to the terms of this Agreement,
the activities and resources of each Party shall be managed by such Party,
acting independently and in its individual capacity.  The relationship between
Vivus and Sanofi is that of independent contractors and neither Party shall have
the power to bind or obligate the other Party in any manner.

 

ARTICLE 4
DEVELOPMENT AND COMMERCIALIZATION

 

4.1                      Development.

 

(a)                                 Obtaining Regulatory Approval.  Sanofi shall
be responsible for filing Regulatory Materials that are necessary for obtaining
the Regulatory Approvals of the Product in the Sanofi Territory in the Field
(“Sanofi Territory Approvals”), including performing any and all Development
activities in the Sanofi Territory in connection therewith.  Sanofi shall file
for the Sanofi Territory Approvals in such countries in the Sanofi Territory at
its cost and expense and on such schedule, in each case, that are consistent
with Commercially Reasonable Efforts and Sanofi’s diligence obligations as set
forth in Section 4.5.  For clarity, the Regulatory Materials for which Sanofi is
responsible hereunder include INDs and MAAs that are specific for countries or
regions in the Sanofi Territory, but expressly exclude any Regulatory Materials
filed with the FDA or EMA.

 

(b)                                 Post-Approval Studies.  Sanofi shall be
responsible, at Sanofi’s sole expense, for conducting any clinical or
non-clinical studies of Product that are required by any of the individual
countries in the Sanofi Territory, whether such studies are conducted prior to
or after receipt of the Sanofi Territory Approvals.  Sanofi shall conduct such
studies using Commercially Reasonable Efforts.

 

(c)                                  Use of Data.  Subject to the limitations
set forth in Section 2.2, Vivus shall have the right, without any additional
payment, to use the Sanofi Know-How in support of Regulatory Approval of Product
in the Vivus Territory.  Sanofi shall have the right, without any additional
payment, to use the Vivus Know-How in support of Regulatory Approval of Product
in the Field in the Sanofi Territory.

 

(d)                                 Other Development. Sanofi shall have the
sole right to conduct any further Development (including clinical trials) on the
Product in the Field in the Sanofi Territory, at its sole discretion. Sanofi
shall be responsible for all of its costs in connection with any further
Development activities that it conducts, unless otherwise mutually agreed by the
Parties.

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

16

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4.2                      Commercialization — General.  Subject to the terms of
this Agreement, Sanofi shall have sole responsibility and decision-making
authority for Commercialization activities for the Sanofi Territory. Sanofi
shall be responsible for all costs and expenses associated with such
Commercialization activities.

 

4.3                      Diligent Commercialization by Sanofi.  Sanofi, itself
or through its Affiliates or sublicensees, shall use Commercially Reasonable
Efforts to seek Regulatory Approval for and Commercialize the Product in the
Core Indication in the Sanofi Territory and to launch the Product in each of the
Major Market Countries within a period of six (6) months following Regulatory
Approval in such country.

 

4.4                      Sales Force.

 

(a)                                 General. Sanofi shall at all times during
the Term maintain a Sales Force containing a reasonable number of sales
representatives in order to meet Sanofi’s obligations under Section 4.4.  The
Sales Force may consist of employees of Sanofi or a contract sales force (or a
combination thereof); provided that Sanofi shall remain responsible for the
management, supervision, and performance of such contract sales force.

 

(b)                                 Qualifications.  Unless otherwise agreed by
the Parties, Sanofi shall subject the members of its Sales Force to
substantially the same minimum qualifications that it applies to its sales
forces for its other products in the Sanofi Territory.

 

(c)                                  Compensation.  Sanofi shall be solely
responsible for all costs and expenses of recruiting, hiring, maintaining and
compensating its Sales Force, including salaries, benefits and incentive
compensation, provided that (i) the compensation structure for the Sales Force
shall include elements that are tied to effective Promotion of Product; and
(ii) the incentive compensation for the Sales Force shall not be structured in a
manner that would reasonably be expected to inappropriately motivate such
individuals to engage in the improper Detailing, Promotion, or sales of Product.

 

4.5                      Promotional Materials.

 

(a)                                 Sanofi shall be responsible, at its expense,
for preparing and producing the Promotional Materials.  The Promotional
Materials used by Sanofi or its Affiliates or sublicensees in a particular
market in the Sanofi Territory shall be consistent with any Regulatory Approval
in the Sanofi Territory that is applicable to such market and shall in any event
comply with Applicable Law.

 

(b)                                 Sanofi shall be solely responsible for
timely submitting, as applicable, any Promotional Materials to Regulatory
Authorities in the Sanofi Territory (including any applicable governmental
authorities in individual countries in the Sanofi Territory).  Sanofi shall use
and distribute the Promotional Materials in accordance with the terms of this
Agreement.

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

17

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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.

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

18

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4.9                      Sanofi Records and Audits.  Sanofi shall keep complete
and accurate records of (a) the number of Details delivered by sales
representatives under Sanofi’s control, (b) the total number of Sample
Distributions distributed and/or redeemed, and (d) Information regarding any
direct mail advertising, journal advertising and DTC advertising. All such
records shall be retained for at least *** years following the Calendar Year in
which they are generated, or longer if required by Applicable Laws. At Vivus’
request, such records and Sanofi’s Detail and Sample Distribution activity
reporting system shall be available for review at Sanofi facilities in the
Sanofi Territory not more than once each calendar year (during normal business
hours on a mutually agreed date with reasonable advance notice) by an
independent Third Party auditor mutually agreed upon by the Parties and subject
to confidentiality and non-use obligations no less stringent than those set
forth in Article 12 for the sole purpose of verifying for Vivus the accuracy of
the reports furnished by Sanofi pursuant to this Section.  The expense of such
auditor shall be borne solely by Vivus unless such audit reveals a numerical
reporting error of *** percent (***%) or more during the applicable audit
period, in which case Sanofi shall bear the full cost of such audit.  Such
auditor shall not disclose Sanofi’s confidential information to Vivus, except to
the extent such disclosure is necessary to verify the accuracy of the reports
furnished by Sanofi.

 

4.10               Cross-Territory Sales.  Sanofi shall not directly solicit,
advertise, sell, distribute, ship, consign, or otherwise Promote the Product
outside the Sanofi Territory.  Sanofi shall use Commercially Reasonable Efforts
to ensure that Products sold in the Sanofi Territory are not used outside the
Sanofi Territory.  Without limiting the generality of the foregoing, Sanofi
shall not sell any Product to a purchaser if Sanofi knows, or has reason to
believe, that such purchaser intends to remove such Product from the Sanofi
Territory or otherwise intends to facilitate the use of such Product outside the
Sanofi Territory.  Sanofi shall use Commercially Reasonable Efforts to ensure
that its sublicensees, distributors, and wholesalers comply with all of the
foregoing obligations.

 

ARTICLE 5
REGULATORY

 

5.1                               Regulatory Materials and Regulatory Approvals.

 

(a)                                 Ownership and Responsibility.  Sanofi, its
Affiliates, sublicensees or, if required by Applicable Laws in the Sanofi
Territory, their distributors or agents, shall be the legal and beneficial owner
of all Sanofi Territory Approvals, and Regulatory Materials relating to the
Sanofi Territory Approvals shall be filed by, and in the name of, Sanofi, its
Affiliates or sublicensees or if required by Applicable Laws in the Sanofi
Territory, their distributors or agents. If Applicable Laws of any country in
the Sanofi Territory require that, in such country, Regulatory Approvals be held
by the Regulatory Approval holder of a specific country in the Vivus Territory
(a “Vivus Territory Regulatory Approval Holder”), Vivus shall or, if Vivus is
not the Vivus Territory Regulatory Approval Holder, shall use Commercially
Reasonable Efforts to cause any such Vivus Territory Regulatory Approval Holder
to: (i) execute all instruments that

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

19

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shall be deemed necessary by Regulatory Authorities of such country in the
Sanofi Territory in this respect and/or (ii) execute any agreement with Sanofi
or its Affiliates for the purpose of transferring to Sanofi or its Affiliates
certain responsibilities that the Vivus Territory Regulatory Approval Holder may
incur by holding the Regulatory Approval in such country of the Sanofi
Territory, all at Sanofi’s expense.  For clarity, as used in the preceding
sentence, “Commercially Reasonable Efforts” shall not require that Vivus incur
any out-of-pocket costs or otherwise amend its agreement with the applicable
Vivus Territory Regulatory Approval Holder in any manner that adversely impacts
Vivus to a material degree.

 

(b)                             Notifications.  During the Term, Sanofi shall
keep Vivus reasonably and regularly informed of the submission to Regulatory
Authorities of all material Regulatory Materials, meetings with Regulatory
Authorities, and receipt of, or any material changes to existing, Regulatory
Approvals, in each case for the Product in the Sanofi Territory.

 

5.2                               Reporting Obligations.

 

(a)                                 Each Party shall keep the other informed, in
a timely manner consistent the other Party’s reporting requirements to
Regulatory Authorities, of any Information that such Party receives (directly or
indirectly) that (i) raises any material concerns regarding the safety or
efficacy of the Product; (ii) indicates or suggests a potential material
liability of either Party to Third Parties in connection with the Product;
(iii) is reasonably likely to lead to a recall or market withdrawal of the
Product; or (iv) relates to the Product and is reasonably likely to have a
material impact on a Regulatory Approval or the Commercialization of the
Product.

 

(b)                                 Each Party shall fully cooperate with and
assist the other Party (the requesting Party) in complying with any of the
requesting Party’s regulatory obligations with respect to the Product in its
Territory, including by providing to the requesting Party, within *** (or sooner
if reasonably required for such Party to meet a deadline set by the relevant
Regulatory Authority or by Applicable Law), such information and documentation
in its possession as may be necessary or helpful for the requesting Party to
prepare a response to an inquiry from a Regulatory Authority.

 

(c)                                  Neither Party shall communicate with any
Regulatory Authority of the other Party’s Commercialization territory regarding
any Product unless explicitly requested or permitted in writing to do so by the
other Party, or unless so ordered by such Regulatory Authority or otherwise
required by Applicable Law, in which case either Party shall immediately provide
notice of such order or legal requirement to the other.

 

5.3                               Vivus Obligations.

 

(a)                                 Transfer of Vivus Know-How and Information.
For the purpose of this Agreement, Vivus shall, and shall cause MTPC and its
Service Providers, as the case may be, at no additional cost to Sanofi, to:
(i) provide Sanofi in a timely manner with all Vivus Know-How that shall be
required with respect to the Manufacture of the Product inside or outside the

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

20

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Territory; (ii) provide Sanofi with all Vivus Know-How that shall be required by
Regulatory Authorities or that may be reasonably useful for obtaining the Sanofi
Territory Approvals, including but not limited to any Information relating to
manufacturing facilities wherein the Product is manufactured (to the extent such
Information is Controlled by Vivus or its Affiliates or is in the possession of
the Service Providers of Vivus or its Affiliates); (iii) permit the inspection
of such manufacturing facilities by Sanofi, its Affiliates or any Regulatory
Authority of a country within the Sanofi Territory, during normal business hours
on a mutually agreed date with reasonable advance notice; (iv) at Sanofi’s
request, provide to Sanofi or its Affiliates timely assistance to answer any
query from Regulatory Authorities; (v) carry-out any additional or specific
stability studies on the Product that are required or reasonably advisable for
the Major Market Countries; (vi) provide Sanofi, within *** after the Effective
Date, with Regulatory Material under CTD/ICH format and content  (including any
additional country specific CMC documentation), as and to the extent such
dossiers and documentation exist and are in Vivus’ Control at the time of
transfer; (vii) upon Sanofi’s request, provide Sanofi or its Affiliates with
(A) reasonable quantities of Product (either in finished form, bulk form or as
API) for Development purposes, in accordance with terms and conditions to be
negotiated in good faith between the Parties, provided however that any
reasonable quantities requested by the Regulatory Authorities in the Sanofi
Territory for registration purposes shall be supplied to Sanofi free of charge;
and (B) the Product’s core labeling documents and Vivus’ Company Core Data Sheet
(“CCDS”), including such CCDS prospective update(s). For clarity, Vivus shall
have no obligation hereunder to transfer (or cause to be transferred, as the
case may be) to Sanofi any Vivus Know-How that is already in Sanofi’s or its
Affiliate’s possession as of the Effective Date.

 

(b)                                 Regulatory Updates. Vivus shall keep Sanofi
informed in a timely manner of any updates of a Regulatory Approval with respect
to the Product in the United States or such countries of Europe that are used as
countries of reference for the Sanofi Territory Approvals. Such updates shall be
provided within *** from the date of any such Regulatory Approval update.

 

5.4                               Rights of Reference. Vivus hereby grants to
Sanofi an exclusive right of reference to all Regulatory Materials and
Regulatory Approvals owned or Controlled by Vivus solely for the purpose of
obtaining or maintaining the Sanofi Territory Approvals during the Term.

 

5.5                               Regulatory Actions.

 

(a)                                 Notice of Non-Compliance.  Each Party
promptly disclose to the other any information pertaining to notices from
Regulatory Authorities of non-compliance with Applicable Laws in connection with
the Product.

 

(b)                                 Inspection or Audit.  If a Regulatory
Authority in the Vivus Territory desires to conduct an inspection or audit of
Sanofi’s facility or a facility under contract with Sanofi with regard to the
Product, Sanofi shall cooperate and cause the contract facility to

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

21

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cooperate with such Regulatory Authority during such inspection or audit.  To
the extent that Sanofi, rather than Vivus, receives the inspection or audit
observations of such Regulatory Authority, Sanofi shall promptly provide a copy
of such observations to Vivus.  Sanofi shall prepare the response to any such
observations, but the submission of the response to the applicable Regulatory
Authority shall be subject to Vivus’ final approval of response, which approval
shall not be unreasonably withheld.  Sanofi agrees to conform its activities
under this Agreement to any commitments made in such a response, except to the
extent it believes in good faith that such commitments violate Applicable Laws.

 

(c)                                  Product Withdrawals and Recalls.  The
Parties shall exchange their internal standard operating procedures (“SOPs”) for
conducting product recalls reasonably in advance of Product Launch, and shall
discuss and resolve any conflicts between such SOPs and issues relating thereto
promptly after such exchange.  In the event of any disagreement as to how to
resolve any such conflicts, Vivus’ SOP shall control.  If either Party becomes
aware of information relating to the Product that indicates that a unit or batch
of the Product in the Sanofi Territory may not conform to the specifications
therefor, or that potential adulteration, misbranding, and/or other issues have
arisen that relate to the safety or efficacy of the Product in the Sanofi
Territory, it shall promptly so notify the other Party.  To the extent
practicable, the Parties shall discuss the circumstances of any potential
product recall, field correction, or withdrawal of any Product in the Sanofi
Territory and possible appropriate courses of action.  If Sanofi decides to
initiate a recall, field correction, or withdrawal of Product in the Sanofi
Territory, Sanofi shall have the right and responsibility, at its expense, to
control such recall, field correction, or withdrawal in a manner consistent with
its internal SOPs (as revised pursuant to the first sentence of this
Section 5.4(c), if applicable); provided, however, Sanofi shall consider in good
faith the views of Vivus as to whether a recall, field correction, or withdrawal
is necessary or appropriate.  If (i) a Regulatory Authority or other Applicable
Law requires a recall, field correction, or withdrawal of Product in the Sanofi
Territory, and (ii) Sanofi fails to initiate such recall, field correction, or
withdrawal within *** of being notified of such requirement, Vivus shall have
the right (but not the obligation), at its expense, to control such recall,
field correction, or withdrawal in a manner consistent with its internal SOPs
(as revised pursuant to the first sentence of this Section 5.4(c), if
applicable); provided, however, Vivus shall consider in good faith the views of
Sanofi as to whether a recall, field correction, or withdrawal is necessary or
appropriate.  For clarity, as between the Parties, Vivus shall have the right
(but not the obligations), at its expense, to control all recalls, field
corrections, and withdrawals of any Product in the Vivus Territory.  Each Party
shall maintain complete and accurate records of any recall, field correction, or
withdrawal in its territory for such periods as may be required by Applicable
Laws, but in no event for less than ***.

 

5.6                               Pharmacovigilance Agreement. Prior to the
grant of the first Regulatory Approval required for the marketing of the Product
in the Sanofi Territory, the Parties (or their Affiliates) shall enter into a
separate pharmacovigilance agreement (the “PV Agreement” or Safety Data Exchange
Agreement (the “SDEA”)) to be negotiated by their respective pharmacovigilance
departments. Such SDEA shall contain specific terms, conditions and

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

22

--------------------------------------------------------------------------------

 

obligations for the Parties to ensure worldwide safety surveillance, signal
detection and risk management for the Product during the Term and as long as
either Party has safety reporting obligations.  Notwithstanding the foregoing,
Vivus, shall, as of the Effective Date, and prior to the grant of any Regulatory
Approval, communicate promptly to Sanofi any safety issue relating to the
Product that comes to its knowledge.

 

ARTICLE 6
MANUFACTURING & SUPPLY

 

6.1                               Manufacturing Generally. Subject to Sections
6.2, 6.3, and 6.5, Sanofi shall be responsible, during the term of this
Agreement, for the Manufacture, under its sole authority, of all of its
requirements of Product and Product’s active pharmaceutical ingredient (“API”),
for use by Sanofi, its Affiliates and their sublicensees in the Sanofi
Territory. On March 25, 2013, Vivus and Sanofi Chimie, an Affiliate of Sanofi
executed a Technology Transfer and Development Services Agreement (the
“Technology Transfer and Development Services Agreement”) for the transfer to
Sanofi Chimie of the manufacturing process for the API described in the
Product’s active substance master file existing as of the Effective Date.

 

6.2                               Vivus Tablet Supply Obligations. Until
June 30, 2015, or, in the event that MTPC’s obligations to supply Product to
Vivus (the “MTPC Supply Obligations”) are amended such that the term thereof is
extended beyond June 30, 2015, until the expiration of the MTPC Supply
Obligations as amended, Vivus shall supply to Sanofi or its designee(s) Sanofi’s
requirements of Product in the form of bulk drug tablet(s) for use by Sanofi,
its Affiliates and their sublicensees (such supply, the “Vivus Tablet Supply
Obligations”).  The Vivus Tablet Supply Obligations shall also include the ***
that Vivus has agreed to supply to Sanofi, as described in the Vivus Supply
Agreement ***.  In order to comply with the Vivus Tablet Supply Obligations,
Vivus may subcontract the Manufacture of Sanofi’s requirements of Product to
***.  Vivus understands and acknowledges that *** of the *** would be a *** of
*** and would ***.  Notwithstanding anything in this Agreement or the Vivus
Supply Agreement to the contrary, Vivus undertakes to ***.  Should Vivus be in
breach of the foregoing undertaking, then (A) Vivus would pay Sanofi, *** an
amount of *** within *** of Sanofi’s written notification to Vivus of its breach
and (B) Sanofi would be relieved of its obligation to ***.  Should Vivus fail to
make the ***.  The Parties agree that it would be extremely difficult and
impracticable to determine precisely the amount of actual damages that would be
suffered by Sanofi as a result of Vivus’ failure to ***.  The Parties further
agree that the *** set forth in this Section 6.2 *** and that such ***
constitute a penalty.  The *** of the *** shall be ***, for *** the ***.

 

6.3                               Vivus Supply Agreement.  Within *** following
the Effective Date, Vivus and Sanofi (or one of its Affiliates) shall execute a
supply agreement substantially in the form of Exhibit E (the “Vivus Supply
Agreement”), whereby, at the request of Sanofi, Vivus will perform the Vivus
Tablet Supply Obligations.  Within *** months of the date of execution of the
Vivus Supply Agreement by the latest of the parties, the parties to such Vivus
Supply Agreement

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

23

--------------------------------------------------------------------------------

 

shall also enter into a quality agreement governing the agreed-upon
specifications and other technical aspects of supply of the Product for
Commercialization in the Sanofi Territory (the “Quality Agreement”).

 

6.4                               Sanofi Manufacturing Responsibility. On
June 30, 2015, Vivus Tablet Supply Obligations shall expire and Sanofi shall
then be solely responsible for the Manufacture of its requirements of Product
and API under this Agreement.

 

6.5                               ***. Vivus shall *** no less than ***
conforming to the *** as set forth in the ***, on a ***, pursuant to the
following schedule ***.  In order to comply with the ***, Vivus may ***.

 

ARTICLE 7
  FINANCIALS

 

7.1                               License Fee.

 

(a)                                 No later than *** after the Effective Date,
Sanofi shall pay to Vivus a one-time license fee of five million U.S. dollars
(US$5,000,000) by wire transfer of immediately available funds to the following
account:

 

***

 

(b)                                 Subject to the timely performance of all
***, Sanofi shall pay to Vivus a one-time, non-refundable additional fee of five
million U.S. dollars (US$5,000,000) by wire transfer of immediately available
funds to the account mentioned in Section 7.1(a) above, in accordance with the
following terms and conditions:

 

(i)                       Sanofi shall pay Vivus *** U.S. dollars (US$***) no
later than *** following the delivery of the quantities specified in subsections
(i) of Section 6.5, within the timeframe set forth therein.

 

(ii)                    Sanofi shall pay Vivus *** U.S. dollars (US$***) no
later than *** following the *** of Section 6.5.  Should the *** be delayed,
then Sanofi’s payment under this Section 7.1(b)(ii) shall be reduced as follows:
***.  This Section 7.1(b)(ii) states VIVUS’s sole liability, and Sanofi’s sole
remedy, for any delay in ***, but not for ***.

 

7.2                               Regulatory Milestone Payments.  In partial
consideration of the licenses granted by Vivus to Sanofi pursuant to
Section 2.1(a) and (b) of this Agreement, Sanofi shall make each of the
milestone payments indicated below to Vivus:

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

24

--------------------------------------------------------------------------------

 

Milestone Event

 

Payment

 

***

 

US$ 

***

 

***

 

US$

 ***

 

***

 

US$

 ***

 

***

 

US$

 ***

 

 

Each regulatory milestone payment in this Section 7.2 shall be paid once in the
Field for the first indication for which Regulatory Approval is obtained in the
applicable country and shall not be payable for any other indication for which
Regulatory Approval may be obtained in such country. The maximum total amount of
payment to Vivus pursuant to this Section 7.2 shall be six million U.S. dollars
(US$6,000,000).  Each such payment shall be made by wire transfer of immediately
available funds into the account designated in Section 7.1.  Each such payment
is nonrefundable and noncreditable against any other payments due hereunder. For
clarity, in the event that Sanofi or sublicensee commences commercial sales of
Product in a country listed in the table above prior to receipt of any
Regulatory Approval in such country (i.e., prior to Regulatory Approval in the
first indication), the Regulatory Approval milestone payment for such country
shall become immediately due and payable, whether or not such Regulatory
Approval is ever received.

 

7.3                               Sales Milestone Payments.  In partial
consideration of the licenses granted by Vivus to Sanofi pursuant to
Section 2.1(a) and (b) of this Agreement, Sanofi shall make each of the sales
milestone payments indicated below to Vivus when aggregate Net Sales of all
Products in any calendar year in the Sanofi Territory reach the specified dollar
values.

 

Aggregate Net Sales in a Calendar Year

 

Payment

 

US$

 ***

 

US$

 ***

 

US$

 ***

 

US$

 ***

 

US$

 ***

 

US$

 ***

 

 

Each sales milestone payment in this Section 7.3 shall be paid only once.  The
maximum total amount of payment to Vivus pursuant to this Section 7.3 shall be
forty-five million U.S. dollars (US$45 million).  Sanofi shall notify and pay to
Vivus the amounts set forth in this Section 7.3 together with the delivery of
the quarterly report pursuant to Section 7.6 for the *** in which the applicable
event was achieved.  For clarity, in the event that more than one of the
aggregate Net Sales thresholds is achieved in a ***, Sanofi shall owe each of
the corresponding payments.  Each such payment shall be made by wire transfer of
immediately available funds into an account designated by Vivus.  Each such
payment is nonrefundable and noncreditable against any other payments due
hereunder.

 

7.4                               Royalty to Vivus.

 

(a)                                 Royalties Generally. In partial
consideration of the licenses granted by Vivus to Sanofi pursuant to
Section 2.1(a) and (b) of this Agreement, Sanofi shall pay to Vivus royalties on
Net Sales of the Product in the Sanofi Territory as follows:

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

25

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Aggregate Net Sales of the Product in a calendar year
in the Sanofi Territory

 

Royalty Rate

 

Portion of Net Sales less than or equal to US$***

 

***

%

Portion of Net Sales greater than US$*** and less than or equal to US$***

 

***

%

Portion of Net Sales greater than US$***

 

***

%

 

For purposes of illustration only, if Net Sales in the Sanofi Territory for each
of the *** in a calendar year was $***, the royalties due to Vivus hereunder
would be as follows:  for the first ***, $***; for the second ***, $***; for the
third ***, $***); and for the fourth ***, $***.

 

(b)                                 Royalty Payment Term. The above royalties
shall be payable for each Product in each country of the Sanofi Territory until
the later to occur of (i) the expiration of the last to expire Valid Claim
within the Vivus Patents that, absent the licenses granted to Sanofi hereunder,
would be infringed by the sale of such Product in such country, and (ii) the
sixteenth anniversary of the Effective Date (the “Royalty Payment Term”).

 

(c)                                  Third Party Royalties. If a Third Party’s
Patent exists in any country of the Sanofi Territory during the Royalty Payment
Term defined in Section 7.4(b), which would make it impractical or impossible
for Sanofi, its Affiliates or its sublicensees to Commercialize the Product in
such country without obtaining a license for such Third Party Patent in such
country, then Sanofi shall be entitled to a deduction from the royalty payments
otherwise due to Vivus upon Net Sales of such Product in the applicable country,
of an amount equal to *** percent (***%) of the royalty, license fee and/or
other amount paid to such Third Party for such license in such country during
the applicable reporting period (notwithstanding Section 7.4(e)).

 

(d)                                 Generic Competition.

 

(i)                                     If, in a country where Sanofi has an
obligation to pay Vivus royalties on Net Sales of the Product, (A) Generic
Products are being sold by one or more Third Parties who are not Affiliates or
sublicensees of Sanofi or otherwise in Sanofi’s, its Affiliate’s or its
sublicensee’s chain of distribution, and (B) *** by *** for a Calendar Quarter
*** by *** for such *** across the ***, the royalty owed to Vivus for Net Sales
of such Product in such country may be reduced by *** percent (***%) (subject to
Section 7.4(e)), but only for so long as the conditions set forth in subclauses
(A) and (B) of this Section 7.4(d)(i) continue to be satisfied.

 

(ii)                                  If, in a country where Sanofi has an
obligation to pay Vivus royalties on Net Sales of the Product, (A) Generic
Products are being sold by one or more Third Parties who are not Affiliates or
sublicensees of Sanofi or otherwise in Sanofi’s, its Affiliate’s or its
sublicensee’s chain of distribution and (B) *** by *** for a Calendar Quarter
*** by *** across the *** for Net Sales of such Product in such country (subject
to Section 7.4(e)), but only for so

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

26

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long as the conditions set forth in subclauses (A) and (B) of this
Section 7.4(d)(ii) continue to be satisfied.

 

(iii)                 Notwithstanding subsections (i) and (ii) above, if one or
more Generic Product(s) is/are ***, then, during any Calendar Quarters in which
the *** in such *** is ***.  As used herein, “***” of the Product means, with
respect to a particular country and time period, the ***, as evidenced by ***.

 

(e)                                  Royalty Floor. Notwithstanding Sections
7.4(b) and 7.4(d), no reduction in, or deduction or offset against, royalties
hereunder shall cause the royalty payable to Vivus hereunder for a given *** to
be less than *** percent (***%) of Sanofi and its sublicensees’ Net Sales.

 

7.5                               Payments to MTPC.  Vivus shall be responsible
for paying all milestone, royalty and other payments owed by Vivus to MTPC under
the MTPC Agreement on account of the activities of Sanofi or its Affiliates or
sublicensees, except that Sanofi shall reimburse Vivus a portion of any sales
milestone paid by Vivus to MTPC pursuant to the MTPC Agreement, based on the
share of Sanofi’s Net Sales in the worldwide net sales amount reported by Vivus
to MTPC triggering the payment of such sales milestone. Such reimbursement shall
be made within *** days following the receipt of an undisputed invoice from
Vivus detailing the calculation of such reimbursement.  To the extent Sanofi’s
reimbursement to Vivus under this Section 7.5 exceeds $*** Sanofi may credit any
such excess (to the extent actually paid by Sanofi) against any future payments
owed by Sanofi under Section 7.3.

 

7.6                               Quarterly Reports and Payments.  Within ***
days after the end of each ***, Sanofi shall provide Vivus with a full and
accurate accounting for such *** of (a) satisfaction of any regulatory or sales
milestone payment due pursuant to Section 7.2 or Section 7.3; and (b) on a
country-by-country basis, the amount of Net Sales and royalty payment due on
such Net Sales pursuant to Section 7.4. Vivus shall invoice Sanofi for all
royalties and other payment hereunder and Sanofi shall pay all such royalties
and other payments that are due no later than *** days after receipt of the
applicable invoice from Vivus, except as otherwise provided in this Agreement. 
If any portion of a payment owed hereunder is subject to a good faith dispute
between the Parties, Sanofi may withhold the disputed portion of such payment,
pending resolution of such dispute pursuant to Article 14, provided that it
timely pays any undisputed portions.  All amounts payable to Vivus under this
Section 7.6 shall be paid in United States dollars by wire transfer of
immediately available funds into an account designated by Vivus.  If Sanofi, its
Affiliates or a sub-licensee receives payment from a Third Party in a currency
other than United States dollars for which a royalty or fee is owed under this
Agreement, then conversion of sales recorded in local currencies to United
States dollars shall be performed in a manner consistent with Sanofi’s normal
practices used to prepare its audited financial statements for external
reporting purposes, which uses a widely accepted source of published exchange
rates.

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

27

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7.7                               Taxes.  Vivus shall pay any and all Taxes
levied on account of any payments made to it under this Agreement.  If Sanofi is
legally required to withhold any Taxes from payments due hereunder, Sanofi shall
(a) deduct such Taxes from the payment made to Vivus, (b) timely pay the taxes
to the proper taxing authority, and (c) send proof of payment to Vivus. If
Sanofi had a duty to withhold Taxes in connection with any payment it made to
Vivus under this Agreement but Sanofi failed to withhold, and such Taxes were
assessed against and paid by Sanofi, then Vivus will reimburse Sanofi for such
Taxes (excluding interest and penalties), upon delivery by Sanofi of the
documents evidencing Sanofi payment of the Taxes and the basis for such payment.
Each Party agrees to cooperate with the other Party in claiming exemptions from
such deductions or withholdings under any agreement or treaty from time to time
in effect. Solely for purposes of this Section 7.7, “Taxes” means any present or
future taxes, levies, imposts, duties, charges, assessments or fees of any
nature (including interest, penalties and additions thereto) that are imposed by
the applicable government or other taxing authority.

 

7.8                               Late Payments.  If a Party does not receive
payment of any sum due to it on or before the due date, simple interest shall
thereafter accrue on the sum due to such Party from the due date until the date
of payment at the rate of *** percent (***%) per month or the maximum annual
rate allowable by Applicable Law, whichever is less.

 

7.9                               Sanofi Records; Audits by Vivus.  Sanofi shall
maintain complete and accurate books and records in accordance with IFRS in
sufficient detail to permit Vivus to confirm the accuracy of milestone payments,
royalty payments, and any other compensation payable under this Agreement for a
period of *** years from the creation of individual records or any longer period
required by Applicable Law.  At Vivus’ request, such records shall be available
for review not more than once each *** (during normal business hours on a
mutually agreed date with reasonable advance notice) at a single location in
France by an independent Third Party auditor selected by Vivus and approved by
Sanofi (such approval not to be unreasonably withheld, conditioned, or delayed)
and subject to confidentiality and non-use obligations no less stringent than
those set forth in Article 12 for the sole purpose of verifying for Vivus the
accuracy of the financial reports furnished by Sanofi pursuant to this Agreement
during the *** preceding years or of any payments made by Sanofi to Vivus
pursuant to this Agreement during the *** preceding years.  Any such auditor
shall not disclose Sanofi’s Confidential Information to Vivus, except to the
extent such disclosure is necessary to verify the accuracy of the financial
reports furnished by Sanofi or the amount of payments due by Sanofi under this
Agreement.  Any amounts shown to be owed but unpaid shall be paid within ***
days from the accountant’s report, plus interest (as set forth in Section 7.9)
from the original due date.  Any amounts shown to have been overpaid may be
credited by Sanofi against future payments to Vivus hereunder.  No payment to
Vivus shall be reduced by more than *** percent (***%) as a result of such
credit, and Sanofi may carry forward any unused credits to future Calendar
Quarters. Vivus shall bear the full cost of such audit unless such audit reveals
a payment or reporting error of *** percent (***%) or more during the applicable
audit period, in which case Sanofi shall bear the full cost of such audit.

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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7.10                        Vivus Records; Audits by Sanofi.  Vivus shall
maintain complete and accurate books and records in accordance with GAAP in
sufficient detail to permit Sanofi to confirm the accuracy of Vivus’ calculation
of any reimbursement payments owed by Sanofi pursuant to Section 7.5 for a
period of *** years from the creation of individual records or any longer period
required by Applicable Law.  At Sanofi’ request, such records shall be available
for review not more than once each *** (during normal business hours on a
mutually agreed date with reasonable advance notice) at a single location in the
United States by an independent Third Party auditor selected by Sanofi and
approved by Vivus (such approval not to be unreasonably withheld, conditioned,
or delayed) and subject to confidentiality and non-use obligations no less
stringent than those set forth in Article 12 for the sole purpose of verifying
for Sanofi the accuracy of Vivus’ calculation of any reimbursement payments owed
by Sanofi pursuant to Section 7.5 during the *** preceding years.  Any such
auditor shall not disclose Vivus’ Confidential Information to Sanofi, except to
the extent such disclosure is necessary to verify the accuracy of such
calculations.  Any amounts shown to be owed by Sanofi but unpaid shall be paid
within *** days from the accountant’s report, plus interest (as set forth in
Section 7.9) from the original due date.  Any amounts shown to have been
overpaid by Sanofi may be credited by Sanofi against future payments to Vivus
hereunder.  No payment to Vivus shall be reduced by more than *** percent (***%)
as a result of such credit, and Sanofi may carry forward any unused credits to
future Calendar Quarters. Sanofi shall bear the full cost of such audit unless
such audit reveals a calculation error of *** percent (***%) or more during the
applicable audit period, in which case Vivus shall bear the full cost of such
audit.

 

ARTICLE 8
INTELLECTUAL PROPERTY

 

8.1                               Ownership of Inventions.  Each Party shall own
all Inventions made solely by its or its Affiliates’ employees, agents, and
independent contractors in the course of conducting its activities under this
Agreement (collectively, “Sole Inventions”), along with any Patents covering
such Sole Inventions.  All Inventions that are made jointly by employees,
Affiliates, agents, or independent contractors of both Parties in the course of
performing activities under this Agreement (collectively, “Joint Inventions”),
along with any Joint Patents, shall be owned jointly by the Parties.  Subject to
any exclusive licenses granted pursuant to Section 2.1 or 2.2, each Party shall
have the right to practice, license and exploit the Joint Inventions and Joint
Patents worldwide, without consent of the other Party (and where consent is
required by law, such consent is hereby deemed granted; and the Parties shall
execute all instruments and documents and otherwise take all actions as shall be
necessary to effectuate such consent) and without a duty of accounting to the
other Party. For the avoidance of doubt, the ownership of Sole Inventions and
Joint Inventions shall be determined according to US patent law.

 

8.2                               Disclosure of Inventions.  Each Party shall
promptly disclose to the other all Sole Inventions or Joint Inventions relating
to Product or its composition, formulation, manufacture,

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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or use, including all invention disclosures or other similar documents submitted
to such Party by its Affiliates’, employees, agents or independent contractors
describing such Sole Inventions or Joint Inventions.  Such Party shall also
respond promptly to reasonable requests from the other Party for more
Information relating to such inventions.

 

8.3                               Prosecution of Patents.

 

(a)                                 Vivus Patents.  Sanofi acknowledges that,
under the terms of the MTPC Agreement, MTPC has the sole right to prosecute and
maintain the Vivus Patents.

 

(b)                                 Joint Patents.  With respect to any
potentially patentable Joint Invention, the Parties shall agree whether a Party
or any external counsel to be jointly appointed by the Parties (the “Joint
Patent Outside Counsel”), shall prepare, file, prosecute (including any
interferences, reissue proceedings and reexaminations) and maintain patent
applications and patents covering such Joint Invention (a “Joint Patent”) in
jurisdictions as mutually agreed by the Parties. Patent expenses for such Joint
Patent will be equally shared by the Parties. For clarity, patent expenses
include any out-of-pocket expenses (such as, without limitation, the fees of the
Joint Patent Outside Counsel), but shall exclude any internal cost (such as
salaries) incurred by the Parties.  If the Parties do not appoint any Joint
Patent Outside Counsel with respect to a Joint Patent: (i) the Party that
prosecutes such Joint Patent (the “Prosecuting Party”) shall provide the other
Party reasonable opportunity to review and comment on such prosecution efforts
regarding the applicable Joint Patent in the particular jurisdictions and such
other Party shall provide the Prosecuting Party reasonable assistance in such
efforts; (ii) the Prosecuting Party shall provide the other Party with a copy of
all material communications from any patent authority in the applicable
jurisdictions regarding the Joint Patent being prosecuted by such Party, and
shall provide drafts of any material filings or responses to be made to such
patent authorities a reasonable amount of time in advance of submitting such
filings or responses; and (iii) the Prosecuting Party shall provide the other
Party with all information necessary or desirable to enable the other Party to
comply with the duty of candor/duty of disclosure requirements of any patent
authority.  Either Party may determine that it is no longer interested in
supporting the continued prosecution or maintenance of a particular Joint Patent
in a country or jurisdiction, in which case the disclaiming Party shall provide
the other Party with written notice of such determination at least *** days
before any deadline for taking action to avoid abandonment and shall provide the
other Party with the opportunity to have the disclaiming Party’s interest in
such Joint Patent in such country or jurisdiction assigned to the other Party
(the “Assignee”); provided that the costs relating to the transfer of rights
from the disclaiming Party to the Assignee shall be borne by the disclaiming
Party.  For the avoidance of doubt, as from the date the other Party’s interest
in such Joint Patent in such country or jurisdiction is assigned to the
Assignee, the Assignee shall bear all cost and expenses relating to the
maintenance and prosecution of such Patent in such country or jurisdiction,
which shall no longer be deemed to be a Joint Patent for the purpose of this
Agreement.

 

(c)                                  Sanofi Patents.  Sanofi shall have the sole
right, but not the obligation, to

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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prepare, file, maintain and prosecute all Sanofi Patents (and control any
interferences, reissue proceedings and reexaminations in connection therewith)
in the Sanofi Territory and the Vivus Territory, at its sole cost and expense.

 

8.4                               Cooperation of the Parties.  Each Party shall
provide the other Party all reasonable assistance and cooperation in the
preparation, filing, prosecution and maintenance of Patents under Sections
8.3(b) and 8.3(c), at the request and expense of the prosecuting Party.  Such
cooperation includes, but is not limited to: (i) executing all papers and
instruments, or requiring its employees or contractors, to execute such papers
and instruments, so as to effectuate the ownership of Inventions set forth in
Section 8.1, and Patents claiming or disclosing such Inventions, and to enable
the other party to apply for and to prosecute Patent in any country as permitted
by Section 8.3 and (ii) promptly informing the other Party of any matters coming
to such party’s attention that may affect the preparation, filing, prosecution
or maintenance of any such Patent.

 

8.5                               Enforcement of Patents.

 

(a)                                 Notification.  If a Party becomes aware of
any infringement, threatened infringement, or alleged infringement of a Vivus
Patent, a Sanofi Patent or a Joint Patent on account of a Third Party’s
manufacture, use or sale of Product (in each case, a “Product Infringement”),
then such Party shall promptly notify the other Party in writing of such Product
Infringement, including any evidence in such Party’s possession demonstrating
such Product Infringement.  Any certification or filing with a governmental
authority that asserts that a Product Infringement will not arise from the
manufacture, use or sale of Product by a Third Party or that asserts that any
claims of a Vivus Patent, Sanofi Patent or Joint Patent covering Product is
invalid or unenforceable shall be deemed to be a Product Infringement hereunder,
and each Party shall provide written notice to other Party of any such filed
certification promptly upon becoming aware thereof.

 

(b)                                 Enforcement Rights. During the Term and
subject to the remainder of this Section 8.5(b), Sanofi shall have the first
right to initiate, prosecute and control legal proceedings against any person or
entity engaged in a Product Infringement of the Vivus Patents in the Sanofi
Territory (the “Enforcement Right”). The foregoing exercise of the Enforcement
Right shall be at Sanofi’s sole expense. If Sanofi decides not to bring such
legal action, or if Sanofi fails to initiate such legal action by the Action
Date, Vivus shall have the right, but not the obligation, to commence a suit or
take action to enforce the applicable Vivus Patent or Joint Patent with respect
to such Product Infringement in the Sanofi Territory, at its own expense.  Each
Party shall provide to the Party enforcing any such rights under this
Section 8.5(b) reasonable assistance in such enforcement, at the request of and
expense of such enforcing Party, including joining such action as a party
plaintiff if required by Applicable Law to pursue such action.  Additionally, to
the extent requested by Sanofi, Vivus agrees to exercise its right under the
MTPC Agreement to require MTPC to cooperate in any enforcement by or on behalf
of Sanofi pursuant to Section 8.5(b), including being joined as a party to such
action if necessary.

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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The enforcing Party shall keep the other Party reasonably and regularly informed
of the status and progress of such enforcement efforts, and shall reasonably
consider the other Party’s comments on any such efforts. The non-enforcing Party
shall have the right to be represented in any action brought under this
Section 8.5(b) by counsel of its choice and at its own expense. For clarity, as
between the Parties, Vivus shall have the exclusive right to bring, control,
and/or settle any legal action, at its own expense, as it reasonably determines
appropriate and by counsel of its own choice, in connection with any actual,
alleged, or threatened infringement of any Patent Controlled by Vivus that
occurs in the Vivus Territory.  In the event Vivus elects to bring any legal
action in connection with any actual, alleged, or threatened infringement of a
Vivus Patent that occurs in the Sanofi Territory but is not a Product
Infringement, Vivus shall (i) use counsel that is approved by Sanofi, such
approval not to be unreasonably withheld, and (ii) prior to bringing any such
action in the Sanofi Territory, obtain Sanofi’s agreement, not to be
unreasonably withheld, on legal strategies and defenses for such action.

 

(c)                                  Joint Patents.  With respect to any
infringement of a Joint Patent by infringing activity other than a Product
Infringement, the Parties shall mutually agree on a case-by-case basis whether
to initiate and prosecute any legal action to enforce any such Joint Patent and,
if the Parties agree to initiate and prosecute any such action, which party will
be responsible for initiating and prosecuting such action, and how costs and
recoveries will be allocated between the parties.

 

(d)                                 Settlement.  Neither Party shall enter into
any settlement or compromise of any action under this Section  8.5 with respect
to Product Infringement in the Sanofi Territory without the prior written
consent of the other Party, such consent not to be unreasonably withheld,
conditioned or delayed.  Notwithstanding the foregoing, in the event that
(A) Sanofi decides not to bring a legal action against Product Infringement in
the Sanofi Territory, or if Sanofi fails to initiate such legal action by the
Action Date, and (B) thereafter MTPC (or a licensee or designee of MTPC other
than VIVUS) brings an action under the VIVUS Patents against such Product
Infringement, settlement of such action shall be at MTPC’s sole discretion and
shall not require the consent of Sanofi.

 

(e)                                   Recoveries; Damages.  Except as otherwise
agreed by the Parties in connection with a cost-sharing arrangement, any
recoveries resulting from an action brought by a Party relating to a claim of
Product Infringement in the Sanofi Territory shall be first applied against
payment of each Party’s costs and expenses in connection therewith. Any such
recoveries in excess of such costs and expenses (the “Remainder”) will be
retained by the enforcing Party, provided that if Sanofi is the enforcing Party,
the Remainder shall be included in Net Sales for purposes of calculating
royalties owed to Vivus hereunder.

 

8.6                               Infringement of Third Party Rights.  Each
Party shall promptly notify the other in writing of any allegation by a Third
Party that the activity of either of the Parties pursuant to this Agreement
infringes or may infringe the intellectual property rights of such Third Party. 
Subject to Article 10, Vivus shall have the sole right to control any defense of
any such claim

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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involving alleged infringement of Third Party rights by Vivus’ activities at its
own expense and by counsel of its own choice.  Subject to Article 10, Sanofi
shall have the sole right to control any defense of any such claim involving
alleged infringement of Third Party rights by Sanofi’s activities at its own
expense and by counsel of its own choice.  Neither Party shall have the right to
settle any litigation under this Section 8.6 in a manner that diminishes the
rights or interests of the other Party without the written consent of such other
party (which shall not be unreasonably withheld).

 

8.7                               Patent Marking.  Sanofi shall, and shall
require its Affiliates and sublicensees, to mark Products sold by it hereunder
with appropriate patent numbers or indicia to the extent permitted by Applicable
Law.

 

8.8                               Trademarks.

 

(a)                                 General. Sanofi shall, at its discretion,
have the right to either use any of the Vivus Trademarks or Trademarks selected
and owned by Sanofi (the “Sanofi Trademarks”) with respect to the Manufacture
and Commercialization of the Product in the Sanofi Territory. Sanofi shall use
Commercially Reasonable Efforts to inform Vivus of its decision within a
reasonable timeline. Sanofi may include its company name and associated logos on
all Product packaging and Promotional Materials for the Sanofi Territory.

 

(b)                                 Vivus Trademarks. If Sanofi elects to use
the Vivus Trademarks to Commercialize the Product across the Sanofi Territory
pursuant to Section 8.8(a), the following shall apply:

 

(i)                                     Sanofi’s use of the Vivus Trademarks
shall be limited to the Manufacture and the Commercialization of the Product in
the Sanofi Territory;

 

(ii)                                  Sanofi shall not at any time register or
cause to be registered any other trademark, name or design confusingly similar
to any of the Vivus Trademarks without the express consent of Vivus, which
consent shall not be unreasonably withheld, conditioned or delayed;

 

(iii)                               Sanofi shall properly designate the Vivus
Trademarks on the packaging of the final Product, to the extent required or
permissible by the applicable Regulatory Approvals.  All rights arising from the
use of the Vivus Trademarks in the Sanofi Territory during the Term shall inure
to Vivus’ benefit. Sanofi agrees that the Products with which the Vivus
Trademarks are used shall conform to all requirements of the Regulatory
Authority in the Sanofi Territory;

 

(iv)                              Vivus shall be responsible for and carry out
all proceedings reasonably necessary to ensure the defense of the Vivus
Trademarks in the Sanofi Territory during the Term at its own costs and expense;

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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(v)                                 Vivus shall use Commercially Reasonable
Efforts, at its own costs and expense, to have the Vivus Trademarks registered
in all countries of the Sanofi Territory and shall keep Sanofi regularly
informed of the completion of such registration process and provide Sanofi with
an updated list of Vivus Trademarks numbers;

 

(vi) Vivus shall use Commercially Reasonable Efforts to maintain the
registrations of the Vivus Trademarks in each Country of the Sanofi Territory
during the Term at its own costs and expense.

 

(c)                                  Infringement of Vivus Trademarks. If Sanofi
elects to use the Vivus Trademarks to Commercialize the Product pursuant to
Section 8.8(a), Sanofi shall, as soon as practicable after receiving notice of
any potential infringement of a Vivus Trademark in the Sanofi Territory, inform
Vivus of any such potential infringement.  Vivus shall have the first right and
discretion to bring infringement or unfair competition proceedings involving the
Vivus Trademark in the Sanofi Territory and Vivus shall bear all costs in
connection with any such proceedings.  Sanofi shall cooperate with Vivus in any
such proceedings at its own expense including by giving testimony and producing
documents and materials supporting the Vivus Trademark, and shall endeavour to
cause the employees of Sanofi, as appropriate, to cooperate with Vivus, all at
Vivus’ expense. Any recoveries obtained as a result of any infringement
litigation undertaken by Vivus alone or in settlement of such infringement shall
be retained by Vivus.  Sanofi shall have the right, but shall not be obliged, to
participate with Vivus as a party plaintiff in any infringement or unfair
competition action undertaken by Vivus hereunder in the Sanofi Territory, at
Sanofi’s costs and expense, and any recovery obtained shall be shared between
Vivus and Sanofi in proportion to incurred expenses, except that any recovery
with respect to unfair competition claims in the Sanofi Territory shall be
retained solely by Sanofi.  Should Vivus fail to institute infringement
proceedings in the Sanofi Territory, Sanofi, if it deems necessary, shall have
the right but shall not be obligated, to bring suit for such infringement under
its name and at its own costs and expenses. Vivus shall cooperate with Sanofi in
any such proceedings at its own expense including giving testimony and producing
document and material supporting the Vivus Trademark and shall endeavour to
cause the employees of Vivus, as appropriate, to cooperate with Sanofi, all at
Sanofi’s expense. Any recoveries obtained in suit for trademark infringement
litigation or in settlement of such infringement undertaken without Vivus’
involvement shall be retained by Sanofi.

 

(d)                                 Sanofi Trademarks. To the extent Sanofi
elects to use a Sanofi Trademark in addition or, pursuant to Section 8.8(a), as
an alternative to the Vivus Trademarks in connection with the Manufacture and
the Commercialization of the Products in the Sanofi Territory, Sanofi shall be
responsible for the selection, adoption, registration, maintenance and defense
of such Sanofi Trademarks, as well as all expenses associated therewith.  Sanofi
shall own all Sanofi Trademarks and all rights arising from the use of the
Sanofi Trademarks in the Sanofi Territory shall inure to Sanofi’s benefit.
Sanofi shall also choose at its own discretion the related packaging and trade
dress.

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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(e)                                  No Similar Trademarks.  Vivus shall not at
any time register or cause to be registered, anywhere in the world, any
trademark, name or design identical or confusingly similar to any of the Sanofi
Trademarks in the Sanofi Territory or outside of the Sanofi Territory without
the express consent of Sanofi. Sanofi shall not at any time register or cause to
be registered, anywhere in the world, any other trademark, name or design
identical to or confusingly similar to any of the Vivus Trademarks without the
express consent of Vivus, which consent shall not be unreasonably withheld,
conditioned or delayed.

 

(f)                                   Further Acts. Vivus shall execute,
acknowledge and deliver such instruments and do all such other acts as may be
necessary or appropriate in order to have this Agreement recorded by any
authority operating as a trademark office in the Sanofi Territory or in order to
ascertain or confirm Sanofi’s right to use the Vivus Trademarks.

 

(g)                                  Infringement of Third Party rights by the
Vivus Trademarks. Notwithstanding the provisions of Section 8.6, Vivus shall:
(i) defend, through counsel of its choosing, at its own cost and expense, any
Claim from a Third Party that claims that the Vivus Trademarks infringe such
Third Party’s intellectual Property in the Sanofi Territory; (ii) consult with
Sanofi, take into consideration Sanofi’s comments,  incorporate and act on such
comments to the extent reasonable in defending against any such Claim; and
(iii) release and hold Sanofi, its Affiliates and sublicensees harmless from any
liabilities arising from or connected with any such Claim.

 

ARTICLE 9
MTPC AGREEMENT

 

9.1                               Representations and Warranties of Vivus with
respect to the MTPC Agreement.  Vivus represents and warrants to Sanofi that, as
of the Effective Date:

 

(a)                                 The MTPC Agreement is in full force and
effect and has not been modified or amended; and

 

(b)                                 Neither Vivus nor, to the best of Vivus’
knowledge and belief, MTPC, is in default with respect to any obligation under,
and neither of Vivus or MTPC has claimed that the other party is in default with
respect to any obligation under the MTPC Agreement; and

 

(c)                                  The rights that MTPC has licensed to Vivus
pursuant to the MTPC Agreement are not subject to any contractual restrictions
or limitations in the MTPC Agreement (or any other agreement between Vivus and
MTPC) that would reasonably be expected to restrict or limit (beyond any
restrictions or limitations expressly set forth herein) the rights granted by
Vivus to Sanofi pursuant to this Agreement; and

 

(d)                                 Vivus has not waived or terminated any of
its rights under the MTPC

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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Agreement, and to Vivus’ knowledge, no such rights under the MTPC Agreement have
otherwise lapsed, expired, or been terminated.

 

9.2                               Vivus Obligations with respect to the MTPC
Agreement.  Vivus agrees that during the term of this Agreement:

 

(a)                                 Vivus shall not breach the MTPC Agreement in
any matter that would reasonably be expected to adversely affect Sanofi or its
rights hereunder; and

 

(b)                                 Vivus shall not enter into any subsequent
agreement with MTPC that modifies or amends the MTPC Agreement in any way that
would reasonably be expected to adversely affect Sanofi’s rights under this
Agreement without Sanofi’s prior written consent, and shall provide Sanofi with
a copy of all executed modifications to or amendments of the MTPC Agreement,
regardless of whether Sanofi’s consent was required with respect thereto; and

 

(c)                                  Vivus shall not terminate, nor take or fail
to take any action that would reasonably be expected to terminate, the MTPC
Agreement in whole or in part, directly or indirectly, without Sanofi’s prior
written consent; and

 

(d)                                 Vivus shall furnish Sanofi with copies of
all notices received by Vivus relating to any alleged breach or default of any
obligation by Vivus under the MTPC Agreement within *** after Vivus’ receipt
thereof.

 

9.3                               Consequences of Termination of MTPC Agreement;
Letter Agreement.  A letter, signed by ***, addressing *** is here-attached as
Exhibit F to this Agreement (the “Letter Agreement”). No further consent of
Vivus shall be required for Sanofi to receive the benefit of the Letter
Agreement, and Sanofi shall have the right to *** as a consequence of *** in the
Letter Agreement being ***.

 

ARTICLE 10
OTHER REPRESENTATIONS, WARRANTIES AND COVENANTS

 

10.1                        Mutual Representations and Warranties. Each Party
hereby represents, warrants, and covenants (as applicable) to the other Party as
follows, as of the Effective Date:

 

(a)                                 Corporate Existence and Power.  It is a
corporation or limited partnership, as applicable, duly organized, validly
existing, and in good standing under the laws of the jurisdiction in which it is
incorporated or formed, and has all requisite power and authority and the legal
right to own and operate its property and assets and to carry on its business as
it is now being conducted and as contemplated in this Agreement, including the
right to grant the licenses granted by it hereunder.

 

(b)                                 Authority and Binding Agreement.  It has the
requisite power and

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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authority and the legal right to enter into this Agreement and perform its
obligations hereunder; it has taken all necessary action on its part required to
authorize the execution and delivery of this Agreement and the performance of
its obligations hereunder; and this Agreement has been duly executed and
delivered on its behalf, and constitutes a legal, valid, and binding obligation
of such Party that is enforceable against it in accordance with its terms,
subject as to enforcement of remedies to applicable bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting generally the enforcement
of creditors’ rights and subject to a court’s discretionary authority with
respect to the granting of a decree ordering specific performance or other
equitable remedies.

 

(c)                                  Consents.  All necessary consents,
approvals and authorizations of all governmental authorities and other Third
Parties required to be obtained by it in connection with the execution, delivery
and performance of this Agreement have been obtained by it.

 

(d)                                 No Conflict.  The execution and delivery of
this Agreement, the performance of such Party’s obligations hereunder and the
licenses and sublicenses to be granted pursuant to this Agreement (i) do not and
will not conflict with or violate any requirement of Applicable Law existing as
of the Effective Date, (ii) do not and will not conflict with or violate the
certificate of incorporation, certificate of formation, by-laws, limited
partnership agreement or other organizational documents of such Party, and
(iii) do not and will not conflict with, violate, breach or constitute a default
under any contractual obligations of such Party or any of its Affiliates
existing as of the Effective Date.

 

10.2                        Vivus Technology. Vivus hereby represents and
warrants to Sanofi as of the Effective Date that:

 

(a)                                 Vivus Controls the Vivus Patents in the
Sanofi Territory;

 

(b)                                 Vivus has not granted rights to any Third
Party under the Vivus Technology with respect to the Commercialization of the
Product in the Field in the Sanofi Territory;

 

(c)                                  To Vivus’ knowledge as of the Effective
Date, the manufacture and commercialization of the Product in the Field in the
Sanofi Territory does not infringe any valid and enforceable Third Party Patents
in the Sanofi Territory.

 

(d)                                 Vivus has not received any written notice
from any Third Party asserting or alleging that the research, development,
making or using of the Product by Vivus prior to the Effective Date has
infringed or otherwise violated, or that the Commercialization of the Product in
the Sanofi Territory will infringe or otherwise violate, the intellectual
property rights of such Third Party;

 

(e)                                  other than the MTPC Agreement, there are no
agreements in effect as of the Effective Date between Vivus and a Third Party
under which intellectual property right or

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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trade secrets within the Vivus Technology are being licensed to Vivus;

 

(f)                                   Vivus has taken reasonable measures to
protect the confidentiality of any confidential Information in the Vivus
Know-How;

 

(g)                                  Vivus has the right to license and disclose
the Vivus Know-How to Sanofi as contemplated by this Agreement and Vivus
Know-How was not obtained by Vivus in violation of any contractual or fiduciary
obligation to which Vivus or any of its employees or staff members are or were
bound, or by the misappropriation of the trade secrets of any Third Party;

 

(h)                                 To Vivus’ knowledge, there is no use,
infringement or misappropriation of the Vivus Technology in derogation of the
rights granted to Sanofi in this Agreement; and

 

(i)                                     Exhibit C attached hereto accurately and
completely identifies all Vivus Patents that have been filed or have issued as
of the Effective Date; and

 

(j)                                    To Vivus’ knowledge, each of the Vivus
Patents listed in Exhibit C hereto, has been prosecuted in material compliance
with all applicable rules, policies and procedures of the jurisdiction in which
such Vivus Patent was filed and is subsisting and in good standing. Vivus is not
aware of any material prior art or other facts that are likely to render any
claims in the Vivus Patents unpatentable, invalid or unenforceable. All
renewable and maintenance fees due as of the Effective Date with respect to the
prosecution and maintenance of the Vivus Patents have been paid;

 

(k)                                 Vivus is not a party to any legal Action
relating to the Vivus Technology or any Compound or Product, nor has Vivus
received any written communication from any Third Party, including, without
limitation, any Regulatory Authority or other government agency, threatening
such action, suit or proceeding;

 

(l)                                     To Vivus’ knowledge, the research and
development of the Compound and Product prior to the Effective Date by Vivus,
its Affiliates, Service Providers and any Third Party, was conducted in
compliance, in all material respects, with all applicable laws and regulations,
including all public health, environmental and safety provisions thereof;

 

(n)                                 To Vivus’ knowledge, all of the Information
that Vivus has provided to Sanofi prior to the Effective Date relating to the
Product is materially accurate, and Vivus has not omitted therefrom any material
data or material Information in Vivus’ possession or Control prior to the
Effective Date relating to the Product that Vivus reasonable believes would be
material to Sanofi’s decision to enter into this Agreement.

 

10.3                        Vivus Trademarks.  Vivus hereby represents and
warrants to Sanofi as of the Effective Date that:

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

38

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(a)                                 it has all right, title, and interest in and
to the Vivus Trademarks existing on the Effective Date;

 

(b)                                 it has pending registrations for the Vivus
Trademarks in Algeria, Bahrain, Kuwait, Oman, Qatar, Russia, Saudi Arabia,
Turkey, and the United Arab Emirates;

 

(c)                                  to the best knowledge of Vivus, there is no
Third Party using or infringing any of the Vivus Trademarks in the Sanofi
Territory in material derogation of the rights granted to Sanofi in this
Agreement;

 

(d)                                 Vivus has not received notice of any
opposition, cancellation action or pending litigation or any communication which
expressly threatens an opposition or cancellation action, or other litigation,
before any trademark office, court or any other governmental entity in the
Sanofi Territory with respect to any of the Vivus Trademarks;

 

(e)                                  the Vivus Trademarks are the only
Trademarks owned, held, Controlled, licensed or otherwise used (or intended to
be used) by Vivus or its Affiliates with respect to the Product in the Field in
the Sanofi Territory (other than Vivus’ corporate name and/or logo);

 

(f)                                   to the best knowledge of Vivus, Vivus has
all rights to use the Vivus Trademarks with respect to the Product in the Sanofi
Territory and to license the Vivus Trademarks to Sanofi hereunder; and

 

(g)                                  to the best knowledge of Vivus, Vivus has
not infringed, misappropriated, diluted or otherwise violated any Trademark of
any Third Party by registering or using the Vivus Trademarks in the Sanofi
Territory; and

 

(h)                                 to the knowledge of Vivus, no claims or
proceedings, asserting that the Vivus Trademarks infringe the right of any Third
Party, are pending or threatened.

 

10.4                        Compliance with Law.  Each Party shall, and shall
ensure that its Affiliates and sublicensees shall, comply with all Applicable
Laws in exercising their rights and fulfilling their obligations under this
Agreement.

 

10.5                        Representations regarding Debarment and Compliance.

 

(a)                                 Each Party represents warrants and covenants
that as of the Effective Date and during the Term, neither it nor its Affiliates
nor any of their respective directors, officers, employees, to its knowledge
based upon reasonable inquiry:

 

(i)                                     is debarred under Section 306(a) or
306(b) of the FD&C Act or under any similar Applicable Laws;

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

39

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(ii)                    has been charged with, or convicted of, any felony or
misdemeanor under Applicable Laws related to any of the following: (A) the
development or approval of any drug product or the regulation of any drug
product under the FD&C Act; Directive 2001/83/EC of the European Parliament and
of the Council of 6 November 2001 on the Community code relating to medicinal
products for human use, Directive 2001/20/EC of the European Parliament and of
the Council of 4 April 2001 on the approximation of the laws, regulations and
administrative provisions of the Member States relating to the implementation of
good clinical practice in the conduct of clinical trials on medicinal products
for human use, the national laws of individual EU Member States implementing the
provisions of these Directives into their national law, Regulation (EC) No
726/2004 of the European Parliament and of the Council of 31 March 2004 laying
down Community procedures for the authorization and supervision of medicinal
products for human and veterinary use and establishing a European Medicines
Agency, or any similar Applicable Laws; (B) a conspiracy to commit, aid or abet
the development or approval of any drug product or regulation of any drug
product; (C) health care program-related crimes (involving Medicare, any state
health care program, or any healthcare program in any country in the European
Union or the Sanofi Territory) or provision of illegal inducements to physicians
or healthcare institutions to recommend, endorse, prescribe, order, supply,
purchase, use or administer any drug product; (D) patient abuse, controlled
substances, bribery, payment of illegal gratuities, fraud, perjury, false
statement, racketeering, blackmail, extortion, falsification or destruction of
records; (E) interference with, obstruction of an investigation into, or
prosecution of, any criminal offense; or (F) a conspiracy to commit, aid or abet
any of these listed felonies or misdemeanors; and

 

(iii)                 is excluded, suspended or debarred from participation, or
otherwise ineligible to participate, in any United States federal or state
health care programs (including convicted of a criminal offense that falls
within the scope of 42 U.S.C. §1320a-7 but not yet excluded, debarred,
suspended, or otherwise declared ineligible), excluded, suspended or debarred
from participation, or otherwise ineligible to participate, in any healthcare
program in any country in the European Union or the Sanofi Territory, or
excluded, suspended or debarred from participation, or otherwise ineligible to
participate, in any United States federal procurement or non-procurement
programs or procurement or non-procurement programs in any country in the
European Union or the Sanofi Territory.

 

(b)                                 Each Party will notify the other Party
promptly, but in no event later than *** days, after knowledge of any exclusion,
debarment, suspension or other ineligibility set forth in
Section 10.5(a)(iii) occurring during the Term, or if such Party concludes based
on its good faith business judgment that a pending action or investigation is
likely to lead to the exclusion, debarment, suspension or other ineligibility of
such Party an Affiliate of such Party or any of such Party’s or such Party’s
Affiliates’ directors, officers, employees, or consultants.

 

10.6                        Representations Regarding Anti-Bribery Laws.  Each
Party represents and warrants that, on or before the Effective Date, to its
knowledge based upon reasonable inquiry, neither it, its Affiliates nor any of
their respective directors, officers, employees: (a) has made or

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

40

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agreed any payment or any offer or promise for payment, either directly or
indirectly, of money or other assets, or transfer anything of value (a
“Payment”), to government or political party officials (where “government
official” shall, for purposes of this Section 10.6, include without limitation
health care providers in state-run hospitals and health care systems and
decision-makers in state-owned or -controlled enterprises), officials of
international organizations, candidates for public office, or representatives of
other businesses or persons action on behalf of any of the foregoing for the
purpose of influencing decisions or actions or where such Payment would
constitute violation of any applicable Anti-Bribery Laws; and (b) has accepted
any Payment for the purpose of influencing any decisions or actions to help
anyone (including but not limited to any of the Parties) obtain or maintain
business where such Payment would constitute violation of any Anti-Bribery Laws.
Each Party covenants that during the Term, it will ensure that neither it, its
Affiliates, nor any of their respective directors, officers and employees will
make, agree to, offer or accept any of the Payment described in (a) and (b).

 

10.7                        No Other Representations or Warranties.  EXCEPT FOR
THE EXPRESS WARRANTIES THAT ARE EXPLICITLY SET FORTH IN ARTICLE 9 AND THIS
ARTICLE 10, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR
IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL
PROPERTY RIGHTS, IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY.  ALL
REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR
OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

 

ARTICLE 11
INDEMNIFICATION

 

11.1                        Indemnification by Vivus.  Vivus shall defend,
indemnify, and hold harmless Sanofi, its Affiliates, and their respective
officers, directors, employees, consultants and authorized agents and their
respective successors and assigns or heirs, as the case may be (the “Sanofi
Indemnitees”) from and against any and all Losses to the extent resulting from
any Claim of a Third Party against such Sanofi Indemnitee based on or arising
out of:

 

(a)                                 any misrepresentation or breach of any of
Vivus’ representations, warranties, covenants or obligations under this
Agreement ***; or

 

(b)                                 the negligence or willful misconduct of, or
violation of Applicable Law by, Vivus, its Affiliates, licensees, licensors,
distributors or their respective officers, directors, employees, consultants or
authorized agents under this Agreement ***; or

 

The foregoing indemnity obligations shall not apply to the extent that the
Losses of such Sanofi Indemnitee were caused by: (i) a breach of any of Sanofi’s
representations, warranties, covenants,

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

41

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or obligations under this Agreement; or (ii) the negligence or willful
misconduct of, or violation of Applicable Law by any Sanofi Indemnitee.

 

11.2                        Indemnification by Sanofi.  Sanofi shall defend,
indemnify and hold harmless Vivus, its Affiliates, and their respective
officers, directors, employees, consultants and authorized agents and their
respective successors and assigns or heirs, as the case may be (the “Vivus
Indemnitees”) from and against any and all Losses to the extent resulting from
any Claim of a Third Party against such Vivus Indemnitee based on or arising out
of:

 

(a)                                 any misrepresentation or breach of any of
Sanofi’s representations, warranties, covenants or obligations under this
Agreement; or

 

(b)                                 the negligence or willful misconduct of, or
violation of Applicable Law by, Sanofi, its Affiliates, licensees, distributors
or their respective officers, directors, employees, consultants or authorized
agents under this Agreement.

 

(c) the Commercialization of any Product by Sanofi, its Affiliates, and
sublicensees.

 

The foregoing indemnity obligation shall not apply to the extent that the Losses
of such Vivus Indemnitee were caused by: (i) a breach of any of Vivus’
representations, warranties, covenants, or obligations under the Agreement ***;
or (ii) the negligence or willful misconduct of, or violation of Applicable Law
by any Vivus Indemnitee.

 

11.3                        Indemnification Procedures.  The Party claiming
indemnity under this Article 11 (the “Indemnified Party”) shall give written
notice to the Party from whom indemnity is being sought (the “Indemnifying
Party”) as soon as reasonably practicable after learning of a written Claim
(“Indemnified Claim”).  Failure by an Indemnified Party to give notice of an
Indemnified Claim as soon as reasonably practicable after receiving a writing
reflecting such Claim shall not relieve the Indemnifying Party of its
indemnification obligations hereunder except and solely to the extent that such
Indemnifying Party is actually prejudiced as a result of such failure to give
such notice.  The Indemnifying Party shall have the right to assume the conduct
and defense of the Indemnified claim with counsel of its choice.  The
Indemnified Party shall provide the Indemnifying Party with reasonable
assistance in connection with the defense of the Indemnified Claim.  The
Indemnified Party may monitor such defense with counsel of its own choosing at
its sole expense.  The Indemnifying Party may not settle the Indemnified Claim
without the prior written consent of the Indemnified Party, such consent shall
not be unreasonably withheld, delayed or conditioned.  If the Indemnifying Party
does not assume and conduct the defense of the Indemnified Claim as provided
above: (a) the Indemnified Party may assume and conduct the defense of the
Indemnified claim at the Indemnifying Party’s expense; (b) the Indemnified Party
may consent to the entry of any judgment or enter into any settlement with
respect to the Indemnified Claim in any manner the Indemnified Party may deem
reasonably appropriate (and the Indemnified Party need not consult with, or
obtain any consent from, the Indemnifying Party

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

42

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in connection therewith); and (c) the Indemnifying Party will remain responsible
to indemnify the Indemnified Party for Losses as provided in this Article 11.

 

11.4                        Limitation of Liability.  NEITHER PARTY SHALL BE
LIABLE TO THE OTHER FOR ANY EXEMPLARY, SPECIAL, CONSEQUENTIAL, INCIDENTAL,
PUNITIVE, OR INDIRECT DAMAGES, COSTS OR EXPENSES (INCLUDING LOST PROFITS, LOST
REVENUES AND/OR LOST SAVINGS) ARISING FROM OR RELATING TO ANY BREACH OF THIS
AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. 
NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.4 IS INTENDED TO OR
SHALL LIMIT OR RESTRICT (A) THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY
PARTY IN CONNECTION WITH THIRD PARTY CLAIMS UNDER SECTION 11.1 OR 11.2,
(B) DAMAGES AVAILABLE FOR A PARTY’S BREACH OF ARTICLE 2, OR THE *** AVAILABLE
FOR SANOFI AS SET FORTH IN SECTION 6.2 OR (C) DAMAGES TO THE EXTENT ARISING FROM
OR RELATING TO WILLFUL MISCONDUCT OR FRAUDULENT ACTS OR OMISSIONS OF A PARTY.

 

11.5                        Insurance. Each Party shall procure and maintain
insurance (or self-insure) adequate to cover its obligations hereunder and which
are consistent with normal business practices of prudent companies similarly
situated.  Such insurance shall be written by insurance companies of good
international reputation.  Without limiting the generality of the foregoing,
Sanofi’s insurance shall include, at minimum, the following coverages:

 

(a)                                 commercial general liability coverage with
minimum per claim limits of at least $*** per occurrence and $*** annual
aggregate;

 

(b)                                 excess liability/umbrella coverage with
minimum per claim limits of at least $*** per occurrence and annual aggregate;

 

(c)                                  products liability coverage with minimum
per claim limits of at least $*** per occurrence and annual aggregate; and

 

It is understood that the insurance requirements above shall not be construed to
create a limit of either Party’s liability with respect to its indemnification
obligations under this Article 11.  Each Party shall provide the other Party
with written evidence of such insurance upon request.

 

ARTICLE 12
CONFIDENTIALITY

 

12.1                        Confidentiality.  Except to the extent expressly
authorized by this Agreement or otherwise agreed in writing by the Parties, each
Party agrees that, for the Term and for *** years thereafter, it shall keep
confidential and shall not publish or otherwise disclose and shall not use for
any purpose other than as provided for in this Agreement any Confidential
Information of the

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

43

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other Party except for that portion of such information or materials that the
receiving Party can demonstrate by competent proof:

 

(a)                                 was already known to the receiving Party or
its Affiliate, other than under an obligation of confidentiality, at the time of
disclosure by the other Party;

 

(b)                                 was generally available to the public or
otherwise part of the public domain at the time of its disclosure to the
receiving Party;

 

(c)                                  became generally available to the public or
otherwise part of the public domain after its disclosure and other than through
any act or omission of the receiving Party in breach of this Agreement;

 

(d)                                 is subsequently disclosed to the receiving
Party or its Affiliate by a Third Party without obligations of confidentiality
with respect thereto; or

 

(e)                                  is subsequently independently discovered or
developed by the receiving Party or its Affiliate without the aid, application,
or use of Confidential Information.

 

Notwithstanding the foregoing, the receiving Party may disclose without
violation of this Agreement such portion of the Confidential Information as is
required or permitted to be disclosed if, on the advice of counsel, it is
required under Applicable Law or pursuant to legal process to disclose such
Confidential Information of the other Party; provided that unless otherwise
prohibited by Applicable Law, the receiving Party first advises the disclosing
Party of such intended disclosure and provides the disclosing Party with the
opportunity to seek appropriate judicial or administrative relief to avoid, or
obtain confidential treatment of, such disclosure at the disclosing Party’s sole
cost and expense.

 

The confidentiality provisions set forth herein shall supersede and replace the
Existing Confidentiality Agreement and shall be deemed to cover all confidential
information disclosed or obtained under the Existing Confidentiality Agreement.

 

12.2                        Authorized Disclosure.  Each Party may disclose
Confidential Information belonging to the other Party to the extent such Party
determines such disclosure is reasonably necessary in the following situations:

 

(a)                                 prosecuting or defending litigation relating
to this Agreement;

 

(b)                                 in the case of Vivus, disclosure to MTPC as
required pursuant to the MTPC Agreement;

 

(c)                                  in the case of Vivus as the receiving
Party, disclosure to its licensees, sublicensees, and collaborators with respect
to the Product outside the Sanofi Territory or outside the Field, but solely to
the extent that such Confidential Information (i) raises any material

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

44

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concerns regarding the safety of any Product; (ii) indicates or suggests a
potential material liability of either Vivus or the applicable licensee,
sublicensee, or collaborator to Third Parties in connection with any Product;
(iii) is reasonably likely to lead to a recall or market withdrawal of any
Product; or (iv) relates to any Product and is reasonably likely to have a
material impact on a Regulatory Approval of any Product in such licensee’s,
sublicensee’s, or collaborator’s territory; provided that each such disclosee
must be bound by obligations of confidentiality and non-use no less stringent
than those set forth in Sections 12.1 and 12.2 prior to any such disclosure and
further provided that Vivus shall cause any of its licensees to commit to the
same obligations and shall disclose to Sanofi any confidential information
received from any licensee of the Vivus Technology in order to enable Sanofi,
its Affiliates and licensees to address adequately the situations set forth in
the sub-sections (i) to (iv) of this Section 12.2 (c);

 

(d)                                 disclosure to its and its Affiliates’
respective directors, officers, employees, consultants, attorneys, professional
advisors, lenders, insurers, Service Providers and sublicensees only on a
need-to-know basis and solely as necessary in connection with this Agreement,
provided that each disclosee must be bound by obligations of confidentiality and
non-use no less stringent than those set forth in Sections 12.1 and 12.2 prior
to any such disclosure; and

 

(e)                                  disclosure to any bona fide potential or
actual investor, acquirer, merger partner, or other potential or actual
financial partner (and/or their respective consultants, attorneys, professional
advisors) on a need-to-know basis and solely for the purpose of evaluating a
potential investment, acquisition, merger, or similar transaction; provided that
each disclosee must be bound by obligations of confidentiality and non-use no
less stringent than those set forth in Sections 12.1 and 12.2 prior to any such
disclosure.  The receiving Party shall be liable for any breach of such
confidentiality and non-use obligations by any such Third Party.

 

12.3                        Publicity; Terms of Agreement.

 

(a)                                 The Parties agree that the material terms of
this Agreement are the Confidential Information of both Parties, subject to the
authorized disclosure provisions set forth in Section 12.2 and this
Section 12.3.

 

(b)                                 Each Party shall have the right to make an
individual public announcement of the execution of this Agreement, the content
and timing of which shall be mutually agreed upon by the Parties.  After release
of the press release announcing this Agreement, if either Party desires to make
a public announcement concerning the material terms of this Agreement, such
Party shall give reasonable prior advance notice of the proposed text of such
announcement to the other Party for its prior review and approval, such approval
not to be unreasonably withheld, conditioned or delayed.  A Party commenting on
such a proposed press release shall provide its comments, if any, within ***
after receiving the press release for review.  Neither Party shall be required
to seek the permission of the other Party to disclose any information already
disclosed or otherwise in the public domain, provided such information

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

45

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remains accurate.

 

(c)                                  Vivus may publicly disclose without
violation of this Agreement, such terms of this Agreement as are, on the advice
of Vivus’ counsel, required by the rules and regulations of the SEC or any other
applicable entity having regulatory authority over Vivus’ securities; provided
that Vivus advises Sanofi of such intended disclosures and requests confidential
treatment of certain commercial terms and technical terms hereof to the extent
such confidential treatment is reasonably available to Vivus.  In the event of
any such filing, Vivus will provide Sanofi, a reasonable time prior to filing,
with a copy of the Agreement marked to show provisions for which Vivus intends
to seek confidential treatment and shall reasonably consider and incorporate
Sanofi’s comments thereon to the extent consistent with the legal requirements
applicable to Vivus and that govern redaction of information from material
agreements that must be publicly filed.  Sanofi shall provide any such comments
as promptly as practicable.

 

ARTICLE 13
TERM AND TERMINATION

 

13.1                        Term. This Agreement shall commence as of the
Effective Date and, unless sooner terminated as provided hereunder, shall expire
as follows:

 

(a) As to the Product in each country in the Sanofi Territory, this Agreement
shall expire upon the expiration of the Royalty Payment Term with respect to
such Product in such country; provided, however, that Sanofi’s obligation under
Section 7.5 to reimburse Vivus for Sanofi’s pro-rata share of any sales
milestone paid by Vivus to MTPC shall survive if such sales milestone has not
yet come due (with such pro-rata share being based on Sanofi’s pre-termination
Net Sales); and

 

(b) This Agreement shall expire in its entirety upon the expiration of all
royalty payment obligations arising under Section 7.4 of this Agreement with
respect to the Product in all countries in the Sanofi Territory.

 

13.2                        Effect of Expiration. Following the expiration of
this Agreement pursuant to Section 13.1, Sanofi shall have the royalty-free,
fully paid-up, perpetual right, under the Vivus Technology and the Vivus
Trademarks to: (i)  Manufacture or have Manufactured the Product inside and
outside of the Sanofi Territory and (ii) Commercialize the Product in the Sanofi
Territory.

 

13.3                        Termination by Either Party for Cause.

 

(a)                                 Breach.  Either Party shall have the right
to terminate this Agreement upon written notice to the other Party if such other
Party, after receiving written notice from the terminating Party identifying a
material breach by such other Party of its obligations under this Agreement,
fails to cure such material breach within *** from the date of such notice (or,
if such

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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material breach cannot be cured within such *** period, if the non-terminating
party does not commence and diligently continue actions to cure same during such
*** period), or, in the case of payment obligations, *** from the date of such
notice.  For the avoidance of doubt (and without limiting Vivus’ remedies for
any other breaches by Sanofi), Sanofi’s uncured failure to pay the amounts set
forth in Section 7.1 or Section 7.2 shall be deemed to be a material breach of
this Agreement.

 

(b)                                 Government Action.  Vivus shall have the
right to terminate this Agreement immediately upon written notice to Sanofi on a
country by country basis if either of the following occurs:  (i)  Sanofi is
subject to investigation or any enforcement actions by the competent authorities
in any country in the Sanofi Territory for violation of the Applicable Laws
governing the promotion of drug products in Sanofi Territory; or (ii) Sanofi is
excluded from participation in a healthcare program in any country in the Sanofi
Territory.

 

13.4                        Termination for Patent Challenge.  Vivus may
terminate this Agreement in its entirety upon written notice to Sanofi if Sanofi
or any Affiliate, directly or indirectly, individually or in association with
any other person or entity, commences any action or proceeding that challenges
the validity, enforceability or scope of any Vivus Patent in the Sanofi
Territory or the Vivus Territory.  In the event Sanofi is aware that a
sublicensee of its license rights hereunder, directly or indirectly,
individually or in association with any other person or entity, commences any
action or proceeding that challenges the validity, enforceability or scope of
any Vivus Patent in the Sanofi Territory or the Vivus Territory, Sanofi shall
promptly terminate the applicable sublicense.  If Sanofi does not terminate such
sublicense within *** of Sanofi becoming aware of such challenge, Vivus may
terminate this Agreement in its entirety upon written notice to Sanofi.

 

13.5                        Termination by Sanofi for Convenience. Sanofi shall
have the right to terminate this Agreement in whole or on a country-by-country
basis, for convenience, at any time during its term upon *** prior written
notice to Vivus.

 

13.6                        Alternative to Termination by Sanofi for Vivus’
Breach. In the event that Vivus defaults with respect to any of its material
obligations under this Agreement and does not cure such default within *** after
the receipt of a notice from Sanofi specifying the nature of, and requiring the
remedy of, such default (or, if such default cannot be cured within such ***
period, if Vivus does not commence and diligently continue actions to cure same
during such *** period), then Sanofi may, in lieu of terminating this Agreement
in its entirety as provided in Section 13.3(a), elect to continue this Agreement
in full force and effect except, upon written notice to Vivus of Sanofi’s
election under this Section 13.6, as follows:

 

(a)                                 Vivus shall have no further rights to
receive reports pursuant to Section 4.8; and

 

(b)                                 Sanofi shall have the right to set off,
against any payments or other amounts due by Sanofi but not paid to Vivus, all
direct damages that have been suffered by

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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Sanofi in whole or in part due to the default that gave rise to Sanofi’s
election under this Section; provided however, that any set off shall only apply
with respect to any undisputed amount of such damages.

 

13.7                        Termination Upon Bankruptcy.  Either Party shall
have the right to terminate this Agreement immediately by providing written
notice, if: (a) the other Party applies for or consents to the appointment of a
receiver, trustee, liquidator or custodian of itself or of all or a substantial
part of its assets, (b) the other Party makes a general assignment for the
benefit of its creditors, (c) the other Party is dissolved or liquidated in full
or in substantial part, (d) the other Party is the subject of voluntary or
involuntary bankruptcy proceedings instituted on behalf of or against such other
Party (except for involuntary bankruptcy proceedings which are dismissed within
***), or (e) the other Party takes any corporate action for the purpose of
effecting any of the foregoing.

 

13.8                        Effect of Early Termination of the Agreement.  Upon
early termination of this Agreement pursuant to Section 13.7 or early
termination by Vivus pursuant to Sections 13.3 or 13.4 or by Sanofi pursuant to
Sections 13.3 or 13.5, the following shall apply (in addition to any other
rights and obligations under Sections 13.9-13.13 or otherwise under this
Agreement with respect to such termination):

 

(a)                                 The licenses granted to Sanofi under
Section 2.1 and the license granted to Vivus under Section 2.2(a)(i) shall
terminate, subject to Section 13.9 (and, as between the Parties, all rights in
the Vivus Technology and the Vivus Trademark shall revert to Vivus, and all
rights in the Sanofi Technology shall revert to Sanofi, subject to the licenses
granted to Vivus under Section 2.2(a)(ii) and, if applicable, Section 13.8(c));

 

(b)                                 Except in the cases of termination by Sanofi
pursuant to Sections 13.3 or 13.7, to the extent permitted by Applicable Law,
Sanofi shall transfer and assign to Vivus all Regulatory Materials and
Regulatory Approvals with respect to Product that are Controlled by Sanofi or
its Affiliates, if any;

 

(c)                                  Except in the cases of termination by
Sanofi pursuant to Sections 13.3 or 13.7, Sanofi shall grant to Vivus a
non-exclusive, royalty-free license under the Sanofi Technology solely as may be
necessary for the Development and Commercialization of the Product by Vivus in
the Sanofi Territory;

 

(d)                                 Except in the cases of termination by Sanofi
pursuant to Sections 13.3 or 13.7, Sanofi shall grant to Vivus an exclusive,
royalty-free license under any Sanofi Trademark, to Commercialize the Product in
any country of the Sanofi Territory where such Sanofi Trademark is used;

 

(e)                                  Except in the cases of termination by
Sanofi pursuant to Sections 13.3 or 13.7, Sanofi shall provide reasonable
assistance, at no cost to Vivus, as may be reasonably necessary for Vivus to
commence or continue Developing and Commercializing the Product in

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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the Sanofi Territory, including without limitation, upon request of Vivus, using
reasonable efforts to (A) transfer any agreements or arrangements with
distributors that apply solely to the sale or supply of Product in the Sanofi
Territory; and (B) amend any agreement or arrangements with distributors that
apply both to the sale or supply of the Product in the Sanofi Territory and to
the sale or supply of other products, so as to transfer to Vivus the rights
solely with respect to Product in the Sanofi Territory; and

 

(f)                                   all sublicenses granted by Sanofi to
Affiliates or Third Parties under the Vivus Technology shall immediately
terminate.

 

13.9                        Right to Sell Stock on Hand.  Provided that Sanofi
is not in material breach of any obligation under this Agreement at the time of
any termination of this Agreement, Sanofi shall have the right for ***
thereafter to dispose of all quantities of Product then in its inventory and to
complete Manufacture of and dispose of any work-in-progress then being
Manufactured, as though this Agreement had not terminated.  Sanofi shall pay
royalties thereon, in accordance with the provisions of this Agreement, as
though this Agreement had not terminated.  Notwithstanding the foregoing, Vivus
shall have the right, at any time following termination, to purchase from Sanofi
any or all of such Product and work-in-progress at the manufacturing cost
therefor.

 

13.10                 Certain Pre-Termination Liabilities.  Following
termination of this Agreement, Sanofi shall retain liability for payment of all
gross to net sales deductions (including returns, rebates and chargeback) of
Products that were sold prior to the effective date of termination (or during
the post-termination sales period contemplated under Section 13.9).  To the
extent that that any such deductions are charged to or otherwise borne by Vivus,
Sanofi shall reimburse Vivus promptly (but in any event no later than *** days)
following Sanofi’s receipt of an invoice therefor.

 

13.11                 Sales Volume.  Sanofi shall use commercially reasonable
efforts to ensure that the average monthly sales volume of each Product leading
up to the effective date of termination (or if applicable, the end of *** period
pursuant to Section 13.9) does not substantially exceed the average monthly
sales volume of such Product for the *** period prior to date of the notice of
termination, and in any event Sanofi shall not take any affirmative action to
cause such outcome.

 

13.12                 Accrued Liabilities; Other Remedies.  Termination or
expiration of this Agreement for any reason shall not release either Party from
any liability or obligation that already has accrued prior to such expiration or
termination (including any milestone or other payment that has been triggered by
an event occurring prior to the effective date of termination or expiration),
nor affect the survival of any provision hereof to the extent it is expressly
stated to survive such termination.  Termination or expiration of this Agreement
for any reason shall not constitute a waiver or release of, or otherwise be
deemed to prejudice or adversely affect, any rights, remedies or claims, whether
for damages or otherwise, that a Party may have hereunder or that may arise out
of or in connection with such termination or expiration.

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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13.13                 Survival.  The following provisions shall survive any
expiration or termination of this Agreement for the period of time specified:
Section 2.2(a) (ii), 2.2(b), 4.9, 7.9, 7.10, 8.1, 13.2, 13.8, 13.9, 13.10,
13.12, and 13.13; Articles 11, 12, 14, and 15; and any necessary definitions in
Article 1.

 

ARTICLE 14
DISPUTE RESOLUTION

 

14.1                        Governing Law.  Resolution of all disputes arising
out of or related to this Agreement or the validity, construction,
interpretation, enforcement, breach, performance, application or termination of
this Agreement and any remedies relating thereto, shall be governed by and
construed under the substantive laws of the State of New York, United States of
America, excluding any conflicts or choice of law rule or principle that might
otherwise refer construction or interpretation of this Agreement to the
substantive law of another jurisdiction.

 

14.2                        Disputes.  The Parties recognize that disputes as to
certain matters may from time to time arise during the Term which relate to
either Party’s rights and/or obligations hereunder.  It is the objective of the
Parties to establish procedures to facilitate the resolution of disputes arising
under this Agreement in an expedient manner by mutual cooperation and without
resort to litigation.  To accomplish this objective, the Parties agree to meet
and discuss in good faith any disputes, controversies or differences which may
arise between the Parties out of or in relation to or in connection with this
Agreement, including any alleged failure to perform, or breach, of this
Agreement, or any issue relating to the interpretation or application of this
Agreement.  Such good faith efforts shall include at least one in-person meeting
between the chief executive officers of each Party.  If the matter is not
resolved within *** following the request for discussions, either Party may then
invoke the provisions of Section 14.3.

 

14.3                        Arbitration.

 

(a)                                 Claims.  Subject to Section 14.4 below, any
claim, dispute, or controversy of whatever nature arising out of or relating to
this Agreement that is not resolved under Section 14.1 within the required ***
period, including, without limitation, any Claim concerning the interpretation,
effect, termination, validity, performance and/or breach of this Agreement shall
be resolved by final and binding arbitration administered by the International
Chamber of Commerce (“ICC”).  The arbitration and all associated discovery
proceedings and communications shall be conducted in English, and the
arbitration shall be held in New York, New York, USA.

 

(b)                                 English Language.  All proceedings shall be
held in English and a transcribed record prepared in English.  Documents
submitted in the arbitration (the originals of which are not in English) shall
be submitted together with a reasonably complete and accurate English
translation.

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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(c)                                  Selection of Arbitrators.  The Parties
shall each choose one arbitrator within *** days of receipt of notice of the
intent to arbitrate and the said two arbitrators shall select by mutual
agreement a third arbitrator within *** days after they have been selected as
arbitrators.  If no arbitrator is appointed within the times herein provided or
any extension of time that is mutually agreed on, the ICC shall make such
appointment (i.e. shall appoint three arbitrators) within *** days of such
failure.

 

(d)                                 Arbitrators’ Award.  The arbitrators’ award
shall include a written statement describing the essential findings and
conclusions on which the award is based, including the calculation of any
damages awarded.  The arbitrator shall, in rendering his or her decision, apply
the substantive laws of the State of New York, without giving effect to its
conflicts of laws principles.  The arbitrators’ authority to award special,
incidental, consequential or punitive damages shall be subject to the limitation
set forth in Section 11.4. The award rendered by the arbitrators shall be final,
binding and non-appealable, and judgment may be entered upon it in any court of
competent jurisdiction.

 

(e)                                  Costs.  Each Party shall bear its own
attorney’s fees, costs, and disbursements arising out of the arbitration, and
shall pay an equal share of the fees and costs of the arbitrators; provided,
however, the arbitrators shall be authorized to determine whether a Party is the
prevailing party, and if so, to award to that prevailing party reimbursement for
any or all of its reasonable attorneys’ fees, costs and disbursements
(including, for example, expert witness fees and expenses, photocopy charges,
travel expenses, etc.), and/or the fees and costs of the ICC and the
arbitrators.

 

14.4                        Court Actions.  Nothing contained in this Agreement
shall deny either Party the right to seek injunctive or other equitable relief
from a court of competent jurisdiction in the context of a bona fide emergency
or prospective irreparable harm, and such an action may be filed and maintained
notwithstanding any ongoing discussions between the Parties or any ongoing
arbitration proceeding.  In addition, either Party may bring an action in any
court of competent jurisdiction to resolve disputes pertaining to the validity,
construction, scope, enforceability, infringement or other violations of Patents
or other intellectual property rights, and no such claim shall be subject to
arbitration pursuant to Section 14.2.

 

ARTICLE 15
MISCELLANEOUS

 

15.1                        Entire Agreement; Amendment.  This Agreement,
including the Exhibits hereto, sets forth the complete, final and exclusive
agreement and all the covenants, promises, agreements, warranties,
representations, conditions and understandings between the Parties hereto with
respect to the subject matter hereof and supersedes, as of the Effective Date,
all prior agreements and understandings between the Parties with respect to the
subject matter hereof, including the Existing Confidentiality Agreement.  The
foregoing shall not be interpreted as a waiver of any remedies available to
either Party as a result of any breach, prior to the Effective

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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Date, by the other Party of its obligations pursuant the Existing
Confidentiality Agreement.  There are no covenants, promises, agreements,
warranties, representations, conditions or understandings, either oral or
written, between the Parties other than as are set forth herein and therein.  No
subsequent alteration, amendment, change or addition to this Agreement shall be
binding upon the Parties unless reduced to writing and signed by an authorized
officer of each Party.

 

15.2                        Force Majeure.  Both Parties shall be excused from
the performance of their obligations under this Agreement to the extent that
such performance is prevented by force majeure and the nonperforming Party
promptly provides notice of the prevention to the other Party.  Such excuse
shall be continued so long as the condition constituting force majeure continues
and the nonperforming Party takes reasonable efforts to remove the condition. 
For purposes of this Agreement, force majeure shall mean conditions beyond the
control of the Parties, including an act of God, war, civil commotion, terrorist
act, labor strike or lock-out, epidemic, failure or default of public utilities
or common carriers, destruction of production facilities or materials by fire,
earthquake, storm or like catastrophe, and failure of plant or machinery
(provided that such failure could not have been prevented by the exercise of
skill, diligence, and prudence that would be reasonably and ordinarily expected
from a skilled and experienced person engaged in the same type of undertaking
under the same or similar circumstances).  Notwithstanding the foregoing, a
Party shall not be excused from making payments owed hereunder because of a
force majeure affecting such Party.

 

15.3                        Notices.  Any notice required or permitted to be
given under this Agreement shall be in writing, shall specifically refer to this
Agreement, and shall be addressed to the appropriate Party at the address
specified below or such other address as may be specified by such Party in
writing in accordance with this Section 15.3, and shall be deemed to have been
given for all purposes when received, if hand-delivered or by means of facsimile
or other electronic transmission, or one Business Day after being sent by a
reputable overnight delivery service.

 

If to
Vivus:                                                                                 
Vivus, Inc.

351 E. Evelyn Avenue

Mountain View, CA 94041

Attention:  General Counsel

Fax: +1 (650) 934-5389

 

With a copy to:                                                            Hogan
Lovells US LLP

4085 Campbell Ave.

Suite 100

Menlo Park, CA 94025

Attention:  Shane Albright

Fax:  +1 (650) 463-4199

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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If to
Sanofi:                                                                            
Sanofi

54 rue La Boétie

75008 Paris, France

Attention: Vice-President Corporate Licensing

Fax: +33 (1) 53 77 46 76

 

With a copy to:                                                           
Sanofi

54 rue La Boétie

75008 Paris, France

Attention: General Counsel

Fax: +33 (1) 53 77 43 03

 

15.4                        No Strict Construction; Headings; Interpretation. 
This Agreement has been prepared jointly and shall not be strictly construed
against either Party.  Ambiguities, if any, in this Agreement shall not be
construed against any Party, irrespective of which Party may be deemed to have
authored the ambiguous provision.  The headings of each Article and Section in
this Agreement have been inserted for convenience of reference only and are not
intended to limit or expand on the meaning of the language contained in the
particular Article or Section.  The definitions of the terms herein apply
equally to the singular and plural forms of the terms defined.  Whenever the
context may require, any pronoun will include the corresponding masculine,
feminine and neuter forms.  The words “include”, “includes” and “including” will
be deemed to be followed by the phrase “without limitation.”  Unless the context
requires otherwise, (a) any definition of or reference to any agreement,
instrument or other document herein will be construed as referring to such
agreement, instrument or other document as from time to time amended,
supplemented or otherwise modified (subject to any restrictions on such
amendments, supplements or modifications set forth herein or therein), (b) any
reference to any laws herein will be construed as referring to such laws and any
rules or regulations promulgated thereunder as from time to time enacted,
repealed or amended, (c) any reference herein to any person will be construed to
include the person’s successors and assigns, (d) the words “herein”, “hereof”
and “hereunder”, and words of similar import, will be construed to refer to this
Agreement in its entirety and not to any particular provision hereof, (e) any
reference herein to the words “mutually agree” or “mutual written agreement”
will not impose any obligation on either Party to agree to any terms relating
thereto or to engage in discussions relating to such terms except as such Party
may determine in such Party’s sole discretion, except as expressly provided in
this Agreement, (f) as applied to a Party, the word “will” shall be construed to
have the same meaning and effect as the word “shall,” and (g) all references
herein without a reference to any other agreement to Articles, Sections, or
Exhibits will be construed to refer to Articles, Sections, and Exhibits of or to
this Agreement.

 

15.5                        Assignment.  Neither Party may assign or transfer
this Agreement or any rights or obligations hereunder without the prior written
consent of the other, except that a Party may make such an assignment without
the other Party’s consent to such Party’s Affiliate or to a

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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successor to all or substantially all of the assets or business of such Party to
which this Agreement pertains.  Any permitted successor or assignee of rights
and/or obligations hereunder shall, in a writing to the other Party, expressly
assume performance of such rights and/or obligations.  Notwithstanding any
assignment of this Agreement, the assigning Party shall remain liable for
performance of its obligations hereunder, unless the non-assigning Party agrees
otherwise in writing.  The Vivus Technology shall exclude any intellectual
property held or developed by a permitted successor of Vivus prior to the
transaction in which it became a successor of such Party, and the Sanofi
Technology shall exclude any intellectual property held or developed by a
permitted successor of Sanofi prior to the transaction in which it became a
successor of such Party.  Any assignment or attempted assignment by either Party
in violation of the terms of this Section 15.5 shall be null, void and of no
legal effect.

 

15.6                        Records Retention.  Each of Vivus and Sanofi will
maintain complete and accurate records pertaining to its activities under this
Agreement, including records pertaining to Development or Commercialization of
any Products and reports and information provided to any Regulatory Authority or
other governmental authority, in accordance with Applicable Law.  Each of Vivus
and Sanofi will retain such records for a duration prescribed by Applicable Law,
but not in any event for less than *** years after the Effective Date (or longer
if a Party is notified, ordered or otherwise required to maintain such records
for a longer period in connection with a legal proceeding or government
investigation).

 

15.7                        No Solicitation.  During *** years following the
Effective Date, neither Sanofi nor any of its Affiliates will solicit or
endeavor to entice away from Vivus or its Affiliates, hire, or offer employment
to, any person or entity who is, or was within the *** period immediately prior
thereto, employed by Vivus or its Affiliates, or otherwise interfere with any
such person’s relationship with Vivus or its Affiliates; provided, however, that
this restrictive covenant shall not prohibit Sanofi or its Affiliates from
making any general solicitation for employees or engaging in public advertising
of employment opportunities (including through the use of employment agencies)
not specifically directed to any of Vivus’ or its Affiliates’ respective
directors, officers or employees.

 

15.8                        Successors and Assigns; No Third Party
Beneficiaries.  This Agreement will be binding upon and inure to the benefit of
the Parties and their successors and permitted assigns.  No provision of this
Agreement, express or implied, is intended to or will be deemed to confer upon
Third Parties any right, benefit, remedy, claim, liability, reimbursement, claim
of action or other right of any nature whatsoever under or by reason of this
Agreement other than the Parties and, to the extent provided in Sections 11.1
and 11.2, the Indemnified Parties.  Without limitation, this Agreement will not
be construed so as to grant employees of either party in any country any rights
against the other Party pursuant to the laws of such country.

 

15.9                        Performance by Affiliates.  Any obligation of Vivus
under or pursuant to this Agreement may be satisfied, met or fulfilled, in whole
or in part, at Vivus’ sole and exclusive option, either by Vivus directly or by
any Affiliate of Vivus that Vivus causes to satisfy, meet or

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

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fulfill such obligation, in whole or in part.  Any obligation of Sanofi under or
pursuant to this Agreement may be satisfied, met or fulfilled, in whole or in
part, at Sanofi’s sole and exclusive option, either by Sanofi directly or by any
Affiliate of Sanofi that Sanofi causes to satisfy, meet or fulfill such
obligation, in whole or in part.  Each of the Parties guarantees the performance
of all actions, agreements and obligations to be performed by any Affiliates of
such Party under the terms and conditions of this Agreement, and shall cause its
Affiliates to comply with the provisions of this Agreement in connection with
such performance.  Any breach by a Party’s Affiliate of any of such Party’s
obligations under this Agreement shall be deemed a breach by such Party, and the
other Party may proceed directly against such Party without any obligation to
first proceed against such Party’s Affiliate.

 

15.10                 Further Assurances and Actions.  Each Party, upon the
request of the other Party, without further consideration, will do, execute,
acknowledge, and deliver or cause to be done, executed, acknowledged or
delivered all such further acts, deeds, documents, assignments, transfers,
conveyances, powers of attorney, instruments and assurances as may be reasonably
necessary to effect complete consummation of the transactions contemplated by
this Agreement, and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement. 
The Parties agree to execute and deliver such other documents, certificates,
agreements and other writings and to take such other actions as may be
reasonably necessary in order to consummate or implement expeditiously the
transactions contemplated by this Agreement.

 

15.11                 Compliance with Applicable Law.  Each Party shall comply
with all Applicable Laws in the course of performing its obligations or
exercising its rights pursuant to this Agreement.

 

15.12                 Severability.  If any one or more of the provisions of
this Agreement is held to be invalid or unenforceable by any court of competent
jurisdiction from which no appeal can be or is taken, the provision shall be
considered severed from this Agreement and shall not serve to invalidate any
remaining provisions hereof.  The Parties shall make a good faith effort to
replace any invalid or unenforceable provision with a valid and enforceable one
such that the objectives contemplated by the Parties when entering this
Agreement may be realized.

 

15.13                 No Waiver.  Any delay in enforcing a Party’s rights under
this Agreement or any waiver as to a particular default or other matter shall
not constitute a waiver of such Party’s rights to the future enforcement of its
rights under this Agreement, except with respect to an express written and
signed waiver relating to a particular matter for a particular period of time.

 

15.14                 Independent Contractors.  Each Party shall act solely as
an independent contractor, and nothing in this Agreement shall be construed to
give either Party the power or authority to act for, bind, or commit the other
Party in any way.  Nothing herein shall be construed to create the relationship
of partners, principal and agent, or joint-venture partners between the Parties.

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

55

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15.15                 Counterparts.  This Agreement may be executed in one
(1) or more counterparts, including by facsimile or other electronic
transmission, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.

 

Signature Page to Follow

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

56

--------------------------------------------------------------------------------

 

IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate
originals by their duly authorized officers as of the Effective Date.

 

VIVUS, INC.

SANOFI

 

 

 

 

 

 

By:

/s/ John L. Slebir

 

By:

/s/ Philippe Goupit

 

 

Name: John L. SLEBIR

Name: Philippe GOUPIT

 

 

Title: Vice President, Business Development

Title:

Vice-President, Corporate Licenses,
Strategy and Business Development

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

--------------------------------------------------------------------------------

 

EXHIBITS

 

Exhibit A                                          Existing PDE-5 Inhibitors

 

Exhibit B                                          Sanofi Territory

 

Exhibit C                                          Vivus Patents

 

Exhibit D                                          Vivus Trademarks /
Trademarks’ Guidelines and Quality Control

 

Exhibit E                                          Terms and Conditions of Vivus
Supply Agreement

 

Exhibit F                                           Letter Agreement between ***

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

--------------------------------------------------------------------------------

 

EXHIBIT A

EXISTING PDE-5 INHIBITORS

 

***

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

1

--------------------------------------------------------------------------------

 

EXHIBIT B

SANOFI TERRITORY

 

Africa:

 

Egypt

Sudan

Algeria

Morocco

South Africa

Tunisia

Libya

Burkina Faso

Gambia

Guinea

Mali

Mauritania

Sao Torne

Senegal

Benin

Ivory Coast

Togo

Niger

Chad

Kenya

Mauritius

Ethiopia

Uganda

Tanzania

Eritrea

Somalia

Seychelles Island

Burundi

Rwanda

Cameroon

Gabon

Congo

Madagascar

Democratic Republic of Congo

Djibouti

Central African Republic

Islamic Republic of Comoros

Republic of Equatorial Guinea

Nigeria

Ghana

Liberia

Sierra Leone

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

1

--------------------------------------------------------------------------------

 

Angola

Mozambique

Zambia

Zimbabwe

Malawi

Botswana

Namibia

 

Middle East — Turkey:

 

Turkey

Saudi Arabia

Yemen

Qatar

Bahrain

United Arab Emirates

Oman

Kuwait

Lebanon

Syria

Jordan

Palestine

Iraq

Iran

Israel

 

Eurasia:

 

Azerbaijan

Kazakhstan

Kirghizstan

Uzbekistan

Georgia

Armenia

Russia

Ukraine

Byelorussia

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

2

--------------------------------------------------------------------------------

 

EXHIBIT C

VIVUS PATENTS

 

***

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

1

--------------------------------------------------------------------------------

 

EXHIBIT D

VIVUS TRADEMARKS / TRADEMARKS GUIDELINES AND QUALITY CONTROL

STENDRA

 

Country in SANOFI Territory

 

Application
Number

 

Filing date

 

Status

Egypt

 

A0031657

 

7-Sep-2012

 

pending

Sudan

 

A0031657

 

7-Sep-2012

 

pending

Algeria

 

130571

 

14-Feb-2013

 

pending

Morocco

 

A0031657

 

7-Sep-2012

 

pending

South Africa

 

2012/24040

 

7-Sep-2012

 

pending

Tunisia

 

TN/E/2013/00295

 

2/13/2013

 

pending

Libya

 

In process

 

 

 

 

Sao Torne

 

A0031657

 

7-Sep-2012

 

pending

Kenya

 

A0031657

 

7-Sep-2012

 

pending

Madagascar

 

A0031657

 

7-Sep-2012

 

pending

Ghana

 

A0031657

 

7-Sep-2012

 

pending

Liberia

 

A0031657

 

7-Sep-2012

 

pending

Sierra Leone

 

A0031657

 

7-Sep-2012

 

pending

Mozambique

 

A0031657

 

7-Sep-2012

 

pending

Zambia

 

A0031657

 

7-Sep-2012

 

pending

Botswana

 

A0031657

 

7-Sep-2012

 

pending

Namibia

 

A0031657

 

7-Sep-2012

 

pending

Turkey

 

A0031657

 

7-Sep-2012

 

pending

Saudi Arabia

 

192302

 

16-Feb-2013

 

pending

Yemen

 

61718

 

17-Feb-2013

 

pending

Qatar

 

In process

 

 

 

 

Bahrain

 

A0031657

 

7-Sep-2012

 

pending

United Arab Emirates

 

190455

 

21-Apr-2013

 

pending

Oman

 

A0031657

 

7-Sep-2012

 

pending

Kuwait

 

137985

 

10-Mar-2013

 

pending

Lebanon

 

149990

 

29-Apr-2013

 

pending

Syria

 

A0031657

 

7-Sep-2012

 

pending

Jordan

 

filed

 

25-Feb-2013

 

pending

Iraq

 

64002

 

21-Feb-2013

 

pending

Iran

 

A0031657

 

7-Sep-2012

 

pending

Israel

 

A0031657

 

7-Sep-2012

 

pending

Azerbaijan

 

A0031657

 

7-Sep-2012

 

pending

Kazakhstan

 

A0031657

 

7-Sep-2012

 

pending

Kirghizstan

 

A0031657

 

7-Sep-2012

 

pending

Uzbekistan

 

A0031657

 

7-Sep-2012

 

pending

Georgia

 

A0031657

 

7-Sep-2012

 

pending

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

2

--------------------------------------------------------------------------------

 

Armenia

 

A0031657

 

7-Sep-2012

 

pending

Russia

 

A0031657

 

7-Sep-2012

 

pending

Ukraine

 

A0031657

 

7-Sep-2012

 

pending

Byelorussia (Belarus)

 

A0031657

 

7-Sep-2012

 

pending

 

SPEDRA

 

Country in SANOFI
Territory

 

Application
No./Registration No.

 

Filing date

 

Status

Egypt

 

A0029395

 

19-Apr-2012

 

pending

Sudan

 

A0029395

 

19-Apr-2012

 

pending

Algeria

 

In process

 

 

 

 

Morocco

 

A0029395

 

19-Apr-2012

 

pending

South Africa

 

2012/10394

 

23-Apr-2012

 

pending

Tunisia

 

In process

 

 

 

 

Libya

 

In process

 

 

 

 

Sao Tome

 

A0029395

 

19-Apr-2012

 

pending

Kenya

 

A0029395

 

19-Apr-2012

 

pending

Madagascar

 

A0029395

 

19-Apr-2012

 

pending

Ghana

 

A0029395

 

19-Apr-2012

 

pending

Liberia

 

A0029395

 

19-Apr-2012

 

pending

Sierra Leone

 

A0029395

 

19-Apr-2012

 

pending

Mozambique

 

A0029395

 

19-Apr-2012

 

pending

Zambia

 

A0029395

 

19-Apr-2012

 

pending

Botswana

 

A0029395

 

19-Apr-2012

 

pending

Namibia

 

A0029395

 

19-Apr-2012

 

pending

Turkey

 

A0029395

 

19-Apr-2012

 

pending

Saudi Arabia

 

In process

 

 

 

 

Yemen

 

In process

 

 

 

 

Qatar

 

In process

 

 

 

 

Bahrain

 

A0029395

 

19-Apr-2012

 

pending

United Arab Emirates

 

In process

 

 

 

 

Oman

 

A0029395

 

19-Apr-2012

 

pending

Kuwait

 

In process

 

 

 

 

Lebanon

 

In process

 

 

 

 

Syria

 

A0029395

 

19-Apr-2012

 

pending

Jordan

 

In process

 

 

 

 

Iraq

 

In process

 

 

 

 

Iran

 

A0029395

 

19-Apr-2012

 

pending

Israel

 

A0029395

 

19-Apr-2012

 

pending

Azerbaijan

 

A0029395

 

19-Apr-2012

 

pending

Kazakhstan

 

A0029395

 

19-Apr-2012

 

pending

Kyrgyzstan

 

A0029395

 

19-Apr-2012

 

pending

Uzbekistan

 

A0029395

 

19-Apr-2012

 

pending

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

3

--------------------------------------------------------------------------------

 

Georgia

 

A0029395

 

19-Apr-2012

 

pending

Armenia

 

A0029395

 

19-Apr-2012

 

pending

Russia

 

A0029395/1118676

 

19-Apr-2012

 

registered

Ukraine

 

A0029395/1118676

 

19-Apr-2012

 

registered

Byelorussia (Belarus)

 

A0029395

 

19-Apr-2012

 

registered

 

Trademark Quality Control Provisions:

 

*** Sanofi agrees that at all times during the term of this Agreement and any
extensions thereof, its services and goods shall be of such standard and quality
as to be adequate and suited to the protection of the Vivus Trademarks and the
goodwill associated therewith (the “Goodwill”). Any use of the Vivus Trademarks
in substantially the same form as they are currently used by Vivus or in
connection with the goods manufactured to substantially the same standards and
quality as are currently in force by Vivus is hereby deemed approved without
further submission being required. If Sanofi intends to make any changes that
would reasonably be expected to adversely affect the Goodwill, Sanofi shall,
before using the Vivus Trademarks or providing the goods and services, obtain
the prior approval of Vivus by submitting representative samples of such
modified trademarks or goods, or materials associated with such services, to
Vivus. Any such proposed use submitted to Vivus shall be deemed approved upon
the passage, without written objection, of *** after submission. Vivus shall
have, at reasonable times and on reasonable notice, the right to inquire
regarding the services provided by Sanofi and the right to inspect Sanofi’s use
of the Vivus Trademarks and the manufacture of the goods on which the Vivus
Trademarks are used or proposed to be used in order to carry out appropriate
quality control.  Sanofi agrees (i) to use the Vivus Trademarks only in a manner
that will not (a) damage the reputation of or integrity of the Vivus Trademarks,
(b) damage in any way the goodwill associated with the Vivus Trademarks,
(c) cause a negative impact upon the good name of such other Party, and
(ii) that it will conduct its business in compliance with all applicable
trademark Laws and use the Vivus Trademarks only in accordance with this
Agreement.

 

The goods or packaging on which the Vivus Trademarks are used shall, where
reasonable, be marked to indicate that the Vivus Trademarks are trademarks of
Vivus and are being used by Sanofi pursuant to a license granted by Vivus.

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

4

--------------------------------------------------------------------------------

 

EXHIBIT E

VIVUS SUPPLY AGREEMENT

 

[A COPY OF THE VIVUS SUPPLY AGREEMENT HAS BEEN SEPARATELY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION]

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

5

--------------------------------------------------------------------------------

 

EXHIBIT F

LETTER AGREEMENT

 

***

 

*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS
REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.

 

6

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