text
stringlengths 1.03k
343k
|
|---|
DANIEL J. MOOS, 59 President (since April 2007) and Chief Executive Officer (effective March 2010) of ARL, TCI, IOT and (effective March 2007) of Prime; Senior Vice President and Business Line Manager for U.S. Bancorp (NYSE:USB) working out of their offices in Houston, Texas from 2003 to April 2007: Executive Vice President and Chief Financial Officer, Fleetcor Technologies a privately held transaction processing company that was headquartered in New Orleans, Louisiana from 1998 to 2003; Senior Vice President and Chief Financial Officer, ICSA a privately held internet security and information company headquartered in Carlisle, Pennsylvania from 1996 to 1998; and for more than ten years prior thereto was employed in various financial and operating roles for PhoneTel Technologies, Inc. which was a publicly traded telecommunication company on the American Stock Exchange headquartered in Cleveland, Ohio (1992-1996) and LDI Corporation which was a publicly traded computer equipment sales/service and asset leasing company listed on the NASDAQ and headquartered in Cleveland, Ohio. |
The Advisory Agreement also provides for Prime to receive an annual incentive sales fee equal to 10.0% of the amount, if any, by which the aggregate sales consideration for all real estate sold by TCI during such fiscal year exceeds the sum of: (1) the cost of each such property as originally recorded in TCI’s books for tax purposes (without deduction for depreciation, amortization or reserve for losses), (2) capital improvements made to such assets during the period owned, and (3) all closing costs, (including real estate commissions) incurred in the sale of such real estate; provided, however, no incentive fee shall be paid unless (a) such real estate sold in such fiscal year, in the aggregate, has produced an 8.0% simple annual return on the net investment including capital improvements, calculated over the holding period before depreciation and inclusive of operating income and sales consideration and (b) the aggregate net operating income from all real estate owned for each of the prior and current fiscal years shall be at least 5.0% higher in the current fiscal year than in the prior fiscal year. |
Additionally, general construction and development activities include the following risks: • construction and leasing of a property may not be completed on schedule, which could result in increased expenses and construction costs, and would result in reduced profitability for that property; • construction costs may exceed original estimates due to increases in interest rates and increased cost of materials, labor or other costs, possibly making the property less profitable because of inability to increase rents to compensate for the increase in construction costs; • some developments may fail to achieve expectations, possibly making them less profitable; • we may be unable to obtain, or face delays in obtaining, required zoning, land-use, building, occupancy, and other governmental permits and authorizations, which could result in increased costs and could require us to abandon our activities entirely with respect to a project; • we may abandon development opportunities after the initial exploration, which may result in failure to recover costs already incurred. |
The following factors, among others, may adversely affect the income generated by our properties: • downturns in the national, regional and local economic conditions (particularly increases in unemployment); • competition from other office, hotel and commercial buildings; • local real estate market conditions, such as oversupply or reduction in demand for office, hotel or other commercial space; • changes in interest rates and availability of financing; • vacancies, changes in market rental rates and the need to periodically repair, renovate and re-let space; • increased operating costs, including insurance expense, utilities, real estate taxes, state and local taxes and heightened security costs; • civil disturbances, earthquakes and other natural disasters, or terrorist acts or acts of war which may result in uninsured or underinsured losses; • significant expenditures associated with each investment, such as debt service payments, real estate taxes, insurance and maintenance costs which are generally not reduced when circumstances cause a reduction in revenues from a property; • declines in the financial condition of our tenants and our ability to collect rents from our tenants; and • decreases in the underlying value of our real estate. |
These current conditions, or similar conditions existing in the future, may adversely affect our results of operations, and financial condition as a result of the following, among other potential consequences: • the financial condition of our tenants may be adversely affected which may result in tenant defaults under leases due to bankruptcy, lack of liquidity, operational failures or for other reasons; • significant job losses within our tenants may occur, which may decrease demand for our office space, causing market rental rates and property values to be negatively impacted; • our ability to borrow on terms and conditions that we find acceptable, or at all, may be limited, which could reduce our ability to pursue acquisition and development opportunities and refinance existing debt, reduce our returns from our acquisition and development activities and increase our future interest expense; • reduced values of our properties may limit our ability to dispose of assets at attractive prices or to obtain debt financing secured by our properties and may reduce the availability of unsecured loans; and • one or more lenders could refuse to fund their financing commitment to us or could fail and we may not be able to replace the financing commitment of any such lenders on favorable terms, or at all. |
Some of the risks and uncertainties that may cause our actual results, performance or achievements to differ materially from those expressed or implied by forward-looking statements include, among others, the following: • general risks affecting the real estate industry (including, without limitation, the inability to enter into or renew leases, dependence on tenants’ financial condition, and competition from other developers, owners and operators of real estate); • risks associated with the availability and terms of financing and the use of debt to fund acquisitions and developments; • failure to manage effectively our growth and expansion into new markets or to integrate acquisitions successfully; • risks and uncertainties affecting property development and construction (including, without limitation, construction delays, cost overruns, inability to obtain necessary permits and public opposition to such activities); • risks associated with downturns in the national and local economies, increases in interest rates, and volatility in the securities markets; • costs of compliance with the Americans with Disabilities Act and other similar laws and regulations; • potential liability for uninsured losses and environmental contamination; • risks associated with our dependence on key personnel whose continued service is not guaranteed; and • the other risk factors identified in this Form 10-K, including those described under the caption “Risk Factors.” The risks included here are not exhaustive. |
SCHEDULE III TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2008 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2008 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2008 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2008 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2008 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2008 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2008 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2008 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2008 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2008 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2008 SCHEDULE IV TRANSCONTINENTAL REALTY INVESTORS, INC. MORTGAGE LOANS ON REAL ESTATE December 31, 2008 SCHEDULE IV (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. MORTGAGE LOANS ON REAL ESTATE December 31, 2008 * Original note became non-performing in August 2005. |
Management Report on Internal Control Over Financial Reporting Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended, as a process designed by, or under the supervision of, the Company’s principal executive and principal financial officers and effected by the Company’s board, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States (“US GAAP”) and includes those policies and procedures that: • pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and disposition of the assets of a company; • provide reasonable assurance that the transactions are recorded as necessary to permit preparation of financial statements in accordance with US GAAP, and that receipts and expenditures of a company are being made only in accordance with authorizations and management and directors of a company; and • provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of a company’s assets that could have a material effect on the financial statements. |
DANIEL J. MOOS, 58 President and Chief Operating Officer (effective April 2007) of ARL, TCI, IOT and (effective March 2007) of Prime; Senior Vice President and Business Line Manager for U.S. Bancorp (NYSE:USB) working out of their offices in Houston, Texas from 2003 to April 2007: Executive Vice President and Chief Financial Officer, Fleetcor Technologies a privately held transaction processing company that was headquartered in New Orleans, Louisiana from 1998 to 2003; Senior Vice President and Chief Financial Officer, ICSA a privately held internet security and information company headquartered in Carlisle, Pennsylvania from 1996 to 1998; and for more than ten years prior thereto was employed in various financial and operating roles for PhoneTel Technologies, Inc. which was a publicly traded telecommunication company on the American Stock Exchange headquartered in Cleveland, Ohio (1992-1996) and LDI Corporation which was a publicly traded computer equipment sales/service and asset leasing company listed on the NASDAQ and headquartered in Cleveland, Ohio. |
The Advisory Agreement also provides for Prime to receive an annual incentive sales fee equal to 10.0% of the amount, if any, by which the aggregate sales consideration for all real estate sold by TCI during such fiscal year exceeds the sum of: (1) the cost of each such property as originally recorded in TCI’s books for tax purposes (without deduction for depreciation, amortization or reserve for losses), (2) capital improvements made to such assets during the period owned, and (3) all closing costs, (including real estate commissions) incurred in the sale of such real estate; provided, however, no incentive fee shall be paid unless (a) such real estate sold in such fiscal year, in the aggregate, has produced an 8.0% simple annual return on the net investment including capital improvements, calculated over the holding period before depreciation and inclusive of operating income and sales consideration and (b) the aggregate net operating income from all real estate owned for each of the prior and current fiscal years shall be at least 5.0% higher in the current fiscal year than in the prior fiscal year. |
Additionally, general construction and development activities include the following risks: • construction and leasing of a property may not be completed on schedule, which could result in increased expenses and construction costs, and would result in reduced profitability for that property; • construction costs may exceed original estimates due to increases in interest rates and increased cost of materials, labor or other costs, possibly making the property less profitable because of inability to increase rents to compensate for the increase in construction costs; • some developments may fail to achieve expectations, possibly making them less profitable; • we may be unable to obtain, or face delays in obtaining, required zoning, land-use, building, occupancy, and other governmental permits and authorizations, which could result in increased costs and could require us to abandon our activities entirely with respect to a project; • we may abandon development opportunities after the initial exploration, which may result in failure to recover costs already incurred. |
Some of the risks and uncertainties that may cause our actual results, performance or achievements to differ materially from those expressed or implied by forward-looking statements include, among others, the following: • general risks affecting the real estate industry (including, without limitation, the inability to enter into or renew leases, dependence on tenants’ financial condition, and competition from other developers, owners and operators of real estate); • risks associated with the availability and terms of financing and the use of debt to fund acquisitions and developments; • failure to manage effectively our growth and expansion into new markets or to integrate acquisitions successfully; • risks and uncertainties affecting property development and construction (including, without limitation, construction delays, cost overruns, inability to obtain necessary permits and public opposition to such activities); • risks associated with downturns in the national and local economies, increases in interest rates, and volatility in the securities markets; • costs of compliance with the Americans with Disabilities Act and other similar laws and regulations; • potential liability for uninsured losses and environmental contamination; • risks associated with our dependence on key personnel whose continued service is not guaranteed; and • the other risk factors identified in this Form 10-K, including those described under the caption “Risk Factors.” The risks included here are not exhaustive. |
In 2008, TCI purchased the following properties: In 2008, TCI sold the following properties: SCHEDULE III TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS INC. REAL ESTATE ACCUMULATED DEPRECIATION December 31, 2007 (1) Purchase accounting basis adjustment. |
Management Report on Internal Control Over Financial Reporting Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended, as a process designed by, or under the supervision of, the Company’s principal executive and principal financial officers and effected by the Company’s board, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States (“GAAP, US”) and includes those policies and procedures that: • pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and disposition of the assets of a company; • provide reasonable assurance that the transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, US and that receipts and expenditures of a company are being made only in accordance with authorizations and management and directors of a company; and • provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of a company’s assets that could have a material effect on the financial statements. |
DANIEL J. MOOS, 57 President and Chief Operating Officer (effective April 2007) of ARI, TCI, IORI and (effective March 2007) of Prime; Senior Vice President and Business Line Manager for U.S. Bancorp (NYSE:USB) working out of their offices in Houston, Texas from 2003 to April 2007: Executive Vice President and Chief Financial Officer, Fleetcor Technologies a privately held transaction processing company that was headquartered in New Orleans, Louisiana from 1998 to 2003; Senior Vice President and Chief Financial Officer, ICSA a privately held internet security and information company headquartered in Carlisle, Pennsylvania from 1996 to 1998; and for more than ten years prior thereto was employed in various financial and operating roles for PhoneTel Technologies, Inc. which was a publicly traded telecommunication company on the American Stock Exchange headquartered in Cleveland, Ohio (1992-1996) and LDI Corporation which was a publicly traded computer equipment sales/service and asset leasing company listed on the NASDAQ and headquartered in Cleveland, Ohio. |
The Advisory Agreement also provides for Prime to receive an annual incentive sales fee equal to 10.0% of the amount, if any, by which the aggregate sales consideration for all real estate sold by TCI during such fiscal year exceeds the sum of: (1) the cost of each such property as originally recorded in TCI’s books for tax purposes (without deduction for depreciation, amortization or reserve for losses), (2) capital improvements made to such assets during the period owned, and (3) all closing costs, (including real estate commissions) incurred in the sale of such real estate; provided, however, no incentive fee shall be paid unless (a) such real estate sold in such fiscal year, in the aggregate, has produced an 8.0% simple annual return on the net investment including capital improvements, calculated over the holding period before depreciation and inclusive of operating income and sales consideration and (b) the aggregate net operating income from all real estate owned for each of the prior and current fiscal years shall be at least 5.0% higher in the current fiscal year than in the prior fiscal year. |
Additionally, general construction and development activities include the following risks: • construction and leasing of a property may not be completed on schedule, which could result in increased expenses and construction costs, and would result in reduced profitability for that property; • construction costs may exceed original estimates due to increases in interest rates and increased cost of materials, labor or other costs, possibly making the property less profitable because of inability to increase rents to compensate for the increase in construction costs; • some developments may fail to achieve expectations, possibly making them less profitable; • TCI may be unable to obtain, or face delays in obtaining, required zoning, land-use, building, occupancy, and other governmental permits and authorizations, which could result in increased costs and could require TCI to abandon its activities entirely with respect to a project; • TCI may abandon development opportunities after the initial exploration, which may result in failure to recover costs already incurred. |
Some of the risks and uncertainties that may cause our actual results, performance or achievements to differ materially from those expressed or implied by forward-looking statements include, among others, the following: • general risks affecting the real estate industry (including, without limitation, the inability to enter into or renew leases, dependence on tenants’ financial condition, and competition from other developers, owners and operators of real estate); • risks associated with the availability and terms of financing and the use of debt to fund acquisitions and developments; • failure to manage effectively our growth and expansion into new markets or to integrate acquisitions successfully; • risks and uncertainties affecting property development and construction (including, without limitation, construction delays, cost overruns, inability to obtain necessary permits and public opposition to such activities); • risks associated with downturns in the national and local economies, increases in interest rates, and volatility in the securities markets; • costs of compliance with the Americans with Disabilities Act and other similar laws and regulations; • potential liability for uninsured losses and environmental contamination; • risks associated with our dependence on key personnel whose continued service is not guaranteed; and • the other risk factors identified in this Form 10-K, including those described under the caption “Risk Factors.” The risks included here are not exhaustive. |
SCHEDULE III TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2006 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2005 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2005 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2005 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2005 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2005 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2005 SCHEDULE III (Continued) TRANSCONTINENTAL REALTY INVESTORS, INC. REAL ESTATE AND ACCUMULATED DEPRECIATION December 31, 2005 (1) The aggregate cost for federal income tax purposes is $978.7 million. |
Management Report on Internal Control Over Financial Reporting Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended, as a process designed by, or under the supervision of, the Company’s principal executive and principal financial officers and effected by the Company’s board, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States (“GAAP, US”) and includes those policies and procedures that: • pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and disposition of the assets of a company; • provide reasonable assurance that the transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, US and that receipts and expenditures of a company are being made only in accordance with authorizations and management and directors of a company; and • provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of a company’s assets that could have a material effect on the financial statements. |
DANIEL J. MOOS, 56 President and Chief Operating Officer (effective April 2007) of ARI, TCI, IORI and (effective March 2007) of Prime; Senior Vice President and Business Line Manager for U.S. Bancorp (NYSE:USB) working out of their offices in Houston, Texas from 2003 to April 2007: Executive Vice President and Chief Financial Officer, Fleetcor Technologies a privately held transaction processing company that was headquartered in New Orleans, Louisiana from 1998 to 2003; Senior Vice President and Chief Financial Officer, ICSA a privately held internet security and information company headquartered in Carlisle, Pennsylvania from 1996 to 1998; and for more than ten years prior thereto was employed in various financial and operating roles for PhoneTel Technologies, Inc. which was a publicly traded telecommunication company on the American Stock Exchange headquartered in Cleveland, Ohio (1992-1996) and LDI Corporation which was a publicly traded computer equipment sales/service and asset leasing company listed on the NASDAQ and headquartered in Cleveland, Ohio. |
The Advisory Agreement also provides for Prime to receive an annual incentive sales fee equal to 10.0% of the amount, if any, by which the aggregate sales consideration for all real estate sold by TCI during such fiscal year exceeds the sum of: (1) the cost of each such property as originally recorded in TCI’s books for tax purposes (without deduction for depreciation, amortization or reserve for losses), (2) capital improvements made to such assets during the period owned, and (3) all closing costs, (including real estate commissions) incurred in the sale of such real estate; provided, however, no incentive fee shall be paid unless (a) such real estate sold in such fiscal year, in the aggregate, has produced an 8.0% simple annual return on the net investment including capital improvements, calculated over the holding period before depreciation and inclusive of operating income and sales consideration and (b) the aggregate net operating income from all real estate owned for each of the prior and current fiscal years shall be at least 5.0% higher in the current fiscal year than in the prior fiscal year. |
Additionally, general construction and development activities include the following risks: • construction and leasing of a property may not be completed on schedule, which could result in increased expenses and construction costs, and would result in reduced profitability for that property; • construction costs may exceed original estimates due to increases in interest rates and increased cost of materials, labor or other costs, possibly making the property less profitable because of inability to increase rents to compensate for the increase in construction costs; • some developments may fail to achieve expectations, possibly making them less profitable; • TCI may be unable to obtain, or face delays in obtaining, required zoning, land-use, building, occupancy, and other governmental permits and authorizations, which could result in increased costs and could require TCI to abandon its activities entirely with respect to a project; • TCI may abandon development opportunities after the initial exploration, which may result in failure to recover costs already incurred. |
Some of the risks and uncertainties that may cause our actual results, performance or achievements to differ materially from those expressed or implied by forward-looking statements include, among others, the following: • general risks affecting the real estate industry (including, without limitation, the inability to enter into or renew leases, dependence on tenants’ financial condition, and competition from other developers, owners and operators of real estate); • risks associated with the availability and terms of financing and the use of debt to fund acquisitions and developments; • failure to manage effectively our growth and expansion into new markets or to integrate acquisitions successfully; • risks and uncertainties affecting property development and construction (including, without limitation, construction delays, cost overruns, inability to obtain necessary permits and public opposition to such activities); • risks associated with downturns in the national and local economies, increases in interest rates, and volatility in the securities markets; • costs of compliance with the Americans with Disabilities Act and other similar laws and regulations; • potential liability for uninsured losses and environmental contamination; • risks associated with our dependence on key personnel whose continued service is not guaranteed; and Index to Financial Statements • the other risk factors identified in this Form 10-K, including those described under the caption “Risk Factors.” The risks included here are not exhaustive. |
The Advisory Agreement also provides for Prime to receive an annual incentive sales fee equal to 10.0% of the amount, if any, by which the aggregate sales consideration for all real estate sold by TCI during such fiscal year exceeds the sum of: (1) the cost of each such property as originally recorded in TCI’s books for tax purposes (without deduction for depreciation, amortization or reserve for losses), (2) capital improvements made to such assets during the period owned, and (3) all closing costs, (including real estate commissions) incurred in the sale of such real estate; provided, however, no incentive fee shall be paid unless (a) such real estate sold in such fiscal year, in the aggregate, has produced an 8.0% simple annual return on the net investment including capital improvements, calculated over the holding period before depreciation and inclusive of operating income and sales consideration and (b) the aggregate net operating income from all real estate owned for each of the prior and current fiscal years shall be at least 5.0% higher in the current fiscal year than in the prior fiscal year. |
The Advisory Agreement also provides for Prime to receive an annual incentive sales fee equal to 10.0% of the amount, if any, by which the aggregate sales consideration for all real estate sold by TCI during such fiscal year exceeds the sum of: (1) the cost of each such property as originally recorded in TCI’s books for tax purposes (without deduction for depreciation, amortization or reserve for losses), (2) capital improvements made to such assets during the period owned, and (3) all closing costs, (including real estate commissions) incurred in the sale of such real estate; provided, however, no incentive fee shall be paid unless (a) such real estate sold in such fiscal year, in the aggregate, has produced an 8.0% simple annual return on the net investment including capital improvements, calculated over the holding period before depreciation and inclusive of operating income and sales consideration and (b) the aggregate net operating income from all real estate owned for each of the prior and current fiscal years shall be at least 5.0% higher in the current fiscal year than in the prior fiscal year. |
Restrictions on Related Party Transactions Article FOURTEENTH of TCI’s Articles of Incorporation provides that TCI shall not, directly or indirectly, contract or engage in any transaction with (1) any director, officer or employee of TCI, (2) any director, officer or employee of the advisor, (3) the advisor or (4) any affiliate or associate (as such terms are defined in Index to Financial Statements Rule 12b-2 under the Securities Exchange Act of 1934, as amended) of any of the aforementioned persons, unless (a) the material facts as to the relationship among or financial interest of the relevant individuals or persons and as to the contract or transaction are disclosed to or are known by the Board of Directors or the appropriate committee thereof and (b) the Board of Directors or committee thereof determines that such contract or transaction is fair to TCI and simultaneously authorizes or ratifies such contract or transaction by the affirmative vote of a majority of independent directors of TCI entitled to vote thereon. |
The Advisory Agreement also provides for Prime to receive an annual incentive sales fee equal to 10% of the amount, if any, by which the aggregate sales consideration for all real estate sold by TCI during such fiscal year exceeds the sum of: (1) the cost of each such property as originally recorded in TCI’s books for tax purposes (without deduction for depreciation, amortization or reserve for losses), (2) capital improvements made to such assets during the period owned, and (3) all closing costs, (including real estate commissions) incurred in the sale of such real estate; provided, however, no incentive fee shall be paid unless (a) such real estate sold in such fiscal year, in the aggregate, has produced an 8% simple annual return on the net investment including capital improvements, calculated over the holding period before depreciation and inclusive of operating income and sales consideration and (b) the aggregate net operating income from all real estate owned for each of the prior and current fiscal years shall be at least 5% higher in the current fiscal year than in the prior fiscal year. |
The Advisory Agreement also provides for BCM to receive an annual incentive sales fee equal to 10% of the amount, if any, by which the aggregate sales consideration for all real estate sold by TCI during such fiscal year exceeds the sum of: (1) the cost of each such property as originally recorded in TCI's books for tax purposes (without deduction for depreciation, amortization or reserve for losses), (2) capital improvements made to such assets during the period owned, and (3) all closing costs, (including real estate commissions) incurred in the sale of such real estate; provided, however, no incentive fee shall be paid unless (a) such real estate sold in such fiscal year, in the aggregate, has produced an 8% simple annual return on the net investment including capital improvements, calculated over the holding period before depreciation and inclusive of operating income and sales consideration and (b) the aggregate net operating income from all real estate owned for each of the prior and current fiscal years shall be at least 5% higher in the current fiscal year than in the prior fiscal year. |
(12)# 10.14 Third Amendment To Lease, by and between Icon Miramar Owner Pool 2 West/Northeast/Midwest, LLC and the Company, dated April 17, 2014 (13) 10.15 Fourth Amendment To Lease, by and between Icon Miramar Owner Pool 2 West/Northeast/Midwest, LLC and the RF Industries, Ltd., dated January 26, 2017 (25) 10.16 Fifth Amendment To Lease, by and between Icon Miramar Owner Pool 2 West/Northeast/Midwest, LLC and the RF Industries, Ltd., dated June 5, 2017 (14) 10.17 Amendment To Lease, by and between K & K Unlimited and Cables Unlimited, Inc., dated June 9, 2017 (14) 10.18 Employment Letter Agreement, dated June 16, 2017, by and between RF Industries, Ltd. and Robert D. Dawson (15)# 10.19 Fifth Amendment To Lease, by and between Icon Kimberly Alvin Property, LLC and Comnet Telecom Supply, Inc., dated June 19, 2017 (16) 10.20 Lease Agreement by and between D’Amato Investments, LLC and Rel-Tech Electronics, Inc., dated July 25, 2017 (17) 10.21 Form of Indemnification Agreement (18)# 10.22 Amendment To Lease, by and between K & K Unlimited and Cables Unlimited, Inc., dated June 6, 2018 (19) 10.23 Stock Purchase Agreement between RF Industries, Ltd. and RAP Acquisition Inc., dated October 31, 2018 (20) 10.24 2019 Corporate Goals-Cash and Equity Incentive Plan, dated December 7, 2018 (23)# 10.25 Option Agreement Amendment- RF Industries, Ltd. 2010 Stock Incentive Plan (24)# 10.26 Employment Letter Agreement, dated July 17, 2019, by and between RF Industries, Ltd. and Robert D. Dawson (21) 10.27 Stock Purchase Agreement between RF Industries, Ltd., DRC Technologies, Inc. and Stockholders of DRC Technologies, Inc., dated November 4, 2019 (22) 10.28 2020 Equity Incentive Plan (26) 10.29 2020 Corporate Goals - Cash and Equity Incentive Plan, dated January 9, 2020 (28)# 14.1 Code of Ethics (1) 21.1 List of Subsidiaries 23.1 Consent of Independent Registered Public Accounting Firm CohnReznick LLP 31.1 Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 31.2 Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 32.1 Certification of Principal Executive Officer Pursuant to 18 U.S.C. |
For internal operating and reporting purposes, and for marketing purposes, as of the end of the fiscal year ended October 31, 2020, we classified our operations into the following five divisions/subsidiaries: (i) The RF Connector and Cable Assembly division designs, manufactures and distributes coaxial connectors and cable assemblies that are integrated with coaxial connectors; (ii) Cables Unlimited, Inc., the subsidiary that manufactures custom and standard cable assemblies, complex hybrid fiber optic power solution cables, adapters, and electromechanical wiring harnesses for communication, computer, LAN, automotive and medical equipment; (iii) Rel-Tech Electronics, Inc., the subsidiary that designs and manufacturers cable assemblies and wiring harnesses for blue chip industrial, oilfield, instrumentation and military customers; (iv) C Enterprises, Inc., the subsidiary that designs and manufactures quality connectivity solutions to telecommunications and data communications distributors; and (v) Schroff Technologies International, Ltd., the subsidiary that manufactures and markets intelligent thermal control systems used by telecommunications companies across the U.S. and Canada, and shrouds for small cell integration and installation. |
(12)# 10.14 Third Amendment To Lease, by and between Icon Miramar Owner Pool 2 West/Northeast/Midwest, LLC and the Company, dated April 17, 2014 (13) 10.15 Fourth Amendment To Lease, by and between Icon Miramar Owner Pool 2 West/Northeast/Midwest, LLC and the RF Industries, Ltd., dated January 26, 2017 (25) 10.16 Fifth Amendment To Lease, by and between Icon Miramar Owner Pool 2 West/Northeast/Midwest, LLC and the RF Industries, Ltd., dated June 5, 2017 (14) 10.17 Amendment To Lease, by and between K & K Unlimited and Cables Unlimited, Inc., dated June 9, 2017 (14) 10.18 Employment Letter Agreement, dated June 16, 2017, by and between RF Industries, Ltd. and Robert D. Dawson (15)# 10.19 Fifth Amendment To Lease, by and between Icon Kimberly Alvin Property, LLC and Comnet Telecom Supply, Inc., dated June 19, 2017 (16) 10.20 Lease Agreement by and between D’Amato Investments, LLC and Rel-Tech Electronics, Inc., dated July 25, 2017 (17) 10.21 Form of Indemnification Agreement (18)# 10.22 Amendment To Lease, by and between K & K Unlimited and Cables Unlimited, Inc., dated June 6, 2018 (19) 10.23 Stock Purchase Agreement between RF Industries, Ltd. and RAP Acquisition Inc., dated October 31, 2018 (20) 10.24 Corporate Goals-Cash and Equity Incentive Plan, dated December 7, 2018 (23)# 10.25 Option Agreement Amendment- RF Industries, Ltd. 2010 Stock Incentive Plan (24)# 10.26 Employment Letter Agreement, dated July 17, 2019, by and between RF Industries, Ltd. and Robert D. Dawson (21) 10.27 Stock Purchase Agreement between RF Industries, Ltd., DRC Technologies, Inc. and Stockholders of DRC Technologies, Inc., dated November 4, 2019 (22) 14.1 Code of Ethics (1) 21.1 List of Subsidiaries 23.1 Consent of Independent Registered Public Accounting Firm CohnReznick LLP 31.1 Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 31.2 Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 32.1 Certification of Principal Executive Officer Pursuant to 18 U.S.C. |
(12)# 10.14Third Amendment To Lease, by and between Icon Miramar Owner Pool 2 West/Northeast/Midwest, LLC and the Company, dated April 17, 2014 (13) 10.15 Fourth Amendment To Lease, by and between Icon Miramar Owner Pool 2 West/Northeast/Midwest, LLC and the RF Industries, Ltd., dated January 26, 2017 10.16Fifth Amendment To Lease, by and between Icon Miramar Owner Pool 2 West/Northeast/Midwest, LLC and the RF Industries, Ltd., dated June 5, 2017 (14) 10.17Amendment To Lease, by and between K & K Unlimited and Cables Unlimited, Inc., dated June 9, 2017 (14) 10.18Employment Letter Agreement, dated June 16, 2017, by and between RF Industries, Ltd. and Robert D. Dawson (15)# 10.19Fifth Amendment To Lease, by and between Icon Kimberly Alvin Property, LLC and Comnet Telecom Supply, Inc., dated June 19, 2017 (16) 10.20Lease Agreement by and between D’Amato Investments, LLC and Rel-Tech Electronics, Inc., dated July 25, 2017 (17) 10.21Form of Indemnification Agreement (18)# 10.22 Amendment To Lease, by and between K & K Unlimited and Cables Unlimited, Inc., dated June 6, 2018 (19) 10.23 Stock Purchase Agreement between RF Industries, Ltd. and RAP Acquisition Inc., dated October 31, 2018 (20) 10.24 2019 Corporate Goals-Cash and Equity Incentive Plan, dated December 7, 2018# 10.25 Option Agreement Amendment - RF Industries, Ltd. 2010 Stock Incentive Plan# 14.1 Code of Ethics (1) 21.1 List of Subsidiaries 23.1 Consent of Independent Registered Public Accounting Firm CohnReznick LLP 31.1 Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 31.2 Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 32.1 Certification of Principal Executive Officer Pursuant to 18 U.S.C. |
(12)# 10.14Third Amendment To Lease, by and between Icon Miramar Owner Pool 2 West/Northeast/Midwest, LLC and the Company, dated April 17, 2014 (13) 10.15Fourth Amendment To Lease, by and between Icon Miramar Owner Pool 2 West/Northeast/Midwest, LLC and the RF Industries, Ltd., dated January 26, 2017 10.16Fifth Amendment To Lease, by and between Icon Miramar Owner Pool 2 West/Northeast/Midwest, LLC and the RF Industries, Ltd., dated June 5, 2017 (14) 10.17Amendment To Lease, by and between K & K Unlimited and Cables Unlimited, Inc., dated June 9, 2017 (14) 10.18Employment Letter Agreement, dated June 16, 2017, by and between RF Industries, Ltd. and Robert D. Dawson (15)# 10.19Fifth Amendment To Lease, by and between Icon Kimberly Alvin Property, LLC and Comnet Telecom Supply, Inc., dated June 19, 2017 (16) 10.20Lease Agreement by and between D’Amato Investments, LLC and Rel-Tech Electronics, Inc., dated July 25, 2017 (17) 10.21Form of Indemnification Agreement (18)# 14.1Code of Ethics (1) 21.1List of Subsidiaries 23.1Consent of Independent Registered Public Accounting Firm CohnReznick LLP 31.1Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 31.2Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 32.1Certification of Principal Executive Officer Pursuant to 18 U.S.C. |
For internal operating and reporting purposes, and for marketing purposes, as of the end of the fiscal year ended October 31, 2017 the Company classified its operations into the following four divisions/subsidiaries: (i) The RF Connector and Cable Assembly division designs, manufactures and distributes coaxial connectors and cable assemblies that are integrated with coaxial connectors; (ii) Cables Unlimited, Inc., the subsidiary that manufactures custom and standard cable assemblies, complex hybrid fiber optic power solution cables, adapters, and electromechanical wiring harnesses for communication, computer, LAN, automotive and medical equipment; (iii) Comnet Telecom Supply, Inc., the subsidiary that manufactures and sells fiber optics cable, distinctive cabling technologies and custom patch cord assemblies, as well as other data center products; and (iv) Rel-Tech Electronics, Inc., the subsidiary that designs and manufacturers of cable assemblies and wiring harnesses for blue chip industrial, oilfield, instrumentation and military customers. |
The following table presents the sales of the Company by geographic area for the years ended October 31, 2017 and 2016 (in thousands): Net sales, income (loss) from continuing operations before provision (benefit) for income taxes and other related segment information for the years ended October 31, 2017 and 2016 are as follows (in thousands): Note 8 - Income tax provision The provision (benefit) for income taxes for the fiscal years ended October 31, 2017 and 2016 consists of the following (in thousands): Income tax at the federal statutory rate is reconciled to the Company’s actual net provision (benefit) for income taxes as follows (in thousands, except percentages): The Company’s total deferred tax assets and deferred tax liabilities at October 31, 2017 and 2016 are as follows (in thousands): Deferred income tax assets and liabilities are recorded for differences between the financial statement and tax basis of the assets and liabilities that will result in taxable or deductible amounts in the future based on enacted laws and rates applicable to the periods in which the differences are expected to affect taxable income. |
ITEM 15.EXHIBITS Lease The following exhibits are filed as part of this report: 3.1Articles of Incorporation, as amended (1) 3.1.1Amended and Restated Articles of Incorporation (12) 3.2.1Company Bylaws as Amended through August, 1985 (2) 3.2.2Amendment to Bylaws dated January 24, 1986 (2) 3.2.3Amendment to Bylaws dated February 1, 1989 (3) 3.2.4Amendment to Bylaws dated June 9, 2006 (6) 3.2.5Amendment to Bylaws dated September 7, 2007 (7) 10.1Form of 2000 Stock Option Plan (4) 10.2Directors’ Nonqualified Stock Option Agreements (2) 10.3Employment Agreement, dated August 22, 2011, between the Company and Howard Hill (8) 10.4Multi-Tenant Industrial Gross Lease, effective March 31, 2009, between RF Industries, Ltd. and Walton CWCA Miramar GL 74, LLC regarding the Company’s facilities in San Diego (9) 10.5Second Amendment to Lease, dated August 25, 2009, to Multi-Tenant Industrial Gross Lease, effective March 31, 2009, between RF Industries, Ltd. and Walton CWCA Miramar GL 74, LLC (9) 10.6Single Tenant Commercial Lease, dated August 2009, between Eagle American LLC and RF Industries, Ltd. regarding the Company’s lease in Las Vegas, Nevada (9) 10.7Single Tenant Commercial Lease, dated June 15, 2011 between K&K and RF Industries, Ltd. regarding the Company’s lease in Yaphank, New York (13) 10.8Form of 2010 Stock Incentive Plan (10) 10.9Form of Stock Option Agreement for the Company’s 2010 Stock Incentive Plan (10) 10.10Amendment of 2000 Stock Incentive Plan (11) 10.11Stock Purchase Agreement, dated January 20, 2015, between RF Industries, Ltd. and Robert A. Portera. |
For internal operating and reporting purposes, and for marketing purposes, as of the end of the fiscal year ended October 31, 2016 the Company classified its operations into the following four divisions/subsidiaries: (i) The Connector and Cable Assembly Division designs, manufactures and distributes coaxial connectors and cable assemblies that are integrated with coaxial connectors; (ii) Cables Unlimited, Inc., the subsidiary that manufactures custom and standard cable assemblies, complex hybrid fiber optic power solution cables, adapters, and electromechanical wiring harnesses for communication, computer, LAN, automotive and medical equipment; (iii) Comnet Telecom Supply, Inc., the subsidiary that manufactures and sells fiber optics cable, distinctive cabling technologies and custom patch cord assemblies, as well as other data center products; and (iv) the recently acquired Rel-Tech Electronics, Inc., the subsidiary that designs and manufacturers of cable assemblies and wiring harnesses for blue chip industrial, oilfield, instrumentation and military customers. |
The following table presents the sales of the Company by geographic area for the years ended October 31, 2016 and 2015 (in thousands): Net sales, income (loss) from continuing operations before provision (benefit) for income taxes and other related segment information for the years ended October 31, 2016 and 2015 are as follows (in thousands): Note 9 - Income tax provision The provision (benefit) for income taxes for the fiscal years ended October 31, 2016 and 2015 consists of the following (in thousands): Income tax at the federal statutory rate is reconciled to the Company’s actual net provision (benefit) for income taxes as follows (in thousands, except percentages): The Company’s total deferred tax assets and deferred tax liabilities at October 31, 2016 and 2015 are as follows (in thousands): Deferred income tax assets and liabilities are recorded for differences between the financial statement and tax basis of the assets and liabilities that will result in taxable or deductible amounts in the future based on enacted laws and rates applicable to the periods in which the differences are expected to affect taxable income. |
The Company conducts its operations through the following five divisions/subsidiaries: (i) The Connector and Cable Assembly Division designs, manufactures and distributes coaxial connectors and cable assemblies that are integrated with coaxial connectors; (ii) the Bioconnect Division manufactures and distributes cabling and interconnect products to the medical monitoring market; (iii) Cables Unlimited, Inc., the subsidiary that manufactures custom and standard cable assemblies, complex hybrid fiber optic power solution cables, adapters, and electromechanical wiring harnesses for communication, computer, LAN, automotive and medical equipment; (iv) Comnet Telecom Supply, Inc., a subsidiary that manufactures and sells fiber optics cable, distinctive cabling technologies and custom patch cord assemblies, as well as other data center products; and (v) the recently acquired Rel-Tech Electronics, Inc. subsidiary that designs and manufactures cable assemblies and wiring harnesses for blue chip industrial, oilfield, instrumentation and military customers. |
EXHIBITS Lease The following exhibits are filed as part of this report: 3.1 Articles of Incorporation, as amended (1) 3.1.1 Amended and Restated Articles of Incorporation (12) 3.2.1 Company Bylaws as Amended through August, 1985 (2) 3.2.2 Amendment to Bylaws dated January 24, 1986 (2) 3.2.3 Amendment to Bylaws dated February 1, 1989 (3) 3.2.4 Amendment to Bylaws dated June 9, 2006(6) 3.2.5 Amendment to Bylaws dated September 7, 2007(7) 10.1 Form of 2000 Stock Option Plan (4) 10.2 Directors’ Nonqualified Stock Option Agreements (2) 10.3 Employment Agreement, dated August 22, 2011, between the Company and Howard Hill (8) 10.4 Multi-Tenant Industrial Gross Lease, effective March 31, 2009, between RF Industries, Ltd. and Walton CWCA Miramar GL 74, LLC regarding the Company’s facilities in San Diego (9) 10.5 Second Amendment to Lease, dated August 25, 2009, to Multi-Tenant Industrial Gross Lease, effective March 31, 2009, between RF Industries, Ltd. and Walton CWCA Miramar GL 74, LLC (9) 10.6 Single Tenant Commercial Lease, dated August 2009, between Eagle American LLC and RF Industries, Ltd. regarding the Company’s lease in Las Vegas, Nevada (9) 10.7 Single Tenant Commercial Lease, dated June 15, 2011 between K&K and RF Industries, Ltd. regarding the Company’s lease in Yaphank, New York (13) 10.8 Form of 2010 Stock Incentive Plan (10) 10.9 Form of Stock Option Agreement for the Company’s 2010 Stock Incentive Plan (10) 10.10 Amendment of 2000 Stock Incentive Plan (11) 10.11 Employment Agreement, dated September 1, 2013, between the Company and Howard Hill (14) 10.12 Employment Agreement, dated September 1, 2013, between the Company and James Doss (14) 10.13 Employment Agreement, dated September 1, 2013, between the Company and Darren Clark (14) 10.14 Stock Purchase Agreement, dated January 20, 2015, between RF Industries, Ltd. and Robert A. Portera (15). |
For internal operating and reporting purposes, and for marketing purposes, as of the end of the fiscal year ended October 31, 2015 the Company classified its operations into the following six divisions/subsidiaries: (i) The Connector and Cable Assembly Division designs, manufactures and distributes coaxial connectors and cable assemblies that are integrated with coaxial connectors; (ii) the Aviel Electronics Division designs, manufactures and distributes specialty and custom RF connectors primarily for aerospace and military customers; (iii) the Bioconnect Division manufactures and distributes cabling and interconnect products to the medical monitoring market; (iv) Cables Unlimited, Inc., the subsidiary that manufactures custom and standard cable assemblies, complex hybrid fiber optic power solution cables, adapters, and electromechanical wiring harnesses for communication, computer, LAN, automotive and medical equipment; (v) Comnet Telecom Supply, Inc. subsidiary that manufactures and sells fiber optics cable, distinctive cabling technologies and custom patch cord assemblies, as well as other data center products; and (vi) the recently acquired Rel-Tech Electronics, Inc. subsidiary is a designer and manufacturer of cable assemblies and wiring harnesses for blue chip industrial, oilfield, instrumentation and military customers. |
For internal operating and reporting purposes, and for marketing purposes, the Company currently classifies its operations into the following five divisions/subsidiaries: (i) The Connector and Cable Assembly Division designs, manufactures and distributes coaxial connectors and cable assemblies that are integrated with coaxial connectors; (ii) the Aviel Electronics Division designs, manufactures and distributes specialty and custom RF connectors primarily for aerospace and military customers, (iii) the Bioconnect Division manufactures and distributes cabling and interconnect products to the medical monitoring market; (iv) Cables Unlimited, Inc., the subsidiary that manufactures custom and standard cable assemblies, complex hybrid fiber optic power solution cables, adapters, and electromechanical wiring harnesses for communication, computer, LAN, automotive and medical equipment; and (v) the recently acquired Comnet Telecom Supply, Inc. subsidiary that manufactures and sells fiber optics cable, distinctive cabling technologies and custom patch cord assemblies, as well as other data center products. |
Each of the foregoing three executives also is entitled to certain compensation from the Company in connection with the termination of his employment under the following circumstances: (i) if the Company terminates an executive’s employment without “cause” (as defined in the employment agreement), the Company has agreed to pay that executive upon termination an amount equal to 12 month’s salary based on the executive’s monthly salary at the time of such termination; (ii) if an executive terminates his employment for Good Reason (as defined in the employment agreement), that executive is entitled to severance compensation in the form of continuation of base salary and existing medical and dental insurance for the balance of his Term; and (iii) within 120 days after a Change of Control (as defined in the employment agreement), each of the foregoing three executives will have the right to terminate his employment, and to receive a cash payment in an amount equal to 12 month’s salary, based on the monthly salary in effect at the time of such termination. |
Additionally, Mr. Walker is entitled to certain compensation from the Company in connection with the termination of his employment under the following circumstances: (i) if the Company terminates Mr. Walker’s employment without “cause” (as defined in the employment agreement), the Company has agreed to pay Mr. Walker upon termination an amount equal to the greater of (x) the salary that would have been paid to Mr. Walker during the balance of the Term, or (y) 12 month’s salary (in each case, based on Mr. Walker’s monthly salary at the time of such termination); (ii) if Mr. Walker terminates his employment for Good Reason (as defined in the employment agreement), Mr. Walker is entitled to severance compensation in the form of continuation of base salary and existing medical and dental insurance for the balance of the Term; and (iii) within 120 days after a Change of Control (as defined in the employment agreement), Mr. Walker will have the right to terminate his employment, and to receive a cash payment in an amount equal to the greater of (x) the salary that would have been paid to Mr. Walker during the balance of the Term, or (y) 12 month’s salary (in each case, based on Mr. Walker’s monthly salary at the time of such termination). |
EXHIBITS The following exhibits are filed as part of this report: 3.1 Articles of Incorporation, as amended (1) 3.1.1 Amended and Restated Articles of Incorporation (12) 3.2.1 Company Bylaws as Amended through August, 1985 (2) 3.2.2 Amendment to Bylaws dated January 24, 1986 (2) 3.2.3 Amendment to Bylaws dated February 1, 1989 (3) 3.2.4 Amendment to Bylaws dated June 9, 2006(6) 3.2.5 Amendment to Bylaws dated September 7, 2007(7) 10.1 Form of 2000 Stock Option Plan (4) 10.2 Directors’ Nonqualified Stock Option Agreements (2) 10.3 Employment Agreement, dated August 22, 2011, between the Company and Howard Hill (8) 10.4 Multi-Tenant Industrial Gross Lease, effective March 31, 2009, between RF Industries, Ltd. and Walton CWCA Miramar GL 74, LLC regarding the Company’s facilities in San Diego (9) 10.5 Second Amendment to Lease, dated August 25, 2009, to Multi-Tenant Industrial Gross Lease, effective March 31, 2009, between RF Industries, Ltd. and Walton CWCA Miramar GL 74, LLC (9) 10.6 Single Tenant Commercial Lease, dated August 2009, between Eagle American LLC and RF Industries, Ltd. regarding the Company’s lease in Las Vegas, Nevada (9) 10.7 Single Tenant Commercial Lease, dated June 15, 2011 between K&K and RF Industries, Ltd. regarding the Company’s lease in Yaphank, New York (13) 10.8 Form of 2010 Stock Incentive Plan (10) 10.9 Form of Stock Option Agreement for the Company’s 2010 Stock Incentive Plan (10) 10.10 Amendment of 2000 Stock Incentive Plan (11) 10.11 Employment Agreement, dated September 1, 2013, between the Company and Howard Hill (14) 10.12 Employment Agreement, dated September 1, 2013, between the Company and James Doss (14) 10.13Employment Agreement, dated September 1, 2013, between the Company and Darren Clark (14) 10.14Stock Purchase Agreement, dated January 20, 2015, between RF Industries, Ltd. and Robert A. Portera (15) 10.15Employment Agreement, dated January 22, 2015, by and among RF Industries, Ltd. and Howard Hill. |
EXHIBITS The following exhibits are filed as part of this report: 3.1 Articles of Incorporation, as amended (1) 3.1.1 Amended and Restated Articles of Incorporation (12) 3.2.1 Company Bylaws as Amended through August, 1985 (2) 3.2.2 Amendment to Bylaws dated January 24, 1986 (2) 3.2.3 Amendment to Bylaws dated February 1, 1989 (3) 3.2.4 Amendment to Bylaws dated June 9, 2006(6) 3.2.5 Amendment to Bylaws dated September 7, 2007(7) 10.1 Form of 2000 Stock Option Plan (4) 10.2 Directors’ Nonqualified Stock Option Agreements (2) 10.3 Employment Agreement, dated August 22, 2011, between the Company and Howard Hill (8) 10.4 Multi-Tenant Industrial Gross Lease, effective March 31, 2009, between RF Industries, Ltd. and Walton CWCA Miramar GL 74, LLC regarding the Company’s facilities in San Diego (9) 10.5 Second Amendment to Lease, dated August 25, 2009, to Multi-Tenant Industrial Gross Lease, effective March 31, 2009, between RF Industries, Ltd. and Walton CWCA Miramar GL 74, LLC (9) 10.6 Single Tenant Commercial Lease, dated August 2009, between Eagle American LLC and RF Industries, Ltd. regarding the Company’s lease in Las Vegas, Nevada (9) 10.7 Single Tenant Commercial Lease, dated June 15, 2011 between K&K and RF Industries, Ltd. regarding the Company’s lease in Yaphank, New York (13) 10.8 Form of 2010 Stock Incentive Plan (10) 10.9 Form of Stock Option Agreement for the Company’s 2010 Stock Incentive Plan (10) 10.10 Amendment of 2000 Stock Incentive Plan (11) 10.11 Employment Agreement, dated September 1, 2013, between the Company and Howard Hill (14) 10.12 Employment Agreement, dated September 1, 2013, between the Company and James Doss (14) 10.13 Employment Agreement, dated September 1, 2013, between the Company and Darren Clark (14) 14.1 Code of Ethics (5) 23.1 Consent of Independent Registered Public Accounting Firm CohnReznick LLP 31.1 Certification of Principal Executive Officer and Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 32.1 Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. |
Additionally, Mr. Hill is entitled to certain compensation from the Company in connection with the termination of his employment under the following circumstances: (i) if the Company terminates Mr. Hill’s employment without “cause” (as defined in the employment agreement), the Company has agreed to pay Mr. Hill upon termination an amount equal to the greater of (x) the salary that would have been paid to Mr. Hill during the balance of the Term, or (y) 12 month’s salary (in each case, based on Mr. Hill’s monthly salary at the time of such termination); (ii) if Mr. Hill terminates his employment for Good Reason (as defined in the employment agreement), Mr. Hill is entitled to severance compensation in the form of continuation of base salary and existing medical and dental insurance for 24 months following termination of employment; and (iii) within 120 days after a Change of Control (as defined in the employment agreement), Mr. Hill will have the right to terminate his employment, and to receive a cash payment in an amount equal to the greater of (x) the salary that would have been paid to Mr. Hill during the balance of the Term, or (y) 12 month’s salary (in each case, based on Mr. Hill’s monthly salary at the time of such termination). |
ITEM 15.EXHIBITS The following exhibits are filed as part of this report: 3.1Articles of Incorporation, as amended (1) 3.1.1Amended and Restated Articles of Incorporation (12) 3.2.1Company Bylaws as Amended through August, 1985 (2) 3.2.2Amendment to Bylaws dated January 24, 1986 (2) 3.2.3Amendment to Bylaws dated February 1, 1989 (3) 3.2.4Amendment to Bylaws dated June 9, 2006(6) 3.2.5Amendment to Bylaws dated September 7, 2007(7) 10.1Form of 2000 Stock Option Plan (4) 10.2Directors’ Nonqualified Stock Option Agreements (2) 10.3Employment Agreement, dated August 22, 2011, between the Company and Howard Hill (8) 10.4Multi-Tenant Industrial Gross Lease, effective March 31, 2009, between RF Industries, Ltd. and Walton CWCA Miramar GL 74, LLC regarding the Company’s facilities in San Diego (9) 10.5Second Amendment to Lease, dated August 25, 2009, to Multi-Tenant Industrial Gross Lease, effective March 31, 2009, between RF Industries, Ltd. and Walton CWCA Miramar GL 74, LLC (9) 10.6Single Tenant Commercial Lease, dated August 2009, between Eagle American LLC and RF Industries, Ltd. regarding the Company’s lease in Las Vegas, Nevada (9) 10.7Single Tenant Commercial Lease, dated June 15, 2011 between K&K and RF Industries, Ltd. regarding the Company’s lease in Yaphank, New York (13) 10.8Form of 2010 Stock Incentive Plan (10) 10.9Form of Stock Option Agreement for the Company’s 2010 Stock Incentive Plan (10) 10.10Amendment of 2000 Stock Incentive Plan (11) 14.1Code of Ethics (5) 23.1Consent of Independent Registered Public Accounting Firm CohnReznick LLP 31.1Certification of Principal Executive Officer and Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 32.1Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. |
The Company currently conducts its operations through seven related business divisions: (i) RF Connector and Cable Division is engaged in the design, manufacture and distribution of coaxial connectors and cable assemblies used primarily in radio and other professional communications applications; (ii) Aviel Division is engaged in the design, manufacture and sales of radio frequency, microwave and specialized connectors and connector assemblies for aerospace, original electronics manufacturers and military electronics applications; (iii) Oddcables.com Division is engaged in sales of microwave and radio frequency connectors and cable assemblies to end users in multi-media, radio and other communications applications; (iv) Bioconnect Division is engaged in the design, manufacture and sales of cable interconnects for medical monitoring applications; (v) Neulink Division is engaged in the design, manufacture and sales of radio links for receiving and transmitting control signals for remote operation and monitoring of equipment, personnel and monitoring services; (vi) RadioMobile Division is engaged as an OEM provider of end-to-end mobile management solutions implemented over wireless networks. |
Based solely upon a review of information furnished to the Company, to the Company’s knowledge, during the fiscal year ended October 31, 2011, the following filings were not timely completed: (i) David Sandberg filed his initial Form 3 three days after the required filing date; (ii) The members of the Board of Directors did not timely file a Form 4 with respect to stock options granted to them in December 2010; (iii) Jim Doss did not timely file a Form 4 with respect to stock options granted to him in October and December 2010, respectively, the exercise of stock options and sale of the underlying shares of common stock in June 2011, and the exercise of stock options in July 2011; (iv) Marvin Fink did not timely file a Form 4 with respect to the exercise of stock options and the sale of the underlying shares of common stock in June 2011; and (v) Howard Hill did not timely file a Form 4 with respect to stock options granted to him in October and December 2010, respectively, and the exercise of stock options and sale of the underlying shares of common stock in June 2011. |
Additionally, Mr. Hill is entitled to certain compensation from the Company in connection with the termination of his employment under the following circumstances: (i) if the Company terminates Mr. Hill’s employment without “cause” (as defined in the employment agreement), the Company has agreed to pay Mr. Hill upon termination an amount equal to the greater of (x) the salary that would have been paid to Mr. Hill during the balance of the Term, or (y) 12 month’s salary (in each case, based on Mr. Hill’s monthly salary at the time of such termination); (ii) if Mr. Hill terminates his employment for Good Reason (as defined in the employment agreement), Mr. Hill is entitled to severance compensation in the form of continuation of base salary and existing medical and dental insurance for 24 months following termination of employment; and (iii) within 120 days after a Change of Control (as defined in the employment agreement), Mr. Hill will have the right to terminate his employment, and to receive a cash payment in an amount equal to the greater of (x) the salary that would have been paid to Mr. Hill during the balance of the Term, or (y) 12 month’s salary (in each case, based on Mr. Hill’s monthly salary at the time of such termination). |
EXHIBITS The following exhibits are filed as part of this report: 3.1 Articles of Incorporation, as amended (1) 3.1.1 Amendment to Articles of Incorporation 3.2.1 Company Bylaws as Amended through August, 1985 (2) 3.2.2 Amendment to Bylaws dated January 24, 1986 (2) 3.2.3 Amendment to Bylaws dated February 1, 1989 (3) 3.2.4 Amendment to Bylaws dated June 9, 2006(6) 3.2.5 Amendment to Bylaws dated September 7, 2007(7) 10.1 Form of 2000 Stock Option Plan (4) 10.2 Directors’ Nonqualified Stock Option Agreements (2) 10.3 Employment Agreement, dated August 22, 2011, between the Company and Howard Hill (8) 10.4 Multi-Tenant Industrial Gross Lease, effective March 31, 2009, between RF Industries, Ltd. and Walton CWCA Miramar GL 74, LLC regarding the Company’s facilities in San Diego (9) 10.5 Second Amendment to Lease, dated August 25, 2009, to Multi-Tenant Industrial Gross Lease, effective March 31, 2009, between RF Industries, Ltd. and Walton CWCA Miramar GL 74, LLC (9) 10.6 Single Tenant Commercial Lease, dated August 2009, between Eagle Americank LLC and RF Industries, Ltd. regarding the Company’s lease in Las Vegas, Nevada (9) 10.7 Single Tenant Commercial Lease, dated June 15, 2011 between K&K and RF Industries, Ltd. regarding the Company’s lease in Yaphank, New York 10.8 Form of 2010 Stock Incentive Plan (10) 10.9 Form of Stock Option Agreement for the Company’s 2010 Stock Incentive Plan (10) 10.10 Amendment of 2000 Stock Incentive Plan (11) 14.1 Code of Ethics (5) 23.1 Consent of Independent Registered Public Accounting Firm J.H. |
The Company currently conducts its operations through seven related business divisions: (i) RF Connector and Cable Division is engaged in the design, manufacture and distribution of coaxial connectors and cable assemblies used primarily in radio and other professional communications applications; (ii) Aviel Division is engaged in the design, manufacture and sales of radio frequency, microwave and specialized connectors and connector assemblies for aerospace, original electronics manufacturers and military electronics applications; (iii) Oddcables.com Division is engaged in sales of microwave and radio frequency connectors and cable assemblies to end users in multi-media, radio and other communications applications; (iv) Bioconnect Division is engaged in the design, manufacture and sales of cable interconnects for medical monitoring applications; (v) Neulink Division is engaged in the design, manufacture and sales of radio links for receiving and transmitting control signals for remote operation and monitoring of equipment, personnel and monitoring services; (vi) RadioMobile Division is engaged as an OEM provider of end-to-end mobile management solutions implemented over wireless networks. |
For internal operational purposes, and for marketing purposes, the Company currently classifies its operations into the following six related divisions: (i) The Connector and Cable Assembly Division designs, manufactures and distributes coaxial connectors and cable assemblies that are integrated with coaxial connectors; (ii) the Aviel Electronics Division designs, manufactures and distributes specialty and custom RF connectors primarily for aerospace and military customers, (iii) the Oddcables.com Division primarily sells coaxial, fiberoptic, and other connectors and cable assemblies on a retail basis to local multi-media and communications customers; (iv) the Bioconnect Division manufactures and distributes cabling and interconnect products to the medical monitoring market; (v) the Neulink Division is engaged in the design, manufacture and sale of RF data links and wireless modems for receiving and transmitting control signals for remote operation and monitoring of equipment, personnel and monitoring services; and (vi) the RadioMobile Division is an original equipment manufacturer (OEM) provider of end-to-end mobile management solutions implemented over wireless networks that supplement the operations of the Company’s Neulink division. |
EXHIBITS The following exhibits are filed as part of this report: 3.1 Articles of Incorporation, as amended (1) 3.2.1 Company Bylaws as Amended through August, 1985 (2) 3.2.2 Amendment to Bylaws dated January 24, 1986 (2) 3.2.3 Amendment to Bylaws dated February 1, 1989 (3) 3.2.4 Amendment to Bylaws dated June 9, 2006(6) 3.2.5 Amendment to Bylaws dated September 7, 2007(7) 10.1 Form of 2000 Stock Option Plan (4) 10.2 Directors’ Nonqualified Stock Option Agreements (2) 10.3 Employment Agreement, dated June 5, 2008, between the Company and Howard Hill (8) 10.4 Multi-Tenant Industrial Gross Lease, effective March 31, 2009, between RF Industries, Ltd. and Walton CWCA Miramar GL 74, LLC regarding the Company’s facilities in San Diego (9) 10.5 Second Amendment to Lease, dated August 25, 2009, to Multi-Tenant Industrial Gross Lease, effective March 31, 2009, between RF Industries, Ltd. and Walton CWCA Miramar GL 74, LLC (9) 10.6 Single Tenant Commercial Lease, dated August 2009, between Eagle Americank LLC and RF Industries, Ltd. regarding the Company’s lease in Las Vegas, Nevada (9) 10.7 Form of 2010 Stock Incentive Plan (10) 10.8 Form of Stock Option Agreement for the Company’s 2010 Stock Incentive Plan (10) 10.9 Amendment of 2000 Stock Incentive Plan (11) 14.1 Code of Ethics (5) 23.1 Consent of Independent Registered Public Accounting Firm J.H. |
The Company currently conducts its operations through six related business divisions: (i) RF Connector and Cable Division is engaged in the design, manufacture and distribution of coaxial connectors and cable assemblies used primarily in radio and other professional communications applications; (ii) Aviel Division is engaged in the design, manufacture and sales of radio frequency, microwave and specialized connectors and connector assemblies for aerospace, original electronics manufacturers and military electronics applications; (iii) Oddcables.com Division is engaged in sales of microwave and radio frequency connectors and cable assemblies to end users in multi-media, radio and other communications applications; (iv) Bioconnect Division is engaged in the design, manufacture and sales of cable interconnects for medical monitoring applications; (v) Neulink Division is engaged in the design, manufacture and sales of radio links for receiving and transmitting control signals for remote operation and monitoring of equipment, personnel and monitoring services; and (vi) RadioMobile Division is engaged as an OEM provider of end-to-end mobile management solutions implemented over wireless networks. |
For internal operational purposes, and for marketing purposes, the Company currently classifies its operations into the following six related divisions: (i) The Connector and Cable Assembly Division designs, manufactures and distributes coaxial connectors and cable assemblies that are integrated with coaxial connectors; (ii) the Aviel Electronics Division designs, manufactures and distributes specialty and custom RF connectors primarily for aerospace and military customers, (iii) the Worswick Division sells coaxial and other connectors and cable assemblies primarily on a retail basis to local multi-media and communications customers; (iv) the Bioconnect Division manufactures and distributes cabling and interconnect products to the medical monitoring market; (v) the Neulink Division is engaged in the design, manufacture and sales of RF data links and wireless modems for receiving and transmitting control signals for remote operation and monitoring of equipment, personnel and monitoring services; and (vi) the RadioMobile Division is an original equipment manufacturer (OEM) provider of end-to-end mobile management solutions implemented over wireless networks that supplement the operations of the Company’s Neulink division. |
The Company currently conducts its operations through six related business divisions: (i) RF Connector and Cable Division is engaged in the design, manufacture and distribution of coaxial connectors and cable assemblies used primarily in radio and other professional communications applications; (ii) Aviel Division is engaged in the design, manufacture and sales of radio frequency, microwave and specialized connectors and connector assemblies for aerospace, original electronics manufacturers and military electronics applications; (iii) Worswick Division is engaged in sales of microwave and radio frequency connectors and cable assemblies to end users in multi-media, radio and other communications applications; (iv) Bioconnect Division is engaged in the design, manufacture and sales of cable interconnects for medical monitoring applications; (v) Neulink Division is engaged in the design, manufacture and sales of radio links for receiving and transmitting control signals for remote operation and monitoring of equipment, personnel and monitoring services; and (vi) RadioMobile Division is engaged as an OEM provider of end-to-end mobile management solutions implemented over wireless networks. |
For internal operational purposes, and for marketing purposes, the Company currently classifies its operations into the following six related divisions: (i) The Connector and Cable Assembly Division designs, manufactures and distributes coaxial connectors and cable assemblies that are integrated with coaxial connectors; (ii) the Aviel Electronics Division designs, manufactures and distributes specialty and custom RF connectors primarily for aerospace and military customers, (iii) Worswick Division sells coaxial and other connectors and cable assemblies primarily on a retail basis to local multi-media and communications customers; (iv) the Bioconnect Division manufactures and distributes cabling and interconnect products to the medical monitoring market; (v) the Neulink Division is engaged in the design, manufacture and sales of RF data links and wireless modems for receiving and transmitting control signals for remote operation and monitoring of equipment, personnel and monitoring services; and (vi) the RadioMobile Division is an original equipment manufacturer (OEM) provider of end-to-end mobile management solutions implemented over wireless networks that supplement the operations of the Company’s Neulink division. |
The products offered by the Neulink Division include: · NL5000 - (replaced the RF 9600) as a cost effective, high performance telemetry modem · NL6000 UHF and VHF feature, high performance wireless modems · NL900 and NL2400 Spread Spectrum point to point wireless modems · Ornnex Control Systems 900mhz Spread-Spectrum wireless modems and I/O modules · Teledesign high-speed wireless modems in VHF, UHF and 900 MHz frequencies · BlueWave, Maxrad, and Antenex antennas · Custom Design and Engineering services · NL 900S - High-speed, high performance wireless data modem 900 MHz frequency Current applications in use worldwide for Neulink products are various and include seismic and volcanic monitoring, industrial remote censoring/control in oil fields, pipelines and warehousing, lottery remote terminals, various military applications, remote camera control and tracking, perimeter and security system control/monitoring, water and waste management, inventory control, HVAC remote control and monitoring, biomedical hazardous material monitoring, fish farming automation of food dispensing, water aeration and monitoring, remote emergency generator startup and monitoring, and police usage for mobile warrant database access. |
The Company currently conducts its operations through six related business divisions: (i) RF Connector and Cable Division is engaged in the design, manufacture and distribution of coaxial connectors and cable assemblies used primarily in radio and other professional communications applications; (ii) Aviel Division is engaged in the design, manufacture and sales of radio frequency, microwave and specialized connectors and connector assemblies for aerospace, original electronics manufacturers and military electronics applications; (iii) Worswick Division is engaged in sales of microwave and radio frequency connectors and cable assemblies to end users in multi-media, radio and other communications applications; (iv) Bioconnect Division is engaged in the design, manufacture and sales of cable interconnects for medical monitoring applications; (v) Neulink Division is engaged in the design, manufacture and sales of radio links for receiving and transmitting control signals for remote operation and monitoring of equipment, personnel and monitoring services; and (vi) RadioMobile Division is engaged as an OEM provider of end-to-end mobile management solutions implemented over wireless networks. |
Clinical trials for our products in development may be delayed or terminated as a result of many factors, including the following: • inability to reach agreements on acceptable terms with prospective contract research organizations (CROs) and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • difficulty in enrolling patients in our clinical trials; • inability to maintain necessary supplies of study drug and comparator to maintain predicted enrollment rates at clinical trial sites; • patients failing to complete clinical trials due to dissatisfaction with the treatment, side effects or other reasons; • failure by regulators to authorize us to commence a clinical trial; • suspension or termination by regulators of clinical research for many reasons, including concerns about patient safety, bias or failure of our contract manufacturers to comply with cGMP requirements; • delays or failure to obtain clinical supply for our products necessary to conduct clinical trials from contract manufacturers, including commercial grade-clinical supply for our Phase 3 clinical trials; • inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication as our product candidates; • drug candidates demonstrating a lack of efficacy during clinical trials; • inability to continue to fund clinical trials or to find a partner to fund the clinical trials; • competition with ongoing clinical trials and scheduling conflicts with participating clinicians; and • delays in completing data collection and analysis for clinical trials. |
Physicians may elect not to prescribe our drugs, and patients may elect not to request or take them, for a variety of reasons, including: • limitations or warnings contained in a drug’s FDA-approved labeling; • changes in the standard of care or the availability of alternative drugs for the targeted indications for any of our drug candidates; • limitations in the approved indications for our drug candidates; • the approval, availability, market acceptance and reimbursement for the companion diagnostic, where applicable; • demonstrated clinical safety and efficacy compared to other drugs; • significant adverse side effects; • effectiveness of education, sales, marketing and distribution support; • timing of market introduction and perceived effectiveness of competitive drugs; • cost-effectiveness; • adverse publicity about our drug candidates or favorable publicity about competitive drugs; • convenience and ease of administration of our drug candidates; and • willingness of third-party payors to reimburse for the cost of our drug candidates. |
In general, other factors that could affect the demand for and sales and profitability of our future drugs include, but are not limited to: • the timing of regulatory approval, if any, of competitive drugs; • our or any other of our partners’ pricing decisions, as applicable, including a decision to increase or decrease the price of a drug, and the pricing decisions of our competitors; • government and third-party payor reimbursement and coverage decisions that affect the utilization of our future drugs and competing drugs; • negative safety or efficacy data from new clinical studies conducted either in the U.S. or internationally by any party, which could cause the sales of our future drugs to decrease or a future drug to be recalled; • the degree of patent protection afforded our future drugs by patents granted to or licensed by us and by the outcome of litigation involving our or any of our licensor’s patents; • marketing exclusivity, if any, awarded by the FDA to our drugs; • the outcome of litigation involving patents of other companies concerning our future drugs or processes related to production and formulation of those drugs or uses of those drugs; • the increasing use and development of alternate therapies; • the rate of market penetration by competing drugs; and • the termination of, or change in, existing arrangements with our partners. |
If our drug candidates are approved for commercialization outside of the United States, we expect that we will be subject to additional risks related to international operations and entering into international business relationships, including: • different regulatory requirements for drug approvals; • reduced protection for intellectual property rights, including trade secret and patent rights; • unexpected changes in tariffs, trade barriers and regulatory requirements; • economic weakness, including inflation, or political instability in particular foreign economies and markets; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; • workforce uncertainty in countries where employment regulations are different than, and labor unrest is more common than, in the United States; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; • business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, including earthquakes, hurricanes, floods and fires; and • difficulty in importing and exporting clinical trial materials and study samples. |
The laws that may affect our ability to operate include: • the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal health care program, such as the Medicare and Medicaid programs; • federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payors that are false or fraudulent; • the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which impose certain requirements relating to the privacy, security and transmission of individually identifiable health information; • the federal transparency requirements under the Patient Protection and Affordable Care Act of 2010 requires manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests; • state law and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; and • state and federal laws, such as the Physician Sunshine Act, directed at generating transparency on financial issues, including drug prices and payments made by drug companies to various entities and individuals involved in healthcare. |
Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as the process designed by, or under the supervision of, our Chief Executive Officer and Chief Financial Officer, and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of our financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that: • pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of assets; • 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 are being made only in accordance with the authorizations of management and directors; and • provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on our financial statements. |
Clinical trials for our products in development may be delayed or terminated as a result of many factors, including the following: • inability to reach agreements on acceptable terms with prospective contract research organizations (CROs) and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • difficulty in enrolling patients in our clinical trials; • inability to maintain necessary supplies of study drug and comparator to maintain predicted enrollment rates at clinical trial sites; • patients failing to complete clinical trials due to dissatisfaction with the treatment, side effects or other reasons; • failure by regulators to authorize us to commence a clinical trial; • suspension or termination by regulators of clinical research for many reasons, including concerns about patient safety, bias or failure of our contract manufacturers to comply with cGMP requirements; • delays or failure to obtain clinical supply for our products necessary to conduct clinical trials from contract manufacturers, including commercial grade-clinical supply for our Phase 3 clinical trials; • inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication as our product candidates; • drug candidates demonstrating a lack of efficacy during clinical trials; • inability to continue to fund clinical trials or to find a partner to fund the clinical trials; • competition with ongoing clinical trials and scheduling conflicts with participating clinicians; and • delays in completing data collection and analysis for clinical trials. |
Physicians may elect not to prescribe our drugs, and patients may elect not to request or take them, for a variety of reasons, including: • limitations or warnings contained in a drug's FDA-approved labeling; • changes in the standard of care or the availability of alternative drugs for the targeted indications for any of our drug candidates; • limitations in the approved indications for our drug candidates; • the approval, availability, market acceptance and reimbursement for the companion diagnostic, where applicable; • demonstrated clinical safety and efficacy compared to other drugs; • significant adverse side effects; • effectiveness of education, sales, marketing and distribution support; • timing of market introduction and perceived effectiveness of competitive drugs; • cost-effectiveness; • adverse publicity about our drug candidates or favorable publicity about competitive drugs; • convenience and ease of administration of our drug candidates; and • willingness of third-party payors to reimburse for the cost of our drug candidates. |
In general, other factors that could affect the demand for and sales and profitability of our future drugs include, but are not limited to: • the timing of regulatory approval, if any, of competitive drugs; • our or any other of our partners' pricing decisions, as applicable, including a decision to increase or decrease the price of a drug, and the pricing decisions of our competitors; • government and third-party payor reimbursement and coverage decisions that affect the utilization of our future drugs and competing drugs; • negative safety or efficacy data from new clinical studies conducted either in the U.S. or internationally by any party, which could cause the sales of our future drugs to decrease or a future drug to be recalled; • the degree of patent protection afforded our future drugs by patents granted to or licensed by us and by the outcome of litigation involving our or any of our licensor's patents; • marketing exclusivity, if any, awarded by the FDA to our drugs; • the outcome of litigation involving patents of other companies concerning our future drugs or processes related to production and formulation of those drugs or uses of those drugs; • the increasing use and development of alternate therapies; • the rate of market penetration by competing drugs; and • the termination of, or change in, existing arrangements with our partners. |
If our drug candidates are approved for commercialization outside of the United States, we expect that we will be subject to additional risks related to international operations and entering into international business relationships, including: • different regulatory requirements for drug approvals; • reduced protection for intellectual property rights, including trade secret and patent rights; • unexpected changes in tariffs, trade barriers and regulatory requirements; • economic weakness, including inflation, or political instability in particular foreign economies and markets; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; • workforce uncertainty in countries where employment regulations are different than, and labor unrest is more common than, in the United States; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; • business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, including earthquakes, hurricanes, floods and fires; and • difficulty in importing and exporting clinical trial materials and study samples. |
The laws that may affect our ability to operate include: • the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal health care program, such as the Medicare and Medicaid programs; • federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payors that are false or fraudulent; • the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which impose certain requirements relating to the privacy, security and transmission of individually identifiable health information; • the federal transparency requirements under the Patient Protection and Affordable Care Act of 2010 requires manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests; and • state law and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. |
Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as the process designed by, or under the supervision of, our Chief Executive Officer and Chief Financial Officer, and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of our financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that: • pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of assets; • 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 are being made only in accordance with the authorizations of management and directors; and • provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on our financial statements. |
Clinical trials for our products in development may be delayed or terminated as a result of many factors, including the following: • inability to reach agreements on acceptable terms with prospective contract research organizations (CROs) and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • difficulty in enrolling patients in our clinical trials; • inability to maintain necessary supplies of study drug and comparator to maintain predicted enrollment rates at clinical trial sites; • patients failing to complete clinical trials due to dissatisfaction with the treatment, side effects or other reasons; • failure by regulators to authorize us to commence a clinical trial; • suspension or termination by regulators of clinical research for many reasons, including concerns about patient safety or failure of our contract manufacturers to comply with cGMP requirements; • delays or failure to obtain clinical supply for our products necessary to conduct clinical trials from contract manufacturers, including commercial grade-clinical supply for our Phase 3 clinical trials; • inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication as our product candidates; • drug candidates demonstrating a lack of efficacy during clinical trials; • inability to continue to fund clinical trials or to find a partner to fund the clinical trials; • competition with ongoing clinical trials and scheduling conflicts with participating clinicians; and • delays in completing data collection and analysis for clinical trials. |
Physicians may elect not to prescribe our drugs, and patients may elect not to request or take them, for a variety of reasons, including: • limitations or warnings contained in a drug's FDA-approved labeling; • changes in the standard of care or the availability of alternative drugs for the targeted indications for any of our drug candidates; • limitations in the approved indications for our drug candidates; • the approval, availability, market acceptance and reimbursement for the companion diagnostic, where applicable; • demonstrated clinical safety and efficacy compared to other drugs; • significant adverse side effects; • effectiveness of education, sales, marketing and distribution support; • timing of market introduction and perceived effectiveness of competitive drugs; • cost-effectiveness; • adverse publicity about our drug candidates or favorable publicity about competitive drugs; • convenience and ease of administration of our drug candidates; and • willingness of third-party payors to reimburse for the cost of our drug candidates. |
In general, other factors that could affect the demand for and sales and profitability of our future drugs include, but are not limited to: • the timing of regulatory approval, if any, of competitive drugs; • our or any other of our partners' pricing decisions, as applicable, including a decision to increase or decrease the price of a drug, and the pricing decisions of our competitors; • government and third-party payor reimbursement and coverage decisions that affect the utilization of our future drugs and competing drugs; • negative safety or efficacy data from new clinical studies conducted either in the U.S. or internationally by any party, which could cause the sales of our future drugs to decrease or a future drug to be recalled; • the degree of patent protection afforded our future drugs by patents granted to or licensed by us and by the outcome of litigation involving our or any of our licensor's patents; • the outcome of litigation involving patents of other companies concerning our future drugs or processes related to production and formulation of those drugs or uses of those drugs; • the increasing use and development of alternate therapies; • the rate of market penetration by competing drugs; and • the termination of, or change in, existing arrangements with our partners. |
If our drug candidates are approved for commercialization outside of the United States, we expect that we will be subject to additional risks related to international operations and entering into international business relationships, including: • different regulatory requirements for drug approvals; • reduced protection for intellectual property rights, including trade secret and patent rights; • unexpected changes in tariffs, trade barriers and regulatory requirements; • economic weakness, including inflation, or political instability in particular foreign economies and markets; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; • workforce uncertainty in countries where employment regulations are different than, and labor unrest is more common than, in the United States; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; • business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, including earthquakes, hurricanes, floods and fires; and • difficulty in importing and exporting clinical trial materials and study samples. |
The laws that may affect our ability to operate include: • the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal health care program, such as the Medicare and Medicaid programs; • federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payors that are false or fraudulent; • the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which impose certain requirements relating to the privacy, security and transmission of individually identifiable health information; • the federal transparency requirements under the Patient Protection and Affordable Care Act of 2010 requires manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests; and • state law and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. |
Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as the process designed by, or under the supervision of, our Chief Executive Officer and Chief Financial Officer, and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of our financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that: • pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of assets; • 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 are being made only in accordance with the authorizations of management and directors; and • provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on our financial statements. |
Clinical trials for glembatumumab vedotin or any of our other products in development may be delayed or terminated as a result of many factors, including the following: • difficulty in enrolling patients in our clinical trials; • patients failing to complete clinical trials due to dissatisfaction with the treatment, side effects or other reasons; • failure by regulators to authorize us to commence a clinical trial; • suspension or termination by regulators of clinical research for many reasons, including concerns about patient safety or failure of our contract manufacturers to comply with cGMP requirements; • delays or failure to obtain clinical supply for our products necessary to conduct clinical trials from contract manufacturers, including commercial grade-clinical supply for our Phase 3 clinical trials; • drug candidates demonstrating a lack of efficacy during clinical trials; • inability to continue to fund clinical trials or to find a partner to fund the clinical trials; • competition with ongoing clinical trials and scheduling conflicts with participating clinicians; and • delays in completing data collection and analysis for clinical trials. |
Physicians may elect not to prescribe our drugs, and patients may elect not to request or take them, for a variety of reasons, including: • limitations or warnings contained in a drug's FDA-approved labeling; • changes in the standard of care or the availability of alternative drugs for the targeted indications for any of our drug candidates; • limitations in the approved indications for our drug candidates; • the approval, availability, market acceptance and reimbursement for the companion diagnostic, where applicable; • demonstrated clinical safety and efficacy compared to other drugs; • significant adverse side effects; • effectiveness of education, sales, marketing and distribution support; • timing of market introduction and perceived effectiveness of competitive drugs; • cost-effectiveness; • adverse publicity about our drug candidates or favorable publicity about competitive drugs; • convenience and ease of administration of our drug candidates; and • willingness of third-party payors to reimburse for the cost of our drug candidates. |
In general, other factors that could affect the demand for and sales and profitability of our future drugs include, but are not limited to: • the timing of regulatory approval, if any, of competitive drugs; • our or any other of our partners' pricing decisions, as applicable, including a decision to increase or decrease the price of a drug, and the pricing decisions of our competitors; • government and third-party payor reimbursement and coverage decisions that affect the utilization of our future drugs and competing drugs; • negative safety or efficacy data from new clinical studies conducted either in the U.S. or internationally by any party, which could cause the sales of our future drugs to decrease or a future drug to be recalled; • the degree of patent protection afforded our future drugs by patents granted to or licensed by us and by the outcome of litigation involving our or any of our licensor's patents; • the outcome of litigation involving patents of other companies concerning our future drugs or processes related to production and formulation of those drugs or uses of those drugs; • the increasing use and development of alternate therapies; • the rate of market penetration by competing drugs; and • the termination of, or change in, existing arrangements with our partners. |
If our drug candidates are approved for commercialization outside of the United States, we expect that we will be subject to additional risks related to international operations and entering into international business relationships, including: • different regulatory requirements for drug approvals; • reduced protection for intellectual property rights, including trade secret and patent rights; • unexpected changes in tariffs, trade barriers and regulatory requirements; • economic weakness, including inflation, or political instability in particular foreign economies and markets; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; • workforce uncertainty in countries where employment regulations are different than, and labor unrest is more common than, in the United States; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; • business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, including earthquakes, hurricanes, floods and fires; and • difficulty in importing and exporting clinical trial materials and study samples. |
The laws that may affect our ability to operate include: • the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal health care program, such as the Medicare and Medicaid programs; • federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payors that are false or fraudulent; • the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which impose certain requirements relating to the privacy, security and transmission of individually identifiable health information; • the federal transparency requirements under the Patient Protection and Affordable Care Act of 2010 requires manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests; and • state law and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. |
Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as the process designed by, or under the supervision of, our Chief Executive Officer and Chief Financial Officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of our financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that: • pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of assets; • 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 are being made only in accordance with the authorizations of management and directors; and • provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on our financial statements. |
Clinical trials for glembatumumab vedotin or any of our other products in development may be delayed or terminated as a result of many factors, including the following: • difficulty in enrolling patients in our clinical trials; • patients failing to complete clinical trials due to dissatisfaction with the treatment, side effects or other reasons; • failure by regulators to authorize us to commence a clinical trial; • suspension or termination by regulators of clinical research for many reasons, including concerns about patient safety or failure of our contract manufacturers to comply with cGMP requirements; • delays or failure to obtain clinical supply for our products necessary to conduct clinical trials from contract manufacturers, including commercial grade clinical supply for our Phase 3 clinical trials; • treatment candidates demonstrating a lack of efficacy during clinical trials; • inability to continue to fund clinical trials or to find a partner to fund the clinical trials; • competition with ongoing clinical trials and scheduling conflicts with participating clinicians; and • delays in completing data collection and analysis for clinical trials. |
Physicians may elect not to prescribe our drugs, and patients may elect not to request or take them, for a variety of reasons including: • limitations or warnings contained in a drug's FDA-approved labeling; • changes in the standard of care or the availability of alternative drugs for the targeted indications for any of our drug candidates; • limitations in the approved indications for our drug candidates; • the approval, availability, market acceptance and reimbursement for the companion diagnostic, where applicable; • demonstrated clinical safety and efficacy compared to other drugs; • significant adverse side effects; • effectiveness of education, sales, marketing and distribution support; • timing of market introduction and perceived effectiveness of competitive drugs; • cost-effectiveness; • adverse publicity about our drug candidates or favorable publicity about competitive drugs; • convenience and ease of administration of our drug candidates; and • willingness of third-party payors to reimburse for the cost of our drug candidates. |
In general, other factors that could affect the demand for and sales and profitability of our future drugs include, but are not limited to: • the timing of regulatory approval, if any, of competitive drugs; • our or any other of our partners' pricing decisions, as applicable, including a decision to increase or decrease the price of a drug, and the pricing decisions of our competitors; • government and third-party payor reimbursement and coverage decisions that affect the utilization of our future drugs and competing drugs; • negative safety or efficacy data from new clinical studies conducted either in the U.S. or internationally by any party could cause the sales of our future drugs to decrease or a future drug to be recalled; • the degree of patent protection afforded our future drugs by patents granted to or licensed by us and by the outcome of litigation involving our or any of our licensor's patents; • the outcome of litigation involving patents of other companies concerning our future drugs or processes related to production and formulation of those drugs or uses of those drugs; • the increasing use and development of alternate therapies; • the rate of market penetration by competing drugs; and • the termination of, or change in, existing arrangements with our partners. |
If our drug candidates are approved for commercialization outside of the United States, we expect that we will be subject to additional risks related to international operations and entering into international business relationships, including: • different regulatory requirements for drug approvals; • reduced protection for intellectual property rights, including trade secret and patent rights; • unexpected changes in tariffs, trade barriers and regulatory requirements; • economic weakness, including inflation, or political instability in particular foreign economies and markets; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; • workforce uncertainty in countries where employment regulations are different than, and labor unrest is more common than, in the United States; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; • business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, hurricanes, floods and fires; and • difficulty in importing and exporting clinical trial materials and study samples. |
The laws that may affect our ability to operate include: • the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs; • federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent; • the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; • the federal transparency requirements under the Patient Protection and Affordable Care Act of 2010 requires manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests; and • state law and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. |
Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as the process designed by, or under the supervision of, our Chief Executive Officer and Chief Financial Officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of our financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that: • pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of assets; • 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 are being made only in accordance with the authorizations of management and directors; and • provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on our financial statements. |
ACT IV and METRIC and clinical trials for other products in development may be delayed or terminated as a result of many factors, including the following: • difficulty in enrolling patients in our clinical trials; • patients failing to complete clinical trials due to dissatisfaction with the treatment, side effects or other reasons; • failure by regulators to authorize us to commence a clinical trial; • suspension or termination by regulators of clinical research for many reasons, including concerns about patient safety or failure of our contract manufacturers to comply with cGMP requirements; • delays or failure to obtain clinical supply for our products necessary to conduct clinical trials from contract manufacturers, including commercial grade clinical supply for our Phase 3 clinical trials; • treatment candidates demonstrating a lack of efficacy during clinical trials; • inability to continue to fund clinical trials or to find a partner to fund the clinical trials; • competition with ongoing clinical trials and scheduling conflicts with participating clinicians; and • delays in completing data collection and analysis for clinical trials. |
Physicians may elect not to prescribe our drugs, and patients may elect not to request or take them, for a variety of reasons including: • limitations or warnings contained in a drug's FDA-approved labeling; • changes in the standard of care or the availability of alternative drugs for the targeted indications for any of our drug candidates; • limitations in the approved indications for our drug candidates; • the approval, availability, market acceptance and reimbursement for the companion diagnostic, where applicable; • demonstrated clinical safety and efficacy compared to other drugs; • significant adverse side effects; • effectiveness of education, sales, marketing and distribution support; • timing of market introduction and perceived effectiveness of competitive drugs; • cost-effectiveness; • adverse publicity about our drug candidates or favorable publicity about competitive drugs; • convenience and ease of administration of our drug candidates; and • willingness of third-party payors to reimburse for the cost of our drug candidates. |
In general, other factors that could affect the demand for and sales and profitability of our future drugs include, but are not limited to: • the timing of regulatory approval, if any, of competitive drugs; • our or any other of our partners' pricing decisions, as applicable, including a decision to increase or decrease the price of a drug, and the pricing decisions of our competitors; • government and third-party payor reimbursement and coverage decisions that affect the utilization of our future drugs and competing drugs; • negative safety or efficacy data from new clinical studies conducted either in the U.S. or internationally by any party could cause the sales of our future drugs to decrease or a future drug to be recalled; • the degree of patent protection afforded our future drugs by patents granted to or licensed by us and by the outcome of litigation involving our or any of our licensor's patents; • the outcome of litigation involving patents of other companies concerning our future drugs or processes related to production and formulation of those drugs or uses of those drugs; • the increasing use and development of alternate therapies; • the rate of market penetration by competing drugs; and • the termination of, or change in, existing arrangements with our partners. |
We expect that we will be subject to additional risks related to international operations and entering into international business relationships, including: • different regulatory requirements for drug approvals; • reduced protection for intellectual property rights, including trade secret and patent rights; • unexpected changes in tariffs, trade barriers and regulatory requirements; • economic weakness, including inflation, or political instability in particular foreign economies and markets; • compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; • foreign taxes, including withholding of payroll taxes; • foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; • workforce uncertainty in countries where employment regulations are different than, and labor unrest is more common than, in the United States; • production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; • business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, hurricanes, floods and fires; and • difficulty in importing and exporting clinical trial materials and study samples. |
The laws that may affect our ability to operate include: • the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs; • federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent; • the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; • the federal transparency requirements under the Patient Protection and Affordable Care Act of 2010 requires manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests; and • state law and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. |
As a result, governmental actions may adversely affect our business, operations or financial condition, including: • new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions, related to health care availability, method of delivery and payment for health care products and services; • changes in the FDA and foreign regulatory approval processes that may delay or prevent the approval of new products and result in lost market opportunity; • changes in FDA and foreign regulations that may require additional safety monitoring, labeling changes, restrictions on product distribution or use, or other measures after the introduction of our products to market, which could increase our costs of doing business, adversely affect the future permitted uses of approved products, or otherwise adversely affect the market for our products; • new laws, regulations and judicial decisions affecting pricing or marketing practices; and • changes in the tax laws relating to our operations. |
Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as the process designed by, or under the supervision of, our Chief Executive Officer and Chief Financial Officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of our financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that: • pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of assets; • 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 are being made only in accordance with the authorizations of management and directors; and • provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on our financial statements. |
ACT IV, METRIC and clinical trials for other products in development may be delayed or terminated as a result of many factors, including the following: • difficulty in enrolling patients in our clinical trials; • patients failing to complete clinical trials due to dissatisfaction with the treatment, side effects or other reasons; • failure by regulators to authorize us to commence a clinical trial; • suspension or termination by regulators of clinical research for many reasons, including concerns about patient safety or failure of our contract manufacturers to comply with cGMP requirements; • delays or failure to obtain clinical supply for our products necessary to conduct clinical trials from contract manufacturers, including commercial grade clinical supply for our Phase 3 clinical trials; • treatment candidates demonstrating a lack of efficacy during clinical trials; • inability to continue to fund clinical trials or to find a partner to fund the clinical trials; • competition with ongoing clinical trials and scheduling conflicts with participating clinicians; and • delays in completing data collection and analysis for clinical trials. |
Subsets and Splits
No saved queries yet
Save your SQL queries to embed, download, and access them later. Queries will appear here once saved.