Pursuant to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, the information for the 20082010 Form 20-F of AstraZeneca PLC (the(“AstraZeneca” or the “Company”) set out below is being incorporated by reference from the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated and submitted on March 17, 2009.April 28, 2011.
References below to major headings include all information under such major headings, including subheadings, unless such reference is part of a reference to a subheading, in which case such reference includes only the information contained under such subheading. Graphs and tabular data are not included unless specifically identified below. Photographs are also not included.
In addition to the information set out below, the information set forth under the headings “Cautionary statement regarding forward-looking statements”, “Inclusion of reported performance, Core financial measures and constant exchange rate and core financial measures”growth rates”, “Statements of competitive position, growth rates and sales”, “AstraZeneca websites” and, “External/third party websites” on page 1, “Trade marks”, “Definitions”, “Use of terms” and, “Statements of dates” and “Figures” on the inside front cover, the paragraph regarding trade marks of the AstraZeneca group on the inside back cover, “Definitions and Interpretation” on page 196, “Cross-Reference to Form 20-F” on page 198 and “Glossary” on pages 199217 to 200,219, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
Not applicable.
Not applicable.
The information (including graphs and tabular data) set forth under the headings “AstraZeneca and our Year in Brief—Financial Highlights” on page 2, “Directors’ Report—Reporting our Performance – Financial” on page 15, “Financial Statements—Notes to the Financial Statements—Note 20—Share Capital of Parent Company” on page 129, “GroupGroup Financial Record” on page 172204 and the first table that appears under “Additional Information—Shareholder Information”Information—AstraZeneca PLC share listings and prices” on page 190,211, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference. The selected financial data incorporated by reference herein is derived from audited financial statements of the Company and its consolidated entities, prepared in accordance with International Financial Reporting Standards (“IFRS”) as adopted by the European Union and IFRS as issued by the International Accounting Standards Board, included in the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009.
B. Capitalization and Indebtedness
Not applicable.
C. Reason for the Offer and Use of Proceeds
Not applicable.
D. Risk Factors
A. History and Development of the Company
The information (including tabular data) set forth under the headings “Additional Information—Corporate Information—History and Developmentdevelopment of the Company” on page 197, “Directors’ Report—Resources, Skills216, “Business Review—Delivering our strategy—Research and Capabilities—Development—Our Resources” andresources” on pages 29 to 30, “—Delivering our strategy—Supply and Manufacturing”Manufacturing—Our resources” on pages 18 (third paragraph only) and 27 respectively, “Directors’ Report—page 35, “Business Review—Financial Position, including Cash Flow and LiquidityReview—Financial position – 2008—Property, plant and equipment” and “—Cash flow”, on pages 35 and 36, respectively, “Directors’ Report— Financial Position, including Cash Flow and Liquidity – 2007—2010—Investments, divestments and capital expenditure” on page 41,86, “Financial Statements—Notes to the Financial Statements—Note 7—Property, Plantplant and Equipment”equipment” on pages 114page 153 and 115 and “Financial Statements—Notes to the Financial Statements—“—Note 22—Acquisitions of Business Operations”business operations” on pages 130167 to 133,168, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
B. Business Overview
The information (including graphs and tabular data) set forth under the headings “AstraZeneca and our Year“Overview—Our year in Brief”brief” on pages 24 to 3, “Directors’ Report”5, “—Chairman’s Statement” on pages 6 to 7, “—CEO’s Review” on pages 8 to 30 (excluding the “Expanding Patient Populations” graphic9, “—Our strategy and the first and third paragraphs under the heading “Expanding Patient Population,performance” on page 10) and pages 4810 to 73,21, “Business Review” on pages 24 to 77, “Additional Information—Development Pipeline” on pages 206 to 210”, “Financial Statements—Notes to the Financial Statements—Note 5—Segment Information” andStatements —Note 1—Product revenue information” on page 147, “—Note 6—Product RevenueSegment Information” on pages 111151 to 113,152, and “Statements of competitive position, growth rates and sales” on page 1,the inside front cover, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
FDA approves orphan drug vandetanib
On April 7, 2011 the Company announced that the U.S. Food and Drug Administration (FDA)FDA has approved SYMBICORT (budesonide/formoterol fumarate dihydrate) 160/4.5 mcg for the twice daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
The FDA approval is based on results from two pivotal clinical trials, SHINE (6-month) and SUN (12-month), which found SYMBICORT improved lung function within five minutes of the first dose and sustained that lung function improvement for the duration of the studies. SYMBICORT pMDI (pressurized metered-dose inhaler) has been available in the U.S. since June, 2007 for the long-term maintenance treatment of asthma in patients 12 years of age and older.
Seroquel XR – FDA Complete Response Letter and Psychopharmacologic Drugs Advisory Committee
On February 27, 2009, the Company announced that it had received a Complete Response Letter (CRL) from the FDA asking for additional information for the supplemental New Drug Application (sNDA) for SEROQUEL XR (quetiapine fumarate) Extended Release Tabletsorphan drug vandetanib for the treatment of Generalised Anxiety Disorder (GAD) in adult patients. AstraZeneca is evaluating the contentsmedullary thyroid cancer that cannot be removed by surgery or that has spread to other parts of the CRL and the proposed labelling revisions.
On February 25, 2009, the Company announced that it had been advised by the FDA that the FDA Psychopharmacologic Drugs Advisory Committee (PDAC)body. Vandetanib is tentatively scheduled to meet on April 8, 2009, to discuss the safety and efficacy of sNDAs for SEROQUEL XR proposeda kinase inhibitor indicated for the treatment of major depressive disorder (MDD) and GAD.symptomatic or progressive medullary thyroid cancer in patients with unresectable (non-operable) locally advanced or metastatic disease.
Partnership with MAP Pharmaceuticals – Unit Dose Budesonide
On February 23, 2009, MAP Pharmaceuticals, Inc. announced that its initial Phase III clinical trial of Unit Dose Budesonide (UDB) for the potential treatment of children with asthma did not meet its co-primary endpoints: asthma control as assessed by changes from baseline in night-time and daytime composite symptom scores, in either of the doses evaluated when compared with placebo.
The Company and MAP Pharmaceuticals announced, in December, 2008, an exclusive worldwide agreement to develop and commercialise UDB, MAP Pharmaceuticals’ proprietary nebulised formulation of budesonide. This agreement is subject to review in the United States under the U.S. Hart-Scott-Rodino Act and becomes effective after the waiting period has ended. The Company intends to work with MAP Pharmaceuticals to conduct further analyses of these data to determine appropriate next steps for the programme.
Primary Endpoint for PN 400 Phase III Clinical Programmes
On January 29, 2009, the Company announced that its co-development partner for the investigational compound PN 400, POZEN Inc., has been informed that the FDA has completed its internal discussions and that there is no change to the previous agreements that gastric ulcer incidence is an acceptable primary endpoint for the PN 400 Phase III clinical programmes. In October, the FDA had announced that they were conducting an internal review on the acceptability of gastric ulcers as a primary endpoint in clinical studies.
C. Organizational Structure
The information (including tabular data) set forth under the headings “Directors’“Corporate Governance—Corporate Governance Report—Other Matters—Other Company Disclosures and Information—matters—Subsidiaries and principal activities” on page 94117 and “Financial Statements—Principal Subsidiaries” on page 164,197, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
D. Property, Plants and Equipment
The information (including tabular data) set forth under the headings “Directors’ Report—“Business Review—Delivering our strategy—Research and Development—Our Resources”resources” on pages 1729 to 30, “—Delivering our strategy—Supply and 18, “Directors’ Report—Manufacturing—Our resources” on page 35, “Business Review—Financial Review—Financial Position,
including Cash Flow and Liquidityposition – 2008 —Property,2010—Property, plant and equipment” and “—Financial Position, including Cash Flow and Liquidityposition – 2007—2009—Property, plant and equipment”, on pages 3585 and 40,89, respectively, “Directors’ Report—“Corporate Governance—Risk—Principal Risksrisks and Uncertainties—Industry/Economic Environment Risks—uncertainties—Legal, regulatory and compliance risks—Environmental/occupational/occupational health and safety liabilities” on page 79,102, “Financial Statements—Notes to the Financial Statements—Note 7—Property, plant and equipment” on page 153, “—Note 25—Commitments and contingent liabilities—Environmental costs and liabilities” on pages 146 to 147page 180 and “Financial Statements—Notes to the Financial Statements—Note 7—Property, Plant and Equipment”“Additional Information—Corporate Information—Articles—Property” on pages 114 to 115,page 216, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
ITEM 4A -4A. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 5 -5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
The information (including graphs and tabular data) set forth under the headings “Directors’ Report—World Pharmaceutical Markets” (comprising first table only) on page 9, “Directors’ Report—“Business Review—Financial Review” on pages 3178 to 47, “Directors Report—93, “Business Review—Geographical Review” on pages 4870 to 52, “Directors’ Report—74, “Business Review—Therapy Area Review—Sales by Therapy Area” (comprising final(consisting of tabular data only)data) on page 53, “Directors’ Report—50,“—Therapy Area Review—Our Financial Performance” (comprisingfinancial performance” (consisting of tabular data only)data) on pages 55, 58, 60,53, 57, 59, 62, 65 and 68, “Directors’ Report—“—Therapy
Area Review—Financial Performance 2008/2007”performance 2010/2009” on pages 56, 58,55, 57, 60, 63, 66 and 69, “Directors’ Report—Resources, Skills and Capabilities—“Business Review—Other Businesses—Our financial performance” (consisting of tabular data) on page 75, “Business Review—Delivering our strategy—Research and Development” on pages 17-21,26 to 30, “Corporate Governance—Corporate Governance Report—Business organization—Portfolio Investment Board (PIB)” on page 116, “Corporate Governance—Risk—Principal risks and uncertainties—Commercialization and business execution risks—Competition, price controls and price reductions” on pages 99 to 100, “Financial Statements—Notes to the Financial Statements—Note 14—Interest Bearing LoansInterest-bearing loans and Borrowings”borrowings” on page 119, “Financial Statements—Notes to the 158, “—Note 15—Financial Statements—Note 16—Financial Instruments”instruments” on pages 122158 to 126, “Financial Statements—Notes to the Financial Statements—161, “—Note 19—Capital and Reserves—reserves—Other reserves” on page 128166, “—Note 23—Financial risk management objectives and “Financial Statements—Notespolicies” on pages 168 to the Financial Statements—172 and “—Note 25—Commitments and Contingent Liabilities”contingent liabilities” on pages 144178 to 162,195, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
Developments in Legal Proceedings
For further information in respect of material legal proceedings in which the Company is currently involved, including those discussed below, please see the information set forth under the heading “Financial Statements—Notes to the Financial Statements—Note 25—Commitments and contingent liabilities” on pages 178 to 195 of the Company’s “Annual Report and Form 20-F Information 2010” included as exhibit 15.1 to this Form 20-F dated April 28, 2011. Unless noted below or in the Company’s “Annual Report and Form 20-F Information 2010”, no provisions have been established in respect of the claims discussed below.
Atacand
Patent litigation – Canada
As previously disclosed, in December 2010, AstraZeneca received a second Notice of Allegation from Teva Canada Limited (Teva) in respect of Canadian Atacand substance patent no. 2,040,955 (the ‘955 patent) and formulation patent no. 2,083,305 (the ‘305 patent) listed on the Canadian Patent Register for Atacand. Teva has confirmed it will await the expiry of the ‘955 patent. AstraZeneca did not commence an application in response.
In March 2011, AstraZeneca received a Notice of Allegation from Apotex Inc. (Apotex) in respect of the ‘955 and ‘305 patents listed on the Canadian Patent Register for Atacand. Apotex has confirmed it will await the expiry of the ‘955 patent. AstraZeneca did not commence an application in response.
Patent litigation – Brazil
As previously disclosed, in October 2010, AstraZeneca filed an infringement action with a request for an interlocutory injunction against Sandoz do Brasil Industria Farmaceutica Ltda (Sandoz) in the Central Court of São Paolo. The Court denied the request for an interlocutory injunction. AstraZeneca appealed the decision and in February 2011, the Court of Appeal upheld the lower court’s decision to deny the request for an interlocutory injunction. The main infringement action continues.
Patent litigation – EU
As previously disclosed, in Portugal, a request was filed with the Lisbon Administrative Court of First Instance in December 2009 seeking a preliminary injunction to suspend the marketing authorizations for generic candesartan cilexetil granted to Sandoz Farmacêutica Limitada (Sandoz). The Court denied the preliminary injunction. The decision was appealed and the Court of Appeal ordered the Court of First Instance to hold a hearing. After a hearing in February 2011 the Lisbon Administrative Court of First Instance granted the request for a preliminary injunction and ordered the suspension of the marketing authorizations granted to Sandoz until October 24, 2012, i.e. the date of expiry of the supplementary protection certificate. This decision can be appealed.
Atacand Plus (candesartan cilexetil/hydrochlorothiazide)
Patent litigation – Canada
As previously disclosed, in April 2010, AstraZeneca received a Notice of Allegation from Pharmascience Inc. (PMS) in respect of the Atacand Plus formulation patent no. 2,083,305 (the ‘305 patent) listed on the Canadian Patent
Register for Atacand Plus. AstraZeneca commenced a proceeding in response in June 2010. In February 2011, AstraZeneca discontinued its application.
As previously disclosed, in December 2010, AstraZeneca received a Notice of Allegation from PMS in respect of the Atacand Plus combination patent no. 2,125,251 (the ‘251 patent). AstraZeneca commenced an application in response in February 2011.
In January 2011, AstraZeneca received two Notices of Allegation from Teva Canada Limited (Teva) in respect of the ‘251 and the ‘305 patents. Teva has agreed to await the expiry of the ‘955 patent. AstraZeneca commenced applications in response in March 2011.
Crestor (rosuvastatin calcium)
Patent litigation – US
US Patent No. RE37,314 (the ‘314 patent)
As previously disclosed, in June 2010, the US District Court for the District of Delaware found the ‘314 patent valid and enforceable and infringed by the eight generic defendants. The defendants appealed the decision to the Court of Appeals for the Federal Circuit. AstraZeneca and Shionogi Seiyaku Kabushiki Kaisha filed a comprehensive responsive brief in March 2011. The defendants filed reply briefs and briefing is now complete. A date for oral argument has not been set.
505(b)(2) New Drug Application for rosuvastatin zinc tablets (the ‘314 patent) and US Patent Nos. 6,858,618 (the ‘618 patent) and 7,030,152 (the ‘152 patent)
As previously disclosed, in October 2010, AstraZeneca and Shionogi Seiyaku Kabushiki Kaisha commenced a patent infringement action in the US District Court for the District of Delaware against Watson Laboratories, Inc. (Watson) for infringement of the ‘314 patent. In March 2011, the Court entered an order based on a stipulation which precludes Watson from re-litigating the invalidity and unenforceability issues currently pending before the Federal Circuit in the Crestor appeal involving the ‘314 patent. The Court has set a case-schedule for discovery and other litigation events, including a trial date in May 2012. On April 19, 2011, in this case, AstraZeneca moved to amend the complaint to add The Brighams & Women’s Hospital as a co-plaintiff and add claims of infringement of the ‘618 and ‘152 method patents.
Abbreviated New Drug Applications for rosuvastatin calcium tablets (the ‘618 and ‘152 patents)
In 2010, AstraZeneca and The Brighams & Women’s Hospital, AstraZeneca’s licensor of the ‘152 patent (together the Plaintiffs), filed ten patent infringement actions involving Crestor in the US District Court for the District of Delaware, based on the ‘152 patent and the ‘618 patent. As previously disclosed in December 2010, the Court dismissed nine of the infringement actions for lack of subject-matter jurisdiction. In January 2011, the Plaintiffs appealed the dismissals to the Federal Circuit. The Plaintiffs also asked the District Court to stay the remaining action against Sandoz Inc. pending the outcome of the appeals. In March 2011, the Plaintiffs filed an opening brief in the Federal Circuit.
Palmetto Pharmaceuticals, LLC v. AstraZeneca Pharmaceuticals LP (Infringement Suit)
AstraZeneca Pharmaceuticals LP v. Palmetto Pharmaceuticals, LLC (Declaratory Judgment suit)
On April 5, 2011, Palmetto Pharmaceuticals, LLC (Palmetto) filed a patent infringement suit in the US District Court for the District of South Carolina asserting that AstraZeneca’s sales of Crestor induce infringement of Palmetto’s US patent no. 6,465,516 (the ‘516 patent), for which an Ex Parte Reexamination Certificate was issued on 5 April 2011.
On April 7, 2011, AstraZeneca filed a declaratory judgment action in the US District Court for the District of Delaware against Palmetto seeking a judgment of non-infringement and invalidity of Palmetto’s ‘516 patent.
On April 26, 2011, Astrazeneca filed a motion seeking dismissal or, alternatively, summary judgement of non-infringement in Palmetto’s patent infringement suit in the District of South Carolina.
Patent litigation – Canada
As previously disclosed, in February 2010, AstraZeneca received a Notice of Allegation from Pharmascience Inc. (PMS) in respect of Crestor substance patent no. 2,072,945 (the ‘945 patent) and formulation patent no. 2,313,783
(the ‘783 patent). AstraZeneca commenced an application in response in April 2010. A 4-day hearing will commence January 9, 2012.
As previously disclosed, in August 2010, AstraZeneca received a Notice of Allegation from Mylan Pharmaceuticals ULC (Mylan) in respect of the ‘945 and ‘783 patents and formulation patent 2,315,141 listed on the Canadian Patent Register for Crestor. In April 2011, AstraZeneca reached a comprehensive settlement resolving the litigation and as part of the agreement, Mylan may enter the Canadian market in April 2012, or earlier in certain circumstances.
Patent litigation – EU
In Portugal, in February and March 2011, the Appeal Court confirmed the preliminary injunctions to suspend the marketing authorizations granted to Teva Pharma Lda and Sandoz Farmaceutica Lda and dismissed the appeal. The suspension of the marketing authorizations will be maintained until a decision is rendered within the main administrative action.
Patent litigation – Brazil
AstraZeneca filed an administrative action against the administrative body ANVISA for a preliminary injunction for immediate suspension of the decision to grant market approval of Germed Farmacêutica Ltda’s (Germed) generic rosuvastatin and to revoke the marketing approval. The preliminary injunction was partially granted on March 4, 2011. On March 15, 2011 the preliminary injunction was dismissed by the court of first instance. AstraZeneca has appealed the decision. On March 18, 2011, AstraZeneca filed a patent infringement action against Germed with a request for a preliminary injunction. On March 31, 2011 the court denied AstraZeneca’s request. AstraZeneca appealed the decision and on April 14, 2011 the Reporting Judge of the Appeal Court rejected the request. AstraZeneca is awaiting the decision by the panel of the Appeal Court.
Iressa
Both the Osaka and Tokyo courts have issued decisions regarding the Iressa product liability litigation (the details of which have been previously disclosed). On February 25, 2011, the Osaka District Court issued its decision, dismissing one claim, and ordering AstraZeneca to pay approximately $670,000 for the remaining three claims, plus interest. AstraZeneca is appealing the Osaka decision. On March 23, 2011, the Tokyo District Court issued its decision dismissing one Iressa claim and ordering AstraZeneca and the Japanese Ministry of Health, Labour and Welfare to pay approximately $192,000 on the remaining two claims, plus interest. AstraZeneca is appealing the Tokyo decision.
Nexium (esomeprazole magnesium)
Patent litigation – US
Abbreviated New Drug Applications (ANDAs)
As previously disclosed, in January 2011, AstraZeneca entered into an agreement to settle the litigation with Dr Reddy’s Laboratories Ltd and Dr Reddy’s Laboratories Inc (together DRL), a prior ANDA filer. As a result of the DRL settlement and entry of a consent judgment, all of the DRL ANDA litigation was dismissed.
As to the remaining ANDA filers, as previously disclosed, in 2008, AstraZeneca received a Paragraph IV Certification notice-letter from Sandoz Inc. (Sandoz) stating that Sandoz had submitted an ANDA for approval to market esomeprazole magnesium delayed-release capsules. In 2009, AstraZeneca commenced patent infringement litigation in the US District Court for the District of New Jersey. In 2009, the Court stayed the Sandoz patent infringement litigation. In view of the settlement with DRL in January 2011, the Court referred the matter back to Magistrate Judge Bongiovanni for scheduling and further proceedings. On April 26, 2011, the magistrate judge entered an order staying for one month the case-schedule that she entered for this case on April 14, 2011.
In addition, as previously disclosed, in 2009, AstraZeneca received a Paragraph IV Certification notice-letter from Lupin Limited (Lupin) stating that Lupin had submitted an ANDA for approval to market esomeprazole magnesium delayed-release capsules. In October 2009, AstraZeneca commenced patent infringement litigation against Lupin in the US District Court for the District of New Jersey. In March 2010, the Court stayed the Lupin
patent infringement litigation. In view of the settlement with DRL in January 2011, the Court has also referred the Lupin matter back to Magistrate Judge Bongiovanni for scheduling and further proceedings.
505(b)(2) New Drug Application for esomeprazole strontium capsules
As previously disclosed, in December 2010, AstraZeneca received a Paragraph IV Certification notice-letter from Hanmi USA Inc. (Hanmi) stating that it had submitted a New Drug Application under section 505(b)(2) for FDA approval to market 20 and 40mg esomeprazole strontium capsules. Hanmi alleges non-infringement or invalidity of 11 patents listed in the FDA’s Orange Book with reference to Nexium. AstraZeneca commenced a patent infringement action against Hanmi in the United States District Court for the District of New Jersey in February 2011.
Patent litigation – Canada
As previously disclosed, AstraZeneca commenced a patent infringement action against Apotex Inc. (Apotex) in October 2010. Trial is set to begin in September 2013. In response to indications in the Canadian market that Apotex launched its generic esomeprazole magnesium product on March 7, 2011, AstraZeneca brought a motion for interim and interlocutory injunctions on March 11, 2011 to prevent such sales pending determination of the patent infringement action between the parties. On April 19, 2011 the Canadian Federal Court conducted a hearing on the motion. The Court reserved judgment.
In March 2011, Apotex served AstraZeneca with a claim for damages pursuant to Section 8 of the Patented Medicines (Notice of Compliance) Regulations. Astrazeneca is considering its response.
Patent Litigation – EU: 10-year countries
In the UK, Consilient Health Limited (Consilient) was granted approval for a generic esomeprazole product manufactured by Krka, d.d., Novo Mesto (Krka) in Slovenia. AstraZeneca initiated infringement proceedings against both companies in September 2010. Consilient and Krka have agreed not to launch their product pending the outcome of the main infringement case and AstraZeneca has undertaken to be liable for losses of the defendants and third parties if the injunction is lifted at a later date. The trial will start on January 23, 2012.
In the UK, in October 2010 AstraZeneca was served an invalidity case in which Ranbaxy (UK) Ltd (Ranbaxy UK) claimed that the Nexium esomeprazole magnesium patent (EP 1020461) and the esomeprazole magnesium trihydrate patent (EP 0984957) are invalid in the UK. Ranbaxy UK further requested the court to confirm that its generic esomeprazole product does not infringe either patent if launched in the UK. In March 2011 AstraZeneca filed suit against Ranbaxy UK claiming that its generic esomeprazole product infringes the Nexium esomeprazole magnesium patent (EP 1020461). The trial of the non-infringement part will commence on June 7, 2011. The invalidity part has been stayed pending the non-infringement trial.
In Germany, in December 2010 the court rejected AstraZeneca’s request for preliminary injunctions to prevent Krka, d.d., Novo Mesto, TAD Pharma GmbH, Abz-Pharma GmbH, CT Artzneimittel GmbH, ratiopharm GmbH, Teva GmbH, Hexal AG and Sandoz Pharmaceuticals GmbH from marketing and selling generic esomeprazole products in Germany. The decision was published in March 2011. AstraZeneca has decided not to appeal.
In Italy, in the Court of Turin, EG s.p.a. (a company in the Stada group) (EG) filed a law suit in June 2010 claiming the Nexium esomeprazole magnesium patent (EP 1020461) as invalid in Italy. These proceedings are in early stages. AstraZeneca has added a counterclaim of infringement against EG and in February 2011, AstraZeneca filed a request for and received a preliminary injunction against EG. The injunction was revoked in April 2011.
In February and March 2011, in the District Court of Trieste, AstraZeneca was granted preliminary injunctions against Teva Italia s.r.l., ratiopharm GmbH, ratiopharm Italia s.r.l., Doc Generici s.r.l., Sandoz Pharmaceuticals GmbH, Sandoz s.p.a. and Mylan s.p.a. The generic companies appealed and in March 2011 the injunctions were revoked. In February and March 2011 in Milan, generic companies including Mylan s.p.a., Sandoz s.p.a., Crinos s.p.a., Ranbaxy Italia s.p.a., Zentiva ks and Zentiva Italia s.r.l. initiated preliminary proceedings for declaratory judgments of non-infringement regarding esomeprazole magnesium patent (EP 1020461). Initial hearings are scheduled for May 2011. In February in Trieste, Mylan s.p.a. filed law suits claiming the Nexium esomeprazole magnesium patent (EP 1020461) and Nexium formulation patent (EP 0984773) as invalid in Italy. Separate hearings are set for July 13, 2011 and July 15, 2011 respectively.
In France, ratiopharm GmbH and Laboratoire ratiopharm S.A. (together ratiopharm) filed a law suit against AstraZeneca in August 2010 claiming the Nexium esomeprazole magnesium patent (EP 1020461) as invalid in France. ratiopharm has since withdrawn this law suit. Ethypharm S.A. filed a law suit against AstraZeneca in August 2010 claiming the Nexium esomeprazole magnesium patent (EP 1020461) and a cloud-point formulation patent (EP 1124539) as invalid in France. The next hearing in these cases will be in June 2011. In February 2011, Mylan S.A.S. filed a law suit against AstraZeneca claiming the Nexium esomeprazole magnesium patent (EP 1020461) as invalid in France. In April 2011, AstraZeneca filed a patent infringement suit against Ethypharm S.A. for infringement of the Nexium esomeprazole magnesium patent (EP1020461) and the Nexium process patent (EP 0773940) and requested a preliminary injunction against Ethypharm S.A. A preliminary injunction hearing is scheduled for May 2011.
Patent Litigation – EU: 6-year countries
In Denmark, in 2010, the court granted AstraZeneca preliminary injunctions preventing Sandoz from continuing to sell the product based on infringement of the Nexium esomeprazole magnesium patent (EP 1020461) and the Nexium process patent (EP 0773940). The injunctions were upheld by the Appeal Court in February 2011.
In Austria, in February 2011, the court denied AstraZeneca’s request for preliminary injunction to prevent ratiopharm Arzneimittel Vertriebs-GmbH from marketing and selling generic esomeprazole magnesium product in Austria. AstraZeneca has appealed this decision.
In Finland in March 2011, AstraZeneca initiated a declaratory action requesting the District Court of Helsinki to confirm that Krka Sverige AB and ratiopharm GmbH would infringe a patent relating to esomeprazole if they were to commercialise generic esomeprazole magnesium products in Finland. AstraZeneca initiated a similar declaratory action against Ranbaxy (UK) Limited in December 2009 and the trial has been scheduled for May 25 and 26 2011.
In Spain, AstraZeneca’s request for a preliminary injunction against Sandoz Farmacéutica S.A., Bexal Farmacéutica S.A., and Acost Comercial Genericpharma, S.L. (all in the Sandoz group) was initially granted by the court but revoked in July 2010 after a hearing. AstraZeneca has appealed this ruling and awaits the appellate decision. Separately, in AstraZeneca’s main patent infringement action against Sandoz Farmacéutica S.A., Bexal Farmacéutica S.A., and Acost Comercial Genericpharma, S.L., trial is scheduled for September 2011.
In Ireland, in August 2010, AstraZeneca initiated a main action against Krka, d.d., Novo Mesto and Pinewood Laboratories Ltd claiming that the sale and marketing of their generic esomeprazole magnesium products infringes the Nexium esomeprazole magnesium patent (EP 1020461). The defendants have filed a counter action claiming that EP 1020461 is invalid in Ireland.
In Lithuania and Estonia in March 2011, the Appeal Courts upheld the interlocutory injunctions against Krka, d.d., Novo Mesto to restrain this company from commercializing generic magnesium esomeprazole product in Lithuania and Estonia.
Patent litigation – Norway
In Norway, in July 2008 Hexal AG, Sandoz AS and Sandoz A/S initiated an invalidity case regarding two esomeprazole-related patents. In December 2009, the Court of Oslo invalidated a formulation patent but upheld a substance patent related to esomeprazole. In March 2011 the Appeal Court confirmed the decision from the Court of Oslo.
Patent Proceedings
As previously disclosed, the European Patent Office (EPO) published the grant of two patents that relate to Nexium (EP 1020461) and Nexium i.v. (EP1020460) in July 2009. The period for filing Notices of Opposition to the grant of these new patents expired in April 2010. Thirteen Notices of Opposition have been filed in relation to EP 1020461 and six Notices of Opposition in relation to EP 1020460. The EPO has now issued summonses to attend oral hearing proceedings relating to both sets of oppositions. Oral proceedings relating to EP 1020461 will be held on June 7, 8 and 9, 2011. Oral proceedings relating to EP 1020460 will be held on June 30 and July 1, 2011.
Pulmicort Respules (budesonide inhalation suspension)
In January 2011, the Court of Appeals for the Federal Circuit denied Apotex Group’s petition for an en banc rehearing of their appeal of the preliminary injunction entered by the US District Court for the District of New Jersey.
In March 2011, the Court ordered the patent case against Sandoz, Inc. to be consolidated with the already consolidated actions against Breath Ltd. (now Watson Pharmaceuticals, Inc.) and the Apotex Group. A new scheduling order for the consolidated cases was subsequently entered by the Court. No trial date has been set.
Seroquel (quetiapine fumarate)
Sales and marketing practices
In March 2011, AstraZeneca completed a previously announced settlement in principle to resolve Seroquel-related consumer protection and deceptive trade practice claims under state law with 37 states and Washington, DC as part of the National Association of Attorneys General for $68.5 million in the aggregate (as to which AstraZeneca previously had established a provision).
As previously disclosed, the states of Alaska, Arkansas, Mississippi, Montana, New Mexico, South Carolina and Utah have sued AstraZeneca under various state laws generally alleging that AstraZeneca made false and/or misleading statements in connection with the marketing and promotion of Seroquel. In February 2011, the state of Utah filed an amended complaint after a federal judge had dismissed its complaint in December 2010.
In March 2011, the US Court of Appeals for the Eleventh Circuit affirmed the November 2008 dismissal by the Seroquel Multi-District Litigation (MDL) court of a putative nationwide class action lawsuit brought on behalf of all individual and non-governmental third-party payers of Seroquel, which had alleged that AstraZeneca promoted Seroquel for off-label uses and misled class members into believing that Seroquel was superior to lower-cost alternative medicines.
Product liability
As of March 31, 2011, approximately 26,085 claims have been settled in principle.
As of March 31, 2011, AstraZeneca was aware of approximately 2,600 Seroquel US product liability claims that have not been settled in principle. The majority of these remaining claims are pending in the New Jersey, New York and California state courts, although some claims are pending in a handful of other state courts and in the federal MDL.
As of March 31, 2011, legal defense costs of approximately $743 million have been incurred in connection with Seroquel-related product liability claims. As previously disclosed, AstraZeneca settled its claims against several of its insurers for a substantial part of those legal defense costs.
As previously disclosed, disputes continue with other insurers about the availability of coverage under certain insurance policies for legal defense costs and potential damages amounts. As of March 31, 2011, out of the legal defense costs of $743 million mentioned above, AstraZeneca believes that approximately $128 million is covered by these other insurance policies.
Patent litigation – Brazil
As previously disclosed, in January 2006 AstraZeneca filed a lawsuit before the Federal Courts of Rio de Janeiro seeking judicial declaration extending the term of one of its patents from 2006 to 2012. In March 2011, the Federal Courts of Rio de Janeiro denied AstraZeneca’s request for an extension. AstraZeneca has decided not to appeal.
Seroquel XR
Patent litigation – US
As previously disclosed, in December 2010, Torrent Pharmaceuticals Ltd. (Torrent) filed a Motion for Clarification and Reconsideration of the decision by the US District Court for the District of New Jersey interpreting claims of the Seroquel XR formulation patent (US patent no. 5,948,437). In February 2011, the Court denied Torrent’s motion.
As previously disclosed, in July 2010, AstraZeneca received a Paragraph IV Certification notice-letter from Osmotica Pharmaceutical Corporation (Osmotica) indicating that it was seeking approval to market generic versions of 200, 300 and 400mg Seroquel XR tablets before the expiration of US Patent No. 5,948,437 (the ‘437 patent). In August 2010, AstraZeneca filed a law suit in the US District Court for the District of New Jersey against Osmotica. In April 2011, AstraZeneca received another Paragraph IV Certification notice-letter from Osmotica indicating that it was seeking approval to market generic versions of 50 and 150mg Seroquel XR tablets before the expiration of the ‘437 patent.
As previously disclosed, in October 2010 AstraZeneca received a Paragraph IV Certification notice-letter from Mylan Pharmaceuticals Inc. (Mylan) indicating that it was seeking approval to market generic versions of 200mg Seroquel XR tablets before the expiration of the ‘437 patent. In October 2010, AstraZeneca filed a lawsuit in the US District Court for the District of New Jersey against Mylan. In April 2011, AstraZeneca received another Paragraph IV Certification notice-letter from Mylan indicating that it was seeking approval to market generic versions of 50, 150, 300 and 400 mg Seroquel XR tablets before expiration of the ‘437 patent.
Patent litigation – EU
In the UK, Teva UK Limited and Teva Pharmaceuticals Limited (together, Teva) issued revocation proceedings against AstraZeneca in December 2010. Teva claims that the formulation patent for Seroquel XR (EP 0907364) is invalid in the UK. Similar revocation actions were filed by Accord Healthcare Limited, Intas Pharmaceuticals Limited, Hexal AG and Sandoz Ltd in March and April 2011.
In Hungary, AstraZeneca was notified that Teva Pharmaceuticals Limited and Teva Gyógyszergyár Zrt (together Teva) had filed a request for nullity of the Hungarian formulation patent for Seroquel XR with the Hungarian Patent Office in January 2011. Teva claims that Hungarian patent no. 225 152 should be declared null and void. AstraZeneca is preparing its response.
In Germany, Teva Deutschland GmbH (Teva) issued revocation proceedings against AstraZeneca in February 2011. Teva claims that the formulation patent for Seroquel XR (EP 0907364) is invalid in Germany. AstraZeneca filed its response in March 2011.
Synagis (palivizumab)
As previously disclosed, this matter concerned MedImmune’s action seeking a declaratory judgment that the Queen patents owned by PDL BioPharma, Inc. (PDL) are invalid and/or not infringed by either Synagis and/or motavizumab, and that no further royalties are owed under a patent license that MedImmune and PDL signed in 1997. The matter was settled in February 2011 with PDL agreeing to pay MedImmune $92.5 million ($65 million in February 2011 and $27.5 million in February 2012). In addition, PDL agreed to the release of approximately $9 million in escrow to MedImmune. MedImmune will pay no further royalties to PDL relative to Synagis.
Vimovo (fixed-dose combination of naproxen and esomeprazole)
In April 2010, the FDA approved Vimovo for marketing in the US. Vimovo was co-developed by POZEN Inc. (Pozen) and AstraZeneca via a collaboration agreement originating in August 2006. AstraZeneca commenced marketing of Vimovo in the US in the third quarter of 2010. Seven patents are listed in the FDA’s Orange Book referencing Vimovo.
In March 2011, the FDA’s web-site reported a filing of a first Abbreviated New Drug Application (ANDA) containing Paragraph IV Certifications and seeking approval to market generic copies of the 375/20 mg and 500/20 mg doses of Vimovo.
On March 14, 2011, AstraZeneca received a Paragraph IV Certification Notice-letter in respect of Vimovo from Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. (together, DRL). DRL certified under Paragraph IV in its ANDA that US Patent No. 6,926,907 (the ‘907 patent) is invalid, unenforceable, and/or not infringed. AstraZeneca licenses the ‘907 patent from Pozen and, with a February 2023 expiry, the patent is the last expiring of the seven Orange Book listed patents. On April 21, 2011, AstraZeneca and Pozen sued DRL in the US District Court for the District of New Jersey.
Zomig (zolmitriptan)
Patent litigation – Canada
In April 2011, AstraZeneca received a Notice of Allegation from Apotex Inc. (Apotex) in respect of Canadian Zomig product-by-process patent no. 2,572,508 listed on the Canadian Patent Register for Zomig. Apotex did not address the listed 2,064,815 substance patent (the ‘815 patent), which expires in June 2011. Therefore, Apotex cannot receive a marketing approval before expiration of the ‘815 patent. AstraZeneca is evaluating the allegations.
Other Commercial Litigation
Dr. George Pieczenik v. AstraZeneca Pharmaceuticals LP, AstraZeneca LP, et al
On March 23, 2011, the District Court granted the defendants’ joint motion to dismiss the plaintiff's claims with prejudice. On March 24, 2011 the plaintiff filed a pro forma Notice of Appeal from the order granting dismissal of the patent infringement and Racketeering Institution and Corrupt Organisation Act claims and denying the motion for recusal.
Resonant Biotechnologies, LLC v. AstraZeneca LP, et al.
In April 2011, AstraZeneca LP, a number of AstraZeneca entities (collectively AstraZeneca) and multiple other entities were named in a patent infringement lawsuit filed in the United States District Court for the District of Delaware. Plaintiff purports to be the exclusive licensee of US patent no. 6,218,194 (the ‘194 Patent) which is titled “Analytical Methods And Apparatus Employing An Optical Sensor Device With Refractive Index Modulation.” Specific to AstraZeneca, Plaintiff alleges that AstraZeneca infringes the ‘194 patent “by using the Corning Epic® system”, described in the complaint as a “high-throughput label-free screening device.” Plaintiff seeks monetary relief. AstraZeneca is considering its response.
Network Signatures, Inc. v. AstraZeneca Pharmaceuticals LP
In April 2011, AstraZeneca Pharmaceuticals LP was named in a patent infringement law suit filed in the United States District Court for the Central District of California. The plaintiff purports to have title to United States Patent No. 5,511,122 (the ‘122 patent) entitled “Intermediate Network Authentication.” The plaintiff alleges that AstraZeneca’s use of “digital certificates and digital signatures implemented through the use of public key infrastructure to facilitate communication with its employees and customers” infringes the ‘122 patent. The plaintiff seeks monetary and injunctive relief. AstraZeneca is considering its response.
Other Pricing Litigation
Average Wholesale Price Litigation
In February 2011, the US District Court for the District of Massachusetts granted final approval of two previously announced settlements that resolve class action law suits brought by Massachusetts-only and multi-state classes of payers of Zoladex for $13 million and $90 million, respectively (which amounts have been paid by AstraZeneca).
340B Class Action Litigation
In March 2011, the US Supreme Court reversed a decision of the US Court of Appeals for the Ninth Circuit and held that covered entities under the 340B program do not have enforceable rights to sue as third party beneficiaries of the Pharmaceutical Pricing Agreement, thereby dismissing this case and entitling AstraZeneca, and the other defendants, to judgment as a matter of law.
Other Anti-trust Litigation and Investigations
Drug importation anti-trust litigation
As previously disclosed, in August 2004, Californian retail pharmacy plaintiffs filed an action in the Superior Court of California alleging a conspiracy by AstraZeneca and approximately 15 other pharmaceutical manufacturer defendants to set the price of drugs sold in California at or above the Canadian sales price for those same drugs and otherwise restrict the importation of pharmaceuticals into the US.
In March 2011, the Superior Court of California granted the defendants’ motion for summary judgment on grounds that the plaintiffs failed to prove their allegations of a conspiracy and that the defendants were entitled to judgment as a matter of law. In April 2011, the plaintiffs appealed the decision to the Court of Appeal of the State of California.
Other Actual and Threatened Government Investigations and Related Litigation
Foreign Corrupt Practices Act
As previously disclosed, AstraZeneca has received inquiries from the US Department of Justice and the Securities and Exchange Commission in connection with an investigation into Foreign Corrupt Practices Act issues in the pharmaceutical industry across several countries. AstraZeneca is co-operating with these inquiries and is investigating, among other things, sales practices, internal controls, certain distributors, and interactions with healthcare providers, institutions, and other government officials. AstraZeneca is investigating inappropriate conduct in certain countries, including China. AstraZeneca's investigations are ongoing and additional governmental authorities could become involved. It is not currently possible to predict the scope, duration or outcome of these matters, which could involve the payment of fines or other penalties.
Tax
Transfer pricing and other international tax contingencies
On March 28, 2011 AstraZeneca announced that HM Revenue & Customs in the UK and the US Internal Revenue Service had agreed the terms of an Advance Pricing Agreement regarding transfer pricing arrangements for AstraZeneca’s US business covering the 13 year period from 2002 to the end of 2014. The Company also announced that an agreement had been reached on a related valuation matter arising on integration of the legacy Astra and legacy Zeneca US businesses in 2000 following the global AstraZeneca merger in 1999. The provision for US transfer pricing and related valuation matters is a substantial proportion of the total net accrual for transfer pricing and other international tax contingencies of $2,310 million disclosed under the heading “Financial Statements—Notes to the Financial Statements—Note 25—Commitments and contingent liabilities” on page 195 of the Company’s “Annual Report and Form 20-F Information 2010” included as exhibit 15.1 to this Form 20-F dated April 28, 2011, incorporated by reference.
Based on the above mentioned agreements, AstraZeneca now expects to pay a net amount of $1.1 billion to resolve all US transfer pricing and related valuation matters for the period from 2000 to the end of 2010 and $540 million of provisions have been released to earnings in the first quarter of 2011. The net amount payable of $1.1 billion reflects expected US tax payments and updated estimates of corresponding tax refunds in other jurisdictions.
ITEM 6 -6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. Directors and Senior Management
The information set forth under the headings “Directors’ Report—Business Organisation“Corporate Governance—Board of Directors and Corporate Governance—Senior Executive Team—Board of Directors at 31 December 2008” on pages 84December” and 85, “—Chief Executive Officer, DelegationBoard of AuthorityDirectors and Senior Executive Team—Senior Executive Team”Team at 31 December” on pages 106 and 107, and page 86 and “Remuneration Report—108, respectively, “Corporate Governance—Directors’ Remuneration Report—Variable Remuneration—Policy on external appointments and retention of fees” on page 181,128 and “—Directors’ Remuneration Report—Directors’ emoluments in 2010—Directors’ remuneration-US dollars” (last sentence only) on page 130, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
On February 27, 2009, the Company announced that Håkan Mogren, Non-Executive Deputy Chairman, will retire from the Company’s Board of Directors at the close of the Company’s AGM on April 30, 2009.
B. Compensation
The information (including graphs and tabular data) set forth under the headings “Remuneration Report—“Corporate Governance—Directors’ Remuneration Report” on pages 174119 to 188,134, “Financial Statements—Notes to the Financial Statements—Note 23—Post-Retirement Benefits”,18—Post-retirement benefits” on pages 162 to 166, “—Note 24—Employee Costscosts and Share Option Plansshare option plans for Employees”employees” on pages 173 to 177 and “—Note 27—Statutory and Other Information—other information—Key management personnel compensation”, on pages 133 to 138, 138 to 143, and 163, respectively,page 196, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
C. Board Practices
The information (including tabular data) set forth under the headings “Directors’ Report—Business Organisation“Corporate Governance—Board of Directors and Corporate Governance—Senior Executive Team—Board of Directors at 31 December 2008”December” and “—Chief Executive Officer, Delegation of Authority
and Senior Executive Team—Senior Executive Team”,Team at 31 December” on pages 84 to 86, “—Operation of the Board of Directors”106 and “—Operation of Board Committees”107, and page 108, respectively, “Corporate Governance—Corporate Governance Report—Leadership” on pages 87109 to 91,110, “—Principal UK and US Governance Requirements—UK Corporate Governance Requirements” and “—US Corporate Governance Requirements”Board effectiveness” on pages 91110 to 93, and “Directors’ Remuneration Report—Executive Directors’ and Senior Executive Team’s Remuneration and Terms of Employment—Details of Executive Directors’ Service Contracts at 31 December 2008”111, “—Board Committee membership” (consisting of tabular data) on page 112, “—Audit Committee” on pages 113 to 114, “—Remuneration Committee”, “—Nomination and Governance Committee” and “—Science Committee”, each on page 115, “—Business organization—Compliance and Group Internal Audit (GIA)” on pages 116 and 117, “Corporate Governance—Directors’ Remuneration Report—Service contracts” and “—Non-Executive Directors”, each on page 181,128, and “—Directors’ Remuneration Report—Audit—Details of Executive Directors’ service contracts at 31 December 2010” and “—Non-Executive Directors’ terms and conditions” each on page 129, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
Jane Henney, who is a current Non-Executive Director of the Company, will not present herself for re-election at the Company’s 2011 Annual General Meeting, which is being held on the date of this Form 20-F, and will leave the Company’s Board of Directors at the close of the Annual General Meeting.
D. Employees
The information set forth under the headings “Directors’ Report—Resources, Skills and Capabilities—“Business Review—Delivering our strategy—People” (comprising the graphical data, and firstthe final two paragraphs set forth under “Simplifying our organizational design” only) on pages 36 and 38 respectively, “Business Review—Delivering our strategy—Research and Development—Our resources” (first and second paragraph only) on pages 29 to 30, “Business Review—Delivering our strategy—Supply and Manufacturing—Our resources” (second paragraph only) on page 28, “—Communication and Dialogue” on pages 28 to 2935, and “Financial Statements—Notes to the Financial Statements—Note 24—Employee Costscosts and Share Option Plansshare option plans for Employees”employees—Employee costs” (including the tabular data) on pages 138 to 143,page 173, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
E. Share Ownership
The information (including graphs and tabular data) set forth under the headings “Financial Statements—Notes to the Financial Statements—Note 24—Employee Costscosts and Share Option Plansshare option plans for Employees”employees” on pages 138173 to 143, “Remuneration177, “Corporate Governance—Corporate Governance Report—Other matters—Directors’ shareholdings” on page 117, “Corporate Governance—Directors’ Remuneration Report —Directors’ InterestsReport—Directors’ interests in Shares”shares” on pages 185132 to 188,134, and “Additional Information—Shareholder Information—Major Shareholdings—Title of class” and “—Shareholder Information—Options to Purchase Securitiespurchase securities from Registrantregistrant or Subsidiaries” (consisting of tabular data and related text), bothsubsidiaries” on page 192,213, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
ITEM 7 -7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. Major Shareholders
The information set forth under the heading “Additional Information—Shareholder Information—Major Shareholdings”shareholdings” (including tabular data) on pages 191212 to 192213 of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
B. Related Party Transactions
The information set forth under the headings “Financial Statements—Notes to the Financial Statements—Note 27—Statutory and Other Information—Related Party Transactions”party transactions” on page 163196 and “Additional Information—Shareholder Information—Related Party Transactions”party transactions” on page 192,213, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
C. Interests of Experts and Counsel
Not applicable.
ITEM 8 -8. FINANCIAL INFORMATION
A. Consolidated Statements and Other Financial Information
The information (including graphs and tabular data) set forth under the headings “Directors’ Report—Financial Review—Capitalisation and Shareholder Return—Dividend and Share Re-Purchases” on page 37, “Directors’ Report—Business Organisation and Corporate Governance—Other Matters—Distributions to shareholders” on page 95, “Financial Statements” on pages 100138 to 163196 (including the information set forth under the subheading “Notes to
the Financial Statements”), “Financial Statements—Principal Subsidiaries” on page 164, “Group197, “Financial Statements—Group Financial Record” on page 172, and204, “Additional Information—Shareholder Information” on pages 190211 to 195,215, “Business Review—Financial Review—Capitalization and shareholder return—Dividend and share repurchases” on page 87 and “Corporate Governance—Corporate Governance Report—Other matters—Distributions to shareholders and dividends for 2010” on page 117, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
Please see the information above under the heading Item 5 – “Operating and Financial Review and Prospects—Developments in Legal Proceedings” for information as to recent developments in certain legal proceedings disclosed under the heading “Financial Statements—Notes to the Financial Statements—Note 25—Commitments and contingent liabilities” on pages 178 to 195 of the Company’s “Annual Report and Form 20-F Information 2010” included as exhibit 15.1 to this Form 20-F dated April 28, 2011.
B. Significant Changes
SincePlease see the information above under the heading Item 5 – “Operating and Financial Review and Prospects—Developments in Legal Proceedings” for information as to recent developments in certain legal proceedings disclosed under the heading “Financial Statements—Notes to the Financial Statements—Note 25—Commitments and contingent liabilities” on pages 178 to 195 of the Company’s “Annual Report and Form 20-F Information 2010” included as exhibit 15.1 to this Form 20-F dated April 28, 2011.
Other than as disclosed herein, since the date of the annual consolidated financial statements included in this Form 20-F dated March 17, 2009,April 28, 2011, no significant change has occurred, except as otherwise disclosed herein.occurred.
ITEM 9 -9. THE OFFER AND LISTING
A. Offer and Listing Details
The information (including graphs and tabular data) set forth under the heading “Additional Information—Shareholder Information”Information—AstraZeneca PLC share listings and prices” on page 190pages 211 to 212 of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
In addition, the table below sets forth, for the periods indicated, the reported high and low share prices of AstraZeneca PLC, on the following bases:
| · | for shares listed on the London Stock Exchange (LSE) the reported high and low middle market closing quotations are derived from Thethe Daily Official List; |
| · | for shares listed on the Stockholm Stock Exchange (SSE) the high and low closing sales prices are as stated in the Official List; and |
| · | for American Depositary Shares (ADS) listed on the New York Stock Exchange the reported high and low sales prices are as reported by Dow Jones (ADR quotations). |
| | | AstraZeneca | |
| | | | | | | | | | |
| | | High | | | Low | | | High | | | Low | | | High | | | Low | |
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
| 2009 – February | | | 2,767 | | | | 2,238 | | | | 40.16 | | | | 31.33 | | | | 330.0 | | | | 287.5 | |
| 2009 – January | | | 2,947 | | | | 2,671 | | | | 41.60 | | | | 38.36 | | | | 331.0 | | | | 309.5 | |
| 2008 – December | | | 2,807 | | | | 2,420 | | | | 41.12 | | | | 35.24 | | | | 326.0 | | | | 300.0 | |
| 2008 – November | | | 2,888 | | | | 2,245 | | | | 44.38 | | | | 34.10 | | | | 340.5 | | | | 280.5 | |
| 2008 – October | | | 2,630 | | | | 2,075 | | | | 44.76 | | | | 36.50 | | | | 320.0 | | | | 253.5 | |
| 2008 – September | | | 2,766 | | | | 2,415 | | | | 48.95 | | | | 43.53 | | | | 321.5 | | | | 292.5 | |
| 2008 | | | 2,888 | | | | 1,748 | | | | 49.85 | | | | 34.10 | | | | 340.5 | | | | 211.5 | |
| 2008 – Quarter 4 | | | 2,888 | | | | 2,075 | | | | 44.76 | | | | 34.10 | | | | 340.5 | | | | 253.5 | |
| 2008 – Quarter 3 | | | 2,766 | | | | 2,130 | | | | 49.85 | | | | 43.42 | | | | 321.5 | | | | 255.5 | |
| 2008 – Quarter 2 | | | 2,289 | | | | 1,981 | | | | 44.57 | | | | 39.36 | | | | 268.0 | | | | 235.5 | |
| 2008 – Quarter 1 | | | 2,345 | | | | 1,748 | | | | 45.70 | | | | 35.50 | | | | 296.5 | | | | 211.5 | |
| 2007 | | | 2,984 | | | | 2,093 | | | | 59.04 | | | | 42.82 | | | | 414.0 | | | | 272.0 | |
| 2007 – Quarter 4 | | | 2,589 | | | | 2,093 | | | | 52.47 | | | | 42.82 | | | | 343.5 | | | | 272.0 | |
| 2007 – Quarter 3 | | | 2,770 | | | | 2,278 | | | | 56.16 | | | | 45.56 | | | | 374.5 | | | | 315.0 | |
| 2007 – Quarter 2 | | | 2,953 | | | | 2,567 | | | | 59.04 | | | | 51.00 | | | | 401.0 | | | | 354.5 | |
| 2007 – Quarter 1 | | | 2,984 | | | | 2,734 | | | | 58.78 | | | | 53.53 | | | | 414.0 | | | | 367.5 | |
| 2006 | | | 3,529 | | | | 2,574 | | | | 66.37 | | | | 45.12 | | | | 484.0 | | | | 352.5 | |
| 2005 | | | 2,837 | | | | 1,861 | | | | 49.50 | | | | 34.72 | | | | 392.0 | | | | 243.0 | |
| 2004 | | | 2,749 | | | | 1,863 | | | | 50.85 | | | | 35.88 | | | | 374.0 | | | | 237.5 | |
| | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
| 2011 – March | | | 2,987 | | | | 2,802 | | | | 48.82 | | | | 45.40 | | | | 307.2 | | | | 289.0 | |
2011 – February | | | 3,035 | | | | 2,933 | | | | 49.38 | | | | 47.56 | | | | 315.3 | | | | 303.9 | |
2011 – January | | | 3,074 | | | | 2,923 | | | | 48.90 | | | | 46.36 | | | | 320.6 | | | | 310.1 | |
2010 – December | | | 3,153 | | | | 2,922 | | | | 49.28 | | | | 45.80 | | | | 336.5 | | | | 309.3 | |
2010 – November | | | 3,144 | | | | 2,996 | | | | 50.34 | | | | 46.93 | | | | 336.9 | | | | 325.7 | |
2010 – October | | | 3,359 | | | | 3,130 | | | | 53.50 | | | | 50.43 | | | | 354.7 | | | | 336.7 | |
| | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
2010 | | | 3,385 | | | | 2,732 | | | | 53.50 | | | | 40.91 | | | | 382.2 | | | | 309.3 | |
2010 – Quarter 4 | | | 3,359 | | | | 2,922 | | | | 53.50 | | | | 45.80 | | | | 354.7 | | | | 309.3 | |
2010 – Quarter 3 | | | 3,385 | | | | 3,052 | | | | 53.41 | | | | 47.05 | | | | 382.2 | | | | 345.0 | |
2010 – Quarter 2 | | | 3,169 | | | | 2,772 | | | | 48.74 | | | | 40.91 | | | | 368.0 | | | | 314.0 | |
2010 – Quarter 1 | | | 3,103 | | | | 2,732 | | | | 50.40 | | | | 43.05 | | | | 363.8 | | | | 310.1 | |
2009 | | | 2,947 | | | | 2,147 | | | | 47.54 | | | | 30.24 | | | | 365.0 | | | | 261.5 | |
2009 – Quarter 4 | | | 2,930 | | | | 2,691 | | | | 47.00 | | | | 43.64 | | | | 339.5 | | | | 308.0 | |
2009 – Quarter 3 | | | 2,878 | | | | 2,644 | | | | 47.54 | | | | 43.01 | | | | 356.0 | | | | 305.0 | |
2009 – Quarter 2 | | | 2,728 | | | | 2,276 | | | | 45.01 | | | | 33.40 | | | | 351.0 | | | | 279.5 | |
2009 – Quarter 1 | | | 2,947 | | | | 2,147 | | | | 41.60 | | | | 30.24 | | | | 331.0 | | | | 261.5 | |
2008 | | | 2,888 | | | | 1,748 | | | | 49.85 | | | | 34.10 | | | | 340.5 | | | | 211.5 | |
2007 | | | 2,984 | | | | 2,093 | | | | 59.04 | | | | 42.82 | | | | 414.0 | | | | 272.0 | |
2006 | | | 3,529 | | | | 2,574 | | | | 66.37 | | | | 45.12 | | | | 484.0 | | | | 352.5 | |
(1) | (1) Principally held in bearer form. |
B. Plan of Distribution
Not applicable.
C. Markets
The information set forth under the heading “Additional Information—Shareholder Information”Information—AstraZeneca PLC share listings and prices” on page 190pages 211 to 212 of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
D. Selling Shareholders
Not applicable.
E. Dilution
Not applicable.
F. Expenses of the Issue
Not applicable.
ITEM 10 -10. ADDITIONAL INFORMATION
A. Share Capital
Not applicable.
B. Memorandum and Articles of Association
The information set forth under the heading “Additional Information—Corporate Information—Memorandum and Articles of Association”Articles” on page 197216 of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
C. Material Contracts
Not applicable.
D. Exchange Controls
The information set forth under the headings “Additional Information—Shareholder Information—Exchange Controlscontrols and Other Limitations Affecting Security Holders”other limitations affecting security holders” on page 194215 of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
E. Taxation
The information set forth under the headings “Additional Information—Shareholder Information—Taxation for US Residents”residents”, “—UK and US Income Taxationincome taxation of Dividends”dividends”, “—Taxation on Capital Gains”capital gains”, “—Passive Foreign Investment Company Rules”(PFIC) rules”, “—UK Inheritance Tax”inheritance tax” and “—UK Stamp Duty Reserve Taxstamp duty reserve tax and Stamp Duty”stamp duty” on pages 193214 to 194215 of the Company’s ���Annual“Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
F. Dividends and Paying Agents
Not applicable.
G. Statement by Experts
Not applicable.
H. Documents on Display
The information set forth under the heading “Additional Information—Shareholder Information—Documents on Display”display” on page 193214 of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
In addition, we file reports and other information with the United States Securities and Exchange Commission (the “SEC”). You can read and copy these reports and other information at the SEC’s Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. You can call the SEC at 1-800-SEC-0330 for further information on the Public Reference Room. The SEC also maintains a website at www.sec.gov which contains in electronic form each of the reports and other information that we have filed electronically with the SEC.
I. Subsidiary Information
Not applicable.
ITEM 11 -11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The information (including graphs and tabular data) set forth under the headings “Directors’ Report—“Business Review—Financial Review—Financial Risk Management”risk management” on pages 41 to 42,page 90 and “Financial Statements—Note 15—23—Financial Risk Management Objectivesrisk management objectives and Policies” and “—Note 16—Financial Instruments—Sensitivity Analysis”policies” on pages 120168 to 126,172, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
ITEM 12 -12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
A. Debt Securities
Not applicable.
B. Warrants and Rights
Not applicable.
C. Other Securities
Not applicable.
D. American Depositary Shares
Fees and Charges Payable by ADR Holders
The Company’s American Depositary Receipt (“ADR”) program is administered by JPMorgan Chase Bank, N.A. (“J.P. Morgan”), as the depositary. The holder of an ADR may have to pay the following fees and charges to J.P. Morgan in connection with ownership of the ADR:
| Category | | Depositary actions | | Associated fee or charge |
| (a) Depositing or substituting the underlying shares | | Issuances against deposits of shares, including deposits and issuances pursuant to a stock dividend or stock split declared by the Company or issuances pursuant to a merger, exchange of securities or any other transaction or event affecting the American Depositary Shares (“ADSs”) or the deposited securities | | Up to US $5.00 for each 100 ADSs (or portion thereof) issued or delivered (as the case may be) The depositary may sell (by public or private sale) sufficient securities and property received in respect of share distributions, rights and other distributions prior to such deposit to pay such charge |
| | | | |
| (b) Receiving or distributing dividends(1) | | Cash distributions made pursuant to the deposit agreement | | US $0.05 or less per ADS |
| | | | |
| (c) Selling or exercising rights | | Distribution or sale of securities, the fee being in an amount equal to the fee for the execution and delivery of ADSs which would have been charged as a result of the deposit of such securities | | Up to US $5.00 for each 100 ADSs (or portion thereof) |
(d) Withdrawing, cancelling or reducing an underlying security | | Acceptance of ADSs surrendered for withdrawal, cancellation or reduction of deposited securities | | Up to US $5.00 for each 100 ADSs (or portion thereof) surrendered, cancelled or reduced (as the case may be) The depositary may sell (by public or private sale) sufficient securities and property received in respect of share distributions, rights and other distributions prior to such deposit to pay such charge |
| | | | |
| (e) Transferring, combination or split-up of receipts | | Transfer, combination and split-up of ADRs | | US $1.50 per ADR |
| | | | |
| (f) General depositary services, particularly those charged on an annual basis(1) | | Services performed by the depositary in administering the ADRs | | US $0.05 or less per ADS per calendar year (or portion thereof), payable at the sole discretion of the depositary by billing ADR holders or by deducting such charge from one or more cash |
| Category | | Depositary actions | | Associated fee or charge |
| | | | |
| | | | dividends or other cash distributions |
| (g) Fees and expenses of the depositary | | Fees and expenses incurred by the depositary or the depositary’s agents on behalf of holders, including in connection with: | | Expenses payable at the sole discretion of the depositary by billing ADR holders or by deducting such charges from one or more cash dividends or other cash distributions |
| | | | |
| | ·compliance with foreign exchange control regulations or any law or regulation relating to foreign investment ·stock transfer or other taxes and governmental charges ·cable, telex and facsimile transmission and delivery charges ·fees for the transfer or registration of deposited securities in connection with the deposit or withdrawal of deposited securities ·expenses of the depositary in connection with the conversion of foreign currency into US dollars ·any other charge payable by the depositary or the depositary’s agents in connection with the servicing of the shares or other deposited securities (which charge shall be assessed against holders as of the record date or dates set by the depositary) | | |
| (1) | J.P. Morgan has agreed that it shall not charge ADR holders any of these fees without the Company’s prior written consent. No such fees have been charged for the year ended December 31, 2010 or from January 1, 2011 to the date hereof. |
Fees and Payments Made by the Depositary to us
J.P. Morgan, as ADR depositary, has agreed to reimburse certain expenses related to the Company’s ADR program and incurred by the Company in connection with the program. For the year ended December 31, 2010, the ADR depositary reimbursed to the Company, or paid on its behalf to third parties, a total sum of US $1,605,085 (comprised of reimbursements of US $1,524,267 and payments to third parties of US $80,818, in each case as detailed in the tables below). The ADR depositary also waived certain of its fees for standard costs associated with the administration of the ADR program in a total amount of US $215,000.
The table below sets forth the types of expenses that the ADR depositary has agreed to reimburse and the amounts reimbursed within each such category for the year ended December 31, 2010:
Category of Expenses – Direct Payments | | Reimbursement for the year ended December 31, 2010 | |
| | | | |
ADR program expenses, including investor relations costs and legal fees | | $ | 1,524,267 | |
Category of Expenses – Direct Payments | | Reimbursement for the year ended December 31, 2010 | |
| | | | | |
Total | | $ | 1,524,267 | |
The ADR depositary has paid certain expenses directly to third parties on behalf of the Company and has agreed to waive certain of its fees for standard costs associated with the administration of the ADR program. The table below sets forth those expenses that the ADR depositary paid directly to third parties, and those fees waived, in each case for the year ended December 31, 2010.
Category of Expenses – Indirect Payment | | Amount paid for the year ended December 31, 2010 | |
| Expenses paid by depositary to third parties on behalf of the Company – NYSE listing fees | | $ | 80,818 | |
Fees waived by depositary for standard ADR program costs | | $ | 215,000 | |
Total | | $ | 295,818 | |
Under certain circumstances, including removal of the ADR depositary or termination of the ADR program by the Company, the Company is required to repay the ADR depositary certain amounts reimbursed and/or expenses paid to or on behalf of the Company. No such repayments were made during the year ended December 31, 2010.
ITEM 13 -13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
(a) There has been no material default in payment of principal, interest, a sinking or purchase fund installment, or any other material default with respect to any indebtedness of the Company or any of its significant subsidiaries.
(b) There have been no arrears in the payment of dividends on, and no material delinquency with respect to, any class of preferred stock of any significant subsidiary of the Company.
ITEM 14 -14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
Not applicable.
ITEM 15 -15. CONTROLS AND PROCEDURES
The information set forth under the heading “Directors’“Corporate Governance—Corporate Governance Report—Business OrganisationAccountability” on pages 111 and Corporate Governance—Operation of Board Committees—112, “—Audit Committee” on page 90114 (the last threefour paragraphs of the “Audit Committee” section only)only, excluding the “Code of Conduct” section), “—Business OrganisationUS corporate governance requirements” on page 115 (the first and Corporate Governance—Principal UK and US Governance Requirements” on pages 91 to 92 (the third, fourth, fifth and sixthsecond paragraphs of the “Principal UK and US Governance Requirements”“US corporate governance requirements” section only) and “Financial Statements—Directors’ Responsibilities for, and Report on, Internal Control over Financial Reporting” on page 98,136, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
Management’s Annual Report on Internal Control over Financial Reporting
As required by US regulations, management is responsible for establishing and maintaining adequate internal control over financial reporting for the company, and is required to identify the framework used to evaluate the effectiveness of the Company’s internal control over financial reporting and to assess the effectiveness of such internal control. In this regard, management has made the same assessment and reached the same conclusion as that set forth in the section entitled “Financial Statements—Director’s Responsibilities for, and Report on, Internal Control over Financial Reporting” on page 98136 of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009,April 28, 2011, which is incorporated herein by reference.
Report of Independent Registered Public Accounting Firm
The Board of Directors and MembersStockholders
AstraZeneca PLC:
We have audited AstraZeneca PLC’s (“AstraZeneca”) internal control over financial reporting as of 31 December 2008,2010, based on criteria established in Internal Control —– Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). AstraZeneca’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
A company'scompany’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company'scompany’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In our opinion, AstraZeneca maintained, in all material respects, effective internal control over financial reporting as of 31 December 2008,2010, based on criteria established in Internal Control —– Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States),PCAOB, the consolidated balance sheetsstatements of financial position of AstraZeneca and subsidiaries as of 31 December 2008, 20072010, 2009 and 2006,2008, and the related consolidated income statements, consolidated statements of recognizedcomprehensive income, changes in equity, and expense, and consolidated cash flow statementsflows for each of the years in the three-year period ended 31 December 2008,2010, and our report dated 2927 January 20092011 expressed an unqualified opinion on those consolidated financial statements.
KPMG Audit Plc
15 Canada Square
London
United Kingdom
E14 5GL
27 January 2011
KPMG Audit Plc
Chartered Accountants
8 Salisbury Square
London
EC4Y 8BB
29 January 2009
ITEM 16 –16. RESERVED
ITEM 16A –16A. AUDIT COMMITTEE FINANCIAL EXPERT
The information set forth under the heading “Corporate Governance—Corporate Governance Report—Board Committee membership” (consisting of tabular data) on page 112 and in the first paragraph under the heading “Directors’ Report—Business Organisation and Corporate Governance—Operation of Board Committees—“—Audit Committee” on pages 89 and 90 and “—Board Committee Membership” (consisting of tabular data) on page 88,113, in each case of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
ITEM 16B –16B. CODE OF ETHICS
The information set forth under the heading “Directors’“Corporate Governance—Corporate Governance Report—Business Organisation and Corporate Governance—Principal UK and US Governance Requirements—Audit Committee—Code of Conduct” on page 93114 of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
The AstraZenecaCompany’s Code of Conduct is available at www.astrazeneca.com.www.astrazeneca.com.
ITEM 16C –16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
| | | |
| | | | | | | |
| | | ($ million) | |
Audit Fees | | | 2.3 | | | | 2.4 | |
Audit-Related Fees | | | 7.1 | | | | 7.1 | |
Tax Fees | | | 1.1 | | | | 1.0 | |
All Other Fees | | | 3.4 | | | | 3.6 | |
Total | | | 13.9 | | | | 14.1 | |
Audit-related fees consist of $6.5 million for the audit of subsidiaries pursuant to legislation and fees of $0.6 million for the audit of subsidiaries’ pension schemes.
Tax fees consist of tax compliance services and, to a lesser extent, tax advice.
All other fees consist of fees of $0.1 million for assurance services in relation to third party compliance with manufacturing and distribution agreements and advisory services supporting management in their development of competency and development frameworks for staff and fees of $3.3 million for other services pursuant to legislation (including fees of $2.4 million in respect of section 404 of the Sarbanes-Oxley Act).
The information (including tabular data) set forth under the heading “Financial Statements—Notes to the Financial Statements—Note 27—Statutory and Other Information” on page 163 and “Directors’“Corporate Governance—Corporate Governance Report—Business Organisation and Corporate Governance—Operation of Board Committees—Audit Committee” (excluding the “Code of Conduct” section) on pages 89 and 90, in each case113 to 114 of the Company’s “Annual Report and Form 20-F Information 2008”2010” included as exhibit 15.1 to this Form 20-F dated March 17, 2009April 28, 2011 is incorporated by reference.
ITEM 16D –16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
Not applicable.
ITEM 16E –16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
| | (a) Total number of Shares (or units) purchased(1) | | | (b) Average Price Paid per Share (or Units) | | | (c) Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs | | | (d) Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs | | | (a) Total number of Shares (or units) Purchased(1) | | | (b) Average Price Paid per Share (or Units) | | | (c) Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs | | | (d) Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs | |
Month #1 Jan 1 - Jan 31 | | 0 | | | - | | | 0 | | | $1.00bn | | | | 0 | | | | 0 | | | | 0 | | | | 2.6 | |
Month #2 Feb 1 - Feb 28 | | 0 | | | - | | | 0 | | | $1.00bn | | | | 500,000 | | | | 43.62 | | | | 500,000 | | | | 2.6 | |
Month #3 Mar 1 - Mar 31 | | 0 | | | - | | | 0 | | | $1.00bn | | | | 4,295,000 | | | | 44.80 | | | | 4,295,000 | | | | 2.4 | |