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SEC Filings

 
Form 10-K
HEARTWARE INTERNATIONAL, INC. filed this Form 10-K on 02/24/2011
Document Outline
Entire Document (1241.5 KB)
Subdocument 1 - 10-K - FORM 10-K
Page 1 - UNITED STATES
Page 2 - N/A
Page 3 - References
Page 4 - Corporate Information
Page 5 - PART I
Page 6 - Destination Therapy
Page 7 - Market Opportunity
Page 8 - CHF Treatment Options
Page 9 - Destination therapy
Page 10 - The HeartWare MVAD
Page 11 - Our Business Strategy
Page 12 - Partner with leading professionals in the fields of cardiovascular surgery around the world
Page 13 - Government Regulation
Page 14 - Premarket Approval
Page 15 - European Union
Page 16 - Healthcare Regulation
Page 17 - Competition
Page 18 - Manufacturing and Assembly
Page 19 - Risks Related to Our Business and Industry
Page 20 - We have a significant amount of indebtedness consisting currently of our convertible senior notes. W
Page 21 - We manufacture a Class III device implanted in the heart that subjects us to numerous risks.
Page 22 - We currently rely entirely on sales of our sole product, the HeartWare System, to generate revenues.
Page 23 - Our ability to achieve profitability from a current net loss level will depend on our ability to inc
Page 24 - We have limited capabilities and manufacturing personnel, and if our manufacturing facilities are un
Page 25 - We may not meet regulatory quality standards applicable to our manufacturing and quality processes,
Page 26 - If we fail to obtain and maintain adequate level of reimbursement for our products by third party pa
Page 27 - The long and variable sales and deployment cycles for our ventricular assist device, or VAD, systems
Page 28 - Our manufacturing facilities and the manufacturing facilities of our suppliers must comply with appl
Page 29 - We may not be able to effectively protect our intellectual property rights which could have an adver
Page 30 - Claims that our current or future products infringe or misappropriate the proprietary rights of othe
Page 31 - We may need to initiate lawsuits to protect or enforce our patents and other intellectual property r
Page 32 - If we are found to have violated laws protecting the confidentiality of patient health information,
Page 33 - If we cannot successfully manage the additional business and regulatory risks that result from our e
Page 34 - The competition for qualified personnel is particularly intense in our industry. If we are unable to
Page 35 - Investors could lose confidence in our financial reports, and the value of our shares may be adverse
Page 36 - We do not intend to pay cash dividends on our common stock in the foreseeable future.
Page 37 - We may undergo an ownership change for U.S. federal income tax purposes, which would limit our abili
Page 38 - Part II
Page 39 - Stock Price Performance Graph
Page 40 - Equity Compensation Plans
Page 41 - N/A
Page 42 - The following discussion and analysis of our financial condition and results of operations should be
Page 43 - Critical Accounting Policies and Estimates
Page 44 - Share-Based Compensation
Page 45 - Income Taxes
Page 46 - Results of Operations
Page 47 - Selling, General and Administrative
Page 48 - Foreign Exchange
Page 49 - Change in Fair Value of Derivative Instrument
Page 50 - Cost of Revenues
Page 51 - Research and Development
Page 52 - Interest Income, net
Page 53 - Cash Used in Operating Activities
Page 54 - Operating Capital and Capital Expenditure Requirements
Page 55 - Off-Balance Sheet Arrangements
Page 56 - HEARTWARE INTERNATIONAL, INC.
Page 57 - Report of Independent Registered Public Accounting Firm
Page 58 - HEARTWARE INTERNATIONAL, INC.
Page 59 - HEARTWARE INTERNATIONAL, INC.
Page 60 - HEARTWARE INTERNATIONAL, INC.
Page 61 - HEARTWARE INTERNATIONAL, INC.
Page 62 - HEARTWARE INTERNATIONAL, INC.
Page 63 - HEARTWARE INTERNATIONAL, INC.
Page 64 - HEARTWARE INTERNATIONAL, INC.
Page 65 - HEARTWARE INTERNATIONAL, INC.
Page 66 - HEARTWARE INTERNATIONAL, INC.
Page 67 - HEARTWARE INTERNATIONAL, INC.
Page 68 - HEARTWARE INTERNATIONAL, INC.
Page 69 - HEARTWARE INTERNATIONAL, INC.
Page 70 - HEARTWARE INTERNATIONAL, INC.
Page 71 - HEARTWARE INTERNATIONAL, INC.
Page 72 - HEARTWARE INTERNATIONAL, INC.
Page 73 - HEARTWARE INTERNATIONAL, INC.
Page 74 - HEARTWARE INTERNATIONAL, INC.
Page 75 - HEARTWARE INTERNATIONAL, INC.
Page 76 - HEARTWARE INTERNATIONAL, INC.
Page 77 - HEARTWARE INTERNATIONAL, INC.
Page 78 - HEARTWARE INTERNATIONAL, INC.
Page 79 - HEARTWARE INTERNATIONAL, INC.
Page 80 - HEARTWARE INTERNATIONAL, INC.
Page 81 - HEARTWARE INTERNATIONAL, INC.
Page 82 - HEARTWARE INTERNATIONAL, INC.
Page 83 - HEARTWARE INTERNATIONAL, INC.
Page 84 - HEARTWARE INTERNATIONAL, INC.
Page 85 - Evaluation of Disclosure Controls and Procedures
Page 86 - Internal Control-Integrated Framework
Page 87 - Changes in Internal Control over Financial Reporting
Page 88 - Part III
Page 89 - Dr. David Hathaway.
Page 90 - Other Information
Page 91 - Distribution of equity security holders as at 31 January 2011
Page 92 - Voting Rights
Page 93 - General Information
Page 94 - Recommendation 1.2 Disclose the process for evaluating the performance of senior executives
Page 95 - Independent advice
Page 96 - Principle 4 Safeguard integrity in financial reporting
Page 97 - Reporting Requirement
Page 98 - Reporting requirement
Page 99 - Reporting requirement
Page 100 - Part IV.
Page 101 - SIGNATURES
Page 102 - Exhibit Index
Page 103 - N/A
Page 104 - N/A
Subdocument 2 - EX-10.08 - EXHIBIT 10.08
Page 1 - Exhibit 10.08
Page 2 - 2. Indemnification.
Page 3 - N/A
Subdocument 3 - EX-10.29 - EXHIBIT 10.29
Page 1 - Exhibit 10.29
Page 2 - Extended Delivery Date
Page 3 - Non-Renewal Notice
Page 4 - FDA Approval
Page 5 - BASE RENT
Page 6 - N/A
Page 7 - (v
Page 8 - N/A
Page 9 - Sales Tax
Page 10 - PERSONAL PROPERTY TAXES
Page 11 - COMPLIANCE WITH LAWS
Page 12 - Tenant s Compliance Obligations
Page 13 - Environmental Laws
Page 14 - Environmental Contingency Program
Page 15 - Confidential Information
Page 16 - Covenant
Page 17 - Alterations
Page 18 - MECHANICS LIENS
Page 19 - de minimis
Page 20 - HOLD HARMLESS
Page 21 - N/A
Page 22 - CASUALTY LOSS
Page 23 - DEFAULT
Page 24 - Tenant s Property
Page 25 - Tenant s Insurance
Page 26 - Landlord s Insurance
Page 27 - NOTICE
Page 28 - HOLDING OVER
Page 29 - ENVIRONMENTAL INDEMNITY
Page 30 - TIME OF ESSENCE
Page 31 - Disclosed Brokers
Page 32 - LANDLORD S LIABILITY
Page 33 - TENANT IMPROVEMENTS.
Page 34 - Parking Spaces
Page 35 - COMMON AREAS
Page 36 - FF E
Page 37 - OPTIONS TO RENEW.
Page 38 - Second Extension Term
Page 39 - Rooftop Rights
Page 40 - Pre-Existing Tenants
Page 41 - Telecommunication Service
Page 42 - ROFO
Page 43 - RIGHT OF FIRST OFFER TO PURCHASE THE PREMISES
Page 44 - SIGNATURE PAGE FOLLOWS
Page 45 - IN WITNESS WHEREOF
Page 46 - EXHIBIT A
Page 47 - EXHIBIT A-1
Page 48 - EXHIBIT A-2
Page 49 - EXHIBIT B
Page 50 - N/A
Page 51 - N/A
Page 52 - Payment Request
Page 53 - Landlord Delay
Page 54 - EXHIBIT B-1
Page 55 - SCHEDULE A
Page 56 - N/A
Page 57 - N/A
Page 58 - N/A
Page 59 - N/A
Page 60 - EXHIBIT C
Page 61 - EXHIBIT A
Page 62 - Prepared by and upon recordation
Page 63 - The foregoing instrument was acknowledged before me this
Page 64 - The foregoing instrument was acknowledged before me this
Subdocument 4 - EX-21.1 - EXHIBIT 21.1
Page 1 - Exhibit 21.1
Subdocument 5 - EX-23.1 - EXHIBIT 23.1
Page 1 - Exhibit 23.1
Subdocument 6 - EX-31.1 - EXHIBIT 31.1
Page 1 - Exhibit 31.1
Subdocument 7 - EX-31.2 - EXHIBIT 31.2
Page 1 - Exhibit 31.2
Subdocument 8 - EX-32.1 - EXHIBIT 32.1
Page 1 - Exhibit 32.1
Subdocument 9 - EX-32.2 - EXHIBIT 32.2
Page 1 - Exhibit 32.2