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So long as no default existed, we would, however, under our senior credit facility agreement, be permitted to repay or refinance our senior notes (i) with the net cash proceeds of permitted refinancing indebtedness (as defined in the senior credit facility agreement or with the net cash proceeds of our common stock); (ii) with the net cash proceeds of the incremental facilities (as defined in the senior credit facility agreement); (iii) with the net cash proceeds of the revolving loans (as defined in the senior credit facility agreement); (iv) with the cash generated by our operations; (v) in an amount equal to the net cash proceeds of qualified capital stock (as defined in the senior credit facility agreement) issued by us after March 22, 2012; and (vi) in exchange for permitted refinancing indebtedness or in exchange for shares of our common stock; provided that such purchases are capped as follows (with respect to clauses (iii), (iv) and (v) on a pro forma consolidated leverage ratio after giving effect to such purchase, cancellation or redemption): TENNECO INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued) Although the senior credit facility agreement would permit us to repay or refinance our senior notes under the conditions described above, any repayment or refinancing of our outstanding notes would be subject to market conditions and either the voluntary participation of note holders or our ability to redeem the notes under the terms of the applicable note indenture. |
Net periodic pension costs for the years 2013, 2012 and 2011, consist of the following components: TENNECO INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued) Amounts recognized in accumulated other comprehensive loss for pension benefits consist of the following components: Amounts recognized for pension and postretirement benefits in other comprehensive income for the year ended December 31, 2013 and 2012 include the following components: In 2014, we expect to recognize the following amounts, which are currently reflected in accumulated other comprehensive loss, as components of net periodic benefit cost: The projected benefit obligation, accumulated benefit obligation and fair value of plan assets for all pension plans with accumulated benefit obligations in excess of plan assets at December 31, 2013 and 2012 were as follows: TENNECO INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued) The following estimated benefit payments are payable from the pension plans to participants: The following assumptions were used in the accounting for the pension plans for the years of 2013, 2012, and 2011: We made contributions of $57 million to our pension plans during 2013. |
We design, manufacture and distribute a variety of products and systems designed to reduce pollution and optimize engine performance, acoustic tuning and weight, including the following: • Catalytic converters and diesel oxidation catalysts - Devices consisting of a substrate coated with precious metals enclosed in a steel casing used to reduce harmful gaseous emissions such as carbon monoxide; • Diesel Particulate Filters (DPFs) - Devices to capture and regenerate particulate matter emitted from diesel engines; • Burner systems - Devices which actively combust fuel and air inside the exhaust system to create extra heat for DPF regeneration, or to improve the efficiency of SCR systems; • Lean NOx traps - Devices which reduce nitrogen oxide (NOx) emissions from diesel powertrains using capture and store technology; • Hydrocarbon vaporizers and injectors - Devices to add fuel to a diesel exhaust system in order to regenerate diesel particulate filters or Lean NOx traps; • Selective Catalytic Reduction (SCR) systems - Devices which reduce NOx emissions from diesel powertrains using injected reductants such as Verband der Automobil Industrie e.V. |
(AdBlue)TM or Diesel Exhaust Fluid (DEF); • Alternative NOx reduction technologies - Devices which reduce NOx emissions from diesel powertrains, by using alternative reductants such as diesel fuel, E85 (85% ethanol, 15% gasoline), or solid forms of ammonia; • Mufflers and resonators - Devices to provide noise elimination and acoustic tuning; • Fabricated Exhaust manifolds - Components that collect gases from individual cylinders of a vehicle’s engine and direct them into a single exhaust pipe; fabricated manifolds can form the core of an emissions module that includes an integrated catalytic converter (maniverter) and/or turbocharger; • Pipes - Utilized to connect various parts of both the hot and cold ends of an exhaust system; • Hydroformed assemblies - Forms in various geometric shapes, such as Y-pipes or T-pipes, which provide optimization in both design and installation as compared to conventional pipes; • Hangers and isolators - Used for system installation and elimination of noise and vibration, and for the improvement of useful life; and • Aftertreatment control units - Computerized electronic devices that utilize embedded software to regulate the performance of active aftertreatment systems, including the control of sensors, injectors, vaporizers, pumps, heaters, valves, actuators, wiring harnesses, relays and other mechatronic components. |
Name and Age Offices Held Gregg M. Sherrill (60) Chairman and Chief Executive Officer Hari N. Nair (53) Chief Operating Officer Josep Fornos (60) Executive Vice President, Ride Performance Division Timothy E. Jackson (56) Executive Vice President Technology, Strategy and Business Development Kenneth R. Trammell (52) Executive Vice President and Chief Financial Officer Neal A. Yanos (51) Executive Vice President, Clean Air Division Brent J. Bauer (57) Senior Vice President and General Manager - North America Original Equipment Emission Control Gregg Bolt (53) Senior Vice President, Global Human Resources and Administration Michael J. Charlton (54) Senior Vice President, Global Manufacturing Development and European Cost Reduction Initiatives James D. Harrington (52) Senior Vice President, General Counsel and Corporate Secretary Barbara A. Kluth (56) Senior Vice President, Global Human Resources Paul D. Novas (54) Vice President and Controller Gregg M. Sherrill - Mr. Sherrill was named the Chairman and Chief Executive Officer of Tenneco in January 2007. |
So long as no default existed, we would, however, under our senior credit facility agreement, be permitted to repay or refinance our senior notes (i) with the net cash proceeds of permitted refinancing indebtedness (as defined in the senior credit facility agreement or with the net cash proceeds of our common stock); (ii) with the net cash proceeds of the incremental facilities (as defined in the senior credit facility agreement); (iii) with the net cash proceeds of the revolving loans (as defined in the senior credit facility agreement); (iv) with the cash generated by our operations; (v) in an amount equal to the net cash proceeds of qualified capital stock (as defined in the senior credit facility agreement) issued by us after March 22, 2012; and (vi) in exchange for permitted refinancing indebtedness or in exchange for shares of our common stock; provided that such purchases are capped as follows (with respect to clauses (iii), (iv) and (v) on a pro forma consolidated leverage ratio after giving effect to such purchase, cancellation or redemption): Although the senior credit facility agreement would permit us to repay or refinance our senior notes under the conditions described above, any repayment or refinancing of our outstanding notes would be subject to market conditions and either the voluntary participation of note holders or our ability to redeem the notes under the terms of the applicable note indenture. |
So long as no default existed, we would, however, under our senior credit facility agreement, be permitted to repay or refinance our senior notes (i) with the net cash proceeds of permitted refinancing indebtedness (as defined in the senior credit facility agreement or with the net cash proceeds of our common stock); (ii) with the net cash proceeds of the incremental facilities (as defined in the senior credit facility agreement); (iii) with the net cash proceeds of the revolving loans (as defined in the senior credit facility agreement); (iv) with the cash generated by our operations; (v) in an amount equal to the net cash proceeds of qualified capital stock (as defined in the senior credit facility agreement) issued by us after March 22, 2012; and (vi) in exchange for permitted refinancing indebtedness or in exchange for shares of our common stock; provided that such purchases are capped as follows (with respect to clauses (iii), (iv) and (v) on a pro forma consolidated leverage ratio after giving effect to such purchase, cancellation or redemption): Although the senior credit facility agreement would permit us to repay or refinance our senior notes under the conditions described above, any repayment or refinancing of our outstanding notes would be subject to market conditions and either the voluntary participation of note holders or our ability to redeem the notes under the terms of the applicable note indenture. |
TENNECO INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued) Net periodic pension costs for the years 2012, 2011 and 2010, consist of the following components: Amounts recognized in accumulated other comprehensive loss for pension benefits consist of the following components: Amounts recognized for pension and postretirement benefits in other comprehensive income for the year ended December 31, 2012 and 2011 include the following components: TENNECO INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued) In 2013, we expect to recognize the following amounts, which are currently reflected in accumulated other comprehensive loss, as components of net periodic benefit cost: The projected benefit obligation, accumulated benefit obligation and fair value of plan assets for all pension plans with accumulated benefit obligations in excess of plan assets at December 31, 2012 and 2011 were as follows: The following estimated benefit payments are payable from the pension plans to participants: The following assumptions were used in the accounting for the pension plans for the years of 2012, 2011, and 2010: TENNECO INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued) We made contributions of $48 million to our pension plans during 2012. |
During 2011, our OEM and Commercial Vehicle engine manufacturer customers included: North America Europe Asia AM General AvtoVAZ Beijing Automotive Caterpillar BMW BMW Club Car Caterpillar Brilliance Automobile Daimler AG Daimler AG Changan Automotive E-Z Go Deutz AG Daimler AG Fiat-Chrysler Ducati Motor Dongfeng Motor Fiat Industrial (CNH) Fiat-Chrysler Ducati Motor Ford Motor Fiat Industrial (Iveco) First Auto Works General Motors Ford Motor Ford Motor Harley-Davidson Geely Automobile Geely Automobile Honda Motors General Motors General Motors Hyundai Motor Harley-Davidson Great Wall Motor John Deere John Deere Hyundai Motor Navistar International Mazda Motor Isuzu Motors Nissan Motor McLaren Automotive Jiangling Motors Oshkosh Truck Nissan Motor Nissan Motor Paccar Paccar SAIC Motor Toyota Motor Porsche Suzuki Motor Volkswagen Group PSA Peugeot Citroen Volkswagen Group Volvo Global Truck Renault Weichai Power Suzuki Motor Tata Motors Toyota Motor Volkswagen Group Volvo Global Truck Australia South America India Club Car Daimler AG Club Car Fiat Industrial (Iveco) Fiat-Chrysler E-Z Go Ford Motor Fiat Industrial (Iveco) Fiat-Chrysler General Motors Ford Motor Ford Motor Mazda Motor General Motors General Motors Toyota Motor MAN SE Isuzu Motor Navistar International Mahindra & Mahindra Nissan Motor Nissan Motor PSA Peugeot Citroen Suzuki Motor Renault Tata Motors Toyota Motor Toyota Motor Volkswagen Group Volkswagen Group Volvo Global Truck The following customers accounted for 10 percent or more of our net sales in any of the last three years. |
We design, manufacture and distribute a variety of products and systems designed to reduce pollution and optimize engine performance, acoustic tuning and weight, including the following: • Catalytic converters and diesel oxidation catalysts - Devices consisting of a substrate coated with precious metals enclosed in a steel casing used to reduce harmful gaseous emissions, such as carbon monoxide; • Diesel Particulate Filters (DPFs) - Devices to capture and regenerate particulate matter emitted from diesel engines; • Burner systems - Devices which actively combust fuel and air inside the exhaust system to create extra heat for DPF regeneration, or for improved efficiency of SCR systems; • Lean NOx traps - Devices which reduce Nitrogen Oxide (NOx) emissions from diesel powertrains using capture and store technology; • Hydrocarbon vaporizers and injectors - Devices to add fuel to a diesel exhaust system in order to regenerate diesel particulate filters or Lean NOx traps; • Selective Catalytic Reduction (SCR) systems - Devices which reduce NOx emissions from diesel powertrains using injected reductants such as Verband der Automobil Industrie e.V. |
(AdBLue)TM or Diesel Exhaust Fluid (DEF); • Alternative NOx reduction technologies - Devices which reduce NOx emissions from diesel powertrains, by using alternative reductants such as diesel fuel, E85 (85% ethanol, 15% gasoline), or solid forms of ammonia; • Mufflers and resonators - Devices to provide noise elimination and acoustic tuning; • Fabricated Exhaust manifolds - Components that collect gases from individual cylinders of a vehicle’s engine and direct them into a single exhaust pipe; fabricated manifolds can form the core of an emissions module including an integrated catalytic converter (maniverter) and/or turbocharger; • Pipes - Utilized to connect various parts of both the hot and cold ends of an exhaust system; • Hydroformed assemblies - Forms in various geometric shapes, such as Y-pipes or T-pipes, which provide optimization in both design and installation as compared to conventional pipes; • Hangers and isolators - Used for system installation and elimination of noise and vibration, and for the improvement of useful life; and • Aftertreatment control units - Computerized electronic devices that utilize embedded software to regulate the performance of active aftertreatment systems, including the control of sensors, injectors, vaporizers, pumps, heaters, valves, actuators, wiring harnesses, relays and other mechatronic components. |
So long as no default existed, we would, however, under our senior credit facility agreement, be permitted to repay or refinance our senior notes: (i) with the net cash proceeds of incremental facilities and permitted refinancing indebtedness (as defined in the senior credit facility agreement); (ii) with the net cash proceeds from the sale of shares of our common stock; (iii) in exchange for permitted refinancing indebtedness or in exchange for shares of our common stock; (iv) with the net cash proceeds of any new senior or subordinated unsecured indebtedness; (v) with the proceeds of revolving credit loans (as defined in the senior credit facility agreement); (vi) with the cash generated by the operations of the Company; and (vii) in an amount equal to the sum of (a) the net cash proceeds of qualified stock issued by the Company after March 16, 2007, plus (b) the portion of annual excess cash flow (beginning with excess cash flow for fiscal year 2010) not required to be applied to payment of the credit facilities and which is not used for other purposes, provided that the aggregate principal amount of senior notes purchased and cancelled or redeemed pursuant to clauses (v), (vi) and (vii), is capped as follows based on the pro forma consolidated leverage ratio after giving effect to such purchase, cancellation or redemption: Although the senior credit facility agreement would permit us to repay or refinance our senior notes under the conditions described above, any repayment or refinancing of our outstanding notes would be subject to market conditions and either the voluntary participation of note holders or our ability to redeem the notes under the terms of the applicable note indenture. |
So long as no default existed, we would, however, under our senior credit facility agreement, be permitted to repay or refinance our senior notes: (i) with the net cash proceeds of incremental facilities and permitted refinancing indebtedness (as defined in the senior credit facility agreement); (ii) with the net cash proceeds from the sale of shares of our common stock; (iii) in exchange for permitted refinancing indebtedness or in exchange for shares of our common stock; (iv) with the net cash proceeds of any new senior or subordinated unsecured indebtedness; (v) with the proceeds of revolving credit loans (as defined in the senior credit facility TENNECO INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued) agreement); (vi) with the cash generated by the operations of the Company; and (vii) in an amount equal to the sum of (a) the net cash proceeds of qualified stock issued by the Company after March 16, 2007, plus (b) the portion of annual excess cash flow (beginning with excess cash flow for fiscal year 2010) not required to be applied to payment of the credit facilities and which is not used for other purposes, provided that the aggregate principal amount of senior notes purchased and cancelled or redeemed pursuant to clauses (v), (vi) and (vii), is capped as follows based on the pro forma consolidated leverage ratio after giving effect to such purchase, cancellation or redemption: Although the senior credit facility agreement would permit us to repay or refinance our senior notes under the conditions described above, any repayment or refinancing of our outstanding notes would be subject to market conditions and either the voluntary participation of note holders or our ability to redeem the notes under the terms of the applicable note indenture. |
We design, manufacture and distribute a variety of products and systems designed to reduce pollution and optimize engine performance, acoustic tuning and weight, including the following: • Catalytic converters and diesel oxidation catalysts - Devices consisting of a substrate coated with precious metals enclosed in a steel casing used to reduce harmful gaseous emissions, such as carbon monoxide; • Diesel Particulate Filters (DPFs) - Devices to capture and regenerate particulate matter emitted from diesel engines; • Burner systems - Devices which actively combust fuel and air inside the exhaust system to create extra heat for DPF regeneration, or for improved efficiency of SCR systems; • Hydrocarbon vaporizers and injectors - Devices to add fuel to a diesel exhaust system in order to regenerate diesel particulate filters or Lean NOx traps; • Lean NOx traps - Devices which reduce Nitrogen Oxide (NOx) emissions from diesel powertrains using capture and store technology; • Selective Catalytic Reduction (SCR) systems - Devices which reduce NOx emissions from diesel powertrains using injected reductants such as AdBLuetm or Diesel Exhaust Fluid (DEF); • Alternative NOx reduction technologies - Devices which reduce NOx emissions from diesel powertrains, by using alternative reductants such as diesel fuel, E85 (85% ethanol, 15% gasoline), or solid ammonium carbamate; • Mufflers and resonators - Devices to provide noise elimination and acoustic tuning; • Exhaust manifolds - Components that collect gases from individual cylinders of a vehicle’s engine and direct them into a single exhaust pipe; • Pipes - Utilized to connect various parts of both the hot and cold ends of an exhaust system; • Hydroformed assemblies - Forms in various geometric shapes, such as Y-pipes or T-pipes, which provide optimization in both design and installation as compared to conventional pipes; • Hangers and isolators - Used for system installation and elimination of noise and vibration, and for the improvement of useful life; and • Aftertreatment control units - Computerized electronic devices that utilize embedded software to regulate the performance of active aftertreatment system, including the control of sensors, injectors, vaporizers, pumps, heaters, valves, actuators, wiring harnesses, relays and other mechatronic components. |
So long as no default existed, we would, however, under our senior credit facility agreement, be permitted to repay or refinance our senior notes: (i) with the net cash proceeds of incremental facilities and permitted refinancing indebtedness (as defined in the senior credit facility agreement); (ii) with the net cash proceeds from the sale of shares of our common stock; (iii) in exchange for permitted refinancing indebtedness or in exchange for shares of our common stock; (iv) with the net cash proceeds of any new senior or subordinated unsecured indebtedness; (v) with the proceeds of revolving credit loans (as defined in the senior credit facility agreement); (vi) with the cash generated by the operations of the company; and (vii) in an amount equal to the sum of (A) the net cash proceeds of qualified stock issued by the Company after March 16, 2007, plus (B) the portion of annual excess cash flow (beginning with excess cash flow for fiscal year 2010) not required to be applied to payment of the credit facilities and which is not used for other purposes, provided that the aggregate principal amount of senior notes purchased and cancelled or redeemed pursuant to clauses (v), (vi) and (vii), is capped as follows based on the pro forma consolidated leverage ratio after giving effect to such purchase, cancellation or redemption: Although the senior credit facility agreement would permit us to repay or refinance our senior notes under the conditions described above, any repayment or refinancing of our outstanding notes would be subject to market conditions and either the voluntary participation of noteholders or our ability to redeem the notes under the terms of the applicable note indenture. |
So long as no default existed, we would, however, under our senior credit facility agreement, be permitted to repay or refinance our senior notes: (i) with the net cash proceeds of incremental facilities and permitted refinancing indebtedness (as defined in the senior credit facility agreement); (ii) with the net cash proceeds from the sale of shares of our common stock; (iii) in exchange for permitted refinancing indebtedness or in exchange for shares of our common stock; (iv) with the net cash proceeds of any new senior or subordinated unsecured indebtedness; (v) with the proceeds of revolving credit loans (as defined in the senior credit facility agreement); (vi) with the cash generated by the operations of the company; and (vii) in an amount equal to the sum of (A) the net cash proceeds of qualified stock issued by the Company after March 16, 2007, plus (B) the portion of annual excess cash flow (beginning with excess cash flow for fiscal year 2010) not required to be applied to payment of the credit facilities and which is not used for other purposes, provided that the aggregate principal amount of senior notes purchased and cancelled or redeemed pursuant to clauses (v), (vi) and (vii), is capped as follows based on the pro forma consolidated leverage ratio after giving effect to such purchase, cancellation or redemption: Although the senior credit facility agreement would permit us to repay or refinance our senior notes under the conditions described above, any repayment or refinancing of our outstanding notes would be subject to market conditions and either the voluntary participation of noteholders or our ability to redeem the notes under the terms of the applicable note indenture. |
We design, manufacture and distribute a variety of products and systems designed to reduce pollution and optimize engine performance, acoustic tuning and weight, including the following: • Catalytic converters and diesel oxidation catalysts - Devices consisting of a substrate coated with precious metals enclosed in a steel casing used to reduce harmful gaseous emissions, such as carbon monoxide; • Diesel Particulate Filters (DPFs) - Devices to eliminate particulate matter emitted from diesel engines; • Burner systems - Devices which actively combust fuel and air inside the exhaust system to create extra heat for DPF regeneration, or for improved efficiency of SCR systems; • Hydrocarbon vaporizers and injectors - Devices to add fuel to a diesel exhaust system in order to regenerate diesel particulate filters or Lean NOx traps; • Lean NOx traps - Devices which reduce Nitrogen Oxide (NOx) emissions from diesel powertrains using capture and store technology; • Selective Catalytic Reduction (SCR) systems - Devices which reduce NOx emissions from diesel powertrains using injected reductants such as AdBLuetm or Diesel Exhaust Fuel (DEF); • Mufflers and resonators - Devices to provide noise elimination and acoustic tuning; • Exhaust manifolds - Components that collect gases from individual cylinders of a vehicle’s engine and direct them into a single exhaust pipe; • Pipes - Utilized to connect various parts of both the hot and cold ends of an exhaust system; • Hydroformed assemblies - Forms in various geometric shapes, such as Y-pipes or T-pipes, which provide optimization in both design and installation as compared to conventional pipes; and • Hangers and isolators - Used for system installation and elimination of noise and vibration. |
The senior credit facility agreement provides the ability to refinance our senior subordinated notes and/or our senior secured notes (i) in exchange for permitted refinancing indebtedness (as defined in the senior credit facility agreement); (ii) in exchange for shares of common stock; or (iii) in an amount equal to the sum of (A) the net cash proceeds of equity issued after March 16, 2007, plus (B) the portion of annual excess cash flow (as defined in the senior credit facility agreement) that is not required to be applied to the payment of the credit facilities and which is not used for other purposes, provided that the amount of the subordinated notes and the aggregate amount of the senior secured notes and the subordinated notes that may be refinanced is capped based upon the pro forma consolidated leverage ratio after giving effect to such refinancing as shown in the following table: In addition, the senior secured notes may be refinanced with (i) the net cash proceeds of incremental facilities and permitted refinancing indebtedness (as defined in the senior credit facility agreement), (ii) shares of common stock, (iii) the net cash proceeds of any new senior or subordinated unsecured indebtedness, (iv) proceeds of revolving credit loans (as defined in the senior credit facility agreement), (v) up to 200 million of unsecured indebtedness of the company’s foreign subsidiaries and (vi) cash generated by the company’s operations provided that the amount of the senior secured notes that may be refinanced is capped based upon the pro forma consolidated leverage ratio after giving effect to such refinancing as shown in the following table: The senior credit facility agreement also contains restrictions on our operations that are customary for similar facilities, including limitations on: (i) incurring additional liens; (ii) sale and leaseback transactions (except for the permitted transactions as described in the amended and restated agreement); (iii) liquidations and dissolutions; (iv) incurring additional indebtedness or guarantees; (v) investments and acquisitions; (vi) dividends and share repurchases; (vii) mergers and consolidations; and (viii) refinancing of subordinated and 101/4 percent senior secured notes. |
The senior credit facility agreement provides the ability to refinance our senior subordinated notes and/or our senior secured notes (i) in exchange for permitted refinancing indebtedness (as defined in the senior credit facility agreement); (ii) in exchange for shares of common stock; or (iii) in an amount equal to the sum of (A) the net cash proceeds of equity issued after March 16, 2007, plus (B) the portion of annual excess cash flow (as defined in the senior credit facility agreement) that is not required to be applied to the payment of the credit facilities and which is not used for other purposes, provided that the amount of the subordinated notes and the aggregate amount of the senior secured notes and the subordinated notes that may be refinanced is capped based upon the pro forma consolidated leverage ratio after giving effect to such refinancing as shown in the following table: In addition, the senior secured notes may be refinanced with (i) the net cash proceeds of incremental facilities and permitted refinancing indebtedness (as defined in the senior credit facility agreement), (ii) shares of common stock, (iii) the net cash proceeds of any new senior or subordinated unsecured indebtedness, (iv) proceeds of revolving credit loans (as defined in the senior credit facility agreement), (v) up to 200 million of unsecured indebtedness of the company’s foreign subsidiaries and (vi) cash generated by the company’s operations provided that the amount of the senior secured notes that may be refinanced is capped based upon the pro forma consolidated leverage ratio after giving effect to such refinancing as shown in the following table: TENNECO INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued) The senior credit facility agreement also contains restrictions on our operations that are customary for similar facilities, including limitations on: (i) incurring additional liens; (ii) sale and leaseback transactions (except for the permitted transactions as described in the amended and restated agreement); (iii) liquidations and dissolutions; (iv) incurring additional indebtedness or guarantees; (v) investments and acquisitions; (vi) dividends and share repurchases; (vii) mergers and consolidations; and (viii) refinancing of subordinated and 101/4 percent senior secured notes. |
We design, manufacture and distribute a variety of products and systems designed to reduce pollution and optimize engine performance, acoustic tuning and weight, including the following: • Catalytic converters and diesel oxidation catalysts - Devices consisting of a substrate coated with precious metals enclosed in a steel casing used to reduce harmful gaseous emissions, such as carbon monoxide; • Diesel Particulate Filters (DPFs) - Devices to eliminate particulate matter emitted from diesel engines; • Burner systems - Devices which actively combust fuel and air inside the exhaust system to create extra heat for DPF regeneration, or for improved efficiency of SCR systems; • Hydrocarbon vaporizers and injectors - Devices to add fuel to a diesel exhaust system in order to regenerate diesel particulate filters or Lean NOx traps; • Lean NOx traps - Devices which reduce Nitrogen Oxide (NOx) emissions from diesel powertrains using capture and store technology; • Selective Catalytic Reduction (SCR) systems - Devices which reduce NOx emissions from diesel powertrains using injected reductants such as AdBLuetm or Diesel Exhaust Fuel (DEF); • Mufflers and resonators - Devices to provide noise elimination and acoustic tuning; • Exhaust manifolds - Components that collect gases from individual cylinders of a vehicle’s engine and direct them into a single exhaust pipe; • Pipes - Utilized to connect various parts of both the hot and cold ends of an exhaust system; • Hydroformed assemblies - Forms in various geometric shapes, such as Y-pipes or T-pipes, which provide optimization in both design and installation as compared to conventional pipes; and • Hangers and isolators - Used for system installation and noise and vibration elimination. |
The senior credit facility agreement provides the ability to refinance our senior subordinated notes and/or our senior secured notes in an amount equal to the sum of (i) the net cash proceeds of equity issued after March 16, 2007, plus (ii) the portion of annual excess cash flow (as defined in the senior credit facility agreement) that is not required to be applied to the payment of the credit facilities and which is not used for other purposes, provided that the amount of the subordinated notes and the aggregate amount of the senior secured notes and the subordinated notes that may be refinanced is capped based upon the pro forma consolidated leverage ratio after giving effect to such refinancing as shown in the following table: In addition, the senior secured notes may be refinanced with (i) the net cash proceeds of incremental facilities and permitted refinancing indebtedness (as defined in the senior credit facility agreement), (ii) the net cash proceeds of any new senior or subordinated unsecured indebtedness, (iii) proceeds of revolving credit loans (as defined in the senior credit facility agreement), (iv) up to 200 million of unsecured indebtedness of the company’s foreign subsidiaries and (v) cash generated by the company’s operations provided that the amount of the senior secured notes that may be refinanced is capped based upon the pro forma consolidated leverage ratio after giving effect to such refinancing as shown in the following table: The senior credit facility agreement also contains restrictions on our operations that are customary for similar facilities, including limitations on: (i) incurring additional liens; (ii) sale and leaseback transactions (except for the permitted transactions as described in the amended and restated agreement); (iii) liquidations and dissolutions; (iv) incurring additional indebtedness or guarantees; (v) investments and acquisitions; (vi) dividends and share repurchases; (vii) mergers and consolidations; and (viii) refinancing of subordinated and 101/4 percent senior secured notes. |
The financial ratios required under the senior credit facility and, the actual ratios we achieved for four quarters of 2008, are shown in the following tables: TENNECO INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued) The financial ratios required under the senior credit facility for 2009 and beyond are set forth below: The senior credit facility agreement provides the ability to refinance our senior subordinated notes and/or our senior secured notes in an amount equal to the sum of (i) the net cash proceeds of equity issued after March 16, 2007, plus (ii) the portion of annual excess cash flow (as defined in the senior credit facility agreement) that is not required to be applied to the payment of the credit facilities and which is not used for other purposes, provided that the amount of the subordinated notes and the aggregate amount of the senior secured notes and the subordinated notes that may be refinanced is capped based upon the pro forma consolidated leverage ratio after giving effect to such refinancing as shown in the following table: In addition, the senior secured notes may be refinanced with (i) the net cash proceeds of incremental facilities and permitted refinancing indebtedness (as defined in the senior credit facility agreement), (ii) the net cash proceeds of any new senior or subordinated unsecured indebtedness, (iii) proceeds of revolving credit loans (as defined in the senior credit facility agreement), (iv) up to 200 million of unsecured indebtedness of the company’s foreign subsidiaries and (v) cash generated by the company’s operations provided that the amount of the senior secured notes that may be refinanced is capped based upon the pro forma consolidated leverage ratio after giving effect to such refinancing as shown in the following table: The senior credit facility agreement also contains restrictions on our operations that are customary for similar facilities, including limitations on: (i) incurring additional liens; (ii) sale and leaseback transactions TENNECO INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued) (except for the permitted transactions as described in the amended and restated agreement); (iii) liquidations and dissolutions; (iv) incurring additional indebtedness or guarantees; (v) investments and acquisitions; (vi) dividends and share repurchases; (vii) mergers and consolidations; and (viii) refinancing of subordinated and 101/4 percent senior secured notes. |
We design, manufacture and distribute a variety of products and systems designed to reduce pollution and optimize engine performance, acoustic tuning and weight, including the following: - Catalytic converters and diesel oxidation catalysts -- Devices consisting of a substrate coated with precious metals enclosed in a steel casing used to reduce harmful gaseous emissions, such as carbon monoxide, below the EPA regulated limits for emissions; - Diesel Particulate Filters -- Devices to eliminate particulate matter emitted from diesel engines; - Selective Catalytic Reduction (SCR) systems -- Devices which reduce Nitrogen Oxide (NOx) emissions from diesel powertrains; - Mufflers and resonators -- Devices to provide noise elimination and acoustic tuning; - Exhaust manifolds -- Components that collect gases from individual cylinders of a vehicle's engine and direct them into a single exhaust pipe; - Pipes -- Utilized to connect various parts of both the hot and cold ends of an exhaust system; - Hydroformed assemblies -- Forms into various geometric shapes, such as Y- pipes or T-pipes, which provides optimization in both design and installation as compared to conventional pipes; and - Hangers and isolators -- Used for system installation and noise and vibration elimination; We entered the emission control product line in 1967 with the acquisition of Walker Manufacturing Company, which was founded in 1888. |
We continue to emphasize product value differentiation with these brands and our other primary brands, including: - The Monroe Reflex(R) shock absorber which features an Acceleration Sensitive Damping Technology (ASD) to maintain better tire-to-road contact and improve handling and safety for high center of gravity vehicles (SUVs and light trucks) requiring more control; - The Monroe Sensa-Trac(R) line of shock absorbers, that has been enhanced by the PSD (Position Sensitive Damping) technology which offers both comfort and control when you need it; - Walker's Quiet-Flow(R) muffler, which features an open flow design that increases exhaust flow, improves sound quality and significantly reduces exhaust back pressure when compared to other replacement mufflers; - Rancho(R) ride control products provide on and off road performance for both stock or raised light truck vehicles; - DynoMax(R), which offers a complete line of mufflers, cat-back performance exhaust systems, headers and pipes engineered to increase the efficiency, horsepower, torque and sound of virtually any car, truck, or light vehicle; - Walker Ultra(TM) catalytic converters, which offer a higher loading of precious metals to help problematic vehicles pass emissions testing; - Monroe(R) Dynamics and Ceramics brakes offer the Complete Solution, combining wire wear sensors, hardware and lube allowing installers to do the job right the first time; and - In European markets, Walker(TM) and Aluminox Pro(TM) mufflers. |
The financial ratios required under the amended and restated senior credit facility and, the actual ratios we achieved for the four quarters of 2007, are shown in the following tables: The senior credit facility agreement provides the ability to refinance our senior subordinated notes and/or our senior secured notes in an amount equal to the sum of (i) the net cash proceeds of equity issued after the closing date plus (ii) the portion of annual excess cash flow (as defined in the senior credit facility agreement) that is not required to be applied to the payment of the credit facilities and which is not used for other purposes, provided that the amount of the subordinated notes and the aggregate amount of the senior secured notes and the subordinated notes that may be refinanced is capped based upon the pro forma consolidated leverage ratio after giving effect to such refinancing as shown in the following table: In addition, the senior secured notes may be refinanced with (i) the net cash proceeds of incremental facilities and permitted refinancing indebtedness (as defined in the senior credit facility agreement), (ii) the net cash proceeds of any new senior or subordinated unsecured indebtedness, (iii) proceeds of revolving credit loans (as defined in the senior credit facility agreement), (iv) up to E200 million of unsecured indebtedness of the company's foreign subsidiaries and (v) cash generated by the company's operations. |
The financial ratios required under the amended and restated senior credit facility and, the actual ratios we achieved for the four quarters of 2007, are shown in the following tables: The senior credit facility agreement provides the ability to refinance our senior subordinated notes and/or our senior secured notes in an amount equal to the sum of (i) the net cash proceeds of equity issued after the closing date plus (ii) the portion of annual excess cash flow (as defined in the senior credit facility agreement) that is not required to be applied to the payment of the credit facilities and which is not used for other purposes, provided that the amount of the subordinated notes and the aggregate amount of the senior secured notes and the subordinated notes that may be refinanced is capped based upon the pro forma consolidated leverage ratio after giving effect to such refinancing as shown in the following table: In addition, the senior secured notes may be refinanced with (i) the net cash proceeds of incremental facilities and permitted refinancing indebtedness (as defined in the senior credit facility agreement), (ii) the net cash proceeds of any new senior or subordinated unsecured indebtedness, (iii) proceeds of revolving credit loans (as defined in the senior credit facility agreement), (iv) up to E200 million of unsecured indebtedness of the company's foreign subsidiaries and (v) cash generated by the company's operations. |
158, "Employers Accounting for Defined Benefit Pension and Other Postretirement Plans," other changes in plan assets and benefit obligations recognized in other comprehensive income consisted of the following components: Amounts recognized in accumulated other comprehensive income consist of: TENNECO INC. AND CONSOLIDATED SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) In 2008, we expect to recognize the following amounts, which are currently reflected in accumulated other comprehensive income, as components of net periodic benefit cost: The projected benefit obligation, accumulated benefit obligation and fair value of plan assets for all pension plans with accumulated benefit obligations in excess of plan assets at December 31, 2007 and September 30, 2006 were as follows: The following estimated benefit payments are payable from the pension plans to participants: The following assumptions were used in the accounting for the pension plans for the years of 2007, 2006, and 2005: TENNECO INC. AND CONSOLIDATED SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) Effective January 1, 2007, we froze our defined benefit plans and replaced them with additional contributions under defined contribution plans for nearly all U.S.-based salaried and non-union hourly employees. |
During 2006, our OE customers included: North America AM General CAMI Automotive Caterpillar Club Car Daimler Chrysler/Freightliner E-Z Go Golf Car Ford General Motors Harley-Davidson Honda Mazda (Auto Alliance) Motor Coach Industries Navistar Nissan Paccar Toyota Volkswagen Volvo Truck South America Daimler Chrysler Fiat Ford General Motors PSA Peugeot Citroen Renault Scania Toyota Volkswagen Europe BMW Daimler Chrysler Fiat Ford General Motors Nissan Paccar Porsche PSA Peugeot Citroen Renault Scania Suzuki Toyota Volkswagen Volvo Truck Australia Club Car Ford General Motors Mazda Mitsubishi Nissan Toyota Asia BMW Chang’an Automobile Daimler Chrysler Dongfeng Motor Co. First Auto Works Ford General Motors Jinbei Automobile Co. Isuzu Mitsubishi PSA Peugeot Citroen Renault Shanghai Automotive (SAIC) Volkswagen India General Motors Mahindra & Mahindra Suzuki TATA Motors Toyota TVS Motors During 2006, our aftermarket customers were comprised of full-line and specialty warehouse distributors, retailers, jobbers, installer chains and car dealers. |
We design, manufacture and distribute a variety of products and systems designed to optimize engine performance, acoustic tuning and weight, including the following: • Mufflers and resonators - Devices to provide noise elimination and acoustic tuning; • Catalytic converters - Devices - consisting of a substrate coated with precious metals enclosed in a steel casing - used to convert harmful gaseous emission, such as carbon monoxide, from a vehicle’s exhaust system into harmless components such as water vapor and carbon dioxide; • Exhaust manifolds - Components that collect gases from individual cylinders of a vehicle’s engine and direct them into a single exhaust pipe; • Pipes - Utilized to connect various parts of both the hot and cold ends of an exhaust system; • Hydroformed tubing - Forms into various geometric shapes, such as Y-pipes or T-pipes, which provides optimization in both design and installation as compared to conventional pipes; • Hangers and isolators - Used for system installation and noise and vibration elimination; • Diesel Particulate Filters - Devices to eliminate particulate matter emitted from diesel engines; and • Selective Catalytic Reduction (SCR) systems - Devices which reduce Nitrogen Oxide (NOx) emissions from diesel powertrains. |
We continue to emphasize product value differentiation with these brands and our other primary brands, including: • The Monroe Reflex® shock absorber which features an Acceleration Sensitive Damping Technology (ASD) to maintain better tire-to-road contact and improve handling and safety for high center of gravity vehicles (SUVs and light trucks) requiring more control; • The Monroe Sensa-Trac® line of shock absorbers, that has been enhanced by the PSD (Position Sensitive Damping) technology which offers both comfort and control when you need it; • Walker’s Quiet-Flow® muffler, which features an open flow design that increases exhaust flow, improves sound quality and significantly reduces exhaust back pressure when compared to other replacement mufflers; • Rancho® ride control products provides on and off road performance for both stock or raised light truck vehicles; • DynoMax®, which offers a complete line of mufflers, cat-back performance exhaust systems, headers and pipes engineered to increase the efficiency, horsepower, torque and sound of virtually any car, truck, or light vehicle; • Walker Ultratm catalytic converters, which offer a higher loading of precision metals to help problematic vehicles pass emissions testing; • Monroe® Dynamics and Ceramics brakes offer the Complete Solution, combining wire wear sensors, hardware and lube allowing installers to do the job right the first time; and • In European markets, Walkertm and Aluminox Protm mufflers. |
158 “Employers Accounting for Defined Benefit Pension and Other Postretirement Plans” other changes in plan assets and benefit obligations recognized in other comprehensive income consisted of the following components: Amounts recognized in accumulated other comprehensive income consist of: In 2007, we expect to recognize the following amounts, which are currently reflected in accumulated other comprehensive income, as components of net periodic benefit cost: TENNECO INC. AND CONSOLIDATED SUBSIDIARIES NOTES TO FINANCIAL STATEMENTS - (Continued) The projected benefit obligation, accumulated benefit obligation and fair value of plan assets for all pension plans with accumulated benefit obligations in excess of plan assets at September 30, 2006 and 2005 were as follows: The following estimated benefit payments are payable from the pension plans to participants: The following assumptions were used in the accounting for the pension plans for the years of 2006, 2005, and 2004: We made contributions of $42 million to these pension plans during 2006. |
We design, manufacture and distribute a variety of products and systems designed to optimize engine performance, acoustic tuning and weight, including the following: - Mufflers and resonators -- Devices to provide noise elimination and acoustic tuning; - Catalytic converters -- Devices -- consisting of a substrate coated with precious metals enclosed in a steel casing -- used to convert harmful gaseous emission, such as carbon monoxide, from a vehicle's exhaust system into harmless components such as water vapor and carbon dioxide; - Exhaust manifolds -- Components that collect gases from individual cylinders of a vehicle's engine and direct them into a single exhaust pipe; - Pipes -- Utilized to connect various parts of both the hot and cold ends of an exhaust system; - Hydroformed tubing -- Forms into various geometric shapes, such as Y-pipes or T-pipes, which provides optimization in both design and installation as compared to conventional pipes; - Hangers and isolators -- Used for system installation and noise elimination; and - Diesel Particulate Filters -- Devices to eliminate particulate matter emitted from diesel engines. |
We continue to emphasize product value differentiation with these brands and our other primary brands, including: - The Monroe Reflex(R) shock absorber which features an Impact Sensor(TM) device to maintain better tire-to-road contact and improve handling and safety under rough road conditions; - The Monroe Sensa-Trac(R) line of shock absorbers, that has been enhanced by the SafeTech(TM) system technology which incorporates a fluon banded piston to improve performance and durability; - Walker's Quiet-Flow(R) muffler, which features an open flow design that increases exhaust flow, improves sound quality and significantly reduces exhaust back pressure when compared to other replacement mufflers; - Rancho(R) ride control products for the high-performance light truck market; - DynoMax(R) high-performance emission control systems; - Walker Perfection(TM) catalytic converters; - Clevite(R) Elastomers elastomeric vibration control components, which are primarily rubber products used to reduce vibration through "cushioning" a connection or contact point; - DNX(TM) sport tunes cars with performance exhaust and adjustable suspension systems; and - In European markets, Walker(TM) and Aluminox Pro(TM) mufflers. |
We design, manufacture and distribute a variety of products and systems designed to optimize engine performance, acoustic tuning and weight, including the following: - Mufflers and resonators -- Devices to provide noise elimination and acoustic tuning; - Catalytic converters -- Devices used to convert harmful gaseous emission, such as carbon monoxide, from a vehicle's exhaust system into harmless components such as water vapor and carbon dioxide; - Exhaust manifolds -- Components that collect gases from individual cylinders of a vehicle's engine and direct them into a single exhaust pipe; - Pipes -- Utilized to connect various parts of both the hot and cold ends of an exhaust system; - Hydroformed tubing -- Forms into various geometric shapes, such as Y-pipes or T-pipes, which provides optimization in both design and installation as compared to conventional pipes; - Hangers and isolators -- Used for system installation and noise elimination; and - Diesel Particulate Filters -- Devices to eliminate particulate matter emitted from diesel engines. |
We continue to emphasize product value differentiation with these brands and our other primary brands, including: - The Monroe Reflex(R) shock absorber which features an Impact Sensor(TM) device to maintain better tire-to-road contact and improve handling and safety under rough road conditions; - The Monroe Sensa-Trac(R) line of shock absorbers, that has been enhanced by the SafeTech(TM) system technology which incorporates a fluon banded piston to improve performance and durability; - Walker's Quiet-Flow(R) muffler, which features an open flow design that increases exhaust flow, improves sound quality and significantly reduces exhaust back pressure when compared to other replacement mufflers; - Rancho(R) ride control products for the high-performance light truck market; - DynoMax(R) high-performance emission control systems; - Walker Perfection(TM) catalytic converters; - Clevite(R) Elastomers elastomeric vibration control components, which are primarily rubber products used to reduce vibration through "cushioning" a connection or contact point; - DNX(TM) sport tunes cars with performance exhaust and adjustable suspension systems; and - In European markets, Walker(TM) and Aluminox Pro(TM) mufflers. |
We design, manufacture and distribute a variety of products and systems designed to optimize engine performance, acoustic tuning and weight, including the following: - Mufflers and resonators -- Devices to provide noise elimination and acoustic tuning; - Catalytic converters -- Devices used to convert harmful gaseous emission, such as carbon monoxide, from a vehicle's exhaust system into harmless components such as water vapor and carbon dioxide; - Exhaust manifolds -- Components that collect gases from individual cylinders of a vehicle's engine and direct them into a single exhaust pipe; - Pipes -- Utilized to connect various parts of both the hot and cold ends of an exhaust system; - Hydroformed tubing -- Forms into various geometric shapes, such as Y-pipes or T-pipes, which provides optimization in both design and installation as compared to conventional pipes; - Hangers and isolators -- Used for system installation and noise elimination; and - Diesel Particulate Filters -- Devices to eliminate particulate matter emitted from diesel engines. |
We continue to emphasize product value differentiation with these brands and our other primary brands, including: - The Monroe Reflex(R) shock absorber which features an Impact Sensor(TM) device to maintain better tire-to-road contact and improve handling and safety under rough road conditions; - The Monroe Sensa-Trac(R) line of shock absorbers, that has been enhanced by the SafeTec(TM) system technology which incorporates a fluon banded piston to improve performance and durability; - Walker's Quiet-Flow(R) muffler, which features an open flow design that increases exhaust flow, improves sound quality and significantly reduces exhaust back pressure when compared to other replacement mufflers; - Rancho(R) ride control products for the high-performance light truck market; - DynoMax(R) high-performance emission control systems; - Walker Perfection(TM) catalytic converters; - Clevite(R) Elastomers elastomeric vibration control components, which are primarily rubber products used to reduce vibration through "cushioning" a connection or contact point; and - In European markets, Walker(TM) and Aluminox(TM) mufflers. |
The financial ratios required under the amended senior credit facility and, in the case of the year ended December 31, 2003, the actual ratios we achieved are shown in the following tables: As part of the amendment and restatement, the terms of our senior credit facility were also revised to: (i) extend the period of time during which we can exclude up to $60 million of cash charges and expenses, before taxes, related to any cost reduction initiatives from the calculation of the financial covenant ratios by another two years through 2006; (ii) permit the refinancing of our senior subordinated notes and/or our 10 1/4 percent senior secured notes using the net cash proceeds from the issuance of similarly structured debt; (iii) permit the repurchase of our senior subordinated notes and/or our 10 1/4 percent senior secured notes using the net cash proceeds form the issuance of shares of common stock of Tenneco Automotive Inc.; and (iv) delete the mandatory prepayment of term loans from excess cash flow in 2003 and reduced the percentage of excess cash flow that must be used to prepay term loans in subsequent years from 75 percent to 50 percent. |
The financial TENNECO AUTOMOTIVE INC. AND CONSOLIDATED SUBSIDIARIES NOTES TO FINANCIAL STATEMENTS -- (CONTINUED) ratios required under the amended senior credit facility and, in the case of the year ended December 31, 2003, the actual ratios we achieved are shown in the following tables: As part of the amendment and restatement, the terms of our senior credit facility were also revised to: (i) extend the period of time during which we can exclude up to $60 million of cash charges and expenses, before taxes, related to any cost reduction initiatives from the calculation of the financial covenant ratios by another two years through 2006; (ii) permit the refinancing of our senior subordinated notes and/or our 10 1/4 percent senior secured notes using the net cash proceeds from the issuance of similarly structured debt; (iii) permit the repurchase of our senior subordinated notes and/or our 10 1/4 percent senior secured notes using the net cash proceeds form the issuance of shares of common stock of Tenneco Automotive Inc.; and (iv) delete the mandatory prepayment of term loans from excess cash flow in 2003 and reduced the percentage of excess cash flow that must be used to prepay term loans in subsequent years from 75 percent to 50 percent. |
We continue to emphasize product value differentiation with these brands and our other primary brands, including: - The Monroe Reflex(R) shock absorber which features an Impact Sensor(TM) device to maintain better tire-to-road contact and improve handling and safety under rough road conditions; - The Monroe Sensa-Trac(R) line of shock absorbers, that has been enhanced by the SafeTec(TM) system technology which incorporates a fluon banded piston to improve performance and durability; - Walker's Quiet-Flow(R) muffler, which features an open flow design that increases exhaust flow, improves sound quality and significantly reduces exhaust back pressure when compared to other replacement mufflers; - Rancho(R) ride control products for the high-performance light truck market; - DynoMax(R) high-performance emissions control systems; - Walker Perfection(TM) catalytic converters; - Clevite(R) elastomeric vibration control components, which are primarily rubber products used to reduce vibration through "cushioning" a connection or contact point; and - In European markets, Walker(TM) and Aluminox(TM) mufflers. |
The FDA or other foreign governmental agencies or we ourselves could delay, suspend or halt our clinical trials of a product candidate for numerous reasons, including with respect to our product candidates and those of our partners in combination agent studies: • deficiencies in the trial design; • deficiencies in the conduct of the clinical trial including failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols; • deficiencies in the clinical trial operations or trial sites resulting in the imposition of a clinical hold; • a product candidate may have unforeseen adverse side effects, including fatalities, or a determination may be made that a clinical trial presents unacceptable health risks; • the time required to determine whether a product candidate is effective may be longer than expected; • fatalities or other adverse events arising during a clinical trial that may not be related to clinical trial treatments; • a product candidate or combination study may appear to be no more effective than current therapies; • the quality or stability of a product candidate may fail to conform to acceptable standards; • the inability to produce or obtain sufficient quantities of a product candidate to complete the trials; • our inability to reach agreement on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • our inability to obtain IRB approval to conduct a clinical trial at a prospective site; • the inability to obtain regulatory approval to conduct a clinical trial; • lack of adequate funding to continue a clinical trial, including the occurrence of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties; • the inability to recruit and enroll individuals to participate in clinical trials for reasons including competition from other clinical trial programs for the same or similar indications; or • the inability to retain participants who have initiated a clinical trial but may withdraw due to side effects from the therapy, lack of efficacy or personal issues, or who are lost to further follow-up. |
The process of establishing and maintaining collaborative relationships is difficult and time-consuming, and even if we establish such relationships, they may involve significant uncertainty, including: • our partners may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; • our shortage of capital resources may impact the willingness of companies to collaborate with us; • our contracts for collaborative arrangements are terminable at will on written notice and may otherwise expire or terminate and we may not have alternative funding available; • our partners may choose to pursue alternative technologies, including those of our competitors; • we may have disputes with a partner that could lead to litigation or arbitration; • we have limited control over the decisions of our partners and they may change the priority of our programs in a manner that would result in termination of the agreement or add significant delay in the partnered program; • our ability to generate future payments and royalties from our partners depends upon the abilities of our partners to establish the safety and efficacy of our drug candidates, obtain regulatory approvals and successfully manufacture and achieve market acceptance of products developed from our drug candidates; • we or our partners may fail to properly initiate, maintain or defend our intellectual property rights, where applicable, or a party may use our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability; • our partners may not devote sufficient capital or resources towards our product candidates; and • our partners may not comply with applicable government regulatory requirements. |
Relevant U.S. laws include: • the federal Anti-Kickback Statute, which prohibits persons from, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal health care programs, such as the Medicare and Medicaid programs; • federal false claims laws, including the False Claims Act, and civil monetary penalty law, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, claims for payment to the government or its agents that are false or fraudulent; • the Federal Food, Drug and Cosmetic Act and governing regulations which, among other things, prohibit off-label promotion of prescription drugs; • the federal Physician Payments Sunshine Act created under the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education and Reconciliation Act of 2010 (collectively, “ACA”) which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services (“CMS”), information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and ownership and investment interests held by such physicians and their immediate family members. |
Beginning in 2022, applicable manufacturers also will be required to report such information regarding its payments and other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives during the previous year; • the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created, among other things, new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which imposes certain requirements on “covered entities,” including certain healthcare providers, health plans, and healthcare clearinghouses, and their respective “business associates” that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity as well as their covered subcontractors relating to the privacy, security, and transmission of individually identifiable health information; • the Foreign Corrupt Practices Act, which prohibits the payment of bribes to foreign government officials and requires that a company’s books and records accurately reflect the company’s transactions; and • foreign and state law equivalents of each of the federal laws described above, such as anti-kickback and false claims laws which may apply to items or services reimbursed by state health insurance programs or any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government; state laws that require drug manufacturers to report information on the pricing of certain drugs; state and local laws that require the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information, many of which differ from each other in significant ways and often are not preempted by HIPAA. |
The risks and uncertainties that we face with respect to our patents and other proprietary rights include the following: • we may not receive an issued patent for any of our patent applications or for any patent applications that we have exclusively licensed now or in the future; • the pending patent applications we have filed or to which we have exclusive rights may take longer than we expect to result in issued patents; • the claims of any patents that are issued may not provide meaningful protection or may not be valid or enforceable; • we might not be able to develop additional proprietary technologies that are patentable; • the patents licensed or issued to us or our collaborators may not provide a competitive advantage; • patents issued to other parties may limit our intellectual property protection or harm our ability to do business; • other parties may independently develop similar or alternative technologies or duplicate our technologies and commercialize discoveries that we attempt to patent; and • other parties may design around technologies we have licensed, patented or developed; • pending patent applications or issued patents may be challenged by third parties in proceedings, such as inter partes review (“IPR”), pre- and post-grant oppositions, and post grant review (“PGR”). |
The market price of our common stock is subject to substantial volatility depending upon many factors, many of which are beyond our control, including: • impact of COVID-19 on our HEPLISAV-B product revenue; • progress or results of any of our clinical trials or regulatory or manufacturing efforts, in particular any announcements regarding the progress or results of our planned trials and BLA filing and communications, from the FDA or other regulatory agencies; • our ability to receive timely regulatory approval for our product candidates; • our ability to establish and maintain collaborations for the development and commercialization of our product candidates; • our ability to raise additional capital to fund our operations; • technological innovations, new commercial products or drug discovery efforts and preclinical and clinical activities by us or our competitors; • changes in our intellectual property portfolio or developments or disputes concerning the proprietary rights of our products or product candidates; • our ability to obtain component materials and successfully enter into manufacturing relationships for our products or product candidates or establish manufacturing capacity on our own; • our ability to establish and maintain licensing agreements for intellectual property necessary for the development of our product candidates; • changes in government regulations, general economic conditions or industry announcements; • changes in the structure of healthcare payment systems; • issuance of new or changed securities analysts’ reports or recommendations; • actual or anticipated fluctuations in our quarterly financial and operating results; and • the volume of trading in our common stock. |
A data security breach or privacy violation that leads to disclosure or modification of or prevents access to patient information, including personally identifiable information or protected health information, could harm our reputation, compel us to comply with federal, state and/or international data breach notification laws, subject us to mandatory corrective action, require us to verify the correctness of database contents and otherwise subject us to liability under laws and regulations that protect personal data, including but not limited to HIPAA, similar state data protection regulations, and the GDPR, resulting in significant penalties; increased costs; loss of revenue; expenses of computer or forensic investigations; material fines and penalties; compensatory, special, punitive or statutory damages; litigation; consent orders regarding our privacy and security practices; requirements that we provide notices, credit monitoring services and/or credit restoration services or other relevant services to impacted individuals; adverse actions against our licenses to do business; or injunctive relief. |
The process required by the FDA before biopharmaceuticals may be marketed in the United States generally involves the following: • submission to the FDA of an IND, which must become effective before human clinical trials may begin and must be updated annually; • completion of extensive pre-clinical laboratory tests and pre-clinical animal studies, all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations; • performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for each proposed indication; • submission to the FDA of a new drug application or a biologics license application, NDA or BLA, depending on the nature of the product after completion of all pivotal clinical trials to demonstrate the safety, purity and potency of the product for the indication for use; • a determination by the FDA to accept the application for review; • satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities to assess compliance with the FDA’s current good manufacturing practices regulations for pharmaceuticals, or cGMPs; and • FDA review and approval of an NDA or BLA prior to any commercial marketing or sale of the product in the United States. |
The FDA or other foreign governmental agencies or we ourselves could delay, suspend or halt our clinical trials of a product candidate for numerous reasons, including with respect to our product candidates and those of our partners in combination agent studies: • deficiencies in the trial design; • deficiencies in the conduct of the clinical trial including failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols; • deficiencies in the clinical trial operations or trial sites resulting in the imposition of a clinical hold; • a product candidate may have unforeseen adverse side effects, including fatalities, or a determination may be made that a clinical trial presents unacceptable health risks; • the time required to determine whether a product candidate is effective may be longer than expected; • fatalities or other adverse events arising during a clinical trial that may not be related to clinical trial treatments; • a product candidate or combination study may appear to be no more effective than current therapies; • the quality or stability of a product candidate may fail to conform to acceptable standards; • the inability to produce or obtain sufficient quantities of a product candidate to complete the trials; • our inability to reach agreement on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • our inability to obtain IRB approval to conduct a clinical trial at a prospective site; • the inability to obtain regulatory approval to conduct a clinical trial; • lack of adequate funding to continue a clinical trial, including the occurrence of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties; • the inability to recruit and enroll individuals to participate in clinical trials for reasons including competition from other clinical trial programs for the same or similar indications; or • the inability to retain participants who have initiated a clinical trial but may withdraw due to side effects from the therapy, lack of efficacy or personal issues, or who are lost to further follow-up. |
The process of establishing and maintaining collaborative relationships is difficult and time-consuming, and even if we establish such relationships, they may involve significant uncertainty, including: • our partners may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; • our shortage of capital resources may impact the willingness of companies to collaborate with us; • our contracts for collaborative arrangements are terminable at will on written notice and may otherwise expire or terminate and we may not have alternative funding available; • our partners may choose to pursue alternative technologies, including those of our competitors; • we may have disputes with a partner that could lead to litigation or arbitration; • we have limited control over the decisions of our partners and they may change the priority of our programs in a manner that would result in termination of the agreement or add significant delay in the partnered program; • our ability to generate future payments and royalties from our partners depends upon the abilities of our partners to establish the safety and efficacy of our drug candidates, obtain regulatory approvals and successfully manufacture and achieve market acceptance of products developed from our drug candidates; • we or our partners may fail to properly initiate, maintain or defend our intellectual property rights, where applicable, or a party may use our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability; • our partners may not devote sufficient capital or resources towards our product candidates; and • our partners may not comply with applicable government regulatory requirements. |
Relevant U.S. laws include: • the federal Anti-Kickback Statute, which prohibits persons from, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal health care programs, such as the Medicare and Medicaid programs; • federal false claims laws, including the civil False Claims Act, and civil monetary penalty law, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, claims for payment to the government or its agents that are false or fraudulent; • the Federal Food, Drug and Cosmetic Act and governing regulations which, among other things, prohibit off-label promotion of prescription drugs; • the federal Physician Payments Sunshine Act created under the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education and Reconciliation Act of 2010 (collectively, “ACA”) which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services (“CMS”), information related to payments and other transfers of value to physicians, as defined by such law, and teaching hospitals, and ownership and investment interests held by such physicians and their immediate family members; • the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created, among other things, new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which imposes certain requirements relating to the privacy, security, and transmission of individually identifiable health information; • the Foreign Corrupt Practices Act, which prohibits the payment of bribes to foreign government officials and requires that a company’s books and records accurately reflect the company’s transactions; and • foreign and state law equivalents of each of the federal laws described above, such as anti-kickback and false claims laws which may apply to items or services reimbursed by state health insurance programs or any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government; state laws that require drug manufacturers to report information on the pricing of certain drugs; state and local laws that require the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information, many of which differ from each other in significant ways and often are not preempted by HIPAA. |
The risks and uncertainties that we face with respect to our patents and other proprietary rights include the following: • we may not receive an issued patent for any of our patent applications or for any patent applications that we have exclusively licensed; • the pending patent applications we have filed or to which we have exclusive rights may take longer than we expect to result in issued patents; • the claims of any patents that are issued may not provide meaningful protection or may not be valid or enforceable; • we might not be able to develop additional proprietary technologies that are patentable; • the patents licensed or issued to us or our collaborators may not provide a competitive advantage; • patents issued to other parties may limit our intellectual property protection or harm our ability to do business; • other parties may independently develop similar or alternative technologies or duplicate our technologies and commercialize discoveries that we attempt to patent; and • other parties may design around technologies we have licensed, patented or developed. |
The market price of our common stock is subject to substantial volatility depending upon many factors, many of which are beyond our control, including: • progress or results of any of our clinical trials or regulatory or manufacturing efforts, in particular any announcements regarding the progress or results of our planned trials and BLA filing and communications, from the FDA or other regulatory agencies; • our ability to receive timely regulatory approval for our product candidates; • our ability to establish and maintain collaborations for the development and commercialization of our product candidates; • our ability to raise additional capital to fund our operations; • the success or failure of clinical trials involving our immuno-oncology product candidates and the product candidates of third-party collaborators in combination studies; • technological innovations, new commercial products or drug discovery efforts and preclinical and clinical activities by us or our competitors; • changes in our intellectual property portfolio or developments or disputes concerning the proprietary rights of our products or product candidates; • our ability to obtain component materials and successfully enter into manufacturing relationships for our product candidates or establish manufacturing capacity on our own; • our ability to establish and maintain licensing agreements for intellectual property necessary for the development of our product candidates; • changes in government regulations, general economic conditions or industry announcements; • changes in the structure of healthcare payment systems; • issuance of new or changed securities analysts’ reports or recommendations; • actual or anticipated fluctuations in our quarterly financial and operating results; and • the volume of trading in our common stock. |
Our Strategy • Commercialize HEPLISAV-B, initially in the United States, to generate cash flows to support continued development of TLR-based immuno-oncology therapeutics and new vaccines • Demonstrate the versatility of our immuno-oncology platform by assessing efficacy in multiple tumor types and in combination with a range of modalities through clinical development of product candidates in three areas: o Intratumoral SD-101 in combination with anti-PD-1 therapies in melanoma, head and neck squamous cell carcinoma (“HNSCC”) and additional tumor types o Combinations of SD-101, DV281 or our other TLR agonists in combination with agents other than anti-PD-1/L-1 alone, including other immuno-modulatory agents or chemotherapy o TLR9 or TLR7/8 agonists designed for targeted delivery beyond intratumoral injection HEPLISAV-B The Company's first commercial product, HEPLISAV-B (Hepatitis B Vaccine, (Recombinant), Adjuvanted), is approved by the FDA for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. |
The process required by the FDA before biopharmaceuticals may be marketed in the United States generally involves the following: • submission to the FDA of an IND, which must become effective before human clinical trials may begin and must be updated annually; • completion of extensive pre-clinical laboratory tests and pre-clinical animal studies, all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations; • performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for each proposed indication; • submission to the FDA of a new drug application or a biologics license application, NDA or BLA, depending on the nature of the product after completion of all pivotal clinical trials to demonstrate the safety, purity and potency of the product for the indication for use; • a determination by the FDA to accept the application for review; • satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities to assess compliance with the FDA’s current good manufacturing practices regulations for pharmaceuticals, or cGMPs; and • FDA review and approval of an NDA or BLA prior to any commercial marketing or sale of the product in the United States. |
The FDA or other foreign governmental agencies or we ourselves could delay, suspend or halt our clinical trials of a product candidate for numerous reasons, including with respect to our product candidates and those of our partners in combination agent studies: • deficiencies in the trial design; • deficiencies in the conduct of the clinical trial including failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols; • deficiencies in the clinical trial operations or trial sites resulting in the imposition of a clinical hold; • a product candidate may have unforeseen adverse side effects, including fatalities, or a determination may be made that a clinical trial presents unacceptable health risks; • the time required to determine whether a product candidate is effective may be longer than expected; • fatalities or other adverse events arising during a clinical trial that may not be related to clinical trial treatments; • a product candidate or combination study may appear to be no more effective than current therapies; • the quality or stability of a product candidate may fail to conform to acceptable standards; • the inability to produce or obtain sufficient quantities of a product candidate to complete the trials; • our inability to reach agreement on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • our inability to obtain IRB approval to conduct a clinical trial at a prospective site; • the inability to obtain regulatory approval to conduct a clinical trial; • lack of adequate funding to continue a clinical trial, including the occurrence of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties; • the inability to recruit and enroll individuals to participate in clinical trials for reasons including competition from other clinical trial programs for the same or similar indications; or • the inability to retain participants who have initiated a clinical trial but may withdraw due to side effects from the therapy, lack of efficacy or personal issues, or who are lost to further follow-up. |
The process of establishing and maintaining collaborative relationships is difficult and time-consuming, and even if we establish such relationships, they may involve significant uncertainty, including: • our partners may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; • our shortage of capital resources may impact the willingness of companies to collaborate with us; • our contracts for collaborative arrangements are terminable at will on written notice and may otherwise expire or terminate and we may not have alternative funding available; • our partners may choose to pursue alternative technologies, including those of our competitors; • we may have disputes with a partner that could lead to litigation or arbitration; • we have limited control over the decisions of our partners and they may change the priority of our programs in a manner that would result in termination of the agreement or add significant delay in the partnered program; • our ability to generate future payments and royalties from our partners depends upon the abilities of our partners to establish the safety and efficacy of our drug candidates, obtain regulatory approvals and successfully manufacture and achieve market acceptance of products developed from our drug candidates; • we or our partners may fail to properly initiate, maintain or defend our intellectual property rights, where applicable, or a party may use our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability; • our partners may not devote sufficient capital or resources towards our product candidates; and • our partners may not comply with applicable government regulatory requirements. |
Relevant U.S. laws include: • the federal Anti-Kickback Statute, which prohibits persons from, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal health care programs, such as the Medicare and Medicaid programs; • federal false claims laws, including the civil False Claims Act, and civil monetary penalty law, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, claims for payment to the government or its agents that are false or fraudulent; • the Federal Food, Drug and Cosmetic Act and governing regulations which, among other things, prohibit off-label promotion of prescription drugs; • the federal Physician Payments Sunshine Act created under the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education and Reconciliation Act of 2010 (collectively, “PPACA”) which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services (“CMS”), information related to payments and other transfers of value to physicians, other healthcare providers, and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members; • the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created, among other things, new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which imposes certain requirements relating to the privacy, security, and transmission of individually identifiable health information; • the Foreign Corrupt Practices Act, which prohibits the payment of bribes to foreign government officials and requires that a company’s books and records accurately reflect the company’s transactions; and • foreign and state law equivalents of each of the federal laws described above, such as anti-kickback and false claims laws which may apply to items or services reimbursed by state health insurance programs or any third party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government; state laws that require drug manufacturers to report information on the pricing of certain drugs; state and local laws that require the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information, many of which differ from each other in significant ways and often are not preempted by HIPAA. |
The risks and uncertainties that we face with respect to our patents and other proprietary rights include the following: • we may not receive an issued patent for any of our patent applications or for any patent applications that we have exclusively licensed; • the pending patent applications we have filed or to which we have exclusive rights may take longer than we expect to result in issued patents; • the claims of any patents that are issued may not provide meaningful protection or may not be valid or enforceable; • we might not be able to develop additional proprietary technologies that are patentable; • the patents licensed or issued to us or our collaborators may not provide a competitive advantage; • patents issued to other parties may limit our intellectual property protection or harm our ability to do business; • other parties may independently develop similar or alternative technologies or duplicate our technologies and commercialize discoveries that we attempt to patent; and • other parties may design around technologies we have licensed, patented or developed. |
The market price of our common stock is subject to substantial volatility depending upon many factors, many of which are beyond our control, including: • progress or results of any of our clinical trials or regulatory or manufacturing efforts, in particular any announcements regarding the progress or results of our planned trials and BLA filing and communications, from the FDA or other regulatory agencies; • our ability to receive timely regulatory approval for our product candidates; • our ability to establish and maintain collaborations for the development and commercialization of our product candidates; • our ability to raise additional capital to fund our operations; • the success or failure of clinical trials involving our immuno-oncology product candidates and the product candidates of third party collaborators in combination studies; • technological innovations, new commercial products or drug discovery efforts and preclinical and clinical activities by us or our competitors; • changes in our intellectual property portfolio or developments or disputes concerning the proprietary rights of our products or product candidates; • our ability to obtain component materials and successfully enter into manufacturing relationships for our product candidates or establish manufacturing capacity on our own; • our ability to establish and maintain licensing agreements for intellectual property necessary for the development of our product candidates; • changes in government regulations, general economic conditions or industry announcements; • changes in the structure of healthcare payment systems; • issuance of new or changed securities analysts’ reports or recommendations; • actual or anticipated fluctuations in our quarterly financial and operating results; and • the volume of trading in our common stock. |
Our Strategy • Commercialize HEPLISAV-B, initially in the United States, to generate cash flows to support continued development of TLR-based immuno-oncology therapeutics and new vaccines • Demonstrate the versatility of our immuno-oncology platform by assessing efficacy in multiple tumor types and in combination with a range of modalities through clinical development of product candidates in three areas: o Intratumoral SD-101 in combination with anti-PD-1 therapies in melanoma, head and neck squamous cell carcinoma (“HNSCC”) and additional tumor types o Combinations of SD-101, DV281 or our other TLR agonists in combination with agents other than anti-PD-1/L-1 alone, including other immuno-modulatory agents or chemotherapy o TLR9 or TLR7/8 agonists designed for targeted delivery beyond intratumoral injection HEPLISAV-B The Company's first commercial product, HEPLISAV-B (Hepatitis B Vaccine, (Recombinant), Adjuvanted), was approved on November 9, 2017 by the FDA for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. |
The process required by the FDA before biopharmaceuticals may be marketed in the United States generally involves the following: • submission to the FDA of an IND, which must become effective before human clinical trials may begin and must be updated annually; • completion of extensive pre-clinical laboratory tests and pre-clinical animal studies, all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations; • performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for each proposed indication; • submission to the FDA of a biologics license application, or BLA, after completion of all pivotal clinical trials to demonstrate the safety, purity and potency of the product for the indication for use; • a determination by the FDA within sixty days of its receipt of a BLA to file the application for review; • satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities to assess compliance with the FDA’s current good manufacturing practices regulations for pharmaceuticals, or cGMPs; and • FDA review and approval of a BLA prior to any commercial marketing or sale of the product in the United States. |
The FDA or other foreign governmental agencies or we ourselves could delay, suspend or halt our clinical trials of a product candidate for numerous reasons, including with respect to our product candidates and those of our partners in combination agent studies: • deficiencies in the trial design; • deficiencies in the conduct of the clinical trial including failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols; • deficiencies in the clinical trial operations or trial sites resulting in the imposition of a clinical hold; • a product candidate may have unforeseen adverse side effects, including fatalities, or a determination may be made that a clinical trial presents unacceptable health risks; • the time required to determine whether a product candidate is effective may be longer than expected; • fatalities or other adverse events arising during a clinical trial that may not be related to clinical trial treatments; • a product candidate or combination study may appear to be no more effective than current therapies; • the quality or stability of a product candidate may fail to conform to acceptable standards; • the inability to produce or obtain sufficient quantities of a product candidate to complete the trials; • our inability to reach agreement on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • our inability to obtain IRB approval to conduct a clinical trial at a prospective site; • the inability to obtain regulatory approval to conduct a clinical trial; • lack of adequate funding to continue a clinical trial, including the occurrence of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties; • the inability to recruit and enroll individuals to participate in clinical trials for reasons including competition from other clinical trial programs for the same or similar indications; or • the inability to retain participants who have initiated a clinical trial but may withdraw due to side effects from the therapy, lack of efficacy or personal issues, or who are lost to further follow-up. |
The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves significant uncertainty, including: • our partners may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; • our shortage of capital resources may impact the willingness of companies to collaborate with us; • our contracts for collaborative arrangements are terminable at will on written notice and may otherwise expire or terminate and we may not have alternative funding available; • our partners may choose to pursue alternative technologies, including those of our competitors; • we may have disputes with a partner that could lead to litigation or arbitration; • we have limited control over the decisions of our partners and they may change the priority of our programs in a manner that would result in termination of the agreement or add significant delay in the partnered program; • our ability to generate future payments and royalties from our partners depends upon the abilities of our partners to establish the safety and efficacy of our drug candidates, obtain regulatory approvals and successfully manufacture and achieve market acceptance of products developed from our drug candidates; • we or our partners may fail to properly initiate, maintain or defend our intellectual property rights, where applicable, or a party may use our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability; • our partners may not devote sufficient capital or resources towards our product candidates; and • our partners may not comply with applicable government regulatory requirements. |
Relevant U.S. laws include: • the federal Anti-Kickback Statute, which prohibits persons from, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal health care programs, such as the Medicare and Medicaid programs; • federal false claims laws, including the civil False Claims Act, and civil monetary penalty law, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, claims for payment to the government or its agents that are false or fraudulent; • the Federal Food, Drug and Cosmetic Act and governing regulations which, among other things, prohibit off-label promotion of prescription drugs; • the federal Physician Payments Sunshine Act created under the Patient Protection and Affordable Care Act (“PPACA”) which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services (“CMS”), information related to payments and other transfers of value to physicians, other healthcare providers, and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members; • the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created, among other things, new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and its implementing regulations, which imposes certain requirements relating to the privacy, security, and transmission of individually identifiable health information; • the Foreign Corrupt Practices Act, which prohibits the payment of bribes to foreign government officials and requires that a company’s books and records accurately reflect the company’s transactions; and • foreign and state law equivalents of each of the federal laws described above, such as anti-kickback and false claims laws which may apply to items or services reimbursed by state health insurance programs or any third party payor, including commercial insurers; and state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government. |
The risks and uncertainties that we face with respect to our patents and other proprietary rights include the following: • we may not receive an issued patent for any of our patent applications or for any patent applications that we have exclusively licensed; • the pending patent applications we have filed or to which we have exclusive rights may take longer than we expect to result in issued patents; • the claims of any patents that are issued may not provide meaningful protection or may not be valid or enforceable; • we might not be able to develop additional proprietary technologies that are patentable; • the patents licensed or issued to us or our collaborators may not provide a competitive advantage; • patents issued to other parties may limit our intellectual property protection or harm our ability to do business; • other parties may independently develop similar or alternative technologies or duplicate our technologies and commercialize discoveries that we attempt to patent; and • other parties may design around technologies we have licensed, patented or developed. |
The market price of our common stock is subject to substantial volatility depending upon many factors, many of which are beyond our control, including: • progress or results of any of our clinical trials or regulatory or manufacturing efforts, in particular any announcements regarding the progress or results of our planned trials and BLA filing and communications, from the FDA or other regulatory agencies; • our ability to receive timely regulatory approval for our product candidates; • our ability to establish and maintain collaborations for the development and commercialization of our product candidates; • our ability to raise additional capital to fund our operations; • the success or failure of clinical trials involving our immuno-oncology product candidates and the product candidates of third party collaborators in combination studies; • technological innovations, new commercial products or drug discovery efforts and preclinical and clinical activities by us or our competitors; • changes in our intellectual property portfolio or developments or disputes concerning the proprietary rights of our products or product candidates; • our ability to obtain component materials and successfully enter into manufacturing relationships for our product candidates or establish manufacturing capacity on our own; • our ability to establish and maintain licensing agreements for intellectual property necessary for the development of our product candidates; • changes in government regulations, general economic conditions or industry announcements; • issuance of new or changed securities analysts’ reports or recommendations; • actual or anticipated fluctuations in our quarterly financial and operating results; and • the volume of trading in our common stock. |
The BLA review process is extensive, lengthy, expensive and uncertain, and the FDA or foreign regulatory agencies may delay, limit or deny approval of our application for many reasons, including: whether the data from our clinical trials, including the Phase 3 results, or the development program are satisfactory to the FDA or foreign regulatory agency; disagreement with the number, design, size, conduct or implementation of our clinical trials or a conclusion that the data fails to meet statistical or clinical significance or safety requirements; acceptability of data generated at our clinical trial sites that are monitored by third party contract research organizations (“CROs”); the results of an advisory committee that may recommend against approval of our BLA or may recommend that the FDA or other agencies require, as a condition for approval, additional preclinical studies or clinical trials; and deficiencies in our manufacturing processes or facilities or those of our third party contract manufacturers and suppliers, if any. |
The FDA or other foreign governmental agencies or we ourselves could delay, suspend or halt our clinical trials of a product candidate for numerous reasons, including with respect to our product candidates and those of our partners in combination agent studies: • deficiencies in the trial design; • deficiencies in the conduct of the clinical trial including failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols; • deficiencies in the clinical trial operations or trial sites resulting in the imposition of a clinical hold; • a product candidate may have unforeseen adverse side effects, including fatalities, or a determination may be made that a clinical trial presents unacceptable health risks; • the time required to determine whether a product candidate is effective may be longer than expected; • fatalities or other adverse events arising during a clinical trial that may not be related to clinical trial treatments; • a product candidate or combination study may appear to be no more effective than current therapies; • the quality or stability of a product candidate may fail to conform to acceptable standards; • the inability to produce or obtain sufficient quantities of a product candidate to complete the trials; • our inability to reach agreement on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • our inability to obtain IRB approval to conduct a clinical trial at a prospective site; • the inability to obtain regulatory approval to conduct a clinical trial; • lack of adequate funding to continue a clinical trial, including the occurrence of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties; • the inability to recruit and enroll individuals to participate in clinical trials for reasons including competition from other clinical trial programs for the same or similar indications; or • the inability to retain participants who have initiated a clinical trial but may withdraw due to side effects from the therapy, lack of efficacy or personal issues, or who are lost to further follow-up. |
The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves significant uncertainty, including: • our partners may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; • our shortage of capital resources may impact the willingness of companies to collaborate with us; • our contracts for collaborative arrangements are terminable at will on written notice and may otherwise expire or terminate and we may not have alternative funding available; • our partners may choose to pursue alternative technologies, including those of our competitors; • we may have disputes with a partner that could lead to litigation or arbitration; • we have limited control over the decisions of our partners and they may change the priority of our programs in a manner that would result in termination of the agreement or add significant delay in the partnered program; • our ability to generate future payments and royalties from our partners depends upon the abilities of our partners to establish the safety and efficacy of our drug candidates, obtain regulatory approvals and successfully manufacture and achieve market acceptance of products developed from our drug candidates; • we or our partners may fail to properly initiate, maintain or defend our intellectual property rights, where applicable, or a party may use our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability; • our partners may not devote sufficient capital or resources towards our product candidates; and • our partners may not comply with applicable government regulatory requirements. |
Relevant U.S. laws include: • the Anti-Kickback Statute, which prohibits persons from, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal health care programs, such as the Medicare and Medicaid programs; • federal false claims laws which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, claims for payment to the government or its agents that are false or fraudulent; • laws that require transparency regarding financial arrangements with health care professionals, such as the reporting and disclosure requirements imposed by the Patient Protection and Affordable Care Act (“PPACA”) and state laws; • the federal Health Insurance Portability and Accountability Act of 1997 (“HIPAA”), which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; • HIPAA, as amended by the Health Information Technology and Criminal Health Act, and its implementing regulations, which imposes certain requirements relating to the privacy, security, and transmission of individually identifiable health information; • the Foreign Corrupt Practices Act, which prohibits the payment of bribes to foreign government officials and requires that a company’s books and records accurately reflect the company’s transactions; and • foreign and state law equivalents of each of the federal laws described above, such as anti-kickback and false claims laws which may apply to items or services reimbursed by state health insurance programs or any third party payor, including commercial insurers; and state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government. |
The risks and uncertainties that we face with respect to our patents and other proprietary rights include the following: • we may not receive an issued patent for any of our patent applications or for any patent applications that we have exclusively licensed; • the pending patent applications we have filed or to which we have exclusive rights may take longer than we expect to result in issued patents; • the claims of any patents that are issued may not provide meaningful protection or may not be valid or enforceable; • we might not be able to develop additional proprietary technologies that are patentable; • the patents licensed or issued to us or our collaborators may not provide a competitive advantage; • patents issued to other parties may limit our intellectual property protection or harm our ability to do business; • other parties may independently develop similar or alternative technologies or duplicate our technologies and commercialize discoveries that we attempt to patent; and • other parties may design around technologies we have licensed, patented or developed. |
The market price of our common stock is subject to substantial volatility depending upon many factors, many of which are beyond our control, including: • progress or results of any of our clinical trials or regulatory or manufacturing efforts, in particular any announcements regarding the progress or results of our planned trials and BLA filing and communications, from the FDA or other regulatory agencies, including a decision by the FDA regarding our response to its 2016 CRL for HEPLISAV-B and the potential for an advisory committee meeting for HEPLISAV-B; • our ability to receive timely regulatory approval for our product candidates; • our ability to establish and maintain collaborations for the development and commercialization of our product candidates; • our ability to raise additional capital to fund our operations; • the success or failure of clinical trials involving our immuno-oncology product candidates and the product candidates of third party collaborators in combination studies; • technological innovations, new commercial products or drug discovery efforts and preclinical and clinical activities by us or our competitors; • changes in our intellectual property portfolio or developments or disputes concerning the proprietary rights of our products or product candidates; • our ability to obtain component materials and successfully enter into manufacturing relationships for our product candidates or establish manufacturing capacity on our own; • our ability to establish and maintain licensing agreements for intellectual property necessary for the development of our product candidates; • changes in government regulations, general economic conditions or industry announcements; • issuance of new or changed securities analysts’ reports or recommendations; • actual or anticipated fluctuations in our quarterly financial and operating results; and • the volume of trading in our common stock. |
The BLA review process is extensive, lengthy, expensive and uncertain, and the FDA or foreign regulatory agencies may delay, limit or deny approval of our application for many reasons, including: whether the data from our clinical trials, including the Phase 3 results, or the development program is satisfactory to the FDA or foreign regulatory agency; disagreement with the number, design, size, conduct or implementation of our clinical trials or a conclusion that the data fails to meet statistical or clinical significance or safety requirements; acceptability of data generated at our clinical trial sites that are monitored by third party contract research organizations (“CROs”); the results of an FDA or other advisory committee that may recommend against approval of our BLA or may recommend that the FDA or other agencies require, as a condition for approval, additional preclinical studies or clinical trials; and deficiencies in our manufacturing processes or facilities or those of our third party contract manufacturers and suppliers, if any. |
The FDA or other foreign governmental agencies or we ourselves could delay, suspend or halt our clinical trials of a product candidate for numerous reasons, including: · deficiencies in the trial design; · deficiencies in the conduct of the clinical trial including failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols; · deficiencies in the clinical trial operations or trial sites resulting in the imposition of a clinical hold; · the product candidate may have unforeseen adverse side effects, including fatalities, or a determination may be made that a clinical trial presents unacceptable health risks; · the time required to determine whether the product candidate is effective may be longer than expected; · fatalities or other adverse events arising during a clinical trial that may not be related to clinical trial treatments; · the product candidate may appear to be no more effective than current therapies; · the quality or stability of the product candidate may fail to conform to acceptable standards; · our inability to produce or obtain sufficient quantities of the product candidate to complete the trials; · our inability to reach agreement on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; · our inability to obtain IRB approval to conduct a clinical trial at a prospective site; · our inability to obtain regulatory approval to conduct a clinical trial; · lack of adequate funding to continue the clinical trial, including the occurrence of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties; · our inability to recruit and enroll individuals to participate in clinical trials for reasons including competition from other clinical trial programs for the same or similar indications; or · our inability to retain participants who have initiated a clinical trial but may withdraw due to side effects from the therapy, lack of efficacy or personal issues, or who are lost to further follow-up. |
The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves significant uncertainty, including: · our partners may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; · our shortage of capital resources may impact the willingness of companies to collaborate with us; · our contracts for collaborative arrangements are terminable at will on written notice and may otherwise expire or terminate and we may not have alternative funding available; · our partners may choose to pursue alternative technologies, including those of our competitors; · we may have disputes with a partner that could lead to litigation or arbitration; · we have limited control over the decisions of our partners and they may change the priority of our programs in a manner that would result in termination of the agreement or add significant delay in the partnered program; · our ability to generate future payments and royalties from our partners depends upon the abilities of our partners to establish the safety and efficacy of our drug candidates, obtain regulatory approvals and successfully manufacture and achieve market acceptance of products developed from our drug candidates; · we or our partners may fail to properly initiate, maintain or defend our intellectual property rights, where applicable, or a party may use our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability; · our partners may not devote sufficient capital or resources towards our product candidates; and · our partners may not comply with applicable government regulatory requirements. |
Relevant U.S. laws include: · the Anti-Kickback Statute, which prohibits persons from, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal health care programs, such as the Medicare and Medicaid programs; · federal false claims laws which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, claims for payment to the government or its agents that are false or fraudulent; · laws that require transparency regarding financial arrangements with health care professionals, such as the reporting and disclosure requirements imposed by the Patient Protection and Affordable Care Act (“PPACA”) and state laws; · the federal Health Insurance Portability and Accountability Act of 1997 (“HIPAA”), which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; · HIPAA, as amended by the Health Information Technology and Criminal Health Act, and its implementing regulations, which imposes certain requirements relating to the privacy, security, and transmission of individually identifiable health information; · the Foreign Corrupt Practices Act, which prohibits the payment of bribes to foreign government officials and requires that a company’s books and records accurately reflect the company’s transactions; and · foreign and state law equivalents of each of the federal laws described above, such as anti-kickback and false claims laws which may apply to items or services reimbursed by state health insurance programs or any third party payor, including commercial insurers; and state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government. |
The risks and uncertainties that we face with respect to our patents and other proprietary rights include the following: · we may not receive an issued patent for any of our patent applications or for any patent applications that we have exclusively licensed; · the pending patent applications we have filed or to which we have exclusive rights may take longer than we expect to result in issued patents; · the claims of any patents that are issued may not provide meaningful protection or may not be valid or enforceable; · we might not be able to develop additional proprietary technologies that are patentable; · the patents licensed or issued to us or our collaborators may not provide a competitive advantage; · patents issued to other parties may limit our intellectual property protection or harm our ability to do business; · other parties may independently develop similar or alternative technologies or duplicate our technologies and commercialize discoveries that we attempt to patent; and · other parties may design around technologies we have licensed, patented or developed. |
The market price of our common stock is subject to substantial volatility depending upon many factors, many of which are beyond our control, including: · progress or results of any of our clinical trials or regulatory or manufacturing efforts, in particular any announcements regarding the progress or results of our planned trials and BLA filing and communications from the FDA or other regulatory agencies; · our ability to receive timely regulatory approval for our drug candidates; · our ability to establish and maintain collaborations for the development and commercialization of our product candidates; · our ability to raise additional capital to fund our operations; · technological innovations, new commercial products or drug discovery efforts and preclinical and clinical activities by us or our competitors; · changes in our intellectual property portfolio or developments or disputes concerning the proprietary rights of our products or product candidates; · our ability to obtain component materials and successfully enter into manufacturing relationships for our product candidates or establish manufacturing capacity on our own; · our ability to establish and maintain licensing agreements for intellectual property necessary for the development of our product candidates; · changes in government regulations, general economic conditions or industry announcements; · issuance of new or changed securities analysts’ reports or recommendations; · actual or anticipated fluctuations in our quarterly financial and operating results; and · the volume of trading in our common stock. |
The BLA review process is extensive, lengthy, expensive and uncertain, and the FDA or foreign regulatory agencies may delay, limit or deny approval of our application for many reasons, including: whether the data from our clinical trials, including the Phase 3 results, or the development program is satisfactory to the FDA or foreign regulatory agency; disagreement with the number, design, size, conduct or implementation of our clinical trials or a conclusion that the data fails to meet statistical or clinical significance; acceptability of data generated at our clinical trial sites that are monitored by third party contract research organizations (“CROs”); the results of an FDA or other advisory committee that may recommend against approval of our BLA or may recommend that the FDA or other agencies require, as a condition for approval, additional preclinical studies or clinical trials; and deficiencies in our manufacturing processes or facilities or those of our third party contract manufacturers and suppliers, if any. |
The FDA or other foreign governmental agencies or we ourselves could delay, suspend or halt our clinical trials of a product candidate for numerous reasons, including: · deficiencies in the trial design; · deficiencies in the conduct of the clinical trial including failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols; · deficiencies in the clinical trial operations or trial sites resulting in the imposition of a clinical hold; · the product candidate may have unforeseen adverse side effects, including fatalities, or a determination may be made that a clinical trial presents unacceptable health risks; · the time required to determine whether the product candidate is effective may be longer than expected; · fatalities or other adverse events arising during a clinical trial that may not be related to clinical trial treatments; · the product candidate may appear to be no more effective than current therapies; · the quality or stability of the product candidate may fail to conform to acceptable standards; · our inability to produce or obtain sufficient quantities of the product candidate to complete the trials; · our inability to reach agreement on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; · our inability to obtain IRB approval to conduct a clinical trial at a prospective site; · our liability to obtain regulatory approval to conduct a clinical trial; · lack of adequate funding to continue the clinical trial, including the occurrence of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties; · our inability to recruit and enroll individuals to participate in clinical trials for reasons including competition from other clinical trial programs for the same or similar indications; or · our inability to retain participants who have initiated a clinical trial but may be prone to withdraw due to side effects from the therapy, lack of efficacy or personal issues, or who are lost to further follow-up. |
The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves significant uncertainty, including: · our partners may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; · our shortage of capital resources may impact the willingness of companies to collaborate with us; · our contracts for collaborative arrangements are terminable at will on written notice and may otherwise expire or terminate and we may not have alternative funding available; · our partners may choose to pursue alternative technologies, including those of our competitors; · we may have disputes with a partner that could lead to litigation or arbitration; · we have limited control over the decisions of our partners and they may change the priority of our programs in a manner that would result in termination of the agreement or add significant delay in the partnered program; · our ability to generate future payments and royalties from our partners depends upon the abilities of our partners to establish the safety and efficacy of our drug candidates, obtain regulatory approvals and successfully manufacture and achieve market acceptance of products developed from our drug candidates; · we or our partners may fail to properly initiate, maintain or defend our intellectual property rights, where applicable, or a party may use our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability; · our partners may not devote sufficient capital or resources towards our product candidates; and · our partners may not comply with applicable government regulatory requirements. |
Relevant U.S. laws include: · the Anti-Kickback Statute, which prohibits persons from, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal health care programs, such as the Medicare and Medicaid programs; · federal false claims laws which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, claims for payment to the government or its agents that are false or fraudulent; · laws that require transparency regarding financial arrangements with health care professionals, such as the reporting and disclosure requirements imposed by the Patient Protection and Affordable Care Act (“PPACA”) and state laws; and · state 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 state health insurance programs or any third-party payer, including commercial insurers. |
The risks and uncertainties that we face with respect to our patents and other proprietary rights include the following: · we may not receive an issued patent for any of our patent applications or for any patent applications that we have exclusively licensed; · the pending patent applications we have filed or to which we have exclusive rights may take longer than we expect to result in issued patents; · the claims of any patents that are issued may not provide meaningful protection or may not be valid or enforceable; · we might not be able to develop additional proprietary technologies that are patentable; · the patents licensed or issued to us or our collaborators may not provide a competitive advantage; · patents issued to other parties may limit our intellectual property protection or harm our ability to do business; · other parties may independently develop similar or alternative technologies or duplicate our technologies and commercialize discoveries that we attempt to patent; and · other parties may design around technologies we have licensed, patented or developed. |
The market price of our common stock is subject to substantial volatility depending upon many factors, many of which are beyond our control, including: · progress or results of any of our clinical trials or regulatory or manufacturing efforts, in particular any announcements regarding the progress or results of our planned trials and BLA filing and communications from the FDA or other regulatory agencies; · our ability to establish and maintain collaborations for the development and commercialization of our product candidates; · our ability to raise additional capital to fund our operations; · technological innovations, new commercial products or drug discovery efforts and preclinical and clinical activities by us or our competitors; · changes in our intellectual property portfolio or developments or disputes concerning the proprietary rights of our products or product candidates; · our ability to obtain component materials and successfully enter into manufacturing relationships for our product candidates or establish manufacturing capacity on our own; · our ability to establish and maintain licensing agreements for intellectual property necessary for the development of our product candidates; · changes in government regulations, general economic conditions or industry announcements; · issuance of new or changed securities analysts’ reports or recommendations; · actual or anticipated fluctuations in our quarterly financial and operating results; · our ability to maintain continued listing on the NASDAQ markets or similar exchanges; and · the volume of trading in our common stock. |
The FDA or other foreign governmental agencies or we ourselves could delay, suspend or halt our clinical trials of a product candidate for numerous reasons, including: · deficiencies in the trial design; · deficiencies in the conduct of the clinical trial including failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols; · deficiencies in the clinical trial operations or trial sites resulting in the imposition of a clinical hold; · the product candidate may have unforeseen adverse side effects, including fatalities, or a determination may be made that a clinical trial presents unacceptable health risks; · the time required to determine whether the product candidate is effective may be longer than expected; · fatalities or other adverse events arising during a clinical trial that may not be related to clinical trial treatments; · the product candidate may appear to be no more effective than current therapies; · the quality or stability of the product candidate may fail to conform to acceptable standards; · our inability to produce or obtain sufficient quantities of the product candidate to complete the trials; · our inability to reach agreement on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; · our inability to obtain IRB approval to conduct a clinical trial at a prospective site; · our liability to obtain regulatory approval to conduct a clinical trial; · lack of adequate funding to continue the clinical trial, including the occurrence of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties; · our inability to recruit and enroll individuals to participate in clinical trials for reasons including competition from other clinical trial programs for the same or similar indications; or · our inability to retain participants who have initiated a clinical trial but may be prone to withdraw due to side effects from the therapy, lack of efficacy or personal issues, or who are lost to further follow-up. |
The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves significant uncertainty, including: · our partners may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; · our shortage of capital resources may impact the willingness of companies to collaborate with us; · our contracts for collaborative arrangements are terminable at will on written notice and may otherwise expire or terminate and we may not have alternative funding available; · our partners may choose to pursue alternative technologies, including those of our competitors; · we may have disputes with a partner that could lead to litigation or arbitration; · we have limited control over the decisions of our partners and they may change the priority of our programs in a manner that would result in termination of the agreement or add significant delay in the partnered program; · our ability to generate future payments and royalties from our partners depends upon the abilities of our partners to establish the safety and efficacy of our drug candidates, obtain regulatory approvals and successfully manufacture and achieve market acceptance of products developed from our drug candidates; · we or our partners may fail to properly initiate, maintain or defend our intellectual property rights, where applicable, or a party may use our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability; · our partners may not devote sufficient capital or resources towards our product candidates; and · our partners may not comply with applicable government regulatory requirements. |
Relevant U.S. laws include: · the Anti-Kickback Statute, which prohibits persons from, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal health care programs, such as the Medicare and Medicaid programs; · federal false claims laws which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, claims for payment to the government or its agents that are false or fraudulent; · laws that require transparency regarding financial arrangements with health care professionals, such as the reporting and disclosure requirements imposed by the Patient Protection and Affordable Care Act (“PPACA”) and state laws; and · state 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 state health insurance programs or any third-party payer, including commercial insurers. |
The risks and uncertainties that we face with respect to our patents and other proprietary rights include the following: · we may not receive an issued patent for any of our patent applications or for any patent applications that we have exclusively licensed; · the pending patent applications we have filed or to which we have exclusive rights may take longer than we expect to result in issued patents; · the claims of any patents that are issued may not provide meaningful protection or may not be valid or enforceable; · we might not be able to develop additional proprietary technologies that are patentable; · the patents licensed or issued to us or our collaborators may not provide a competitive advantage; · patents issued to other parties may limit our intellectual property protection or harm our ability to do business; · other parties may independently develop similar or alternative technologies or duplicate our technologies and commercialize discoveries that we attempt to patent; and · other parties may design around technologies we have licensed, patented or developed. |
The market price of our common stock is subject to substantial volatility depending upon many factors, many of which are beyond our control, including: · progress or results of any of our clinical trials or regulatory or manufacturing efforts, in particular any announcements regarding the progress or results of our planned trials and communications from the FDA or other regulatory agencies; · our ability to establish and maintain collaborations for the development and commercialization of our product candidates; · our ability to raise additional capital to fund our operations; · technological innovations, new commercial products or drug discovery efforts and preclinical and clinical activities by us or our competitors; · changes in our intellectual property portfolio or developments or disputes concerning the proprietary rights of our products or product candidates; · our ability to obtain component materials and successfully enter into manufacturing relationships for our product candidates or establish manufacturing capacity on our own; · our ability to establish and maintain licensing agreements for intellectual property necessary for the development of our product candidates; · changes in government regulations, general economic conditions or industry announcements; · issuance of new or changed securities analysts’ reports or recommendations; · actual or anticipated fluctuations in our quarterly financial and operating results; · our ability to maintain continued listing on the NASDAQ markets or similar exchanges; and · the volume of trading in our common stock. |
3.2(1) Amended and Restated Bylaws 3.3(2) Form of Certificate of Designation of Series A Junior Participating Preferred Stock 3.4(3) Certificate of Amendment of Amended and Restated Certificate of Incorporation 3.5(4) Certificate of Amendment of Amended and Restated Certificate of Incorporation 3.6(5) Certificate of Amendment of Amended and Restated Certificate of Incorporation 3.7(6) Certificate of Designation of Series B Convertible Preferred Stock 4.1 Reference is made to Exhibits 3.1, 3.2, 3.3, 3.4, 3.5, 3.6 and 3.7 above 4.2(7) Registration Rights Agreement, dated as of July 18, 2007, by and between the Company and Deerfield Entities 4.3(7) Form of Warrant to Purchase Common Stock 4.4(8) Form of Specimen Common Stock Certificate 4.5(2) Rights Agreement, dated as of November 5, 2008, by and between the Company and Mellon Investor Services LLC 4.6(2) Form of Right Certificate 4.7(9) Form of Restricted Stock Unit Award Agreement under the 2004 Stock Incentive Plan 4.8(10) Form of Warrant to Purchase Common Stock 4.9(11) Form of Warrant to Purchase Common Stock 4.11(6) Form of Specimen Preferred Stock Certificate Exhibit Number Document 10.30(13)† Research Collaboration and License Agreement, dated September 1, 2006, by and between the Company and AstraZeneca AB 10.32(14)† License Agreement, dated June 26, 2007, between Coley Pharmaceuticals Group, Inc. and the Company 10.38(9)+ Form of Amended Management Continuity Agreement between the Company and certain of its executive officers 10.39† Research and Development Collaboration and License Agreement, dated December 15, 2008, between Glaxo Group Limited and the Company 10.40(15) Amendment No. |
5 to the Agreement, dated September 1, 2006, by and between AstraZeneca AB and the Company, dated January 7, 2014 12.1 Statement of Computation of Ratio of Earnings to Fixed Charges 21.1 List of Subsidiaries 23.1 Consent of Independent Registered Public Accounting Firm 31.1 Certification of Chief 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 Chief Executive Officer to Section 906 of the Sarbanes-Oxley Act of 2002 32.2* Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 101.INS XBRL Instance Document 101.SCH XBRL Taxonomy Extension Schema Document 101.CAL XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF XBRL Taxonomy Extension Definition Linkbase 101.LAB XBRL Taxonomy Extension Labels Linkbase Document 101.PRE XBRL Taxonomy Extension Presentation Linkbase Document * The certifications attached as Exhibits 32.1 and 32.2 that accompany this Annual Report on Form 10-K, are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of this Form 10-K), irrespective of any general incorporation language contained in such filing. |
3.2(1) Amended and Restated Bylaws 3.3(2) Form of Certificate of Designation of Series A Junior Participating Preferred Stock 3.4(3) Certificate of Amendment of Amended and Restated Certificate of Incorporation 3.5(4) Certificate of Amendment of Amended and Restated Certificate of Incorporation 3.6(5) Certificate of Amendment of Amended and Restated Certificate of Incorporation 3.7(6) Certificate of Designation of Series B Convertible Preferred Stock 4.1 Reference is made to Exhibits 3.1, 3.2, 3.3, 3.4, 3.5, 3.6 and 3.7 above 4.2(7) Registration Rights Agreement, dated as of July 18, 2007, by and between the Company and Deerfield Entities 4.3(7) Form of Warrant to Purchase Common Stock 4.4(8) Form of Specimen Common Stock Certificate 4.5(2) Rights Agreement, dated as of November 5, 2008, by and between the Company and Mellon Investor Services LLC 4.6(2) Form of Right Certificate 4.7(9) Form of Restricted Stock Unit Award Agreement under the 2004 Stock Incentive Plan 4.8(10) Form of Warrant to Purchase Common Stock 4.9(11) Form of Warrant to Purchase Common Stock 4.11(6) Form of Specimen Preferred Stock Certificate 10.30(13)† Research Collaboration and License Agreement, dated September 1, 2006, by and between the Company and AstraZeneca AB 10.32(14)† License Agreement, dated June 26, 2007, between Coley Pharmaceuticals Group, Inc. and the Company 10.38(9)+ Form of Amended Management Continuity Agreement between the Company and certain of its executive officers 10.39† Research and Development Collaboration and License Agreement, dated December 15, 2008, between Glaxo Group Limited and the Company 10.40(15) Amendment No. |
4 to the Research Collaboration and License Agreement, dated September 1, 2006, by and between AstraZeneca AB and the Company, dated September 23, 2011 10.69(27) Amended and Restated 2004 Non-Employee Director Option Program and Amended and Restated 2005 Non-Employee Director Cash Compensation Program, amended April 17, 2012 10.70(28) + Employment Offer Letter to Christine R. Larson, dated August 1, 2012 10.72(29) Fourth Amendment to Lease, dated as of December 14, 2012, between the Company and 2929 Seventh Street, LLC 10.73(29) New Lease, dated as of December 14, 2012, between the Company and 2929 Seventh Street, LLC 10.74(29) Consulting Agreement, dated as of November 14, 2012, by and between the Company and Stanley A. Plotkin 10.75(29)+ Amended and Restated Management Continuity and Severance Agreement, dated October 31, 2012, between the Company and J. Tyler Martin 10.77(30) Consulting Agreement, dated as of March 29, 2013, by and between Solutio Partners and the Company 10.78(30+) Termination letter, dated as of March 29, 2013, by and between Stephen Tuck and the Company 10.79(31) + Employment Agreement, dated as of April 3, 2013, by and between Eddie Gray and the Company 10.80(31) + Management Continuity and Severance Agreement, dated as of April 3, 2013, by and between Eddie Gray and the Company 10.81(31) + Consulting Agreement, dated as of May 1, 2013, by and between Dino Dina, M.D. |
5 to the Agreement, dated September 1, 2006, by and between AstraZeneca AB and the Company, dated January 7, 2014 12.1 Statement of Computation of Ratio of Earnings to Fixed Charges 21.1 List of Subsidiaries 23.1 Consent of Independent Registered Public Accounting Firm 31.1 Certification of Chief 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 Chief Executive Officer to Section 906 of the Sarbanes-Oxley Act of 2002 32.2* Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 101.INS XBRL Instance Document 101.SCH XBRL Taxonomy Extension Schema Document 101.CAL XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF XBRL Taxonomy Extension Definition Linkbase 101.LAB XBRL Taxonomy Extension Labels Linkbase Document 101.PRE XBRL Taxonomy Extension Presentation Linkbase Document * The certifications attached as Exhibits 32.1 and 32.2 that accompany this Annual Report on Form 10-K, are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of this Form 10-K), irrespective of any general incorporation language contained in such filing. |
Factors that may inhibit our efforts to commercialize HEPLISAV directly or indirectly with a partner if approved include: • our inability to recruit and retain adequate numbers of effective sales and marketing personnel; • the inability of sales personnel to obtain access to or persuade adequate numbers of physicians to administer our products; • the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; • our inability to expand and sustain qualified manufacturing capacity to meet demand, in particular if there is a significant increase in demand due to the recommendation to vaccinate persons with diabetes if we should obtain approval to market to those patients; • our inability to determine appropriate pricing and reimbursement strategies for HEPLISAV in the potential patient populations that may use HEPLISAV, particularly in the diabetes market; and • possible claims against us, including enjoining sales of HEPLISAV, based on the patent rights of others; and • unanticipated delays, costs and expenses associated with manufacturing and commercialization of our products, including costs of maintaining and scaling up manufacturing capabilities and creating and sustaining an independent sales and marketing organization in various territories. |
The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves significant uncertainty, including: • our partners may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; • our shortage of capital resources may impact the willingness of companies to collaborate with us; • our contracts for collaborative arrangements are terminable at will on written notice and may otherwise expire or terminate and we may not have alternative funding available; • our partners may choose to pursue alternative technologies, including those of our competitors; • we may have disputes with a partner that could lead to litigation or arbitration; • we have limited control over the decisions of our partners and they may change the priority of our programs in a manner that would result in termination of the agreement or add significant delay in the partnered program; • our ability to generate future payments and royalties from our partners depends upon the abilities of our partners to establish the safety and efficacy of our drug candidates, obtain regulatory approvals and successfully manufacture and achieve market acceptance of products developed from our drug candidates; • we or our partners may fail to properly initiate, maintain or defend our intellectual property rights, where applicable, or a party may use our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability; • our partners may not devote sufficient capital or resources towards our product candidates; and • our partners may not comply with applicable government regulatory requirements. |
Relevant U.S. laws include: • the Anti-Kickback Statute, which prohibits persons from, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal health care programs, such as the Medicare and Medicaid programs; • federal false claims laws which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, claims for payment to the government or its agents that are false or fraudulent; • laws that require transparency regarding financial arrangements with health care professionals, such as the reporting and disclosure requirements imposed by the Patient Protection and Affordable Care Act (“PPACA”) and state laws; and • state 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 state health insurance programs or any third-party payer, including commercial insurers. |
The risks and uncertainties that we face with respect to our patents and other proprietary rights include the following: • we may not receive an issued patent for any of our patent applications or for any patent applications that we have exclusively licensed; • the pending patent applications we have filed or to which we have exclusive rights may take longer than we expect to result in issued patents; • the claims of any patents that are issued may not provide meaningful protection or may not be valid or enforceable; • we might not be able to develop additional proprietary technologies that are patentable; • the patents licensed or issued to us or our collaborators may not provide a competitive advantage; • patents issued to other parties may limit our intellectual property protection or harm our ability to do business; • other parties may independently develop similar or alternative technologies or duplicate our technologies and commercialize discoveries that we attempt to patent; and • other parties may design around technologies we have licensed, patented or developed. |
The market price of our common stock is subject to substantial volatility depending upon many factors, many of which are beyond our control, including: • progress or results of any of our clinical trials or regulatory or manufacturing efforts, in particular any announcements regarding the progress or results of our planned trials and communications from the FDA or other regulatory agencies, for example as evidenced by our stock decline of over 30% following our February 2013 announcement of a Complete Response Letter from the FDA; • our ability to establish and maintain collaborations for the development and commercialization of our product candidates; • our ability to raise additional capital to fund our operations; • technological innovations, new commercial products or drug discovery efforts and preclinical and clinical activities by us or our competitors; • changes in our intellectual property portfolio or developments or disputes concerning the proprietary rights of our products or product candidates; • our ability to obtain component materials and successfully enter into manufacturing relationships for our product candidates or establish manufacturing capacity on our own; • our ability to establish and maintain licensing agreements for intellectual property necessary for the development of our product candidates; • changes in government regulations, general economic conditions or industry announcements; • issuance of new or changed securities analysts’ reports or recommendations; • actual or anticipated fluctuations in our quarterly financial and operating results; • our ability to maintain continued listing on the NASDAQ markets or similar exchanges; and • the volume of trading in our common stock. |
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