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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Title of each class
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Name of each exchange on which registered
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Ordinary shares, par value NIS 0.01 per share
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NASDAQ Global Market
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
x
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U.S. GAAP
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International Financial Reporting Standards as issued
by the International Accounting Standards Board
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Other
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i
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PART I
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1
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1
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1
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28
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54
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54
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66
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84
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87
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88
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89
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103
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104
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PART II
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105
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105
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105
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106
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106
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106
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106
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107
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107
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107
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107
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107
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PART III
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108
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108
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108
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109
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F-1
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the timing and conduct of our trials of NexoBrid and our pipeline product candidates, including statements regarding the timing, progress and results of current and future preclinical studies and clinical trials, and our research and development programs;
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the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of NexoBrid and our pipeline products;
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our expectations regarding future growth, including our ability to develop new products;
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our commercialization, marketing and manufacturing capabilities and strategy and the ability of our marketing team to cover regional burn centers and units;
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our ability to maintain adequate protection of our intellectual property;
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our plans to develop and commercialize our pipeline products;
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our estimates regarding expenses, future revenues, capital requirements and the need for additional financing;
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our estimates regarding the market opportunity for NexoBrid and our pipeline products;
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our expectation regarding the duration of our inventory of intermediate drug substance and products;
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the impact of our research and development expenses as we continue developing product candidates;
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our expectations regarding the time during which we will be an emerging growth company under the JOBS Act; and
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the impact of government laws and regulations.
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A.
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Selected Financial Data
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Year Ended December 31,
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||||||||||||||||||||
2011
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2012
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2013
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2014
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2015
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||||||||||||||||
(in thousands except share and per share data)
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||||||||||||||||||||
Consolidated statements of operations data:
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||||||||||||||||||||
Revenues
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$ | — | $ | — | $ | — | $ | 259 | $ | 601 | ||||||||||
Cost of revenues (1)
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— | — | — | 2,785 | 2,519 | |||||||||||||||
Gross income (loss)
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— | — | — | (2,526 | ) | (1,918 | ) | |||||||||||||
Operating expenses:
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||||||||||||||||||||
Research and development, gross
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6,149 | 3,804 | 4,513 | 6,054 | 8,139 | |||||||||||||||
Participation by OCS, BARDA and others
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3,128 | 2,247 | 878 | 705 | 2,118 | |||||||||||||||
Research and development, net of participations(1)(2)
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3,021 | 1,557 | 3,635 | 5,349 | 6,021 | |||||||||||||||
Selling and marketing(1)
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— | — | 2,259 | 8,829 | 9,284 | |||||||||||||||
General and administrative(1)
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1,266 | 1,173 | 1,687 | 4,723 | 4,004 | |||||||||||||||
Total operating expenses
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4,287 | 2,730 | 7,581 | 18,901 | 19,309 | |||||||||||||||
Operating loss
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(4,287 | ) | (2,730 | ) | (7,581 | ) | (21,427 | ) | (21,227 | ) | ||||||||||
Financial income (expense), net
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(532 | ) | 14,715 | (920 | ) | 2,552 | (444 | ) | ||||||||||||
Income (loss) from continuing operations
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(4,819 | ) | 11,985 | (8,501 | ) | (18,875 | ) | (21,671 | ) | |||||||||||
Loss from discontinued operation(1)(3)
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(1,350 | ) | (1,045 | ) | (6,850 | ) | - | (417 | ) | |||||||||||
Net income (loss)
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$ | (6,169 | ) | $ | 10,940 | $ | (15,351 | ) | $ | (18,875 | ) | $ | (22,088 | ) | ||||||
Foreign currency translation adjustments
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— | — | (32 | ) | 14 | 2 | ||||||||||||||
Total comprehensive income (loss)
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$ | (6,169 | ) | $ | 10,940 | $ | (15,383 | ) | $ | (18,861 | ) | $ | (22,086 | ) | ||||||
Basic net income (loss) per share(4)
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$ | (0.39 | ) | $ | 0.70 | $ | (0.98 | ) | $ | (0.95 | ) | (1.02 | ) | |||||||
Diluted net income (loss) per share(4)
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$ | (0.39 | ) | $ | 0.64 | $ | (0.98 | ) | $ | (0.95 | ) | (1.02 | ) | |||||||
Weighted average number of ordinary shares used in computing net income (loss) per ordinary share:
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Basic:
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15,683 | 15,683 | 15,671 | 19,940 | 21,718 | |||||||||||||||
Diluted:
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15,683 | 17,199 | 15,671 | 19,940 | 21,718 |
As of December 31,
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2012
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2013
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2014
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2015
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(in thousands)
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||||||||||||||||
Consolidated balance sheet data:
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Cash and cash equivalents
and short-term bank deposits
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$ | 337 | $ | 9,553 | $ | 64,853 | $ | 45,768 | ||||||||
Working capital, net(5)
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(112 | ) | 10,042 | 64,600 | 45,189 | |||||||||||
Total assets
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25,438 | 14,826 | 71,121 | 52,523 | ||||||||||||
Total non-current liabilities
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6,440 | 32,607 | 24,353 | 23,847 | ||||||||||||
Total shareholders’ equity (deficit)
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15,634 | (19,804 | ) | 42,871 | 23,470 |
Year Ended December 31,
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||||||||||||||||||||
2011
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2012
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2013
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2014
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2015
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(in thousands)
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||||||||||||||||||||
Cost of revenues
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$ | — | $ | — | $ | — | $ | 763 | $ | 372 | ||||||||||
Research and development
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182 | 124 | 315 | 657 | 511 | |||||||||||||||
Selling and marketing
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— | — | 24 | 1,430 | 669 | |||||||||||||||
General and administrative
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373 | 210 | 192 | 1,977 | 1,107 | |||||||||||||||
Share-based compensation expenses from continuing operations
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555 | 334 | 531 | 4,827 | 2,659 | |||||||||||||||
Discontinued operation
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109 | 30 | 76 | — | — | |||||||||||||||
Total share-based compensation expenses
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$ | 664 | $ | 364 | $ | 607 | $ | 4,827 | $ | 2,659 |
(2)
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Research and development expenses, net is presented net of participation by the U.S. Biomedical Advanced Research and Development Authority (“BARDA”) and others and net of the change in the fair value of the liability associated with government grants from the Office of the Chief Scientist. Participation by others totaled $2.7 million and $2.2 million for the years ended December 31, 2011 and 2012, a
nd had no effect on subsequent years
. The effect of the participation by the Office of the Chief Scientist totaled $0.4 million, $0.1 million, $0.9 million, $0.7 million and $1.3 million for the years ended December 31, 2011, 2012, 2013, 2014 and 2015, respectively. The effect of the participation by BARDA totaled $0.8 million for the year ended December 31, 2015. See “ITEM 5.A. Operating Results—Research and development” for more information.
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(3)
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Discontinued operation consists of revenues and expenses related to our exclusive, worldwide license for the development, production and commercialization of the PolyHeal Product, which expired following the termination of our collaboration with Teva. We account for our discontinued operation in accordance with IFRS accounting standard 5, “Non-current Assets Held for Sale and Discontinued Operations.” See “ITEM 5.A. Operating Results—Discontinued operation” for more information.
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(4)
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Basic and diluted net income (loss) per ordinary share is computed based on the basic and diluted weighted average number of ordinary shares outstanding during each period. For additional information, see Note 21 to our consolidated annual financial statements included elsewhere in this report.
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(5)
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Working capital, net is defined as total current assets minus total current liabilities.
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B.
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Capitalization and Indebtedness
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C.
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Reasons for the Offer and Use of Proceeds
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D.
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Risk Factors
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·
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the willingness of physicians, burn care teams and hospital administrators to administer our products and their acceptance as part of the medical department routine;
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the consent of hospitals to fund/purchase NexoBrid or obtain third-party coverage or reimbursement for our products;
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the ability to offer NexoBrid and our pipeline products for sale at an attractive value;
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the efficacy and potential advantages of NexoBrid and our pipeline products relative to current standard of care;
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the prevalence and severity of any side effects; and
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the efficacy, potential advantages and timing of introduction to the market of alternative treatments.
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the market acceptance or demand for NexoBrid or any of our pipeline products, if approved;
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the ability to set a price that we believe is fair for NexoBrid or any of our pipeline products, if approved;
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our ability to generate revenues and achieve or maintain profitability;
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the level of taxes that we are required to pay; and
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the availability of capital.
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regulators may not authorize us to conduct a clinical trial within a country or at a prospective trial site or may change the design of a study;
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delays may occur in reaching agreement on acceptable clinical trial terms with regulatory authorities or prospective sites, or obtaining institutional review board approval;
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our preclinical tests or clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional trials or to abandon strategic projects;
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the number of patients required for our clinical trials may be larger than we anticipate, enrollment in our clinical trials may be slower or more difficult than we expect, or patients may not participate in necessary follow-up visits to obtain required data, any of which would result in significant delays in our clinical testing process;
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our third-party contractors, such as a research institute, may fail to comply with regulatory requirements or meet their contractual obligations to us;
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we may be forced to suspend or terminate our clinical trials if the participants are being exposed, or are thought to be exposed, to unacceptable health risks or if any participant experiences an unexpected serious adverse event;
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regulators or institutional review boards may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;
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undetected or concealed fraudulent activity by a clinical researcher, if discovered, could preclude the submission of clinical data prepared by that researcher, lead to the suspension or substantive scientific review of one or more of our marketing applications by regulatory agencies, and result in the recall of any approved product distributed pursuant to data determined to be fraudulent;
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the cost of our clinical trials may be greater than we anticipate;
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an audit of preclinical or clinical studies by regulatory authorities may reveal noncompliance with applicable protocols or regulations, which could lead to disqualification of the results and the need to perform additional studies; and
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delays may occur in obtaining our clinical materials.
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accelerate our clinical development activities, particularly with respect to our NexoBrid pediatric clinical trial in severe burns in Europe, our continued clinical development of EscharEx for the debridement of chronic and other hard-to-heal wounds and our clinical trials for our product candidate for the treatment of connective tissue disorders or other indications;
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continue to operate our sales, marketing and distribution infrastructure in Europe and thereafter in the United States to commercialize NexoBrid and any pipeline products for which we obtain marketing approval;
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further scale-up the manufacturing process for NexoBrid;
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seek regulatory and marketing approvals for NexoBrid and any pipeline product that successfully completes clinical trials;
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initiate additional preclinical, clinical or other studies for NexoBrid and our pipeline products and seek to identify and validate new products;
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acquire rights to other product candidates and technologies;
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change or add suppliers;
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maintain, expand and protect our intellectual property portfolio;
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attract and retain skilled personnel; and
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experience any delays or encounter issues with any of the above.
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restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market or voluntary or mandatory product recalls;
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fines, warning letters or holds on clinical trials;
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harm to our reputation, reduced demand for our products and loss of market acceptance;
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refusal by the applicable regulatory authority to approve pending applications or supplements to approved applications filed by us, or suspension or revocation of product license approvals;
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product seizure or detention, or refusal to permit the import or export of products; and
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injunctions or the imposition of civil or criminal penalties.
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delay, scale back or discontinue the development, manufacturing scale-up or commercialization of NexoBrid or our pipeline products;
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seek corporate partners for NexoBrid or one or more of our pipeline products on terms that are less favorable than might otherwise be available; or
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relinquish or license on unfavorable terms, our rights to NexoBrid or our pipeline products that we otherwise would seek to develop or commercialize ourselves.
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the Federal Acquisition Regulations (“FAR”) and agency-specific regulations supplemental to the FAR, which comprehensively regulate the procurement, formation, administration and performance of government contracts;
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business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and include other requirements such as the Anti-Kickback Statute and Foreign Corrupt Practices Act;
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export and import control laws and regulations; and
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laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data.
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any of our present or future patents or patent claims or other intellectual property rights will not lapse or be invalidated, circumvented, challenged or abandoned;
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our intellectual property rights will provide competitive advantages or prevent competitors from making or selling competing products;
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our ability to assert our intellectual property rights against potential competitors or to settle current or future disputes will not be limited by our agreements with third parties;
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any of our pending or future patent applications will be issued or have the coverage originally sought;
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our intellectual property rights will be enforced in jurisdictions where competition may be intense or where legal protection may be weak; or
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we will not lose the ability to assert our intellectual property rights against, or to license our technology to, others and collect royalties or other payments.
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actual or anticipated variations in our and our competitors’ results of operations and financial condition;
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market acceptance of our products;
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general economic and market conditions and other factors, including factors unrelated to our operating performance;
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the mix of products that we sell and related services that we provide;
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changes in earnings estimates or recommendations by securities analysts, if our ordinary shares continue to be covered by analysts;
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publication of the results of preclinical or clinical trials for NexoBrid or any of our pipeline products;
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failure by us to achieve a publicly announced milestone;
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delays between our expenditures to develop and market new or enhanced products and the generation of sales from those products;
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development of technological innovations or new competitive products by others;
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announcements of technological innovations or new products by us;
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regulatory developments and the decisions of regulatory authorities as to the marketing of our current products or the approval or rejection of new or modified products;
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developments concerning intellectual property rights, including our involvement in litigation;
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changes in our expenditures to develop, acquire or license new products, technologies or businesses;
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changes in our expenditures to promote our products;
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our sale or proposed sale, or the sale by our significant shareholders, of our ordinary shares or other securities in the future;
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changes in key personnel;
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success or failure of our research and development projects or those of our competitors; and
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the trading volume of our ordinary shares.
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A.
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History and Development of the Company
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B.
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Business Overview
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The extent of the surface the burn occupies is usually referred to as percent of total body surface area (“TBSA”). A burn on an adult’s entire palm would generally amount to 1% TBSA, and the average hospitalized patient has a burn covering approximately 10% TBSA. Burns covering more than 15-20% TBSA usually require hospitalization and may result in dehydration, shock and increased risk of mortality.
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The depth of the burn, referred to in terms of “degree” is generally classified into four categories:
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o
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Superficial or first degree burns
. Such burns do not penetrate the basal membrane and usually heal naturally.
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o
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Dermal/partial thickness or second degree burns
. Such burns are characterized by varying amounts of damaged dermis and can be further subdivided into superficial and deep partial-thickness burns. Superficial partial-thickness burns may heal spontaneously after removal of the covering thin eschar. Conversely, deep partial-thickness burns are often difficult for physicians to accurately diagnose before eschar removal and may progress and transform into full-thickness burns if not debrided in a timely manner, depending on the magnitude of latent tissue death of the surrounding skin.
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o
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Full thickness or third degree burns
. Such burns are characterized by death of the entire dermal tissue down to the subcutaneous fat and must be debrided and treated by autografting, which is the process of harvesting skin from healthy donor sites on a patient’s body and transplanting it on the post-debridement, clean wound bed.
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o
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Fourth degree burns
. Such burns, which are rare, extend beyond the subcutaneous fat tissue into the underlying structures, such as muscle or bone, and also require debridement and further substantial treatment.
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Other factors include the age of the victim, the body part where the burn occurred and any co-morbidities of the patient. For example, some patients may require hospitalization regardless of the TBSA or degree of the burn, such as children, the elderly or victims with burns to the extremities, joints or head/neck area or with co-morbidities such as smoke inhalation, diabetes or obesity.
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the prevention of local infection, sepsis (a systemic inflammatory response caused by severe infection) and additional damage to surrounding viable tissue; and
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the initiation of the body’s healing process and scar prevention.
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Surgical debridement
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o
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Surgical debridement predominantly includes tangential excision, a procedure in which a surgeon amputates the entire dead tissue mass, layer after layer, down to healthy, viable tissue. The excision is extended into healthy intact tissue to make sure that no trace of the eschar remains, resulting in up to an estimated 30-50% of healthy tissue being excised during this procedure. Other methods include dermabrasion, in which a mechanically powered, hand-held rotating abrading cylinder is used to slowly scrape off tissue, and hydro surgery, in which a high-pressure flow of water abrades the tissue. These alternative methods have attempted to limit the trauma associated with tangential excision, but entail spray of contaminated eschar or take a significantly longer time to complete than tangential excision.
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o
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The benefits of surgical eschar removal are that it is usually fast and effective. Disadvantages include the significant trauma of the procedure, associated blood loss, risk of surgery in delicate areas of the body such as hands, added costs, and, most importantly, the loss of viable tissue that necessitates additional surgical procedures for harvesting skin from healthy donor sites and autografting.
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o
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Due to the disadvantages of surgery in extensive burns some surgeons limit their debriding surgery to only a part of the affected area in a single session (15-30% TBSA in most centers), thus delaying full debridement by days. After several days, complications related to eschar contamination may begin and some of the benefits of the earlier debridement may not be realized. On the other hand, when excising burns immediately, all suspected necrotic tissue will be excised, inevitably resulting in over-excision, especially in “indeterminate” burns, as after surgical excision, the remaining skin often no longer has any spontaneous healing potential and will heal only by autografting.
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Non-surgical debridement
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o
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Non-surgical debridement includes many different treatment options that do not require direct surgical removal of the skin to remove eschar. With non-surgical debridement, the eschar is naturally, but slowly, removed by contaminant microorganisms, tissue autolysis, or self-decomposition, and the inflammatory process that may lead to serious local and systemic complications. In seeking to facilitate such natural processes, topical medication, anti-microbial agents, enzymes and biological/chemical applications are often applied onto the eschar.
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o
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The benefits of this approach are that it is non-surgical, reduces trauma to the patient and is easier to apply. Disadvantages include numerous dressing changes and mechanical scraping with limited debridement efficacy. This prolongs the eschar removal process, which may lead to death of the tissue surrounding the initial burn wound, causing partial-thickness wounds to transform into full-thickness wounds and forming granulation tissue that may develop into heavy scars.
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·
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Diabetic foot ulcers.
Diabetes can lead to a reduction in blood flow, which can cause patients to lose sensation in their feet and may prevent them from noticing injuries, sometimes leading to the development of DFUs, which are open sores or ulcers on the feet that may take several weeks to heal, if ever. In the United States alone, over 23 million people, or approximately 8% of the population, suffer from diabetes, a chronic, life-threatening disease. Every year, in the United States alone, over 900,000 people develop a DFU and over 600,000 undergo debridement of DFUs.
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·
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Venous leg ulcers.
VLUs develop as a result of vascular insufficiency, or the inability for the vasculature of the leg to return blood back toward the heart properly, and, in the United States alone, affect approximately 1.25 million people per year, out of which over 650,000 undergo debridement of VLUs. These ulcers usually form on the sides of the lower leg, above the ankle and below the calf, and are slow to heal and often recur if preventative steps are not taken. The risk of VLUs can increase as a result of a blood clot forming in the deep veins of the legs, obesity, smoking, lack of physical activity or work that requires many hours of standing.
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·
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Pressure ulcers.
Pressure ulcers form as a result of pressure sores, or bed sores, which are injuries to the skin or the tissue beneath the skin. Constant pressure on an area of skin reduces blood supply to the area and over time can cause the skin to break down and form an open ulcer. These often occur in patients who are hospitalized or confined to a chair or bed, and usually form over bony areas, where there is little cushion between the bone and the skin, such as lower parts of the body. Annually, 2.5 million pressure ulcers are treated in the United States in acute care facilities alone.
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·
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Surgical/traumatic wounds.
Surgical wounds form as a result of various types of surgical procedures such as investigative or corrective, minor or major, open (traditional) or minimal access surgery, elective or emergency, and incisions (simple cuts) or excision (removal of tissue), among others. Traumatic wounds form as a result of cuts, lacerations or puncture wounds, which have caused damage to the skin and underlying tissue. Severe traumatic wounds may require surgical intervention to close the wound and stabilize the patient. Surgical/traumatic hard-to-heal wounds develop for various reasons, such as local surgical complications, suboptimal closure techniques, presence of foreign materials, exposed bones or tendons and infection. In the United States, millions receive post-surgical wound care annually.
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·
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Dupuytren’s disease:
a condition where one or more fingers are permanently flexed, caused by the formation of scar-like tissues below the palmar skin (Palmar Fascia), forming hard “cords” that freeze the fingers in non-functional flexion contraction. This condition affects approximately 6.2 million people in the United States alone.
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·
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Peyronie’s disease:
the development of scar-like tissue, similar to Dupuytren’s cords in the shaft of the penis, causing pain and distortion on erection, preventing intercourse. Peyronie’s disease is typically caused by trauma and affects men over 50 years old. Surgical treatment may be an option in some cases, but can cause complications and may result in a shortening and even greater distortion of the penis. Approximately 3.7% to 7.1% of the male population above the age of 50 suffers from Peyronie’s disease in the United States and approximately 3.2% of such age group suffer from the disease in Europe.
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|
·
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Frozen shoulder syndrome:
a disorder that causes the smooth tissues of the shoulder capsule to become thick, stiff and inflamed, affecting approximately 2% to 5% of the worldwide population and 10% to 20% of people with diabetes according to industry sources.
|
|
·
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Excessive/unaesthetic scars:
A scar is a mark on the skin which is formed due to infection, injury, surgery, inflammation of tissue, burns, and acne. Scars can be of various sizes, shapes, and colors, depending on the age of the scar, the site of the scar and family history. Scar formation is unpredictable and varies from person to person. Excessive scarring can have unpleasant physical, aesthetic, psychological and social consequences. Estimates indicate that each year around 100 million people in the developed world acquire scars following elective surgery and surgery for trauma. Of these, approximately 15% have excessive or unaesthetic scars.
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Trial 1
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Trial 2
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Trial 3
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Trial 4
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Trial 5
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Trial 6
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Study Type
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• Retrospective Phase 2
• Investigator initiated
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• Dose range Phase 2
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• Prospective Phase 2
• IND/FDA
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• Phase 2
• IND/FDA
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• Phase 3
• EMA
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• Phase 3b
• EMA
|
Design
|
• Data collected from files
of
patients treated with
NexoBrid
|
• Parallel, controlled,
observer-
blind, randomized,
single-center
|
• Parallel, controlled,
observer-
blind, three-arm,
randomized,
multi-center
|
• Parallel, controlled, open
label,
three-arm,
randomized,
single-center
|
• Parallel, controlled, open
label, two-arm, randomized,
multi-center
|
• Parallel, controlled, blinded, two-arm,
multi-center
|
Main Objectives
|
• Safety
• Efficacy
|
• Comparison of efficacy and safety
|
• Safety
• Efficacy
|
• Safety
|
• Safety
• Efficacy
|
• Long-term scar assessment
• Quality of life
|
Wound Types
|
• Deep partial/full
thickness
thermal
burns
|
• Deep partial/full thickness thermal burns
|
• Deep partial/full thickness
thermal burns
|
• Deep partial/full thickness
thermal burns
|
• Deep partial/full thickness
thermal burns
|
• Scar formation
|
Number of Patients
|
• 154
|
• 20
|
• 140
|
• 30
|
• 182
|
• 89
|
Study Length
|
• 1985-2000
|
• 2002-2005
|
• 2003-2004
|
• 2006-2007
|
• 2006-2009
|
• 2011
|
Location
|
• Israel
|
• Israel
|
• International
|
• United States
|
• International
|
• International
|
|
(1)
|
Only deep partial-thickness wounds are presented, as full-thickness wounds always require autografting due to the lack of viable dermis, regardless of the technique used to remove the eschar.
|
|
·
|
laboratory tests, animal studies and formulation studies all performed in accordance with the applicable E.U. GLP or GMP regulations;
|
|
·
|
submission to the relevant national authorities of a clinical trial application (“CTA”), which must be approved before human clinical trials may begin;
|
|
·
|
performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed indication;
|
|
·
|
submission to the relevant competent authorities of a marketing authorization application (“MAA”), which includes the data supporting preclinical and clinical safety and efficacy as well as detailed information on the manufacture and composition and control of the product development and proposed labeling as well as other information;
|
|
·
|
inspection by the relevant national authorities of the manufacturing facility or facilities and quality systems (including those of third parties) at which the product is produced, to assess compliance with strictly enforced cGMP;
|
|
·
|
potential audits of the non-clinical and clinical trial sites that generated the data in support of the MAA; and
|
|
·
|
review and approval by the relevant competent authority of the MAA before any commercial marketing, sale or shipment of the product.
|
|
·
|
Phase 1 (Most typical kind of study: Human Pharmacology);
|
|
·
|
Phase 2 (Most typical kind of study: Therapeutic Exploratory);
|
|
·
|
Phase 3 (Most typical kind of study: Therapeutic Confirmatory); and
|
|
·
|
Phase 4 (Variety of Studies: Therapeutic Use).
|
|
·
|
medicines that have been authorized for marketing in the European Union with the results of PIP studies included in the product information are eligible for an extension of their patent protection by six months. This is the case even when the studies’ results are negative;
|
|
·
|
for orphan medicines, such as NexoBrid, the incentive is an additional two years of market exclusivity instead of one;
|
|
·
|
scientific advice and protocol assistance at the EMA are free of charge for questions relating to the development of medicines for children; and
|
|
·
|
medicines developed specifically for children that are already authorized, but are not protected by a patent or supplementary protection certificate, can apply for a pediatric use marketing authorization (“PUMA”). If a PUMA is granted, the product will benefit from 10 years of market protection as an incentive.
|
|
·
|
Mutual recognition procedure.
If an authorization has been granted by one member state, or the Reference Member State, an application may be made for mutual recognition in one or more other member states, or the Concerned Member State(s).
|
|
·
|
Decentralized procedure.
The decentralized procedure may be used to obtain a marketing authorization in several European member states when the applicant does not yet have a marketing authorization in any country.
|
|
·
|
National procedure.
Applicants following the national procedure will be granted a marketing authorization that is valid only in a single member state. Furthermore, this marketing authorization is not based on recognition of another marketing authorization for the same product awarded by an assessment authority of another member state. If marketing authorization in only one member state is preferred, an application can be filed with the national competent authority of a member state. The national procedure can also serve as the first phase of a mutual recognition procedure.
|
|
·
|
completion of laboratory tests, animal studies and formulation studies in compliance with the FDA’s GLP or GMP regulations, as applicable;
|
|
·
|
submission to the FDA of an investigational new drug application (“IND”), which must become effective before clinical trials may begin;
|
|
·
|
approval by an independent institutional review board (“IRB”) at each clinical site before each trial may be initiated;
|
|
·
|
performance of adequate and well-controlled clinical trials in accordance with GCP to establish the safety and efficacy of the product for each indication;
|
|
·
|
preparation and submission to the FDA of a BLA or supplemental BLA;
|
|
·
|
satisfactory completion of an FDA advisory committee review, if applicable;
|
|
·
|
satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with cGMP requirements, and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; and
|
|
·
|
payment of user fees and FDA review and approval of the BLA.
|
Phase 1:
|
The drug is initially introduced into healthy human subjects or patients with the target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness and to determine optimal dosage.
|
|
Phase 2:
|
The drug is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.
|
|
Phase 3:
|
The drug is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy and safety of the product for approval, to establish the overall risk-benefit profile of the product, and to provide adequate information for the labeling of the product.
|
|
·
|
increases the minimum level of Medicaid rebates payable by manufacturers of brand-name drugs from 15.1% to 23.1%;
|
|
·
|
requires collection of rebates for drugs paid by Medicaid managed care organizations; and
|
|
·
|
imposes a non-deductible annual fee on pharmaceutical manufacturers or importers who sell “branded prescription drugs” to specified federal government programs.
|
|
·
|
the federal healthcare Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid;
|
|
·
|
the federal False Claims Act imposes civil penalties, and provides for civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
|
|
·
|
the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
|
|
·
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
|
·
|
the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;
|
|
·
|
the federal transparency requirements under the Affordable Care Act require manufacturers of drugs, devices and medical supplies to report to the Department of Health and Human Services information related to payments and other transfers of value to physicians and teaching hospitals and physician ownership and investment interests; and
|
|
·
|
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers.
|
|
C.
|
Organizational Structure
|
|
D.
|
Property, Plants and Equipment
|
|
A.
|
Operating Results
|
|
·
|
the scope, rate of progress and expense of our research and development activities;
|
|
·
|
preclinical results;
|
|
·
|
clinical trial results;
|
|
·
|
the terms and timing of regulatory approvals;
|
|
·
|
the expense of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights; and
|
|
·
|
the ability to market, commercialize and achieve market acceptance for NexoBrid or any other product candidate that we may develop in the future.
|
Years Ended December 31,
|
||||||||||||
2013
|
2014
|
2015
|
||||||||||
(in thousands)
|
||||||||||||
Consolidated statements of operations data:
|
||||||||||||
Revenues
|
$ | — | $ | 259 | $ | 601 | ||||||
Cost of revenues
|
— | 2,785 | 2,519 | |||||||||
Gross loss
|
— | (2,526 | ) | (1,918 | ) | |||||||
Operating expenses:
|
||||||||||||
Research and development, gross
|
4,513 | 6,054 | 8,139 | |||||||||
Participation by OCS and BARDA
|
878 | 705 | 2,118 | |||||||||
Research and development, net of participations
|
3,635 | 5,349 | 6,021 | |||||||||
Selling and marketing
|
2,259 | 8,829 | 9,284 | |||||||||
General and administrative
|
1,687 | 4,723 | 4,004 | |||||||||
Total operating expenses
|
7,581 | 18,901 | 19,309 | |||||||||
Operating loss
|
7,581 | 21,427 | 21,227 | |||||||||
Financial income
|
2,401 | 4,665 | 1,052 | |||||||||
Financial expense
|
(3,321 | ) | (2,113 | ) | (1,496 | ) | ||||||
Loss from continuing operations
|
8,501 | 18,875 | 21,671 | |||||||||
Loss from discontinued operation
|
6,850 | — | 417 | |||||||||
Net loss
|
$ | 15,351 | $ | 18,875 | $ | 22,088 |
|
B.
|
Liquidity and Capital Resources
|
Issuance of Ordinary Shares and Warrants
|
Net Loans from Shareholders
|
Government Grants and BARDA Funding, net
|
Total
|
|||||||||||||
(in thousands)
|
||||||||||||||||
Year ended December 31, 2015
|
$ | 26 | $ | — | $ | 1,552 | $ | 1,578 | ||||||||
Year ended December 31, 2014
|
72,130 | — | 345 | 72,475 | ||||||||||||
Year ended December 31, 2013
|
15,950 | 3,015 | 276 | 19,241 |
Year Ended December 31,
|
||||||||||||
2013
|
2014
|
2015
|
||||||||||
(in thousands)
|
||||||||||||
Net cash provided by (used in):
|
||||||||||||
Continuing operating activities
|
$ | (8,075 | ) | $ | (16,493 | ) | $ | (19,601 | ) | |||
Continuing investing activities
|
(2,855 | ) | (37,154 | ) | 36,046 | |||||||
Continuing financing activities
|
19,241 | 72,475 | 778 | |||||||||
Discontinued operation
|
(1,665 | ) | — | — |
|
C.
|
Application of Critical Accounting Policies and Estimates
|
|
·
|
Fair value of our ordinary shares
. Prior to the completion of our IPO, due to absence of an active market for our ordinary shares, the fair value of our ordinary shares for purposes of determining the exercise price for award grants was determined in good faith by our management and approved by our board of directors. In connection with preparing our financial statements, our management considered the fair value of our ordinary shares based on a number of objective and subjective factors consistent with the methodologies outlined in the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation, referred to as the AICPA Practice Aid.
|
|
·
|
Volatility
. The expected share price volatility was based on the historical equity volatility of the ordinary shares of comparable companies that are publicly traded.
|
|
·
|
Expected term
. The expected term of options granted represents the period of time that options granted are expected to be outstanding. Since adequate historical experience is not available to provide a reasonable estimate, the expected term is determined based on the midpoint between the available exercise dates (the end of the vesting periods) and the last available exercise date (the contracted expiry date).
|
|
·
|
Risk-free rate
. The risk-free interest rate is based on the yield from U.S. Treasury zero-coupon bonds with a term equivalent to the contractual life of the options.
|
|
·
|
Expected dividend yield
. We have never declared or paid any cash dividends and do not presently plan to pay cash dividends in the foreseeable future. Consequently, we used an expected dividend yield of zero.
|
|
D.
|
Research and Development, Patents and Licenses, etc.
|
|
E.
|
Trend Information
|
|
F.
|
Off-Balance Sheet Arrangements
|
|
G.
|
Contractual Obligations
|
Payments Due by Period
|
||||||||||||||||
Total
|
2016
|
2017
|
2018 and thereafter
|
|||||||||||||
(in thousands)
|
||||||||||||||||
Operating lease obligations(1)
|
$ | 1,111 | $ | 905 | $ | 116 | $ | 90 |
(1)
|
Operating lease obligations consist of payments pursuant to lease agreements for office and laboratory facilities, as well as lease agreements for 22 vehicles, which generally run for a period of three years.
|
|
A.
|
Directors and Senior Management
|
Name
|
Age
|
Position
|
||
Executive Officers
|
||||
Gal Cohen
|
43
|
President and Chief Executive Officer
|
||
Sharon Malka
|
44
|
Chief Financial and Operations Officer
|
||
Lior Rosenberg M.D.
|
70
|
Chief Medical Technology Officer
|
||
Ety Klinger Ph.D
|
54
|
Chief Research and Development Officer
|
||
Carsten Henke
|
50
|
Chief Commercial Officer EU
|
||
Yaron Meyer
|
37
|
General Counsel and Corporate Secretary
|
||
Nirit Freikorn
|
42
|
Chief Marketing Officer
|
||
Directors
|
||||
Aharon Yaari
|
64
|
Chairman of the Board of Directors
|
||
Ofer Gonen
|
42
|
Director
|
||
Marian Gorecki Ph.D (1)(2)(3)
|
75
|
Director
|
||
Meron Mann (3)
|
64
|
Director
|
||
Sarit Firon (1)(2)(3)(4)
|
49
|
Director
|
||
Abraham Havron (1)(2)(3)(4)
|
68
|
Director
|
(1)
|
Member of our audit committee
|
(2)
|
Member of our compensation committee
|
(3)
|
Independent director under the rules of the NASDAQ Stock Market
|
(4)
|
External director under the Companies Law.
|
|
B.
|
Compensation
|
Name and Position
|
Salary & Social Benefits
(1)
|
Bonus
|
Share-Based Payment (2)
|
Other Compensation (3)
|
Total
|
|||||||||||||||
(U.S. dollars) (4)
|
||||||||||||||||||||
Gal Cohen,
President and Chief Executive Officer
|
353,916 | 221,918 | (5) | 439,964 | 4,910 | 1,020,708 | ||||||||||||||
Sharon Malka,
Chief Financial and Operations Officer
|
237,356 | 139,209 | 351,567 | 25,033 | 753,165 | |||||||||||||||
Lior Rosenberg, M.D.,
Chief Medical Technology Officer
|
267,738 | 185,362 | 219,309 | 19,084 | 691,493 | |||||||||||||||
Carsten Henke,
Chief Commercial Officer EU
&
Managing Director of MediWound Germany GmbH
|
266,380 | 60,879 | 273,716 | 35,076 | 636,051 | |||||||||||||||
Ety Klinger,
Chief Research & Development Officer
|
198,445 | 122,835 | 140,776 | 28,452 | 490,509 |
|
(1)
|
Represents the officer’s gross salary plus payment of mandatory social benefits made by the company on behalf of such officer. Such benefits may include, to the extent applicable to the executive, payments, contributions and/or allocations for savings funds (e.g., Managers’ Life Insurance Policy), education funds (referred to in Hebrew as “keren hishtalmut”), pension, severance, risk insurances (e.g., life or work disability insurance) and payments for social security.
|
|
(2)
|
Represents the equity-based compensation expenses recorded in the company’s consolidated financial statements for the year ended December 31, 2015 based on the options’ grant date fair value in accordance with accounting guidance for equity-based compensation.
|
|
(3)
|
Represents the other benefits to such officer, which includes either or both of (i) car expenses, including lease costs, gas and maintenance, provided to the officers and (ii) vacation benefits.
|
|
(4)
|
Converted (i) from NIS into U.S. dollars at the rate of NIS 3.88 = U.S.$1.00, based on the average representative rate of exchange between the NIS and the U.S. dollar as reported by the Bank of Israel in the year ended December 31, 2015 and (ii) from Euro into U.S. dollars at the rate of Euro 1.1 = U.S$1.00, based on the average representative rate of exchange between the Euro and the U.S. dollar as reported by the Bank of Israel in the year ended December 31, 2015.
|
|
(5)
|
Subject to approval by our shareholders at the extraordinary general meeting of our shareholders scheduled for January 28, 2016.
|
Name
|
Number of Options
|
Grant Date
|
Exercise Price
|
Vested Options as of January 15, 2016
|
Expiration Date
|
|||||||||
Gal Cohen,
(1)
President and Chief Executive Officer
|
208,332 |
11/14/2006
|
$ | 2.63 | 208,332 |
11/13/2016
|
||||||||
45,600 |
1/15/2011
|
$ | 9.82 | 45,600 |
1/14/2021
|
|||||||||
152,000 |
12/24/2013
|
$ | 12.89 | 72,000 |
12/23/2023
|
|||||||||
70,000 | (1) |
1/28/2016
|
$ | 9.58 | 0 |
12/22/2025
|
||||||||
Lior Rosenberg,
Chief Medical Technology Officer
|
76,000 |
12/24/2013
|
$ | 12.89 | 38,000 |
12/23/2023
|
||||||||
25,000 |
12/23/2015
|
$ | 9.58 | 0 |
12/22/2025
|
|
C.
|
Board Practices
|
|
·
|
such majority includes at least a majority of the shares held by all shareholders who are not controlling shareholders and do not have a personal interest in the election of the external director (other than a personal interest not deriving from a relationship with a controlling shareholder) that are voted at the meeting, excluding abstentions, to which we refer as a disinterested majority; or
|
|
·
|
the total number of shares voted by non-controlling shareholders and by shareholders who do not have a personal interest in the election of the external director against the election of the external director does not exceed 2% of the aggregate voting rights in the company.
|
|
(i)
|
his or her service for each such additional term is recommended by one or more shareholders holding at least 1% of the company’s voting rights and is approved at a shareholders meeting by a disinterested majority, where the total number of shares held by non-controlling, disinterested shareholders voting for such reelection exceeds 2% of the aggregate voting rights in the company, subject to additional restrictions set forth in the Israeli Companies Law with respect to affiliations of external director nominee; or
|
|
(ii)
|
his or her service for each such additional term is recommended by the board of directors and is approved at a meeting of shareholders by the same majority required for the initial election of an external director (as described above).
|
|
·
|
an employment relationship;
|
|
·
|
a business or professional relationship even if not maintained on a regular basis (excluding insignificant relationships);
|
|
·
|
control; and
|
|
·
|
service as an office holder, excluding service as a director in a private company prior to the initial public offering of its shares if such director was appointed as a director of the private company in order to serve as an external director following the initial public offering.
|
|
·
|
he or she meets the qualifications for being appointed as an external director, except for the requirement (i) that the director be an Israeli resident (which does not apply to companies such as ours whose securities have been offered outside of Israel or are listed for trading outside of Israel) and (ii) for accounting and financial expertise or professional qualifications; and
|
|
·
|
he or she has not served as a director of the company for a period exceeding nine consecutive years. For this purpose, a break of less than two years in the service shall not be deemed to interrupt the continuation of the service.
|
|
·
|
oversight of our independent registered public accounting firm and recommending the engagement, compensation or termination of engagement of our independent registered public accounting firm to the board of directors in accordance with Israeli law;
|
|
·
|
recommending the engagement or termination of the person filling the office of our internal auditor; and
|
|
·
|
recommending the terms of audit and non-audit services provided by the independent registered public accounting firm for pre-approval by our board of directors.
|
|
·
|
determining whether there are deficiencies in the business management practices of our company, including in consultation with our internal auditor or the independent auditor, and making recommendations to the board of directors to improve such practices;
|
|
·
|
determining whether to approve certain related party transactions (including transactions in which an office holder has a personal interest and whether such transaction is extraordinary or material under the Israeli Companies Law) (see “—Approval of Related Party Transactions Under Israeli Law”);
|
|
·
|
establishing the approval process (including, potentially, the approval of the audit committee and conducting a competitive procedure supervised by the audit committee) for certain transactions with a controlling shareholder or in which a controlling shareholder has a personal interest;
|
|
·
|
where the board of directors approves the working plan of the internal auditor, examining such working plan before its submission to the board of directors and proposing amendments thereto;
|
|
·
|
examining our internal audit controls and internal auditor’s performance, including whether the internal auditor has sufficient resources and tools to fulfill his responsibilities;
|
|
·
|
examining the scope of our auditor’s work and compensation and submitting a recommendation with respect thereto to our board of directors or shareholders, depending on which of them is considering the appointment of our auditor; and
|
|
·
|
establishing procedures for the handling of employees’ complaints as to the management of our business and the protection to be provided to such employees.
|
|
·
|
the knowledge, skills, expertise and accomplishments of the relevant office holder;
|
|
·
|
the office holder’s roles and responsibilities and prior compensation agreements with him or her;
|
|
·
|
the relationship between the terms offered and the average compensation of the other employees of the company, including those employed through manpower companies;
|
|
·
|
the impact of disparities in salary upon work relationships in the company;
|
|
·
|
the possibility of reducing variable compensation at the discretion of the board of directors;
|
|
·
|
the possibility of setting a limit on the exercise value of non-cash variable equity-based compensation; and
|
|
·
|
as to severance compensation, the period of service of the office holder, the terms of his or her compensation during such service period, the company’s performance during that period of service, the person’s contribution towards the company’s achievement of its goals and the maximization of its profits, and the circumstances under which the person is leaving the company.
|
|
·
|
the link between variable compensation and long-term performance and measurable criteria;
|
|
·
|
the relationship between variable and fixed compensation, and the ceiling for the value of variable compensation;
|
|
·
|
the conditions under which an office holder would be required to repay compensation paid to him or her if it was later shown that the data upon which such compensation was based was inaccurate and was required to be restated in the company’s financial statements;
|
|
·
|
the minimum holding or vesting period for variable, equity-based compensation; and
|
|
·
|
maximum limits for severance compensation.
|
|
·
|
recommending whether a compensation policy should continue in effect, if the then-current policy has a term of greater than three years (approval of either a new compensation policy or the continuation of an existing compensation policy must in any case occur every three years);
|
|
·
|
recommending to the board of directors periodic updates to the compensation policy and assessing implementation of the compensation policy;
|
|
·
|
approving compensation terms of executive officers, directors and employees that require approval of the compensation committee;
|
|
·
|
determining whether the compensation terms of a chief executive officer nominee, which were determined pursuant to the compensation policy, will be exempt from approval of the shareholders because such approval would harm the ability to engage with such nominee; and
|
|
·
|
determining, subject to the approval of the board and under special circumstances, override a determination of the company’s shareholders regarding certain compensation related issues.
|
|
·
|
the responsibilities set forth in the compensation policy;
|
|
·
|
reviewing and approving the granting of options and other incentive awards to the extent such authority is delegated by our board of directors; and
|
|
·
|
reviewing, evaluating and making recommendations regarding the compensation and benefits for our non-employee directors.
|
|
·
|
a person (or a relative of a person) who holds 5% or more of the company’s outstanding shares or voting rights;
|
|
·
|
a person (or a relative of a person) who has the power to appoint a director or the general manager of the company;
|
|
·
|
an office holder (including a director) of the company (or a relative thereof); or
|
|
·
|
a member of the company’s independent accounting firm, or anyone on its behalf.
|
|
·
|
information on the advisability of a given action brought for his or her approval or performed by virtue of his or her position; and
|
|
·
|
all other important information pertaining to any such action.
|
|
·
|
refrain from any conflict of interest between the performance of his or her duties to the company and his or her other duties or personal affairs;
|
|
·
|
refrain from any activity that is competitive with the business of the company;
|
|
·
|
refrain from exploiting any business opportunity of the company to receive a personal gain for himself or herself or others; and
|
|
·
|
disclose to the company any information or documents relating to the company’s affairs which the office holder received as a result of his or her position as an office holder.
|
|
·
|
a transaction other than in the ordinary course of business;
|
|
·
|
a transaction that is not on market terms; or
|
|
·
|
a transaction that may have a material impact on a company’s profitability, assets or liabilities.
|
|
·
|
at least a majority of the shares held by all shareholders who do not have a personal interest in the transaction and who are present and voting at the meeting approves the transaction, excluding abstentions; or
|
|
·
|
the shares voted against the transaction by shareholders who have no personal interest in the transaction and who are present and voting at the meeting do not exceed 2% of the voting rights in the company.
|
|
·
|
an amendment to the company’s articles of association;
|
|
·
|
an increase of the company’s authorized share capital;
|
|
·
|
a merger; or
|
|
·
|
the approval of related party transactions and acts of office holders that require shareholder approval.
|
|
·
|
financial liability imposed on him or her in favor of another person pursuant to a judgment, including a settlement or arbitrator’s award approved by a court. However, if an undertaking to indemnify an office holder with respect to such liability is provided in advance, then such an undertaking must be limited to events which, in the opinion of the board of directors, can be foreseen based on the company’s activities when the undertaking to indemnify is given, and to an amount or according to criteria determined by the board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned foreseen events and amount or criteria;
|
|
·
|
reasonable litigation expenses, including attorneys’ fees, incurred by the office holder (1) as a result of an investigation or proceeding instituted against him or her by an authority authorized to conduct such investigation or proceeding, provided that (i) no indictment was filed against such office holder as a result of such investigation or proceeding, and (ii) no financial liability was imposed upon him or her as a substitute for the criminal proceeding as a result of such investigation or proceeding or, if such financial liability was imposed, it was imposed with respect to an offense that does not require proof of criminal intent; and (2) in connection with a monetary sanction; and
|
|
·
|
reasonable litigation expenses, including attorneys’ fees, incurred by the office holder or imposed by a court in proceedings instituted against him or her by the company, on its behalf, or by a third party, or in connection with criminal proceedings in which the office holder was acquitted, or as a result of a conviction for an offense that does not require proof of criminal intent.
|
|
·
|
a breach of the duty of loyalty to the company, provided that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company;
|
|
·
|
a breach of duty of care to the company or to a third party, to the extent such a breach arises out of the negligent conduct of the office holder; and
|
|
·
|
a financial liability imposed on the office holder in favor of a third party.
|
|
·
|
a breach of the duty of loyalty, except for indemnification and insurance for a breach of the duty of loyalty to the company to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company;
|
|
·
|
a breach of duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office holder;
|
|
·
|
an act or omission committed with intent to derive illegal personal benefit; or
|
|
·
|
a fine or forfeit levied against the office holder.
|
|
D.
|
Employees
|
Department
|
As of December 31,
|
|||||||||||
2013
|
2014
|
2015
|
||||||||||
Administrative
|
6 | 6 | 6 | |||||||||
Research and development
|
10 | 14 | 16 | |||||||||
Manufacturing
|
19 | 21 | 20 | |||||||||
Sales and marketing
|
8 | 22 | 25 | |||||||||
Total
|
43 | 63 | 67 |
|
E.
|
Share Ownership
|
|
A.
|
Major Shareholders
|
|
·
|
each person or entity known by us to own beneficially more than 5% of our outstanding shares;
|
|
·
|
each of our directors and executive officers individually; and
|
|
·
|
all of our executive officers and directors as a group.
|
Name of Beneficial Owner
|
Number of Shares
Beneficially Held
|
Percentage of Class
|
||||||
Directors and Executive Officers
|
||||||||
Aharon Yaari
|
- | - | ||||||
Ofer Gonen
|
* | * | ||||||
Marian Gorecki
|
* | * | ||||||
Meron Mann
|
* | * | ||||||
Sarit Firon
|
* | * | ||||||
Abraham Havron
|
* | * | ||||||
Gal Cohen (1)
|
329,932 | 1.5 | % | |||||
Sharon Malka
|
* | * | ||||||
Lior Rosenberg (2)
|
1,889,272 | 8.6 | % | |||||
Carsten Henke
|
* | * | ||||||
Ety Klinger
|
* | * | ||||||
Yaron Meyer
|
* | * | ||||||
Nirit Freikorn
|
* | * | ||||||
All executive officers and directors as a group (14 persons)(3)
|
2,551,210 | 11.3 | % | |||||
Principal Shareholders
|
||||||||
Clal Biotechnology Industries Ltd.(4)
|
9,789,555 | 44.8 | % | |||||
Harel Insurance Investments & Financial Services Ltd. (5)
|
1,366,333 | 6.3 | % | |||||
Migdal Insurance & Financial Holdings Ltd. (6)
|
1,685,947 | 7.7 | % |
*
|
Less than 1%.
|
(1)
|
Shares beneficially owned consist of 329,932 ordinary shares issuable upon exercise of outstanding options.
|
(2)
|
Shares beneficially owned consist of: (i) 141,067 ordinary shares held directly by Prof. Rosenberg; (ii) 38,000 ordinary shares issuable upon exercise of outstanding options held directly by Prof. Rosenberg; and (iii) 1,710,205 ordinary shares held by L.R. Research and Development Ltd. in trust for the benefit of Prof. Rosenberg. Prof. Rosenberg is the sole shareholder of L.R. Research and Development Ltd.
|
(3)
|
Shares beneficially owned consist of 1,856,729 ordinary shares held directly or indirectly by such executive officers and directors and 694,481 ordinary shares issuable upon exercise of outstanding options.
|
(4)
|
Shares beneficially owned consist of: (i) 8,208,973 ordinary shares held by Clal Life Sciences, LP, an Israeli limited partnership, whose managing partner is Clal Application Center Ltd., a wholly-owned subsidiary of CBI; and (ii) 1,580,582 ordinary shares held by CBI, as reported by CBI to the Company. Access Industries Holdings LLC indirectly owns 100% of the outstanding shares of Clal Industries Ltd., which owns the majority of the outstanding shares of, and controls, CBI. The address of Clal Industries Ltd. is the Triangular Tower, 3 Azrieli Center, Tel Aviv 67023, Israel and the address of Access Industries Holdings LLC is c/o Access Industries Group, 730 Fifth Avenue, New York, New York 10019, United States.
|
(5)
|
Shares beneficially owned consist of (i) 1,229,016 ordinary shares held by certain subsidiaries of Harel Insurance Investments & Financial Services Ltd. (“Harel”) and (ii) 137,317 ordinary shares beneficially held by Harel for its own account, as reported by Harel to the company. Harel is a widely held public company listed on the Tel Aviv Stock Exchange. The address of Harel is 3 Abba Hillel Road, Ramat Gan 52118, Israel.
|
(6)
|
Shares beneficially owned consist of: (i) 1,469,001 ordinary shares held by certain subsidiaries of Migdal Insurance & Financial Holdings Ltd. (“Migdal”) and (ii) 216,946 ordinary shares beneficially held by Migdal for its own account, as reported by Migdal to the company. Migdal is a widely held public company listed on the Tel Aviv Stock Exchange. The address of Migdal is 4 Efal Street, Petah Tikva 49512, Israel.
|
|
B.
|
Related Party Transactions
|
|
C.
|
Interests of Experts and Counsel
|
|
A.
|
Consolidated Statements and Other Financial Information
|
|
B.
|
Significant Changes
|
|
A.
|
Listing Details
|
Low
|
High
|
|||||||
Annual:
|
||||||||
2015
|
$ | 5.00 | $ | 10.47 | ||||
2014 (beginning March 20, 2014)
|
$ | 4.88 | $ | 18.16 | ||||
Quarterly:
|
||||||||
First Quarter 2016 (through January 15, 2016)
|
$ | 7.37 | $ | 9.29 | ||||
Fourth Quarter 2015
|
$ | 7.28 | $ | 10.47 | ||||
Third Quarter 2015
|
$ | 6.10 | $ | 8.22 | ||||
Second Quarter 2015
|
$ | 5.00 | $ | 7.50 | ||||
First Quarter 2015
|
$ | 6.60 | $ | 9.15 | ||||
Fourth Quarter 2014
|
$ | 4.88 | $ | 6.81 | ||||
Third Quarter 2014
|
$ | 6.01 | $ | 11.64 | ||||
Second Quarter 2014
|
$ | 10.10 | $ | 14.13 | ||||
First Quarter 2014 (beginning March 20, 2014)
|
$ | 14.41 | $ | 18.16 | ||||
Most Recent Six Months:
|
||||||||
December 2015
|
$ | 8.39 | $ | 10.31 | ||||
November 2015
|
$ | 8.71 | $ | 10.47 | ||||
October 2015
|
$ | 7.28 | $ | 9.85 | ||||
September 2015
|
$ | 6.10 | $ | 8.22 | ||||
August 2015
|
$ | 6.64 | $ | 7.25 | ||||
July 2015
|
$ | 6.29 | $ | 7.74 |
|
B.
|
Plan of Distribution
|
|
C.
|
Markets
|
|
D.
|
Selling Shareholders
|
|
E.
|
Dilution
|
|
F.
|
Expenses of the Issue
|
|
A.
|
Share Capital
|
|
B.
|
Articles of Association
|
|
·
|
amendments to our articles of association;
|
|
·
|
appointment or termination of our auditors;
|
|
·
|
appointment of external directors;
|
|
·
|
approval of certain related party transactions;
|
|
·
|
increases or reductions of our authorized share capital;
|
|
·
|
a merger; and
|
|
·
|
the exercise of our board of director’s powers by a general meeting, if our board of directors is unable to exercise its powers and the exercise of any of its powers is required for our proper management.
|
|
C.
|
Material Contracts
|
|
D.
|
Exchange Controls
|
|
E.
|
Taxation
|
|
·
|
amortization of the cost of purchased a patent, rights to use a patent, and know-how, which are used for the development or advancement of the Industrial Enterprise, over an eight-year period, commencing on the year in which such rights were first exercised;
|
|
·
|
under limited conditions, an election to file consolidated tax returns with related Israeli Industrial Companies controlled by it; and
|
|
·
|
expenses related to a public offering are deductible in equal amounts over a three years period commencing on the year of the offering.
|
|
·
|
banks, financial institutions or insurance companies;
|
|
·
|
real estate investment trusts, regulated investment companies or grantor trusts;
|
|
·
|
dealers or traders in securities, commodities or currencies;
|
|
·
|
tax-exempt entities or organizations, including an “individual retirement account” or “Roth IRA” as defined in Section 408 or 408A of the Code, respectively;
|
|
·
|
certain former citizens or long-term residents of the United States;
|
|
·
|
persons that received our shares as compensation for the performance of services;
|
|
·
|
persons that holds our shares as part of a “hedging,” “integrated” or “conversion” transaction or as a position in a “straddle” for U.S. federal income tax purposes;
|
|
·
|
partnerships (including entities classified as partnerships for U.S. federal income tax purposes) or other pass-through entities, or holders that will hold our shares through such an entity;
|
|
·
|
S corporations;
|
|
·
|
holders that acquired ordinary shares as a result of holding or owning our preferred shares;
|
|
·
|
U.S. Holders (as defined below) whose “functional currency” is not the U.S. dollar; or
|
|
·
|
holders that own directly, indirectly or through attribution 10.0% or more of the voting power or value of our shares.
|
|
·
|
a citizen or individual resident of the United States;
|
|
·
|
a corporation, or other entity taxable as a corporation for U.S. federal income tax purposes, created or organized in or under the laws of the United States, any state thereof, or the District of Columbia;
|
|
·
|
an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or
|
|
·
|
a trust that (1) is subject to the primary supervision of a U.S. Court and one or more U.S. persons that have the authority to control all substantial decisions of the trust or (2) has a valid election in effect under applicable Treasury regulations to be treated as a U.S. person.
|
|
·
|
such gain is effectively connected with your conduct of a trade or business in the United States (or, if required by an applicable income tax treaty, the gain is attributable to a permanent establishment or fixed base that such holder maintains in the United States); or
|
|
·
|
you are an individual and have been present in the United States for 183 days or more in the taxable year of such sale or exchange and certain other conditions are met.
|
|
·
|
at least 75% of its gross income is “passive income”; or
|
|
·
|
at least 50% of the average quarterly value of its total gross assets (which may be determined in part by the market value of our ordinary shares, which is subject to change) is attributable to assets that produce “passive income” or are held for the production of passive income.
|
|
F.
|
Dividends and Paying Agents
|
|
G.
|
Statement by Experts
|
|
H.
|
Documents on Display
|
|
I.
|
Subsidiary Information
|
Change in Average Exchange Rate
|
||||||||
Period
|
Shekel against the
U.S. dollar (%)
|
Euro against the
U.S. dollar (%)
|
||||||
2011
|
(7.7 | ) | (3.2 | ) | ||||
2012
|
2.3 | 2.0 | ||||||
2013
|
7.0 | 4.5 | ||||||
2014
|
(12.0 | ) | (11.8 | ) | ||||
2015
|
(0.3 | ) | (10.4 | ) |
|
·
|
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;
|
|
·
|
accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
|
|
·
|
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.
|
2014
|
2015
|
|||||||
Audit Fees
|
$ | 140,000 | $ | 140,000 | ||||
Audit-Related Fees
|
- | - | ||||||
Tax Fees
|
- | - | ||||||
Total
|
$ | 140,000 | $ | 140,000 |
|
·
|
Quorum.
As permitted under the Israeli Companies Law pursuant to our articles of association, the quorum required for an ordinary meeting of shareholders will consist of at least two shareholders present in person, by proxy or by other voting instrument in accordance with the Israeli Companies Law, who hold at least 25% of the voting power of our shares (and in an adjourned meeting, with some exceptions, at least two shareholders), instead of 33 1/3% of the issued share capital required under the NASDAQ Stock Market rules.
|
|
·
|
Nomination of directors.
With the exception of external directors and directors elected by our board of directors due to vacancy, our directors are elected by an annual meeting of our shareholders to hold office until the next annual meeting following one year from his or her election. The nominations for directors, which are presented to our shareholders by our board of directors, are generally made by the board of directors itself, in accordance with the provisions of our articles of association and the Israeli Companies Law. Nominations need not be made by a nominating committee of our board of directors consisting solely of independent directors or otherwise, as required under the NASDAQ Stock Market rules.
|
|
·
|
Majority of independent directors.
Under the Companies Law, we are only required to appoint at least two external directors, within the meaning of the Companies Law, to our board of directors. Currently, four of our directors (of which two are external directors, within the meaning of the Companies Law) qualify as independent directors under the rules of the U.S. federal securities laws and the NASDAQ Stock Market rules.
|
MediWound Ltd.
|
|||
Date: January 25, 2016
|
By:
|
/s/ Sharon Malka
|
|
Sharon Malka
|
|||
Chief Financial and Operation Officer
|
|||
†
|
Portions of each agreement were omitted and a complete copy of each agreement has been provided
separately
to the Securities and Exchange Commission pursuant to the company’s application requesting confidential treatment under Rule 406 of the Securities Act of 1993 as amended, or Rule 24b-2 of the Securities Exchange Act of 1934, as amended, as applicaple.
|
(1)
|
Previously filed with the SEC on March 14, 2014 pursuant to a registration statement on Form F-1 (File No. 333-193856) and incorporated by reference herein.
|
(2)
|
Previously filed with the SEC on March 3, 2014 pursuant to a registration statement on Form F-1 (File No. 333-193856) and incorporated by reference herein.
|
(3)
|
Previously filed with the SEC on February 10, 2014 pursuant to a registration statement on Form F-1 (File No. 333-193856) and incorporated by reference herein.
|
(4)
|
Previously filed with the SEC on August 5, 2014 as Annex A to Exhibit 99.1 to the Registrant’s Form 6-K and incorporated by reference herein.
|
(5)
|
Previously filed with the SEC on February 12, 2015 pursuant to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2014 (File No. 001-36349) and incorporated by reference herein.
|
Page
|
|
F
-
2
|
|
F
-
3
|
|
F
-
4
|
|
F
-
5
|
|
F
-
6 - F-7
|
|
F
-
8
-
F
-
42
|
|
Kost Forer Gabbay & Kasierer
3 Aminadav St.
Tel-Aviv 6706703, Israel
|
Tel: +972-3-6232525
Fax: +972-3-5622555
ey.com
|
Tel-Aviv, Israel
|
KOST FORER GABBAY & KASIERER
|
January 25, 2016
|
A Member of Ernst & Young Global
|
December 31,
|
||||||||||||
Note
|
2014
|
2015
|
||||||||||
CURRENT ASSETS:
|
||||||||||||
Cash and cash equivalents
|
5 | 25,422 | 42,502 | |||||||||
Short-term bank deposits
|
6 | 39,431 | 3,266 | |||||||||
Trade receivables
|
64 | 238 | ||||||||||
Inventories
|
7 | 1,421 | 1,715 | |||||||||
Other receivables
|
8, 22 | 2,159 | 2,674 | |||||||||
68,497 | 50,395 | |||||||||||
LONG-TERM ASSETS:
|
||||||||||||
Long term deposits
|
168 | 192 | ||||||||||
Property, plant and equipment, net
|
9 | 1,088 | 1,040 | |||||||||
Intangible assets, net
|
10 | 951 | 896 | |||||||||
Other assets
|
19 | 417 | - | |||||||||
2,624 | 2,128 | |||||||||||
71,121 | 52,523 | |||||||||||
CURRENT LIABILITIES:
|
||||||||||||
Trade payables
|
1,214 | 1,123 | ||||||||||
Other payables
|
11, 22 | 2,683 | 4,083 | |||||||||
3,897 | 5,206 | |||||||||||
LONG-TERM LIABILITIES:
|
||||||||||||
Liabilities in respect of Chief Scientist government grants
|
12,13 | 6,985 | 7,275 | |||||||||
Contingent consideration for the purchase of treasury shares
|
13 | 17,361 | 16,475 | |||||||||
Severance pay liability, net
|
14 | 7 | 97 | |||||||||
24,353 | 23,847 | |||||||||||
SHAREHOLDERS' EQUITY:
|
16 | |||||||||||
Ordinary shares of NIS 0.01 par value:
|
||||||||||||
Authorized: 32,244,508 shares as of December 31, 2014 and 2015; Issued and Outstanding 21,550,300 and 21,850,300 shares respectively.
|
59 | 60 | ||||||||||
Share premium
|
109,117 | 111,801 | ||||||||||
Foreign currency translation adjustments
|
(18 | ) | (16 | ) | ||||||||
Accumulated deficit
|
(66,287 | ) | (88,375 | ) | ||||||||
42,871 | 23,470 | |||||||||||
71,121 | 52,523 |
Year ended
December 31,
|
||||||||||||||||
Note
|
2013
|
2014
|
2015
|
|||||||||||||
Revenues
|
- | 259 | 601 | |||||||||||||
Cost of revenues
|
20a | - | 2,785 | 2,519 | ||||||||||||
Gross loss
|
- | (2,526 | ) | (1,918 | ) | |||||||||||
Research and development, net of participations
|
20b | 3,635 | 5,349 | 6,021 | ||||||||||||
Selling and marketing
|
20c | 2,259 | 8,829 | 9,284 | ||||||||||||
General and administrative
|
20d | 1,687 | 4,723 | 4,004 | ||||||||||||
Operating loss
|
(7,581 | ) | (21,427 | ) | (21,227 | ) | ||||||||||
Financial income
|
20e | 2,401 | 4,665 | 1,052 | ||||||||||||
Financial expense
|
20e | (3,321 | ) | (2,113 | ) | (1,496 | ) | |||||||||
Loss from continuing operations
|
(8,501 | ) | (18,875 | ) | (21,671 | ) | ||||||||||
Loss from discontinued operation
|
19 | (6,850 | ) | - | (417 | ) | ||||||||||
Net loss
|
(15,351 | ) | (18,875 | ) | (22,088 | ) | ||||||||||
Other comprehensive (loss) income:
|
||||||||||||||||
Items to be reclassified to profit or loss in subsequent periods:
|
||||||||||||||||
Foreign currency translation adjustments
|
(32 | ) | 14 | 2 | ||||||||||||
Total comprehensive loss
|
(15,383 | ) | (18,861 | ) | (22,086 | ) | ||||||||||
Basic and diluted net income (loss) per share
|
21 | (0.98 | ) | (0.95 | ) | (1.02 | ) |
Share capital
|
Share premium
|
Treasury
shares
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
equity
|
|||||||||||||||||||
Balance as of January 1, 2013
|
9 | 47,686 | - | - | (32,061 | ) | 15,634 | |||||||||||||||||
Loss for the period
|
- | - | - | - | (15,351 | ) | (15,351 | ) | ||||||||||||||||
Other comprehensive income
|
- | - | - | (32 | ) | (32 | ) | |||||||||||||||||
Total comprehensive (loss) income
|
- | - | - | (32 | ) | (15,351 | ) | (15,383 | ) | |||||||||||||||
Exercise of options
|
* | ) | 279 | - | - | - | 279 | |||||||||||||||||
Purchase of treasury shares
|
- | - | (34,600 | ) | - | - | (34,600 | ) | ||||||||||||||||
Share-based compensation
|
- | 607 | - | - | - | 607 | ||||||||||||||||||
Issuance of shares, net
|
2 | 13,657 | - | - | - | 13,659 | ||||||||||||||||||
Balance as of December 31, 2013
|
11 | 62,229 | (34,600 | ) | (32 | ) | (47,412 | ) | (19,804 | ) | ||||||||||||||
Loss for the period
|
- | - | - | - | (18,875 | ) | (18,875 | ) | ||||||||||||||||
Other comprehensive income
|
- | - | - | 14 | 14 | |||||||||||||||||||
Total comprehensive (loss) income
|
- | - | - | 14 | (18,875 | ) | (18,861 | ) | ||||||||||||||||
Exercise of warrants
|
1 | 4,711 | - | - | - | 4,712 | ||||||||||||||||||
Exercise of options
|
1 | 305 | - | - | - | 306 | ||||||||||||||||||
Cancellation of treasury shares
|
(2 | ) | (34,598 | ) | 34,600 | - | - | - | ||||||||||||||||
Effect of share split
|
32 | (32 | ) | - | - | - | - | |||||||||||||||||
Share-based compensation
|
- | 4,827 | - | - | - | 4,827 | ||||||||||||||||||
Issuance of shares, net
|
16 | 71,675 | - | - | - | 71,691 | ||||||||||||||||||
Balance as of December 31, 2014
|
59 | 109,117 | - | (18 | ) | (66,287 | ) | 42,871 | ||||||||||||||||
Loss for the period
|
- | - | - | - | (22,088 | ) | (22,088 | ) | ||||||||||||||||
Other comprehensive income
|
- | - | - | 2 | - | 2 | ||||||||||||||||||
Total comprehensive (loss) income
|
- | - | - | 2 | (22,088 | ) | (22,086 | ) | ||||||||||||||||
Exercise of options
|
1 | 25 | - | - | - | 26 | ||||||||||||||||||
Share-based compensation
|
- | 2,659 | - | - | - | 2,659 | ||||||||||||||||||
Balance as of December 31, 2015
|
60 | 111,801 | - | (16 | ) | (88,375 | ) | (23,470 | ) |
Year ended
December 31,
|
||||||||||||
2013
|
2014
|
2015
|
||||||||||
Cash Flows from Operating Activities:
|
||||||||||||
Net loss
|
(15,351 | ) | (18,875 | ) | (22,088 | ) | ||||||
Adjustments to reconcile net loss to net cash used in continuing operating activities:
|
||||||||||||
Adjustments to profit and loss items:
|
||||||||||||
Loss from discontinued operation
|
6,850 | - | 417 | |||||||||
Depreciation and amortization
|
336 | 492 | 503 | |||||||||
Revaluation of warrants to shareholders
|
820 | (4,491 | ) | - | ||||||||
Share-based compensation
|
531 | 4,827 | 2,659 | |||||||||
Revaluation of liabilities in respect of Chief Scientist government grants
|
(106 | ) | 87 | (474 | ) | |||||||
Revaluation of contingent consideration for the purchase of treasury shares
|
(2,400 | ) | 612 | (764 | ) | |||||||
Increase in severance pay liability
|
- | - | 90 | |||||||||
Accrued interest in respect of financial loans
|
1,669 | - | - | |||||||||
Net financing expenses (income)
|
(35 | ) | 226 | (219 | ) | |||||||
7,665 | 1,753 | 2,212 | ||||||||||
Changes in asset and liability items:
|
||||||||||||
Increase in trade receivables
|
- | (67 | ) | (181 | ) | |||||||
(Increase) decrease in other receivables
|
(532 | ) | 186 | (556 | ) | |||||||
Increase in inventories
|
- | (1,421 | ) | (273 | ) | |||||||
Increase (decrease) in trade payables
|
405 | 22 | (76 | ) | ||||||||
(Decrease) increase in other payables
|
(262 | ) | 1,909 | 1,361 | ||||||||
(389 | ) | 629 | 275 | |||||||||
Net cash used in continuing operating activities
|
(8,075 | ) | (16,493 | ) | (19,601 | ) | ||||||
Net cash used in discontinued operating activities
|
(1,665 | ) | - | - | ||||||||
Net cash flows used in operating activities
|
(9,740 | ) | (16,493 | ) | (19,601 | ) |
Year ended
December 31,
|
||||||||||||
2013
|
2014
|
2015
|
||||||||||
Cash Flows from Investing Activities:
|
||||||||||||
Purchase of property and equipment
|
(268 | ) | (366 | ) | (376 | ) | ||||||
Purchase of intangible assets
|
(90 | ) | (30 | ) | (30 | ) | ||||||
Interest received
|
3 | 173 | 287 | |||||||||
Proceeds from (investment in) short term bank deposits, net
|
(2,500 | ) | (36,931 | ) | 36,165 | |||||||
Net cash provided by (used in) investing activities
|
(2,855 | ) | (37,154 | ) | 36,046 | |||||||
Cash Flows from Financing Activities:
|
||||||||||||
Proceeds from exercise of options
|
279 | 306 | 26 | |||||||||
Proceeds from issuance of shares and warrants, net
|
15,800 | 71,824 | - | |||||||||
Proceeds from shareholders' loans
|
3,930 | - | - | |||||||||
Repayment of shareholders' loans
|
(915 | ) | - | - | ||||||||
Deferred issuance costs
|
(129 | ) | - | - | ||||||||
Proceeds from the Chief Scientist government grants, net of re-payment
|
276 | 345 | 752 | |||||||||
Net cash provided by financing activities
|
19,241 | 72,475 | 778 | |||||||||
Exchange rate differences on cash and cash equivalent balances
|
70 | (459 | ) | (143 | ) | |||||||
Increase in cash and cash equivalents from continuing activities
|
8,311 | 18,828 | 17,223 | |||||||||
Decrease in cash and cash equivalents from discontinued activities
|
(1,665 | ) | - | - | ||||||||
Balance of cash and cash equivalents at the beginning of the year
|
337 | 7,053 | 25,422 | |||||||||
Balance of cash and cash equivalents at the end of the year
|
7,053 | 25,422 | 42,502 | |||||||||
Non-cash activities:
|
||||||||||||
Treasury shares cancellation against share premium
|
- | 34,600 | - | |||||||||
Exercise of cashless warrants into shares
|
- | 4,709 | - | |||||||||
Contingent consideration for the purchase of treasury shares
|
19,200 | - | - | |||||||||
Exercise of derivative instrument into treasury shares
|
15,400 | - | - | |||||||||
Conversion of loans and realization of derivatives into shares and warrants
|
6,239 | - | - |
NOTE 1:
|
GENERAL
|
|
a.
|
General description of the company and its operations:
|
|
b.
|
The Company has two wholly-owned subsidiaries: MediWound Germany GmbH, acting as EU marketing authorization holder and EU sales and marketing arm and MediWound UK Limited, an inactive company. In addition, the Company owns approximately 7% of PolyHeal Ltd., a private life sciences company ("PolyHeal").
|
|
c.
|
On March 25, 2014, the Company closed its initial public offering in the United States and listing on the NASDAQ Global Select Market ("the IPO") of 5,750,000 ordinary shares in the offering, including 750,000 additional shares to cover underwriters over-allotments, which was exercised on March 25, 2014 by the underwriters. As a result, the Company issued and sold a total of 5,750,000 ordinary shares at a price per share of $14.00 with aggregate gross proceeds of $80,500. Under the terms of the offering, the Company incurred aggregate underwriting discounts of approximately $5,635 and expenses of approximately $3,172 in connection with the offering, resulting in net proceeds to the Company of approximately $71,691. Following the IPO the Company's securities are listed for trading on NASDAQ.
|
|
d.
|
On September 29, 2015, the Company was awarded a U.S. Biomedical Advanced Research and Development Authority ("BARDA") contract valued up to $112 million for development and procurement of NexoBrid for the U.S. The contract is for the advancement of the development and manufacturing, as well as the procurement of NexoBrid, as a medical countermeasure as part of BARDA preparedness for mass casualty events.
The five-year base contract includes $24 million of funding to support development activities to complete the U.S. Food and Drug Administration (FDA) approval process for NexoBrid for use in thermal burn injuries, as well as $16 million for procurement of NexoBrid, which is contingent upon FDA Emergency Use Authorization (EUA) and/or FDA marketing authorization for NexoBrid. In addition, the contract includes options for further funding of up to $22 million for expanding NexoBrid’s indications and of up to $50 million for additional procurement of NexoBrid.
|
NOTE 2:
|
SIGNIFICANT ACCOUNTING POLICIES
|
|
a.
|
Basis of presentation of financial statements:
|
|
b.
|
The Company's operating cycle is one year.
|
|
c.
|
Consolidated financial statements include the financial statements of companies that the Company controls (subsidiaries). Control is achieved when the Company is exposed, or has rights, to variable returns from its investment with the investee and has the ability to affect those returns through its power over the investee.
|
|
d.
|
Functional currency, reporting currency and foreign currency:
|
|
1.
|
Functional currency and reporting currency:
The reporting currency of the financial statements is the U.S. dollar.
The Company determines the functional currency based on the currency in which it primarily generates and expends cash. The Company determined that its functional currency is the U.S. dollar since most of the Company's expenses are in U.S. dollars and the economic environment in which the Company operates in and performs its transactions is mostly affected by the U.S dollar. A certain portion of the Company's costs are denominated in NIS mainly due to payroll and related benefit costs incurred in Israel. To further support the Company's determination, the Company has analyzed the currency in which funds from financing activities are generated or held and the currency in which receipts from operating activities are usually retained. In this respect, funds from financing activities were principally derived from significant funds raised in U.S. dollars including the public offering completed in 2014.
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
|
2.
|
Transactions, assets and liabilities in foreign currency:
|
|
e.
|
Cash equivalents:
|
|
f.
|
Short-term bank deposits:
|
|
g.
|
Inventories:
|
|
Cost of inventories is determined as follows:
|
Raw materials
|
-
|
At cost of purchase using the first-in, first-out method.
|
Finished goods
|
-
|
On the basis of average costs including materials, labor and other direct and indirect manufacturing costs based on normal capacity.
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
|
h.
|
Government support:
|
|
i.
|
Property, plant and equipment, net:
|
%
|
||||
Laboratory equipment
|
15 - 20 | |||
Office furniture
|
6 - 15 | |||
Computers
|
33 | |||
Leasehold improvements
|
See below
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
|
j.
|
Intangible assets, net:
|
|
k.
|
Revenue recognition
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
|
l.
|
Research and development expenses, net of participations:
|
|
m.
|
Impairment of non-financial assets:
|
|
n.
|
Financial instruments:
|
|
1.
|
Financial assets:
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
|
2.
|
Financial liabilities:
|
|
3.
|
Fair value:
|
|
4.
|
Offsetting financial instruments:
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
|
5.
|
Classification of financial instruments by fair value hierarchy:
All assets and liabilities measured at fair value or for which fair value is disclosed are categorized into levels within the fair value hierarchy based on the lowest level input that is significant to the entire fair value measurement:
|
Level 1
|
-
|
quoted prices (unadjusted) in active markets for identical assets or liabilities.
|
Level 2
|
-
|
inputs other than quoted prices included within level 1 that are observable either directly or indirectly.
|
Level 3
|
-
|
inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data).
|
|
6.
|
De-recognition of financial instruments:
|
|
a)
|
Financial assets:
A financial asset is derecognized when the contractual rights to the cash flows from the financial asset expire or the Company has transferred its contractual rights to receive cash flows from the financial asset or assumes an obligation to pay the cash flows in full without material delay to a third party and has transferred substantially all the risks and rewards of the asset, or has neither transferred nor retained substantially all the risks and rewards of the asset, but has transferred control of the asset.
|
|
b)
|
Financial liabilities:
A financial liability is derecognized when it is extinguished, that is when the obligation is discharged or cancelled or expires. A financial liability is extinguished when the debtor (the Company) discharges the liability by paying in cash, other financial assets, goods or services; or is legally released from the liability.
|
|
7.
|
Treasury shares:
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
|
o.
|
Provisions:
|
|
p.
|
Severance pay liability, net:
|
|
1.
|
Short-term employee benefits:
|
|
2.
|
Post-employment benefits:
|
NOTE 2:-
|
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
|
q.
|
Share-based compensation:
|
|
r.
|
Discontinued operation:
|
|
s.
|
Income (loss) per share:
|
NOTE 3:-
|
SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUMPTIONS USED IN THE PREPARATION OF THE FINANCIAL STATEMENTS
|
|
•
|
Determining the fair value of share based compensation to employees and directors:
The fair value of share based compensation to employees and directors as well as of warrants to shareholders is determined using acceptable option pricing models.
The assumptions used in the models include the expected volatility, expected life, early exercise factor, expected dividend and risk-free interest rate.
|
|
•
|
Chief Scientist government grants:
Government grants received from the OCS are recognized as a liability if future economic benefits are expected from the research and development activity that will result in royalty-bearing sales. There is uncertainty regarding the estimated future cash flows and the estimated discount rate used to measure the amortized cost of the liability.
|
|
•
|
Contingent consideration for the purchase of treasury shares:
Contingent consideration for acquisition of treasury shares was first measured at fair value. After initial recognition, the liability is measured at amortized cost using the effective interest method. As the contingent consideration is calculated based on future royalty-bearing sales, there is uncertainty regarding the estimated future cash flows and the estimated discount rate used to measure the fair value of this liability.
|
NOTE 4:-
|
DISCLOSURE OF NEW STANDARDS IN THE PERIOD PRIOR TO THEIR ADOPTION
|
|
IFRS 9-Financial Instruments
:
|
|
IF
RS 15-Revenue
recognition
:
|
NOTE 5:-
|
CASH AND CASH EQUIVALENTS
|
December 31,
|
||||||||
2014
|
2015
|
|||||||
USD cash for immediate withdrawal
|
20,497 | 34,856 | ||||||
Non-USD cash for immediate withdrawl
|
4,925 | 7,646 | ||||||
25,422 | 42,502 |
NOTE 6:-
|
SHORT-TERM BANK DEPOSITS
|
December 31,
|
||||||||
2014
|
2015
|
|||||||
USD bank deposits
|
37,001 | - | ||||||
EURO bank deposits
|
2,430 | 3,266 | ||||||
39,431 | 3,266 |
|
The EURO deposits bear interest of 0.08% and 0.04% for 2015 and 2014, respectively. The USD deposits bear interest ranging from 0.28%-0.76%. The bank deposits are for periods ranging from 106 to 273 days.
|
NOTE 7:-
|
INVENTORIES
|
Year ended
December 31,
|
||||||||
2014
|
2015
|
|||||||
Raw materials
|
402 | 387 | ||||||
Finished goods
|
1,019 | 1,328 | ||||||
1,421 | 1,715 |
NOTE 8:-
|
OTHER RECEIVABLES
|
Year ended
December 31,
|
||||||||
2014
|
2015
|
|||||||
Government authorities
|
218 | 172 | ||||||
Related parties
|
136 | 20 | ||||||
Former related parties
|
1,597 | 1,477 | ||||||
BARDA funds receivable
|
- | 800 | ||||||
Prepaid expenses and other
|
208 | 205 | ||||||
2,159 | 2,674 |
NOTE 9:-
|
PROPERTY, PLANT AND EQUIPMENT, NET
|
|
Balance as of December 31, 2015:
|
Office
furniture
|
Electronic
machinery
and lab
equipment
|
Computers
|
Leasehold
improvements
|
Total
|
||||||||||||||||
Cost
|
||||||||||||||||||||
Balance as of January 1, 2015
|
201 | 1,875 | 185 | 2,015 | 4,276 | |||||||||||||||
Disposals
|
- | (136 | ) | (62 | ) | - | (198 | ) | ||||||||||||
Additions
|
27 | 216 | 53 | 80 | 376 | |||||||||||||||
Foreign currency translation
|
(7 | ) | - | (2 | ) | - | (9 | ) | ||||||||||||
Balance as of December 31, 2015
|
221 | 1,955 | 174 | 2,095 | 4,445 | |||||||||||||||
Accumulated Depreciation
|
||||||||||||||||||||
Balance as of January 1, 2015
|
79 | 1,084 | 93 | 1,932 | 3,188 | |||||||||||||||
Disposals
|
- | (136 | ) | (62 | ) | - | (198 | ) | ||||||||||||
Additions
|
26 | 257 | 55 | 80 | 418 | |||||||||||||||
Foreign currency translation
|
(3 | ) | - | - | - | (3 | ) | |||||||||||||
Balance as of December 31, 2015
|
102 | 1,205 | 86 | 2,012 | 3,405 | |||||||||||||||
Depreciated cost as of December 31, 2015
|
119 | 750 | 88 | 83 | 1,040 |
|
Balance as of December 31, 2014:
|
Office
furniture
|
Electronic
machinery
and lab
equipment
|
Computers
|
Leasehold
improvements
|
Total
|
||||||||||||||||
Cost
|
||||||||||||||||||||
Balance as of January 1, 2014
|
169 | 1,723 | 119 | 1,999 | 4,010 | |||||||||||||||
Disposals
|
- | (69 | ) | (21 | ) | - | (90 | ) | ||||||||||||
Additions
|
41 | 221 | 88 | 16 | 366 | |||||||||||||||
Foreign currency translation
|
(9 | ) | - | (1 | ) | - | (10 | ) | ||||||||||||
Balance as of December 31, 2014
|
201 | 1,875 | 185 | 2,015 | 4,276 | |||||||||||||||
Accumulated Depreciation
|
||||||||||||||||||||
Balance as of January 1, 2014
|
54 | 904 | 70 | 1,846 | 2,874 | |||||||||||||||
Disposals
|
- | (69 | ) | (21 | ) | - | (90 | ) | ||||||||||||
Additions
|
29 | 249 | 45 | 86 | 409 | |||||||||||||||
Foreign currency translation
|
(4 | ) | - | (1 | ) | - | (5 | ) | ||||||||||||
Balance as of December 31, 2014
|
79 | 1,084 | 93 | 1,932 | 3,188 | |||||||||||||||
Depreciated cost as of December 31, 2014
|
122 | 791 | 92 | 83 | 1,088 |
NOTE 10:-
|
INTANGIBLE ASSETS, NET
|
|
Balance as of December 31, 2015
|
License and
Knowhow
|
||||
Cost
|
||||
Balance as of January 1, 2015
|
1,436 | |||
Additions
|
30 | |||
Balance as of December 31, 2015
|
1,466 | |||
Accumulated Amortization
|
||||
Balance as of January 1, 2015
|
485 | |||
Additions
|
85 | |||
Balance as of December 31, 2015
|
570 | |||
Amortized cost
|
||||
Balance as of December 31, 2015
|
896 |
|
Balance as of December 31, 2014
|
Cost
|
||||
Balance as of January 1, 2014
|
1,406 | |||
Additions
|
30 | |||
Balance as of December 31, 2014
|
1,436 | |||
Accumulated Amortization
|
||||
Balance as of January 1, 2014
|
402 | |||
Additions
|
83 | |||
Balance as of December 31, 2014
|
485 | |||
Amortized cost
|
||||
Balance as of December 31, 2014
|
951 |
NOTE 11:-
|
OTHER PAYABLES
|
Year ended
December 31,
|
||||||||
2014
|
2015
|
|||||||
Employees and payroll accruals
|
1,038 | 2,453 | ||||||
Accrued expenses
|
1,154 | 1,263 | ||||||
Current maturities of Chief Scientist government grants
|
49 | 28 | ||||||
Related parties
|
442 | 248 | ||||||
Deferred revenues
|
- | 91 | ||||||
2,683 | 4,083 |
NOTE 12:-
|
CHIEF SCIENTIST GOVERNMENT GRANTS
|
Year ended
December 31,
|
||||||||
2014
|
2015
|
|||||||
Balance as of January 1
|
6,604 | 7,034 | ||||||
Grants received
|
348 | 764 | ||||||
Royalties payments
|
(5 | ) | (21 | ) | ||||
Amounts carried to (profit) or loss
|
87 | (474 | ) | |||||
Balance as of Decmber 31
|
7,034 | 7,303 | ||||||
Current maturities
|
(49 | ) | (28 | ) | ||||
Long term liabilities in respect of Chief Scientist government grants
|
6,985 | 7,275 |
NOTE 13:-
|
FINANCIAL INSTRUMENTS
|
|
a.
|
Financial risk factors:
|
|
Foreign currency
risk
|
|
b.
|
Fair value:
|
|
c.
|
Sensitivity tests relating to changes in market factors:
|
NOTE 13:-
|
FINANCIAL INSTRUMENTS (Cont.)
|
December 31,
|
||||||||||||
2013
|
2014
|
2015
|
||||||||||
Sensitivity test to changes in NIS and EURO exchange rates
|
||||||||||||
Gain (loss) from change:
|
||||||||||||
5% increase in exchange rate
|
$ | 15 | $ | 259 | $ | 361 | ||||||
5% decrease in exchange rate
|
$ | (15 | ) | $ | (259 | ) | $ | (361 | ) |
NOTE 14:-
|
SEVERANCE PAY LIABILTY, NET
|
NOTE 14:-
|
SEVERANCE PAY LIABILTY, NET (Cont.)
|
Year ended
December 31,
|
||||||||||||
2013
|
2014
|
2015
|
||||||||||
Deposits in defined contribution plan
|
42 | 48 | 71 |
NOTE 15:-
|
CONTINGENT LIABILITIES AND COMMITMENTS
|
|
a.
|
In 2000, the Company signed an exclusive license agreement (as amended in 2007) with a third party with regard to its patents and intellectual property. Pursuant to the agreement, the Company received an exclusive license to use the third party's patents and intellectual property, for the purpose of developing, manufacturing, marketing, and commercializing products for treatment of burns and other wounds.
|
|
b.
|
Under the Research and Development Law, (the "R&D Law") the Company undertook to pay royalties of 3% - 3.5% on the revenues derived from sales of products or services developed in whole or in part using these OCS grants. The maximum aggregate royalties paid generally cannot exceed 100% of the grants received by the Company, plus annual interest generally equal to the 12-month LIBOR applicable to dollar deposits, as published on the first business day of each calendar year. The maximum royalty amount payable by the Company as of December 31, 2015 is approximately $ 11,509, which represents the total amount of grants actually received by the Company from the OCS including accrued interest, net of royalties actually paid by the Company.
|
|
c.
|
On November 24, 2010, the Company signed an agreement with one of its shareholders, to purchase a patent for the production and sale of related products for the treatment of burns. In consideration for the transfer and assignment of all rights and title relating to the patent, the Company paid a one-time payment in the amount of $ 88 and undertook to pay annual fixed payments in the amount of $ 30 as long as the patent is valid in the US and/or in any EU member country. The patent expires in May 2018, and the Company's accumulated outstanding obligation with respect to this agreement as of December 31, 2015 is $ 73.
|
|
d.
|
On September 15, 2014, a Statement of Claim was filed against the Company by some shareholders of Polyheal. The plaintiffs allege that the Company is obligated to pay them a total amount of $1,475 in exchange for their respective portion of PolyHeal's shares,
following the commencement of a feasibility study for the next generation of the PolyHeal Product in November 15, 2012, which constituted a milestone under a buyout option agreement between the Company, PolyHeal and its shareholders. For further details, see note 19.
|
NOTE 15:-
|
CONTINGENT LIABILITIES AND COMMITMENTS (Cont.)
|
|
e.
|
Operating Lease Agreements:
|
|
1.
|
The Company's offices and its production facility in Israel are located in a building that the Company leases from its Parent Company, in accordance with a sub lease agreement from July 2004. The sub lease agreement has been amended multiple times, most recently in September 2014. According to the most recently amended sub lease agreement, the Company subleases approximately 1,150 square meters of laboratory, office and clean room space at a monthly rent fee of $54.6. This sub lease agreement expires in December 2016. The Company's subsidiary offices are located in Germany. The monthly rent fee is currently €2.7 (approximately $ 2.9) and the lease agreement expires on April 30, 2019.
|
|
2.
|
The Company and its subsidiary have operating lease agreements for 22 vehicles. According to these agreements, the Company leases cars for its employees for a period of three years. As of December 31, 2015, the Company deposited $ 124 in respect of the vehicles operating leases.
|
|
3.
|
Minimum future lease fees for both agreements as of December 31, 2015 are as follows:
|
2016
|
905 | |||
2017
|
116 | |||
2018
|
90 | |||
1,111 |
NOTE 16:-
|
EQUITY
|
|
a.
|
Share capital
|
|
On March 3, 2014, the Company effected a bonus share distribution under which: (i) two and eight tenths (2.8) bonus shares were issued for each ordinary share outstanding prior to such distribution; and (ii) the conversion rate for each preferred share, option and warrant was adjusted to reflect such bonus share distribution. For accounting purposes, this transaction was recorded as a stock split and accordingly (unless otherwise noted), all ordinary shares, options, warrants and earnings (losses) per share amounts have been adjusted retroactively for all periods presented in these financial statements.
|
|
b.
|
Rights attached to shares:
|
|
c.
|
In January 2013 and June 2013, the Company and certain of its existing shareholders entered into convertible bridge financing agreements in the amounts of $ 3,000 (of which $ 2,579 were received from Clal Biotechnology Industries Ltd. (the "Parent Company")) and $ 1,585 (of which $ 1,500 were received from the Parent Company),
respectivel
y
. In June 2013, the Company further entered into a share purchase agreement pursuant to which the Company issued 1,530,233 ordinary shares in consideration for $ 15,800 net of issuance expenses. In addition, the Company issued to the investors warrants to purchase 765,127 ordinary shares at an exercise price of $ 10.34 per share. Upon the closing of such share purchase agreement on August 19, 2013, the convertible bridge loans were converted into 603,189 ordinary shares and warrants to purchase 223,131 and 78,477 ordinary shares at exercise prices of $ 6.72 and $ 10.34, respectively.
|
|
d.
|
On March 25, 2014 the Company completed its initial public offering in the United States and listing on the NASDAQ Global Select Market of 5,750,000 new ordinary shares at $14 per share. including the underwriters' option to purchase an additional 750,000 shares at the offering price that was exercised prior to closing. The Company's total proceeds from the issuance of the above shares were $71,691 thousands, net of underwriter’s discount and issuance expenses in the amount of $8,809.
|
|
e.
|
Transactions between the Company and Teva:
|
NOTE 17:-
|
SHARE-BASED COMPENSATION
|
|
a.
|
Expense recognized in the financial statements:
|
Year ended
December 31,
|
||||||||||||
2013
|
2014
|
2015
|
||||||||||
Cost of revenues
|
- | 763 | 372 | |||||||||
Research and development
|
315 | 657 | 511 | |||||||||
Selling and marketing
|
24 | 1,430 | 669 | |||||||||
General and administrative
|
192 | 1,977 | 1,107 | |||||||||
Expenses attributable to continuing operations
|
531 | 4,827 | 2,659 | |||||||||
Expenses attributable to discontinued operation
|
76 | - | - | |||||||||
Total share-based compensation
|
607 | 4,827 | 2,659 |
|
b.
|
Share-based payment plan for employees and directors:
|
NOTE 17:-
|
SHARE-BASED COMPENSATION (Cont.)
|
|
c.
|
Option grants:
|
|
1.
|
On January 6, 2013, the Company granted 62,700 options to purchase ordinary shares under the Plan for an exercise price of $ 13.76 per share to its employees. The total fair value of the options at the date of grant was estimated at $713.
|
|
2.
|
On December 24, 2013, the Company granted 904,400 options to purchase ordinary shares under the Plan for an exercise price of $ 12.89 per share to its employees. The total fair value of the options at the date of grant was estimated at $9,570.
|
|
3.
|
On July 30, 2014, the Company's Board of Directors approved the grant of 40,000 options to purchase ordinary shares under the Plan for an exercise price of $ 7.26 per share to the external directors of the Company. The board of Directors approval was subject to shareholder approval. On September 22, 2014 the Company's general shareholders meeting approved the grant of the options to the Company's directors. The total fair value of the options at the date of grant was estimated at $155.
|
|
4.
|
On January 1, 2015, the Company granted 57,000 options to purchase ordinary shares under the Plan for an exercise price of $ 6.02 per share to its employees. The total fair value of the options at the date of grant was estimated at $269.
|
|
5.
|
On May 3, 2015, the Company granted 10,000 options to purchase ordinary shares under the Plan for an exercise price of $ 6.73 per share to its employees. The total fair value of the options at the date of grant was estimated at $39.
|
|
6.
|
On December 23, 2015, the Company granted 672,500 options to purchase ordinary shares under the Plan for an exercise price of $ 9.58 per share to its employees. The total fair value of the options at the date of grant was estimated at $4,028.
The board of directors approval of granting 70,000 options to purchase ordinary shares to CEO, is subject to the shareholders approval dated January 28, 2016.
|
NOTE 17:-
|
SHARE-BASED COMPENSATION (Cont.)
|
|
d.
|
Share options activity:
|
2013
|
2014
|
2015
|
||||||||||||||||||||||
Number of
options
|
Weighted
Average
Exercise price
|
Number of
options
|
Weighted
Average
Exercise price
|
Number of
options
|
Weighted
Average
Exercise price
|
|||||||||||||||||||
Outstanding at beginning of year
|
1,514,946 | 2.14 | 2,376,064 | 6.71 | 1,902,324 | 7.98 | ||||||||||||||||||
Granted
|
967,100 | 12.95 | 40,000 | 7.26 | 739,500 | 9.27 | ||||||||||||||||||
Exercised
|
(67,268 | ) | 4.15 | (449,714 | ) | 0.68 | (300,000 | ) | 0.09 | |||||||||||||||
Forfeited
|
(38,714 | ) | 8.56 | (64,026 | ) | 11.60 | (28,600 | ) | 12.69 | |||||||||||||||
Outstanding at end of year
|
2,376,064 | 6.71 | 1,902,324 | 7.98 | 2,313,224 | 9.35 | ||||||||||||||||||
Exercisable at end of year
|
1,360,514 | 2.16 | 1,155,584 | 5.03 | 1,535,055 | 9.39 |
Options outstanding as of
December 31, 2015
|
||||||||||||
Range of exercise prices ($ )
|
Number of
options
|
Weighted
Average
Remaining
contractual
life
|
Weighted
average exercise
price
|
|||||||||
0.09
|
159,773 | 1.95 | 0.09 | |||||||||
2.63
|
208,332 | 0.87 | 2.63 | |||||||||
7.26 - 9.82
|
1,061,618 | 4.88 | 9.08 | |||||||||
12.89 - 13.76
|
883,500 | 7.92 | 12.95 | |||||||||
Total
|
2,313,224 | 5.48 | 9.35 |
|
e.
|
The fair value of the Company's share options granted to employees for the years ended December 31, 2013, 2014 and 2015 was estimated using acceptable option pricing models using the following assumptions:
|
December 31,
|
||||||||||||
2013
|
2014
|
2015
|
||||||||||
Dividend yield (%)
|
- | - | - | |||||||||
Expected volatility of the share prices (%)
|
84 | 75 | 71 | |||||||||
Risk-free interest rate (%)
|
1.03 - 2.43 | 0.1-1.80 | 0.25-2.24 | |||||||||
Expected life of share options (years)
|
5.5 - 7.0 | - | - | |||||||||
Early exercise factor
|
- | 100 | % | 100%-150 | % | |||||||
Weighted average share prices (Dollar)
|
$ | 14.41 | $ | 6.91 | $ | 8.98 |
NOTE 17:-
|
SHARE-BASED COMPENSATION (Cont.)
|
NOTE 18:-
|
TAXES ON INCOME
|
|
a.
|
The Company operates in two main tax jurisdictions: Israel and Germany. As such, the Company is subject to the applicable tax rates in the jurisdictions in which it conducts its business.
|
|
b.
|
Corporate tax rates in Israel:
|
|
Tax benefits under the Israel Law for the Encouragement of Capital Investments, 1959 (the "Investment Law"):
|
NOTE 18:-
|
TAXES ON INCOME (Cont.)
|
|
c.
|
Corporate tax rate in Germany:
|
|
d.
|
Final tax assessments:
The Company received final tax assessments through 2010.
|
|
e.
|
Net operating carryforward losses for tax purposes and other temporary differences:
|
|
f.
|
Deferred taxes:
|
|
g.
|
Current taxes on income:
|
|
h.
|
Theoretical tax:
|
NOTE 19:-
|
DISCONTINUED OPERATION
|
|
a.
|
In December 2010, the Company, Teva and PolyHeal, entered into a series of agreements to collaborate in the development, manufacturing and commercialization of PolyHeal's wound care product, or the PolyHeal Product(“ 2010 PolyHeal Agreement”).
|
NOTE 19:-
|
DISCONTINUED OPERATION (Cont.)
|
|
•
|
License agreements:
Under the 2010 PolyHeal Agreement, PolyHeal granted the Company an exclusive global license to manufacture, develop and commercialize all the Polyheal Products in consideration for royalty payments. Concurrently, the Company granted Teva an exclusive global sub license to commercialize the Polyheal Products in consideration for certain royalties and milestone payments. In addition, Teva undertook to finance the Company's future development of the Polyheal Product and all of its manufacturing costs.
|
|
•
|
Share purchase agreements:
Under the 2010 PolyHeal Agreement, Teva initially invested $ 6,750 in the Company, and undertook to invest an additional $ 6,750 in the Company subject to the achievement of a development milestone. Concurrent with Teva's investment in the Company, the Company purchased shares of PolyHeal for total consideration of $ 6,750. Additionally, the Company undertook to purchase additional shares of PolyHeal for the same amount, subject to the achievement of the same abovementioned development milestone.
|
|
b.
|
On November 15, 2012, the Company informed Teva of the commencement of a feasibility study for the next generation of the PolyHeal Product, which constituted a milestone under the 2010 PolyHeal Agreement. In accordance with the terms of the agreement, Upon achievement of this milestone, Teva was to invest an additional $ 6,750 in exchange of the Company's ordinary shares and the Company was to purchase, following and pending the consummation of this investment, for an identical amount, ordinary shares of PolyHeal from its existing shareholders. As of December 31, 2015, Teva had not made the investment despite the Company’s demand. Consequently, the
Company was not under any obligation to purchase and accordingly has not purchased any of the additional shares of PolyHeal from its shareholders.
|
NOTE 19:-
|
DISCONTINUED OPERATION (Cont.)
|
|
c.
|
As of December 31, 2012, all of the Company's collaborations with Teva under both the 2007 Teva Agreement and the 2010 PolyHeal agreement were terminated and consequently the Company's exclusive license for the PolyHeal Product expired as a result of the Company's failure to find a substitute strategic successor to Teva within the nine month period following the termination of the Company's agreement with Teva. Following the expiration of the license agreement with PolyHeal, the Company classified the results of PolyHeal operations for all periods presented, and the related cash flows, as a discontinued operation in accordance with IFRS 5. Furthermore, during the year ended December 31, 2013, the Company has fully impaired the license for the PolyHeal Product in the amount of $ 3,657.
|
|
d.
|
On September 15, 2014, a Statement of Claim was filed against the Company by certain shareholders of Polyheal. The plaintiffs allege that the Company is obligated to pay them a total amount of $1,475 in exchange for their respective portion of PolyHeal's shares, following the commencement of a milestone under a buyout option agreement between the Company, PolyHeal and its shareholders.
On December 14, 2014, the Company filed its Petition for a Right to Defend, or the Petition, in which it: (i) rejected the arguments raised against it in the Statement of Claim; (ii) emphasized that its obligation under the 2010 Polyheal Agreement to purchase the 7.5% of Polyheal’s ordinary shares is subject to the consumption of the deferred closing, as defined in the buyout agreement, including the receipt of the funds from Teva on a “back to back” basis; and (iii) stated that since no such payment has been made by Teva, the Company is not subject to any obligation to purchase Polyheal shares and/or make any payments to Polyheal’s shareholders.
|
|
e.
|
The Company has been acknowledged during 2015 about certain changes in circumstances indicating that the carrying amount of its royalty rights arising from the Company's ownership of shares of Polyheal would not be recoverable. Accordingly, a full impairment of these royalty rights amounting to $417 is included within the loss from discontinued operation.
|
NOTE 19:-
|
DISCONTINUED OPERATION (Cont.)
|
|
f.
|
As discussed above, the Company decided to classify the results of operations in PolyHeal as discontinued operation.
Below is the data of the operating results attributed to the discontinued operation:
|
Year ended
December 31,
|
||||||||||||
2013
|
2014
|
2015
|
||||||||||
Revenues
|
392 | - | - | |||||||||
Cost of revenues *)
|
2,015 | - | - | |||||||||
Gross loss
|
(1,623 | ) | - | - | ||||||||
Research and development, net of participations
|
607 | - | - | |||||||||
Selling and marketing
|
963 | - | - | |||||||||
Impairment of intangible assets
|
3,657 | - | 417 | |||||||||
Total operating expenses
|
(5,227 | ) | - | (417 | ) | |||||||
Operating loss
|
(6,850 | ) | - | (417 | ) | |||||||
Loss from discontinued operation
|
(6,850 | ) | - | (417 | ) |
|
*)
|
During the year ended December 31, 2013, the cost of revenues included a write- off of inventory in the amount of $ 490.
|
NOTE 20:-
|
SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF COMPREHENSIVE INCOME
|
|
a.
|
Cost of revenues:
|
Year ended
December 31,
|
||||||||||||
2013
|
2014
|
2015
|
||||||||||
Salary and benefits (including share-based compensation)
|
- | 2,219 | 1,961 | |||||||||
Subcontractors
|
- | 199 | 67 | |||||||||
Depreciation and amortization
|
- | 416 | 417 | |||||||||
Cost of materials
|
- | 600 | 486 | |||||||||
Other manufacturing expenses
|
- | 880 | 934 | |||||||||
Increase in inventory of finished products
|
- | (1,529 | ) | (1,346 | ) | |||||||
- | 2,785 | 2,519 |
|
b.
|
Research and development expenses, net of participations:
|
Year ended
December 31,
|
||||||||||||
2013
|
2014
|
2015
|
||||||||||
Salary and benefits (including share-based compensation)
|
2,137 | 2,182 | 2,610 | |||||||||
Subcontractors
|
1,372 | 3,362 | 4,464 | |||||||||
Depreciation and amortization
|
278 | - | 5 | |||||||||
Materials
|
181 | 510 | 841 | |||||||||
Other research and development expenses
|
545 | - | 219 | |||||||||
4,513 | 6,054 | 8,139 | ||||||||||
Participation by the Chief Scientist
|
(878 | ) | (705 | ) | (1,318 | ) | ||||||
Participation by BARDA
|
- | - | (800 | ) | ||||||||
3,635 | 5,349 | 6,021 |
NOTE 20:-
|
SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF COMPREHENSIVE INCOME (Cont.)
|
|
c.
|
Selling and marketing expenses:
|
Year ended
December 31,
|
||||||||||||
2013
|
2014
|
2015
|
||||||||||
Salary and benefits (including share based compensation)
|
890 | 4,966 | 5,631 | |||||||||
Marketing and advertising
|
1,141 | 3,356 | 2,835 | |||||||||
Depreciation and amortization
|
19 | 25 | 22 | |||||||||
Shipping and delivery
|
5 | 60 | 180 | |||||||||
Registration and marketing fees
|
204 | 422 | 616 | |||||||||
2,259 | 8,829 | 9,284 |
|
d.
|
General and administrative expenses:
|
Salary and benefits (including share-based compensation)
|
951 | 3,521 | 2,670 | |||||||||
Professional fees
|
349 | 869 | 1,054 | |||||||||
Depreciation and amortization
|
57 | 49 | 59 | |||||||||
Other
|
330 | 284 | 221 | |||||||||
1,687 | 4,723 | 4,004 |
|
e.
|
Financial income and expense:
|
Financial income:
|
||||||||||||
Interest income
|
1 | 174 | 288 | |||||||||
Revaluation of financial derivatives
|
- | 4,491 | - | |||||||||
Revaluation of contingent consideration for the purchase of treasury shares
|
2,400 | - | 764 | |||||||||
2,401 | 4,665 | 1,052 | ||||||||||
Financial expense
|
||||||||||||
Interest in respect of Chief Scientist government grants
|
772 | 792 | 844 | |||||||||
Revaluation of contingent consideration for the purchase of treasury shares
|
- | 612 | - | |||||||||
Revaluation of warrants to shareholders
|
820 | - | - | |||||||||
Exchange differences, net
|
44 | 652 | 614 | |||||||||
Interest in respect to convertible loans
|
1,669 | - | - | |||||||||
Other
|
16 | 57 | 38 | |||||||||
3,321 | 2,113 | 1,496 |
NOTE 21:-
|
NET LOSS PER SHARE
|
|
a.
|
Details of the number of shares and loss used in the computation of loss per share from continuing operations:
|
Year ended
December 31,
|
||||||||||||||||||||||||
2013 | 2014 | 2015 | ||||||||||||||||||||||
Weighted
average
number of shares
|
Loss
|
Weighted
average
number of shares
|
Loss
|
Weighted
average
number of shares
|
Loss
|
|||||||||||||||||||
Basic and diluted income (loss)
|
15,671 | (8,501 | ) | 19,940 | (18,875 | ) | 21,718 | (21,671 | ) |
|
b.
|
Details of the number of shares and loss used in the computation of loss per share from discontinued operation:
|
Year ended
December 31,
|
||||||||||||||||||||||||
2013 | 2014 | 2015 | ||||||||||||||||||||||
Weighted
average
number of shares
|
Loss
|
Weighted
average
number of shares
|
Loss
|
Weighted
average
number of shares
|
Loss
|
|||||||||||||||||||
Basic and diluted income (loss) | 15,671 | (6,850 | ) | - | - | 21,718 | (417 | ) |
|
c.
|
Net loss per share from continuing and discontinued operations:
|
Year ended
December 31,
|
||||||||||||
2013
|
2014
|
2015
|
||||||||||
Basic and Diluted loss per share:
|
||||||||||||
Net loss from continuing operations
|
(0.54 | ) | (0.95 | ) | (1.00 | ) | ||||||
Loss from discontinued operation
|
(0.44 | ) | - | (0.02 | ) | |||||||
Net loss per share
|
(0.98 | ) | (0.95 | ) | (1.02 | ) |
NOTE 22:-
|
BALANCES AND TRANSACTIONS WITH RELATED PARTIES AND KEY OFFICERS
|
|
a.
|
Related parties consist of:
|
|
•
|
Clal Biotechnologies Industries Ltd.-the Parent Company.
|
|
•
|
Teva - a former shareholder which the Company had a collaboration agreement with (see Note 16(e)).
|
|
•
|
PolyHeal-in which the Company holds approximately 7% (see Note 19).
|
|
•
|
Directors of the Company.
|
|
b.
|
Balances with related parties:
|
Receivables
|
Payables
|
|||||||
Parent Company
(1):
|
||||||||
2014
|
- | 151 | ||||||
2015
|
- | 207 | ||||||
Other related parties:
|
||||||||
2014
|
136 | 291 | ||||||
2015
|
20 | 41 | ||||||
Former related party
(2):
|
||||||||
2014
|
1,597 | - | ||||||
2015
|
1,477 | - |
|
(1)
|
The Company leases office space and a production facility from the Parent Company in accordance with a sublease agreement for two years with an option for extension (see Note 15 (e)).
|
|
(2)
|
Participation by Teva.
|
NOTE 22:-
|
BALANCES AND TRANSACTIONS WITH RELATED PARTIES AND KEY OFFICERS (Cont.)
|
|
c.
|
Transactions with related parties:
|
Professional
Fee (1)
|
Rent expenses
|
Revenues (2)
|
Participations (3)
|
Royalties
|
||||||||||||||||
Parent company:
|
||||||||||||||||||||
2013
|
- | (612 | ) | - | - | - | ||||||||||||||
2014
|
(12 | ) | (576 | ) | - | - | - | |||||||||||||
2015
|
(52 | ) | (730 | ) | - | - | - | |||||||||||||
Other related parties:
|
||||||||||||||||||||
2013
|
- | - | - | 219 | (16 | ) | ||||||||||||||
2014
|
(80 | ) | - | - | - | - | ||||||||||||||
2015
|
(127 | ) | - | - | - | - | ||||||||||||||
Former related party:
|
||||||||||||||||||||
2013
|
- | - | 368 | - | - | |||||||||||||||
2014
|
- | - | - | - | 51 | |||||||||||||||
2015
|
- | - | - | - | 121 |
|
(1)
|
Proffesional fees do not include short-term employee benefits and share-based compensation to one of the Company's shareholders, who is a key officer, in the amounts of $266, $699 and $619 for the years 2013, 2014 and 2015, respectively.
|
|
(2)
|
Attributable to the discontinued operation.
|
|
(3)
|
Including certain participation by Teva which is attributable to the discontinued operation.
|
|
d.
|
Compensation of key officers of the Company:
|
Year ended
December 31,
|
||||||||||||
2013
|
2014
|
2015
|
||||||||||
Short-term employee benefits
|
1,307 | 2,314 | 2,639 | |||||||||
Share-based compensation
|
170 | 2,949 | 1,702 | |||||||||
1,477 | 5,263 | 4,341 | ||||||||||
Number of key officers
|
6 | 7 | 7 |
Exhibit 4.13
[ * * * ] Portions of this agreement were omitted and a complete copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
AWARD/CONTRACT | 1. | THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 700) | RATING | PAGE OF PAGES | ||
1 | 48 |
2. | CONTRACT (Proc. Inst. Ident) NO. | 3. | EFFECTIVE DATE | 4. | REQUISITION/PURCHASE REQUEST/PROJECT NO |
HHSO100201500035C | See Block 20C | OS164559 |
5. ISSUED BY | CODE | ASPR–BARDA | 6. ADMINISTERED BY (If other than Item 5) | CODE | ASPR–BARDA01 |
ASPR–BARDA
|
ASPR–BARDA
330 Independence Ave, SW, Rm G644 Washington DC 20201 |
7. NAME AND ADDRESS OF CONTRACTOR (No., Street, City, Country, State and ZIP Code) | 8. DELIVERY | |||
o FOB ORIGIN | x OTHER (See below) | |||
MEDIWOUND LTD 1477616
MEDIWOUND LTD 42 HAYARKON 42 HAYARKON YAVNE 00812 |
9. DISCOUNT FOR PROMPT PAYMENT | |||
10. SUBMIT INVOICES
(4 copies unless otherwise specified) TO THE ADDRESS SHOWN IN |
ITEM | |||
CODE 1477616 | FACILITY CODE |
11. SHIP TO/MARK FOR | CODE | HHS/OS/ASPR | 12. PAYMENT WILL BE MADE BY | CODE | PSC |
HHS/OS/ASPR
200 C St SW WASHINGTON DC 20201 |
PSC
Program Support Center 5600 Fishers Lane Room 17-21 Rockville MD-20852 |
||||
13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: | 14. ACCOUNTING AND APPROPRIATION DATA | ||||
o 10 U.S.C. 2304 (c) ( ) o 41 U.S.C. 253 (c) ( ) | 2015.1990002.26201 |
15A. ITEM NO | 15B. SUPPLIES/SERVICES |
15C.
QUANTITY |
15D.
UNIT |
15E. UNIT PRICE | 15F. AMOUNT | |
Continued |
||||||
15G. TOTAL AMOUNT OF CONTRACT | $40,430,469.00 |
16. TABLE OF CONTENTS
(X) | SEC. | DESCRIPTION | PAGE(S) | (X) | SEC. | DESCRIPTION | PAGE(S) |
PART I - THE SCHEDULE | PART II - CONTRACT CLAUSES | ||||||
A | SOLICITATION/CONTRACT FORM | I | CONTRACT CLAUSES | ||||
B | SUPPLIES OR SERVICES AND PRICES/COSTS | PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH . | |||||
C | DESCRIPTION/SPECS/WORK STATEMENT | J | LIST OF ATTACHMENTS | ||||
D | PACKAGING AND MARKING | PART IV - REPRESENTATIONS AND INSTRUCTIONS | |||||
E | INSPECTION AND ACCEPTANCE | K | REPRESENTATIONS. CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS | ||||
F | DELIVERIES OR PERFORMANCE | ||||||
G | CONTRACT ADMINISTRATION DATA | L | INSTRS., CONDS., AND NOTICES TO OFFERORS | ||||
H | SPECIAL CONTRACT REQUIREMENTS | M | EVALUATION FACTORS FOR AWARD |
CONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-B1D OR NEGOTIATED PROCUREMENT) OR 18 (SEALED-B1D PROCUREMENT) AS APPLICABLE
17. o CONTRACTOR’ S NEGOTIATED AGREEMENT (Contractor is required to sign this document and return ___________ copies to issuing office.) Contractor agrees to furnish and deliver all items of perform all the services set forth or otherwise identified above and on any continuation sheets for the consideration staled herein. The rights and obligations of the parties to this contract shall be subject to and governed by the following documents: (a) this award/contract. (b) the solicitation, if any, and (c) such provisions, representations, certifications, and specification as are attached or incorporated by reference herein. | 16. þ SEALED-BIO AWARD (Contractor is not required to sign this document.) Your bid on Soliciation Number _________________________________________ including the additions or changes made by you which additions or changes are set forth in full above, is hereby accepted as to the items listed above and on any continuation sheets. This award consummates the contract which consists of the following documents: (a) the Government’s solicitation and your bid, and (b) this award/contract. No further contractual document is necessary. (Block 18 should be checked City when awarding a seated-bid contract.) |
19A | Name And Title Of Signer ( Type of Print) | 20A | NAME OF CONTRACTING OFFICER | |||||
Sharon
Malka
Chief Finance Officer MediWound Ltd |
Gal Cohen
President & Chief Executive Officer MediWound Ltd |
BROOKE T. BERNOLD | ||||||
19B. | NAME OF CONTRACTOR | 19C. DATE SIGNED | 20B. | UNITED STATES OF AMERICA | 20C. DATE SIGNED | |||
BY | BY | |||||||
(Signature of person authorized to sign) | 9/29/2015 | (Signature of the Contracting Officer) | 9/29/2015 |
AUTHORIZED FOR LOCAL REPRODUCTION
Previous edition is NOT usable |
STANDARD FORM 26 (Rev. 5/2011)
Prescribed by GSA - FAR (48 CFR) 53.214(a) |
PART I – THE SCHEDULE
SECTION B – SUPPLIES OR SERVICE AND PRICE / COST
Non-Surgical Debridement for Definitive Care of Burn Injuries
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
Mediwound Ltd. is developing NexoBrid, a unique Debridement product that enables clinicians to restore, normal skin when treating partial thickness or full thickness burns. The product has the potential to greatly improve the patient’s quality of life while reducing hospital stays and the need for reconstructive surgery. This product could find utility in day-to-day care, while simultaneously improving our capability to respond to mass casualty incidents.
Under the base period-of-performance, Mediwound Ltd. will further enhance their product to improve its commercial viability through the FDA approval process and potentially complete an initial purchase, storage, and delivery of product. The contract options may be exercised to perform follow-on studies as directed by the FDA, perform additional studies which further extend the ability to protect children and the elderly population, and purchase additional treatment courses.
The Research and Development (R&D) effort will progress in specific stages that cover the base performance segment and several options as specified in this contract. The period of performance for the base period is 60 months.
ARTICLE B.2. BASE PERIOD
CLIN |
Period
of
Performance |
Supplies/ Services |
Total
Est.
Cost |
Fixed
Fee
(7%) |
Total
Cost
Plus Fixed Fee |
COST REIMBURSEMENT | |||||
0001
(Base) |
09/28/2015
–
09/27/2020 |
Licensure, approval, and clearance of product through the FDA | $22,693,160 | $1,262,501 |
$23,955,661
(Funded) |
FIRM FIXED PRICE | |||||
CLIN |
Period
of
Performance |
Supplies/ Services |
Units
(# of
Product) |
Unit
Price
($) |
Total ($) |
0002
(Base) |
09/28/2017 – 09/27/2019*(* see advanced understanding h.) | Initial Purchase, storage, and delivery of product | 10,588 |
$1,052
(includes VMI) |
$11,138,576
(Funded) |
0002
(Base) |
09/28/2019
–
09/27/2020 |
Initial Purchase, storage, and delivery of product | 5412 |
$986
(includes VMI) |
$5,336,232
(Funded) |
Total CLINS 1&2 |
09/28/2015
–
09/27/2020 |
See Above Descriptions |
$40,430,469
(Funded) |
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ARTICLE B.3. OPTION PRICES
CLIN |
Period
of
Performance |
Supplies/ Services |
Units
(# of
Product) |
Unit
Price
($) |
Total ($) |
FIRM FIXED PRICE | |||||
0003
(Option
Quantity) |
60 Months | Phase IV post marketing commitments /Requirements (This is an option that may or may not be exercised during the base period as determined by the need and as established by the FDA) | N/A | N/A |
$5,639,146
(Not Funded) |
COST REIMBURSEMENT | |||||
CLIN |
Period
of
Performance |
Total Est. Cost |
Fixed
Fee
(7%) |
Total
Cost
Plus Fixed Fee |
|
0004 A (Option Quantity) | 60 Months | Pediatric Study (This is an option that may or may not be exercised during the base period for expansion of the label indication with guidance from the FDA) | $11,237,608 | $688,011 |
$11,925,619
(Not Funded) |
0004 B (Option Quantity) | 60 Months | Burn Induced Compartment Syndrome Study(BICS) (This is an option that may or may not be exercised during the base period for expansion of the label indication with guidance from the FDA) | $4,185,894 | $261,819 |
$4,447,713
(Not Funded) |
FIRM FIXED PRICE | |||||
CLIN |
Period
of
Performance |
Supplies/ Services |
Units
(# of
Product) |
Unit
Price
($) |
Total ($) |
0005A
(Option
Quantity)
|
60 Months | US Facility validation for manufacture of product (in USA) | N/A | N/A |
$4,819,074
(Ceiling Not Funded) |
0005B
(Option
Quantity)
|
12 Months | Additional Surge Capacity 1 to 23,530 units | 1 to 23,530 | $986 |
$23,200,580
(Ceiling Not Funded) |
0005B
(Option
Quantity)
|
12 Months | Additional Surge Capacity 23,531 to 47,060 units |
23,531 to
47,060 |
$950 |
$22,353,500
(Ceiling Not Funded) |
Total
CLINs 3-5 |
60 Months | See Above Descriptions |
$72,385,632
(Not
Funded)
|
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ARTICLE B.4. LIMITATIONS APPLICABLE TO DIRECT COSTS
a. Items Unallowable Unless Otherwise Provided
Notwithstanding the clause FAR 52.216-7, Allowable Cost and Payment, incorporated in this contract, the costs of the following items or activities shall be unallowable as direct costs unless authorized in writing in advance by the Contracting Officer :
1. | Acquisition, by purchase or lease, of any interest in real property; | |
2. | Special rearrangement or alteration of facilities; | |
3. | Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.); | |
4. | Travel to attend general scientific meetings; | |
5. | Unapproved foreign travel | |
6. | Consultant costs, except costs incurred under firm-fixed price consultant agreements valued at $150,000 or less are allowable without prior authorization. | |
7. | Subcontracts; except costs incurred under firm-fixed price subcontracts valued at $150,000 or less are allowable without prior authorization. | |
8. | Patient care costs; | |
9. | Accountable Government property (defined as both real and personal property with an acquisition cost of $1,000 or more and a life expectancy of more than two years) and “sensitive items” (defined as items of personal property, supplies and equipment that are highly desirable and easily converted to personal use), regardless of acquisition value. | |
10. | Printing Costs (as defined in the Government Printing and Binding Regulations). | |
11. | Light Refreshment and Meal Expenditures - Requests to use contract funds to provide light refreshments and/or meals to either federal or nonfederal employees must be submitted to the Contracting Officer’s Representative (COR), with a copy to the Contracting Officer, at least six (6) weeks in advance of the event and are subject to “HHS Policy on Promoting Efficient Spending: Use of Appropriate Funding for Conferences and Meeting, Food and Promotional Items and Printing and Publications.” The request shall contain the following information: (a) name, date, and location of the event at which the light refreshments and/or meals will be provided; (b) a brief description of the purpose of the event; (c) a cost breakdown of the estimated light refreshments and/or meals costs; (d) the number of nonfederal and federal attendees receiving light refreshments and/or meals; and (e) if the event will be held at a government facility. | |
12. | Meeting room or conference space used for face to face meetings with USG staff in the performance of this contract. Justification for why the meeting cannot be held at a government facility must be provided. COA requests must be made at least (2) two weeks prior to meeting date. |
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b. Travel Costs
1. | Travel incurred by the Prime Contractor in direct performance of this contract shall require and be consistent with advance written approval by the Contracting Officer for expenditures such as (transportation, lodging, subsistence, and incidental expenses). | |
2. | FAR 52.247-63 – Preference for U.S.-Flag Air Carriers is applicable. | |
3. | The Contactor shall invoice and be reimbursed for all travel costs in accordance with FAR 31.703 and FAR 31.205-46, Contracts with Commercial Organizations, Travel Costs. | |
4. | Requests for foreign travel must be submitted at least six weeks in advance and shall contain the following: | |
(i) Meeting(s) and place(s) to be visited, with costs and dates; | ||
(ii) Names(s) and title(s) of Contractor personnel to travel and their functions in the contract project; | ||
(iii) Contract purpose to be served by the travel; | ||
(iv) How travel of Contractor personnel will benefit and contribute to accomplishing the contract project, or will otherwise justify the expenditure of AMCG contract funds; | ||
(v) How such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and | ||
(vi) What additional functions may be performed by the travelers to accomplish other purpose of the contract and thus further benefit the project. |
ARTICLE B.5. ADVANCE UNDERSTANDINGS
a. | Subcontracts and Consultants |
Award of any FFP subcontract or FFP consulting agreement in excess of $150,000 or any cost reimbursement subcontract or consulting agreement shall not proceed without the prior written consent of the Contracting Officer via a Contracting Officer Authorization (COA) Letter. COA letters will only be issued upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the contracting Officer, a copy of the signed, executed subcontract and consulting agreement shall be provided to the Contracting Officer within ten (10) days.
b. | Site Visits, Inspections and General Audits |
At the discretion of the USG and independent of activities conducted by the Contractor, with 48 hours’ notice to the Contractor, the USG reserves the right to conduct site visits and inspections on an as needed basis, including collection of product samples and intermediates held by the Contractor, or subcontractor. In case of subcontractor visits and inspections that are independent of activities conducted by the Contractor, the USG shall demonstrate cause for such visit and/or inspection. All costs reasonably incurred by the Contractor and subcontractor for such visit and/or inspection shall be allowable costs. The Contractor shall coordinate these visits and shall have the opportunity to accompany the USG on any such visits. Under time-sensitive or critical situations, the USG reserves the right to suspend the 48 hour notice to the Contractor. If the Government, Contractor, or other party identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to the Government for review and acceptance.
· | If issues are identified during the audit, Contractor shall submit a report to the CO and COR within 10 business days detailing the finding and corrective action(s) of the audit. |
· | COR and CO will review the report and provide a response to the Contractor within 10 business days. |
· | Once corrective action is completed, the Contractor will provide a final report to the CO and COR within 10 business days. |
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c. QA Audits
BARDA reserves the right to participate in QA audits. Upon completion of the QA audit the Contractor shall provide a report capturing the findings, results, and next steps in proceeding with any potential subcontractors. If action is requested for a subcontractor, detailed corrective and preventative plans for addressing areas of non-conformance to ICH and FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA for review and acceptance. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.
• | Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of weekly communications. |
• | Contractor shall notify the COR and CO within 5 business days of report completion. The Contractor shall complete the report within 60 days of the audit/site visit, or as negotiated with the COR in writing dependent upon the audit findings. |
d. Man-in-Plant
At the discretion of the Government and seven (7) days advance notice to the Contractor in writing from the Contracting Officer, the Government may place a man-in-plant in the Contractor’s facility, who shall be subject to the Contractor’s policies and procedures regarding security and facility access at all times while in the Contractor’s facility. As determined by federal law, no Government representative shall publish, divulge, disclose, or make known in any manner, or to any extent not authorized by law, any information coming to him in the course of employment or official duties, while stationed in a contractor plant.
e. Confidential Treatment of Sensitive Information
The Contractor shall, to the extent permitted by law, guarantee strict confidentiality of the information/data that is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature.
Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.
Notwithstanding the foregoing, such information/data shall not be deemed of a sensitive nature with respect to the Contractor for purposes of this contract if such information/data: (a) was already known to the Contractor; (b) was generally available or known, or was otherwise part of the public domain, at the time of its disclosure to the Contractor; (c) became generally available or known, or otherwise became part of the public domain, after its disclosure to, or, with respect to the information/data by, the Contractor through no fault of the Contractor; (d) was disclosed to the Contractor, other than under an obligation of confidentiality or non-use, by a third party who had no obligation to the Government that controls such information/data not to disclose such information/data to others; or (e) was independently discovered or developed by the Contractor, as evidenced by its written records, without the use of information/data belonging to the Government.
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The Contractor may disclose information/data of a sensitive nature provided by the Government to the extent that such disclosure is: (a) made in response to a valid order of a court of competent jurisdiction (b) otherwise required by law, (c) made by the Contractor to the Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval; provided , however , that reasonable measures shall be taken to assure confidential treatment of such information/data
f. Emergency Use Authorization (EAU)
The Contractor shall be responsible for generating the data to support the USG’s filing of a Pre-Emergency Use Authorization (Pre-EUA) package for use of the product prior to FDA licensure or approval during a declared emergency, declared potential emergency, or identification of material threat under an Emergency Use Authorization (EUA).
The Contractor commits to supporting the potential use of the product under a pre-EUA package as submitted by BARDA or the CDC/SNS. The Contractor shall supply BARDA or the CDC/SNS with the data needed to support such a submission, including expanded access INDs, right to hold product, right of reference to the Contractor’s Investigational New Drug (IND), or other application that contains the supporting data. The Contractor shall address any FDA comments on all pre-EUA packages as applicable. The Contractor shall maintain and update, as required by the FDA, all required regulatory documentation (investigator brochure, regulatory binder, etc.), that will be used to support use under EUA and approval/licensure.
Any product which has not received FDA approval or licensure, but has completed submission of the Pre-EUA package and has met the three (3) criteria listed below may be considered for procurement at the discretion of the USG. The Contractor would be required to demonstrate the three (3) essential criteria listed below for consideration of procurement of any unapproved products by seeking a COA. The COA shall include a product delivery schedule for consideration and the following:
• | Substantial evidence, including a validated process, of the Contractor’s ability to manufacture a product that would be identical to the commercial scale as required for product approval or licensure. A clear understanding of the outstanding risks, if any, for approval or licensure must be demonstrated. |
• | Completion of pivotal clinical studies with substantial evidence of safety and efficacy for the indicated use. A list of outstanding activities and targets for completion, adverse events/safety profile which do not pose unusual risks or challenges for FDA approval or licensure shall be provided. |
• | Substantial evidence of product familiarity/acceptance for use in burn centers. The Contractor shall provide a list of burn centers familiar with the product, feedback received, and corrective actions required to address any concerns to ensure effective use of the product by burn care providers unfamiliar with the product. Evidence of the company’s ability to educate such providers on the use of the product (as allowed within the constraints of law) will be useful. |
A tentative delivery schedule of product delivery to the inventory (acceptable as in the Quality Agreement) shall be required as part of the COA. The delivery schedule shall be updated periodically as necessary.
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For
information concerning EUA, please consult
http://www.fda.gov/RegulatoryInformation/Guidances/ucm 125127
and
http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucml82568.htm
g. Sharing of contract deliverables within United States Government (USG)
In an effort to build a robust medical countermeasure pipeline through increased collaboration, BARDA may share technical deliverables with USG entities responsible for Medical Countermeasure Development. In accordance with recommendations from the Public Health Emergency Medical Countermeasure Enterprise Review, agreements established in the Integrated Portfolio’s Portfolio Advisory Committee (PAC) Charter, and agreements between BARDA and the Department of Defense and the National Institutes of Health, BARDA may share technical deliverables and data created in the performance of this contract with colleagues within the Integrated Portfolio. This advance understanding does not authorize BARDA to share financial information outside HHS. The Contractor is advised to review the terms of FAR 52.227-14, Rights in Data – General, regarding the Government’s rights to deliverables submitted during performance as well as the Government’s rights to data contained within those deliverables.
h. Overtime Compensation
No overtime (premium) compensation is authorized under the subject contract. Billing of actual hours should be limited to total productive hours in a month.
i. Option CLINS
The USG reserves the right to re-negotiate the option CLINS based availability of funds and feedback received from the FDA.
j. Contract Number Designation
On all correspondence submitted under this contract, the Contractor agrees to clearly identify the contract number that appears on the face page of the contract as follows:
HHS100201500035C
h. Quality Agreement
The Quality Agreement shall specify the responsibilities of both the Contractor and the USG (i.e. – CDC/SNS-Quality Control and BARDA) for event-driven and product shipping, receiving, acceptance into the inventory and/or custody by the USG. This document shall be drafted and signed by all parties prior to the commencement of product procurement and acceptance, transport and custody of the product under the VMI/DMI or the CDC/SNS. The Contractor shall provide documentation and resolution for all concerns raised by USG and commits to cooperation in execution of this agreement.
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SECTION C – DESCRIPTION/SPECIFICATIONS/WORKSTATEMENT
C.1. STATEMENT OF WORK
ARTICLE C.1. STATEMENT OF WORK
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Work dated September 28, 2015 set forth in SECTION J - List of Attachments, attached hereto and made a part of the contract.
ARTICLE C.2. REPORTING REQUIREMENTS
See Section F for specific reporting requirements.
All reports required herein shall be submitted in electronic format. All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).
ARTICLE C.3. TWICE MONTHLY CONFERENCE CALLS
A conference call between the Contracting Officer’s Representative and the Contractor’s Project Leaders/delegates and designees shall occur twice-monthly or as directed by the Contracting Officer and Contracting Officer’s Representative. During this call the Contractor’s Project Leaders/delegates and designees will discuss the activities since the last call, any problems that have arisen and the activities planned until the next call takes place. The Contractor’s Project Leaders/delegates may choose to include other key personnel on the conference call to give detailed updates on specific projects or this may be requested by the Contracting Officer’s Representative.
ARTICLE C.4. PROJECT MEETINGS
The Contractor shall participate in Project Meetings to coordinate the performance of the contract, as requested by the Contracting Officer’s Representative. These meetings may include face-to-face meetings with AMCG/BARDA in Washington, D.C. and at work sites of the Contractor. Such meetings may include, but are not limited to, meetings of the Contractor to discuss study designs, site visits to the Contractor’s facilities, and meetings with the Contractor and HHS officials to discuss the technical, regulatory, and ethical aspects of the program. Subject to the data rights provisions in this contract, the Contractor will provide data, reports, and presentations to groups of outside experts and USG personnel as required by the Contracting Officer and Contracting Officer’s Representative in order to facilitate review of contract activities.
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SECTION D – PACKAGING, MARKING AND SHIPPING
All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the date, contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.
The US storage facility will be a subcontractor that must be acceptable to the USG and approved under a COA. Issuance of a COA shall meet the conditions specified in the Quality Agreement between BARDA, CDC and MediWound.
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SECTION E – INSPECTION AND ACCEPTANCE
ARTICLE E.1. INSPECTION AND ACCEPTANCE
The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided under this contract.
For the purpose of this SECTION E, the designated Contracting Officer’s Representative (COR) is the authorized representative of the Contracting Officer. The COR will assist in resolving technical issues that arise during performance. The COR however is not authorized to change any contract terms or authorize any changes in the Statement of Work or modify or extend the period of performance, or authorize reimbursement of any costs incurred during performance. The Contractor is advised to review FAR 52.243–1 Changes – Fixed Price Contracts Alternate V and FAR 52.243-2 Changes–Cost reimbursement contracts Alternative V, which is incorporated by reference into this contract in ARTICLE I.1.
Inspection and acceptance will be performed at:
Office
of Acquisition Management, Contracts, and Grants (AMCG)
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services
200 C St. SW
Washington, D.C. 20024
Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.
The contract incorporates the following clause by reference with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.
FAR 52.246-4, Inspection of Services - Fixed Price (August 1996)
FAR 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984)
FAR 52.246-9, Inspection of Research and Development (Short Form) (April 1984)
FAR 52.246-16, Responsibility for Supplies (April 1984)
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SECTION F – DELIVERIES OR PERFORMANCE
ARTICLE F.1. PERIOD OF PERFORMANCE
The period of performance for this contract shall be from September 28, 2015 through September 27, 2020. The period of performance for the base period of this contract shall be consistent with the dates set forth in SECTION B. If the Government exercises option(s), the period of performance will be extended as described under in SECTION B of this contract.
ARTICLE F.2. REPORTING REQUIREMENTS
In all cases the reports are intended to provide sufficient detail to understand the Contractor’s approach and progress to addressing the technical requirements. The reports supplement, and do NOT replace, routine (i.e. daily) communication between the COR and project manager and/or their designee(s) regarding project plans and progress.
A. Monthly Progress Report
This report shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.
The Contractor shall submit a Monthly Progress Report on or before the 15th calendar day following the last day of each reporting period and shall include the following:
Title Page: The title page for this report shall include the contract number and title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail address; and the date of submission.
Distribution List : A list of individuals receiving the Technical Progress report.
Progress:
SECTION I - An introduction covering the purpose and scope of the contract effort.
SECTION II Part A: SUMMARY - A description or table summarizing ongoing activities.
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE – This section shall include a description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating and managing subcontractor performance and personnel changes). Please include all Quality Management System, Quality Control, and Quality Assurance updates as part of this report or as requested by the COR.
SECTION II Part C: TECHNICAL PROGRESS – This section shall document the results of work completed and costs incurred during the period covered in relation to the proposed progress, effort, and budget. The report shall be in sufficient detail to explain comprehensively the results achieved.
SECTION II Part D: ISSUES – This section shall include a description of problems encountered and proposed corrective action; differences between planned and actual progress; why the differences have occurred and what corrective actions are planned; and if a project activity is delinquent, then what corrective action steps are planned. Revised timelines shall be provided.
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SECTION II Part E: PROPOSED WORK – This section shall include a summary of work proposed as a rolling three (3) month forecast for the next reporting period, by a certain date, and by whom.
SECTION II Part F: MANUFACTURING AND SUPPLY CHAIN MANAGEMENT – This section shall include a summary of the manufacturing and supply-chain related activities. Also include in this section updates to the production plan, capacity projections, stability results, inventory and shipment/distribution information.
Invoices: Summary of any invoices submitted during the reporting period.
A Monthly Progress Report will not be required in the same month Annual or Final Technical Progress Reports are due.
B. Annual Progress Report
This report shall include a summation of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full year of performance plus any fractional part of the initial year. Thereafter, the reporting period shall consist of each calendar year.
The Contractor shall submit an Annual Progress Report on or before the 30th calendar day following the last day of each reporting period and shall include the following:
Title Page: The title page for this report shall include the contract number and title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail address; and the date of submission.
Distribution List : A list of individuals receiving the Technical Progress report.
Progress:
SECTION I - An introduction covering the purpose and scope of the contract effort.
SECTION II Part A: SUMMARY - A description or table summarizing ongoing activities.
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE – This section shall include a description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating and managing subcontractor performance and personnel changes). Please include all Quality Management System, Quality Control, and Quality Assurance updates as part of this report or as requested by the COR.
SECTION II Part C: TECHNICAL PROGRESS – This section shall document the results of work completed and costs incurred during the period covered in relation to proposed progress, effort, and budget. The report shall be in sufficient detail to explain comprehensively the results achieved.
SECTION II Part D: ISSUES – This section shall include a description of problems encountered and proposed corrective action; differences between planned and actual progress; why the differences have occurred and what corrective actions are planned; and if a project activity is delinquent, then what corrective action steps are planned. Revised timelines shall be provided.
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SECTION II Part E: PROPOSED WORK – This section shall include a summary of work proposed as a rolling three (3) month forecast for the next reporting period, by a certain date, and by whom.
SECTION II Part F: MANUFACTURING AND SUPPLY CHAIN MANAGEMENT – This section shall include a summary of the manufacturing and supply-chain related activities. Also include in this section updates to the production plan, capacity projections, stability results, inventory and shipment/distribution information.
Invoices: Summary of any invoices submitted during the reporting period.
An Annual Progress Report will not be required for the period when the Final Technical Progress Report is due.
C. | Draft Final Report and Final Report |
These reports are to include a summation of the work performed and results obtained for execution of various studies or technical work packages during the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Draft Final Progress Report shall be due forty-five (45) calendar days prior to the expiration date of the contract and the Final Progress Report is due no later than 30 days following the expiration date of the contract. The report shall conform to the following format:
Title Page: The title for these reports shall include the contract number and title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail address; and the date of submission.
Distribution List: A list of individuals receiving the Technical Progress report.
Progress:
SECTION I: EXECUTIVE SUMMARY - Summarize the purpose and scope of the contract effort including a summary of the major accomplishments relative to the specific activities set forth in the Statement of Work.
SECTION II: RESULTS - A detailed description of the work performed and the results obtained including all expenses for the entire contract period of performance.
D. | FDA Regulatory Agency Correspondence, Meeting Summaries, and Submissions. |
a. | Within five business days of any formal meeting with the FDA or other regulatory agency, the Contractor shall forward the initial draft minutes to BARDA. The Contractor shall forward the final minutes when available. |
b. | Within five business days of any informal meeting with the FDA or other regulatory agency, the Contractor shall forward the initial draft minutes to BARDA. The Contractor shall forward the final minutes when available and if applicable. |
c. | The Contractor shall forward the dates and times of any meeting with the FDA and other regulatory agencies to BARDA as soon as the meeting times are known and make arrangements for appropriate BARDA staff to attend the meetings. |
d. | The Contractor shall provide BARDA the opportunity to review and comment upon any documents to be submitted to the FDA or other regulatory agency. The Contractor shall provide BARDA with five (5) business days in which to review and provide comments back to the Contractor prior to the Contractor’s submission to the FDA. |
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e. | The Contractor shall forward Standard Operating Procedures (SOPs) upon request from COR. |
f. | The Contractor shall provide raw data and/or specific analysis of data generated with USG funds upon request from the COR. |
g. | The Contractor shall notify the Contracting Officer’s Representative and Contracting Officer within 24 hours of all FDA arrivals to conduct site visits/audits by any regulatory agency. The Contractor shall provide the USG with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR). The Contractor shall provide the Contracting Officer’s Representative and Contracting Officer copies of the plan for addressing areas of non-conformance to FDA regulations for GLP guidelines as identified in the audit report, status updates during the plans execution, and a copy of all final responses to the FDA. The Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. The Contractor shall make arrangements with the COR for the appropriate BARDA representative(s) to be present during the final debrief by the regulatory inspector. |
E. | Other Requirements/Deliverables |
a. |
Integrated Master Project Plan
The Contractor shall provide an Integrated Master Project Plan (including tabular and Gantt forms) to BARDA that clearly indicates the critical path to annual deliverables and Work Breakdown Structure (WBS) elements. Attention shall be placed on providing sufficient turnaround time for the USG (BARDA, FDA, and CDC) for review of critical documentation. The Contractor shall integrate to demonstrate interdependencies among all CLINS. The Integrated Master Project Plan shall be incorporated into any potential contract and will be used to monitor performance of the contract. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Co- COR. |
i. |
Critical Path Milestones
The Integrated Master Project Plan shall outline key, critical path milestones, with “Go/No Go” decision criteria (entrance and exit criteria for each phase of the project). This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Co-COR. |
ii. |
Work Breakdown Structure
The USG has provided a Contract Work Breakdown Structure (CWBS) template (See http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx ) and the Contractor shall further delineate the CWBS to Level 5 as part of their Integrated Master Project Plan. The WBS shall be discernable and consistent. BARDA may require Contractor to furnish WBS data at the work package level or at a lower level if there is significant complexity and risk associated with the task. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Co-COR. |
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iii. |
Risk Mitigation Plan/Matrix
The Contractor shall develop and maintain a risk management plan that highlights potential problems and/or issues that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan shall reference relevant WBS/SOW elements where appropriate. The USG has provided a Risk Mitigation Matrix template (See http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx) to be completed by any prospective Contractor. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Co-COR. |
b. |
Technology Packages
Technology packages developed under the contract that includes complete protocols must be submitted at the request of the BARDA Contracting Officer’s Representative. See FAR clauses 52.227-11, Patent Rights-Ownership by the Contractor, and 52.227-14, Rights in Data. This report shall be due upon request from the COR or Co-COR. |
c. |
Annual/Final Invention Report
All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor, including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification. An Annual Invention Report shall be due on or before the 30 th calendar day after the completion of each reporting period. A Final Invention Report (see FAR 27.303 (b)(2)(ii)) shall be due on or before the expiration date of the contract. If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer. |
d. |
Publications
Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted to COR for review prior to submission. Reports shall be due within 30 calendar days for manuscripts and 15 calendar days for abstracts. |
e. |
Press Releases
The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. The Contractor shall ensure the Contracting Officer has received and approved an advanced copy of any press release not less than two (2) business days prior to the issuance of any potential press release. |
g. |
Incident Security Report
The Contractor shall report to the government any activity; or incident that is in violation of established security standards; or indicates the loss or theft of government products. Reports shall be due within 24 hours after occurrence of an activity or incident. |
h. |
Security Plan
The Contractor shall submit a draft security plan within 90 days of contract award. A detailed security plan with any updates shall be submitted for approval at least three (3) months prior to the initiation of product procurement with proper documentation. The Contractor shall cooperate with USG representatives to develop a sustainable security plan to ensure continued security of the premises. Security plan updates are required when an incident security report has been filed. |
i. |
Quality Management System (QMS) Plan
The Contractor shall provide a QMS plan within 90 days of contract award with updates at least three (3) months prior to initiation of product procurement or as directed by the COR or Co-COR. The Contractor agrees to incorporate USG feedback and address concerns relating to QMS plans. |
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j. |
Quality Agreement Report
The Quality Agreement Report shall specify the responsibilities of both the Contractor and the USG (i.e. – CDC/SNS-Quality Control and BARDA) for event-driven and product shipping, receiving, acceptance into the inventory and/or custody by the USG. These documents shall be drafted and signed by all parties prior to the commencement of product procurement and acceptance, transport and custody of the product under the VMI/DMI or the CDC/SNS. The Contractor shall provide documentation and resolution for all concerns raised by USG and commits to cooperation in execution of this agreement. Quality Agreement Reports are due at least three (3) months prior to initiation of product procurement or as directed by the COR or Co-COR. |
k. |
Vendor Managed Inventory (VMI) Plan
The Contractor shall develop a plan to establish VMI in alignment with the Quality Agreement Report. Interim draft plans shall be submitted to USG as part of the development process. Draft submission for review is due upon completion of pre-EUA package. Final submission is required to initiate product procurement through a COA. Documents shall be updated as required by the COR or Co-COR. Developmental updates should be reported in the monthly reports as requested by the COR or Co-COR. |
A minimum of three (3) product deliveries from different manufacturing lots shall be delivered and accepted by USG to the inventory (considered as substantial delivery to the inventory) before the Contractor shall invoice for the product payment.
F. | Earned Value Management System Plan |
a. | Earned Value Management System Plan: |
Subject to the requirements under HHSAR Clause 352.234-3, the Contractor shall use principles of Earned Value Management System (EVMS) in the management of this contract (include this plan as part of the monthly, annual, and final reports). The Seven Principles are:
I. | Plan all work scope for the program to completion. |
II. | Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives. |
III. | Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured. Control changes to the baseline. |
IV. | Use actual cost incurred and recorded in accomplishing the work performed. |
V. | Objectively assess accomplishments at the work performance level. |
VI. | Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed. |
VII. | Use earned value information in the company’s management processes. |
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VIII. | Elements of EVMS shall be applied to all CLINs as part of the Integrated Master Project Plan, the Contractor shall submit a written summary of the management procedures that it will establish, maintain and use to comply with EVMS requirements. |
b. | Performance Measurement Baseline Review (PMBR): |
The Contractor shall submit a PMBR plan electronically via email to the CO and COR for a PMBR to occur within 90 days of contract award. At the PMBR, the Contractor and BARDA shall mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines shall be the basis for monitoring and reporting progress throughout the life of the contract. The PMBR is conducted to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and logically planned, and have adequate resources assigned. The goals of the PMBR are as FOLLOWS:
I. | Jointly assess areas such as the Contractor’s planning for complete coverage of the SOW, logical scheduling of the work activities, adequate resources, and identification of inherent risks. |
II. | Confirm the integrity of the Performance Measurement Baseline (PMB). |
III. | Foster the use of EVM as a means of communication. |
IV. | Provide confidence in the validity of Contractor reporting |
V. | Identify risks associated with the PMB. |
VI. | Present any revised PMBs for approval. |
VII. | Present an Integrated Master Schedule: The Contractor shall deliver an initial program level Integrated Master Schedule (IMS) that rolls up all time-phased WBS elements down to the activity level. This IMS shall include the dependencies that exist between tasks. This IMS will be agreed to and finalized at the PMBR. DI-MGMT-81650 may be referenced as guidance in creation of the IMS (see http://www.acq.osd.mil/pm/). |
VIII. | Present the Risk Management Plan. |
c. | Integrated Master Schedule |
The Contractor shall submit an IMS electronically via email as outlined in a format agreed upon by BARDA to the COR and the Contracting Officer for approval prior to the initiation of any activities of sufficient size and cost to require EVMS. The Integrated Master Schedule shall be incorporated into the contract, and shall be used to monitor performance of the contract. The Contractor shall include the key milestones and Go/No Go decision gates. The Contractor shall include BARDA Portfolio Management Milestones (See the AMCG Business Toolkit for a description and sample ( http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx ) in their IMS and provide monthly updates within their IMS. This IMS shall include the following fields at a minimum; baseline start and finish, forecast start and finish, actual start and finish, predecessor and/or successor. The Contractor shall deliver the Integrated Master Schedule, viewed at the work package level in MS Project file format
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d. | Earned Value Contract Performance Report (EV-CPR) |
a. | The Offeror shall deliver an Earned Value Contract Performance Report (CPR) on a monthly basis per the instruction in DI-MGMT-81466A (see http://www.acq.osd.mil/pm/ ). The Contractor shall provide Format 1, Format 3, and Format 5 only. Format 1 will be reported at the Work Breakdown Structure level agreed to by BARDA and the Contractor. |
b. | EV Variance thresholds will be negotiated with the Contractor post-award but for planning purposes will likely be (+/- 10%). In conjunction with the CPR, the Contractor shall provide a monthly update to the IMS with up to date performance data and shall include actual start/finish and projected start / finish dates. |
c. | The supplemental monthly CAP report shall contain, at the work package level, time phased budget (budgeted cost of work scheduled (BCWS)), earned value (budgeted cost of work performed (BCWP)), and actual costs of work performed (ACWP) as captured in the Contractor’s EVM systems. |
d. | The Contractor and BARDA shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the COR. Such meetings may include, but are not limited to, site visits to the Contractor’s and/or subcontractor’s facilities, meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The Contractor shall provide data, reports, and presentations to groups of outside experts and USG personnel and Government-contracted subject matter experts as required by the BARDA COR in order to facilitate review of contract activities. |
e. | The Contractor shall provide a list of individuals to serve as primary and secondary points of contact who will be available 24 hours a day, seven days a week, to be notified in case of a public health emergency. |
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ARTICLE F.3. DELIVERIES
Successful performance of the final contract shall be deemed to occur upon performance of the work set forth in the Statement of Work dated September 28, 2015 set forth in SECTION J - List of Attachments of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule below:
Item
No. |
Description | Addresses | Deliverable Schedule |
1 | Monthly Progress Report |
CO: (1) electronic copy
COR: (1) electronic copy
|
Reports are due on or before the 15 th of each month following the end of each reporting period. |
2 | Annual Progress Report |
CO: (1) electronic copy
COR: (1) electronic copy
|
Reports are due on or before the 30 th calendar day following the end of each reporting period. |
3 | Draft Final Progress Report |
CO: (1) electronic copy
COR: (1) electronic copy
|
Report is due 45 Calendar days prior to the expiration date of the contract. |
4 | Final Progress Report |
CO: (1) electronic copy
COR: (1) electronic copy
|
Report is due no later than 30 calendar days after the expiration date of the contract. |
5 |
FDA/ Regulatory Agency Correspondence and Meeting Summaries
|
COR: (1) electronic copy | Reports are due within 5 business days of each meeting for Contractor’s minutes, upon receipt of minutes from FDA/ regulatory agency, and upon request from the COR or Co-COR. |
6 |
Integrated Master Project Plan
- Work Breakdown Structure - Risk Mitigation Plan/Matrix
|
COR: (1) electronic copy | Report is due within 90 days of contract award. Updates are due as requested by the COR or Alternate COR. |
7 | Technology Packages | COR: (1) electronic copy | Upon request from the COR or Co-COR. |
8 | Experimental Protocols | COR: (1) electronic copy | Upon request from the COR or Co-COR. |
9 | Annual/Final Invention Report |
CO: (1) electronic copy
COR: (1) electronic copy
|
An Annual Invention Report is due on or before the 30 th calendar day after the completion of each reporting period. A Final Invention Report is due on or before the expiration date of the contract. |
10 | Publications | COR: (1) electronic copy | Reports are due within 30 calendar days for manuscripts and 15 calendar days for abstracts. |
11 | Press Releases |
CO: (1) electronic copy
COR: (1) electronic copy
|
Reports/Notices are due for approval to the CO not less than two (2) business days prior to the issuance of any potential press release. |
12 | Incident Security Report |
CO: (1) electronic copy
COR: (1) electronic copy
|
Reports are due within 24 hours after occurrence of an activity or incident. |
13 | Security Plan |
CO: (1) electronic copy
COR: (1) electronic copy
|
Draft report is due within 90 days of contract award. Updates are due at least 3 months prior to product procurement or as requested by the COR or Co-COR. |
14 | Quality Management System (QMS) Plan | COR: (1) electronic copy | Draft report is due within 90 days of contract award. Updates are due at least 3 months prior to product procurement or as requested by the COR or Co-COR. |
15 | Quality Agreement Report | COR: (1) electronic copy | Reports are due at least 3 months prior to product procurement or as directed by the COR or Co-COR. |
16 | VMI Plan |
CO: (1) electronic copy
COR: (1) electronic copy
|
Plan is due upon completion of the Pre-EAU package. |
17 | Earned Value Management Requirements |
CO: (1) electronic copy
COR: (1) electronic copy
|
As detailed in Section F.2 Reporting Requirements, subpart -F. |
Email Addresses: CO –
matthew.rose@hhs.gov
COR – Julio.Barrera-Oro@hhs.gov
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ARTICLE F.4. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)
This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. The full text of each clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html.
FAR 52.242-15, Stop Work Order (August 1989)
FAR 52.242-15, Stop Work Order (August 1989), Alternate 1 (April 1984)
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SECTION G – CONTRACT ADMINISTRATION DATA
ARTICLE G.1. CONTRACTING OFFICER
The following Contracting Officer (CO) will represent the Government for the purpose of this contract:
Matthew
Rose, CO
DHHS/OS/ASPR/AMCG
200 C St.
Washington, D.C. 20024
a. | The Contracting Officer (CO) is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the CO can make any changes to the terms, conditions, general provisions, specifications or other requirements of this contract. |
b. | The Contracting Officer (CO) is the only person with authority to act as agent of the Government under this contract. Only the CO has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. |
c. | No information, other than that which may be contained in an authorized modification to this contract duly issued by the CO, shall be considered grounds for deviation from this contract. |
d. | The Government may unilaterally change its CO designation |
ARTICLE G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)
The following Contracting Officer’s Representative (COR) will represent the Government for the purpose of this contract:
Julio
Barrera-Oro, PhD
Contracting Officer’s Representative
Biomedical
Advanced Research and Development Authority (BARDA)
Office of the Assistant Secretary for Preparedness and Response
Department
of Health and Human Services
Julio.Barrera-Oro@hhs.gov
(202) 260-0393
Mailing Address:
330
Independence Avenue, S.W.
Room 640G
Washington, D.C. 20201
Alternate COR :
Narayan Iyer, PhD
Alternate Project Officer (PO), Alternate Contracting Officer’s Representative (COR)
Biomedical Advanced Research and Development Authority (BARDA)
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
narayan.iyer@hhs.gov
(202) 260-0455
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Mailing Address:
330
Independence Avenue, SW, RM G-640
Washington, D.C. 20201
The COR is responsible for:
a. | Monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; |
b. | Assisting the Contracting Officer in interpreting the statement of work and any other technical performance requirements; |
c. | Performing technical evaluation as required; |
d. | Performing technical inspections and assisting the Contracting Officer in acceptances of deliverables required by this contract; and |
e. | Assisting in the resolution of technical problems encountered during performance. |
f. | The Government may unilaterally change its COR designation(s). |
ARTICLE G.3. KEY PERSONNEL
The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.
The following individuals are considered to be essential to the work being performed hereunder:
ARTICLE G.4. INVOICE SUBMISSION
a. | The Contractor shall submit an electronic copy of contract monthly invoices/financial reports to the Contracting Officer as defined above, in ARTICLE G of this contract. |
b. | Contractor invoices/financial reports shall conform to the form, format, and content requirements of the instructions for Invoice/Financing requests made a part of the contract at Section J, Attachments 2 & 3. |
c. | Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government. |
d. | The Contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the estimated costs for the base period or any options for additional quantities (See estimated costs under Articles B.2 and B.3) and the reasons for the variance. Also refer to the requirements of FAR Clause 52.232-20, Limitation of Cost. |
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e. | The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor’s name, contract number, and unique invoice number. |
f. | All invoice submissions shall be in accordance with FAR Clause 52.232-25, Prompt Payment. |
ARTICLE G.5. INDIRECT COST RATES
1. | The following interim provisional indirect rates will be utilized for billing purposes during the period of performance: 80%. Final rate proposals must be sent to the Contracting Officer, within 6 months of the fiscal year end. See FAR Clause 52.216-7, Allowable Cost and Payment. |
2. | The interim provisional indirect rates used in this contract have been established after approval by the AMCG/BARDA Auditor. |
ARTICLE G.6. REIMBURSEMENT OF COST
1) | The Government shall reimburse the Contractor those costs determined by the Contracting Officer to be allowable (hereinafter referred to as allowable cost) in accordance with FAR 52.216-7, Allowable Cost and Payment and FAR Subpart 31.2. Examples of allowable costs include, but are not limited to, the following: |
a) | All direct materials and supplies that are used in the performing of the work provided for under the contract, including those purchased for subcontracts and purchase orders. |
b) | All direct labor, including supervisory, that is properly chargeable directly to the contract, plus fringe benefits. |
c) | All other items of cost budgeted for and accepted in the negotiation of this basic contract or modifications thereto. |
d) | Travel costs including per diem or actual subsistence for personnel while in an actual travel status in direct performance of the work and services required under this contract subject to the following: |
i. | Air travel shall be by the most direct route using “air coach” or “air tourist” (less than first class) unless it is clearly unreasonable or impractical (e.g., not available for reasons other than avoidable delay in making reservations, would require circuitous routing or entail additional expense offsetting the savings on fare, or would not make necessary connections). |
ii. | Rail travel shall be by the most direct route, first class with lower berth or nearest equivalent. |
iii. | Costs incurred for lodging, meals, and incidental expenses shall be considered reasonable and allowable to the extent that they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulation (FTR). |
iv. | Travel via privately owned automobile shall be reimbursed at not more than the current General Services Administration (GSA) FTR established mileage rate. | |
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ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
1. Contractor Performance Evaluations
Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) will be prepared annually as to coincide with the Anniversary date of the contract.
Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer whose decision will be final.
Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.
2. Electronic Access to Contractor Performance Evaluations
Contractors may access evaluations through a secure website for review and comment at the following:
http://cpars.gov
ARTICLE G.8. CONTRACT COMMUNICATIONS/CORRESPONDENCE (JULY 1999)
The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting the contract number HHSO100201500035C from Page 1 of the contract
ARTICLE G.9. GOVERNMENT PROPERTY
1. | In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall comply with the provisions of HHS Publication, “Contractor’s Guide for Control of Government Property,” which is incorporated into this contract by reference. This document can be accessed at: |
http://www.hhs.gov/hhsmanuals/ (HHS Logistics Management Manual)
Among other issues, this publication provides a summary of the Contractor’s responsibilities regarding purchasing authorizations and inventory and reporting requirements under the contract.
2. | Notwithstanding the provisions outlined in the HHS Publication, “Contractor’s Guide for Control of Government Property,” which is incorporated in this contract in paragraph 1. above, the Contractor shall use the form entitled, “Report of Government Owned, Contractor Held Property” for submitting summary reports required under this contract, as directed by the Contracting Officer or his/her designee. This form is included as an attachment in SECTION J of this contract. |
3. | Title will vest in the Government for equipment purchased as a direct cost. |
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SECTION H – SPECIAL CONTRACT REQUIREMENTS
ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (January 2006)
a. | The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor’s current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance. |
b. | The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. The Contractor shall not deem anything in this contract to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees. |
c. | If at any time during the performance of this contract, the Contracting Officer determines, in consultation with OHRP that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with approved Human Subject Assurances. |
ARTICLE H.2. CLINICAL RESEARCH
These Clinical Terms apply to all contracts that involve clinical research.
The Government shall have unlimited rights to all protocols, data generated from the execution of these protocols, and final reports, funded by the Government under this contract, as defined in Rights in Data Clause in FAR 52.227-14. The Government reserves the right to request that the Contractor provide any contract deliverable in a non-proprietary form, to ensure the Government has the ability to review and distribute the deliverables, as the Government deems necessary.
H.2.1 Safety and Monitoring Issues
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval
Before award and then with Annual Progress Reports, the Contractor shall submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site.
If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution’s IRB or IEC must review and approve the protocol. They must also provide the Government initial and annual documentation of continuing review and approval, including the current approved informed consent document and FWA number.
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The grantee institution must ensure that the applications as well as all protocols are reviewed by their IRB or IEC.
To help ensure the safety of participants enrolled in BARDA-funded studies, the Contractor must provide the Government a summary explanation and copies of documents related to all major changes in the status of ongoing protocols, including the following:
1. | All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid. | |
2. | All changes in informed consent documents, identified by version number, date, or both and dates it is valid. | |
3. | Termination or temporary suspension of patient accrual. | |
4. | Termination or temporary suspension of the protocol. | |
5. | Any change in IRB approval. | |
6. | Any other problems or issues that could affect the participants in the studies. |
Contractors must notify BARDA through the Contracting Officer’s Technical Representative (COR) and Contracting Officer (CO) of any of the above changes within 24 hours by email, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IRB and a copy of any responses from the IRB or IEC.
If a clinical protocol has been reviewed by an Institutional Bio-safety Committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Contractor must provide information about the initial and ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules.
H.2.2. Data and Safety Monitoring Requirements
The Contractor may be required to conduct independent safety monitoring for clinical trials of investigational drugs, devices, or biologics; clinical trials of licensed products; and clinical research of any type involving more than minimal risk to volunteers. Independent monitoring can take a variety of forms. Phase III clinical trials must have an assigned independent data and safety monitoring board (DSMB); other trials may require DSMB oversight as well. The Contractor shall inform the Government of any upcoming site visits and/or audits of Contractor facilities funded under this effort. BARDA reserves the right to accompany the Contractor on site visits and/or audits of Contractors and Subcontractors as the Government deems necessary.
The type of monitoring to be used shall be mutually agreed upon between the Contractor and the Government before enrollment starts. Discussions with the responsible BARDA COR regarding appropriate safety monitoring and approval of the final monitoring plan by BARDA must occur before patient enrollment begins and may include discussions about the appointment of one of the following:
1. | Independent Safety Monitor – a physician or other appropriate expert who is independent of the study and available in real time to review and recommend appropriate action regarding adverse events and other safety issues. | |
2. | Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC) – a small group of independent investigators and biostatisticians who review data from a particular study. | |
3. | Data and Safety Monitoring Board – an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination. The Contractor may be required to use an established BARDA DSMB or to organize an independent DSMB. All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy. The Government retains the right to place a nonvoting member on the DSMB. |
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When a monitor or monitoring board is organized, a description of it, its charter or operating procedures (including a proposed meeting schedule and plan for review of adverse events), and roster and curriculum vitae from all members must be submitted to and approved by the Government before enrollment starts.
Additionally, the Contractor must submit written summaries of all reviews conducted by the monitoring group to the Government within 30 days of reviews or meetings.
H.2.3. BARDA Protocol Review Process Before Patient Enrollment Begins
BARDA has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in BARDA-supported clinical trials. Therefore, before patient accrual or participant enrollment, the Contractor must provide the following (as applicable) for review and approval by the Government:
1. | IRB or IEC approved clinical research protocol identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility, and exclusion criteria; | |
2. | Documentation of IRB or IEC approval, including OHRP FWA number, IRB or IEC registration number, and IRB or IEC name; | |
3. | IRB or IEC approved informed consent document, identified by version number, date, or both and date it is valid; | |
4. | Plans for the management of side effects; | |
5. | Procedures for assessing and reporting adverse events; | |
6. | Plans for data and safety monitoring (see B above) and monitoring of the clinical study site, pharmacy, and laboratory; | |
7. | Documentation that the Contractor and all study staff responsible for the design or conduct of the research have received Good Clinical Practice (GCP) training in the protection of human subjects. |
BARDA comments will be forwarded to the Contractor within two weeks (10 business days) of receipt of the above information. The Contractor must address in writing all study design, safety, regulatory, ethical, and conflict of interest concerns raised by the BARDA COR to the satisfaction of the Government before patient accrual or participant enrollment can begin. After the Government receives the corrected documentation, a written protocol approval will be provided by the COR to the Contractor. This written approval provides authorization to the Contractor to execute the specific clinical study funded in part or in whole by the Government.
Documentation of IRB or IEC approval, including OHRP FWA number, IRB or IEC registration number, and IRB and IEC name, must be provided to the BARA COR within 24 hours of receipt by the Contractor.
H.2.4. Required Time-Sensitive Notification
Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer’s representative (COR) as follows:
1 . | Expedited safety report of unexpected or life-threatening experience or death – A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer’s Representative within 24 hours of FDA notification. |
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2. | Expedited safety reports of serious and unexpected adverse experiences – A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer’s Representative within 24 hours of FDA notification. |
3. | IDE reports of unanticipated adverse device effect – A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the Contracting Officer’s Representative within 24 hours of FDA notification. |
4. | Expedited safety reports – shall be sent to the COR concurrently with the report to FDA. |
5. | Other adverse events documented during the course of the trial shall be included in the annual IND or IDE report and reported to the BARDA annually. |
In case of problems or issues, the COR will contact the Contractor within 10 working days by email, followed within 7 calendar days by an official letter to the Contractor. The Contractor shall forward the official letter to the principal investigator listing issues and appropriate actions to be discussed.
Safety reporting for research not performed under an IND or IDE
Ongoing safety reporting requirements for research not performed under an IND or IDE shall be mutually agreed upon by the Contracting Officer’s Representative and the Contractor.
ARTICLE H.3. | HUMAN MATERIALS |
The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.
ARTICLE H.4. | CARE OF LIVE VERTEBRATE ANIMALS |
a. | Before undertaking performance of any contract involving animal-related activities where the species is regulated by USDA, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer. |
b. | The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections. |
c. | The Contractor agrees that the care, use and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern. |
d. | If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with approved Assurances. |
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Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail: ace@aphis.usda.gov ; Web site: ( http://www.aphis.usda.gov/animal welfare ).
ARTICLE H.5. | ANIMAL WELFARE |
All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. This policy may be accessed at: http://grants1.nih.gov/grants/olaw/references/phspol.htm
ARTICLE H.6. | INFORMATION ON COMPLIANCE WITH ANIMAL CARE REQUIREMENTS |
Registration with the U. S. Dept. of Agriculture (USDA) is required to use regulated species of animals for biomedical purposes. USDA is responsible for the enforcement of the Animal Welfare Act (7 U.S.C. 2131 et. seq.), http://www.nal.usda.gov/awic/legislat/awa.htm .
The Public Health Service (PHS) Policy is administered by the Office of Laboratory Animal Welfare (OLAW) http://grants2.nih.gov/grants/olaw/olaw.htm . An essential requirement of the PHS Policy http://grants2.nih.gov/grants/olaw/references/phspol.htm is that every institution using live vertebrate animals must obtain an approved assurance from OLAW before they can receive funding from any component of the U. S. Public Health Service.
The PHS Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals http://www.nap.edu/readingroom/books/labrats/ and that they comply with the regulations (9 CFR, Subchapter A) http://www.nal.usda.gov/awic/legislat/usdaleg1.htm issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act. The Guide may differ from USDA regulations in some respects. Compliance with the USDA regulations is an absolute requirement of this Policy.
The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) http://www.aaalac.org is a professional organization that inspects and evaluates programs of animal care for institutions at their request. Those that meet the high standards are given the accredited status. As of the 2002 revision of the PHS Policy, the only accrediting body recognized by PHS is the AAALAC. While AAALAC Accreditation is not required to conduct biomedical research, it is highly desirable. AAALAC uses the Guide as their primary evaluation tool. They also use the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. It is published by the Federated of Animal Science Societies http://www.fass.org .
ARTICLE H.7. | REQUIREMENTS FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE ANIMAL SUBJECTS |
The PHS Policy on Humane Care and Use of Laboratory Animals requires that applicant organizations proposing to use vertebrate animals file a written Animal Welfare Assurance with the Office for Laboratory Animal Welfare (OLAW), establishing appropriate policies and procedures to ensure the humane care and use of live vertebrate animals involved in research activities supported by the PHS. The PHS Policy stipulates that an applicant organization, whether domestic or foreign, bears responsibility for the humane care and use of animals in PHS- supported research activities. Also, the PHS policy defines “animal” as “any live, vertebrate animal used, or intended for use, in research, research training, experimentation, biological testing or for related purposes.” This Policy implements and supplements the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, and requires that institutions use the Guide for the Care and Use of Laboratory Animals as a basis for developing and implementing an institutional animal care and use program. This Policy does not affect applicable State or local laws or regulations that impose more stringent standards for the care and use of laboratory animals. All institutions are required to comply, as applicable, with the Animal Welfare Act as amended (7 USC 2131 et. seq.) and other Federal statutes and regulations relating to animals. These documents are available from the Office of Laboratory Animal Welfare, National Institutes of Health, Bethesda, MD 20892, (301) 496-7163. See http://grants.nih.gov/grants/olaw/olaw.htm .
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No PHS supported work for research involving vertebrate animals will be conducted by an organization, unless that organization is operating in accordance with an approved Animal Welfare Assurance and provides verification that the Institutional Animal Care and Use Committee (IACUC) has reviewed and approved the proposed activity in accordance with the PHS policy. Applications may be referred by the PHS back to the institution for further review in the case of apparent or potential violations of the PHS Policy. No award to an individual will be made unless that individual is affiliated with an assured organization that accepts responsibility for compliance with the PHS Policy. Foreign applicant organizations applying for PHS awards for activities involving vertebrate animals are required to comply with PHS Policy or provide evidence that acceptable standards for the humane care and use of animals will be met. Foreign applicant organizations are not required to submit IACUC approval, but should provide information that is satisfactory to the Government to provide assurances for the humane care of such animals.
ARTICLE H.8. | APPROVAL OF REQUIRED ASSURANCE BY OLAW |
Under governing regulations, federal funds which are administered by the Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority (BARDA) shall not be expended by the Contractor for research involving live vertebrate animals, nor shall live vertebrate animals be involved in research activities by the Contractor under this award unless a satisfactory assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 is submitted within 30 days of the date of this award and approved by the Office of Laboratory Animal Welfare (OLAW). Each performance site (if any) must also assure compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 with the following restriction: Only activities which do not directly involve live vertebrate animals (i.e. are clearly severable and independent from those activities that do involve live vertebrate animals) may be conducted by the Contractor or individual performance sites pending OLAW approval of their respective assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28. Additional information regarding OLAW may be obtained via the Internet at http://grants2.nih.gov/grants/olaw/references/phspol.htm
ARTICLE H.9. | NEEDLE DISTRIBUTION |
The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.
ARTICLE H.10. | ACKNOWLEDGEMENT OF FEDERAL FUNDING |
The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.
ARTICLE H.11. | RESTRICTION ON ABORTIONS |
The Contractor shall not use funds for any abortion.
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ARTICLE H.12. | CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH |
The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of Injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term “human embryo or embryos” includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.
Additionally, in accordance with the March 4, 1997 Presidential Memorandum entitled “Prohibition on Federal Funding for Cloning of Human Beings”, federal funds may not be used for cloning of human beings.
ARTICLE H.13. | DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION |
The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.
ARTICLE H.14. | OMB CLEARANCE |
In accordance with HHSAR 352.201-70, Paperwork Reduction Act of 1980, (44 U.S.C. section 3501) the Contractor shall not proceed with surveys or interviews until such time as Office of Management and Budget (OMB) Clearance for conducting interviews has been obtained by the Contracting Officer’s Representative (COR) and the Contracting Officer has issued written approval to proceed.
ARTICLE H.15. | RESEARCH INVOLVING HUMAN FETAL TISSUE |
All research involving human fetal tissue shall be conducted in accordance with the Public Health Service Act, 42 U.S.C. 289g-1 and 289g-2. Implementing regulations and guidance for conducting research on human fetal tissue may be found at 45 CFR 46, Subpart B and http://grants1.nih.gov/grants/guide/notice- files/not93-235.html and any subsequent revisions to this NIH Guide to Grants and Contracts (“Guide”) Notice.
The Contractor shall make available, for audit by the Secretary, HHS, the physician statements and informed consents required by 42 USC 289g-1 (b) and (c), or ensure HHS access to those records, if maintained by an entity other than the Contractor.
ARTICLE H.16. | REPORTING MATTERS INVOLVING FRAUD, WASTE, AND ABUSE |
Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in BARDA funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is:
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026
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ARTICLE H.17. | PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES |
The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.
ARTICLE H.18. | RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS |
The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.
ARTICLE H.19. | CERTIFICATION OF FILING AND PAYMENT OF TAXES |
The Contractor must be in compliance with Section 518 of the Consolidated Appropriations Act of FY 2014.
ARTICLE H.20. | ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY NOTICE |
a. | Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency. |
b. | Accordingly, any Offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508 . The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm . |
c. | The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility. |
In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, Offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows Offerors or developers to self-evaluate their supplies and document--in detail--whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508 .
In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, Offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.
d. | Respondents to this solicitation must identify any exception to Section 508 requirements. If a Offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense. |
(End of provision)
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ARTICLE H. 21. | FULL EARNED VALUE MANAGEMENT SYSTEM, HHSAR 352.234-3 (October 2008) with ALTERNATE I (October 2008) |
a. | The Contractor shall use an Earned Value Management System (EVMS) that is compliant with the guidelines in ANSI/EIA Standard-748 (current version at the time of award) to manage this contract. If the Contractor’s current EVMS is not compliant at the time of award, see paragraph (b) of this clause. The Contractor shall submit EVM reports in accordance with the requirements of this contract. |
b. | If, at the time of award, the Contractor’s EVM system is not in compliance with the EVMS guidelines in ANSI/EIA Standard-748 (current version at time of award), the Contractor shall: |
a. | Apply the current system to the contract; and |
b. | Take necessary and timely actions to meet the milestones in the Contractor’s EVMS plan approved by the Contracting Officer. |
c. | HHS will not formally validate or accept the Contractor’s EVMS with respect to this contract. The use of the Contractor’s EVMS for this contract does not imply HHS acceptance of the Contractor’s EVMS for application to future contracts. The Contracting Officer or designee will conduct a Compliance Review to assess the Contractor’s compliance with its approved plan. If the Contractor does not follow the approved implementation schedule or correct all resulting system deficiencies noted during the Compliance Review within a reasonable time, the Contracting Officer may take remedial action that may include, but is not limited to, suspension of or reduction in progress payments, or a reduction in fee. |
d. | HHS will conduct a Performance Measurement Baseline Review (PMBR). If a pre-award PMBR has not been conducted, a post-award PMBR will be conducted by HHS as early as practicable, but no later than ninety (90) days after contract award. The Contracting Officer may also require a PMBR as part of the exercise of an option or the incorporation of a major modification. |
e. | The Contractor shall provide access to all pertinent records and data requested by the Contracting Officer or a duly authorized representative as necessary to permit Government surveillance to ensure that the EVMS conforms, and continues to conform to the requirements referenced in paragraph (a) of this clause. |
f. | The Contractor shall require the subcontractors specified below to comply with the requirements of the clause: |
ARTICLE H. 22. | CONFIDENTIALITY OF INFORMATION |
a. | Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization. |
b. | The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the “Disputes” clause. |
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c. | If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act. |
d. | Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization. |
e. | Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor shall obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication. |
f. | Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials. |
The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.
ARTICLE H.23. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR CONFLICTS OF INTERESTS
The
Institution (includes any Contractor, public or private, excluding a Federal agency) shall comply with the requirements of 45
CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure that
Investigators (defined as the project director or principal Investigator and any other person, regardless of title or position,
who is responsible for the design, conduct, or reporting of research funded under BARDA contracts, or proposed for such funding,
which may include, for example, collaborators or consultants) will not be biased by any Investigator financial conflicts of interest.
45 CFR Part 94 is available at the following Web site:
http://www.ecfr.gov/cgi- bin/text-
idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=
45
As required by 45 CFR Part 94, the Institution shall, at a minimum:
a. | Maintain an up-to-date, written, enforceable policy on financial conflicts of interest that complies with 45 CFR Part 94, inform each Investigator of the policy, the Investigator’s reporting responsibilities regarding disclosure of significant financial interests, and the applicable regulation, and make such policy available via a publicly accessible Web site, or if none currently exist, available to any requestor within five business days of a request. A significant financial interest means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities: |
1. | With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Included are payments and equity interests; |
2. | With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest; or |
3. | Intellectual property rights and interests, upon receipt of income related to such rights and interest. |
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Significant financial interests do not include the following:
4. | Income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes with an Institution of higher learning; and |
5. | Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles. |
b. | Require each Investigator to complete training regarding the Institution’s financial conflicts of interest policy prior to engaging in research related to any BARDA funded contract and at least every four years. The Institution must take reasonable steps [see Part 94.4(c)] to ensure that investigators working as collaborators, consultants or subcontractors comply with the regulations. |
c. | Designate an official(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the BARDA funded research. |
d. | Require that each Investigator who is planning to participate in the BARDA funded research disclose to the Institution’s designated official(s) the Investigator’s significant financial interest (and those of the Investigator’s spouse and dependent children) no later than the date of submission of the Institution’s proposal for BARDA funded research. Require that each Investigator who is participating in the BARDA funded research to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by the Institution during the period of the award as well as within thirty days of discovering or acquiring a new significant financial interest. |
e. | Provide guidelines consistent with the regulations for the designated official(s) to determine whether an Investigator’s significant financial interest is related to BARDA funded research and, if so related, whether the significant financial interest is a financial conflict of interest. An Investigator’s significant financial interest is related to BARDA funded research when the Institution, thorough its designated official(s), reasonably determines that the significant financial interest: Could be affected by the BARDA funded research; or is in an entity whose financial interest could be affected by the research. A financial conflict of interest exists when the Institution, through its designated official(s), reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the BARDA funded research. |
f. | Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a subcontractor Investigator. Management of an identified financial conflict of interest requires development and implementation of a management plan and, if necessary, a retrospective review and mitigation report pursuant to Part 94.5(a). |
g. | Provide initial and ongoing FCOI reports to the Contracting Officer pursuant to Part 94.5(b). |
h. | Maintain records relating to all Investigator disclosures of financial interests and the Institution’s review of, and response to, such disclosures, and all actions under the Institution’s policy or retrospective review, if applicable, for at least 3 years from the date of final payment or, where applicable, for the other time periods specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention. |
i. | Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate. |
j. | Complete the certification in Section K - Representations, Certifications, and Other Statements of Contractors titled “Certification of Institutional Policy on Financial Conflicts of Interest”. |
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If the failure of an Institution to comply with an Institution’s financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the BARDA funded research, the Institution must promptly notify the Contracting Officer of the corrective action taken or to be taken. The Contracting Officer will consider the situation and, as necessary, take appropriate action or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the BARDA funded research project.
The Contracting Officer and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial interests, and the Institution’s review of, and response to, such disclosure, regardless of whether the disclosure resulted in the Institution’s determination of a financial conflict of interests. The Contracting Officer may require submission of the records or review them on site. On the basis of this review of records or other information that may be available, the Contracting Officer may decide that a particular financial conflict of interest will bias the objectivity of the BARDA funded research to such an extent that further corrective action is needed or that the Institution has not managed the financial conflict of interest in accordance with Part 94.6(b). The issuance of a Stop Work Order by the Contracting Officer may be necessary until the matter is resolved.
If the Contracting Officer determines that BARDA funded clinical research, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the Institution, the Institution shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.
ARTICLE H.24. PUBLICATION AND PUBLICITY
The Contractor shall acknowledge the support of the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:
“This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500035C
Press Releases:
The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money that: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by non-Governmental sources.
ARTICLE H.25. ACCESS TO DOCUMENTATION/DATA
The Government shall have physical and electronic access to all documentation and data generated under this contract, including: all data documenting Contractor performance, all data generated, all communications and correspondence with regulatory agencies and bodies to include all audit observations, inspection reports, milestone completion documents, and all Contractor commitments and responses. Contractor shall provide the Government with an electronic copy of all correspondence with the FDA within 24 hours of receipt. The Government shall acquire unlimited rights to all data funded under a contract awarded in response to this RFP in accordance with FAR Subpart 27.4 and FAR Clause 52.227-14.
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ARTICLE H.26. DISSEMINATION OF INFORMATION
No information related to data obtained under this contract shall be released or publicized without the prior written consent of the COR, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that no such consent is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any government entity’ for submission to any securities exchange on which the Contractor’s (or its parent corporation’s) securities may be listed for trading; or to third parties relating to securing, seeking, establishing or maintaining regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers, acquisitions, or other business transactions.
ARTICLE H.27. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION
The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.
ARTICLE H.28. IDENTIFICATION AND DISPOSITION OF DATA
The Contractor will be required to provide certain data generated under this contract to the Department of Health and Human Services (HHS). HHS reserves the right to review any other data determined by HHS to be relevant to this contract. The Contractor shall keep copies of all data required by the Food and Drug Administration (FDA) relevant to this contract for the time specified by the FDA.
ARTICLE H.29. CONFLICT OF INTEREST
The Contractor represents and warrants that, to the best of the Contractor’s knowledge and belief, there are no relevant facts or circumstances which could give rise to an organizational conflict of interest, as defined in FAR 2.101 and Subpart 9.5, or that the Contractor has disclosed all such relevant information. Prior to commencement of any work, the Contractor agrees to notify the Contracting Officer promptly that, to the best of its knowledge and belief, no actual or potential conflict of interest exists or to identify to the Contracting Officer any actual or potential conflict of interest the firm may have. In emergency situations, however, work may begin but notification shall be made within five (5) working days. The Contractor agrees that if an actual or potential organizational conflict of interest is identified during performance, the Contractor shall promptly make a full disclosure in writing to the Contracting Officer. This disclosure shall include a description of actions which the Contractor has taken or proposes to take, after consultation with the Contracting Officer, to avoid, mitigate, or neutralize the actual or potential conflict of interest. The Contractor shall continue performance until notified by the Contracting Officer of any contrary action to be taken. Remedies include termination of this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid an organizational conflict of interest. If the Contractor was aware of a potential organizational conflict of interest prior to award or discovered an actual or potential conflict after award and did not disclose it or misrepresented relevant information to the Contracting Officer, the Government may terminate the contract for default, debar the Contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.
ARTICLE H.30. IN-PROCESS REVIEW
In Process Reviews (IPR) will be conducted at the discretion of the Government to discuss the progression of the milestones. The Government reserves the right to revise the milestones and budget pending the development of the project. Deliverables may be required when the IPRs are conducted. The Contractor’s success in completing the required tasks under each work segment must be demonstrated through the Deliverables and Milestones specified under SECTION F. Those deliverables will constitute the basis for the Government’s decision, at its sole discretion, to proceed with the work segment, or unilaterally institute changes to the work segment, or terminate the work segment.
IPRs may be scheduled at the discretion of the Government to discuss progression of the contract. The Contractor shall provide a presentation following a prescribed template which will be provided by the Government at least 30 days prior to the IPR. The Contractor shall provide a draft presentation to the Contracting Officer at least 10 days prior to the IPR.
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ARTICLE H.31. PRIVACY ACT APPLICABILITY
1) | Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of the Privacy Act to the same extent as employees of the Government. The Contractor shall assure that each of its employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal penalty for violation of the Act. A copy of 45 CFR Part 5b, Privacy Act Regulations, may be obtained at http://www.gpoaccess.gov/cfr/index.html |
2) | The Project Officer is hereby designated as the official who is responsible for monitoring contractor compliance with the Privacy Act. |
3) | The Contractor shall follow the Privacy Act guidance as contained in the Privacy Act System of Records number 09-25-0200. This document may be obtained at the following link: http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm |
ARTICLE H.32. QA AUDIT REPORTS
BARDA reserves the right to participate in QA audits. Upon completion of the audit/site visit the Contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, detailed concerns for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.
· | Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of weekly communications. The Contractor shall notify the CO and COR reasonably in advance of upcoming QA audit so that Government personnel may participate in person at BARDA’s discretion. |
· | Contractor shall notify the COR and CO within 5 business days of report completion. |
ARTICLE H.33. BARDA AUDITS
Contractor shall accommodate periodic or ad hoc site visits by the Government. If the Government, the Contractor, or other parties identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to the Government.
· | If issues are identified during the audit, Contractor shall submit a report to the CO and COR detailing the finding and corrective action(s) within 10 business days of the audit. |
· | COR and CO will review the report and provide a response to the Contractor with 10 business days. |
· | Once corrective action is completed, the Contractor will provide a final report to the CO and COR. |
ARTICLE H.34. SECURITY REPORTING REQUIREMENT
Violations of established security protocols shall be reported to the CO and COR upon discovery within 24 hours of its receipt of any compromise, intrusion, loss or interference of its security processes and procedures. The Contractor shall ensure that all software components that are not required for the operation and maintenance of the database/control system has been removed and/or disabled. The Contractor shall provide to the CO and the COR information appropriate to Information and Information Technology software and service updates and/or workarounds to mitigate all vulnerabilities associated with the data and shall maintain the required level of system security.
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The Contractor will investigate violations to determine the cause, extent, loss or compromise of sensitive program information, and corrective actions taken to prevent future violations. The CO in coordination with BARDA will determine the severity of the violation. Any contractual actions resulting from the violation will be determined by the CO.
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PART II – CONTRACT CLAUSES
SECTION I - CONTRACT CLAUSES
ARTICLE I.1. FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)
This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/FAR/ . HHSAR Clauses at: http://www.hhs.gov/policies/hhsar/subpart352.html .
General Clauses for Cost-Reimbursement/Fixed Price Research and Development Contract
(1) FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
Reg | Clause | Date | Clause Title |
FAR | 52.202-1 | Nov 2013 | Definitions |
FAR | 52.203-3 | Apr 1984 | Gratuities |
FAR | 52.203-5 | May 2014 | Covenant Against Contingent Fees |
FAR | 52.203-6 | Sep 2006 | Restrictions on Subcontractor Sales to the Government |
FAR | 52.203-7 | May 2014 | Anti-Kickback Procedures |
FAR | 52.203-8 | May 2014 | Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity |
FAR | 52.203-10 | May 2014 | Price or Fee Adjustment for Illegal or Improper Activity |
FAR | 52.203-12 | Oct 2010 | Limitation on Payments to Influence Certain Federal Transactions |
FAR | 52.203-13 | Apr 2010 | Contractor Code of Business Ethics and Conduct |
FAR | 52.203-14 | Dec 2007 | Display of Hotline Posters |
FAR | 52.203-17 | Apr 2014 | Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights |
FAR | 52.204-4 | May 2011 | Printed or Copied Double-Sided on Postconsumer Fiber Content Paper |
FAR | 52.204-7 | Jul 2013 | System for Award Management |
FAR | 52.204-10 | Jul 2013 | Reporting Executive Compensation and First-Tier Subcontract Awards |
FAR | 52.204-13 | Jul 2013 | System for Award Management Maintenance |
FAR | 52.209-6 | Aug 2013 | Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment |
FAR | 52.209-10 | Dec 2014 | Prohibition on Contracting with Inverted Domestic Corporations |
FAR | 52.210-1 | Apr 2011 | Market Research |
FAR | 52.215-2 | Oct 2010 | Audit and Records – Negotiation |
FAR | 52.215-8 | Oct 1997 | Order of Precedence - Uniform Contract Format |
FAR | 52.215-10 | Aug 2011 | Price Reduction for Defective Cost or Pricing Data |
FAR | 52.215-11 | Aug 2011 | Price Reduction for Defective Certified Cost or Pricing Data—Modifications. |
FAR | 52.215-12 | Oct 2010 | Subcontractor Certified Cost or Pricing Data |
FAR | 52.215-13 | Oct 2010 | Subcontractor Certified Cost or Pricing Data—Modifications |
FAR | 52.215-15 | Oct 2010 | Pension Adjustments and Asset Reversions |
FAR | 52.215-18 | Jul 2005 | Reversion or Adjustment of Plans for Postretirement Benefits (PRB) other than Pensions |
FAR | 52.215-19 | Oct 1997 | Notification of Ownership Changes |
FAR | 52.215-21 | Oct 2010 | Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data -Modifications |
FAR | 52.215-23 | Oct 2009 | Limitations on Pass-Through Charges |
FAR | 52.216-7 | Jun 2013 | Allowable Cost and Payment |
FAR | 52.216-8 | Jun 2011 | Fixed Fee |
FAR | 52.219-8 | Oct 2014 | Utilization of Small Business Concerns |
FAR | 52.219-28 | July 2013 | Post-Award Small Business Program Representation |
FAR | 52.222-1 | Feb 1997 | Notice to the Government of Labor Disputes |
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FAR | 52.222-2 | Jul 1990 | Payment for Overtime Premiums |
FAR | 52.222-3 | Jun2003 | Convict Labor |
FAR | 52.222-21 | Apr 2015 | Prohibition of Segregated Facilities |
FAR | 52.222-26 | Apr 2015 | Equal Opportunity |
FAR | 52.222-35 | Jul 2014 | Equal Opportunity for Veterans |
FAR | 52.222-36 | Jul 2014 | Equal Opportunity for Workers with Disabilities |
FAR | 52.222-37 | Jul 2014 | Employment Reports on Veterans |
FAR | 52.222-40 | Dec 2010 | Notification of Employee Rights Under the National Labor Relations Act |
FAR | 52.222-50 | Mar 2015 | Combating Trafficking in Persons |
FAR | 52.222-54 | Aug 2013 | Employment Eligibility Verification |
FAR | 52.223-6 | May 2001 | Drug-Free Workplace |
FAR | 52.223-18 | Aug 2011 | Encouraging Contractor Policy to Ban Text Messaging While Driving |
FAR | 52.224-1 | April 1984 | Privacy Act Notification |
FAR | 52.224-2 | April 1984 | Privacy Act |
FAR | 52.225-13 | Jun 2008 | Restrictions on Certain Foreign Purchases |
FAR | 52.227-1 | Dec 2007 | Authorization and Consent, Alternate 1 (APR 1984) |
FAR | 52.227-2 | Dec 2007 | Notice and Assistance Regarding Patent and Copyright Infringement |
FAR | 52.227-3 | Apr 1984 | Patent Indemnity |
FAR | 52.227-11 | May 2014 | Patent Rights – Ownership by the Contractor |
FAR | 52.227-14 | May 2014 | Rights in Data - General |
FAR | 52.227-14 | Dec 2007 | Alt II |
FAR | 52.228-7 | Mar 1996 | Insurance – Liability to Third Persons |
FAR | 52.229-3 | Feb 2013 | Federal, State and Local Taxes |
FAR | 52.230-4 | May 2014 | Disclosure and Consistency of Cost Accounting Practices—Foreign Concerns |
FAR | 52.230-6 | June 2010 | Administration of Cost Accounting Standards |
FAR | 52.232-1 | Apr 1984 | Payments |
FAR | 52.232-2 | Apr 1984 | Payments under Fixed-Price Research and Development Contracts |
FAR | 52.232-8 | Feb 2002 | Discounts for Prompt Payment |
FAR | 52.232-9 | Apr 1984 | Limitation on Withholding of Payments |
FAR | 52.232-11 | Apr 1984 | Extras |
FAR | 52.232-17 | May 2014 | Interest |
FAR | 52.232-20 | Apr 1984 | Limitation of Cost |
FAR | 52.232-23 | May 2014 | Assignment of Claims |
FAR | 52.232-25 | Jul 2013 | Prompt Payment |
FAR | 52.232-33 | Jul 2013 | Payment by Electronic Funds Transfer--System for Award Management |
FAR | 52.233-1 | May 2014 | Disputes |
FAR | 52.233-3 | Aug 1996 | Protest After Award, Alternate I |
FAR | 52.233-4 | Oct 2004 | Applicable Law for Breach of Contract Claim |
FAR | 52.242-1 | Apr 1984 | Notice of Intent to Disallow Costs |
FAR | 52.242-3 | May 2014 | Penalties for Unallowable Costs |
FAR | 52.242-4 | Jan 1997 | Certification of Final Indirect Costs |
FAR | 52.242-13 | Jul 1995 | Bankruptcy |
FAR | 52.242-15 | Aug 1989 | Stop Work Order, Alternate I (Aug 1984) |
FAR | 52.243-1 | Aug 1987 | Changes - Fixed-Price Alternate V (Apr 1984). |
FAR | 52.243-2 | Aug 1987 | Changes—Cost-Reimbursement Alternate V (Apr 1984). |
FAR | 52.243-7 | Apr 1984 | Notification of Changes |
FAR | 52.244-2 | Oct 2010 | Subcontracts, Alternate 1 (Jun 2007) |
FAR | 52.244-5 | Dec 1996 | Competition in Subcontracting |
FAR | 52.244-6 | Apr 2015 | Subcontracts for Commercial Items |
FAR | 52.245-1 | Apr 2012 | Government Property |
FAR | 52.245-9 | Apr 2012 | Use and Charges |
FAR | 52.246-23 | Feb 1997 | Limitation of Liability. |
FAR | 52.246-25 | Feb 1997 | Limitation of Liability—Services |
FAR | 52.248-1 | October 2010 | Value Engineering |
FAR | 52.249-2 | Apr 2012 | Termination for the Convenience of the Government (Fixed-Price) |
FAR | 52.249-6 | May 2004 | Termination (Cost-Reimbursement) |
FAR | 52.249-8 | Apr 1984 | Default (Fixed-Price Supply and Service) |
FAR | 52.249-9 | Apr 1984 | Default (Fixed-Price Research and Development) |
FAR | 52.249-14 | Apr 1984 | Excusable Delays |
FAR | 52.253-1 | Jan 1991 | Computer Generated Forms |
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(2) DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:
HHSAR | 352.201-70 | Sept 2010 | Paperwork Reduction Act |
HHSAR | 352.202-1 | Jan 2006 | Definitions - with Alternate paragraph (h) |
HHSAR | 352.203-70 | Mar 2012 | Anti-Lobbying |
HHSAR | 352.216-70 | Jan 2006 | Additional Cost Principles |
HHSAR | 352.222-70 | Jan 2010 | Contractor Cooperation in Equal Employment Opportunity Investigations |
HHSAR | 352.223-70 | Sept 2010 | Safety and Health |
HHSAR | 352.224-70 | Jan 2006 | Privacy Act |
HHSAR | 352.227-70 | Jan 2006 | Publications and Publicity |
HHSAR | 352.228-7 | Dec 1991 | Insurance - Liability to Third Persons |
HHSAR | 352.231-70 | Jan 2006 | Salary Rate Limitation |
HHSAR | 352.231-71 | Jan 2001 | Pricing of Adjustments |
HHSAR | 352.233-71 | Jan 2006 | Litigation and Claims |
HHSAR | 352.242-70 | Jan 2006 | Key Personnel |
HHSAR | 352.242-73 | Jan 2006 | Withholding of Contract Payments |
HHSAR | 352.242-74 | Apr 1984 | Final Decisions on Audit Findings |
ARTICLE I.2. ADDITIONAL CONTRACT CLAUSES
This contract incorporates the following clauses by reference, with the same force and effect, as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
1. FAR 52.215-17, Waiver of Facilities Capital Cost of Money (October 1997).
2. FAR 52.227-16, Additional Data Requirements (June 1987).
ARTICLE I.3. ADDITIONAL FAR CLAUSES INCLUDED IN FULL TEXT
352.231-70 Salary rate limitation (August 2012)
1. Pursuant to the current and applicable prior HHS appropriations acts, the Contractor shall not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date an expense is incurred.
2. For purposes of the salary rate limitation, the terms “direct salary,” “salary”, and “institutional base salary”, have the same meaning and are collectively referred to as “direct salary”, in this clause. An individual’s direct salary is the annual compensation that the Contractor pays for an individual’s direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative [F&A] costs).
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Note: The salary rate limitation does not restrict the salary that an organization may pay an individual working under an HHS contract or order; it merely limits the portion of that salary that may be paid with Federal funds.
1. The salary rate limitation also applies to individuals under subcontracts. If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act in effect when the expense is incurred regardless of the rate initially used to establish contract or order funding.
2. See the salaries and wages pay tables on the U.S. Office of Personnel Management Web site for Federal Executive Schedule salary levels that apply to the current and prior periods.
FAR 52.217-7 Option for Increased Quantity-Separately Priced Line Item (Mar 1989)
The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days . Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.
FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)
(a) The Government may extend the term of this contract by written notice to the Contractor within 30 Days provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.
(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.
(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 8 years.
FAR 52.219-1 Small Business Program Representations (Oct 2014)
(a) | (1) | The North American Industry Classification System (NAICS) code for this acquisition is 541711 . |
(2) | The small business size standard is 500 employees. | |
(3) | The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees. | |
(b) Representations . | ||
(1) | The Offeror represents as part of its offer that it [X] is, [_] is not a small business concern. | |
(2) | [ Complete only if the Offeror represented itself as a small business concern in paragraph (b)(1) of this provision .] The Offeror represents, for general statistical purposes, that it [_] is, [X] is not, a small disadvantaged business concern as defined in 13 CFR 124.1002. | |
(3) | [ Complete only if the Offeror represented itself as a small business concern in paragraph (b)(1) of this provision .] The Offeror represents as part of its offer that it [X] is, [_] is not a women-owned small business concern. |
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(4) | Women-owned small business (WOSB) concern eligible under the WOSB Program. [Complete only if the Offeror represented itself as a women-owned small business concern in paragraph (b)(3) of this provision.] The Offeror represents as part of its offer that— | |
(i) It [_] is, [X] is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and (ii) It [_] is, [X] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (b)(4)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: __________.] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation. |
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(5) | Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a women-owned small business concern eligible under the WOSB Program in (b)(4) of this provision.] The Offeror represents as part of its offer that— | |
(i) It [_] is, [X] is not an EDWOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and (ii) It [_] is, [X] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (b)(5)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The Offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: __________.] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation. |
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(6) | [ Complete only if the Offeror represented itself as a small business concern in paragraph (b)(1) of this provision. ] The Offeror represents as part of its offer that it [_] is, [X] is not a veteran-owned small business concern . | |
(7) | [Complete only if the Offeror represented itself as a veteran-owned small business concern in paragraph (b)(6) of this provision.] The Offeror represents as part of its offer that is [_] is, [_] is not a service-disabled veteran-owned small business concern. | |
(8) | [ Complete only if the Offeror represented itself as a small business concern in paragraph (b)(1) of this provision. ] The Offeror represents, as part of its offer, that – | |
(i) It [_] is, [X] is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR part 126; and (ii) It [_] is, [X] is not a HUBZone joint venture that complies with the requirements of 13 CFR part 126, and the representation in paragraph (b)(8)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [ The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture: __________. ] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation. |
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(c) Definitions . As used in this provision— | ||
“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business concern eligible under the WOSB Program. | ||
“Service-disabled veteran-owned small business concern”— | ||
(1) Means a small business concern— | ||
(i) Not
less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business,
not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and
(ii) The management
and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled
veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.
|
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(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16). | ||
“Small business concern,” means a concern, including its affiliates that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and the size standard in paragraph (a) of this provision. “Veteran-owned small business concern” means a small business concern— |
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(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and | ||
(2) The management and daily business operations of which are controlled by one or more veterans. | ||
“Women-owned small business concern,” means a small business concern – | ||
(1) |
That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and |
|
(2) | Whose management and daily business operations are controlled by one or more women. | |
“Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127),” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States. | ||
(d) Notice. | ||
(1) | If this solicitation is for supplies and has been set aside, in whole or in part, for small business concerns, then the clause in this solicitation providing notice of the set-aside contains restrictions on the source of the end items to be furnished. | |
(2) | Under 15 U.S.C. 645(d), any person who misrepresents a firm’s status as a business concern that is small, HUBZone small, small disadvantaged, service-disabled veteran-owned small, economically disadvantaged women-owned small, or women-owned small eligible under the WOSB Program in order to obtain a contract to be awarded under the preference programs established pursuant to section 8, 9, 15, 31, and 36 of the Small Business Act or any other provision of Federal law that specifically references section 8(d) for a definition of program eligibility, shall – | |
(i) Be punished by imposition of fine, imprisonment, or both; (ii) Be subject to administrative remedies, including suspension and debarment; and (iii) Be ineligible for participation in programs conducted under the authority of the Act. |
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FAR 52.232-40, Providing Accelerated Payment to Small Business Subcontractors (Dec 2013) | ||
(a) | Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor. | |
(b) | The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act. | |
(c) | Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items. | |
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PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS | ||
SECTION J - LIST OF ATTACHMENTS | ||
The following documents are attached and incorporated in this contract: | ||
1. | Statement of Work, dated September 29, 2015 | |
2. | Invoice/Financing Instructions for Cost-Reimbursement Type Contracts | |
3. | Invoice Instructions for Fixed-Priced Type Contracts | |
4. | Sample Invoice Form | |
5. | Research Patient Care Costs | |
6. | Report of Government Owned, Contractor Held Property | |
7. | Form SF-LLL, Disclosure of Lobbying Activities | |
8. | Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01) |
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Final Revised Proposal
Volume II: Technical Proposal
Full Proposal Submitted for Consideration under Solicitation 15-100-SOL-00021
Non-Surgical Debridement for Definitive Care of Burn Injuries
This proposal is made in agreement with all the terms and conditions of this Solicitation.
Advanced Development of NexoBrid
as
a Medical Countermeasure for Injury Associated
with Burns
SOW Portion of the Base pages 66-89
Submitted to:
Biomedical Advanced Research and Development Authority
U.S. Department of Health and Human Services
Assistant Secretary for Preparedness and Response
Contracting Officer – Matthew Rose
ASPR-AMCG-202-205-2901
200 C St. SW
Washington, D.C. 20024
Attention: Matthew Rose, Contracting Officer
Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
Throughout this proposal, MediWound refers to various trademarks, service marks and trade names that it uses in its business. The “MediWound” design logo, “MediWound”, “NexoBrid”, “EscharEx” and other trademarks or service marks of MediWound appearing in this proposal are the property of MediWound. MediWound has several other trademarks, service marks and pending applications relating to its applications. Other trademarks and service marks appearing in this proposal are the property of their respective holders.
TABLE OF CONTENTS
MediWound Ltd. Confidential Information | Version 3.0 | Page 2 of 28 |
[ * * * ] Portions of this agreement were omitted and a complete copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
MediWound Ltd. Confidential Information | Version 3.0 | Page 3 of 28 |
[ * * * ] Portions of this agreement were omitted and a complete copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
MediWound Ltd. Confidential Information | Version 3.0 | Page 4 of 28 |
[ * * * ] Portions of this agreement were omitted and a complete copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
1.1 | Statement of Work |
The Statement of Work has a separate numb ering system from the section numbers in this document. SOW section numbers correspond to the correct WBS numbers.
1. | Base Period Statement of Work |
1.1 | Program Management (WBS 1.1) |
Program Management encompasses contract management (e.g., contract reporting), program management (e.g., subcontractor oversight, program progress), and risk management (e.g., EVM, risk evaluation). Project Management milestones and activities in this section are listed below, corresponding to management in the period described.
1.1.1 | Technical and Project Management (WBS 1.1.1) |
WBS# and Title | Milestone | Deliverables |
1.1.1 Technical and Project Management | Successful completion of technical and project management activities for each option period. | Project scheduled completed and reports submitted to BARDA PO/CO after completion of each option period. |
Objective/Description of Work : These activities encompass all Program Management for the listed contract period.
1.1.1.1. | Update Project Schedule (WBS 1.1.1.1) |
1.1.1.2. | Complete Project Baseline Schedule (WBS 1.1.1.2) |
1.1.1.3. | Complete Integrated Master Project Plan (WBS 1.1.1.3) |
1.1.1.4. | Base Period Management (CLIN 0001)/Report (WBS 1.1.1.4) |
Objective/Description of Work: An overall project schedule in the form of a Gantt chart will be created and maintained as part of project management. This schedule will be updated and formally completed within 90 days after the contract award.
Milestones:
Complete Project Baseline Schedule (WBS 1.1.1.2)
Complete Integrated Master Project Plan (WBS 1.1.1.3)
Deliverables: The project schedule will be submitted to the BARDA PO/CO. Reports on these activities will be included as part of regular project status updates to the BARDA PO/CO as listed below.
Complete Project Baseline Schedule (WBS 1.1.1.2)
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Complete Integrated Master Project Plan (WBS 1.1.1.3)
Base Period Management/ Report (WBS 1.1.1.4)
1.1.2 | Subcontractor Management (WBS 1.1.2) |
WBS# and Title | Milestone | Deliverables |
1.1.2 Subcontractor Management | Completion of subcontractor management plan | Subcontractor management plan submitted to BARDA |
Objective/Description of Work : Company will compile all necessary materials and finalize all aspects of the project related to preparing the Subcontractor Management Plan, including a description of how MediWound will communicate with each subcontractor’s lead representative on a regular basis; monitor subcontractor costs, technical performance, and conformance to schedules; and stay informed of changes and availability of the subcontractor’s technical team personnel.
Milestones:
Completion of plan development stages as indicated above within 90 days of award.
Develop Subcontractor Management Plan (WBS 1.1.2.1)
Complete Subcontractor Plan and submit to BARDA(WBS 1.1.2.2)
Implementation of Subcontractor Management Plan (WBS 1.1.2.3)
Deliverables:
- | Submit subcontractor management plan to BARDA within 90 days of contract award (WBS 1.1.2.2). |
1.1.3 | Risk management (WBS 1.1.3) |
Objective/Description of Work : MediWound will prepare a Risk Mitigation Plan and Matrix consistent with the template provided by BARDA, and submit such documents to BARDA within 90 days of contract award. The risk mitigation plan will highlight potential problems and/or issues that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan shall reference relevant WBS/SOW elements where appropriate. MediWound will maintain and update the plan as necessary throughout the term of the contract and provide updates as requested by the COR. A report on these activities will be included as part of regular quarterly project status updates to the BARDA PO/CO.
WBS# and Title | Milestone | Deliverables |
1.1.3 Risk Management | Completion of risk management plan | Risk management plan submitted to BARDA |
Milestones:
Completion of plan development stages as indicated above.
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Develop Risk Management Plan (WBS 1.1.3.1)
Complete Risk Management Plan (WBS 1.1.3.2)
Quarterly RMP Update (WBS 1.1.3.3)
Deliverables:
- | Complete Risk Management Plan and Submit Report to BARDA (WBS 1.1.3.2) |
- | Quarterly RMP Update Report to BARDA (WBS 1.1.3.3) |
1.1.4 | EVMS (WBS 1.1.4) |
WBS# and Title | Milestone | Deliverables |
1.1.4 EVMS | Development and implementation of EVMS system. | Completion of EVMS system and regular EVMS reports to BARDA CO/PO. |
Objective/Description of Work : MediWound will use principles of Earned Value Management in the management of this contract and develop an EVMS plan as part of its deliverables. Documents maintained and utilized as part of MediWound’s EVMS will include: Integrated Master Schedule, Baseline Budget, WBS Dictionary, Control Account Work Authorization Documents, Control Account Plans, Baseline Logs and budget revision documentation, documentation required for the Performance Measurement Baseline Review (PMBR), and Monthly Earned Value Contract Performance Report (CPR).
Milestones:
Develop EVMS Plan Within 90 days of contract award. (WBS 1.1.4.1)
Complete EVMS Plan Implementation Within 90 days of contract award. (WBS 1.1.4.3)
Deliverables
- | EVMS System Implementation (WBS 1.1.4.2) |
- | EVMS Monthly Report (WBS 1.1.4.4) |
- | EVMS reports will be submitted on a monthly basis to the BARDA CO/PO commencing after the first report is delivered. |
1.2 | Non Clinical Toxicology (WBS 1.2) |
1.2.1 | Safety (WBS 1.2.1) |
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1.2.1.1 | [ * * * ] (WBS 1.2.1.1) |
Objective/Description of Work : [ * * * ]
.
Milestones:
[ * * * ] (WBS 1.2.1.1).
Deliverables:
- | Study protocol for BARDA review and approval. |
- | Final study report submitted to BARDA (WBS 1.2.1.1). |
1.2.1.2 | [ * * * ] (WBS 1.2.1.2) |
Objective/Description of Work
: [ * * * ]
.
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Milestones:
[ * * * ] (WBS 1.2.1.2).
Deliverables:
- | Study protocol for BARDA review/approval (WBS 1.2.1.2). |
- | Final study report submitted to BARDA (WBS 1.2.1.2). |
1.2.1.3 | [ * * * ] (WBS 1.2.1.3). |
Objective/Description of Work: [ * * * ]
Milestones:
[ * * * ] (WBS 1.2.1.3).
Deliverables:
- | Study protocol for BARDA review/approval (WBS 1.2.1.3). |
- | Final study report submitted to BARDA (WBS 1.2.1.3). |
1.2.1.4 | [ * * * ] (WBS 1.2.1.4). |
Objective/Description of Work : [ * * * ]
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Milestones:
[ * * * ] (WBS 1.2.1.4).
Deliverables:
- | Study protocol for BARDA review/approval (WBS 1.2.1.4). |
- | Final study report submitted to BARDA (WBS 1.2.1.4). |
1.2.1.5 | [ * * * ] (WBS 1.2.1.5). |
Objective/Description of Work :
Milestones:
[ * * * ] (WBS 1.2.1.5).
Deliverables:
- | Study protocol for BARDA review/approval (WBS 1.2.1.5). |
- | Final study report submitted to BARDA (WBS 1.2.1.5). |
1.3 | Non- Clinical Pharmacology (WBS 1.3) |
1.3.1 | Mechanism of Action Studies (WBS 1.3.1) |
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1.3.1.1 | [ * * * ] (WBS 1.3.1.1) |
Objective/Description of Work : [ * * * ]
.
Milestones: .
Completion of study (WBS 1.3.1.1).
Deliverables:
- | Study protocol for BARDA review/approval (WBS 1.3.1.1). |
- | Final study report submitted to BARDA (WBS 1.3.1.1). |
1.3.1.2 |
[ * * * ]
(WBS 1.3.1.2). |
Objective/Description of Work: [ * * * ]
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Milestones: .
Completion of study (WBS 1.3.1.2).
Deliverables:
- | Study protocol for BARDA review/approval (WBS 1.3.1.2). |
- | Final study report submitted to BARDA (WBS 1.3.1.2). |
1.3.1.3 | [ * * * ] (WBS 1.3.1.3) |
Objective/Description of Work: [ * * * ]
Milestones: .
Completion of study (WBS 1.3.1.3).
Deliverables:
- | Study protocol for BARDA review/approval (WBS 1.3.1.3). |
- | Final study report submitted to BARDA (WBS 1.3.1.3). |
1.3.1.4 | [ * * * ] (WBS 1.3.1.4) |
Objective/Description of Work: [ * * * ]
Milestones: .
Completion of study (WSB 1.3.1.4).
Deliverables:
- | Study protocol for BARDA review/approval (WBS 1.3.1.4). |
- | Final study report submitted to BARDA (WBS 1.3.1.4). |
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1.3.2 | Product Characterization (WBS 1.3.2) |
WBS# and Title | Milestone | Deliverables |
1.3.2 [ * * * ] |
[ * * * ]
. |
Study report submitted to BARDA |
1.3.2.6 | [ * * * ] (WBS 1.3.2.1) |
Objective/Description of Work: [ * * * ]
.
Milestones: .
Completion of study (WBS 1.3.2.1).
Deliverables:
- | Study protocol for BARDA review/approval (WBS 1.3.2.1). |
- | Final study report submitted to BARDA (WBS 1.3.2.1). |
1.3.3 | Efficacy and Safety (WBS 1.3.3) |
1.3.3.1 | [ * * * ] (WBS 1.3.3.1) |
WBS# and Title | Milestone | Deliverables |
1.3.3.1 [ * * * ] |
[ * * * ]
|
Study report submitted to BARDA |
Objective/Description of Work
: [ * * * ]
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Milestones: .
Completion of study (WBS 1.3.3.1).
Deliverables:
- | Study protocol for BARDA review/approval (WBS 1.3.3.1). |
- | Final study report submitted to BARDA (WBS 1.3.3.1) |
1.4 | Clinical (WBS 1.4) |
1.4.1 | US phase 3 study (WBS 1.4.1) |
WBS# and Title | Milestone | Deliverables |
1.4.1 US phase 3 study | Completion of Phase 3 clinical trial. | Final clinical study report (CSR) accepted by BARDA. |
Objective/Description of Work: MediWound will complete a multicenter, multinational, randomized, controlled, assessor blinded phase 3 study in subjects with thermal burns, to evaluate the efficacy and safety of NexoBrid compared to Gel Vehicle and compared to Standard of Care. This study is currently ongoing.
Study primary endpoint is to demonstrate superiority of NexoBrid over Gel Vehicle for eschar removal as measured by incidence of complete eschar removal. The following secondary endpoints will be evaluated in this study and compared between NexoBrid and SOC to further support the clinical benefit of NexoBrid.
1. Reduction in surgical need - Demonstrate superiority of NexoBrid over SOC in reduction of surgical need for excisional eschar removal as measured by an analysis of incidence of surgical eschar removal (tangential/ minor/ avulsion/ Versajet and/or dermabrasion excision).
2. Earlier eschar removal - Demonstrate superiority of NexoBrid over SOC with regard to the time when complete eschar removal has been achieved. For definition of complete eschar removal see primary endpoint.
3. Blood loss related to eschar removal - Demonstrate superiority of NexoBrid over SOC with regard to the blood loss occurred during the eschar removal procedures.
This clinical trial is underway, however a study protocol will be provided to BARDA for reference. Any changes to the study protocol will be submitted to BARDA in advance for review.
[ * * * ]
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• |
[ * * * ]
. |
• |
[ * * * ]
|
• |
[ * * * ]
|
175 Hospitalized adults with Deep Partial Thickness (DPT) and Full Thickness (FT) thermal burns will be enrolled. The total duration of the study treatment and follow up period of each participating subject is approximately 25 months. Approximately [ * * * ] sites will participate in the study from the US ([ * * * ]), Europe ([ * * * ]) and Israel and data will be monitored by local CROs from the US and Europe.
Milestones
First Patient In (WBS 1.4.1.1)
Last Patient In (WBS 1.4.1.2)
Last Patient Out (WBS 1.4.1.5)
Deliverables:
This study is currently on-going. Protocol amendments (if will be applied) will be provided to BARDA for review and approval before submission.
[ * * * ] (WBS 1.4.1.3).
[ * * * ]
[ * * * ] (WBS 1.4.1.4).
[ * * * ]
[ * * * ] (WBS 1.4.1.6).
[ * * * ]
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1.5 | Regulatory |
1.5.1 | IND |
WBS# and Title | Milestone | Deliverables |
1.5.1 IND | Completion of all pre-BLA activities in support of NexoBrid as an MCM. | [ * * * ] |
Objective/Description of Work:
[ * * * ]
1.5.1.1 |
[ * * * ]
(WBS 1.5.1.1) |
Objective/Description of Work:
[ * * * ]
Milestones:
[ * * * ] (WBS 1.5.1.1).
Deliverables:
Final meeting minutes submitted to BARDA (WBS 1.5.1.1).
1.5.1.2 | [ * * * ] (WBS 1.5.1.2) |
Objective/Description of Work:
[ * * * ]
Milestones:
Completion of the FDA meeting (WBS 1.5.1.2).
Deliverables:
Final official meeting minutes submitted to BARDA (WBS 1.5.1.2).
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1.5.1.3 | [ * * * ] (WBS 1.5.1.3) |
Objective/Description of Work:
[ * * * ]
Milestones:
Completion of the study protocol to FDA (WBS 1.5.1.3).
Deliverables:
Study protocol submitted to FDA for approval (WBS 1.5.1.3).
1.5.1.4 | [ * * * ] (WBS 1.5.1.4) |
Objective/Description of Work:
[ * * * ]
Milestones:
Completion of the study protocol after FDA guidance is received (WBS 1.5.1.4).
Deliverables:
- | Prior to study initiation, the study protocol will be provided to BARDA for review and approval |
- | Study protocol submitted to FDA for approval (WBS 1.5.1.4). |
1.5.1.5 |
[ * * * ]
(WBS 1.5.1.5) |
Objective/Description of Work:
[ * * * ]
Milestones:
[ * * * ] (WBS 1.5.1.5).
Deliverables:
[ * * * ] (WBS 1.5.1.5).
1.5.1.6 | FDA Submission Request For [ * * * ] (WBS 1.5.1.6) |
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Objective/Description of Work:
In an attempt to expedite the development and review process of NexoBrid, MediWound plans to submit a request for [ * * * ] designation. Prior to submission, the [ * * * ] application request will be provided to BARDA for review and approval.
Milestones:
Completion of the [ * * * ] application (WBS 1.5.1.6).
Deliverables:
[ * * * ] submitted to FDA for approval (WBS 1.5.1.6).
1.5.2 | BLA (WBS 1.5.2) |
WBS# and Title | Milestone | Deliverables |
1.5.2 BLA | Completion of all preparatory and regulatory activities for the BLA submission of NexoBrid as an MCM. | This includes all activities in support of the BLA submission. |
Objective/Description of Work
: [ * * * ]
1.5.2.1 | [ * * * ] (WBS 1.5.2.1) |
Objective/Description of Work:
[ * * * ]
Milestones:
[ * * * ] (WBS 1.5.2.1).
Deliverables:
[ * * * ] (WBS 1.5.2.1).
1.5.2.2 | Pre-BLA Meeting (WBS 1.5.2.2) |
Objective/Description of Work:
[ * * * ]
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Milestones:
Completion of FDA pre-BLA meeting (WBS 1.5.2.2).
Deliverables:
Final official meeting minutes submitted to BARDA (WBS 1.5.2.2).
1.5.2.3 | BLA preparation and submission (WBS 1.5.2.3) |
Objective/Description of Work: [ * * * ]
Milestones:
BLA completion (WBS 1.5.2.3).
Deliverables:
[ * * * ] (WBS 1.5.2.3)
[ * * * ] (US, PIP) (WBS 1.5.2.4)
[ * * * ] (WBS 1.5.2.5)
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1.6 | Chemistry, Manufacturing and Control (CMC) (WBS 1.6) |
1.6.1 | [ * * * ] (WBS 1.6.1) |
WBS# and Title | Milestone | Deliverables |
1.6.1 [ * * * ] |
[ * * * ]
. |
Reports submitted to BARDA CO/PO. |
1.6.1.1 | [ * * * ] (LC-MS) (WBS 1.6.1.1) |
Objective/Description of Work:
[ * * * ]
Milestones:
[ * * * ] (WBS 1.6.1.1).
Deliverables:
Report on method submitted to BARDA PO/CO (WBS 1.6.1.1).
1.6.1.2 | [ * * * ] (WBS 1.6.1.2) |
Objective/Description of Work:
[ * * * ]
Milestones:
[ * * * ]
(WBS 1.6.1.2).
Deliverables:
- | Method validation protocol submitted to BARDA for review and approval. |
- | Report on method submitted to BARDA PO/CO (WBS 1.6.1.2). |
1.6.1.3 | Analytical Support and Troubleshooting (WBS 1.6.1.3) |
MediWound will give analytical support and troubleshooting to the production processes of NexoBrid to ensure the quality of the product.
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Deliverables:
Report on support submitted to BARDA PO/CO (WBS 1.6.1.3).
1.6.2 | [ * * * ] Development (WBS 1.6.2) |
WBS# and Title | Milestone | Deliverables |
1.6.2.1 [ * * * ]
|
Completion
of study to [ * * * ]
|
Final development report submitted to BARDA |
1.6.2.2 [ * * * ]
|
Completion
of study to [
* * * ]
|
[ * * * ] |
1.6.2.3 MediWound will conduct [ * * * ]
|
[ * * * ]. |
[ * * * ] |
1.6.2.4 [ * * * ]
|
[ * * * ]. | [ * * * ] |
1.6.2.1 | NexoBrid [ * * * ] (WBS 1.6.2.1) |
Objective/Description of Work
: [ * * * ]
Milestones:
[ * * * ] (WBS 1.6.2.1).
Deliverables:
- | Study protocols will be provided to BARDA for review and approval. |
- | Final development report submitted to BARDA (WBS 1.6.2.1). |
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1.6.2.2 | [ * * * ] (WBS 1.6.2.2) |
Objective/Description of Work:
[ * * * ]
Milestones:
[ * * * ] (WBS 1.6.2.2).
Deliverables:
- | Validation protocol will be provided to BARDA for review and approval. |
- | Final process validation and stability reports (WBS 1.6.2.2). |
1.6.2.3 | [ * * * ] (WBS 1.6.2.3) |
Objective/Description of Work:
[ * * * ].
Milestones:
[ * * * ] study completion (WBS 1.6.2.3).
Deliverables:
- | [ * * * ]. |
- | Final study report (WBS 1.6.2.3). |
1.6.2.4 | [ * * * ] (WBS 1.6.2.4) |
Deliverables:
[ * * * ] (WBS 1.6.2.4).
1.6.3 | Quality by Design (QbD) (WBS 1.6.3) |
WBS# and Title | Milestone | Deliverables |
1.6.3 Quality by Design | Completion of QbD studies defining the critical parameters and design space of the NexoBrid manufacturing process. | Reports submitted to BARDA CO/PO. |
1.6.3.1 | Risk Based Design of Experiment (DOE) Plan (WBS 1.6.3.1) |
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Objective/Description of Work:
MediWound will conduct
together with [ * * * ] Ltd., or will assist other subcontractor approved by BARDA, risk based design of experiment (DOE) for creating
a design space for the NexoBrid production process. [ * * * ]
. The objective of the QbD research is to follow the FDA initiative of the Quality by Design approach. The QbD studies will follow
the relevant ICH guidelines such as ICH Q8, ICH Q9 and Q10. QbD Studies protocol will be provided to BARDA for review and approval.
Milestones:
DOE study completion (WBS 1.6.3.1).
Deliverables:
- | QbD Study protocol will be provided to BARDA for review and approval. |
- | Final study report submitted to BARDA (WBS 1.6.3.1). |
1.6.3.2 | [ * * * ] (WBS 1.6.3.2) |
Objective/Description of Work:
[ * * * ]
Milestones:
[ * * * ] (WBS 1.6.3.2).
Deliverables:
- | Study protocol will be provided to BARDA for review and approval. |
- | Final study report submitted to BARDA (WBS 1.6.3.2). |
1.6.3.3 | Statistical Analysis and Summary of the Results (WBS 1.6.3.3) |
Objective/Description of Work: [ * * * ]
Milestones:
[ * * * ] (WBS 1.6.3.3).
Deliverables:
- | Final study report submitted to BARDA (WBS 1.6.3.3). |
1.6.4 | Agriculture Raw Material Studies (WBS 1.6.4) |
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Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
WBS# and Title | Milestone | Deliverables |
1.6.4 Agriculture Raw Material Studies | [ * * * ] | Reports submitted to BARDA CO/PO. |
1.6.4.1 |
[ * * * ]
(WBS 1.6.4.1) |
Objective/Description of Work:
[ * * * ]
Milestones:
[ * * * ] (WBS 1.6.4.1).
Deliverables:
- | Study protocols will be provided to BARDA for review and approval. |
- | Final study report submitted to BARDA (WBS 1.6.4.1). |
1.6.4.2 | Analytical Chemistry Testing and Statistical Analysis (WBS 1.6.4.2) |
Objective/Description of Work:
[ * * * ]
.
Milestones:
Study and analysis completion (WBS 1.6.4.2).
Deliverables:
- | Study protocols will be provided to BARDA for review and approval. |
- | Final study report submitted to BARDA (WBS 1.6.4.2). |
1.6.5 | [ * * * ] (WBS 1.6.5 |
WBS# and Title | Milestone | Deliverables |
1.6.5 [ * * * ] |
[ * * * ]
|
Reports submitted to BARDA CO/PO; submissions sent to FDA for approval. |
MediWound Ltd. Confidential Information | Version 3.0 | Page 24 of 28 |
[ * * * ] Portions of this agreement were omitted and a complete copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
1.6.5.1 | [ * * * ] (WBS 1.6.5.1) |
Objective/Description of Work:
[ * * * ]
Milestones:
Design completion (WBS 1.6.5.1).
Deliverables:
Final design submitted to BARDA (WBS 1.6.5.1).
1.6.5.2 | [ * * * ] (WBS 1.6.5.2) |
- | Objective/Description of Work : [ * * * ] |
Milestones:
Validation/PQ activities completed (WBS 1.6.5.2).
Deliverables:
- | Validation protocols will be provided to BARDA for review and approval. |
- | Report on validation activities submitted to BARDA (WBS 1.6.5.2). |
1.6.5.3 | File Submission, Inspection & Approving (WBS 1.6.5.3) |
- |
Objective/Description of Work:
[ * * * ]
. |
MediWound Ltd. Confidential Information | Version 3.0 | Page 25 of 28 |
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Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
Milestones:
Completion of submission preparation (WBS 1.6.5.3).
Deliverables:
[ * * * ] (WBS 1.6.5.3).
1.6.5.4 | [ * * * ] (WBS 1.6.5.4) |
Objective/Description of Work:
[ * * * ]
Milestones:
Completion of stability study (WBS 1.6.5.4).
Deliverables:
- | Stability protocols for BARDA review and approval |
- | Submission of stability report to BARDA and FDA (WBS 1.6.5.4). |
1.6.5.5 | FDA Approval of Scale-up (WBS 1.6.5.5) |
- |
Objective/Description of Work:
[ * * * ]
|
- | . Application file will be provided to BARDA for review and approval prior to submission. |
Milestones:
Completion of application for approval (WBS 1.6.5.5).
Deliverables:
Submission of application to BARDA and FDA (WBS 1.6.5.5).
MediWound Ltd. Confidential Information | Version 3.0 | Page 26 of 28 |
[ * * * ] Portions of this agreement were omitted and a complete copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
1.7 | Procurement (WBS 1.7) |
1.7.1 | Acquisition (WBS 1.7.1) |
WBS# and Title | Milestone | Deliverables |
1.7.1 Acquisition | Acquisition of [ * * * ]of NexoBrid. | [ * * * ] of NexoBrid successfully delivered to BARDA. |
1.7.2 | Warm Base (Inventory Stockpile) (WBS 1.7.2) |
WBS# and Title | Milestone | Deliverables |
1.7.2 Warm Base | Establishment of operational readiness to manufacture NexoBrid. | Report submitted to BARDA PO/CO. |
1.7.2.1 | Setup of vendor managed inventory system (VMI) plan (WBS 1.7.2.1) |
Objective/Description of Work: [ * * * ]
Milestones:
[ * * * ] and plan development (WBS 1.7.2.1).
Deliverables:
Submission of the VMI plan by BARDA (WBS 1.7.2.1).
1.7.2.2 | Implementation of vendor managed inventory system (VMI) plan (WBS 1.7.2.2) |
Objective/Description of Work : MediWound will implement the VMI plan with the approved vendor.
Milestones:
Implementation of VMI plan (WBS 1.7.2.2).
Deliverables:
Notification to BARDA of successful implementation (WBS 1.7.2.2).
MediWound Ltd. Confidential Information | Version 3.0 | Page 27 of 28 |
[ * * * ] Portions of this agreement were omitted and a complete copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
1.7.3 | Sustainment (WBS 1.7.3) |
WBS# and Title | Milestone | Deliverables |
1.7.3 Sustainment | Replacement of expired material as necessary. | Replacement of expired material as necessary. |
1.7.4 | Disposal (WBS 1.7.4) |
WBS# and Title | Milestone | Deliverables |
1.7.4 Disposal | Disposal of expired material as necessary. | Disposal of expired material as necessary. |
MediWound Ltd. Confidential Information | Version 3.0 | Page 28 of 28 |
Final Revised Proposal
Volume II: Technical Proposal
Full Proposal Submitted for Consideration under Solicitation 15-100-SOL-00021
Non-Surgical Debridement for Definitive Care of Burn Injuries
This proposal is made in agreement with all the terms and conditions of this Solicitation.
Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns
SOW Portion of the Options pages 89-98
Submitted to:
Biomedical Advanced Research and Development Authority
U.S. Department of Health and Human Services
Assistant Secretary for Preparedness and Response
Contracting Officer – Matthew Rose
ASPR-AMCG-202-205-2901
200 C St. SW
Washington, D.C. 20024
Attention: Matthew Rose, Contracting Officer
Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
Throughout this proposal, MediWound refers to various trademarks, service marks and trade names that it uses in its business. The “MediWound” design logo, “MediWound”, “NexoBrid”, “EscharEx” and other trademarks or service marks of MediWound appearing in this proposal are the property of MediWound. MediWound has several other trademarks, service marks and pending applications relating to its applications. Other trademarks and service marks appearing in this proposal are the property of their respective holders.
TABLE OF CONTENTS
MediWound Ltd. Confidential Information | Version 3.0 | Page 2 of 12 |
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Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
1. | Option Period Statement of Work (CLIN 0003, 0004, 0005) |
1.1 | Program Management (WBS 1.1) |
Updated SOW(s) and accompanying budgets will be provided to BARDA for each option period to define the execution of each CLIN.
Program Management encompasses contract management (e.g., contract reporting), program management (e.g., subcontractor oversight, program progress), and risk management (e.g., EVM, risk evaluation). Project Management milestones and activities in this section are listed below, corresponding to management in the period described.
1.1.1 | Technical and Project Management (WBS 1.1.1) |
WBS# and Title | Milestone | Deliverables |
1.1.1 Technical and Project Management | Successful completion of technical and project management activities for each option period. | Project scheduled completed and reports submitted to BARDA PO/CO after completion of each option period. |
Objective/Description of Work : These activities encompass all Program Management for the listed contract period.
1.1.1.5 | [ * * * ] / Report (WBS 1.1.1.5) |
1.1.1.6 | [ * * * ] / Report (WBS 1.1.1.6) |
1.1.1.7 | Post-Marketing Option Management (CLIN 0003)/ Report (WBS 1.1.1.7) |
1.1.1.8 | VMI Implementation Option Management (CLIN 0005A)/Report (WBS 1.1.1.8) |
Objective/Description of Work: An overall project schedule in the form of a Gantt chart will be created and maintained as part of project management. This schedule will be updated and formally completed within 90 days after the contract award.
Milestones:
[ * * * ] / Report (WBS 1.1.1.5)
Option 2 Management/ Report (WBS 1.1.1.6)
Option 3 Management/ Report (WBS 1.1.1.7)
Option 4 Management/ Report (WBS 1.1.1.8)
1.4 | Clinical (WBS 1.4) |
1.4.2 | [ * * * ] (WBS 1.4.2) |
WBS# and Title | Milestone | Deliverables |
1.4.2 [ * * * ] | Completion of Phase 3 clinical trial | Final clinical study report (CSR) accepted by BARDA. |
MediWound Ltd. Confidential Information | Version 3.0 | Page 3 of 12 |
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Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
Objective/Description
of Work
: [ * * * ].
[
* * * ]
Milestones:
First Patient In (WBS 1.4.2.1)
Last Patient In (WBS 1.4.2.2)
MediWound Ltd. Confidential Information | Version 3.0 | Page 4 of 12 |
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Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
Last Patient Out (WBS 1.4.2.5)
Deliverables:
- | Study protocol for BARDA review/approval prior to submission to FDA (WBS 1.4.2.1). |
- | Safety analysis, [ * * * ] patient (WBS 1.4.2.3) |
- | [ * * * ] month follow up: Data analysis + CSR (WBS 1.4.2.4) |
- | [ * * * ] month follow up: Data analysis + CSR (WBS 1.4.2.6) |
MediWound Ltd. Confidential Information | Version 3.0 | Page 5 of 12 |
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Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
1.4.3 | [ * * * ] (WBS 1.4.3) |
WBS# and Title | Milestone | Deliverables |
1.4.3 [ * * * ] | Completion of Phase 3 clinical trial. | Final clinical study report (CSR) accepted by BARDA. |
This
is a phase 3 study to assess NexoBrid effect on [ * * * ]. The main objective is to demonstrate the ability of NexoBrid to prevent
and resolve [ * * * ]. The study will include approximately [ * * * ] patients from US sites and will be managed locally by a
US CRO. The main endpoints will be [ * * * ].
[
* * * ]
Milestones:
Set up (WBS 1.4.3.1)
First Patient In (WBS 1.4.3.2)
Last Patient In (WBS 1.4.3.3)
Last Patient Out (WBS 1.4.3.5)
MediWound Ltd. Confidential Information | Version 3.0 | Page 6 of 12 |
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Advanced Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
Deliverables:
- | Prior to study initiation, the study protocol will be provided to BARDA for review and approval. (WBS 1.4.3.1). |
- | [ * * * ] (WBS 1.4.3.4) |
- | [ * * * ] (WBS 1.4.3.6) |
MediWound Ltd. Confidential Information | Version 3.0 | Page 7 of 12 |
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Advanced
Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
1.5 | Regulatory |
1.5.3 | Post Marketing Activities (WBS 1.5.3) |
WBS# and Title | Milestone | Deliverables |
1.5.3 Post Marketing Activities | Initiation of FDA required post-marketing activities. | Successful establishment of required post-marketing activities. |
1.5.3.1 | Marketing Requirement- Infrastructure/Obligation (PhV, Call Center) (WBS 1.5.3.1) |
Objective/Description of Work:
In order to comply with regulatory requirements for NexoBrid in the US market following approval, MediWound will establish an appropriate pharmacovigilance system, overseeing all safety aspects of the marketed product.
Milestones:
Establishment of the pharmacovigilance system in compliance with FDA guidance (WBS 1.5.3.1).
Deliverables:
Report on implemented pharmacovigilance system submitted to BARDA PO/CO (WBS 1.5.3.1).
1.5.3.2 | Phase IV Post-Marketing Study (WBS 1.5.3.2) |
Objective/Description of Work:
Following product approval, MediWound anticipates the necessity of conducting post approval activities (as was required in Europe by the EMA) that may or may not be required during the base period but may be required by the FDA. [ * * * ].
Milestones:
Initiation of post-approval marketing studies in compliance with FDA guidance (WBS 1.5.3.2).
Deliverables:
Report on implemented post-approval marketing studies submitted to BARDA PO/CO (WBS 1.5.3.2).
1.5.3.3 | [ * * * ] (WBS 1.5.3.3) |
Objective/Description of Work:
[ * * * ]
MediWound Ltd. Confidential Information | Version 3.0 | Page 8 of 12 |
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Advanced
Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
Milestones:
Initiation of post-approval marketing studies in compliance with FDA guidance (WBS 1.5.3.3).
Deliverables:
- | Study protocol will be provided to BARDA for review and approval. |
- | Report on implemented post-approval marketing studies submitted to BARDA PO/CO (WBS 1.5.3.3). |
MediWound Ltd. Confidential Information | Version 3.0 | Page 9 of 12 |
Advanced
Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
1.6 | Chemistry, Manufacturing and Control (CMC) (WBS 1.6) |
1.6.6 |
[ * * * ]
(WBS 1.6.6) |
WBS# and Title | Milestone | Deliverables |
1.6.6 1. [ * * * ] |
[ * * * ]
. |
Reports submitted to BARDA CO/PO |
1.6.6.1 | [ * * * ] (WBS 1.6.6.1) |
- |
Objective/Description of Work
: [ * * * ]
. |
Milestones:
Completion of application for approval (WBS 1.6.6.1).
Deliverables:
- | Submission of design and technology transfer protocol and report to BARDA for review (WBS 1.6.6.1). |
1.6.6.2 | Subcontractor Facility technical batches and validations (WBS 1.6.6.2) |
Objective/Description of Work
: [ * * * ]
.
Milestones:
Validation/PQ activities completed (WBS 1.6.6.2).
Deliverables:
Validation protocol and Report on validation activities submitted to BARDA (WBS 1.6.6.2).
1.6.6.3 | File submission, Inspection & Approving (WBS 1.6.6.3) |
MediWound Ltd. Confidential Information | Version 3.0 | Page 10 of 12 |
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Advanced
Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
Objective/Description of Work:
MediWound will contract
with consultants approved by BARDA, to prepare and submit a file of the [ * * * ]
.
Milestones:
Completion of submission preparation (WBS 1.6.6.3).
Deliverables:
[ * * * ] (WBS 1.6.6.3).
1.6.6.4 | File submission, Inspection & Approving (WBS 1.6.6.4) |
Objective/Description of Work: MediWound will contract with consultants approved by BARDA to [ * * * ].
Milestones:
Completion of stability study (WBS 1.6.6.4).
Deliverables:
Submission of stability protocol and report to BARDA and FDA (WBS 1.6.6.4).
1.6.6.5 | File submission, Inspection & Approving (WBS 1.6.6.5) |
Objective/Description of Work:
[ * * * ]
.
Milestones:
Completion of application for approval (WBS 1.6.6.5).
Deliverables:
Submission of application to BARDA and FDA (WBS 1.6.6.5).
MediWound Ltd. Confidential Information | Version 3.0 | Page 11 of 12 |
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Advanced
Development of NexoBrid
as a Medical Countermeasure for Injury Associated with Burns |
1.8 | Surge Capacity (WBS 1.8) |
1.8.1 | Acquisition (WBS 1.8.1) |
WBS# and Title | Milestone | Deliverables |
1.8.1 Acquisition | Acquisition of [ * * * ] of NexoBrid. | [ * * * ] of NexoBrid successfully delivered to BARDA. |
1.8.2 | Warm Base (Inventory Stockpile) (WBS 1.8.2) |
1.8.3 | Sustainment (WBS 1.8.3) |
1.8.4 | Disposal (WBS 1.8.4) |
MediWound Ltd. Confidential Information | Version 3.0 | Page 12 of 12 |
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HHSO100201500035C | Mediwound Ltd |
ATTACHMENT #2
INVOICE/FINANCING
REQUEST INSTRUCTIONS - FOR COST-REIMBURSEMENT TYPE
CONTRACTS
Format:
Payment requests shall be submitted on the Contractor’s self-generated form in the manner and format prescribed herein
and as illustrated in the Sample Invoice/Financing Request. Standard Form 1034, Public Voucher for Purchases and Services Other
Than Personal, may be used in lieu of the Contractor’s self-generated form provided it contains all of the information shown
on the Sample Invoice/Financing Request. DO NOT include a cover letter with the payment request.
Number of Copies:
Payment requests shall be submitted in the quantity specified in the Invoice Submission Instructions
in Section G of the Contract Schedule.
Frequency: Payment requests shall not be submitted more frequently than once every two weeks in accordance with the Allowable Cost and Payment Clause incorporated into this contract. Small business concerns may submit invoices/financing requests more frequently than every two weeks when authorized by the Contracting Officer.
Cost Incurrence Period: Costs incurred must be within the contract performance period or covered by pre-contract cost provisions.
Billing of Costs Incurred: If billed costs include (1) costs of a prior billing period, but not previously billed, or (2) costs incurred during the contract period and claimed after the contract period has expired, the Contractor shall site the amount(s) and month(s) in which it incurred such costs.
Contractor’s Fiscal Year: Payment requests shall be prepared in such a manner that the Government can identify costs claimed with the Contractor’s fiscal year.
Currency: All BARDA contracts are expressed in United States dollars. When the Government pays in a currency other than United States dollars, billings shall be expressed, and payment by the Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices paid under this contract may not exceed the United States dollars authorized.
Costs Requiring Prior Approval: Costs requiring the Contracting Officer’s approval, including those set forth in an Advance Understanding in the contract, shall be identified and reference the Contracting Officer’s Authorization (COA) Number. In addition, the Contractor shall show any cost set forth in an Advance Understanding as a separate line item on the payment request.
Invoice/Financing Request Identification: Each payment request shall be identified as either:
(a) | Interim Invoice/Contract Financing Request: These are interim payment requests submitted during the contract performance period. |
(b) | Completion Invoice: The completion invoice shall be submitted promptly upon completion of the work, but no later than one year from the contract completion date, or within 120 days after settlement of the final indirect cost rates covering the year in which the contract is physically complete (whichever date is later). The Contractor shall submit the completion invoice when all costs have been assigned to the contract and it completes all performance provisions. |
(c) | Final Invoice: A final invoice may be required after the amounts owed have been settled between the Government and the Contractor (e.g., resolution of all suspensions and audit exceptions). |
HHSO100201500035C | Mediwound Ltd |
Preparation and Itemization of the Invoice/Financing Request: The Contractor shall furnish the information set forth in the instructions below. The instructions are keyed to the entries on the Sample Invoice/Financing Request.
(a) | Designated Billing Office Name and Address: Enter the designated billing office name and address, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule. |
(b) | Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number: Show the Contractor’s name and address exactly as they appear in the contract, along with the name, title, phone number, and e-mail address of the person to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds Transfer, to whom payment is to be sent. Provide the Contractor’s Vendor Identification Number (VIN), and Data Universal Numbering System (DUNS) number or DUNS+4. The DUNS number must identify the Contractor’s name and address exactly as stated on the face page of the contract. When an approved assignment has been made by the Contractor, or a different payee has been designated, provide the same information for the payee as is required for the Contractor (i.e., name, address, point of contact, VIN, and DUNS). |
(c) | Invoice/Financing Request Number: Insert the appropriate serial number of the payment request. |
(d) | Date Invoice/Financing Request Prepared: Insert the date the payment request is prepared. |
(e) | Contract Number and Order Number (if applicable): Insert the contract number and order number (if applicable). |
(f) | Effective Date: Insert the effective date of the contract or if billing under an order, the effective date of the order. |
(g) | Total Estimated Cost of Contract/Order: Insert the total estimated cost of the contract, exclusive of fixed-fee. If billing under an order, insert the total estimated cost of the order, exclusive of fixed-fee. For incrementally funded contracts/orders, enter the amount currently obligated and available for payment. |
(h) | Total Fixed-Fee: Insert the total fixed-fee (where applicable) or the portion of the fixed-fee applicable to a particular invoice as defined in the contract. |
(i) | Two-Way/Three-Way Match: Identify whether payment is to be made using a two-way or three-way match. To determine required payment method, refer to the Invoice Submission Instructions in Section G of the Contract Schedule. |
(j) | Office of Acquisitions: Insert the name of the Office of Acquisitions, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule. |
(k) | Central Point of Distribution: Insert the Central Point of Distribution, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule. |
(l) | Billing Period: Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed. |
(m) | Amount Billed - Current Period: Insert the amount claimed for the current billing period by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item. |
HHSO100201500035C | Mediwound Ltd |
(n) | Amount Billed - Cumulative: Insert the cumulative amounts claimed by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item. |
(o) | Direct Costs: Insert the major cost elements. For each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval” on page 1 of these instructions. |
(1) | Direct Labor: Include salaries and wages paid (or accrued) for direct performance of the contract. List individuals by name, title/position, hourly/annual rate, level of effort (actual hours or % of effort), breakdown by task performed by personnel, and amount claimed. | |
(2) | Fringe Benefits: List any fringe benefits applicable to direct labor and billed as a direct cost. Do not include in this category fringe benefits that are included in indirect costs. | |
(3) | Accountable Personal Property: Include any property having a unit acquisition cost of $5,000 or more, with a life expectancy of more than two years, and sensitive property regardless of cost (see the HHS Contractor’s Guide for Control of Government Property) (e. g. personal computers). Note this is not permitted for reimbursement without pre-authorization from the CO. | |
On a separate sheet of paper attached to the payment request, list each item for which reimbursement is requested. Include reference to the following (as applicable): | ||
- Item number for the specific piece of equipment listed in the Property Schedule, and | ||
- COA number, if the equipment is not covered by the Property Schedule. | ||
The Contracting Officer may require the Contractor to provide further itemization of property having specific limitations set forth in the contract. | ||
(4) | Materials and Supplies: Include all consumable material and supplies regardless of amount. Detailed line-item breakdown (e.g. receipts, quotes, etc.) is required. | |
(5) | Premium Pay: List remuneration in excess of the basic hourly rate. | |
(6) | Consultant Fee: List fees paid to consultants. Identify consultant by name or category as set forth in the contract or COA, as well as the effort (i.e., number of hours, days, etc.) and rate billed. | |
(7) | Travel: Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel. | |
(8) | Subcontract Costs: List subcontractor(s) by name and amount billed. Provide subcontract invoices/receipts as backup documentation. If subcontract is of the cost-reimbursement variety, detailed breakdown will be required. Regardless, include backup documentation (e.g. subcontractor invoices, quotes, etc.). |
HHSO100201500035C | Mediwound Ltd |
(9) | Other: Include all other direct costs not fitting into an aforementioned category. If over $1,000, list cost elements and dollar amounts separately. If the contract contains restrictions on any cost element, that cost element must be listed separately. | |
(p) | Cost of Money (COM): Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed, if applicable. |
(q) | Indirect Costs: Identify the indirect cost base (IDC), indirect cost rate, and amount billed for each indirect cost category. |
(r) | Fixed-Fee: Cite the formula or method of computation for fixed-fee, if applicable. The fixed-fee must be claimed as provided for by the contract. |
(s) | Total Amounts Claimed: Insert the total amounts claimed for the current and cumulative periods. |
(t) | Adjustments: Include amounts conceded by the Contractor, outstanding suspensions, and/or disapprovals subject to appeal. |
(u) | Grand Totals |
(v) | Certification of Salary Rate Limitation: If required by the contract (see Invoice Submission Instructions in Section G of the Contract Schedule), the Contractor shall include the following certification at the bottom of the payment request: |
“I hereby certify that the salaries billed in this payment request are in compliance with the Salary Rate Limitation Provisions in Section H of the contract.” | |
**Note the Contracting Officer may require the Contractor to submit detailed support for costs claimed on payment requests. Every cost must be determined to be allocable, reasonable, and allowable per FAR Part 31. |
HHSO100201500035C | Mediwound Ltd |
ATTACHMENT #3
INVOICE/FINANCING REQUEST INSTRUCTIONS FOR FIXED PRICE TYPE CONTRACTS
General The Contractor shall submit vouchers or invoices as prescribed herein.
Format Standard Form I034, Public Voucher for Purchases and Services Other Than Personal, and Standard Form I035, Public Voucher for Purchases and Services Other than Personal--Continuation Sheet, and the payee’s letterhead or self-designed form should be used to submit claims for reimbursement.
Number of Copies: As indicated in the contract.
Frequency Invoices submitted in accordance with the Payment Clause shall be submitted monthly upon delivery of goods or services unless otherwise authorized by the Contracting Officer.
Preparation and Itemization of the Invoice The invoice shall be prepared as follows:
(a) Designated Billing Office and address:
HHS/ASPR/BARDA
330
Independence Ave, Room G640
Washington DC 20201
ATTN: Contracting Officer
(b) Invoice Number
(c) Date of Invoice
(d) Contract number and date
(e) Payee’s name and address. Show the Contractor’s name (as it appears in the contract), correct address, and the title and phone number of the responsible official to whom payment is to be sent. When an approved assignment has been made by the Contractor, or a different payee has been designated, then insert the name and address of the payee instead of the Contractor.
(f) Description of goods or services, quantity, unit price, (where appropriate), and total amount.
(g) Charges for freight or express shipments other than F.O.B. destination. (If shipped by freight or express and charges are more than $25, attach prepaid bill.)
(h) Equipment - If there is a contract clause authorizing the purchase of any item of equipment, the final invoice must contain a statement indicating that no item of equipment was purchased or include a completed form HHS-565, Report of Capitalized Nonexpendable Equipment.
Currency: Where payments are made in a currency other than United States dollars, billings on the contract shall be expressed, and payment by the United States Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices paid under this contract may not exceed the United States dollars authorized.
HHSO100201500035C | Mediwound Ltd |
ATTACHMENT #4 - SAMPLE INVOICE FORM
Company Name
Designated Billing Office Name and Address: | Invoice/Finance Number: |
DHHS/OS/ASPR/AMCG | Date Invoice Prepared: |
Attn: Contracting Officer | |
200 C St., S.W. | Contract No. and Title: |
Washington, D.C. 20201 | Effective Date & Period of Performance: |
Contractor’s Address and Contact Information: | Total Estimated Cost of Order: |
Office of Acquisitions: | |
Contracting Officer (insert name here) | |
Office of Acquisitions Management, Contracts, and | |
POC: Name of accountant or COO or signatory authority for invoice | Grants (AMCG) |
Title: | |
Phone: | |
E-Mail: | Central Point of Distribution: |
TIN: | |
DUNS #: |
This invoice represents reimbursable costs for the period from | ||||
Expenditure Category | Amount Billed | |||
Current | Cumulative | Contract Value | ||
Direct Costs: | ||||
Direct Labor | ||||
Fringe Benefits 0.00% | ||||
Total Labor Costs: | ||||
Overhead 0.00% | ||||
Travel | ||||
Subcontracts | ||||
Consultant Fees | ||||
Materials and Supplies | ||||
Other | ||||
Total Direct Costs | ||||
G&A Rate 0.00% | ||||
Subtotal: | ||||
Fixed Fee 0.0 | ||||
Total Amount Claimed | ||||
Adjustments | ||||
Grand Total | $ | — |
I certify that all payments requested are for appropriate purposes and in accordance with the contract.
Name/signature of signatory authority for invoicing
HHSO100201500035C | Mediwound Ltd |
ATTACHMENT #5
RESEARCH PATIENT CARE COSTS
(a) | Research patient care costs are the costs of routine and ancillary services provided to patients participating in research programs described in this contract. |
(b) | Patient care costs shall be computed in a manner consistent with the principles and procedures used by the Medicare Program for determining the part of Medicare reimbursement based on reasonable costs. The Diagnostic Related Group (DRG) prospective reimbursement method used to determine the remaining portion of Medicare reimbursement shall not be used to determine patient care costs. Patient care rates or amounts shall be established by the Secretary of HHS or his duly authorized representative. |
(c) | Prior to submitting an invoice for patient care costs under this contract, the Contractor must make every reasonable effort to obtain third party payment, where third party payors (including Government agencies) are authorized or are under a legal obligation to pay all or a portion of the charges incurred under this contract for patient care. |
(d) | The Contractor must maintain adequate procedures to identify those research patients participating in this contract who are eligible for third party reimbursement. |
(e) | Only those charges not recoverable from third party payors or patients and which are consistent with the terms and conditions of the contract are chargeable to this contract. |
Attachment 6
REPORT OF GOVERNMENT OWNED, CONTRACTOR HELD PROPERTY | |||||||||||||
CONTRACTOR: |
CONTRACT NUMBER:
|
||||||||||||
ADDRESS: | REPORT DATE: | ||||||||||||
ADDRESS1: | |||||||||||||
ADDRESS2: | FISCAL YEAR: | ||||||||||||
CITY: | |||||||||||||
STATE: | |||||||||||||
ZIP: | |||||||||||||
CLASSIFICATION |
BEGINNING
OF
PERIOD |
ADJUSTMENTS | END OF PERIOD | ||||||||||
#ITEMS | VALUE |
GFP
ADDED |
CAP
ADDED |
DELETIONS | #ITEMS | VALUE | |||||||
LAND >=$25K | |||||||||||||
LAND <$25K | |||||||||||||
OTHER REAL >=$25K | |||||||||||||
OTHER REAL <$25K | |||||||||||||
PROPERTY UNDER CONST >=$25K | |||||||||||||
PROPERTY UNDER CONST <$25K | |||||||||||||
PLANT EQUIP >=$25K | |||||||||||||
PLANT EQUIP <$25K | |||||||||||||
SPECIAL TOOLING >=$25K | |||||||||||||
SPECIAL TOOLING <$25K | |||||||||||||
SPECIAL TEST EQUIP >=$25K | |||||||||||||
SPECIAL TEST EQUIP <$25K | |||||||||||||
AGENCY PECULIAR >=$25K | |||||||||||||
AGENCY PECULIAR <$25K | |||||||||||||
MATERIAL >=$25K (CUMULATIVE) | |||||||||||||
PROPERTY UNDER MFR >=$25K | |||||||||||||
PROPERTY UNDER MFR <$25K | |||||||||||||
SIGNED BY: | |||||||||||||
SIGNATURE |
DATE SIGNED: |
|
|||||||||||
NAME PRINTED |
|
||||||||||||
TITLE |
TELEPHONE
|
||||||||||||
Report of Government Owned, Contractor Held Property (Rev 10/2014)
Attachment
7
Complete
this form to disclose lobbying activities pursuant to 31 U.S.C. 1352
|
Approved
by OMB
0348-0046 |
1. Type of Federal Action: | 2. Status of Federal Action: | 3. Report Type: |
☐ a. contract b. grant c. cooperative agreement d. loan e. loan guarantee f. loan insurance |
☐ a. bid/offer/application b. initial award c. post-award
|
☐ a. initial filing b. material change For Material Change Only: year _______ quarter __________ date of last report _____________ |
Federal Use Only: |
Authorized
for Local Reproduction
Standard Form LLL (Rev. 7-97) |
INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES
This disclosure form shall be completed by the reporting entity, whether subawardee or prime Federal recipient, at the initiation or receipt of a covered Federal action, or a material change to a previous filing, pursuant to title 31 U.S.C. section 1352. The filing of a form is required for each payment or agreement to make payment to any lobbying entity for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with a covered Federal action. Complete all items that apply for both the initial filing and material change report. Refer to the implementing guidance published by the Office of Management and Budget for additional information.
According to the Paperwork Reduction Act, as amended, no persons are required to respond to a collection of information unless it displays a valid OMB Control Number. The valid OMB control number for this information collection is OMB No. 0348-0046. Public reporting burden for this collection of information is estimated to average 10 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Office of Management and Budget, Paperwork Reduction Project (0348-0046), Washington, DC 20503. |
Cumulative Inclusion Enrollment Report
This report format should NOT be used for collecting data from study participants.
Study Title:
Comments:
Racial Categories | Ethnic Categories | Total | ||||||||
Not Hispanic or Latino | Hispanic or Latino | Unknown/Not Reported Ethnicity | ||||||||
Female | Male |
Unknown/
Not Reported |
Female | Male |
Unknown/
Not Reported |
Female | Male |
Unknown/
Not Reported |
||
American Indian/ Alaska Native | 0 | |||||||||
Asian | 0 | |||||||||
Native Hawaiian or Other Pacific Islander | 0 | |||||||||
Black or African American | 0 | |||||||||
White | 0 | |||||||||
More Than One Race | 0 | |||||||||
Unknown or Not Reported | 0 | |||||||||
Total | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
PHS 398 / PHS 2590 (Rev. 08/12 Approved Through 8/31/2015) | OMB No. 0925-0001/0002 | |
Cumulative Inclusion Enrollment Report | ||
Exhibit 4.14
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT | 1. CONTRACT ID CODE | PAGE OF PAGES | ||||||
1 | 3 | ||||||||
2. AMENDMENT/MODIFICATION
NO.
0001 |
3.
EFFECTIVE DATE
10/05/2015 |
4. REQUISITION/PURCHASE REQ. NO. | 5. PROJECT NO. (If applicable) | |||||
6. ISSUED BY | CODE | ASPR–BARDA | 7. ADMINISTERED BY (If other than Item 6) | CODE | ASPR–BARDA01 | |||
ASPR–BARDA
200
Independence Ave., S.W.
|
ASPR–BARDA
330
Independence Ave, SW, Rm G644
|
|||||||
8.
NAME AND ADDRESS OF CONTRACTOR
(No., street, county, State and ZIP Code)
MEDIWOUND
LTD 1477616
|
(x) | 9A. AMENDMENT OF SOLICITATION NO. | ||||||
9B. DATED (SEE ITEM 11) | ||||||||
x |
10A. MODIFICATION OF CONTRACT/ORDER
NO.
HHSO100201500035C |
|||||||
10B. DATED (SEE ITEM 13) | ||||||||
CODE 1477616 | FACILITY CODE | 09/29/2015 | ||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS | ||||||||
☐ | The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers ☐ is extended. ☐ is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing Items B and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which Includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. |
12. ACCOUNTING AND APPROPRIATION DATA (If required) |
2015.1990002.26201 |
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
CHECK ONE | A. THIS CHANGE ORDER IS ISSUED PURSUANT TO; (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. |
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). | |
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: | |
D. OTHER (Specify type of modification and authority) | |
E. IMPORTANT: Contractor ☒ is not. ☐ is required to sign this document and return _____________ copies to the issuing office. |
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
Tax ID Number: C0–0000387
DUNS Number: 532040334
PURPOSE: To add option CLINs 0003, 0004, and 0005A into PRISM as an administrative modification. This modification only clarifies language and does not change the any amounts obligated in the base contract.
Funds Obligated Prior to this Modification | $40,430,469.00 |
Funds Obligated with mod #01 $ 0.00 | |
Total Funds Obligated to Date | $40,430,469.00 |
Continued ...
CONTINUATION SHEET | REFERENCE NO. OF DOCUMENT BEING CONTINUED | PAGE OF | |
HHS0100201500035C/0001 | 2 | 3 |
NAME
OF
OFFEROR OR CONTRACTOR
MEDIWOUND LTD 1477616
CONTINUATION SHEET | REFERENCE NO. OF DOCUMENT BEING CONTINUED | PAGE OF | |
HHS0100201500035C/0001 | 3 | 3 |
NAME
OF OFFEROR OR CONTRACTOR
MEDIWOUND LTD 1477616
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
|
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
|
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Tel Aviv, Israel
January 25, 2016
|
/s/
KOST, FORER, GABBAY & KASIERER.
KOST, FORER, GABBAY & KASIERER
A Member of Ernst & Young Global
|