UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 20-F

(Mark One)

OR

For the fiscal year ended December 31, 20062009

OR

OR

Date of event requiring this shell company report . . . . . . . . . . . . . . . . . . . .

For the transition period from              to             

Commission File Number: 001-31368

Sanofi-Aventis

(Exact name of registrant as specified in its charter)

N/A

(Translation of registrant’s name into English)

France

(Jurisdiction of incorporation or organization)

174, avenue de France, 75013 Paris, France

(Address of principal executive offices)

Karen Linehan, Senior Vice President Legal Affairs and General Counsel

174, avenue de France, 75013 Paris, France. Fax: 011 + 33 1 53 77 43 03

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act:

Securities registered pursuant to Section 12(g) of the Act:

American Depositary Shares, each representing one quarter of a Participating Share Series A, par value €70.89 per share (removed from listing and registration on the New York Stock Exchange effective July 31, 1995).

The number of outstanding shares of each of the issuer’s classes of capital or

common stock as of December 31, 20062009 was:

ordinaryOrdinary shares:    1,359,434,6831,318,479,052

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405

of the Securities Act.

YES  x        NO  ¨.

If this report is an annual or transition report, indicate by check mark if the registrant is not

required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

YES  ¨        NO  x.

Note — Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes  x        No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

U.S. GAAP  ¨        International Financial Reporting Standards as issued by the International Accounting Standards Board  x        Other  ¨

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

Item 17  ¨        Item 18  x¨

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

YES  ¨        NO  x.

PRESENTATION OF FINANCIAL AND OTHER INFORMATION

The consolidated financial statements contained in this annual report on Form 20-F have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and with IFRS as adopted by the European Union, as of December 31, 2006 and with IFRS issued by the International Accounting Standards Board (IASB) as of the same date. IFRS differ in certain significant respects from U.S. generally accepted accounting principles (U.S. GAAP). For a description of the principal differences between IFRS and U.S. GAAP, as they relate to us and to our consolidated subsidiaries, and for a reconciliation of our shareholders’ equity and net income to U.S. GAAP, see Note F to our consolidated financial statements included at Item 18, of this annual report.2009.

Our results of operations and financial condition as of and for the year ended December 31, 2004 have been significantly affected by our August 2004 acquisition of Aventis and certain subsequent transactions (including the merger of Aventis with and into our Company in December 2004). The results of operations of Aventis for the period between August 20, 2004 and December 31, 2004 have been included in our consolidated income statement and cash flow statement. This resulted in a significant increase in revenues and significant changes in other financial statement items in 2004 compared to 2003. The assets and liabilities of Aventis are also included in our consolidated balance sheet at December 31, 2004. See “Item 5. Operating and Financial Review and Prospects.”

Unless the context requires otherwise, the terms “sanofi-aventis,” the “Company,” the “Group,” “we,” “our” or “us” refer to sanofi-aventis and ourits consolidated subsidiaries. References to “Aventis” refer to Aventis and its consolidated subsidiaries for periods prior to August 20, 2004.

All references herein to “United States” or “U.S.” are to the United States of America, references to “dollars” or “$” are to the currency of the United States, references to “France” are to the Republic of France, and references to “euro” and “€” are to the currency of the European Union member states (including France) participating in the European Monetary Union.

Brand names appearing in this annual report are trademarks of sanofi-aventis and/or its affiliates, with the exception of:

The data relative to market shares and ranking information presented in particular in “Item 4. Information on the Company — B. Business Overview — Markets — Competition” isMarketing and distribution” are based on sales data from IMS Health MIDAS (IMS) and GERS (for France), retail and hospital, for calendar year 2006,2009, in constant euros (unless otherwise indicated).

While we believe that the IMS/GERSIMS sales data we present below are generally useful comparative indicators for our industry, they may not precisely match the sales figures published by the companies that sell the products (including our company and other pharmaceutical companies). In particular, the rules used by IMS to attribute the sales of a product covered by an alliance or license agreement do not always exactly match the rules of the agreement.

In order to allow a reconciliation with our basis of consolidation as defined in “Item 5. Operating and Financial Review and Prospects — Presentation of Net Sales,” IMS data shown in the present document have been adjusted and include:

Data relative to market shares and ranking information presented herein for our vaccines business are based on internal estimates unless stated otherwise.

Product indications described in this annual report are composite summaries of the major indications approved in the product’s principal markets. Not all indications are necessarily available in each of the markets in which the products are approved. The summaries presented herein for the purpose of financial reporting do not substitute for careful consideration of the full labeling approved in each market.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This annual report contains forward-looking statements. We may also make written or oral forward-looking statements in our periodic reports to the Securities and Exchange Commission on Form 6-K, in our annual report to shareholders, in our proxy statements, in our offering circulars and prospectuses, in press releases and other written materials and in oral statements made by our officers, directors or employees to third parties. Examples of such forward-looking statements include:

Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “target,” “estimate,” “project,” “predict,” “forecast,” “guideline,” “should” and similar expressions are intended to identify forward-looking statements but are not the exclusive means of identifying such statements.

Forward-looking statements involve inherent risks and uncertainties. We caution you that a number of important factors could cause actual results to differ materially from those contained in any forward-looking statements. Such factors, some of which are discussed under “Risk“Item 3. Key Information — D. Risk Factors” below, include but are not limited to:

We caution you that the foregoing list of factors is not exclusive and that other risks and uncertainties may cause actual results to differ materially from those in forward-looking statements.

Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments.

TABLE OF CONTENTS

PART I

Item 1. Identity of Directors, Senior Management and Advisers

N/A

Item 2. Offer Statistics and Expected Timetable

N/A

Item 3. Key Information

A. Selected Financial Data

SUMMARY OF SELECTED FINANCIAL DATA

The tables below set forth selected consolidated financial data for sanofi-aventis. These financial data are derived from the sanofi-aventis consolidated financial statements. Sanofi-aventisThe sanofi-aventis consolidated financial statements for the years ended December 31, 2006, 20052009, 2008 and 20042007 are included in Item 18 of this annual report.

The consolidated financial statements of sanofi-aventis for the years ended December 31, 20062009, 2008 and 20052007 have been prepared in compliance with IFRS adopted by the European Union and with the IFRS issued by the International Accounting Standards Board (IASB). and with IFRS adopted by the European Union. The term “IFRS” refers collectively to International Accounting Standards (IAS), International Financial Reporting Standards (IFRS), Standing Interpretations Committee (SIC)international accounting and financial reporting standards (IAS and IFRS) and to interpretations and International Financial Reporting Interpretations Committee (IFRIC) Interpretations issued by the IASB. The opening balance sheet as of the IFRS transition date (January 1, 2004)interpretations committees (SIC and the comparative financial statements for the year ended December 31, 2004 have been prepared in accordance with the same principles.IFRIC).

Sanofi-aventis reports its financial results in euro and in conformity with IFRS, with a reconciliation to U.S. GAAP. Sanofi-aventis also publishes condensed U.S. GAAP information. A description of the principal differences between IFRS and U.S. GAAP as they relate to the sanofi-aventis consolidated financial statements is set forth in Note F to the sanofi-aventis audited consolidated financial statements included in this annual report.euros.

SELECTED CONDENSED FINANCIAL INFORMATION

Certain data as of and for the year ended December 31, 2004 have been reclassified to conform to the presentation adopted under IFRS with respect to joint ventures that are no longer accounted for under the proportionate consolidation method.

SELECTED EXCHANGE RATE INFORMATION

Exchange Rates

The following table sets forth, for the periods and dates indicated, certain information concerning the exchange rates for the euro from 20022005 through March 2007February 2010 expressed in U.S. dollar per euro. The information concerning the U.S. dollar exchange rate is based on the noon buying rate in New York City for cable transfers in foreign currencies as certified for customs purposes by the Federal Reserve Bank of New York (the “Noon Buying Rate”). We provide the exchange rates below solely for your convenience. We do not represent that euros were, could have been, or could be, converted into U.S. dollars at these rates or at any other rate. For information regarding the effect of currency fluctuations on our results of operations, see “Item 5. Operating and Financial Review and Prospects.Prospects” and “Item 11. Quantitative and Qualitative Disclosures about Market Risk.”

Selected Exchange Rate Information

On March 30, 200710, 2010 the Noon BuyingEuropean Central Bank Rate was 1.33741.3610 per euro.

B. Capitalization and Indebtedness

N/A

C. Reasons for Offer and Use of Proceeds

N/A

D. Risk Factors

Important factors that could cause actual financial, business, research or operating results to differ materially from expectations are disclosed in this annual report, including without limitation the following risk factors and the factors described under “Cautionary Statement Regarding Forward-Looking Statements.” In addition to the risks listed below, we may be subject to other material risks that as of the date of this report are not currently known to us or that we deem immaterial at this time.

Risks Relating to Our CompanyLegal Matters

We incurred substantial debtGeneric versions of some of our products may be approved for sale in connection with the acquisitionone or more of Aventis, which limits our business flexibility and requires us to devote cash resources to debt service payments.their major markets.

In connection withCompetitors may file marketing authorization requests for generic versions of our acquisitionproducts. Approval and market entry of Aventis, our consolidated debt increased substantially, becausea generic product would reduce the price that we incurred debt to financereceive for these products and/or the cash portionvolume of the acquisition consideration,product that we would be able to sell, and because our consolidated debt includes the debt incurred by Aventis prior to the acquisition. As of December 31, 2006, our debt, net of cash and cash equivalents was €5.8 billion. We make significant debt service payments to our lenders and our current debt level could limit our ability to engage in additional transactions or incur additional indebtedness. For more information on our debt, see “Item 5. Operating and Financial Review and Prospectus — Liquidity and Capital Resources” in this annual report.

We depend on the United States market for a significant part of our current and future operating results. A failure to continue our strategy of profitable operations in that market couldmaterially adversely affect our business, results of operations and financial condition. The market for our products could also be affected if a competitor’s innovative drug in the same market were to become available as a generic. Additionally, a number of our products acquired through business combinations have substantial balance sheet carrying values, as disclosed at Note D.4. to our consolidated financial statements, which could be substantially impaired by the introduction of a generic competitor, with adverse effects on our financial condition or prospects.and the value of our assets.

WeThrough patent and other proprietary rights, we hold exclusivity rights for a number of our research-based products. However, the patent protection that we are able to obtain varies from product to product and country to country and may not achievebe sufficient, including to maintain product exclusivity. Furthermore we are involved in litigation worldwide to enforce certain of these patent rights against generics and proposed generics (see Note D.22.b) to our growth strategy ifconsolidated financial statements included in this annual report at Item 18 for additional information). Moreover, patent rights are limited in time and do not always provide effective protection for our products: competitors may successfully avoid patents through design innovation, we may not hold sufficient evidence of infringement to bring suit, or our infringement claim may not result in a decision that our rights are valid, enforceable or infringed.

Moreover, even in cases where we do ultimately prevail in our infringement claim, legal remedies available for harm caused to us by infringing products may be inadequate to make us whole. A competitor may launch “at risk” before the initiation or completion of the court proceedings, and the court may decline to grant us a preliminary injunction to halt further “at risk” sales and remove the infringing product from the market. Additionally, while we would be entitled to obtain damages in such a case, the amount that we may ultimately be awarded and able to collect may be insufficient to compensate all harm caused to us.

Finally, our successful assertion of a given patent against one competing product is not maintainnecessarily predictive of our future success or failure in asserting the same patent against a second competing product because of such factors as possible differences in the formulations of the competing products, intervening developments in law or jurisprudence, or inconsistent judgments. Moreover, patents differ from country to country and continuea successful result in one country may not predict success in another country because of local variations in the patents and differences in national law or legal systems.

A number of the Group’s products are already subject to expand profitably our presenceaggressive generic competition (in particular, in the United States the world’s largest pharmaceuticals market. We have identified the United States, which accounted for approximately 35.1% of our net sales in 2006, as a potential major source of continued future growth and plan to capitalize on our direct presence in the United States in the coming years to build a strong position in this market. We face a number of challenges in maintaining profitable growth in the United States, including:

A slowdown of global economic growth could have negative consequences for our business.⁽¹⁾

Over the past several years, growth of the global pharmaceutical market has become increasingly tied to global economic growth. In this context, a substantial and lasting slowdown of the global economy or major national economies could negatively affect growth in the global pharmaceutical market and, as a result, adversely affect our business. This effect may be expected to be particularly strong in markets having significant co-pays or lacking a developed third-party payer system, as individual patients may delay or decrease out-of-pocket healthcare expenditures. Such a slowdown could also reduce the sources of funding for national social security systems, leading to heightened pressure on drug prices, increased substitution of generic drugs, and the exclusion of certain products from formularies.

Additionally, to the extent the slowing economic environment may lead to financial difficulties or even the default or failure of major players including wholesalers or public sector buyers financed by insolvent States, the Group could experience disruptions in the distribution of its products as well as the adverse effects described below at “— We are subject to the risk of non-payment by our customers.”

We dependrely on third parties for the marketing of some of our products. These third parties may act in ways that could harm our business.

We market some of our products in collaboration with other pharmaceutical companies. For example, we currently have major collaborative arrangements with Bristol-Myers Squibb (BMS) for the marketing of Plavix^® and Aprovel^® in the United States and several other countries, with Procter & Gamble PharmaceuticalsWarner Chilcott for the osteoporosis treatment Actonel^®, with Teva for Copaxone^®, and with Merck & Co., Inc. for the distribution of vaccines in Europe. We also have alliances with several Japanese companies for the marketing of some of our products in Japan. See “Item 4. Information on the Company — B. Business Overview — Markets — Marketing and Distribution.”Overview”; our major alliances are detailed under “— Main pharmaceutical products”. When we market our products through collaboration arrangements, we are subject to the risk that certain decisions, such as the establishment of budgets and promotion strategies, are subject to the control of our collaboration partners, and that deadlocks may adversely affect the activities conducted through the collaboration arrangements. For example, our alliances with BMS are subject to the operational management of BMS in some countries, including the United States. We cannot be certainAny conflicts that we may have with our partners will perform their obligations as expected. Further,may affect the marketing of certain of our partners might pursue their own existing or alternative technologies or product candidatesproducts. Such difficulties may cause a decline in preference to those being developed or marketed in collaboration with us.our revenues and affect our results of operations.

The manufacture of our products is technically complex, and supply interruptions, product recalls or inventory losses caused by unforeseen events may reduce sales, delay the launch of new products and adversely affect our operating results and financial condition.

Many of our products are manufactured using technically complex processes requiring specialized facilities, highly specific raw materials and other production constraints. Our vaccine products in particular are subject to the risk of manufacturing stoppages or the risk of loss of inventory because of the difficulties inherent to the sterile processing of biological materials and the potential for the unavailability of adequate amounts of raw materials meeting our standards. Additionally, specific conditions must be respected both by the Group and its customers for the storage and distribution of many of our products, e.g.e.g., cold storage for certain vaccines.vaccines and insulin-based products. The complexity of these processes, as well as strict companyinternal and government standards for the manufacture of our products, subject us to risks. The occurrence or suspected occurrence of out-of-specification production or storage can lead to lost inventories, and in some cases product recalls, with consequential reputational damage and the risk of product liability (See “— Risks Relating to Our IndustryLegal Matters — Product liability claims could adversely affect our business, results of operations and financial condition,” below)condition” above). The investigation and remediation of any identified problems can cause production delays, substantial expense, lost sales and the delay of new product launches.launches and can adversely affect our operating results and financial condition.

We dependrely on third parties for the manufacture and supply of a substantial portion of our raw materials, specialized components, active ingredients and medical devices.

Availability of Raw Materials and Specialized Components.Third parties supply us with a substantial portion of our raw materials, and specialized components. Some raw materials and specialized components essential to the manufacture of our products are not widely available from sources we consider reliable — for example, there is a limited number of approved suppliers of heparins, which are used in the manufacture of Lovenox^®. See “Item 4. Information on the Company — B. Business Overview — Production and Raw Materials” for a description of these outsourcing arrangements.

Third-Party Manufacturing of Active Ingredients. Although our general policy is to manufacture the active ingredients for our products ourselves, we subcontract the manufacture of some of our active ingredients to third parties,and medical devices, which exposes us to the risk of a supply interruption in the event that ourthese suppliers experience financial difficulties or are unable to manufacture a sufficient supply of our products. The manufactureproducts meeting Group quality standards. It also increases the risk of quality issues, even with the active ingredients for Eloxatinemost scrupulously selected suppliers. For example, in 2008 we recalled a limited number of batches of Lovenox^® and Xatral^® and partwrote down significant unused inventory following the discovery of the manufacturequality issues at a Chinese supplier of the active ingredient for Stilnox^® are currently carried out by third parties, as are some of the manufacturing steps in the production of Lovenox^®. Additionally, under our collaborative arrangement with BMS, pharmaceutical production of Plavix^® and Aprovel^® is conducted partly in sanofi-aventis plants and partly in BMS plants.

Third-Party Supply of Medical Devices. Medical devices related to some of our products, such as certain pens used to dispense insulin, are manufactured by third parties. Reliance on third parties exposes us to the risk of supply interruptions, including as a result of third-party manufacturing problems, as well as the risk of product liability for materials not produced by the Group. See “— Product liability claims could adversely affect our business, results of operations and financial condition,” below.

raw materials. If disruptions or quality concerns were to arise in the third-party supply of raw materials, specialized components, active ingredients or medical devices, this could adversely affect our ability to sell our products in the quantities demanded by the market and could damage our reputation and relationships with our customers. See also “— The manufacture of our products is technically complex, and supply interruptions, product recalls or inventory losses caused by unforeseen events may reduce sales, delay the launch of new products and adversely affect our operating results and financial condition,”condition” above. Even though we aim to have backup sources of supply whenever possible, including by manufacturing backup supplies of our principal active ingredients at a second or third facility when practicable, we cannot be certain they will be sufficient if our principal sources become unavailable. Switching sources and manufacturing facilities may require significant time. Some raw materials essential to the manufacture of our products are not widely available from sources we consider reliable; for example, we have approved only a limited number of suppliers of heparins for use in the manufacture of Lovenox^®. Heparin purchase prices can also fluctuate. See “Item 4. Information on the Company — B. Business Overview — Production and Raw Materials” for a description of these outsourcing arrangements. Any of these factors could adversely affect our business, operating results or financial condition.

Our collaborations with third parties expose us to risks that they will claim intellectual property rights on our inventions or fail to keep our unpatented technology confidential.

We occasionally provide information and materials to research collaborators in academic institutions or other public or private entities, or request them to conduct tests to investigate certain materials. In all cases we enter into appropriate confidentiality and intellectual property rights agreements with such entities. However,

those entities might claim intellectual property rights with respect to the results of the tests conducted by their collaborators, and might not grant licenses to us regarding their intellectual property rights on acceptable terms.

We also rely upon unpatented proprietary technology, processes, know-how and data that we regard as trade secrets and protect them in part by entering into confidentiality agreements with our employees, consultants and certain contractors. We cannot be sure that these agreements or other trade secret protections will provide meaningful protection, or, if they are breached, that we will have adequate remedies. You should read “Item 4. Information on the Company — B. Business Overview — Patents, Intellectual Property and Other Rights” for more information about our patents and licenses.

Claims and investigations relating to marketing practices and competition law could adversely affect our business, results of operations and financial condition.

The marketing of our products is heavily regulated, and alleged failures to comply fully with applicable regulations could result in civil or criminal actions against us, and in some circumstances potential disqualification from participation in government health programs. Sanofi-aventis and certain of its subsidiaries are under investigation by various federal government entities in the United States, and are defendants in a number of lawsuits, relating to antitrust and/or pricing and marketing practices, including, for example, class action lawsuits and qui tam litigation. See Note D.22.c) to our consolidated financial statements included at Item 18 of this annual report.

Following judgments holding the U.S. patent protection of Lovenox^® and of DDAVP^® tablets to be unenforceable, a number of civil antitrust and fair trade claims have been filed against sanofi-aventis as putative class actions alleging that the Group has prevented competition and generated excess profits. Similar claims have followed an attempt to settle our U.S. Plavix^® patent litigation. The proposed settlement of the U.S. Plavix^® patent litigation against Apotex by the parties thereto is also the subject of a criminal investigation by the Antitrust Division of the U.S. Department of Justice, of which the outcome and impact on sanofi-aventis cannot reasonably be assessed at this time. See “Item 8. Financial Information — A. Consolidated Financial Statements and other Financial Information — Information on Legal or Arbitration Proceedings” and Note D.22.c) to our consolidated financial statements included at Item 18 of this annual report.

Because many of these cases allege substantial unquantified damages, may be subject to treble damages, and frequently seek significant punitive damages and penalties, it is possible that any final determination of liability or settlement of these claims or investigations could have a material adverse effect on our business, results of operations or financial condition.

Fluctuations in currency exchange rates could adversely affect our results of operations and financial condition.

Because we sell our products in numerous countries, our results of operations and financial condition could be adversely affected by fluctuations in currency exchange rates. We are particularly sensitive to movements in exchange rates between the euro and the U.S. dollar, the British pound, the Japanese yen, and to a lesser extent to currencies in emerging countries. In 2006, approximately 35.1% of our net sales were realized in the United States. While we incur expenses in those currencies, the impact of currency exchange rates on these expenses does not fully offset the impact of currency exchange rates on our revenues. As a result, currency exchange rate movements can have a considerable impact on our earnings. When deemed appropriate, we enter into transactions to hedge our exposure to foreign exchange risks. These efforts, when undertaken, may fail to offset the effect of adverse currency exchange rate fluctuations on our results of operations or financial condition. For more information concerning our exchange rate exposure, see “Item 11. Quantitative and Qualitative Disclosures About Market Risk.”

Risks Relating to Our Industry

We must invest substantial sums in research and development in order to remain competitive, and we may not fully recover these investments if our products are unsuccessful in clinical trials or fail to receive and maintain regulatory approval.

To be successful in the highly competitive pharmaceutical industry, we must commit substantial resources each year to research and development in order to develop new products. In 2006, we spent €4,430 million on

research and development, amounting to approximately 15.6 % of our net sales. Our ongoing investments in new product launches and research and development for future products could result in higher costs without a proportionate increase in revenues.

The research and development process is lengthy and carries a substantial risk of product failure. If our research and development does not yield sufficient new products that achieve commercial success, our future operating results may be adversely affected.

The research and development process typically takes from 10 to 15 years from discovery to commercial product launch. This process is conducted in various stages, and during each stage there is a substantial risk that we will not achieve our goals and will have to abandon a product in which we have invested substantial amounts.

For example, in order to develop a commercially viable product, we must demonstrate, through extensive pre-clinical and human clinical trials, that the pharmacological compounds have an acceptable benefit/risk profile for human use in the proposed indications. There is also no assurance that favorable results obtained in pre-clinical trials will be confirmed by later clinical trials, or that the clinical trials will establish safety and efficacy data sufficient for regulatory approval. In the first quarter of 2007, we had 125 compounds in pre-clinical and clinical development in our targeted therapeutic areas, of which 58 were in Phase II or Phase III clinical trials. For additional information regarding clinical trials and the definition of the phases of clinical trials, see “Item 4. Information on the Company — B. Business Overview — Research & Development.” There can be no assurance that any of these compounds will be proven safe or effective, or that they will produce commercially successful products.

After completing the research and development process, we must invest substantial additional resources with a view to obtaining government approval in multiple jurisdictions, with no assurance that approval will be obtained. We must obtain and maintain regulatory approval for our pharmaceutical products from the European Union, the United States and other regulatory authorities before a given product may be sold in these markets. The submission of an application to a regulatory authority provides no assurance that the regulatory authority will grant a license to market the product. Each authority may impose its own requirements, including requiring local clinical studies, and may delay or refuse to grant approval, even though a product has already been approved in another country.

In our principal markets, the approval process for one or more indications of a new product is complex and lengthy, and typically takes from six months to two years from the date of application depending on the country. Moreover, if regulatory approval of a product is granted, the approval may place limitations on the indicated uses for which it may be marketed. A marketed product is also subject to continual review even after regulatory approval. Later discovery of previously unknown problems may result in marketing restrictions or withdrawal of the product, as well as an increased risk of litigation. See also “— Product liability claims could adversely affect our business, results of operations and financial condition,” below. In addition, we are subject to strict government controls on the manufacture, labeling, distribution and marketing of our products. Each of these factors may increase our costs of developing new products and the risk that we may not succeed in selling them successfully.

Obtaining regulatory marketing approval is not a guarantee that the product will achieve commercial success. Commercial success is dependent on a number of factors beyond our control, notably the level of reimbursement which is accorded to the product by public health entities and third-party payers in each country, the acceptance of the product by the medical establishment and patients, and the existence and price of competing products and alternative therapies.

If we are unable to protect our proprietary rights, we may fail to compete effectively or operate profitably.

It is important for our success that we be able to effectively obtain and enforce our patents and other proprietary rights. We hold a broad portfolio of patents, patent licenses and patent applications worldwide. To the extent effective patent protection of our products is not maintained, these products will become exposed to competition from generic products. The entry of a generic product into the market typically is followed by a substantial decline in the brand-name product’s sales volume and revenues.

Obtaining Patent Rights. Patent law relating to the scope of claims in the pharmaceutical field in which we operate is continually evolving and can be the subject of some uncertainty. Accordingly, we cannot be sure that:

Patent protection once obtained is limited in time (typically 20 years), after which competitors may use the covered technology without obtaining a license from us. Because of the time required to obtain regulatory marketing approval, the period of effective patent protection for a marketed product is frequently substantially shorter.

Enforcing Patent Rights. Our competitors may infringe our patents or successfully avoid them through design innovation. To prevent infringement, we may file infringement claims, which are expensive and time consuming and which may result in decisions unfavorable to us. Policing unauthorized use of our intellectual property is difficult, and we may not be able to prevent misappropriation of our proprietary rights. We may also be accused of infringing the rights of others who then seek substantial damages from us. This risk is increased by the growth in the number of patent applications filed and patents granted in the pharmaceutical industry.

Even prior to the scheduled expiration of a patent, third parties may challenge the validity of the patents issued or licensed to us, which may result in the invalidation of these rights and the loss of sales derived from the related products. Such challenges have become increasingly common in recent years. Typical assertions in suits challenging a patent are that (i) the competing product does not fall within the scope of the patent, (ii) that the patent claims matters that are not in fact patentable, for example because they are not a true innovation; or (iii) that there were procedural flaws that invalidate the patent office’s decision to issue the patent. Patent litigation is subject to substantial uncertainty, and we cannot be sure how much protection, if any, will be provided by our patents if we attempt to enforce them and they are challenged in court or in other proceedings.

Additionally, if a competitor chooses to take the risk of launching an infringing product prior to a court’s determination that our patent rights are valid, enforceable and infringed, there can be no assurance that we will (i) be successful in obtaining a preliminary injunction to halt further sales and remove the infringing product from the market prior to obtaining a final injunction at trial, and even if we are successful, (ii) be able to obtain an award of sufficient damages from the competitor to repair all harm caused to us and (iii) effectively collect this award. By way of example, following the Group’s failure to obtain a preliminary injunction halting the launch at risk of a generic version of Allegra^® in October 2005, the Allegra^® franchise in the United States has been substantially eroded and the asserted patent claims have still not gone to trial. While we were successful in obtaining a preliminary injunction halting further sales of a generic Plavix^® in August 2006, the significant quantities of generic product already distributed prior to the injunction have had a significant negative effect on 2006 earnings and caused us substantial and persistent commercial harm.

Our patent rights are material to our business, and if we were unsuccessful in asserting them or they were deemed invalid, any resulting introduction of generic versions of our products in the United States, in Europe or in other markets would reduce the price that we receive for these products and the volume of the product that we would be able to sell, and could materially adversely affect our business, results of operations and financial condition. Additionally, a number of our products acquired through business combinations have substantial balance sheet carrying values, as disclosed at Note D.4 to our consolidated financial statements, which could be substantially impaired by the introduction of a generic competitor, with adverse effects on our financial results and assets.

Significant challenges to our proprietary rights concern such leading Group products as Plavix^®, Lovenox^®, Eloxatine^® and Allegra^®. We are also involved in litigation challenging the validity or enforceability of patents related to a number of other products in the United States, the European Union and elsewhere, and challenges to other products may be expected in the future. We can give no assurance that as a result of these challenges we will not face generic competition for additional group products. See “Item 8. Financial Information — A. Consolidated Financial Statements and Other Financial Information — Information on Legal or Arbitration Proceedings” and Note D.22.b) to our consolidated financial statements included in this annual report at Item 18 for additional information.

Product liability claims could adversely affect our business, results of operations and financial condition.

Product liability is a significant commercial risk for us, and has become a more significant risk as we expand in the United States (where product liability claims can be particularly costly). Substantial damage awards have been made in certain jurisdictions against pharmaceutical companies based upon claims for injuries allegedly caused by the use of their products. Not all possible side effects of a drug can be anticipated based on preapproval clinical studies involving only several hundred to several thousand patients. Routine review and analysis of the continually growing body of post-marketing safety surveillance and clinical trials provide additional information — for example potential evidence of rare, population-specific or long-term adverse reactions or of drug interactions that were not observed in preapproval clinical studies — and may cause product labeling to evolve. Several pharmaceutical companies have recently recalled or withdrawn products from the market based on actual or suspected adverse reactions to their products, and currently face significant product liability claims. We are currently defending a number of product liability claims (see Note D.22 to the consolidated financial statements included at Item 18 of this annual report and “Item 8. Financial Information — A. Consolidated Financial Statements and Other Financial Information — Information on Legal or Arbitration Proceedings”), and there can be no assurance that the Group will not face additional claims in the future. Although we maintain insurance to cover the risk of product liability, available insurance may not be sufficient to cover all potential liabilities. Further, we face a general trend in the insurance industry to reduce product liability coverage, by excluding products or by imposing limits for liabilities, causing companies to rely increasingly on self-insurance. Substantial product liability claims, if successful, could adversely affect our business, results of operations and financial condition.

Counterfeit versions of the Group’s products could harm the business of sanofi-aventis.our business.

The prescription drug supply has been increasingly challenged by the vulnerability of distribution channels to illegal counterfeiting and the presence of counterfeit products in a growing number of markets and over the internet.Internet. Counterfeit products are frequently unsafe or ineffective, and can be potentially life-threatening. To distributors and users, counterfeitscounterfeit products may be visually indistinguishable from the authentic version. Reports of adverse reactions to counterfeit drugs or increased levels of counterfeiting could materially affect patient confidence in the authentic product, and could harm the business of companies such as sanofi-aventis. Additionally, it is possible that adverse events caused by unsafe counterfeit products will mistakenly be attributed to the authentic product. If a Group product entailingwere the subject of counterfeits, the Group could incur substantial reputational and financial harm toharm. See “Item 4. Information on the manufacturer of the authentic product.Company — B. Business Overview — Competition.”

Use of biologically derived ingredients may face consumer resistance from patients or the purchasers of these products, which could adversely affect sales and cause us to incur substantial costs.

In line with industry practice, we manufacture our vaccines and many of our prescription pharmaceutical products with ingredients derived from animal or plant tissue. Most of these products cannot be made economically, if at all, with synthetic ingredients. We subject our products incorporating these ingredients to extensive tests and believe them to be safe. There have been instances in the past where the use of biologically derived ingredients by sanofi-aventis or its competitors has been alleged to be an actual or theoretical source of harm, including infection or allergic reaction, or instances where production facilities have been subject to prolonged periods of closure because of possible contamination. Such allegations have on occasion led to damage claims and increased consumer resistance on the part of patients to such ingredients. A substantial claim of harm caused by a product incorporating biologically derived ingredients or a contamination event could lead us to incur potentially substantial costs as a result of, among other things, litigation of claims, product recalls, adoption of additional safety measures, manufacturing delays, investment in consumerpatient education, and development of synthetic substitutes for ingredients of biological origin. Such claims could also generate consumerpatient resistance, with a corresponding adverse effect on sales and results of operations.

We face uncertainties overare subject to the pricingrisk of pharmaceutical products.non-payment by our customers.⁽¹⁾

The commercial successWe run the risk of non-payment by our products depends in part oncustomers, which consist principally of wholesalers, distributors, pharmacies, hospitals, clinics and government agencies. This risk is accentuated by the conditions under which our products are reimbursed. Price pressure is strong due to:

Price pressure is considerable in our two largest markets, Europe and thecurrent worldwide financial crisis. The United States, which representedis our largest market in terms of sales, poses particular client credit risk issues, because of the concentrated distribution system in which approximately 43.1% and 35.1%, respectively,78% of our netconsolidated U.S. pharmaceutical sales were accounted for by just three wholesalers. In addition, the Group’s three main customers represent 22% of our total revenues. We are also exposed to large wholesalers in 2006. Pricingother markets, particularly in the German market posed significant challenges for the Group in 2006, including a decisionEurope. An inability of one or more of these wholesalers to classify Acomplia^® as a non-reimbursed quality-of-life drug; substantial restrictions on the reimbursement of fast-acting analog insulin; and the announcement that the government was evaluating restrictions on additional products. Changes in the pricing environments in the United States or European marketshonor their debts to us could have a significant impact on our sales and results of operations. See “Item 4. Information on the Company — B. Business Overview — Markets — Pricing” for a description of certain regulatory pricing systems thatadversely affect our Group.financial condition (see Note D.34. to our consolidated financial statements included at Item 18 of this annual report).

Our pension liabilities are affected by factors such as the performance of plan assets, interest rates, actuarial data and experience and changes in laws and regulations.

Our future funding obligations for our main defined-benefit pension plans depend on changes in the future performance of assets held in trust for these plans, the interest rates used to determine funding levels (or company liabilities), actuarial data and experience, inflation trends, the level of benefits provided for by the plans, as well as changes in laws and regulations. Adverse changes in those factors could increase our unfunded obligations under such plans, which would require more funds to be contributed and hence negatively affect our cash flow and results may also be adversely affected by parallel imports, a practice by which traders exploit price differentials among markets by purchasing in lower-priced markets for resale in higher-priced markets.(see Note D.18.1 to our consolidated financial statements included at Item 18 of this annual report).

Changes in the marketing status or competitive environmentEnvironmental Risks of our major products could adversely affect our results of operations.Our Industrial Activities

In some cases, pharmaceutical products face the risk of being switched from prescription drug status to over-the-counter (OTC) drug status by national regulatory authorities. OTC drugs may not benefit from the same reimbursement schemes and are generally priced significantly lower than brand-name prescription drugs. The competitive environment for our products could also be adversely affected if generic or OTC versions of competitors’ products were to become available.

Risks from the handling of hazardous materials could adversely affect our results of operations.

Pharmaceutical manufacturing

Manufacturing activities, such as the chemical manufacturing of the active ingredients in our products and the related storage and transportation of raw materials, products and wastes, expose us to various risks, including:

These operating risks can cause personal injury, property damage and environmental contamination, and may result in:

The occurrence of any of these events may significantly reduce the productivity and profitability of a particular manufacturing facility and adversely affect our operating results.

Although we maintain property, business interruption and casualty insurance that we believe is in accordance with customary industry practices, we cannot assure you that this insurance will be adequate to cover fully all potential hazards incidental to our business. For more detailed information on environmental issues, see “Item 4. Information on the Company — B. Business Overview — Health, Safety and Environment.”

Environmental liabilities and compliance costs may have a significant adverse effect on our results of operations.

The environmental laws of various jurisdictions impose actual and potential obligations on our Group to remediate contaminated sites. These obligations may relate to sites:

These environmental remediation obligations could significantly reduce our operating results. In particular, our accruals for these obligations may be insufficient if the assumptions underlying these accruals prove incorrect or if we are held responsible for additional, currently undiscovered contamination. Sanofi-aventis accrues reservesprovisions for remediation when our management believes the need is probable and that it is reasonably possible to estimate the cost. See “Item 4. Information on the Company — B. Business Overview — Health, Safety and Environment (HSE)” for additional information regarding our environmental policies. In particular, our provisions for these obligations may be insufficient if the assumptions underlying these provisions prove incorrect or if we are held responsible for additional, currently undiscovered contamination. These judgments and estimates may later prove inaccurate, and any shortfalls could have a material adverse effect on our results of operations. See “Item 4. Information on the Company — B. Business Overview — Health, Safetyoperations and Environment” for additional information regarding our environmental policies.financial condition.

Furthermore, we are or may become involved in claims, lawsuits and administrative proceedings relating to environmental matters. Some current and former sanofi-aventis subsidiaries have been named as “potentially responsible parties” or the equivalent under the U.S. Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended (also known as “Superfund”), and similar statutes in the United States, France, Germany, Italy, Brazil and elsewhere. As a matter of statutory or contractual obligation, we and/or our subsidiaries may retain responsibility for environmental liabilities at some of the sites of our predecessor companies, or our subsidiaries that we demerged, divested or may divest. We have disputes outstanding, for example, with Albemarle and Rhodia, over costs related to environmental remediation at severalliabilities regarding certain sites no longer owned by the Group. An adverse outcome in such disputes might have a significant adverse effect on our operating results. See Note D.22.e) to the consolidated financial statements included at Item 18 of this annual report.

Finally, stricterEnvironmental regulations are evolving (i.e., in Europe, REACH, SEVESO, IPPC, the Waste Framework Directive, the Emission Trading Scheme Directive, the Water Framework Directive and the Directive on Taxation of Energy Products and Electricity and several other regulations aiming at preventing global warming). Stricter environmental, safety and health laws and enforcement policies could result in substantial costs and liabilities to our Group and could subject our handling, manufacture, use, reuse or disposal of substances or pollutants, site restoration and compliance costs to more rigorous scrutiny than is currently the case. Consequently, compliance with these laws could result in significant capital expenditures as well as other costs and liabilities, thereby adversely affecting our business, results of operations or financial condition. For more detailed information on environmental issues, see “Item 4. Information on the Company — B. Business Overview — Health, Safety and Environment (HSE).”

Risks Related to Financial Markets⁽¹⁾

Fluctuations in currency exchange rates could adversely affect our results of operations and financial condition.

Because we sell our products in numerous countries, our results of operations and financial condition could be adversely affected by fluctuations in currency exchange rates. We are particularly sensitive to movements in exchange rates between the euro and the U.S. dollar, the British pound, the Japanese yen, and to currencies in emerging countries. In 2009, approximately 32% of our net sales were realized in the United States. While we incur expenses in those currencies, the impact of currency exchange rates on these expenses does not fully offset the impact of currency exchange rates on our revenues. As a result, currency exchange rate movements can have a considerable impact on our earnings. When deemed appropriate and when technically feasible, we enter into transactions to hedge our exposure to foreign exchange risks. These efforts, when undertaken, may fail to offset the effect of adverse currency exchange rate fluctuations on our results of operations or financial condition. For more information concerning our exchange rate exposure, see “Item 11. Quantitative and Qualitative Disclosures about Market Risk.”

In the context of the worldwide financial crisis, our liquidity may be constrained.

As of December 31, 2009, the Group’s net debt amounted to €4.1 billion. In addition to debt outstanding, the Group has contracted a number of credit lines and put into place commercial paper and medium term note programs with the aim of providing liquidity. See “Item 11. Quantitative and Qualitative Disclosures about Market Risk.” In the event of a market-wide liquidity crisis, the Group might be faced with reduced access to

sources of financing, including under programs currently in place, or less favorable conditions. While liquidity conditions in the financial markets have improved somewhat in recent months, they could deteriorate once again, in which case our sources of financing could be substantially reduced, and we might find it difficult to refinance existing debt or to incur new debt on terms that we would consider to be commercially reasonable.

Risks Relating to an Investment in our Shares or ADSs

Foreign exchange fluctuations may adversely affect the U.S. dollar value of our ADSs and dividends (if any).

As a holderHolders of ADSs you may face exchange rate risk. Our ADSs trade in U.S. dollars and our shares trade in euro.euros. The value of the ADSs and our shares could fluctuate as the exchange rates between these currencies fluctuate. If and when we do pay dividends, they would be denominated in euro.euros. Fluctuations in the exchange rate between the euro and the U.S. dollar will affect the U.S. dollar amounts received by owners of ADSs upon conversion by the depositary of cash dividends, if any. Moreover, these fluctuations may affect the U.S. dollar price of the ADSs on the New York Stock Exchange (NYSE), whether or not we pay dividends in addition to the amounts, if any, that youa holder would receive upon our liquidation or upon the sale of assets, merger, tender offer or similar transactions denominated in euroeuros or any foreign currency other than U.S. dollars.

If you holdPersons holding ADSs rather than shares it may be difficult for you to exercise some of yourhave difficulty exercising certain rights as a shareholder.

As a holderHolders of ADSs it may behave more difficult for you to exercise yourdifficulty exercising their rights as a shareholder than it would be if youthey directly held shares. For example, if we offer new shares and youthey have the right to subscribe for a portion of them, the depositary is allowed, at its own discretion, to sell for yourtheir benefit that right to subscribe for new shares instead of making it available to you.them. Also, to exercise yourtheir voting rights, as a holderholders of ADSs, youthey must instruct the depositary how to vote yourtheir shares. Because of this extra procedural step involving the depositary, the process for exercising voting rights will take longer for you, as a holderholders of ADSs than for holders of shares. ADSs for which the depositary does not receive timely voting instructions will not be voted at any meeting.

Our two largest shareholders own a significant percentage of the share capital and voting rights of sanofi-aventis.

AtAs of December 31, 2006,2009, Total and L’Oréal, our two largest shareholders, held approximately 13.1%7.33% and 10.5%8.97% of our issued share capital, respectively, accounting for approximately 19.3%12.36% and approximately 17.3%15.32%, respectively, of the voting rights (excluding treasury shares) of sanofi-aventis. See “Item 7. Major Shareholders and Related Party Transactions — A. Major Shareholders.”

Affiliates of each of these shareholders are currently serving on our Board of Directors. To the extent these shareholders continue to hold a large percentage of our share capital and voting rights, Total and L’Oréal will remain in a position to exert heightened influence in the election of the directors and officers of sanofi-aventis and in other corporate actions that require shareholders’ approval. Continued ownership of a large percentage of the share capital and voting rights of sanofi-aventis by these two principal shareholders, affiliates of whom may also continue to be members of the sanofi-aventis board of directors, may have the effect of delaying, deferring or preventing a future change in the control of sanofi-aventis and may discourage future bids for sanofi-aventis other than with the support of these shareholders.

Sales of our shares may cause the market price of our shares or ADSs to decline.

Neither Total nor L’Oréal are,is, to our knowledge, subject to any contractual restrictions on the sale of the shares each holds in our Company. Both of these shareholders have announced their intent to sell all or part of their stakes in our company, and have recently liquidated a significant part of their respective holdings. Sales of a substantial numberlarge numbers of our shares, or a perception that such sales may occur, could adversely affect the market price for our shares and ADSs.

Item 4. Information on the Company

Introduction

We are a global pharmaceutical group engaged in the research, development, manufacture and marketing of healthcare products. In 2006,2009, our net sales amounted to €28,373€29,306 million. Based on 20062009 sales, we are the fourth largest pharmaceutical group in the world and the second largest pharmaceutical group in Europe (source: IMS/GERS consolidatedIMS sales year end 2006; all available channels)2009). Sanofi-aventis is the parent of a consolidated group of companies. A list of the principal subsidiaries included in this consolidation is shown at Note EF. to theour consolidated financial statements included underat Item 18 of this annual report.

Our business includes two main activities: pharmaceuticals, and human vaccines (Vaccines)through sanofi pasteur. The Group is also present in animal health products through Merial Limited (“Merial”).

In our pharmaceutical activity, which generated net sales of €25,840€25,823 million in 2006,2009, we specialize in sixthe following therapeutic areas:

Our top fifteenThe global portfolio of sanofi-aventis also comprises a wide range of other pharmaceutical products in terms of net sales generated in 2006 are Lovenox^®, Plavix^®, Stilnox^®, Taxotere^®, Eloxatine^®, Lantus^®, Copaxone^®, Aprovel^®, Tritace^®, Allegra^®, Amaryl^®, Xatral^®, Actonel^®, Depakine^®Consumer Health Care (“CHC”) and Nasacort^® which together accounted for 66.9% of our 2006 net sales for the pharmaceutical activity, or €17,289 million.other prescription drugs including generics.

We are a major playerworld leader in the vaccines industry, withindustry. Our net sales of €2,533amounted to €3,483 million in 2006; and2009, with leading vaccines in five areas:

•

Adult and adolescent booster vaccines protecting against pertussis, tetanus, diphtheria and polio. Our main products include: Adacel® (the first trivalent booster against pertussis, tetanus and diphtheria for adolescents and adults)adults, launched in the U.S. in 2005), Adacel Polio®, Decavac®, Repevax® and Revaxis®;

In 2006,2009, our Vaccinesvaccines activity was favorably impactedinfluenced by the successcontinued uptake of three products launchedPentacel^® sales following its U.S. launch in 20052008, and by the sales growth of Pentaxim^® in the United States (Decavacinternational⁽¹⁾ region. Sanofi Pasteur also strengthened its leadership position in both seasonal and pandemic influenza.

Our animal health activity is managed through Merial, formerly a joint venture in which we and Merck & Co., Inc. (“Merck”) each held 50%. On September 17, 2009 we acquired Merck’s interest in Merial. On March 8, 2010, sanofi-aventis exercised its contractual right to combine the Intervet/Schering-Plough Animal Health business with Merial to form an animal health joint venture that would be equally owned by the new Merck and sanofi-aventis. In addition to execution of final agreements, formation of the new animal health joint venture remains subject to approval by the relevant competition authorities and other closing conditions (for more information see “Item 8 — B. Significant Changes — Merial” and Notes D.1 and D.8.1 to our consolidated financial statements included at Item 18 of this annual report). Merial is one of the world’s leading animal healthcare companies dedicated to the research, development, manufacture and delivery of innovative pharmaceuticals and vaccines used by veterinarians, farmers and pet owners. Its net sales for 2009 (which are not included in the Group’s 2009 net sales) amounted to $2,554 million. The company’s top-selling products include Frontline^®, Menactraa topical anti-parasitic flea and tick brand for dogs and cats, Heartgard^® and Adacel, a parasiticide for control of heartworm in companion animals as well as Ivomec^®), a parasiticide for the control of internal and by a favorable influenza season.

We have a strong commitment to research and development. We have 29 research centers and over 19,000 employees (including Vaccines, Industrial Development and Medical/Regulatory staffexternal parasites in subsidiaries) devoted to research and development.livestock.

In the description below, the following should be kept in mind:

A. History and Development of the Company

Sanofi-aventis was incorporated under the laws of France in 1994 as asociété anonyme, a form of limited liability company, for a term of 99 years. We operate under the commercial name “sanofi-aventis.”“sanofi-aventis”. Our registered office is located at 174, avenue de France, 75013 Paris, France, and our main telephone number is +33 1 53 77 40 00. Our principal U.S. subsidiary’s office is located at 55 Corporate Drive, Bridgewater, NJ 908.981.5000.08807; Telephone: +1 (908) 981-5000.

We are present in more than 100approximately 110 countries on five continents with around 100,000about 105,000 employees worldwide at year end 2006.2009, not including an additional 5,600 employees of Merial. Our legacy companies, Sanofi-Synthélabo (formed by a merger between Sanofi and Synthélabo in 1999) and Aventis our legacy companies,(formed by the combination of Rhône-Poulenc and Hoechst also in 1999), bring to the Group more than a century of experience in the pharmaceutical industry.

Sanofi was founded in 1973 by Elf Aquitaine, a French oil company, when it took control of the Labaz group, (aa pharmaceutical company) for diversification purposes. Sanofi launched its first major product on the market, Ticlid^®, in 1978.company. Its first significant venture into the United StatesU.S. market was the acquisition of the prescription pharmaceuticals business of Sterling Winthrop — an affiliate of Eastman Kodak — in 1994, followed by the launch of its first major products: Aprovel^® in 1997 and Plavix^® in 1998.

Synthélabo was founded in 1970 through the merger of two French pharmaceutical laboratories, Laboratoires Dausse (founded in 1834) and Laboratoires Robert & Carrière (founded in 1899). In 1973, the French cosmetics group L’Oréal acquired the majority of its share capital, and in 1988 Synthélabo launched two major products on the French market: Stilnox^® and Xatral^®. By 1994, Stilnox^® had become the leading insomnia prescription medication worldwide (IMS Health).capital.

Sanofi and Synthélabo merged in 1999.

The formation of Aventis on December 1999 was the result of the combination of Rhône-Poulenc and Hoechst bringing together a broad portfolio of activities including prescription drugs and vaccines, which became the core business of Aventis.

Hoechst traces its origins to the second half of the 19th century, with the German industrial revolution and the emergence of the chemical industry. Traditionally active in pharmaceuticals, (notably penicillin), Hoechst strengthened its position in that industry by taking a controlling interest in Roussel-Uclaf in 1974 and the U.S. pharmaceutical company Marion Merrell in 1995. Hoechst was especially strong in metabolic disorders with Amaryl^® and several insulin products, and cardiovascular diseases with Tritace^®.

Rhône-Poulenc was formed in 1928 from the merger of two French companies: a chemical company created by the Poulenc brothers and the Société Chimique des Usines du Rhône, which was founded in 1895. The company’s activities in the first half of the 20th century focused on producing chemicals, textiles and pharmaceuticals (acetylsalicylic acid and penicillin).pharmaceuticals. Rhône-Poulenc began to focus its activities on life sciences in the 1990s, which led to the successive purchases of Rorer, a U.S. pharmaceutical company acquired in two stages in 1990 and 1997, InstitutPasteur Mérieux Connaught in the area of vaccines in 1994 and the U.K.-based pharmaceuticals company Fisons in 1995. Rhône-Poulenc’s main therapeutic fields were thrombosis with Lovenox^®, oncology with Taxotere^® and respiratory diseases with Nasacort^®, and vaccines.

Subsequent to a bid to acquire all of the shares of Aventis announced in April 2004, Sanofi-Synthélabo took control of Aventis in August 2004 and changed its registered name to “sanofi-aventis”. On December 31, 2004, Aventis merged with and into sanofi-aventis, with sanofi-aventis as the surviving company.

ForMerial was founded in 1997 as a descriptioncombination of our main divestitures since 2004,the animal health activities of Rhône-Poulenc and Merck. Merial was a joint venture in which we and Merck each held 50%. On September 17, 2009, sanofi-aventis acquired Merck’s 50% interest in Merial and Merial is now a wholly-owned subsidiary of sanofi-aventis. On March 8, 2010, sanofi-aventis exercised its contractual right to combine the Intervet/Schering-Plough Animal Health business with Merial to form an animal health joint venture that would be equally owned by the new Merck and sanofi-aventis. Formation of the new animal health joint venture remains subject to approval by the relevant competition authorities and other closing conditions (for more information see Note D.2“Item 8 — B. Significant Changes — Merial” and Notes D.1 and D.8.1 to our consolidated financial statements included inat Item 18 of this annual report.

Mandatory Offers Subsequent to the Acquisition of Aventis

Hoechstreport).

The Prague-based branded generics group Zentiva was acquired by sanofi-aventis through a tender offer completed on March 11, 2009.

On February 9, 2010 Sanofi-aventis successfully completed its tender offer for all outstanding shares of Hoechst AG not already indirectlycommon stock of Chattem, Inc., (“Chattem”) a leading U.S. consumer healthcare company. Immediately following the tender offer, sanofi-aventis held approximately 97% of Chattem’s outstanding shares, and acquired through the acquisition of Aventis were first tendered intoremaining shares in a mandatory offer during 2004. The mandatory offer was then followed by a squeeze-out taking legal effect in July 2005.

Following the squeeze-out, a number of former minority shareholders commenced litigation contesting the adequacy of the price paid by sanofi-aventis. These suits, which do not contest sanofi-aventis’ ownership of the shares acquired through the squeeze-out, are still ongoing. See Note D.2 to our consolidated financial statements included under Item 18 of this annual report.

Aventis Pharma Limited India

Following the acquisition of Aventis and in execution of its legal obligations under the Securities and Exchange Board of India takeover regulations,“short form” merger on August 11, 2004, sanofi-aventis announced an offer to acquire up to 4,606,125 equity shares of Aventis Pharma Limited India, for a cash offer price of Rupee 792.20 (€13.96) per equity share. As a result of this offer, which closed in August 2006, the Group’s total interest in Aventis Pharma Limited India is now 50.12% of that company’s share capital.March 10, 2010.

B. Business Overview

Strategy

AsSanofi-aventis is a leading playerdiversified global healthcare leader with a number of core strengths: a strong and long-established presence in emerging markets ⁽¹⁾, a portfolio of diabetes drugs including the biggest selling insulin in the pharmaceutical industry (no.1world: Lantus^®, a market-leading position in Europevaccines, a broad range of consumer health care products and no.4 in the world basedresearch that is increasingly focused on 2006 sales), sanofi-aventis continues to be dedicated to serving patients worldwide.biological products, allied with a track record of adapting cost structures and a solid financial position.

Focused on our core business — the discovery, development and marketing of innovative molecules and vaccines that drive medical progress andLike most pharmaceutical companies, we are effective to combat disease — we seek to ensure the developmentfacing competition from generics for several of our Group through our strategy of strong, sustainable and profitable growth. In addition, we continue to be actively engaged to making our drugs accessible to as many people as possible thanks to a well-adapted mix ofmajor products, in terms of pricean environment subject to cost containment pressures from both third party payers and therapeutic indications.healthcare authorities as well as tougher regulatory hurdles. We have decided to respond to these major challenges by developing our platforms for growth.

InThroughout 2009, we have been engaged in a tough, fast-changing business environment, we remain highly adaptive and responsive in pursuing our major objectives:wide-ranging transformation program designed to secure sources of sustainable growth. Our strategy focuses on three key themes:

We conducted a complete and objective review of our research portfolio in 2009, in order to reassess the substantial potentialallocation of resources. This review led to a rationalization of our portfolio, targeting the pharmaceuticals market by providing a total response to stakeholders.most promising projects. In an increasingly tight regulatory context, with mounting pressure on healthcare spending, we can rely onFebruary 2010, 60% of our global presence in fast-growing therapeutic fields serving major healthcare needs, especially thrombosis, cardiovascular, metabolic disorders, oncology, central nervous system, internal medicinedevelopment portfolio consisted of biological products and vaccines. We offer highlyalso redefined our decision-making processes so that new commercial potential and the scope for value creation are better integrated into our development choices. The ongoing reorganization of our R&D is intended to help us become more flexible and innovative, drugs, mature productswith some of excellent qualityour existing resources being reallocated to external collaborations. In line with this policy, we have signed a number of alliance and more selectively, generics which play an essential role inlicensing agreements with partners including Kyowa Hakko Kirin Co. Ltd (“Kyowa Hakko Kirin”), Exelixis, Inc. (“Exelixis”), Merrimack Pharmaceuticals, Inc. (“Merrimack”), Wellstat Therapeutics Corporation (“Wellstat”), Micromet, Inc. (“Micromet”), and Alopexx Pharmaceuticals LLC (“Alopexx”). These agreements are designed to give us access to new technologies, or to broaden or strengthen our existing fields of research. We have also signed additional agreements with Regeneron Pharmaceuticals, Inc. to broaden and extend our existing collaboration on the financial balanceresearch, development and commercialization of healthcare systems. We also propose a large rangefully human therapeutic monoclonal antibodies. In February 2010, 55% of vaccines;

During 2009, we adapted our operating model, previously too focused on the most important prescription drugs in our traditionally important markets, to reflect the diversity of our activities and our geographical reach. In particular, we tailored our strategy, structure and offering to each region’s needs, so as to deliver the most appropriate solution to each patient. 25% of our 2009 sales were in emerging markets. We strengthened our presence in vaccines and expanded our consumer health care operations, so as to address our customers’ needs more thoroughly and take better advantage of growth opportunities. We also realigned our industrial capacity to reflect our anticipation of changes in volumes and our analysis of the opportunities for growth. Streamlining our structures and our operating model have also enabled us to further improve our operating ratios. In 2009, the initial results of our cost control program fed into a one percentage point reduction in each of the ratios of our research and development expenses and our selling and general expenses to our net sales. Sanofi-aventis generated €480 million of savings in 2009 compared to 2008 cost structures.

Business development is wholly integrated into our overall strategy, and translates into disciplined acquisitions and alliances that create or strengthen platforms for long-term growth and create value for our shareholders. During 2009, we conducted an active and targeted policy of acquisitions and R&D alliances. We successfully completed our offer for Zentiva N.V. (“Zentiva”), a branded generics group with products tailored to the Eastern and Central European markets, and we also acquired Laboratorios Kendrick (“Kendrick”), one of Mexico’s leading generics manufacturers, and Medley, a leading generics company in Brazil. In R&D, we acquired two companies: BiPar Sciences, Inc. (“BiPar”), an American biopharmaceutical company developing novel tumor-selective approaches for the treatment of different types of cancers, and Fovea Pharmaceuticals SA (“Fovea”), a French biopharmaceutical R&D company specializing in ophthalmology. In consumer health care, we finalized the acquisition of Laboratoire Oenobiol (“Oenobiol”), one of France’s leading players in health and beauty dietary supplements. At the end of the year, we finalized an agreement to acquire Chattem, Inc. (“Chattem”), one of the leading manufacturers and distributors of branded consumer health products, toiletries and dietary supplements in the United States. In human vaccines, we took control of Shantha Biotechnics (“Shantha”), an Indian biotechnology company that develops, produces and markets vaccines to international

standards. We also strengthened our animal health interests by acquiring the remaining 50% of Merial not previously held by us and subsequently exercised on March 8, 2010, our contractual right to combine the Intervet/Schering-Plough Animal Health business with Merial to form an animal health joint venture that would be equally owned by the new Merck and sanofi-aventis. In addition to execution of final agreements, formation of the new animal health joint venture remains subject to approval by the relevant competition authorities and other closing conditions (for more information see “Item 8 — B. Significant Changes — Merial” and Notes D.1 and D.8.1 to our consolidated financial statements included at Item 18 of this annual report).

Our sound financial position should give us significant potential to create value via external growth opportunities, with the aim of securing a return on investment in excess of our cost of capital.

Pharmaceutical Products

Main Pharmaceutical Products

Within our pharmaceuticalsPharmaceuticals business, we focus on six mainthe following therapeutic areas: diabetes, oncology, thrombosis & cardiovascular, metabolic disorders, oncology, central nervous system and internal medicine.

Top 15 products

The following table sets forth the net sales of our top 15 pharmaceutical products for the year ended December 31, 2006.

The sections that follow provide additional information on the indications and market position of our top 15these products in their principal markets. The Group’s intellectual property relating to our top 15its pharmaceutical products is material to our operations and is described at “ —“— Patents, Intellectual Property and Other Rights — Product Overview,”other Rights” below. As disclosed in Note D.22.b)D.22.b to our consolidated financial statements included at Item 18 of this annual report, we are involved in significant litigation concerning the patent protection of a number of our top 15 products including notably Lovenox^® (the U.S. patent has been ruled unenforceable; we intend to appeal), Plavix^®, Tritace^®, Eloxatine^®, Ambien CR^™, Allegra^®, Nasacort^®, and Actonel^®.these products.

Top 15The following table sets forth the net sales of our best selling pharmaceutical products for the year ended December 31, 2009. These products are major contributors to public health.

Thrombosis

Thrombosis occurs when a thrombus, or blood clot, forms inside a blood vessel. Left unchecked, a thrombus can eventually grow large enough to block the blood vessel, preventing blood and oxygen from reaching the organ being supplied. Our principal products for the treatment and prevention of thrombosis are:

Lovenox^®/Clexane^®

Lovenox^® (enoxaparin sodium) is the most widely studied and used low molecular weight heparin (LMWH) in the world. It has been used to treat an estimated 185 million patients in 96 countries since it was first introduced in 1987 and is approved for more clinical indications than any other LMWH. Numerous clinical studies have demonstrated the benefits of Lovenox^® as an effective treatment for deep vein thrombosis (DVT), and for significantly reducing the incidence of DVT in a wide range of patient populations, as well as for its effective treatment of acute coronary syndromes (ACS) when administered concomitantly with other treatments.

In the cardiovascular field, Lovenox^® has proven good efficacy and safety in two recent international clinical trials:

In the major field of medical prophylaxis of venous thrombo-embolism (medical, as opposed to surgical), Lovenox^® continues to grow and gain patient share from UFH in the United States. (Source: Solucient).

Two major trials with the aim of replacing UFH and expanding the Lovenox^® medical prophylaxis indication have been or are going to be presented to the medical community:

In terms of medical practice registry, GRACE (Global Registry of Acute Coronary Events) continues and, as of today, has evaluated more than 50,000 patients with acute coronary syndromes around the world.

In the field of venous thrombosis prevention, ENDORSE will collect hospital medical practice data on a scale never reached so far, i.e. 67,000 patients in 358 hospitals, 32 countries and 5 continents. This registry will enroll medical and surgical patients at risk of venous thrombo-embolism (VTE) and determine the proportion of patients who receive effective types of VTE prophylaxis according to international guidelines.

Lovenox^® is the leader in anti-thrombotics in the United States, Germany, France, Italy, Spain and the United Kingdom. (source: IMS/GERS sales full year 2006, all channels).

Plavix^® / Iscover^®

Plavix^® (clopidogrel), a platelet adenosine diphosphate (ADP) receptor antagonist with a rapid onset of action that selectively inhibits platelet aggregation induced by ADP, is indicated for long-term prevention of atherothrombotic events in patients with a history of recent myocardial infarction, recent ischemic stroke or established peripheral arterial disease. Plavix^® is currently the only drug indicated for the secondary prevention of atherothrombosis regardless of the location of the arteries initially affected (heart, brain, lower limbs). This indication is supported by the results of the landmark CAPRIE trial, including almost 20,000 patients. CAPRIE demonstrated the superior efficacy of Plavix^® over acetylsalicylic acid (ASA, the active ingredient in Aspirin^®), with a comparable safety profile.

Plavix^® was launched in 1998, and is now marketed in over 80 countries, including the United States, through our alliance with Bristol Myers Squibb (BMS). In Japan a New Drug Application (NDA) for marketing authorization was approved in January 2006 and launch took place in May 2006. Sales of Plavix^® in Japan are consolidated by sanofi-aventis and are outside the scope of our alliance with BMS.

Since 2002, Plavix^® has also been indicated for the treatment of non ST segment elevation Acute Coronary Syndrome (ACS; non-Q-wave myocardial infarction and unstable angina) in combination with ASA following the very significant results of the CURE trial. This indication was rapidly incorporated into the guidelines of the American Heart Association, the American College of Cardiology and the European Society of Cardiology. The CURE trial demonstrated that Plavix^® provided significant early- and long-term benefits in patients with Non ST segment elevation Acute Coronary Syndrome (ACS). Plavix^® reduced the relative risk of atherothrombotic events (myocardial infarction, stroke and death from a cardiovascular cause) by 20% when added to standard therapy including ASA, with a 1% increase in the rate of major bleeding. With more than 12,000 patients enrolled, CURE is the largest clinical trial ever conducted in patients presenting unstable angina or non-Q-wave myocardial infarction. Based on its broad clinical evidence base in this population, Plavix^® has gained the highest grade of recommendation in recent guidelines issued by medical societies for the management of ACS and Percutaneous Coronary Intervention (PCI).

Also in the cardiology field, the results of the CLARITY and COMMIT clinical trials have led to the approval of a new indication in ST-segment elevation ACS (Q-wave myocardial infarction). This approval was granted by the FDA in August 2006 and by the EMEA in September 2006.

The CLARITY trial, which enrolled nearly 3,500 patients, demonstrated that Plavix^®, added to standard therapy including fibrinolytics and ASA, reduced the odds of acute myocardial infarction patients having another occluded artery, a second heart attack or dying after one week of hospitalization, as well as the odds of clinical events such as cardiovascular death, recurrent myocardial infarction and certain recurrent ischemias at 30 days.

The COMMIT trial, which enrolled nearly 46,000 patients, demonstrated that Plavix^®, added to standard therapy including ASA, reduced mortality in acute myocardial infarction patients at day 28 in an in-hospital setting.

The indications resulting from the results of the CURE, CLARITY and COMMIT trials make Plavix^® a cornerstone therapy in management of ACS patients.

Other studies have also contributed to further explore the role of clopidogrel in various patients’ profiles (mostly atherothrombotic patients):

The results of the CHARISMA trial were released at the 55th Annual Scientific Session of the American College of Cardiology in March 2006. The CHARISMA trial enrolled over 15,600 patients and aimed to demonstrate the clinical value of Plavix^® on top of standard therapy including ASA in patients at high risk of future cardiovascular events. The study findings did not demonstrate an improvement of the risk/benefit ratio but significant differences by sub-group:

Other planned or ongoing clinical trials that are designed to support the long-term value of Plavix^® by providing complementary clinical data include:

Since 2003, following an FDA written request for pediatric data, the development of a pediatric indication for Plavix^® in the United States is ongoing. The dose ranging Phase II (PICOLO study) has helped determine the right dose to be studied in Phase III (CLARINET).

In addition to randomized controlled trials, one of the largest disease registries was initiated in 2003 to evaluate the real-life risk of patients with atherothrombosis. This registry, called REACH (Reduction of Atherothrombosis for Continued Health) includes 63,000 patients in more than 44 countries. The one-year results show a considerable rate of events, although in a population receiving the contemporary standard of care. This illustrates the high burden of atherothrombotic disease and the need to evolve pharmacological management more aggressively.

The extensive clinical program for Plavix^®, including all completed, ongoing and planned studies, is one of the largest of its kind and will enroll more than 100,000 patients overall. In addition, over 52 million patients worldwide are estimated to have been treated with Plavix^® since its launch, providing significant evidence of real-life efficacy and safety experience with this product.

Plavix^® sales in the United States have been negatively impacted by the launch of an at-risk generic of 75 mg clopidogrel bisulfate on August 8, 2006. See Note D.22.b, to our consolidated financial statements, included at Item 18.

Nevertheless Plavix^® remains the leading product in the European and the U.S. markets for anti-platelet agents (source: IMS/GERS full year 2006 sales, all channels).

Cardiovascular

Within the cardiovascular market, hypertension remains the most prevalent disease. Hypertension is defined as blood pressure above the normal level and is one of the main causes of severe kidney, heart, brain, vessel and eye complications. Our principal products for the treatment of cardiovascular diseases are:

Aprovel^®/Avapro^®/Karvea^®

Aprovel^® (irbesartan) belongs to the fastest growing class of anti-hypertensives, angiotensin II receptor antagonists, and is indicated as a first-line treatment for hypertension. Angiotensin II receptor antagonists, which are highly effective, act by blocking the effect of angiotensin, the hormone responsible for blood vessel contraction, thereby enabling blood pressure to return to normal. In addition to Aprovel^®/Avapro^®/Karvea^®, we market CoAprovel^®/Avalide^®/Karvezide^®, a fixed dose combination of irbesartan and hydrochlorothiazide (HCTZ), a diuretic that increases the excretion of water by the kidneys and provides an additive blood pressure lowering effect. These products achieve control of blood pressure in over 80% of patients with a very good safety profile.

Aprovel^® was launched in 1997 and is now marketed in more than 80 countries, including the United States (under the brand name Avapro^®), through an alliance with Bristol-Myers Squibb, (BMS). In Japan the product is licensed/sub-licensed to Shionogi and Dai-Nippon Sumitomo respectively. The application for marketing authorization for the treatment of hypertension was resubmitted at the end of 2006, after it was supplemented with additional studies at the request of the Japanese health authorities.

Aprovel^® is also approved for the treatment of nephropathy in hypertensive patients with type 2 diabetes, in both Europe and the United States. These approvals were based on the results of the PRIME program, a clinical program that demonstrated that irbesartan protects type-2 diabetic hypertensive patients from the progression of renal impairment, at both early and more advanced stages of the disease. Following the announcement of the PRIME results in 2002, the American Diabetes Association (ADA) recommended the use of angiotensin receptor antagonists, such as Aprovel^®, as a first-line treatment for renal disease in hypertensive patients with type-2 diabetes.

In August 2006, the European Medicines Agency (EMEA) approved a new fixed dose combination of 300 mg CoAprovel^® with 25 mg of HCTZ. This important introduction to the European market increases the efficacy spectrum of the brand on blood pressure reduction and can result in the achievement of blood pressure goals in over 80% of patients. As less than a third of treated hypertensive patients are currently at the blood pressure goal recommended by international guidelines, this new dosage raises the standard of blood pressure control that can be achieved with CoAprovel^®.

The results of two further efficacy trials have been released in 2006, demonstrating the benefits of rapid blood pressure control with CoAprovel^® as a first-line treatment in patients with severe and moderate hypertension. The data have been submitted to regulatory authorities in the United States and Europe for inclusion in the label.

To continue to demonstrate the protective effects of Aprovel^® beyond the blood pressure lowering efficacy, several clinical trials are ongoing:

In 2006, based on the total sales of Aprovel^®/Avapro^®/Karvea^® and CoAprovel^®/Avalide^®/Karvezide^®, we rank third in Europe and in the United States among the angiotensin II receptor antagonists in the hypertension market. (source: IMS/GERS full year 2006 sales, all channels, class C9C/C9G).

Tritace^®/Triatec^®/Delix^®/Altace^®

Tritace^® (ramipril) is an angiotensin converting enzyme (ACE) inhibitor for the treatment of hypertension, congestive heart failure after myocardial infarction and nephropathy. Its use has widely increased since the initial publication of the Heart Outcomes Prevention Evaluation (HOPE) study in 2000 showing it to be effective in reducing the incidence of stroke, heart attacks and cardiovascular death in high-risk patients. Tritace^® is the only ACE inhibitor approved for the prevention of stroke, heart attack and death in people at high risk for cardiovascular events.

The DREAM trial was published in the New England Journal of Medicine in September 2006. The results of DREAM showed the impact of Tritace^® on glucose metabolism in individuals with impaired glucose tolerance (IGT) and / or impaired fasting glucose (IFG) with a significant positive effect of Tritace^® in the regression of IGT and IFG towards normo-glycemia. DREAM is the first study to demonstrate prospectively that a cardiovascular drug such as Tritace^® can have a positive effect on glucose metabolism and insulin resistance. The DREAM trial has demonstrated that Tritace^® is a key treatment for hypertensive patients at risk of developing diabetes.

In 2006, Tritace^® was the market leader in Canada, Spain and Italy. Tritace^® continues to be a leader in Germany, with demand volumes still constant, despite the end of market exclusivity in Germany in January 2004. (source: IMS full year 2006 sales, All channels C9A/C9B).

In Canada, notwithstanding ongoing legal actions relating to a number of patents, the health authorities granted, effective December 12, 2006, a marketing authorization for ramipril generic (see “Item 8. Financial Information — A. Consolidated Financial Statements and other Financial Information — Information on Legal or Arbitration Proceedings” and Note D.22.b) to our consolidated financial statements included herein at Item 18) to a local manufacturer. Additionally, an authorized generic has been launched through a third party agreement.

The U.S. rights to Tritace^® were sold to King Pharmaceuticals in 1998.

Metabolic Disorders

The prevalence of diabetes is expected to increase significantly over the next 20 years, as a direct result of sedentary life style,lifestyle, excessive weight and obesity, unhealthy diet and population ageing.aging population. Our principal diabetes products are Lantus^®, ana long-acting analog of human insulin, Apidra^®, a rapid-acting analog of human insulin and Amaryl^®, a sulfonylurea. Sanofi-aventis is planning to strengthen its presence in metabolic disorders in particular with the launch of Acomplia^®, a CB-1 receptor blocker critically involved in the regulation of body mass and body weight, lipid metabolism and insulin resistance.

Lantus^®

Lantus^® (insulin glargine) is a long-acting basalanalog of human insulin, analog which offersoffering improved pharmacokinetic and pharmacodynamic profiles compared with Neutral Protamine Hagedorn (NPH) insulin.to other basal insulins. Lantus^® is indicated for once-daily subcutaneous administration in the treatment of adult patients with type 2 diabetes mellitus (T2DM) who require basal insulin for the control of hyperglycemia, and for adult and pediatric patients ofaged six years and above with type 1 diabetes mellitus (T1DM). mellitus.

Lantus^® is a well established treatment with 24 million patient-years exposure since 2000. Over 70,000 patients throughout the first basal insulin with a peak-less, 24-hour duration of action, allowing a once-daily regimen that can be taken at any time but at the same time every day, titration under safer conditions, and with less hypoglycemia (low blood sugar level) than with NPH.world have been involved in Lantus^® clinical trials.

Studies demonstrate the safety and efficacy of simple Lantus^® treatment algorithms that allow patient involvementcan be administered subcutaneously using syringes or specific pens including the Lantus^® SoloSTAR^® disposable pen and empowerment in the titration of the insulin dose and may offer patients with T2DM flexibility with respect to the choice of treatment regimen. In this context, a recent American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) consensus statement for the Initiation and Adjustment ofnew ClikSTAR^® reusable pen:

Therapy emphasized the importance of achieving and maintaining near normal glycemic goals for T2DM with initial therapy with lifestyle intervention and metformin and early addition of insulin therapy in patients who do not meet target goals.

A number of controlledNew meta-analyses and randomizednew studies have investigated the efficacy and safety of Lantus^® plus prandial (meal-time) insulins in T1DM. For instance,type 2 diabetes mellitus:

In June 2009, four registry analyses discussing a potential link between the Porcellati study evaluated the effectsuse of Lantus^® when tightand an increased risk of breast cancer were published inDiabetologia based on a retrospective follow-up of diabetic patients. Clinical studies have not indicated an association between insulin titration is applied. In this one-year study, patients treated with 4 times/day NPHglargine and lispro were randomized to either continuation of this regimen or once dailycancer, and no conclusion can be drawn from these analyses regarding a possible causal relationship between Lantus^® at dinner. A1C (HbA1c, glycosylated hemoglobin) did not change with NPHuse and decreased withthe occurrence of malignancies, as their authors pointed out.

Patient safety being the primary concern of sanofi-aventis, we convened a group of fourteen internationally-recognized experts in the fields of endocrinology, oncology and epidemiology to review the findings of the registry analyses. On July 15, 2009, they published a statement concluding that all four manuscripts had significant methodological limitations and shortcomings, and that they provided inconsistent and inconclusive results. This statement followed cautionary statements by the European Medicines Agency (“EMA”), the U.S. FDA as well as patient and scientific organizations such as the American Diabetes Association, the American Association of Clinical Endocrinologists, and the International Diabetes Federation warning against over-interpretation of and over reaction to these data.

On July 23, 2009, the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) re-confirmed its initial assessment of Lantus^® (from 7.1, based on a review of existing evidence and of the recent publications of registry analyses inDiabetologia, and concluded that the available data does not provide a cause for concern and that changes to 6.7%).the prescribing advice were therefore not necessary. All four registry analyses were found to have methodological limitations and to provide inconsistent and inconclusive results regarding a potential link between Lantus^® use and an increased risk of cancer.

A numberIn September 2009, we announced an action plan to provide methodologically robust research that will contribute to the scientific resolution of controlledthe debate over insulin safety, including insulin analogs and randomizedLantus^®. The research program encompasses both pre-clinical and clinical programs involving human insulin and insulin glargine and is designed to generate more information on whether there is any association between cancer and insulin use and to assess if there is any difference in risk between insulin glargine and other insulins. The plan is structured to yield short-term and longer-term results. Three epidemiological studies are planned (two retrospectives cohort studies and one case-control study). We expect to complete the two retrospectives cohort studies and analyze their results in time for scientific presentations at medical conferences in 2012. We aim to present the results of the case-control study in 2013. We are also conducting pre-clinical studies that for which we expect to have investigatedresults in 2010 and in 2011.

The American Diabetes Association (“ADA”) and European Association for the efficacyStudy of Diabetes (“EASD”) have maintained their 2008 treatment recommendations for type 2 diabetes. As a reminder, these guidelines further established basal insulins such as Lantus^®, or a sulfonylurea such as Amaryl^®, as two preferred second-line treatment options for people with diabetes who are unable to achieve glycemic control targets with lifestyle intervention and safetymetformin alone. These treatment recommendations reinforce the timely use of basal insulin as a core therapy for type 2 diabetes.

Lantus^® is the number-one sold insulin in the world in both sales and units (source: IMS, 2009 sales) and is available in over 70 countries worldwide. The three leading countries for sales of Lantus^® plus oral anti-diabetic agents (OADs)are the United States, France and Germany.

Apidra^®

Apidra^® (insulin glulisine) is a rapid-acting analog of human insulin. Apidra^® is indicated for the treatment of adults with type 1 and in T2DM:type 2 diabetes for supplementary glycemic control. Apidra^® has a more rapid onset and shorter duration of action than fast-acting human insulin and can be associated with long-acting insulins such as Lantus^® for supplementary glycemic control at mealtime.

In addition, Apidra^® is equally effective in adult diabetics ranging from lean to obese and offers patients greater flexibility of administration, either before or just after mealtime.

Apidra^® can be administered subcutaneously using syringes or specific pens including the Apidra^® SoloSTAR^® disposable pen and the new ClikSTAR^® reusable pen:

The ORIGIN trial is a large ongoing worldwide morbidity/mortality trial and will determine if Lantus^®-mediated normoglycemia reduces cardiovascular events in high-risk dysglycemic patients. The recruitment of ORIGIN has been completed with a total of 12,612 subjects from 40 countries who are being followed for at least 4 years.

Following the approval of OptiClikApidra^® for use with Lantus^® by the relevant authorities, this reusable pen was launched in Germany in 2004, in other European countries in 2005, in the United States in 2006, and in Canada and Japan in 2005 and in the United Kingdom, Italy, Spain and Germany in 2006.

Similarly, the reusable pen, Autopen 24 (manufactured by Owen Mumford), has been launched in 32 markets since April 2006 for use with Lantus^® and2009. Apidra^® (a rapid acting insulin).

In September 2006, the EMEA approved the new disposable insulin pen, SoloSTAR^®, for Lantus^® andis now available in over 26 countries worldwide. The top three countries contributing to sales of Apidra^® administration. SoloSTAR^® will be launched in Europe during 2007. U.S. registration of this device is pending.

Overall, Lantus^® has been launched in over 70 countries worldwide.

Lantus^® has beenare the leading insulin brand worldwide since August 2005 with sales in value exceeding €1 billion and since August 2006 Lantus^® has also become the leading insulin worldwide in units. The United States, is the largest contributor of Lantus^® sales, followed by Germany and France (source: IMS/GERS full year 2006 sales, all channels).Italy.

Amaryl^®/Amarel^®/Solosa^®

Amaryl^® (glimepiride) is a latest-generation, orally administered once-daily sulfonylurea for the oral treatment of type 2 diabetes,(a glucose-lowering agent) indicated as an adjunct to diet and exercise. Sulfonylureas are part of the guidelines for the first step of treatment forexercise to improve glycemic control in patients with type 2 diabetes patients. Studies also prove the effective combination of Amaryl^® with Lantus^®, if oral treatment alone does not provide tight diabetes control.diabetes. Amaryl^® reduces the body’s blood sugar level in two ways: by helping the body to

produce more insulin both at mealtime and between meals and by decreasing insulin resistance. Studies demonstrate thatAmaryl^® has a patient canmore rapid onset and longer duration of action than first-generation agents, allowing patients to achieve a very good level of control with a lowlower risk of hypoglycemia.

Amaryl^® was the first oral diabetes drug in its class to receive approval for administration in one of three ways: either as a monotherapy or in combination with insulin or metformin.

The combination of metformin (which reduces hepatic glucose production and improves insulin resistance) with a sulfonylurea such as Amaryl^® is the rational combination for counteracting the two defects seen in type 2 diabetes. It is one of the most prescribed combination of diabetes drugs worldwide. Amaryl M^®, a fixed-dose combination of Amaryl^® plus metformin in a single presentation was launched in 19952007. The fixed dose treatment is more effective than either agent alone in patients with type 2 diabetes and has been approvedequal efficacy and better compliance than the free combination of glimepiride and metformin. In 2009, Amaryl M^® was launched in about 100 countries worldwide. The key marketsChile and in the United Arab Emirates.

Our leading market for Amaryl^® areis Japan, (rank: #1), France (rank: #2)where it is the leading oral anti-diabetes product by volume (source: IMS 2009 sales). A number of generics have received marketing authorization and have been launched in Europe and the United States (rank: #3) (source: IMS/GERS year end 2006 sales).States.

Acomplia^®The main compounds currently in Phase II or III clinical development in the Diabetes field are:

Oncology

Sanofi-aventis is a leading groupleader in the oncology field, primarily in chemotherapy, with two major agents: Taxotere^® and Eloxatine^®.

Taxotere^®

Taxotere^® (docetaxel), a drug in the taxoid class of chemotherapeutic agents,derivative, inhibits cancer cell division by essentially “freezing” the cell’s internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. Taxotere^® promotes their assembly and blocks their disassembly, thereby preventing many cancer cells from dividing and resulting in death in some cancer cells.

Taxotere^® was first licensed in 1995 in Europe, for use in patients with locally advanced or metastatic breast cancer. The following year, it was granted approval in the United States, Canada and Japan. It is now available in more than 100 countries and, in the 10 years since its launch, Taxotere^®as an injectable solution. It has gained approval for use in teneleven indications in five different tumor types — breast,(breast, prostate, gastric, lung and head and neck.

neck). Taxotere^® is indicated for early stage and metastatic breast cancer, first-line and second-line non-small cell lung cancer (NSCLC)metastatic Non-Small Cell Lung Cancer (“NSCLC”), androgen-independent (hormone-refractory) metastatic prostate cancer, advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction and for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck. The advanced gastric

In June 2009, the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA issued a positive opinion on Roche’s Avastin^® (bevacizumab) in combination with Taxotere^® as a first line treatment for women with metastatic breast cancer, and head and neck cancer approvals were grantedbased on the results of the AVADO study. This combination, which presents a better efficacy (significantly better Progression Free Survival — PFS) than the Taxotere^® monotherapy, allows a larger number of patients to be treated with Taxotere^®. In the United States, a Taxotere^®-bevacizumab combination is being reviewed by the FDA for an expected approval in the United States and EMEA in Europe in March and October 2006 respectively.second quarter of 2010.

In breast cancerBased on the GEICAM 9805 trial results, which showed significant survival benefit in favor of the Taxotere^® is now used-based regimen compared to a fluorouracil-based regimen in a variety of doses and schedules, as first-line and second-line treatment. It has demonstrated a survival benefit in five studies for four indications in this setting: as monotherapy, or in combination with doxorubicin, capecitabine or trastuzumab.

Important new data on Taxotere^® were presented at the American Society of Clinical Oncology (ASCO) in 2006. The Tax 324 study is a Phase III trial of Taxotere^®, Cisplatin and 5-Fluorouracil (TPF) versus Cisplatin and 5-Fluorouracil (PF) induction chemotherapy, followed by chemoradiotherapy in1,100 patients with locally advanced squamous cell carcinoma of the head and neck, which confirmed that Taxotere^® based sequential therapy is associated with a significant improvement in survival in head and neck cancer.

Other data was supportive of the major therapeutic indications and especially in breast and non-small cell lung cancer. The BIG-0298 adjuvantnode negative early stage breast cancer, study provided important information aboutsanofi-aventis filed a dossier with the best way to include Taxotere^®EMA in adjuvant chemotherapyNovember 2009 for node positive breast cancer. The BCIRG007 study compared Taxotere^® combined with trastuzumab “TH regimen” to Taxotere^® combined with platinum salt and trastuzumab “TCH regimen” demonstrating that both regimens are effective therapies for the treatment of HER2-positive metastatic breast cancer and therefore that the “TH regimen” does not benefit from the addition of carboplatin. Finally, a large NSCLC meta-analysis confirmed Taxotere^®’s superiority over another 3rd generation chemotherapeutic agent (vinorelbine) in both improved survival and lower toxicity.

The ARD6562 Phase II studynew indication of Taxotere^® in association with doxorubicin and cyclophosphamide for the treatment of hormone refractorypatients with node negative early stage breast cancer. In the United States, this Taxotere^® regimen is already considered as a standard treatment in this indication.

For patients with androgen-independent (hormone-refractory) metastatic prostate cancer, is ongoingTaxotere^® remains the standard of care for a first-line treatment and new clinical studies on Taxotere^® in Japan. Results are expectedcombination with targeted therapies could lead to more frequent use of Taxotere^®.

In November 2009, the European Commission approved a new single vial formulation of Taxotere^® in 2007 and sanofi-aventis plansEurope. This new formulation was also filed for approval in the United States in December 2008. A pediatric data dossier on Taxotere^® was submitted for regulatory approval in the United States in November 2009, in response to file for this indication in Japan in 2007.the FDA’s prior written request.

The top four countries contributing to the sales of Taxotere^® in 2006 were respectively2009 are the United States, France, Germany and Japan (based on 2006 net sales).Japan.

Eloxatine^®

Eloxatine^® (oxaliplatin) is an innovative platinum agent and currentlya platinum-based cytotoxic agent. Eloxatine^® combined with infusional (given through bloodstream) administration of two other chemotherapy drugs, 5-fluorouracil/leucovorin (the FOLFOX regimen) is approved by the only one indicated both for the treatment of metastatic colorectal cancer and under developmentFDA for adjuvant treatment of people with stage III colon cancer.cancer who have had their primary (original) tumors surgically removed. This approval was based on evidence of an improvement in disease-free survival after four years.

In the United States, France, Germany, Italy, Spain, the United Kingdom and Japan more than 500,000 people are diagnosed every yearclinical studies of patients with colorectalstage III colon cancer for the first time. Colorectal cancer is the second cause of death from cancer in the United States. Colorectal cancer with distant metastases (referred to as “stage IV”) makes up around 30% of all new colorectal cancer diagnoses per year. When diagnosed at an early stage, chances of cure with surgery increase dramatically. Chemotherapy is used as an adjuvant therapy to surgery in order to prevent recurrences.

The development ofwho had their primary tumors surgically removed, Eloxatine^® has led to major progress in the treatment of metastatic colorectal cancer. First, median survivalFOLFOX regimen has been prolonged to 2 yearsshown to:

For patients with initially unresectable liver metastases. Due to its consistently high and sustained efficacy in treating metastaticstage IV colorectal cancer, the FOLFOX regimen is a mainstay treatment of metastatic colorectal cancer in the United States, Europe and certain countries in the Asia-Pacific region.

Eloxatine^® has been developed for adjuvant treatment of colon cancer. Eloxatine^® was the first anticancer agent to result in a significant improvement of the adjuvant treatment of colon cancer in a decade. FOLFOX is now the standard treatment for stage III colon cancer patients who have undergone complete resection of the primary tumor.

A new liquid formulation (Eloxatine^® Injection), approved by the FDA and EMEAfor the treatment of advanced colorectal cancer (cancer of the colon and/or rectum). The FOLFOX regimen showed the following benefits in 2005, has now been launched in most countries. This new formulation offers additional safety benefits and convenience to pharmacists and nurses since it involves fewer steps in the reconstitutionclinical trials of Eloxatine^®. In addition, sanofi-aventis also obtained European approval for a new 200 mg dosage, more adapted to central reconstitution chemotherapy units, in March 2006. This new dosage was launched in the United Kingdom and in Germany in 2006 and will be launched in most European countries in the course of 2007.patients with advanced colorectal cancer:

Following the end of the Eloxatine^® European regulatory data exclusivity in April 2006, a number of oxaliplatin (powder for solution for infusion) generics have received national marketing authorization. In particular,authorization and have been launched throughout Europe. With regard to the United States market, in August and September 2009, a number of oxaliplatin generics received final marketing authorization from the FDA and have since been launched.

Eloxatine^® is in-licensed from Debiopharm and is marketed in more than 70 countries worldwide. The top countries contributing to the sales of Eloxatine^® in 2009 were the United States, Canada, China and South Korea.

The oncologypipeline includes a broad spectrum of novel agents with a variety of mechanisms of action for treating cancer and/or cancer side-effects, including cytotoxic agents, anti-mitotic agents, anti-angiogenic agents, anti-vascular agents, monoclonal anti-bodies, and supportive care therapies.

In May 2009, two compounds were in-licensed from Exelixis:XL147 (PI3K inhibitor) andXL765 (PI3K/mTOR dual inhibitor). Multiple Phase I studies as single agent or in combination are ongoing with both compounds. Besides the license, under an exclusive discovery collaboration, sanofi-aventis and Exelixis will combine research efforts to establish several preclinical programs related to isoform-selective inhibitors of P13K (phosphoinositide-3 kinase).

An exclusive worldwide licence and collaboration agreement has been signed with the U.S. biotechnology company Merrimack relating toMM-121, currently in Phase I for solid malignancies.

A collaboration and worldwide license agreement was announced in October 2009 between Micromet and sanofi-aventis for the development of a BiTE^® antibody, directed against an antigen present on the surface of tumor cells. BiTE^® antibodies are novel therapeutic antibodies that activate T-cells so that they will identify and destroy tumor cells.

Thrombosis and Cardiovascular

Thrombosis occurs when a thrombus, or blood clot, forms inside an artery or a vein. Left untreated, a thrombus can eventually grow large enough to block the blood vessel, preventing blood and oxygen from reaching the organ being supplied. Our principal products for the treatment and prevention of thrombosis are Lovenox^®/Clexane^® and Plavix^®/ Iscover^®.

Within the cardiovascular market, hypertension remains the most prevalent disease. Hypertension is defined as blood pressure above the normal level and is one of the main causes of severe heart, brain, blood vessel and eye complications. Our principal products for the treatment of cardiovascular diseases are Aprovel^®/Avapro^®/Karvea^® and Tritace^®/Triatec^®/Delix^®/Altace^®.

The incidence of atrial fibrillation (“AF”) is growing worldwide in relation to aging populations. It is emerging as a public health concern and affects about 4.5 million people in Europe and 2.5 million people in the United States. AF leads to potential life-threatening complications, and increases the risk of stroke up to five-fold, worsens the prognosis of patients with cardiovascular risk factors, and doubles the risk of mortality and the risk of hospitalization with significant burden on patients, health care providers and payers. 70% of AF management costs are driven by hospital care and interventional procedures in the European Union. In July 2009, we launched Multaq^® (dronedarone) in the United States. Multaq^® is the first and only anti-arrhythmic drug to have shown a significant reduction in cardiovascular hospitalization or death in patients with AF/ Atrial flutter (“AFL”).

Lovenox^®/Clexane^®

Lovenox^® (enoxaparin sodium) is the most widely studied and used low molecular weight heparin (“LMWH”) in the world. It has been used to treat an estimated 200 million patients in 100 countries since its launch and is approved for more clinical indications than any other LMWH. A comprehensive dossier of clinical studies has demonstrated the benefits and safety of Lovenox^® in the prophylaxis and treatment of deep vein thrombosis and in treatment of acute coronary syndromes (“ACS”). It has become the product of reference in clinical trials for the development of new anti-coagulants in both venous and arterial indications.

In the field of venous thromboembolism (“VTE”) prevention, Lovenox^® use continues to grow especially for prevention of VTE in hospitalized patients not undergoing surgery.

In 2009, two publications from the ENDORSE survey further highlighted the prevalence of patients at risk of VTE after undergoing surgery other than orthopedic surgery and the underuse of prophylaxis in those patients. It showed that the use of prophylaxis is even lower across different types of hospitalized patients not undergoing surgery and at risk of VTE, prompting the need to further improve the use of effective prophylaxis, as recommended by international guidelines.

After approval for the prevention of VTE in patients undergoing orthopedic surgery of the lower limbs such as total hip replacement, total knee replacement and hip fracture surgery in Japan (January 2008), Lovenox^® was approved for VTE prevention in patients undergoing abdominal surgery in February 2009.

In the cardiovascular area, Lovenox^® was approved in 2007 in the United States for the treatment of patients with ST-segment elevation myocardial infarction, and since then has been approved in some majormore than 40 countries such asworldwide for this indication.

Lovenox^® is the leader in anti-thrombotics in the United States, Germany, France, Italy, Spain, and the United Kingdom in September 2006 and Germany in October 2006. It is expected that all European countries will have one generic of oxaliplatin in 2007.(source: IMS 2009 sales).

Plavix^® / Iscover^®

Plavix^® (clopidogrel bisulfate), a platelet adenosine diphosphate (“ADP”) receptor antagonist with a rapid onset of action that selectively inhibits platelet aggregation induced by ADP, is indicated for long-term prevention of atherothrombotic events in patients with a history of recent myocardial infarction, recent ischemic stroke or established peripheral arterial disease. Plavix^® is indicated for the secondary prevention of atherothrombosis regardless of the location of the arteries initially affected (heart, brain, lower limbs). This

indication is supported by the results of the landmark CAPRIE trial, including almost 20,000 patients. CAPRIE demonstrated the superior efficacy of Plavix^® over acetylsalicylic acid (ASA, the active ingredient of Aspirin^®), with a comparable safety profile.

Following the significant results of several clinical trials, involving almost 62,000 patients altogether, Plavix^® is now also indicated for the treatment of acute coronary syndrome (“ACS”) with and without ST segment elevation in combination with ASA. These indications are incorporated into the guidelines of the American Heart Association, the American College of Cardiology and the European Society of Cardiology.

In addition to the 75 mg tablet, a Plavix^® 300 mg tablet was launched in 2008. This 300 mg tablet reinforces Plavix^® early use by simplifying its approved loading dose administration in patients with ACS.

In December 2009, the CHMP adopted a positive opinion, recommending granting marketing authorization for DuoPlavin^®, a new fixed combination of clopidogrel bisulfate and acetylsalicylic acid. The drug is indicated for prevention of atherothrombotic events in adult patients with acute coronary syndrome who are already taking both clopidogrel and ASA. The benefit of DuoPlavin^® is its simplification of treatment. The combination was launched in Australia in December 2009.

The extensive clinical program for Plavix^® including all completed, ongoing and planned studies, is among the largest of its kind as it has involved more than 130,000 patients overall. In addition, over 100 million patients worldwide are estimated to have been treated with Plavix^® since its launch, providing significant evidence of real-life efficacy and safety experience with this product.

In 2009, ACTIVE-A study results (7,554 patients) demonstrated that, for patients with atrial fibrillation who were at increased risk of stroke and could not take an oral anti-coagulant medication, taking Plavix^® (clopidogrel bisulfate) in addition to aspirin significantly reduced major vascular events over aspirin alone. The greatest benefit was seen in the reduction of stroke. Compared to aspirin alone, taking Plavix^® in addition to aspirin significantly and as expected increased the rate of major bleeding. A dossier for a new indication was submitted to U.S. and E.U. authorities.

In addition, preliminary data of CURRENT-OASIS 7 trial (25,087 patients) that was designed to assess the efficacy and safety of an intensified clopidogrel regimen, have shown that the primary end-point (cardiovascular death, heart attack, or stroke at thirty days) for the entire study population did not reach statistical significance. For the population with percutaneous coronary interventions, however, the data have shown both a consistent reduction in major cardiovascular events and a significant increase in major bleeding.

The development of a pediatric indication for Plavix^® is ongoing. The dose ranging Phase II study has helped determine the right dose to be studied in the Phase III study, study which is ongoing and the results of which are expected in 2010.

In addition to this clinical program, sanofi-aventis and Bristol-Myers Squibb (“BMS”), in close collaboration with the FDA, are conducting additional studies to further understand and characterize the variability of response with Plavix^®. The objective of this program is to provide health care professionals with the best possible guidance on the use of Plavix^®. Based on this program the label has been updated including new results on the pharmacological interaction with omeprazole. Sanofi-aventis and BMS continue to update the label especially with recent pharmacogenomics data and will make certain existing warnings more prominent.

Plavix^® is marketed in over 115 countries. The marketing of Plavix^® is organized through our alliance with BMS (see “—Alliance with BMS” below).

Sales of Plavix^® in Japan are consolidated by sanofi-aventis and are outside the scope of our alliance with BMS. In 2009, Plavix^® obtained the highest level recommendation in the Japanese stroke and ACS guidelines.

Plavix^® is the leading anti-platelet in the European and U.S. markets (source: IMS 2009 sales) even though European markets have been affected by launches of generic clopidogrel.

Aprovel^®/Avapro^®/Karvea^®

Aprovel^® (irbesartan) is an anti-hypertensive belonging to the class of angiotensin II receptor antagonists. These highly effective and well tolerated antagonists act by blocking the effect of angiotensin II, the hormone

responsible for blood vessel contraction, thereby enabling blood pressure to return to normal. In addition to Aprovel^®/Avapro^®/Karvea^®, we also market CoAprovel^®/Avalide^®/Karvezide^®, a fixed dose combination of irbesartan and hydrochlorothiazide (“HCTZ”), a diuretic that increases the excretion of water and sodium by the kidneys and provides an additional blood pressure lowering effect. These products achieve control of blood pressure in over 80% of patients, with a very good safety profile.

Aprovel^® and CoAprovel^® tablets are available in various dosages, to fit the needs of patients with different levels of hypertension severity.

Aprovel^® is indicated as a first-line treatment for hypertension and for the treatment of nephropathy in hypertensive patients with type 2 diabetes, in both Europe and the United States. CoAprovel^® is indicated in patients whose blood pressure is not adequately controlled with a monotherapy, but also as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals (in the United States only).

Several clinical trials have been undertaken in recent years in an effort to demonstrate the effects of Aprovel^® beyond blood pressure control including the ACTIVE-I study evaluating the effect of irbesartan in preventing cardiovascular events in patients with atrial fibrillation. The results were presented in September 2009 during the European Society of Cardiology congress. Although the study did not meet its principal goal, irbesartan demonstrated a reduction in hospitalization in heart failure. Irbesartan was also very well tolerated in these patients with atrial fibrillation.

Aprovel^® and CoAprovel^® are marketed in more than 80 countries. The marketing of Aprovel^® and CoAprovel^® is organized through an alliance with BMS (see “— Alliance with BMS” below).

In Japan, where the product is licensed/sub-licensed to Shionogi Co. Ltd and Dainippon Sumitomo Pharma Co. Ltd, respectively, specific 50 mg and 100 mg dosages developed for the Japanese market were launched in June 2008.

Irbesartan generics in monotherapy are marketed in Spain and Portugal.

Alliance with BMS

Plavix^® and Aprovel^® are marketed through a series of alliances with BMS. The alliance agreements include marketing and financial arrangements that vary depending on the country in which the products are marketed.

There are three principal marketing arrangements that are used in the BMS alliance:

Under the alliance arrangements, there are two territories, one under our operational management and the other under the operational management of BMS. The territory under our operational management consists of Europe and most of Africa and Asia, while the territory under the operational management of BMS consists of the rest of the world excluding Japan. In Japan, Aprovel^® has been marketed jointly by Shionogi Pharmaceuticals and Dainippon Sumitomo Pharma Co. Ltd since June 2008. The BMS alliance does not cover rights to Plavix^® in Japan; sales of Plavix^® in Japan are consolidated by sanofi-aventis.

In the territory under our operational management, the marketing arrangements are as follows:

•

We use the co-marketing system in Germany, Spain and Greece for both Aprovel® and Plavix® and in Italy for Aprovel®; and