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SEC Filings

 
Form 10-K
HEARTWARE INTERNATIONAL, INC. filed this Form 10-K on 02/23/2010
Document Outline
Entire Document (1583.6 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 - Market Opportunity
Page 7 - CHF Treatment Options
Page 8 - Bridge-to-decision therapy
Page 9 - The HeartWare System
Page 10 - Enhanced Quality of Life with Smaller Peripherals and Implantable Devices
Page 11 - Our Business Strategy
Page 12 - Intellectual Property
Page 13 - Government Regulation
Page 14 - Premarket Approval
Page 15 - Pervasive and Continuing FDA Regulation
Page 16 - Australia
Page 17 - Competition
Page 18 - Manufacturing and Assembly
Page 19 - Risks Related to Our Business and Industry
Page 20 - We currently rely entirely on sales of our sole product, the HeartWare System, to generate revenues.
Page 21 - We have limited sales, marketing and distribution experience.
Page 22 - Our products have not yet been approved for commercial sale within the United States, and our succes
Page 23 - We may not meet regulatory quality standards applicable to our manufacturing and quality processes,
Page 24 - Product issues could result in substantial costs and write-downs leading to delay or termination of
Page 25 - If hospitals do not conduct or encourage the conduct of destination therapy procedures using the Hea
Page 26 - Healthcare reform legislation could adversely affect our revenue and financial condition.
Page 27 - We may not be able to effectively protect our intellectual property rights which could have an adver
Page 28 - Claims that our current or future products infringe or misappropriate the proprietary rights of othe
Page 29 - We may need to initiate lawsuits to protect or enforce our patents and other intellectual property r
Page 30 - We may be subject to claims that our employees or we have inadvertently or otherwise used or disclos
Page 31 - If we choose to acquire or invest in new businesses, products or technologies, instead of developing
Page 32 - We compete against companies that have longer operating histories, more established or approved prod
Page 33 - The competition for qualified personnel is particularly intense in our industry. If we are unable to
Page 34 - Risk Factors Related to Our Common Stock
Page 35 - Your interests may differ or conflict with those of the Company s largest shareholder.
Page 36 - Results of Special Meeting of Stockholders
Page 37 - N/A
Page 38 - Part II
Page 39 - N/A
Page 40 - The following discussion and analysis of our financial condition and results of operations should be
Page 41 - Critical Accounting Policies and Estimates
Page 42 - Inventory Capitalization
Page 43 - Fair Value Measurements
Page 44 - Fiscal Years 2009 and 2008
Page 45 - Selling, General and Administrative
Page 46 - Foreign Exchange
Page 47 - Other, net
Page 48 - Foreign Exchange
Page 49 - Contractual Obligations
Page 50 - Interest Rate Risk
Page 51 - HEARTWARE INTERNATIONAL, INC.
Page 52 - Report of Independent Registered Public Accounting Firm
Page 53 - HEARTWARE INTERNATIONAL, INC.
Page 54 - HEARTWARE INTERNATIONAL, INC.
Page 55 - HEARTWARE INTERNATIONAL, INC.
Page 56 - HEARTWARE INTERNATIONAL, INC.
Page 57 - HEARTWARE INTERNATIONAL, INC.
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 - Evaluation of Disclosure Controls and Procedures
Page 77 - Attestation Report of Independent Registered Public Accounting Firm
Page 78 - Changes in Internal Control over Financial Reporting
Page 79 - Part III
Page 80 - Dr. David Hathaway.
Page 81 - Australian Disclosure Requirements
Page 82 - Substantial Shareholders
Page 83 - Options Unlisted
Page 84 - General Information
Page 85 - Recommendation 1.2 Disclose the process for evaluating the performance of senior executives
Page 86 - Independent advice
Page 87 - Principle 3 Promote ethical and responsible decision-making
Page 88 - Principle 5 Make timely and balanced disclosure
Page 89 - Principle 7 Recognise and manage risk
Page 90 - Reporting requirement
Page 91 - Reporting requirement
Page 92 - Part IV.
Page 93 - N/A
Page 94 - Exhibit Index
Page 95 - N/A
Page 96 - N/A
Subdocument 2 - EX-10.05 - EXHIBIT 10.05
Page 1 - 16 December 2009
Page 2 - 4. Vacation, Insurance and Benefits; Expenses.
Page 3 - (v)
Page 4 - (c)
Page 5 - (e)
Page 6 - (f)
Page 7 - (b)
Page 8 - (b)
Page 9 - 13. Blue Pencil; Severability
Page 10 - (e)
Page 11 - 21. Successors, Binding Agreement.
Page 12 - Dated: December 16, 2009
Page 13 - Exhibit A
Subdocument 3 - EX-10.06 - EXHIBIT 10.06
Page 1 - 16 December 2009
Page 2 - 4. Vacation, Insurance and Benefits; Expenses.
Page 3 - (c)
Page 4 - (i)
Page 5 - (g)
Page 6 - (b)
Page 7 - (c)
Page 8 - 13. Waivers.
Page 9 - (e)
Page 10 - Dated: December 16, 2009
Page 11 - Exhibit A
Subdocument 4 - EX-10.27 - EXHIBIT 10.27
Page 1 - Exhibit 10.27
Page 2 - N/A
Page 3 - N/A
Page 4 - Exhibit B Floor Plan Showing Tenant s Space
Page 5 - 1.4 Data Certificate
Page 6 - N/A
Page 7 - Exhibit B-1
Page 8 - Exhibit B
Page 9 - Exhibit F-1
Page 10 - Exhibit H:
Page 11 - Exhibit G
Page 12 - LEASE
Page 13 - N/A
Page 14 - N/A
Page 15 - N/A
Page 16 - ARTICLE 2 PREMISES AND TERM
Page 17 - N/A
Page 18 - ARTICLE 3 ALTERATIONS
Page 19 - ARTICLE 4 RENT
Page 20 - N/A
Page 21 - N/A
Page 22 - N/A
Page 23 - ARTICLE 5 LANDLORD S COVENANTS
Page 24 - N/A
Page 25 - ARTICLE 6 TENANT S COVENANTS
Page 26 - N/A
Page 27 - N/A
Page 28 - N/A
Page 29 - ARTICLE 7 CASUALTY AND TAKING
Page 30 - N/A
Page 31 - ARTICLE 8 RIGHTS OF MORTGAGEE
Page 32 - N/A
Page 33 - ARTICLE 9 DEFAULTS
Page 34 - N/A
Page 35 - N/A
Page 36 - ARTICLE 10 MISCELLANEOUS
Page 37 - N/A
Page 38 - N/A
Page 39 - N/A
Page 40 - ARTICLE 11 ARBITRATION
Page 41 - N/A
Page 42 - EXHIBIT A
Page 43 - EXHIBIT B
Page 44 - N/A
Page 45 - EXHIBIT C
Page 46 - N/A
Page 47 - EXHIBIT D
Page 48 - N/A
Page 49 - EXHIBIT E
Page 50 - N/A
Page 51 - EXHIBIT F
Subdocument 5 - EX-21.1 - EXHIBIT 21.1
Page 1 - LIST OF SUBSIDIARIES
Subdocument 6 - EX-23.1 - EXHIBIT 23.1
Page 1 - N/A
Subdocument 7 - EX-31.1 - EXHIBIT 31.1
Page 1 - CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO RULE 13A-14(a) OR RULE
Subdocument 8 - EX-31.2 - EXHIBIT 31.2
Page 1 - CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO RULE 13A-14(a) OR RULE
Subdocument 9 - EX-32.1 - EXHIBIT 32.1
Page 1 - CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO 18 U.S.C.
Subdocument 10 - EX-32.2 - EXHIBIT 32.2
Page 1 - CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO 18 U.S.C.