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FRANCE
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2834
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NOT APPLICABLE
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(State or other jurisdiction of
incorporation or organization) |
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(Primary Standard Industrial
Classification Code Number) |
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(I.R.S. Employer
Identification Number) |
|
|
John G. Crowley, Esq.
Davis Polk & Wardwell LLP 450 Lexington Avenue New York, NY 10017 |
| |
Jacques Naquet-Radiguet, Esq.
Davis Polk & Wardwell LLP 121 Avenue des Champs-Elysées 75008 Paris, France |
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David S. Rosenthal, Esq.
Dechert LLP 1095 Avenue of the Americas New York, NY 10036 |
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Title of each class of securities to be registered
|
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Proposed maximum
aggregate offering price(1)(2) |
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Amount of registration fee
|
| ||||||||
Ordinary shares, €0.10 nominal value per share, in the form of ADSs(3)
|
| | | $ | 100,000,000 | | | | | $ | 11,620 | | | ||
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| | |
Per ADS
|
| |
Total
|
| ||||||
Public offering price
|
| | | $ | | | | | $ | | | ||
Underwriting discounts and commissions
|
| | | $ | | | | | $ | | | ||
Proceeds, before expenses, to us
|
| | | $ | | | | | $ | | | |
| Citigroup | | |
Jefferies
|
|
| Canaccord Genuity | | |
JMP Securities
|
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Product
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Description
|
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Applications
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Marketing Authorizations
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Gluscan / Gluscan 500 / Barnascan
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| |
Our brand names for FDG (concentration = 600MBq*/ml and 500MBq*/ml at calibration time for Gluscan and Gluscan 500, respectively; 3,000MBq*/ml for Barnascan at calibration time)
|
| |
PET tracer for oncology, cardiology, neurology and infectious/inflammatory diseases
|
| | Gluscan: Belgium, France, Italy, Luxembourg, Switzerland | |
| Gluscan 500: France, Germany, Poland, Portugal, Spain | | ||||||||
| Barnascan: Spain | | ||||||||
IASOflu
|
| | Our licensed brand name for Sodium Fluoride-18 | | | PET tracer used as a bone imaging agent in defining areas of altered osteogenic activity | | | Belgium, France, Germany, Italy, Luxembourg, Poland | |
IASOdopa
|
| | Our licensed brand name for 6-fluoro-(18F)-L-DOPA, a DOPA analogue | | | PET tracer for diagnostic use, with key applications in neurology and oncology | | | France, Germany, Italy | |
IASOcholine
|
| | Our licensed brand name for 18F-choline (FCH) | | | PET tracer for detecting metastasis of prostate cancer and hepatocellular carcinoma (liver cancer) | | | Belgium, France, Germany, Italy, Luxembourg, Poland | |
Product
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Description
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Applications
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Marketing Authorizations
|
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MIBITEC / Adamibi
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Our brand names for a generic version of a widely-used SPECT cardiac imaging agent
|
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SPECT tracer for myocardial exploration, localization of parathyroid tissue and breast cancer diagnosis
|
| | MIBITEC: Austria, France, Germany, Luxembourg, Poland, Slovenia | |
| Adamibi: Greece, Italy | | ||||||||
Leukokit
|
| | Medical device for the separation and labeling of autologous leukocytes | | | Identifies sites of infection or inflammation in the body | | | CE mark: can be commercialized throughout Europe | |
| | |
Year Ended December 31,
|
| |
Nine Months Ended September 30,
|
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| | |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| |
2014
|
| |
2013
|
| |||||||||||||||||||||||||||
| | |
US$(1)
|
| |
Euro
|
| |
Euro
|
| |
Euro
|
| |
US$(1)
|
| |
Euro
|
| |
Euro
|
| |||||||||||||||||||||
| | |
(US Dollars and Euros in thousands unless otherwise
noted except share and per share amounts) |
| |||||||||||||||||||||||||||||||||||||||
Consolidated Statements of Income:
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||
Sales
|
| | | | 67,946 | | | | | | 53,806 | | | | | | 40,834 | | | | | | 33,864 | | | | | | 63,350 | | | | | | 50,166 | | | | | | 38,919 | | |
Raw materials and consumables used
|
| | | | (11,599) | | | | | | (9,185) | | | | | | (6,296) | | | | | | (4,061) | | | | | | (12,351) | | | | | | (9,781) | | | | | | (7,142) | | |
Personnel costs
|
| | | | (20,539) | | | | | | (16,265) | | | | | | (13,259) | | | | | | (10,657) | | | | | | (18,745) | | | | | | (14,844) | | | | | | (11,942) | | |
Other operating expenses
|
| | | | (31,120) | | | | | | (24,644) | | | | | | (22,032) | | | | | | (16,021) | | | | | | (28,922) | | | | | | (22,903) | | | | | | (16,399) | | |
Other operating income
|
| | | | 5,022 | | | | | | 3,977 | | | | | | 3,560 | | | | | | 1,520 | | | | | | 4,215 | | | | | | 3,338 | | | | | | 2,837 | | |
Depreciation and amortization
|
| | | | (12,053) | | | | | | (9,545) | | | | | | (6,495) | | | | | | (4,342) | | | | | | (9,164) | | | | | | (7,257) | | | | | | (5,436) | | |
Operating income (loss)
|
| | | | (2,343) | | | | | | (1,856) | | | | | | (3,688) | | | | | | 303 | | | | | | (1,618) | | | | | | (1,281) | | | | | | 837 | | |
Finance income (including changes in fair value of contingent consideration)
|
| | | | 489 | | | | | | 387 | | | | | | 232 | | | | | | 492 | | | | | | 1,666 | | | | | | 1,319 | | | | | | 95 | | |
Finance costs (including changes
in fair value of contingent consideration) |
| | | | (12,824) | | | | | | (10,155) | | | | | | (16,512) | | | | | | (733) | | | | | | (1,012) | | | | | | (801) | | | | | | (3,023) | | |
Net finance costs
|
| | | | (12,335) | | | | | | (9,768) | | | | | | (16,280) | | | | | | (241) | | | | | | 654 | | | | | | 518 | | | | | | (2,928) | | |
Profit/(Loss) before income taxes
|
| | | | (14,680) | | | | | | (11,624) | | | | | | (19,968) | | | | | | 62 | | | | | | (964) | | | | | | (763) | | | | | | (2,091) | | |
Income taxes
|
| | | | (1,462) | | | | | | (1,157) | | | | | | (536) | | | | | | (844) | | | | | | (2,125) | | | | | | (1,683) | | | | | | (583) | | |
Net loss for the period
|
| | | | (16,140) | | | | | | (12,781) | | | | | | (20,504) | | | | | | (782) | | | | | | (3,089) | | | | | | (2,446) | | | | | | (2,674) | | |
Attributable to owners of the company
|
| | | | (15,346) | | | | | | (12,152) | | | | | | (20,047) | | | | | | (239) | | | | | | (1,955) | | | | | | (1,548) | | | | | | (2,309) | | |
Non-controlling interests
|
| | | | (794) | | | | | | (629) | | | | | | (457) | | | | | | (544) | | | | | | (1,134) | | | | | | (898) | | | | | | (365) | | |
Loss per share: | | | | | | | | | |||||||||||||||||||||||||||||||||||
Basic (US$ and € per share)
|
| | | | (0.28) | | | | | | (0.22) | | | | | | (0.38) | | | | | | (0.00) | | | | | | (0.03) | | | | | | (0.02) | | | | | | (0.04) | | |
Diluted (US$ and € per share)
|
| | | | (0.28) | | | | | | (0.22) | | | | | | (0.38) | | | | | | (0.00) | | | | | | (0.03) | | | | | | (0.02) | | | | | | (0.04) | | |
Weighted average ordinary shares
outstanding used in computing per share amounts |
| | | | | | | | |||||||||||||||||||||||||||||||||||
Basic
|
| | | | 54,156,067 | | | | | | 54,156,067 | | | | | | 52,364,094 | | | | | | 48,054,083 | | | | | | 62,514,233 | | | | | | 62,514,233 | | | | | | 54,036,813 | | |
Diluted
|
| | | | 54,156,067 | | | | | | 54,156,067 | | | | | | 52,364,094 | | | | | | 48,054,083 | | | | | | 62,514,233 | | | | | | 62,514,233 | | | | | | 54,036,813 | | |
| | |
At December 31,
|
| |
At September 30,
|
| ||||||||||||||||||||||||||||||||||||
| | |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| |
2014
|
| ||||||||||||||||||||||||||||||
| | |
US$(1)
|
| |
Euro
|
| |
Euro
|
| |
Euro
|
| |
US$(1)
|
| |
Euro
|
| ||||||||||||||||||||||||
| | |
(US Dollars and Euros in thousands)
|
| |||||||||||||||||||||||||||||||||||||||
Consolidated Statements of Financial Position:
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||
Assets | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||
Non-current assets
|
| | | | 130,635 | | | | | | 103,449 | | | | | | 104,613 | | | | | | 80,457 | | | | | | 140,162 | | | | | | 110,993 | | | ||||||
Goodwill
|
| | | | 26,837 | | | | | | 21,252 | | | | | | 22,285 | | | | | | 13,141 | | | | | | 28,105 | | | | | | 22,256 | | | ||||||
Other intangible assets
|
| | | | 38,618 | | | | | | 30,581 | | | | | | 33,845 | | | | | | 32,434 | | | | | | 40,881 | | | | | | 32,373 | | | ||||||
Property, plant and equipment
|
| | | | 62,231 | | | | | | 49,280 | | | | | | 45,762 | | | | | | 34,327 | | | | | | 67,894 | | | | | | 53,765 | | | ||||||
Financial assets
|
| | | | 2,950 | | | | | | 2,336 | | | | | | 2,721 | | | | | | 555 | | | | | | 3,282 | | | | | | 2,599 | | | ||||||
Current assets
|
| | | | 50,548 | | | | | | 40,028 | | | | | | 38,543 | | | | | | 46,295 | | | | | | 102,101 | | | | | | 80,853 | | | ||||||
Inventories
|
| | | | 2,877 | | | | | | 2,278 | | | | | | 1,833 | | | | | | 1,244 | | | | | | 4,398 | | | | | | 3,483 | | | ||||||
Trade and other receivables
|
| | | | 20,385 | | | | | | 16,143 | | | | | | 15,537 | | | | | | 10,910 | | | | | | 23,919 | | | | | | 18,941 | | | ||||||
Other current assets
|
| | | | 10,099 | | | | | | 7,997 | | | | | | 7,107 | | | | | | 4,351 | | | | | | 12,309 | | | | | | 9,747 | | | ||||||
Cash and cash equivalents
|
| | | | 17,187 | | | | | | 13,610 | | | | | | 14,066 | | | | | | 29,790 | | | | | | 61,476 | | | | | | 48,682 | | | ||||||
Total assets
|
| | | | 181,183 | | | | | | 143,477 | | | | | | 143,156 | | | | | | 126,752 | | | | | | 242,263 | | | | | | 191,846 | | | ||||||
Equity and liabilities | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||
Equity attributable to owners of the company
|
| | | | 70,367 | | | | | | 55,723 | | | | | | 58,389 | | | | | | 78,013 | | | | | | 125,640 | | | | | | 99,493 | | | ||||||
Share capital
|
| | | | 6,838 | | | | | | 5,415 | | | | | | 5,244 | | | | | | 5,210 | | | | | | 7,947 | | | | | | 6,293 | | | ||||||
Share premium
|
| | | | 96,723 | | | | | | 76,594 | | | | | | 69,650 | | | | | | 69,155 | | | | | | 149,579 | | | | | | 118,450 | | | ||||||
Reserves and retained earnings
|
| | | | (17,848) | | | | | | (14,134) | | | | | | 3,542 | | | | | | 2,887 | | | | | | (29,931) | | | | | | (23,702) | | | ||||||
Net profit/(loss) for the period
|
| | | | (15,346) | | | | | | (12,152) | | | | | | (20,047) | | | | | | (239) | | | | | | (1,955) | | | | | | (1,548) | | | ||||||
Non-controlling interests
|
| | | | 1,717 | | | | | | 1,360 | | | | | | 2,188 | | | | | | 2,198 | | | | | | 804 | | | | | | 637 | | | ||||||
Total equity
|
| | | | 72,084 | | | | | | 57,083 | | | | | | 60,577 | | | | | | 79,211 | | | | | | 126,444 | | | | | | 100,130 | | | ||||||
Non-current liabilities
|
| | | | 78,359 | | | | | | 62,052 | | | | | | 56,447 | | | | | | 28,227 | | | | | | 80,151 | | | | | | 63,471 | | | ||||||
Non-current provisions
|
| | | | 7,615 | | | | | | 6,029 | | | | | | 5,592 | | | | | | 3,390 | | | | | | 10,065 | | | | | | 7,970 | | | ||||||
Non-current financial liabilities
|
| | | | 25,709 | | | | | | 20,359 | | | | | | 21,056 | | | | | | 11,789 | | | | | | 26,449 | | | | | | 20,945 | | | ||||||
Deferred tax liabilities
|
| | | | 5,287 | | | | | | 4,187 | | | | | | 5,386 | | | | | | 5,767 | | | | | | 5,689 | | | | | | 4,505 | | | ||||||
Other non-current liabilities
|
| | | | 39,749 | | | | | | 31,477 | | | | | | 24,413 | | | | | | 7,281 | | | | | | 37,948 | | | | | | 30,051 | | | ||||||
Current liabilities
|
| | | | 30,739 | | | | | | 24,342 | | | | | | 26,132 | | | | | | 19,314 | | | | | | 35,668 | | | | | | 28,245 | | | ||||||
Current provisions
|
| | | | 145 | | | | | | 115 | | | | | | 300 | | | | | | 0 | | | | | | 119 | | | | | | 94 | | | ||||||
Current financial liabilities
|
| | | | 6,892 | | | | | | 5,458 | | | | | | 4,012 | | | | | | 3,967 | | | | | | 7,608 | | | | | | 6,025 | | | ||||||
Trade and other payables
|
| | | | 11,640 | | | | | | 9,218 | | | | | | 9,857 | | | | | | 7,933 | | | | | | 11,769 | | | | | | 9,320 | | | ||||||
Other current liabilities
|
| | | | 12,061 | | | | | | 9,551 | | | | | | 11,963 | | | | | | 7,414 | | | | | | 16,171 | | | | | | 12,806 | | | ||||||
Total liabilities
|
| | | | 109,098 | | | | | | 86,394 | | | | | | 82,579 | | | | | | 47,541 | | | | | | 115,819 | | | | | | 91,716 | | | ||||||
Total Equity and liabilities
|
| | | | 181,183 | | | | | | 143,477 | | | | | | 143,156 | | | | | | 126,752 | | | | | | 242,263 | | | | | | 191,846 | | | ||||||
|
| | |
Year Ended December 31,
|
| |
Nine Months Ended September 30,
|
| ||||||||||||||||||||||||||||||
| | |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| |
2014
|
| ||||||||||||||||||||||||
| | |
US$(1)
|
| |
Euro
|
| |
Euro
|
| |
Euro
|
| |
US$(1)
|
| |
Euro
|
| ||||||||||||||||||
| | |
(US Dollars and Euros in thousands)
|
| |||||||||||||||||||||||||||||||||
Adjusted EBITDA(2)
|
| | | | 9,711 | | | | | | 7,690 | | | | | | 2,807 | | | | | | 4,645 | | | | | | 7,546 | | | | | | 5,976 | | |
Adjusted EBITDA margin(3)
|
| | | | 14.3% | | | | | | 14.3% | | | | | | 6.9% | | | | | | 13.7% | | | | | | 11.9% | | | | | | 11.9% | | |
| |
Year Ended December 31,
|
| |
Nine Months Ended
September 30, |
| |||||||||||||||||||||||||||||||||||||
| | |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| |
2014
|
| ||||||||||||||||||||||||||||||
| | |
US$(1)
|
| |
Euro
|
| |
Euro
|
| |
Euro
|
| |
US$(1)
|
| |
Euro
|
| ||||||||||||||||||||||||
| | |
(US Dollars and Euros in thousands)
|
| |||||||||||||||||||||||||||||||||||||||
Net profit/(loss) for the period (Restated)
|
| | | | (16,140) | | | | | | (12,781) | | | | | | (20,504) | | | | | | (782) | | | | | | (3,089) | | | | | | (2,446) | | | ||||||
Adjustments: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||
Finance income (including changes in fair value of contingent consideration)
|
| | | | (489) | | | | | | (387) | | | | | | (232) | | | | | | (492) | | | | | | (1,666) | | | | | | (1,319) | | | ||||||
Finance costs (including changes in fair value of contingent consideration)
|
| | | | 12,824 | | | | | | 10,155 | | | | | | 16,512 | | | | | | 733 | | | | | | 1,012 | | | | | | 801 | | | ||||||
Income taxes
|
| | | | 1,462 | | | | | | 1,158 | | | | | | 536 | | | | | | 844 | | | | | | 2,125 | | | | | | 1,683 | | | ||||||
Depreciation and amortization
|
| | | | 12,053 | | | | | | 9,545 | | | | | | 6,495 | | | | | | 4,342 | | | | | | 9,164 | | | | | | 7,257 | | | ||||||
Adjusted EBITDA
|
| | | | 9,711 | | | | | | 7,690 | | | | | | 2,807 | | | | | | 4,645 | | | | | | 7,546 | | | | | | 5,976 | | | ||||||
Sales | | | | | 67,946 | | | | | | 53,806 | | | | | | 40,834 | | | | | | 33,864 | | | | | | 63,350 | | | | | | 50,166 | | | ||||||
Adjusted EBITDA margin
|
| | | | 14.3% | | | | | | 14.3% | | | | | | 6.9% | | | | | | 13.7% | | | | | | 11.9% | | | | | | 11.9% | | | ||||||
|
| | |
September 30, 2014 (unaudited)
|
| |||||||||||||||||||||||||
| | |
Actual
|
| |
As Adjusted
|
| |
Actual
|
| |
As Adjusted
|
| ||||||||||||||||
| | |
(in thousands of US$(1))
|
| |
(in thousands of Euros)
|
| ||||||||||||||||||||||
Cash and cash equivalents
|
| | | | 61,476 | | | | | | | | | | | 48,682 | | | | | | | | ||||||
Non-current financial liabilities
|
| | | | 26,449 | | | | | | | | | | | | 20,945 | | | | | | | | | ||||
Equity | | | | | | | | | | | | | | | | | | | | | | | | | | ||||
Ordinary shares, €0.10 nominal value per share, 62,934,041 ordinary shares authorized, issued and outstanding, actual; and ordinary shares authorized and ordinary shares issued and outstanding, as adjusted
|
| | | | 7,947 | | | | | | | | | | | | 6,293 | | | | | | | | | ||||
Share premium
|
| | | | 149,579 | | | | | | | | | | | | 118,453 | | | | | | | | | ||||
Reserves and retained earnings
|
| | | | (29,931) | | | | | | | | | | | | (23,702) | | | | | | | | | ||||
Net profit/(loss) for the period
|
| | | | (1,955) | | | | | | | | | | | | (1,548) | | | | | | | | | ||||
Non-controlling interests in equity
|
| | | | 804 | | | | | | | | | | | | 1,535 | | | | | | | | | ||||
Non-controlling interests in net profit/(loss) for the period
|
| | | | (1,134) | | | | | | | | | | | | (898) | | | | | | | | | ||||
Total equity(2)
|
| | | | 126,444 | | | | | | | | | | | | 100,130 | | | | | | | | | ||||
Total capitalization(2)(3)
|
| | | | 152,894 | | | | | | | | | | | | 121,075 | | | | | | | | | ||||
|
|
Net tangible book value per ADS at September 30, 2014
|
| | | US$ | | | |
|
Increase in net tangible book value per ADS attributable to new investors
|
| | |||||
|
Pro forma net tangible book value per ADS after the offering
|
| | |||||
|
Dilution per ADS to new investors
|
| | |||||
|
Percentage of dilution in net tangible book value per ADS for new investors
|
| | | | % | | |
| | |
Ordinary Shares/
ADSs Purchased from Us |
| |
Total Consideration
|
| |
Average
Price per Ordinary Share/ADS |
| ||||||||||||||||||||||
| | |
Number
|
| |
Percent
|
| |
Amount
|
| |
Percent
|
| |||||||||||||||||||
Existing shareholders
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||
New investors
|
| | | | | | | | | | | | | | | | | | | | | | | | ||||||||
Total | | | | | | | | | | | | | | | | | | | | | | | | | ||||||||
|
| | |
Period-End
|
| |
Average for
Period |
| |
Low
|
| |
High
|
| ||||||||||||
| | |
(US dollar per Euro)
|
| |||||||||||||||||||||
| | |
US$
|
| |
US$
|
| |
US$
|
| |
US$
|
| ||||||||||||
Year Ended December 31: | | | | | | | | | | | | | | | | | | | | | | | | | |
2010
|
| | | | 1.3269 | | | | | | 1.3218 | | | | | | 1.1959 | | | | | | 1.4536 | | |
2011
|
| | | | 1.2973 | | | | | | 1.4002 | | | | | | 1.2926 | | | | | | 1.4875 | | |
2012
|
| | | | 1.3186 | | | | | | 1.2909 | | | | | | 1.2062 | | | | | | 1.3463 | | |
2013
|
| | | | 1.3779 | | | | | | 1.3302 | | | | | | 1.2774 | | | | | | 1.3816 | | |
2014 (through December 24, 2014)
|
| | | | 1.2188 | | | | | | 1.3217 | | | | | | 1.2180 | | | | | | 1.3927 | | |
Quarter Ended: | | | | | | | | | | | | | | | | | | | | | | | | | |
December 31, 2013
|
| | | | 1.3779 | | | | | | 1.3660 | | | | | | 1.3357 | | | | | | 1.3816 | | |
March 31, 2014
|
| | | | 1.3777 | | | | | | 1.3694 | | | | | | 1.3500 | | | | | | 1.3927 | | |
June 30, 2014
|
| | | | 1.3690 | | | | | | 1.3733 | | | | | | 1.3522 | | | | | | 1.3924 | | |
September 30, 2014
|
| | | | 1.2628 | | | | | | 1.3056 | | | | | | 1.2628 | | | | | | 1.3681 | | |
Month Ended: | | | | | | ||||||||||||||||||||
June 30, 2014
|
| | | | 1.3690 | | | | | | 1.3595 | | | | | | 1.3522 | | | | | | 1.3690 | | |
July 31, 2014
|
| | | | 1.3390 | | | | | | 1.3533 | | | | | | 1.3378 | | | | | | 1.3681 | | |
August 31, 2014
|
| | | | 1.3150 | | | | | | 1.3150 | | | | | | 1.3150 | | | | | | 1.3436 | | |
September 30, 2014
|
| | | | 1.2628 | | | | | | 1.2889 | | | | | | 1.2628 | | | | | | 1.3136 | | |
October 31, 2014
|
| | | | 1.2530 | | | | | | 1.2677 | | | | | | 1.2517 | | | | | | 1.2812 | | |
November 30, 2014
|
| | | | 1.2438 | | | | | | 1.2473 | | | | | | 1.2394 | | | | | | 1.2554 | | |
December 31, 2014 (through December 24, 2014)
|
| | | | 1.2188 | | | | | | 1.2359 | | | | | | 1.2180 | | | | | | 1.2504 | | |
| | |
Year Ended December 31,
|
| |
Nine Months Ended September 30,
|
| |||||||||||||||||||||||||||||||||||||||||||
| | |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| |
2014
|
| |
2013
|
| ||||||||||||||||||||||||||||||||||
| | |
US$(1)
|
| |
Euro
|
| |
Euro
|
| |
Euro
|
| |
US$(1)
|
| |
Euro
|
| |
Euro
|
| ||||||||||||||||||||||||||||
| | |
(US Dollars and Euros in thousands unless otherwise noted except share
and per share amounts) |
| ||||||||||||||||||||||||||||||||||||||||||||||
Consolidated Statements of Income:
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||||||||||||||||||
Sales
|
| | | | 67,946 | | | | | | 53,806 | | | | | | 40,834 | | | | | | 33,864 | | | | | | 63,350 | | | | | | 50,166 | | | | | | 38,919 | | | |||||||
Raw materials and consumables used
|
| | | | (11,599) | | | | | | (9,185) | | | | | | (6,296) | | | | | | (4,061) | | | | | | (12,351) | | | | | | (9,781) | | | | | | (7,142) | | | |||||||
Personnel costs
|
| | | | (20,539) | | | | | | (16,265) | | | | | | (13,259) | | | | | | (10,657) | | | | | | (18,745) | | | | | | (14,844) | | | | | | (11,942) | | | |||||||
Other operating expenses
|
| | | | (31,120) | | | | | | (24,644) | | | | | | (22,032) | | | | | | (16,021) | | | | | | (28,922) | | | | | | (22,903) | | | | | | (16,399) | | | |||||||
Other operating income
|
| | | | 5,022 | | | | | | 3,977 | | | | | | 3,560 | | | | | | 1,520 | | | | | | 4,215 | | | | | | 3,338 | | | | | | 2,837 | | | |||||||
Depreciation and amortization
|
| | | | (12,053) | | | | | | (9,545) | | | | | | (6,495) | | | | | | (4,342) | | | | | | (9,164) | | | | | | (7,257) | | | | | | (5,436) | | | |||||||
Operating income (loss)
|
| | | | (2,343) | | | | | | (1,856) | | | | | | (3,688) | | | | | | 303 | | | | | | (1,618) | | | | | | (1,281) | | | | | | 837 | | | |||||||
Finance income (including changes in fair value of contingent consideration)
|
| | | | 489 | | | | | | 387 | | | | | | 232 | | | | | | 492 | | | | | | 1,666 | | | | | | 1,319 | | | | | | 95 | | | |||||||
Finance costs (including changes in fair value of contingent consideration)
|
| | | | (12,824) | | | | | | (10,155) | | | | | | (16,512) | | | | | | (733) | | | | | | (1,012) | | | | | | (801) | | | | | | (3,023) | | | |||||||
Net finance costs
|
| | | | (12,335) | | | | | | (9,768) | | | | | | (16,280) | | | | | | (241) | | | | | | 654 | | | | | | 518 | | | | | | (2,928) | | | |||||||
Profit (Loss) before income taxes
|
| | | | (14,680) | | | | | | (11,624) | | | | | | (19,968) | | | | | | 62 | | | | | | (964) | | | | | | (763) | | | | | | (2,091) | | | |||||||
Income taxes
|
| | | | (1,462) | | | | | | (1,157) | | | | | | (536) | | | | | | (844) | | | | | | (2,125) | | | | | | (1,683) | | | | | | (583) | | | |||||||
Net loss for the year
|
| | | | (16,140) | | | | | | (12,781) | | | | | | (20,504) | | | | | | (782) | | | | | | (3,089) | | | | | | (2,446) | | | | | | (2,674) | | | |||||||
|
| | |
Year Ended December 31,
|
| |
Nine Months Ended September 30,
|
| ||||||||||||||||||||||||||||||||||||
| | |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| |
2014
|
| |
2013
|
| |||||||||||||||||||||||||||
| | |
US$(1)
|
| |
Euro
|
| |
Euro
|
| |
Euro
|
| |
US$(1)
|
| |
Euro
|
| |
Euro
|
| |||||||||||||||||||||
| | |
(US Dollars and Euros in thousands unless otherwise noted except share
and per share amounts) |
| |||||||||||||||||||||||||||||||||||||||
Attributable to | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||||||||||
Owners of the company
|
| | | | (15,346) | | | | | | (12,152) | | | | | | (20,047) | | | | | | (239) | | | | | | (1,955) | | | | | | (1,548) | | | | | | (2,309) | | |
Non-controlling interests
|
| | | | (794) | | | | | | (629) | | | | | | (457) | | | | | | (544) | | | | | | (1,134) | | | | | | (898) | | | | | | (365) | | |
Loss per share: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||||||||||
Basic (US$ and € per share)
|
| | | | (0.28) | | | | | | (0.22) | | | | | | (0.38) | | | | | | (0.00) | | | | | | (0.03) | | | | | | (0.02) | | | | | | (0.04) | | |
Diluted (US$ and € per share)
|
| | | | (0.28) | | | | | | (0.22) | | | | | | (0.38) | | | | | | (0.00) | | | | | | (0.03) | | | | | | (0.02) | | | | | | (0.04) | | |
Weighted average
ordinary shares outstanding used in computing per share amounts |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||||||||||
Basic | | | | | 54,156,067 | | | | | | 54,156,067 | | | | | | 52,364,094 | | | | | | 48,054,083 | | | | | | 62,514,233 | | | | | | 62,514,233 | | | | | | 54,036,813 | | |
Diluted | | | | | 54,156,067 | | | | | | 54,156,067 | | | | | | 52,364,094 | | | | | | 48,054,083 | | | | | | 62,514,233 | | | | | | 62,514,233 | | | | | | 54,036,813 | | |
| |
At
December 31, 2013 (Restated) |
| |
At September 30, 2014
|
| ||||||||||||||||
| | |
Euro
|
| |
US$(1)
|
| |
Euro
|
| ||||||||||||
| | |
(US Dollars and Euros in thousands)
|
| ||||||||||||||||||
Consolidated Statements of Financial Position: | | | | | | | | | | | | | | | | | | | | |||
Assets | | | | | ||||||||||||||||||
Non-current assets
|
| | | | 103,449 | | | | | | 140,162 | | | | | | 110,993 | | | |||
Goodwill
|
| | | | 21,252 | | | | | | 28,105 | | | | | | 22,256 | | | |||
Other intangible assets
|
| | | | 30,581 | | | | | | 40,881 | | | | | | 32,373 | | | |||
Property, plant and equipment
|
| | | | 49,280 | | | | | | 67,894 | | | | | | 53,765 | | | |||
Financial assets
|
| | | | 2,336 | | | | | | 3,282 | | | | | | 2,599 | | | |||
Current assets
|
| | | | 40,028 | | | | | | 102,101 | | | | | | 80,853 | | | |||
Inventories
|
| | | | 2,278 | | | | | | 4,398 | | | | | | 3,483 | | | |||
Trade and other receivables
|
| | | | 16,143 | | | | | | 23,919 | | | | | | 18,941 | | | |||
Other current assets
|
| | | | 7,997 | | | | | | 12,309 | | | | | | 9,747 | | | |||
Cash and cash equivalents
|
| | | | 13,610 | | | | | | 61,476 | | | | | | 48,682 | | | |||
Total assets
|
| | | | 143,477 | | | | | | 242,263 | | | | | | 191,846 | | | |||
Equity and liabilities | | | | | | | | | | | | | | | | | | | | |||
Equity attributable to owners of the company
|
| | | | 55,723 | | | | | | 125,640 | | | | | | 99,493 | | | |||
Share capital
|
| | | | 5,415 | | | | | | 7,947 | | | | | | 6,293 | | | |||
Share premium
|
| | | | 76,594 | | | | | | 149,579 | | | | | | 118,450 | | | |||
Reserves and retained earnings
|
| | | | (14,134) | | | | | | (29,931) | | | | | | (23,702) | | | |||
Net loss for the year
|
| | | | (12,152) | | | | | | (1,955) | | | | | | (1,548) | | | |||
Non-controlling interests
|
| | | | 1,360 | | | | | | 804 | | | | | | 637 | | | |||
Total equity
|
| | | | 57,083 | | | | | | 126,444 | | | | | | 100,130 | | | |||
Non-current liabilities
|
| | | | 62,052 | | | | | | 80,151 | | | | | | 63,471 | | | |||
Non-current provisions
|
| | | | 6,029 | | | | | | 10,065 | | | | | | 7,970 | | | |||
Non-current financial liabilities
|
| | | | 20,359 | | | | | | 26,449 | | | | | | 20,945 | | | |||
Deferred tax liabilities
|
| | | | 4,187 | | | | | | 5,689 | | | | | | 4,505 | | | |||
Other non-current liabilities
|
| | | | 31,477 | | | | | | 37,948 | | | | | | 30,051 | | | |||
Current liabilities
|
| | | | 24,342 | | | | | | 35,668 | | | | | | 28,245 | | | |||
Current provisions
|
| | | | 115 | | | | | | 119 | | | | | | 94 | | | |||
Current financial liabilities
|
| | | | 5,458 | | | | | | 7,608 | | | | | | 6,025 | | | |||
Trade and other payables
|
| | | | 9,218 | | | | | | 11,769 | | | | | | 9,320 | | | |||
Other current liabilities
|
| | | | 9,551 | | | | | | 16,171 | | | | | | 12,806 | | | |||
Total liabilities
|
| | | | 86,394 | | | | | | 115,819 | | | | | | 91,716 | | | |||
Total Equity and liabilities
|
| | | | 143,477 | | | | | | 242,263 | | | | | | 191,846 | | | |||
|
| | |
Year Ended December 31,
|
| |
Nine Months Ended September 30,
|
| ||||||||||||||||||||||||||||||||||||
| | |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| |
2014
|
| |
2013
|
| |||||||||||||||||||||||||||
| | |
US$(1)
|
| |
Euro
|
| |
Euro
|
| |
Euro
|
| |
US$(1)
|
| |
Euro
|
| |
Euro
|
| |||||||||||||||||||||
| | |
(US Dollars and Euros in thousands except percentages)
|
| |||||||||||||||||||||||||||||||||||||||
Financial metrics | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||||||||||
Sales
|
| | | | 67,946 | | | | | | 53,806 | | | | | | 40,834 | | | | | | 33,864 | | | | | | 63,350 | | | | | | 50,166 | | | | | | 38,919 | | |
Year-over-year percentage increase
|
| | | | | | | | | | 31.8% | | | | | | 20.6% | | | | | | | | | | | | | | | | | | 28.9% | | | | | | | | |
Operating income/(loss)
|
| | | | (2,343) | | | | | | (1,856) | | | | | | (3,688) | | | | | | 303 | | | | | | (1,618) | | | | | | (1,281) | | | | | | 837 | | |
Net loss for the period
|
| | | | (16,140) | | | | | | (12,781) | | | | | | (20,504) | | | | | | (782) | | | | | | (3,089) | | | | | | (2,446) | | | | | | (2,674) | | |
Adjusted EBITDA(2)
|
| | | | 9,711 | | | | | | 7,690 | | | | | | 2,807 | | | | | | 4,645 | | | | | | 7,546 | | | | | | 5,976 | | | | | | 6,273 | | |
Adjusted EBITDA margin(2)
|
| | | | 14.3% | | | | | | 14.3% | | | | | | 6.9% | | | | | | 13.7% | | | | | | 11.9% | | | | | | 11.9% | | | | | | 16.1% | | |
Net cash from operating
activities |
| | | | 9,780 | | | | | | 7,745 | | | | | | 1,226 | | | | | | 7,201 | | | | | | 4,566 | | | | | | 3,616 | | | | | | 4,751 | | |
Cash and cash equivalents
|
| | | | 17,187 | | | | | | 13,610 | | | | | | 14,066 | | | | | | 29,790 | | | | | | 61,476 | | | | | | 48,682 | | | | | | 15,977 | | |
| | |
For the nine months ended September 30,
|
| |||||||||||||||||||||
| | |
2014
|
| |
2014
|
| |
2013
|
| |
% Change from
prior period |
| ||||||||||||
| | |
US$(1)
|
| |
Euro
|
| |
Euro
|
| | | | | | | |||||||||
| | |
(US Dollars and Euros in thousands except percentages)
|
| |||||||||||||||||||||
Consolidated Statements of Income: | | | | | | | | | | | | | | | | | | | | | | | | | |
Sales
|
| | | | 63,350 | | | | | | 50,166 | | | | | | 38,919 | | | | | | 28.9% | | |
Raw materials and consumables used
|
| | | | (12,351) | | | | | | (9,781) | | | | | | (7,142) | | | | | | 37.0% | | |
Personnel costs
|
| | | | (18,745) | | | | | | (14,844) | | | | | | (11,942) | | | | | | 24.3% | | |
Other operating expenses
|
| | | | (28,922) | | | | | | (22,903) | | | | | | (16,399) | | | | | | 39.7% | | |
Other operating income
|
| | | | 4,215 | | | | | | 3,338 | | | | | | 2,837 | | | | | | 17.7% | | |
Depreciation and amortization
|
| | | | (9,164) | | | | | | (7,257) | | | | | | (5,436) | | | | | | 33.5% | | |
Operating income (loss)
|
| | | | (1,618) | | | | | | (1,281) | | | | | | 837 | | | | | | — | | |
Finance income (including changes in fair value of contingent consideration)
|
| | | | 1,666 | | | | | | 1,319 | | | | | | 95 | | | | | | 1,288.4% | | |
Finance costs (including changes in fair value of contingent consideration)
|
| | | | (1,012) | | | | | | (801) | | | | | | (3,023) | | | | | | (73.5%) | | |
Net finance costs
|
| | | | 654 | | | | | | 518 | | | | | | (2,928) | | | | | | — | | |
Loss before income taxes
|
| | | | (964) | | | | | | (763) | | | | | | (2,091) | | | | | | (63.5%) | | |
Income taxes
|
| | | | (2,625) | | | | | | (1,683) | | | | | | (583) | | | | | | 188.7% | | |
Net loss for the period
|
| | | | (3,089) | | | | | | (2,446) | | | | | | (2,674) | | | | | | (8.5%) | | |
Attributable to owners of the company
|
| | | | (1,955) | | | | | | (1,548) | | | | | | (2,309) | | | | | | (33.0%) | | |
Non-controlling interests
|
| | | | (1,134) | | | | | | (898) | | | | | | (365) | | | | | | 146.0% | | |
Loss per share: | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic (US$ and € per share)
|
| | | | (0.03) | | | | | | (0.02) | | | | | | (0.04) | | | | | | | | |
Diluted (US$ and € per share)
|
| | | | (0.03) | | | | | | (0.02) | | | | | | (0.04) | | | | | | | | |
Weighted average ordinary shares outstanding used in computing per share amounts
|
| | | | | | | | | | | | | | | | | | | | | | | | |
Basic | | | | | 62,514,233 | | | | | | 62,514,233 | | | | | | 54,036,813 | | | | | | | | |
Diluted | | | | | 62,514,233 | | | | | | 62,514,233 | | | | | | 54,036,813 | | | | | | | | |
| | |
For the year ended December 31,
|
| |||||||||||||||||||||
| | |
2013
(Restated) |
| |
2013
(Restated) |
| |
2012
(Restated) |
| |
% Change from
prior year |
| ||||||||||||
| | |
US$(1)
|
| |
Euro
|
| |
Euro
|
| | | | | | | |||||||||
| | |
(US Dollars and Euros in thousands except percentages)
|
| |||||||||||||||||||||
Consolidated Statements of Income: | | | | | | | | | | | | | | | | | | | | | | | | | |
Sales
|
| | | | 67,946 | | | | | | 53,806 | | | | | | 40,834 | | | | | | 31.8% | | |
Raw materials and consumables used
|
| | | | (11,599) | | | | | | (9,185) | | | | | | (6,296) | | | | | | 45.9% | | |
Personnel costs
|
| | | | (20,539) | | | | | | (16,265) | | | | | | (13,259) | | | | | | 22.7% | | |
Other operating expenses
|
| | | | (31,120) | | | | | | (24,644) | | | | | | (22,032) | | | | | | 11.9% | | |
Other operating income
|
| | | | 5,022 | | | | | | 3,977 | | | | | | 3,560 | | | | | | 11.7% | | |
Depreciation and amortization
|
| | | | (12,053) | | | | | | (9,545) | | | | | | (6,495) | | | | | | 47.0% | | |
Operating income (loss)
|
| | | | (2,343) | | | | | | (1,856) | | | | | | (3,688) | | | | | | (49.7%) | | |
Finance costs (including changes in fair value of contingent consideration)
|
| | | | (12,824) | | | | | | (10,155) | | | | | | (16,512) | | | | | | (38.5%) | | |
Finance income (including changes in fair value of contingent consideration)
|
| | | | 489 | | | | | | 387 | | | | | | 232 | | | | | | 66.8% | | |
Net finance costs
|
| | | | (12,335) | | | | | | (9,768) | | | | | | (16,280) | | | | | | (40.0%) | | |
Loss before income taxes
|
| | | | (14,680) | | | | | | (11,624) | | | | | | (19,968) | | | | | | (41.8%) | | |
Income taxes
|
| | | | (1,462) | | | | | | (1,158) | | | | | | (536) | | | | | | 116.0% | | |
Net loss for the year
|
| | | | (16,140) | | | | | | (12,781) | | | | | | (20,504) | | | | | | (37.7%) | | |
Attributable to owners of the company
|
| | | | (15,346) | | | | | | (12,152) | | | | | | (20,047) | | | | | | (39.4%) | | |
Non-controlling interests
|
| | | | (794) | | | | | | (629) | | | | | | (457) | | | | | | 37.6% | | |
Loss per share: | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic (US$ and € per share)
|
| | | | (0.28) | | | | | | (0.22) | | | | | | (0.38) | | | | | | (42.1%) | | |
Diluted (US$ and € per share)
|
| | | | (0.28) | | | | | | (0.22) | | | | | | (0.38) | | | | | | (42.1%) | | |
Weighted average ordinary shares outstanding used in computing per share amounts
|
| | | | | | | | | | | | | | | | | | | | | | | | |
Basic | | | | | 54,156,067 | | | | | | 54,156,067 | | | | | | 52,364,094 | | | | | | | | |
Diluted | | | | | 54,156,067 | | | | | | 54,156,067 | | | | | | 52,364,094 | | | | | | | | |
| | |
For the year ended December 31,
|
| |||||||||||||||||||||
| | |
2012
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| |
% Change from
prior year |
| ||||||||||||
| | |
US$(1)
|
| |
Euro
|
| |
Euro
|
| | | | | | | |||||||||
| | |
(US Dollars and Euros in thousands except percentages)
|
| |||||||||||||||||||||
Consolidated Statements of Income: | | | | | | | | | | | | | | | | | | | | | | | | | |
Sales
|
| | | | 51,565 | | | | | | 40,834 | | | | | | 33,864 | | | | | | 20.6% | | |
Raw materials and consumables used
|
| | | | (7,951) | | | | | | (6,296) | | | | | | (4,061) | | | | | | 55.0% | | |
Personnel costs
|
| | | | (16,743) | | | | | | (13,259) | | | | | | (10,657) | | | | | | 24.4% | | |
Other operating expenses
|
| | | | (27,822) | | | | | | (22,032) | | | | | | (16,021) | | | | | | 37.5% | | |
Other operating income
|
| | | | 4,496 | | | | | | 3,560 | | | | | | 1,520 | | | | | | 134.2% | | |
Depreciation and amortization
|
| | | | (8,202) | | | | | | (6,495) | | | | | | (4,342) | | | | | | 49.6% | | |
Operating income (loss)
|
| | | | (4,657) | | | | | | (3,688) | | | | | | 303 | | | | | | — | | |
Finance costs (including changes in fair value of contingent consideration)
|
| | | | (20,851) | | | | | | (16,512) | | | | | | (733) | | | | | | 2,152.7% | | |
Finance income (including changes in fair value of contingent consideration)
|
| | | | 293 | | | | | | 232 | | | | | | 492 | | | | | | (52.8%) | | |
Net finance costs
|
| | | | (20,558) | | | | | | (16,280) | | | | | | (241) | | | | | | 6,655.2% | | |
Profit (Loss) before income taxes
|
| | | | (25,216) | | | | | | (19,968) | | | | | | 62 | | | | | | — | | |
Income taxes
|
| | | | (677) | | | | | | (536) | | | | | | (844) | | | | | | (36.5%) | | |
Net loss for the year
|
| | | | (25,892) | | | | | | (20,504) | | | | | | (782) | | | | | | 2,522.0% | | |
Attributable to owners of the company
|
| | | | (25,315) | | | | | | (20,047) | | | | | | (239) | | | | | | 8,287.0% | | |
Non-controlling interests
|
| | | | (577) | | | | | | (457) | | | | | | (544) | | | | | | (16.0%) | | |
Loss per share: | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic (US$ and € per share)
|
| | | | (0.48) | | | | | | (0.38) | | | | | | (0.00) | | | | | | | | |
Diluted (US$ and € per share)
|
| | | | (0.48) | | | | | | (0.38) | | | | | | (0.00) | | | | | | | | |
Weighted average ordinary shares outstanding used in computing per share amounts
|
| | | | | | | | | | | | | | | | | | | | | | | | |
Basic | | | | | 52,364,094 | | | | | | 52,364,094 | | | | | | 48,054,083 | | | | | | | | |
Diluted | | | | | 52,364,094 | | | | | | 52,364,094 | | | | | | 48,054,083 | | | | | | | | |
| |
For the Years Ended December 31,
|
| |
For the Nine Months Ended
September 30, |
| ||||||||||||||||||||||||||||||||||||||||||||
| | |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| |
2014
|
| |
2013
|
| ||||||||||||||||||||||||||||||||||
| | |
US$(1)
|
| |
Euro
|
| |
Euro
|
| |
Euro
|
| |
US$(1)
|
| |
Euro
|
| |
Euro
|
| ||||||||||||||||||||||||||||
| | |
(US Dollars and Euros in thousands)
|
| | |||||||||||||||||||||||||||||||||||||||||||||
Net cash from operating activities
|
| | | | 9,780 | | | | | | 7,745 | | | | | | 1,226 | | | | | | 7,201 | | | | | | 4,566 | | | | | | 3,616 | | | | | | 4,751 | | | |||||||
Net cash used in investing
activities |
| | | | (14,275) | | | | | | (11,304) | | | | | | (23,436) | | | | | | (13,256) | | | | | | (12,368) | | | | | | (9,794) | | | | | | (7,270) | | | |||||||
Net cash from financing activities
|
| | | | 4,078 | | | | | | 3,229 | | | | | | 7,348 | | | | | | 24,639 | | | | | | 51,819 | | | | | | 41,035 | | | | | | 4,548 | | | |||||||
Net increase/(decrease) in cash and cash equivalents
|
| | | | (417) | | | | | | (330) | | | | | | (14,862) | | | | | | 18,584 | | | | | | 44,017 | | | | | | 34,857 | | | | | | 2,029 | | | |||||||
Effect of exchange rate changes on cash and cash equivalents
|
| | | | (9) | | | | | | (7) | | | | | | 6 | | | | | | 6 | | | | | | 272 | | | | | | 215 | | | | | | 5 | | | |||||||
Cash and cash equivalents at the end of the period
|
| | | | 17,187 | | | | | | 13,610 | | | | | | 13,947(2) | | | | | | 28,803(2) | | | | | | 61,476 | | | | | | 48,682 | | | | | | 15,980 | | | |||||||
|
Contractual Obligations
|
| |
Less than
1 year |
| |
Between 1 and
3 years |
| |
Between 4 and
5 years |
| |
More than
5 years |
| |
Total
|
| ||||||||||||||||||||
| | |
(amounts in thousands of Euros)
|
| ||||||||||||||||||||||||||||||||
Finance lease obligations(1)
|
| | | | 1,876 | | | | | | 3,118 | | | | | | 2,499 | | | | | | 2,909 | | | | | | 10,402 | | | |||||
Other loans and financial liabilities(1)
|
| | | | 4,149 | | | | | | 5,994 | | | | | | 4,412 | | | | | | 2,013 | | | | | | 16,568 | | | |||||
Total
|
| | | | 6,025 | | | | | | 9,112 | | | | | | 6,911 | | | | | | 4,922 | | | | | | 26,970 | | | |||||
|
Regimen*
|
| |
Type of
Tumor* |
| |
Number
of Patients |
| |
PR/CR
(%) |
| |
Median
PFS (months) |
| |
Median
Overall Survival (months) |
| |
Study (year)
|
|
STZ + DOX
|
| |
NEP
|
| |
16
|
| |
6
|
| |
N/A
|
| |
N/A
|
| |
Cheng (1999)
|
|
DAC | | |
Carc
|
| |
56
|
| |
16
|
| |
N/A
|
| |
20
|
| |
Bukowski (1994)
|
|
DAC | | |
Carc
|
| |
7
|
| |
14
|
| |
N/A
|
| |
N/A
|
| |
Ritzel (1995)
|
|
FU + IFN-α
|
| |
Carc/NEP
|
| |
24
|
| |
21
|
| |
8
|
| |
23
|
| |
Andreyev (1995)
|
|
MIT | | |
Carc/NEP
|
| |
30
|
| |
7
|
| |
N/A
|
| |
16
|
| |
Neijt (1995)
|
|
PAC | | |
Carc/NEP
|
| |
24
|
| |
4
|
| |
3
|
| |
18
|
| |
Ansell (2001)
|
|
STZ + FU + DOX
|
| |
NEP
|
| |
84
|
| |
39
|
| |
18
|
| |
37
|
| |
Kouvaraki (2004)
|
|
DOX + FU
|
| |
Carc
|
| |
85
|
| |
13
|
| |
5
|
| |
16
|
| |
Sun (2005)
|
|
STZ + FU
|
| |
Carc
|
| |
78
|
| |
15
|
| |
5
|
| |
24
|
| |
Sun (2005)
|
|
IRI + FU
|
| |
Carc/NEP
|
| |
20
|
| |
5
|
| |
5
|
| |
15
|
| |
Ducreux (2006)
|
|
OXA + CAP
|
| |
Well-diff NET
|
| |
27
|
| |
30
|
| |
N/A
|
| |
40
|
| |
Bajetta (2007)
|
|
Lutate (Lutathera)
|
| |
Carc/NEP
|
| |
310
|
| |
30
|
| |
32
|
| |
46
|
| |
Kwekkeboom (2008)
|
|
Tumor Type
|
| |
Total number
of patients |
| |
Objective
Responses (CR+PR+MR) |
| |
Not Evaluable
(NE) |
| |
95% Confidence Interval (CI)
(referring to patients showing objective response) |
| ||||||||||||||||||
|
(% of subpopulation shown in
parentheses) |
| |
Lower
|
| |
Upper
|
| |||||||||||||||||||||||
Bronchial Carcinoid
|
| | | | 15 | | | | | | 8 (53.3)% | | | | | | 2 (13.3)% | | | | | | 26.59% | | | | | | 78.73% | | |
Carcinoids
|
| | | | 212 | | | | | | 116 (54.7)% | | | | | | 18 (8.5)% | | | | | | 47.75% | | | | | | 61.55% | | |
Gastrinoma
|
| | | | 15 | | | | | | 13 (86.7)% | | | | | | 0 (0.0)% | | | | | | 59.54% | | | | | | 98.34% | | |
Insulinoma
|
| | | | 7 | | | | | | 5 (71.4)% | | | | | | 1 (14.3)% | | | | | | 29.04% | | | | | | 96.33% | | |
NET
|
| | | | 43 | | | | | | 25 (58.1)% | | | | | | 3 (7.0)% | | | | | | 42.13% | | | | | | 72.99% | | |
NET Pancreas
|
| | | | 103 | | | | | | 67 (65.1)% | | | | | | 7 (6.8)% | | | | | | 55.02% | | | | | | 74.18% | | |
Other
|
| | | | 9 | | | | | | 6 (66.7) | | | | | | 2 (22.2)% | | | | | | 29.93% | | | | | | 92.51% | | |
Tumor Type
|
| |
Number of
Patients Evaluated |
| |
Progression Free Survival and 95% CI
|
| ||||||||||||||||||
|
Median Days
(Months) |
| |
Lower Days
(Months) |
| |
Upper Days
(Months) |
| |||||||||||||||||
Overall
|
| | | | 265 | | | | | | 904 (29.6) | | | | | | 812 (26.6) | | | | | | 994 (32.6) | | |
Bronchus
|
| | | | 11 | | | | | | 904 (29.6) | | | | | | 578 (19.0) | | | | | | 1103 (36.2) | | |
Carcinoid
|
| | | | 135 | | | | | | 1034 (33.9) | | | | | | 892 (29.2) | | | | | | 1323 (43.4) | | |
Gastrinoma
|
| | | | 10 | | | | | | 681 (22.3) | | | | | | 453 (14.9) | | | | | | 1274 (41.8) | | |
Insulinoma
|
| | | | 5 | | | | | | 665 (21.8) | | | | | | 438 (14.4) | | | | | | — | | |
NET
|
| | | | 32 | | | | | | 595 (19.5) | | | | | | 416 (13.6) | | | | | | 708 (23.2) | | |
NET- Pancreas
|
| | | | 65 | | | | | | 916 (30.0) | | | | | | 767 (25.1) | | | | | | 1096 (35.9) | | |
Other
|
| | | | 7 | | | | | | 561 (18.4) | | | | | | 402 (13.2) | | | | | | 994 (26.6) | | |
Product
|
| |
Description
|
| |
Applications
|
| |
Marketing Authorizations
|
|
Gluscan/Gluscan 500/ Barnascan | | | Our brand names for FDG (concentration = 600MBq*/ml and 500MBq*/ml at calibration time for Gluscan and Gluscan 500, respectively; 3,000MBq*/ml for Barnascan at calibration time) | | | PET tracer for oncology, cardiology, neurology and infectious/inflammatory diseases | | |
Gluscan: Belgium, France, Italy, Luxembourg, Switzerland
Gluscan 500: France, Germany, Poland, Portugal, Spain
Barnascan: Spain
|
|
IASOflu | | | Our licensed brand name for Sodium Fluoride-18 | | | PET tracer used as a bone imaging agent in defining areas of altered osteogenic activity | | | Belgium, France, Germany, Italy, Luxembourg, Poland | |
IASOdopa | | | Our licensed brand name for 6-fluoro-(18F)-L-DOPA, a DOPA analogue | | | PET tracer for diagnostic use, with key applications in neurology and oncology | | | France, Germany, Italy | |
Product
|
| |
Description
|
| |
Applications
|
| |
Marketing Authorizations
|
|
IASOcholine | | | Our licensed brand name for 18F-choline (FCH) | | | PET tracer for detecting metastasis of prostate cancer and hepatocellular carcinoma (liver cancer) | | | Belgium, France, Germany, Italy, Luxembourg, Poland | |
MIBITEC/Adamibi | | | Our brand names for a generic version of a widely-used SPECT cardiac imaging agent | | | SPECT tracer for myocardial exploration, localization of parathyroid tissue and breast cancer diagnosis | | |
MIBITEC: Austria, France, Germany, Luxembourg, Poland, Slovenia
Adamibi: Greece, Italy
|
|
Leukokit | | | Medical device for the separation and labeling of autologous leukocytes | | | Identifies sites of infection or inflammation in the body | | | CE mark: can be commercialized throughout Europe | |
Location
|
| |
Offices Only
|
| |
PET
Production |
| |
SPECT
Production |
| |
Enriched
Water Production |
| |
R&D
|
| |||||||||||||||
Saint-Genis-Pouilly, France (Headquarters)
|
| | | | | | | | | | x | | | | | | | | | | | | | | | | | | x | | |
Troyes, France
|
| | | | | | | | | | x | | | | | | | | | | | | | | | | | | | | |
Béthune, France
|
| | | | | | | | | | x | | | | | | | | | | | | | | | | | | | | |
Nantes, France
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | x | | |
St. Cloud, Paris, France
|
| | | | | | | | | | x | | | | | | | | | | | | | | | | | | x | | |
Marseille, France
|
| | | | | | | | | | x | | | | | | | | | | | | | | | | | | x | | |
Colleretto Giacosa, Italy
|
| | | | | | | | | | x | | | | | | | | | | | | | | | | | | x | | |
Saluggia, Italy (Gipharma)
|
| | | | | | | | | | | | | | | | x | | | | | | | | | | | | x | | |
Meldola, Italy
|
| | | | | | | | | | x | | | | | | | | | | | | | | | | | | x | | |
Pozzilli, Italy
|
| | | | | | | | | | x | | | | | | |||||||||||||||
Almuna de Dona Godina, Spain
|
| | | | | | | | | | x | | | | | | |||||||||||||||
Barcelona, Spain (Barnatron)
|
| | | | | | | | | | x | | | | | | | | | | | | | | | | | | x | | |
Barcelona, Spain (Cadisa)
|
| | | | | | | | | | | | | | | | x | | | | | | | | | | | | | | |
Madrid, Spain
|
| | | | x | | | | | | | | | | | | | | | | | | | | | | | | | | |
Porto, Portugal
|
| | | | | | | | | | x | | | | | | | | | | | | | | | | | | | | |
Lisboa, Portugal
|
| | | | x | | | | | | | ||||||||||||||||||||
Geneva, Switzerland (AAA Switzerland/AAA International)
|
| | | | x | | | | | | | ||||||||||||||||||||
Bonn, Germany
|
| | | | | | | | | | x | | | | | | | | | | | | | | | | | | | | |
Warsaw, Poland
|
| | | | | | | | | | x | | | | | | | | | | | | | | | | | | | | |
Beer Tuvia, Israel (Marshall Isotopes)
|
| | | | | | | | | | | | | | | | | | | | | | x | | | | | | | | |
Chilcompton, United Kingdom (IEL)
|
| | | | x | | | | | | | | | | | | | | | | | | | | | | | | | | |
New York, USA
|
| | | | x | | | | | | | | | | | | | | | | | | | | | | | | | | |
Ottawa, Canada (Atreus)
|
| | | | x | | | | | | | | | | | | | | | | | | | | | |
|
Name
|
| |
Age
|
| |
Position
|
| |
Initial Year of
Appointment |
|
| Executive Officers and Key Employees | | | | | ||||||
|
Stefano Buono
|
| |
48
|
| | Chief Executive Officer | | |
2002
|
|
|
Heinz Mäusli
|
| |
51
|
| | Chief Financial Officer | | |
2008
|
|
|
Gérard Ber
|
| |
56
|
| | Chief Operating Officer | | |
2002
|
|
|
Maurizio Franco Mariani
|
| |
55
|
| |
Head of Research & Business Development
|
| |
2009
|
|
|
Claude Hariton
|
| |
59
|
| | Head of Clinical Development | | |
2014
|
|
| Board of Directors | | | | | ||||||
|
Claudio Costamagna
|
| |
58
|
| | Chairman | | |
2010
|
|
|
Stefano Buono
|
| |
48
|
| | Director and Chief Executive Officer | | |
2002
|
|
|
Muriel de Szilbereky
|
| |
61
|
| | Director | | |
2013
|
|
|
Kapil Dhingra
|
| |
54
|
| | Director | | |
2014
|
|
|
Steve Gannon
|
| |
53
|
| | Director | | |
2014
|
|
|
Yvonne Greenstreet
|
| |
52
|
| | Director | | |
2014
|
|
|
Christian Merle
|
| |
60
|
| | Director | | |
2014
|
|
|
Leopoldo Zambeletti
|
| |
45
|
| | Director | | |
2014
|
|
| | |
Year Ended December 31,
|
| |
Total
|
| ||||||||||||||||||
Shares Granted
|
| |
2011
|
| |
2012
|
| |
2013
|
| |||||||||||||||
Stefano Buono (CEO)
|
| | | | 0 | | | | | | 0 | | | | | | 0 | | | | | | 0 | | |
Gérard Ber (COO)
|
| | | | 35,000 | | | | | | 35,000 | | | | | | 35,000 | | | | | | 105,000 | | |
Heinz Mäusli (CFO)
|
| | | | 35,000 | | | | | | 35,000 | | | | | | 35,000 | | | | | | 105,000 | | |
Total Shares Granted to Senior Management
|
| | | | 70,000 | | | | | | 70,000 | | | | | | 70,000 | | | | | | 210,000 | | |
| | |
Ordinary Shares Beneficially
Owned Before the Offering |
| |
Ordinary Shares Beneficially
Owned After the Offering |
| ||||||||||||
Name of Beneficial Owner
|
| |
Number
|
| |
Percent
|
| |
Number
|
| |
Percent
|
| ||||||
Directors and Senior Management | | | | | | | | | | | | | | | | | | | |
Claudio Costamagna
|
| | | | 1,050,000 | | | | | | 1.7% | | | | | | | | |
Christian Merle
|
| | | | — | | | | | | — | | | | | | | | |
Kapil Dhingra
|
| | | | — | | | | | | — | | | | | | | | |
Leopoldo Zambeletti
|
| | | | — | | | | | | — | | | | | | | | |
Maurizio Franco Mariani
|
| | | | * | | | | | | * | | | | | | | | |
Muriel de Szilbereky
|
| | | | — | | | | | | — | | | | | | | | |
Philippe Dasse
|
| | | | * | | | | | | * | | | | | | | | |
Stefano Buono
|
| | | | 5,060,800 | | | | | | 8.0% | | | | | | | | |
Steve Gannon
|
| | | | — | | | | | | — | | | | | | | | |
Yvonne Greenstreet
|
| | | | — | | | | | | — | | | | | | | | |
Gérard Ber
|
| | | | 1,425,600 | | | | | | 2.3% | | | | | | | | |
Heinz Mäusli
|
| | | | 736,050 | | | | | | 1.2% | | | | | | | | |
Claude Hariton
|
| | | | — | | | | | | — | | | | | | | | |
All directors and senior management as a group (13 persons)(1)
|
| | | | 8,589,950 | | | | | | 13.6% | | | | | | | | |
| | |
Ordinary Shares Beneficially
Owned Before the Offering |
| |
Ordinary Shares Beneficially
Owned After the Offering |
| ||||||||||||
Name of Beneficial Owner
|
| |
Number
|
| |
Percent
|
| |
Number
|
| |
Percent
|
| ||||||
5% Shareholders | | | | | | | | | | | | | | | | | | | |
Alberto Colussi(2)
|
| | | | 3,000,000 | | | | | | 4.8% | | | | | | | | |
Andrea Ruben Osvaldo Levi(3)
|
| | | | 4,996,000 | | | | | | 7.9% | | | | | | | | |
Carpéfin S.r.l.(4)
|
| | | | 3,517,251 | | | | | | 5.6% | | | | | | | | |
HBM Healthcare Investments (Cayman) Ltd.(5)
|
| | | | 5,000,000 | | | | | | 7.9% | | | | | | | | |
Life Sciences Capital S.p.A.(6)
|
| | | | 4,301,740 | | | | | | 6.8% | | | | | | | | |
Sergio Dompé S.r.l.(7)
|
| | | | 5,625,000 | | | | | | 8.9% | | | | | | | | |
| | |
France
|
| |
Delaware
|
|
Number of Directors | | | Under French law, a société anonyme must have at least 3 and may have up to 18 directors. The number of directors is fixed by or in the manner provided in the by-laws. | | | Under Delaware law, a corporation must have at least one director and the number of directors shall be fixed by or in the manner provided in the by-laws. | |
| | |
France
|
| |
Delaware
|
|
Director Qualifications
|
| | Under French law, a corporation may prescribe qualifications for directors under its by-laws, subject to applicable regulations. | | | Under Delaware law, a corporation may prescribe qualifications for directors under its certificate of incorporation or by-laws. | |
Removal of Directors | | | Under French law, directors may be removed from office, with or without cause, at any shareholders’ meeting without notice or justification, by a simple majority vote. | | | Under Delaware law, unless otherwise provided in the certificate of incorporation, directors may be removed from office, with or without cause, by a majority shareholder vote, though in the case of a corporation whose board is classified, shareholders may effect such removal only for cause. | |
Vacancies on the board of directors | | | Under French law, vacancies on the board of directors resulting from death or a resignation, provided that at least 3 directors remain in office, may be filled by a majority of the remaining directors pending ratification by the next shareholders’ meeting. | | | Under Delaware law, vacancies on a corporation’s board of directors, including those caused by an increase in the number of directors, may be filled by a majority of the remaining directors. | |
Annual General Meeting | | | Under French law, the annual general meeting of shareholders shall be held at such place, on such date and at such time as decided each year by the board of directors and notified to the shareholders in the convening notice of the annual meeting, within 6 months after the close of the relevant fiscal year unless such period is extended by court order. | | | Under Delaware law, the annual meeting of shareholders shall be held at such place, on such date and at such time as may be designated from time to time by the board of directors or as provided in the certificate of incorporation or by the by-laws. | |
General Meeting | | | Under French law, general meetings of the shareholders may be called by the board of directors or, failing that, by the statutory auditors, or by a court appointed agent or liquidator in certain circumstances, or by the majority shareholder in capital or voting rights following a public tender offer or exchange offer or the transfer of a controlling block on the date decided by the board of directors or the relevant person. | | | Under Delaware law, special meetings of the shareholders may be called by the board of directors or by such person or persons as may be authorized by the certificate of incorporation or by the by-laws. | |
| | |
France
|
| |
Delaware
|
|
Notice of General Meetings | | | Under French law, for corporations all the shares of which are in registered form, written notice of any meeting of the shareholders must be given at least 15 calendar days before the date of the meeting. When the shareholders’ meeting cannot deliberate due to the lack of the required quorum, the second meeting must be called at least ten calendar days in advance in the same manner as used for the first notice. The notice shall specify the name of the company, its legal form, share capital, registered office address, registration number with the French Registry of commerce and companies, the place, date, hour and agenda of the meeting and its nature (ordinary or extraordinary meeting). | | | Under Delaware law, unless otherwise provided in the certificate of incorporation or by-laws, written notice of any meeting of the shareholders must be given to each shareholder entitled to vote at the meeting not less than 10 nor more than 60 days before the date of the meeting and shall specify the place, date, hour, and purpose or purposes of the meeting. | |
Proxy | | | Under French law, any shareholder may vote by mail or grant a proxy to his/her spouse, his/her partner with whom he/she has entered into a civil union or another shareholder for physical persons or to any person for legal entities. General proxies are not valid and a separate proxy must be provided for each shareholders’ meeting, unless it concerns an ordinary and an extraordinary meeting held the same day or within the next 15 days, or a consecutive general meeting with the same agenda (in the event the quorum has not been reached). | | | Under Delaware law, at any meeting of shareholders, a shareholder may designate another person to act for such shareholder by proxy, but no such proxy shall be voted or acted upon after three years from its date, unless the proxy provides for a longer period. | |
Shareholder action by written consent | | | Under French law, shareholders’ action by written consent is not permitted in a société anonyme. | | | Under Delaware law, a corporation’s certificate of incorporation (1) may permit shareholders to act by written consent if such action is signed by all shareholders, (2) may permit shareholders to act by written consent signed by shareholders having the minimum number of votes that would be necessary to take such action at a meeting or (3) may prohibit actions by written consent. | |
| | |
France
|
| |
Delaware
|
|
Preemptive Rights | | | Under French law, in case of issuance of additional shares or other securities for cash or set-off against cash debts, the existing shareholders have preferential subscription rights to these securities on a pro rata basis unless such rights are waived by a two-thirds majority of the votes held by the shareholders present, at the extraordinary meeting deciding or authorizing the capital increase, represented by proxy or voting by mail. In case such rights are not waived by the extraordinary general meeting, each shareholder may individually either exercise, assign or not exercise its preferential rights. | | | Under Delaware law, unless otherwise provided in a corporation’s certificate of incorporation, a shareholder does not, by operation of law, possess preemptive rights to subscribe to additional issuances of the corporation’s stock. | |
Sources of Dividends | | |
Under French law, dividends may only be paid by a French société anonyme out of “distributable profits,” plus any distributable reserves and “distributable premium” that the shareholders decide to make available for distribution, other than those reserves that are specifically required by law. “Distributable profits” consist of the unconsolidated net profits of the relevant corporation for each fiscal year, as increased or reduced by any profit or loss carried forward from prior years.
“Distributable premium” refers to the contribution paid by the shareholders in addition to the nominal value of their shares for their subscription that the shareholders decide to make available for distribution. Except in case of a share capital reduction, no distribution can be made to the shareholders when the net equity is, or would become, lower than the amount of the share capital plus the reserves which cannot be distributed in accordance with the law.
|
| | Under Delaware law, dividends may be paid by a Delaware corporation either out of (1) surplus or (2) in case there is no surplus, out of its net profits for the fiscal year in which the dividend is declared and/or the preceding fiscal year, except when the capital is diminished by depreciation in the value of its property, or by losses, or otherwise, to an amount less than the aggregate amount of capital represented by issued and outstanding stock having a preference on the distribution of assets. | |
| | |
France
|
| |
Delaware
|
|
Repurchase of Shares | | |
Under French law, a private corporation (being specified that the company will not qualify as a public corporation for French law purposes for so long as it shall be listed in the United States only) may acquire its own shares for the following purposes only:
•
to decrease its share capital, provided that such decision is not driven by losses and that a purchase offer is made to all shareholders on a pro rata basis, with the approval of the shareholders at the extraordinary general meeting deciding the capital reduction;
•
with a view to distributing within one year of their repurchase the relevant shares to employees, corporate officers and directors under a profit-sharing or equity incentive plan;
|
| | Under Delaware law, a corporation may generally redeem or repurchase shares of its stock unless the capital of the corporation is impaired or such redemption or repurchase would impair the capital of the corporation. | |
| | |
•
to sell the relevant shares to any shareholders willing to purchase them as part of a process organized by the corporation within five years of their repurchase; or
•
within the limit of 5% of its issued share capital, in payment or in exchange for assets acquired by the corporation within two years of their repurchase.
No such repurchase of shares may result in the company holding, directly or through a person acting on its behalf, more than 10% of its issued share capital.
|
| |
| | |
France
|
| |
Delaware
|
|
Liability of Directors and Officers | | | Under French law, the by-laws may not include any provisions limiting the liability of directors. | | |
Under Delaware law, a corporation’s certificate of incorporation may include a provision eliminating or limiting the personal liability of a director to the corporation and its shareholders for damages arising from a breach of fiduciary duty as a director. However, no provision can limit the liability of a director for: any breach of the director’s duty of loyalty to the corporation or its shareholders;
•
acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law;
•
intentional or negligent payment of unlawful dividends or stock purchases or redemptions; or
•
any transaction from which the director derives an improper personal benefit.
|
|
Voting Rights | | | French law provides that, unless otherwise provided in the by-laws, each shareholder is entitled to one vote for each share of capital stock held by such shareholder. | | | Delaware law provides that, unless otherwise provided in the certificate of incorporation, each shareholder is entitled to one vote for each share of capital stock held by such shareholder. | |
Shareholder Vote on Certain Transactions | | |
Generally, under French law, completion of a merger, dissolution, sale, lease or exchange of all or substantially all of a corporation’s assets requires:
•
the approval of the board of directors; and
•
approval by a two-thirds majority of the votes held by the shareholders present, represented by proxy or voting by mail at the relevant meeting or, in the case of a merger with a non-EU company, approval of all shareholders of the corporation may be required, depending on the nationality of the concerned companies and therefore the applicable laws.
|
| |
Generally, under Delaware law, unless the certificate of incorporation provides for the vote of a larger portion of the stock, completion of a merger, consolidation, sale, lease or exchange of all or substantially all of a corporation’s assets or dissolution requires:
•
the approval of the board of directors; and
•
approval by the vote of the holders of a majority of the outstanding stock or, if the certificate of incorporation provides for more or less than one vote per share, a majority of the votes of the outstanding stock of a corporation entitled to vote on the matter.
|
|
| | |
France
|
| |
Delaware
|
|
Dissent or Dissenters’ Appraisal Rights | | | French law does not provide for any such right but provides that a merger is subject to shareholders’ approval by a two-thirds majority vote as stated above. | | |
Under Delaware law, a holder of shares of any class or series has the right, in specified circumstances, to dissent from a merger or consolidation by demanding payment in cash for the shareholder’s shares equal to the fair value of those shares, as determined by the Delaware Chancery Court in an action timely brought by the corporation or a dissenting shareholder. Delaware law grants these appraisal rights only in the case of mergers or consolidations and not in the case of a sale or transfer of assets or a purchase of assets for stock. Further, no appraisal rights are available for shares of any class or series that is listed on a national securities exchange or held of record by more than 2,000 shareholders, unless the agreement of merger or consolidation requires the holders to accept for their shares anything other than:
•
shares of stock of the surviving corporation;
•
shares of stock of another corporation that are either listed on a national securities exchange or held of record by more than 2,000 shareholders;
•
cash in lieu of fractional shares of the stock described in the two preceding bullet points; or
•
any combination of the above.
In addition, appraisal rights are not available to holders of shares of the surviving corporation in specified mergers that do not require the vote of the shareholders of the surviving corporation.
|
|
| | |
France
|
| |
Delaware
|
|
Standard of Conduct for Directors | | | French law does not contain specific provisions setting forth the standard of conduct of a director. However, directors have a duty to act without self-interest, on a well-informed basis and they cannot make any decision against a corporation’s corporate interest (intérêt social). | | | Delaware law does not contain specific provisions setting forth the standard of conduct of a director. The scope of the fiduciary duties of directors is generally determined by the courts of the State of Delaware. In general, directors have a duty to act without self-interest, on a well-informed basis and in a manner they reasonably believe to be in the best interest of the shareholders. | |
Shareholder Suits | | |
French law provides that a shareholder, or a group of shareholders, may initiate a legal action to seek indemnification from the directors of a corporation in the corporation’s interest if it fails to bring such legal action itself. If so, any damages awarded by the court are paid to the corporation and any legal fees relating to such action are borne by the relevant shareholder or the group of shareholders.
The plaintiff must remain a shareholder through the duration of the legal action.
A shareholder may alternatively or cumulatively bring individual legal action against the directors, provided he has suffered distinct damages from those suffered by the corporation. In this case, any damages awarded by the court are paid to the relevant shareholder.
|
| |
Under Delaware law, a shareholder may initiate a derivative action to enforce a right of a corporation if the corporation fails to enforce the right itself. The complaint must:
•
state that the plaintiff was a shareholder at the time of the transaction of which the plaintiff complains or that the plaintiff’s shares thereafter devolved on the plaintiff by operation of law; and
•
allege with particularity the efforts made by the plaintiff to obtain the action the plaintiff desires from the directors and the reasons for the plaintiff’s failure to obtain the action; or
•
state the reasons for not making the effort.
Additionally, the plaintiff must remain a shareholder through the duration of the derivative suit. The action will not be dismissed or compromised without the approval of the Delaware Court of Chancery.
|
|
| | |
France
|
| |
Delaware
|
|
Amendment of Certificate of Incorporation | | | Under French law, there is no certificate of incorporation per se. The equivalent of the certificate of incorporation is called “extrait K-bis” and reflects all the significant information with regards to a French company, such as its name, date of registration, identification number, form, share capital, registered office, governance and administration, etc. Any changes of the By-laws, or in the situation of the company as reflected in the extrait K-bis, shall be registered with the competent Registry of Commerce and Companies on the French territory. | | |
Under Delaware law, generally a corporation may amend its certificate of incorporation if:
•
its board of directors has adopted a resolution setting forth the amendment proposed and declared its advisability; and
•
the amendment is adopted by the affirmative votes of a majority (or greater percentage as may be specified by the corporation) of the outstanding shares entitled to vote on the amendment and a majority (or greater percentage as may be specified by the corporation) of the outstanding shares of each class or series of stock, if any, entitled to vote on the amendment as a class or series.
|
|
Amendment of By-laws
|
| | Under French law, bylaws may only be adopted or amended at extraordinary shareholders’ meetings. | | | Under Delaware law, the shareholders entitled to vote have the power to adopt, amend or repeal by-laws. A corporation may also confer, in its certificate of incorporation, that power upon the board of directors. | |
Persons depositing or withdrawing shares or ADS holders must pay: |
| |
For:
|
|
$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)
|
| | Issuance of ADSs, including issuances resulting from a distribution of shares or rights or other property | |
| Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates | | ||
$.05 (or less) per ADS | | | Any cash distribution to ADS holders | |
A fee equivalent to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance of ADSs | | | Distribution of securities distributed to holders of deposited securities which are distributed by the depositary to ADS holders | |
$.05 (or less) per ADS per calendar year | | | Depositary services | |
Registration or transfer fees | | | Transfer and registration of shares on our share register to or from the name of the depositary or its agent when you deposit or withdraw shares | |
Persons depositing or withdrawing shares or ADS holders must pay: |
| |
For:
|
|
Expenses of the depositary | | | Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement) converting foreign currency to U.S. dollars | |
Taxes and other governmental charges the depositary or the custodian has to pay on any ADSs or shares underlying ADSs, such as stock transfer taxes, stamp duty or withholding taxes | | | As necessary | |
Any charges incurred by the depositary or its agents for servicing the deposited securities | | | As necessary | |
If we:
|
| |
Then:
|
|
•
Change the nominal or par value of our shares,
•
Reclassify, split up or consolidate any of the deposited securities,
•
Distribute securities on the shares that are not distributed to you, or
•
Recapitalize, reorganize, merge, liquidate, sell all or substantially all of our assets, or take any similar action
|
| | The cash, shares or other securities received by the depositary will become deposited securities. Each ADS will automatically represent its equal share of the new deposited securities. | |
| The depositary may distribute new ADSs representing the new deposited securities or ask you to surrender your outstanding ADRs in exchange for new ADRs identifying the new deposited securities. | |
Underwriter
|
| |
Number of
ADSs |
|
Citigroup Global Markets Inc.
|
| |
|
|
Jefferies LLC
|
| | | |
Canaccord Genuity Inc.
|
| | | |
JMP Securities LLC
|
| | | |
Total
|
| | | |
|
| | |
No Exercise
|
| |
Full Exercise
|
| ||||||
Per ADS
|
| | | $ | | | | | | $ | | | |
Total
|
| | | $ | | | | | | $ | | | |
Expenses
|
| |
Amount
|
|||
SEC registration fee
|
| | | $ | ||
Nasdaq listing fee
|
| | | | | |
FINRA filing fee
|
| | | | | |
Printing and engraving expenses
|
| | | | | |
Legal fees and expenses
|
| | | | | |
Accounting fees and expenses
|
| | | | | |
Miscellaneous costs
|
| | | | | |
Total
|
| | | | | |
|
| Unaudited Interim Condensed Consolidated Financial Statements — Advanced Accelerator Applications S.A. | | ||||||
| | | | | F-2 | | | |
| | | | | F-3 | | | |
| | | | | F-4 | | | |
| | | | | F-5 | | | |
| | | | | F-7 | | | |
| | | | | F-9 | | | |
| Audited Consolidated Financial Statements — Advanced Accelerator Applications S.A. | | ||||||
| | | | | F-24 | | | |
| | | | | F-25 | | | |
|
Consolidated Statements of Comprehensive Income for the years ended December 31, 2013, 2012 and 2011
|
| | | | F-26 | | |
| | | | | F-27 | | | |
| | | | | F-28 | | | |
| | | | | F-31 | | | |
| | | | | F-34 | | |
In thousands of Euros
|
| |
Notes
|
| |
09.30.2014
|
| |
09.30.2013
|
| ||||||||||||
Sales
|
| | | | 4.1 | | | | | | 50,166 | | | | | | 38,919 | | | |||
Raw materials and consumables used
|
| | | | | | | | | | (9,781) | | | | | | (7,142) | | | |||
Personnel costs
|
| | | | 4.2 | | | | | | (14,844) | | | | | | (11,942) | | | |||
Other operating expenses
|
| | | | | | | | | | (22,903) | | | | | | (16,399) | | | |||
Other operating income
|
| | | | | | | | | | 3,338 | | | | | | 2,837 | | | |||
Depreciation and amortization
|
| | | | | | | | | | (7,257) | | | | | | (5,436) | | | |||
Operating income
|
| | | | | | | | | | (1,281) | | | | | | 837 | | | |||
Finance income (including changes in fair value of contingent consideration)
|
| | | | 4.3 | | | | | | 1,319 | | | | | | 95 | | | |||
Finance costs (including change in fair value of contingent
consideration) |
| | | | 4.3 | | | | | | (801) | | | | | | (3,023) | | | |||
Net finance Income/(costs)
|
| | | | | | | | | | 518 | | | | | | (2,928) | | | |||
Income/(loss) before income taxes
|
| | | | | | | | | | (763) | | | | | | (2,091) | | | |||
Income taxes
|
| | | | 4.4 | | | | | | (1,683) | | | | | | (583) | | | |||
Income/(loss) for the period
|
| | | | | | | | | | (2,446) | | | | | | (2,674) | | | |||
Attributable to: | | | | | | | | | | | | | | | | | | | | |||
Owners of the company
|
| | | | | | | | | | (1,548) | | | | | | (2,309) | | | |||
Non-controlling interests
|
| | | | | | | | | | (898) | | | | | | (365) | | | |||
Earnings per share | | | | | | | | | | | | | | | | | | | | |||
Basic (€ per share)
|
| | | | 5.4 | | | | | | (0.02) | | | | | | (0.04) | | | |||
Diluted (€ per share)
|
| | | | 5.4 | | | | | | (0.02) | | | | | | (0.04) | | | |||
|
In thousands of Euros
|
| |
09.30.2014
|
| |
09.30.2013
|
| ||||||
Income/(loss) for the period
|
| | | | (2,446) | | | | | | (2,674) | | |
Other comprehensive income: | | | | | | | | | | | | | |
Items that may be reclassified subsequently to profit or loss | | | | | | | | | | | | | |
Exchange differences on translating foreign operations
|
| | | | 1,646 | | | | | | 57 | | |
Items that will never be reclassified subsequently to profit or loss | | | | | | | | | | | | | |
Remeasurement of defined benefit liability
|
| | | | (57) | | | | | | 9 | | |
Other comprehensive income net of tax(1)
|
| | |
|
1,589
|
| | | |
|
66
|
| |
Total comprehensive income/(loss) for the period
|
| | | | (857) | | | | | | (2,608) | | |
Total comprehensive income/(loss) attributable to: | | | | | | | | | | | | | |
Owners of the company
|
| | | | (10) | | | | | | (2128) | | |
Non-controlling interests
|
| | | | (847) | | | | | | (476) | | |
(In thousands of Euros)
|
| |
Notes
|
| |
09.30.2014
|
| |
12.31.2013
(Restated)* |
| ||||||||||||
ASSETS | | | | | | | | | | | | | | | | | | | | |||
Non-current assets
|
| | | | | | | | | | 110,993 | | | | | | 103,449 | | | |||
Goodwill
|
| | | | 5.2 | | | | | | 22,256 | | | | | | 21,252 | | | |||
Other intangible assets
|
| | | | 5.2 | | | | | | 32,373 | | | | | | 30,581 | | | |||
Property, plant and equipment
|
| | | | 5.3 | | | | | | 53,765 | | | | | | 49,280 | | | |||
Financial assets
|
| | | | | | | | | | 2,599 | | | | | | 2,336 | | | |||
Current assets
|
| | | | | | | | | | 80,853 | | | | | | 40,028 | | | |||
Inventories
|
| | | | | | | | | | 3,483 | | | | | | 2,278 | | | |||
Trade and other receivables
|
| | | | | | | | | | 18,941 | | | | | | 16,143 | | | |||
Other current assets
|
| | | | | | | | | | 9,747 | | | | | | 7,997 | | | |||
Cash and cash equivalents
|
| | | | | | | | | | 48,682 | | | | | | 13,610 | | | |||
TOTAL ASSETS
|
| | | | | | | | | | 191,846 | | | | | | 143,477 | | | |||
EQUITY AND LIABILITIES | | | | | | | | | | | | | | | | | | | | |||
Equity attributable to owners of the company
|
| | | | | | | | | | 99,493 | | | | | | 55,723 | | | |||
Share capital
|
| | | | | | | | | | 6,293 | | | | | | 5,415 | | | |||
Share premium
|
| | | | | | | | | | 118,450 | | | | | | 76,594 | | | |||
Reserves and retained earnings
|
| | | | | | | | | | (23,702) | | | | | | (14,134) | | | |||
Net income (loss) for the period
|
| | | | | | | | | | (1,548) | | | | | | (12,152) | | | |||
Non-controlling interests
|
| | | | | | | | | | 637 | | | | | | 1,360 | | | |||
Total equity
|
| | |
|
5.4
|
| | | | | 100,130 | | | | | | 57,083 | | | |||
Non-current liabilities
|
| | | | | | | | | | 63,471 | | | | | | 62,052 | | | |||
Non-current provisions
|
| | | | | | | | | | 7,970 | | | | | | 6,029 | | | |||
Non-current financial liabilities
|
| | | | 5.6 | | | | | | 20,945 | | | | | | 20,359 | | | |||
Deferred tax liabilities
|
| | | | | | | | | | 4,505 | | | | | | 4,187 | | | |||
Other non-current liabilities
|
| | | | 5.7 | | | | | | 30,051 | | | | | | 31,477 | | | |||
Current liabilities
|
| | | | | | | | | | 28,245 | | | | | | 24,342 | | | |||
Current provisions
|
| | | | | | | | | | 94 | | | | | | 115 | | | |||
Current financial liabilities
|
| | | | 5.6 | | | | | | 6,025 | | | | | | 5,458 | | | |||
Trade and other payables
|
| | | | | | | | | | 9,320 | | | | | | 9,218 | | | |||
Other current liabilities
|
| | | | 5.7 | | | | | | 12,806 | | | | | | 9,551 | | | |||
Total liabilities
|
| | | | | | | | | | 91,716 | | | | | | 86,394 | | | |||
TOTAL EQUITY AND LIABILITIES
|
| | | | | | | | | | 191,846 | | | | | | 143,477 | | | |||
|
| | |
Attributable to the company
|
| | | | | | | | | | | |||||||||||||||||||||||||||||||||||||||||
In thousands of Euros
|
| |
Share
capital |
| |
Share
premium |
| |
Translation
reserve |
| |
Income/
(loss) for the period |
| |
Group
reserves |
| |
Total
attributable to owners of the Company |
| |
Non-
controlling interests |
| |
TOTAL
|
|||||||||||||||||||||||||||||||
At December 31, 2013 (Restated)*
|
| | | | 5,415 | | | | | | 76,594 | | | | | | (433) | | | | | | (12,152) | | | | | | (13,701) | | | | | | 55,723 | | | | | | 1,360 | | | | | | 57,083 | ||||||||
Comprehensive income/(loss) for the period | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||||
Net income/(loss) for the period
|
| | | | — | | | | | | — | | | | | | — | | | | | | (1,548) | | | | | | — | | | | | | (1,548) | | | | | | (898) | | | | |
|
(2,446)
|
||||||||
Other comprehensive income/(loss) for the
period |
| | | | — | | | | | | — | | | | | | 1,595 | | | | | | — | | | | | | (57) | | | | | | 1,538 | | | | | | 51 | | | | |
|
1,589
|
||||||||
Total comprehensive income/(loss)
|
| | | | — | | | | | | — | | | | | | 1,595 | | | | | | (1,548) | | | | | | (57) | | | | | | (10) | | | | | | (847) | | | | | | (857) | ||||||||
Transactions with owners of the company | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||||
Issue of ordinary shares(1)
|
| | | | 878 | | | | | | 41,856 | | | | | | — | | | | | | — | | | | | | (603) | | | | | | 42,131 | | | | | | — | | | | |
|
42,131
|
||||||||
Appropriation of 2013 net income/(loss)
|
| | | | — | | | | | | — | | | | | | — | | | | | | 12,152 | | | | | | (12,152) | | | | | | — | | | | | | — | | | | |
|
—
|
||||||||
Equity-settled share-based payments
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 1,739 | | | | | | 1,739 | | | | | | — | | | | |
|
1,739
|
||||||||
Transactions between shareholders
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (90) | | | | | | (90) | | | | | | 124 | | | | |
|
34
|
||||||||
Total transactions with owners of the company
|
| | | | 878 | | | | | | 41,856 | | | | | | — | | | | | | 12,152 | | | | | | (11,106) | | | | | | 43,780 | | | | | | 124 | | | | | | 43,904 | ||||||||
At September 30, 2014
|
| | | | 6,293 | | | | | | 118,450 | | | | | | 1,161 | | | | | | (1,548) | | | | | | (24,864) | | | | | | 99,493 | | | | | | 637 | | | | | | 100,130 | ||||||||
|
| | |
Attributable to the company
|
| | | |||||||||||||||||||||||||||||||||||||||||||||||||||
In thousands of Euros
|
| |
Share
capital |
| |
Share
premium |
| |
Translation
reserve |
| |
Income/
(loss) for the period |
| |
Group
reserves |
| |
Total
attributable to owners of the Company |
| |
Non-
controlling interests |
| |
TOTAL
|
| ||||||||||||||||||||||||||||||||
Balance as at December 31, 2012 (Restated)*
|
| | | | 5,244 | | | | | | 69,650 | | | | | | (507) | | | | | | (20,047) | | | | | | 4,049 | | | | | | 58,389 | | | | | | 2,188 | | | | | | 60,577 | | | ||||||||
Comprehensive income/(loss) for the period | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||||
Net income/(loss) for the period
|
| | | | — | | | | | | — | | | | | | — | | | | | | (2,309) | | | | | | — | | | | | | (2,309) | | | | | | (365) | | | | |
|
(2,674)
|
| | ||||||||
Other comprehensive income for the year
|
| | | | — | | | | | | — | | | | | | 172 | | | | | | — | | | | | | 9 | | | | | | 181 | | | | | | (111) | | | | |
|
70
|
| | ||||||||
Total comprehensive income/(loss)
|
| | | | — | | | | | | — | | | | | | 172 | | | | | | (2,309) | | | | | | 9 | | | | | | (2,128) | | | | | | (476) | | | | | | (2,604) | | | ||||||||
Transactions with owners of the company | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||||
Issue of ordinary shares
|
| | | | 153 | | | | | | 6,962 | | | | | | — | | | | | | — | | | | | | — | | | | | | 7,115 | | | | | | — | | | | |
|
7,115
|
| | ||||||||
Appropriation of 2012 net income/(loss)
|
| | | | — | | | | | | — | | | | | | — | | | | | | 20,047 | | | | | | (20,047) | | | | | | — | | | | | | — | | | | |
|
—
|
| | ||||||||
Equity-settled share-based payments
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 1,525 | | | | | | 1,525 | | | | | | — | | | | |
|
1,525
|
| | ||||||||
Other | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||||
Total transactions with owners of the company
|
| | | | 153 | | | | | | 6,962 | | | | | | — | | | | | | 20,047 | | | | | | (18,522) | | | | | | 8,640 | | | | | | — | | | | | | 8,640 | | | ||||||||
Balance as at September 30, 2013
|
| | | | 5,397 | | | | | | 76,612 | | | | | | (335) | | | | | | (2,309) | | | | | | (14,464) | | | | | | 64,901 | | | | | | 1,712 | | | | | | 66,613 | | | ||||||||
|
In thousands of Euros
|
| |
Notes
|
| |
09.30.2014
|
| |
09.30.2013
|
| ||||||||||||
Cash flows from operating activities | | | | | | | | | | | | | | | | | | | | |||
Net income/(loss) for the period
|
| | | | | | | | | | (2,446) | | | | | | (2,674) | | | |||
Adjustments: | | | | | | | | | | | | | | | | | | | | |||
Depreciation, amortization and impairment of non-current assets
|
| | | | | | | | | | 7,257 | | | | | | 5,436 | | | |||
Share-based payment expense
|
| | | | | | | | | | 1,739 | | | | | | 1,524 | | | |||
Gain on disposal of property, plant and equipment
|
| | | | | | | | | | 41 | | | | | | (23) | | | |||
Financial result
|
| | | | | | | | | | (518) | | | | | | 2,928 | | | |||
Income tax expense
|
| | | | | | | | | | 1,683 | | | | | | 583 | | | |||
Subtotal
|
| | | | | | | | | | 7,756 | | | | | | 7,774 | | | |||
Increase in inventories
|
| | | | | | | | | | (1,205) | | | | | | (289) | | | |||
Increase in trade receivables
|
| | | | | | | | | | (2,798) | | | | | | 341 | | | |||
Increase/(decrease) in trade payables
|
| | | | | | | | | | 102 | | | | | | (1,075) | | | |||
Change in other receivable and other payables
|
| | | | | | | | | | (1,605) | | | | | | (1,408) | | | |||
Increase/(decrease) in provisions
|
| | | | | | | | | | 1,919 | | | | | | (47) | | | |||
Change in working capital requirements
|
| | | | | | | | | | (3,587) | | | | | | (2,478) | | | |||
Income tax paid
|
| | | | | | | | | | (553) | | | | | | (545) | | | |||
Net cash from operating activities
|
| | | | | | | | | | 3,616 | | | | | | 4,751 | | | |||
Cash flows from investing activities | | | | | | | | | | | | | | | | | | | | |||
Acquisition of property, plant and equipment
|
| | | | | | | | | | (8,687) | | | | | | (6,828) | | | |||
Acquisition of intangible assets
|
| | | | | | | | | | (494) | | | | | | (168) | | | |||
Repayment of financial assets
|
| | | | | | | | | | (263) | | | | | | — | | | |||
Proceeds from disposal of property, plant and equipment
|
| | | | | | | | | | — | | | | | | 29 | | | |||
Acquisition of subsidiaries, net of cash acquired
|
| | | | 5.1 | | | | | | (350) | | | | | | (303) | | | |||
Net cash used in investing activities
|
| | | | | | | | | | (9,794) | | | | | | (7,270) | | | |||
Cash flows from financing activities | | | | | | | | | | | | | | | | | | | | |||
Payment of deferred and contingent liabilities to former owners
of acquired subsidiaries |
| | | | | | | | | | (384) | | | | | | — | | | |||
Issuance of share capital
|
| | | | 5.5 | | | | | | 40,666 | | | | | | 4,820 | | | |||
Proceeds from borrowings
|
| | | | | | | | | | 5,277 | | | | | | 3,050 | | | |||
Repayment of borrowings
|
| | | | | | | | | | (3,963) | | | | | | (2,720) | | | |||
Interests paid
|
| | | | | | | | | | (561) | | | | | | (602) | | | |||
Net cash from financing activities
|
| | | | | | | | | | 41,035 | | | | | | 4,548 | | | |||
Net increase in cash and cash equivalents
|
| | | | | | | | | | 34,857 | | | | | | 2,029 | | | |||
Cash and cash equivalents at the beginning of the period
|
| | | | | | | | | | 13,610 | | | | | | 13,946 | | | |||
Effect of exchange rate changes on cash and cash equivalents
|
| | | | | | | | | | 215 | | | | | | 5 | | | |||
Cash and cash equivalents at the end of the period
|
| | | | | | | | | | 48,682 | | | | | | 15,980 | | | |||
|
| | | | | F-9 | | | |
| | | | | F-9 | | | |
| | | | | F-9 | | | |
| | | | | F-9 | | | |
| | | | | F-9 | | | |
| | | | | F-10 | | | |
| | | | | F-10 | | | |
| | | | | F-10 | | | |
| | | | | F-11 | | | |
| | | | | F-11 | | | |
| | | | | F-11 | | | |
| | | | | F-12 | | | |
| | | | | F-12 | | | |
| | | | | F-13 | | | |
| | | | | F-13 | | | |
| | | | | F-14 | | | |
| | | | | F-14 | | | |
| | | | | F-14 | | | |
| | | | | F-15 | | | |
| | | |
|
| | ||
| | | | | F-15 | | | |
| | | | | F-17 | | | |
| | | | | F-17 | | | |
| | | | | F-17 | | | |
| | | | | F-18 | | | |
| | | | | F-18 | | | |
| | | | | F-18 | | | |
| | | | | F-19 | | | |
| | | | | F-19 | | | |
| | | | | F-20 | | | |
| | | | | F-21 | | | |
| | | |
|
| |
Sales by products
|
| | | | | | | | | | | | | ||
In KEUR
|
| |
09.30.2014
|
| |
09.30.2013
|
| ||||||||
Product PET
|
| | | | 35,036 | | | | | | 30,487 | | | ||
Product SPECT – Diagnostic
|
| | | | 5,757 | | | | | | 5,596 | | | ||
Product – Therapy
|
| | | | 3,993 | | | | | | 2,221 | | | ||
Other products
|
| | | | 5,380 | | | | | | 615 | | | ||
Total | | | | | 50,166 | | | | | | 38,919 | | | ||
|
Sales by country
|
| | | | | | | | | | | | | ||
In KEUR
|
| |
09.30.2014
|
| |
09.30.2013
|
| ||||||||
France
|
| | | | 18,819 | | | | | | 16,654 | | | ||
Abroad | | | | ||||||||||||
Italy
|
| | | | 12,742 | | | | | | 10,728 | | | ||
Spain
|
| | | | 4,809 | | | | | | 4,408 | | | ||
Israel
|
| | | | 2,236 | | | | | | 3,089 | | | ||
Canada
|
| | | | 5 | | | | | | 162 | | | ||
United States
|
| | | | — | | | | | | — | | | ||
Germany
|
| | | | 711 | | | | | | 647 | | | ||
Portugal
|
| | | | 2,338 | | | | | | 1,266 | | | ||
United Kingdom
|
| | | | 6,148 | | | | | | — | | | ||
Other countries
|
| | | | 2,358 | | | | | | 1,965 | | | ||
Total | | | | | 50,166 | | | | | | 38,919 | | | ||
|
Non current assets by country In KEUR |
| |
09.30.2014
|
| |
12.31.2013
(Restated) |
| ||||||||
France
|
| | | | 28,278 | | | | | | 26,893 | | | ||
Abroad | | | | | | | | | | | | | | ||
Italy
|
| | | | 17,295 | | | | | | 17,169 | | | ||
Spain
|
| | | | 15,992 | | | | | | 16,962 | | | ||
Israel
|
| | | | 12,183 | | | | | | 12,210 | | | ||
Canada
|
| | | | 5,838 | | | | | | 5,485 | | | ||
United States
|
| | | | 14,728 | | | | | | 13,365 | | | ||
Germany
|
| | | | 9,175 | | | | | | 5,648 | | | ||
Portugal
|
| | | | 2,931 | | | | | | 3,181 | | | ||
United Kingdom
|
| | | | 1,679 | | | | | | — | | | ||
Other countries
|
| | | | 295 | | | | | | 200 | | | ||
Total | | | | | 108,394 | | | | | | 101,113 | | | ||
|
Grant date
|
| |
06/2009
|
| |
08/2009
|
| |
11/2010
|
| |
12/2011
|
| |
01/2012
|
| |
12/2012
|
| |
08/2013
|
| |||||||||||||||||||||
Number of shares granted
|
| | | | 690,000 | | | | | | 40,000 | | | | | | 370,000 | | | | | | 370,000 | | | | | | 15,000 | | | | | | 562,500 | | | | | | 477,500 | | |
Fair value at grant date
|
| | | | 2.5 | | | | | | 2.5 | | | | | | 2.5 | | | | | | 4.0 | | | | | | 4.0 | | | | | | 4.0 | | | | | | 5.0 | | |
Total fair value
|
| | | | 1,725,000 | | | | | | 100,000 | | | | | | 925,000 | | | | | | 1,480,000 | | | | | | 60,000 | | | | | | 2,250,000 | | | | | | 2,387,500 | | |
Vesting period (in years)
|
| | | | 2 | | | | | | 2 | | | | | | 2 | | | | | | 2 | | | | | | 2 | | | | | | 2 | | | | | | 2 | | |
In KEUR
|
| |
09.30.2014
|
| |
09.30.2013
|
| ||||||||
Change in fair value of contingent consideration
|
| | | | 1,256 | | | | | | — | | | ||
Other
|
| | | | 63 | | | | | | 95 | | | ||
Total finance income
|
| | | | 1,319 | | | | | | 95 | | | ||
|
In KEUR
|
| |
09.30.2014
|
| |
09.30.2013
|
| ||||||||
Interest expenses
|
| | | | (713) | | | | | | (682) | | | ||
Net foreign exchange (Income/loss)
|
| | | | 321 | | | | | | (526) | | | ||
Change in fair value of contingent consideration
|
| | | | (162) | | | | | | (1,595) | | | ||
Other
|
| | | | (247) | | | | | | (220) | | | ||
Total finance costs
|
| | | | (801) | | | | | | (3,023) | | | ||
|
Recognised amounts of identifiable assets acquired and liabilities assumed
|
| | | | | | | | | | | | | ||
(in thousands)
|
| |
GBP
|
| |
EUR
|
| ||||||||
Customer relationships
|
| | | | 1,424 | | | | | | 1,742 | | | ||
Property, plant and equipment
|
| | | | 57 | | | | | | 70 | | | ||
Investments
|
| | | | 20 | | | | | | 24 | | | ||
Inventory
|
| | | | 406 | | | | | | 497 | | | ||
Trade receivables
|
| | | | 1,710 | | | | | | 2,091 | | | ||
Cash and cash equivalent
|
| | | | 296 | | | | | | 362 | | | ||
Loans
|
| | | | (21) | | | | | | (26) | | | ||
Other debt
|
| | | | (1,961) | | | | | | (2,398) | | | ||
Deferred tax liabilities
|
| | | | (299) | | | | | | (366) | | | ||
Total net assets acquired
|
| | | | 1,632 | | | | | | 1,996 | | | ||
Negative Goodwill
|
| | | | (77) | | | | | | (94) | | | ||
Total consideration
|
| | | | 1,555 | | | | | | 1,902 | | | ||
Satisfied by: | | | | | | | | | | | | | | ||
Cash
|
| | | | 350 | | | | | | 428 | | | ||
Equity instruments (294,743 ordinary shares at € 5)
|
| | | | 1,205 | | | | | | 1,474 | | | ||
Total consideration transferred
|
| | | | 1,555 | | | | | | 1,902 | | | ||
Net cash outflow arising on acquisition | | | | | | | | | | | | | | ||
Cash consideration
|
| | | | 350 | | | | | | 428 | | | ||
Less: cash and cash equivalents acquired
|
| | | | (296) | | | | | | (362) | | | ||
| | | | | 54 | | | | | | 66 | | | ||
|
Recognised amounts of identifiable assets acquired and liabilities assumed
|
| | | | | | | |
(in thousands)
|
| |
EUR
|
| ||||
Customer relationships
|
| | | | 952 | | | |
License
|
| | | | 100 | | | |
Property, plant and equipment
|
| | | | 33 | | | |
Inventory
|
| | | | 71 | | | |
Trade receivables
|
| | | | 142 | | | |
Other debt
|
| | | | (36) | | | |
Deferred tax liabilities
|
| | | | (299) | | | |
Goodwill
|
| | | | 286 | | | |
Total consideration
|
| | | | 1,249 | | | |
Satisfied by: | | | | | | | | |
Cash
|
| | | | 284 | | | |
Cash yet to pay (Liability)
|
| | | | 214 | | | |
Contingent consideration(i)
|
| | | | 751 | | | |
Total consideration transferred
|
| | | | 1,249 | | | |
Net cash outflow arising on acquisition | | | ||||||
Cash consideration
|
| | | | 284 | | | |
Less: cash and cash equivalents acquired
|
| | | | 0 | | | |
| | | | | 284 | | | |
|
| | |
09.30.2014
|
| |||||||||||||||||||||||||
| | |
Goodwill
|
| |
Acquired
IPR&D |
| |
Accumulated
impairment |
| |
Total
|
| ||||||||||||||||
Italy (AAA Italy)
|
| | | | 286 | | | | | | | | | | | | | | | | | | 286 | | | ||||
Italy (Gipharma)
|
| | | | 1,947 | | | | | | | | | | | | — | | | | | | 1,947 | | | ||||
Canada
|
| | | | 588 | | | | | | 5,249 | | | | | | — | | | | | | 5,837 | | | ||||
USA
|
| | | | 3,564 | | | | | | 10,404 | | | | | | — | | | | | | 13,968 | | | ||||
Germany
|
| | | | 1,027 | | | | | | — | | | | | | — | | | | | | 1,027 | | | ||||
Spain
|
| | | | 6,261 | | | | | | — | | | | | | — | | | | | | 6,261 | | | ||||
Israel
|
| | | | 7,705 | | | | | | — | | | | | | — | | | | | | 7,705 | | | ||||
Portugal
|
| | | | 1,855 | | | | | | — | | | | | | (1,015) | | | | | | 840 | | | ||||
Other countries
|
| | | | 38 | | | | | | — | | | | | | — | | | | | | 38 | | | ||||
Total | | | | | 23,271 | | | | | | 15,653 | | | | | | (1,015) | | | | | | 37,909 | | | ||||
|
| | |
12.31.2013 (Restated)
|
| |||||||||||||||||||||||||
| | |
Goodwill
|
| |
Acquired
IPR&D |
| |
Accumulated
impairment |
| |
Total
|
| ||||||||||||||||
Italy (Gipharma)
|
| | | | 1,947 | | | | | | | | | | | | — | | | | | | 1,947 | | | ||||
Canada
|
| | | | 416 | | | | | | 5,064 | | | | | | — | | | | | | 5,480 | | | ||||
USA
|
| | | | 3,223 | | | | | | 9,571 | | | | | | — | | | | | | 12,794 | | | ||||
Germany
|
| | | | 1,027 | | | | | | — | | | | | | — | | | | | | 1,027 | | | ||||
Spain
|
| | | | 6,261 | | | | | | — | | | | | | — | | | | | | 6,261 | | | ||||
Israel
|
| | | | 7,500 | | | | | | — | | | | | | — | | | | | | 7,500 | | | ||||
Portugal
|
| | | | 1,855 | | | | | | — | | | | | | (1,015) | | | | | | 840 | | | ||||
Other countries
|
| | | | 38 | | | | | | — | | | | | | — | | | | | | 38 | | | ||||
Total | | | | | 22,267 | | | | | | 14,635 | | | | | | (1,015) | | | | | | 35,887 | | | ||||
|
| | |
Net income
(loss) (KEUR) |
| |
Average number
of shares outstanding |
| |
Earning per share
(EUR) |
| ||||||||||||
30.09.2014
|
| | | | (1,548) | | | | | | | | | | | | | | | |||
Earning per basic share
|
| | | | | | | | | | 62,514,233 | | | | | | (0.02) | | | |||
Earning per diluted share
|
| | | | | | | | | | 62,514,233 | | | | | | (0.02) | | | |||
30.09.2013
|
| | | | (2,309) | | | | | | | | | | | | | | | |||
Earning per basic share
|
| | | | | | | | | | 54,036,813 | | | | | | (0.04) | | | |||
Earning per diluted share
|
| | | | | | | | | | 54,036,813 | | | | | | (0.04) | | | |||
|
KEUR
|
| |
09.30.2014
|
| |
12.31.2013
|
| ||||||||
Finance lease obligations(1)
|
| | | | 10,402 | | | | | | 7,591 | | | ||
Loans(1) | | | | | 16,568 | | | | | | 18,226 | | | ||
Total | | | | | 26,970 | | | | | | 25,817 | | | ||
|
| | |
2014
|
| | | |||||||||||||||||||||||||
KEUR
|
| |
< 1 year
|
| |
1 – 5 years
|
| |
> 5 years
|
| |
Total
|
| | | ||||||||||||||||
Finance lease obligations
|
| | | | 1,876 | | | | | | 5,617 | | | | | | 2,909 | | | | | | 10,402 | | | | | ||||
Loans
|
| | | | 4,149 | | | | | | 10,406 | | | | | | 2,013 | | | | | | 16,568 | | | | | ||||
Total | | | | | 6,025 | | | | | | 16,023 | | | | | | 4,922 | | | | | | 26,970 | | | | | ||||
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | |
2013
|
| |||||||||||||||||||||||||
KEUR
|
| |
< 1 year
|
| |
1 – 5 years
|
| |
> 5 years
|
| |
Total
|
| ||||||||||||||||
Finance lease obligations
|
| | | | 1,584 | | | | | | 4,281 | | | | | | 1,725 | | | | | | 7,591 | | | ||||
Loans
|
| | | | 3,873 | | | | | | 10,993 | | | | | | 3,360 | | | | | | 18,226 | | | ||||
Total | | | | | 5,457 | | | | | | 15,274 | | | | | | 5,085 | | | | | | 25,817 | | | ||||
|
KEUR
|
| |
average
interest rate |
| |
09.30.2014
|
| |
12.31.2013
|
| ||||||||||||
Fixed rates
|
| | | | 3.34% | | | | | | 19,729 | | | | | | 17,603 | | | |||
Floating rates
|
| | | | 2.26% | | | | | | 7,241 | | | | | | 8,214 | | | |||
Total | | | | | | | | | | | 26,970 | | | | | | 25,817 | | | |||
|
KEUR
|
| |
09.30.2014
|
| |
12.31.2013
(Restated) |
| ||||||||
Due to former owners of acquired companies(1)
|
| | | | 29,344 | | | | | | 29,786 | | | ||
Government subsidies
|
| | | | 707 | | | | | | 1,691 | | | ||
Other non-current liabilities
|
| | | | 30,051 | | | | | | 31,477 | | | ||
Due to former owners of acquired companies(1)
|
| | | | 2,712 | | | | | | 2,793 | | | ||
Tax, personnel and social charges
|
| | | | 6,122 | | | | | | 3,886 | | | ||
Other debts(2)
|
| | | | 3,972 | | | | | | 2,872 | | | ||
Other current liabilities
|
| | | | 12,806 | | | | | | 9,551 | | | ||
|
| | |
09.30.2014
|
| ||||||||||||||||||||||||||||||||||||||||||||||
| | |
Carrying amount
|
| |
Fair value
|
| |||||||||||||||||||||||||||||||||||||||||||
In KEUR
|
| |
Note
|
| |
Designated
at fair value |
| |
Loans and
receivables |
| |
Available-
for-sale |
| |
Other
financial liabilities |
| |
Total
|
| | | | | | | |||||||||||||||||||||||||
Measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Available-for-sale financial assets
|
| | |
|
(3)
|
| | | | | | | | | | | | | | | | | 98 | | | | | | | | | | | | 98 | | | | | | 98 | | | |||||||
Total measured at fair value
|
| | | | | | | | | | — | | | | | | — | | | | | | 98 | | | | | | — | | | | | | 98 | | | | | | 98 | | | |||||||
Not measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Trade receivables and other receivables
|
| | |
|
(1)
|
| | | | | | | | | | | 18,941 | | | | | | | | | | | | | | | | | | 18,941 | | | | | | 18,941 | | | |||||||
Other assets
|
| | |
|
(1)
|
| | | | | | | | | | | 9,747 | | | | | | | | | | | | | | | | | | 9,747 | | | | | | 9,747 | | | |||||||
Guarantee deposits
|
| | |
|
(1)
|
| | | | | | | | | | | 2,501 | | | | | | | | | | | | | | | | | | 2,501 | | | | | | 2,501 | | | |||||||
Cash and cash equivalent
|
| | |
|
(1)
|
| | | | | | | | | | | 48,682 | | | | | | | | | | | | | | | | | | 48,682 | | | | | | 48,682 | | | |||||||
Total not measured at fair value
|
| | | | | | | | | | — | | | | | | 79,871 | | | | | | — | | | | | | — | | | | | | 79,871 | | | | | | 79,871 | | | |||||||
Total financial assets
|
| | | | | | | | | | — | | | | | | 79,871 | | | | | | 98 | | | | | | — | | | | | | 79,969 | | | | | | 79,969 | | | |||||||
Measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Debt due to former owners of
acquired companies |
| | |
|
(2)
|
| | | | | 32,056 | | | | | | | | | | | | | | | | | | | | | | | | 32,056 | | | | | | 32,056 | | | |||||||
Total measured at fair value
|
| | | | | | | | | | 32,056 | | | | | | — | | | | | | — | | | | | | — | | | | | | 32,056 | | | | | | 32,056 | | | |||||||
Not measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Financial liabilities
|
| | |
|
(3)
|
| | | | | | | | | | | | | | | | | | | | | | | 26,970 | | | | | | 26,970 | | | | | | 27,728 | | | |||||||
Trade payables
|
| | |
|
(1)
|
| | | | | | | | | | | | | | | | | | | | | | | 9,320 | | | | | | 9,320 | | | | | | 9,320 | | | |||||||
Other liabilities
|
| | |
|
(1)
|
| | | | | | | | | | | | | | | | | | | | | | | 10,798 | | | | | | 10,798 | | | | | | 10,798 | | | |||||||
Total not measured at fair value
|
| | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | 47,088 | | | | | | 47,088 | | | | | | 47,846 | | | |||||||
Total financial liabilities
|
| | | | | | | | | | 32,056 | | | | | | — | | | | | | — | | | | | | 47,088 | | | | | | 79,144 | | | | | | 79,902 | | | |||||||
|
| | |
12.31.2013 (Restated)
|
| ||||||||||||||||||||||||||||||||||||||||||||||
| | |
Carrying amount
|
| |
Fair value
|
| |||||||||||||||||||||||||||||||||||||||||||
In KEUR
|
| |
Note
|
| |
Designated
at fair value |
| |
Loans and
receivables |
| |
Available-
for-sale |
| |
Other
financial liabilities |
| |
Total
|
| | | | | | | |||||||||||||||||||||||||
Measured at fair value | | | | | | | | | ||||||||||||||||||||||||||||||||||||||||||
Available-for-sale financial assets
|
| | |
|
(3)
|
| | | | | | | | | | | | | | | | | 54 | | | | | | | | | | | | 54 | | | | | | 54 | | | |||||||
Total measured at fair value
|
| | | | | | | | | | — | | | | | | — | | | | | | 54 | | | | | | — | | | | | | 54 | | | | | | 54 | | | |||||||
Not measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Trade receivables and other receivables
|
| | |
|
(1)
|
| | | | | | | | | | | 16,143 | | | | | | | | | | | | | | | | | | 16,143 | | | | | | 16,143 | | | |||||||
Other assets
|
| | |
|
(1)
|
| | | | | | | | | | | 7,997 | | | | | | | | | | | | | | | | | | 7,997 | | | | | | 7,997 | | | |||||||
Guarantee deposits
|
| | |
|
(1)
|
| | | | | | | | | | | 2,282 | | | | | | | | | | | | | | | | | | 2,282 | | | | | | 2,282 | | | |||||||
Cash and cash equivalent
|
| | |
|
(1)
|
| | | | | | | | | | | 13,610 | | | | | | | | | | | | | | | | | | 13,610 | | | | | | 13,610 | | | |||||||
Total not measured at fair value
|
| | | | | | | | | | — | | | | | | 40,032 | | | | | | — | | | | | | — | | | | | | 40,032 | | | | | | 40,032 | | | |||||||
Total financial assets
|
| | | | | | | | | | — | | | | | | 40,032 | | | | | | 54 | | | | | | — | | | | | | 40,086 | | | | | | 40,086 | | | |||||||
Measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Debt due to former owners of
acquired companies |
| | |
|
(2)
|
| | | | | 32,579 | | | | | | | | | | | | | | | | | | | | | | | | 32,579 | | | | | | 32,579 | | | |||||||
Total measured at fair value
|
| | | | | | | | | | 32,579 | | | | | | — | | | | | | — | | | | | | — | | | | | | 32,579 | | | | | | 32,579 | | | |||||||
Not measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Financial liabilities
|
| | |
|
(3)
|
| | | | | | | | | | | | | | | | | | | | | | | 25,817 | | | | | | 25,817 | | | | | | 26,445 | | | |||||||
Trade payables
|
| | |
|
(1)
|
| | | | | | | | | | | | | | | | | | | | | | | 9,218 | | | | | | 9,218 | | | | | | 9,218 | | | |||||||
Other liabilities
|
| | |
|
(1)
|
| | | | | | | | | | | | | | | | | | | | | | | 8,449 | | | | | | 8,449 | | | | | | 8,449 | | | |||||||
Total not measured at fair value
|
| | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | 43,484 | | | | | | 43,484 | | | | | | 44,112 | | | |||||||
Total financial liabilities
|
| | | | | | | | | | 32,579 | | | | | | — | | | | | | — | | | | | | 43,484 | | | | | | 76,063 | | | | | | 76,691 | | | |||||||
|
In thousands of Euros
|
| |
Notes
|
| |
12.31.2013
(Restated)* |
| |
12.31.2012
(Restated)* |
| |
12.31.2011
(Restated)* |
| ||||||||||||||||
Sales | | | | | 4.1 | | | | | | 53,806 | | | | | | 40,834 | | | | | | 33,864 | | | ||||
Raw materials and consumables used
|
| | | | | | | | | | (9,185) | | | | | | (6,296) | | | | | | (4,061) | | | ||||
Personnel costs
|
| | | | 4.2 | | | | | | (16,265) | | | | | | (13,259) | | | | | | (10,657) | | | ||||
Other operating expenses
|
| | | | 4.4 | | | | | | (24,644) | | | | | | (22,032) | | | | | | (16,021) | | | ||||
Other operating income
|
| | | | 4.5 | | | | | | 3,977 | | | | | | 3,560 | | | | | | 1,520 | | | ||||
Depreciation and amortization
|
| | | | 4.6 | | | | | | (9,545) | | | | | | (6,495) | | | | | | (4,342) | | | ||||
Operating (loss)/income
|
| | | | | | | | | | (1,856) | | | | | | (3,688) | | | | | | 303 | | | ||||
Finance income (including changes in fair value of contingent consideration)
|
| | | | | | | | | | 387 | | | | | | 232 | | | | | | 492 | | | ||||
Finance costs (including changes in fair value of contingent consideration)
|
| | | | 4.7 | | | | | | (10,155) | | | | | | (16,512) | | | | | | (733) | | | ||||
Net finance costs
|
| | | | | | | | | | (9,768) | | | | | | (16,280) | | | | | | (241) | | | ||||
(Loss)/income before income taxes
|
| | | | | | | | | | (11,624) | | | | | | (19,968) | | | | | | 62 | | | ||||
Income taxes
|
| | | | 4.8 | | | | | | (1,157) | | | | | | (536) | | | | | | (844) | | | ||||
Loss for the year
|
| | | | | | | | | | (12,781) | | | | | | (20,504) | | | | | | (782) | | | ||||
Attributable to: | | | | | | | | | | | | | | | | | | | | | | | | | | ||||
Owners of the company
|
| | | | | | | | | | (12,152) | | | | | | (20,047) | | | | | | (239) | | | ||||
Non-controlling interests
|
| | | | 5.9 | | | | | | (629) | | | | | | (457) | | | | | | (544) | | | ||||
Earnings per share | | | | | | | | | | | | | | | | | | | | | | | | | | ||||
Basic (€ per share)
|
| | | | | | | | | | (0.22) | | | | | | (0.38) | | | | | | (0.00) | | | ||||
Diluted (€ per share)
|
| | | | | | | | | | (0.22) | | | | | | (0.38) | | | | | | (0.00) | | | ||||
|
In thousands of Euros
|
| |
12.31.2013
(Restated)* |
| |
12.31.2012
(Restated)* |
| |
12.31.2011
(Restated)* |
| |||||||||
Loss for the year
|
| | | | (12,781) | | | | | | (20,504) | | | | | | (782) | | |
Other comprehensive income/(expense): | | | | | |||||||||||||||
Items that may be reclassified subsequently to profit or loss | | | | | | | | | | | | | | | | | | | |
Exchange differences on translating foreign operations
|
| | | | (125) | | | | | | 150 | | | | | | 82 | | |
Items that will never be reclassified subsequently to profit or
loss |
| | | | | | | | | | | | | | | | | | |
Remeasurement of defined benefit liability
|
| | | | 17 | | | | | | (52) | | | | | | 7 | | |
Other comprehensive (expense)/income net of tax(1)
|
| | | | (108) | | | | | | 98 | | | | | | 89 | | |
Total comprehensive income/(loss) for the year
|
| | | | (12,889) | | | | | | (20,406) | | | | | | (693) | | |
Total comprehensive income/(loss) attributable to: | | | | | | | | | | | | | | | | | | | |
Owner of the company
|
| | | | (12,061) | | | | | | (20,116) | | | | | | (149) | | |
Non-controlling interests
|
| | | | (828) | | | | | | (290) | | | | | | (544) | | |
(In thousands of Euros)
|
| |
Notes
|
| |
12.31.2013
(Restated)* |
| |
12.31.2012
(Restated)* |
| |
12.31.2011
(Restated)* |
| ||||||||||||||||
ASSETS | | | | | | | | | | | | | | | | | | | | | | | | | | ||||
Non-current assets
|
| | | | | | | | | | 103,449 | | | | | | 104,613 | | | | | | 80,457 | | | ||||
Goodwill
|
| | | | 5.1 | | | | | | 21,252 | | | | | | 22,285 | | | | | | 13,141 | | | ||||
Other intangible assets
|
| | | | 5.1 | | | | | | 30,581 | | | | | | 33,845 | | | | | | 32,434 | | | ||||
Property, plant and equipment
|
| | | | 5.2 | | | | | | 49,280 | | | | | | 45,762 | | | | | | 34,327 | | | ||||
Financial assets
|
| | | | 5.3 | | | | | | 2,336 | | | | | | 2,721 | | | | | | 555 | | | ||||
Current assets
|
| | | | | | | | | | 40,028 | | | | | | 38,543 | | | | | | 46,295 | | | ||||
Inventories
|
| | | | 5.5 | | | | | | 2,278 | | | | | | 1,833 | | | | | | 1,244 | | | ||||
Trade and other receivables
|
| | | | 5.4 | | | | | | 16,143 | | | | | | 15,537 | | | | | | 10,910 | | | ||||
Other current assets
|
| | | | 5.6 | | | | | | 7,997 | | | | | | 7,107 | | | | | | 4,351 | | | ||||
Cash and cash equivalents
|
| | | | 5.7 | | | | | | 13,610 | | | | | | 14,066 | | | | | | 29,790 | | | ||||
TOTAL ASSETS
|
| | | | | | | | | | 143,477 | | | | | | 143,156 | | | | | | 126,752 | | | ||||
EQUITY AND LIABILITIES | | | | | | | | | | | | | | | | | | | | | | | | | | ||||
Equity attributable to owners of the company
|
| | | | | | | | | | 55,723 | | | | | | 58,389 | | | | | | 77,013 | | | ||||
Share capital
|
| | | | | | | | | | 5,415 | | | | | | 5,244 | | | | | | 5,210 | | | ||||
Share premium
|
| | | | | | | | | | 76,594 | | | | | | 69,650 | | | | | | 69,155 | | | ||||
Reserves and retained earnings
|
| | | | | | | | | | (14,134) | | | | | | 3,542 | | | | | | 2,887 | | | ||||
Net loss for the year
|
| | | | | | | | | | (12,152) | | | | | | (20,047) | | | | | | (239) | | | ||||
Non-controlling interests
|
| | | | 5.9 | | | | | | 1,360 | | | | | | 2,188 | | | | | | 2,198 | | | ||||
Total equity
|
| | |
|
5.8
|
| | | | | 57,083 | | | | | | 60,577 | | | | | | 79,211 | | | ||||
Non-current liabilities
|
| | | | | | | | | | 62,052 | | | | | | 56,447 | | | | | | 28,227 | | | ||||
Non-current provisions
|
| | | | 5.10 | | | | | | 6,029 | | | | | | 5,592 | | | | | | 3,390 | | | ||||
Non-current financial liabilities
|
| | | | 5.11 | | | | | | 20,359 | | | | | | 21,056 | | | | | | 11,789 | | | ||||
Deferred tax liabilities
|
| | | | 4.8 | | | | | | 4,187 | | | | | | 5,386 | | | | | | 5,767 | | | ||||
Other non-current liabilities
|
| | | | 5.12 | | | | | | 31,477 | | | | | | 24,413 | | | | | | 7,281 | | | ||||
Current liabilities
|
| | | | | | | | | | 24,342 | | | | | | 26,132 | | | | | | 19,314 | | | ||||
Current provisions
|
| | | | 5.10 | | | | | | 115 | | | | | | 300 | | | | | | 0 | | | ||||
Current financial liabilities
|
| | | | 5.11 | | | | | | 5,458 | | | | | | 4,012 | | | | | | 3,967 | | | ||||
Trade and other payables
|
| | | | | | | | | | 9,218 | | | | | | 9,857 | | | | | | 7,933 | | | ||||
Other current liabilities
|
| | | | 5.12 | | | | | | 9,551 | | | | | | 11,963 | | | | | | 7,414 | | | ||||
Total liabilities
|
| | | | | | | | | | 86,394 | | | | | | 82,579 | | | | | | 47,541 | | | ||||
TOTAL EQUITY AND LIABILITIES
|
| | | | | | | | | | 143,477 | | | | | | 143,156 | | | | | | 126,752 | | | ||||
|
| | |
Attributable to the company
|
| | | |||||||||||||||||||||||||||||||||||||||||||||||||||
In thousands of Euros
|
| |
Share
capital |
| |
Share
premium |
| |
Translation
reserve |
| |
Group
Share of Net Income/ (loss) for the year |
| |
Group
reserves |
| |
Total
Attributable to owners of the Company |
| |
Non-
controlling interests |
| |
TOTAL
|
| ||||||||||||||||||||||||||||||||
As at January 1, 2013 (Restated)*
|
| | | | 5,244 | | | | | | 69,650 | | | | | | (507) | | | | | | (20,047) | | | | | | 4,049 | | | | | | 58,389 | | | | | | 2,188 | | | | | | 60,577 | | | ||||||||
Comprehensive income/(loss) for the year | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||||
Loss for the year (Restated)*
|
| | | | — | | | | | | — | | | | | | — | | | | | | (12,152) | | | | | | — | | | | | | (12,152) | | | | | | (629) | | | | |
|
(12,781)
|
| | ||||||||
Other comprehensive income for the year
|
| | | | — | | | | | | — | | | | | | 74 | | | | | | — | | | | | | 17 | | | | | | 91 | | | | | | (199) | | | | |
|
(108)
|
| | ||||||||
Total comprehensive income (Restated)*
|
| | | | — | | | | | | — | | | | | | 74 | | | | | | (12,152) | | | | | | 17 | | | | | | (12,061) | | | | | | (828) | | | | | | (12,889) | | | ||||||||
Transactions with owners of the company | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||||
Issue of ordinary shares(1)
|
| | | | 171 | | | | | | 6,944 | | | | | | — | | | | | | — | | | | | | — | | | | | | 7,115 | | | | | | — | | | | |
|
7,115
|
| | ||||||||
Appropriation of 2012 net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | (20,047) | | | | | | (20,047) | | | | | | — | | | | | | — | | | | |
|
—
|
| | ||||||||
Equity-settled share-based payments
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 2,280 | | | | | | 2,280 | | | | | | — | | | | |
|
2,280
|
| | ||||||||
Total transactions with owners of the company
|
| | | | 171 | | | | | | 6,944 | | | | | | — | | | | | | (20,047) | | | | | | (17,767) | | | | | | 9,395 | | | | | | — | | | | | | 9,395 | | | ||||||||
At December 31, 2013 (Restated)*
|
| | | | 5,415 | | | | | | 76,594 | | | | | | (433) | | | | | | (12,152) | | | | | | (13,701) | | | | | | 55,723 | | | | | | 1,360 | | | | | | 57,083 | | | ||||||||
|
| | |
Attributable to the company
|
| | | |||||||||||||||||||||||||||||||||||||||||||||||||||
In thousands of Euros
|
| |
Share
capital |
| |
Share
premium |
| |
Translation
reserve |
| |
Group
share of net Income/ (loss) for the year |
| |
Group
reserves |
| |
Total
Attributable to owners of the Company |
| |
Non-
controlling interests |
| |
TOTAL
|
| ||||||||||||||||||||||||||||||||
As at January 1, 2012 (Restated)*
|
| | | | 5,210 | | | | | | 69,155 | | | | | | (490) | | | | | | (239) | | | | | | 3,377 | | | | | | 77,013 | | | | | | 2,198 | | | | |
|
79,211
|
| | ||||||||
Comprehensive income (loss) for the year | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||||
Net income/loss for the year (Restated)*
|
| | | | — | | | | | | — | | | | | | — | | | | | | (20,047) | | | | | | — | | | | | | (20,047) | | | | | | (457) | | | | |
|
(20,504)
|
| | ||||||||
Other comprehensive income for the year
|
| | | | — | | | | | | — | | | | | | (16) | | | | | | — | | | | | | (52) | | | | | | (69) | | | | | | 165 | | | | |
|
98
|
| | ||||||||
Total comprehensive income/(loss) (Restated)*
|
| | | | — | | | | | | — | | | | | | (16) | | | | | | (20,047) | | | | | | (52) | | | | | | (20,116) | | | | | | (292) | | | | | | (20,406) | | | ||||||||
Transactions with owners of the company | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||||
Issue of ordinary shares
|
| | | | 34 | | | | | | 495 | | | | | | — | | | | | | — | | | | | | — | | | | | | 529 | | | | | | — | | | | |
|
529
|
| | ||||||||
Appropriation of 2011 net income/(loss)
|
| | | | — | | | | | | — | | | | | | — | | | | | | 239 | | | | | | (239) | | | | | | — | | | | | | — | | | | |
|
—
|
| | ||||||||
Equity-settled share-based payments
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 1,250 | | | | | | 1,250 | | | | | | — | | | | |
|
1,250
|
| | ||||||||
Transactions between shareholders
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (289) | | | | | | (289) | | | | | | 282 | | | | |
|
(7)
|
| | ||||||||
Total transactions with owners of the company
|
| | | | 34 | | | | | | 495 | | | | | | — | | | | | | 239 | | | | | | 724 | | | | | | 1,492 | | | | | | 282 | | | | | | 1,772 | | | ||||||||
At December 31, 2012 (Restated)*
|
| | | | 5,244 | | | | | | 69,650 | | | | | | (507) | | | | | | (20,047) | | | | | | 4,049 | | | | | | 58,389 | | | | | | 2,188 | | | | | | 60,577 | | | ||||||||
|
| | |
Attributable to the company
|
| | | |||||||||||||||||||||||||||||||||||||||||||||||||||
In thousands of Euros
|
| |
Share
capital |
| |
Share
premium |
| |
Translation
reserve |
| |
Group
share of net Income/ (loss) for the year |
| |
Group
reserves |
| |
Total
Attributable to owners of the Company |
| |
Non-
controlling interests |
| |
TOTAL
|
| ||||||||||||||||||||||||||||||||
As at January 1, 2011 (As previously reported)
|
| | | | 4,159 | | | | | | 30,016 | | | | | | (572) | | | | | | 1,232 | | | | | | 2,314 | | | | | | 37,149 | | | | | | 2,742 | | | | |
|
39,891
|
| | ||||||||
Adjustments | | | | | — | | | | | | — | | | | | | — | | | | | | 159 | | | | | | (1,260) | | | | | | (1,101) | | | | | | — | | | | |
|
(1,101)
|
| | ||||||||
As at January 1, 2011 (Restated)*
|
| | | | 4,159 | | | | | | 30,016 | | | | | | (572) | | | | | | 1,391 | | | | | | 1,054 | | | | | | 36,048 | | | | | | 2,742 | | | | |
|
38,790
|
| | ||||||||
Comprehensive income for the year | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||||
Net income / (loss) for the year (Restated)*
|
| | | | — | | | | | | — | | | | | | — | | | | | | (239) | | | | | | — | | | | | | (239) | | | | | | (544) | | | | |
|
(783)
|
| | ||||||||
Other comprehensive income for the year
|
| | | | — | | | | | | — | | | | | | 82 | | | | | | — | | | | | | 7 | | | | | | 89 | | | | | | — | | | | |
|
89
|
| | ||||||||
Total comprehensive income (Restated)*
|
| | | | — | | | | | | — | | | | | | 82 | | | | | | (239) | | | | | | 7 | | | | | | (150) | | | | | | (544) | | | | | | (694) | | | ||||||||
Transactions with owners of the company | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||||
Issue of ordinary shares
|
| | | | 1,051 | | | | | | 39,139 | | | | | | — | | | | | | — | | | | | | — | | | | | | 40,190 | | | | | | — | | | | |
|
40,190
|
| | ||||||||
Appropriation of 2010 net income / (loss)
|
| | | | — | | | | | | — | | | | | | — | | | | | | (1,391) | | | | | | 1,391 | | | | | | — | | | | | | — | | | | |
|
—
|
| | ||||||||
Equity-settled share-based payments
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 925 | | | | | | 925 | | | | | | — | | | | |
|
925
|
| | ||||||||
Total transactions with owners of the company
|
| | | | 1,051 | | | | | | 39,139 | | | | | | — | | | | | | (1,391) | | | | | | 2,316 | | | | | | 41,115 | | | | | | — | | | | | | 41,115 | | | ||||||||
At December 31, 2011 (Restated)*
|
| | | | 5,210 | | | | | | 69,155 | | | | | | (490) | | | | | | (239) | | | | | | 3,377 | | | | | | 77,013 | | | | | | 2,198 | | | | | | 79,211 | | | ||||||||
|
In thousands of Euros
|
| |
12.31.2013
(Restated)* |
| |
12.31.2012
(Restated)* |
| |
12.31.2011
(Restated)* |
| ||||||||||||
Cash flows from operating activities | | | | | | | | | | | | | | | | | | | | |||
Net income/(loss) for the year
|
| | | | (12,781) | | | | | | (20,504) | | | | | | (782) | | | |||
Adjustments: | | | | | | | | | | | | | | | | | | | | |||
Depreciation, amortization and impairment of non-current
assets |
| | | | 9,544 | | | | | | 6,496 | | | | | | 4,342 | | | |||
Share based payment expense
|
| | | | 2,281 | | | | | | 1,249 | | | | | | 925 | | | |||
Gain on disposal of property, plant and equipment
|
| | | | (62) | | | | | | 32 | | | | | | 28 | | | |||
Financial result
|
| | | | 9,768 | | | | | | 16,280 | | | | | | 242 | | | |||
Income tax expense
|
| | | | 1,158 | | | | | | 536 | | | | | | 844 | | | |||
Subtotal | | | | | 9,908 | | | | | | 4,089 | | | | | | 5,599 | | | |||
Increase in inventories
|
| | | | (445) | | | | | | (439) | | | | | | (216) | | | |||
Increase in trade receivables
|
| | | | (606) | | | | | | (2,917) | | | | | | (3,848) | | | |||
Increase/(decrease) in trade payables
|
| | | | (639) | | | | | | 821 | | | | | | 4,796 | | | |||
Change in other receivables and payables
|
| | | | (63) | | | | | | (402) | | | | | | 807 | | | |||
Increase in provisions
|
| | | | 253 | | | | | | 553 | | | | | | 399 | | | |||
Change in working capital
|
| | | | (1,500) | | | | | | (2,384) | | | | | | 1,938 | | | |||
Income tax paid
|
| | | | (663) | | | | | | (479) | | | | | | (336) | | | |||
Net cash from operating activities
|
| | | | 7,745 | | | | | | 1,226 | | | | | | 7,201 | | | |||
Cash flows from investing activities | | | | | | | | | | | | | | | | | | | | |||
Acquisition of property, plant and equipment
|
| | | | (9,289) | | | | | | (9,934) | | | | | | (7,948) | | | |||
Acquisition of intangible assets
|
| | | | (634) | | | | | | (195) | | | | | | (685) | | | |||
Acquisition of financial assets
|
| | | | (116) | | | | | | (2,166) | | | | | | (29) | | | |||
Proceeds from disposal of property, plant and equipment
|
| | | | 130 | | | | | | 178 | | | | | | 0 | | | |||
Receipts from government grants
|
| | | | 0 | | | | | | 245 | | | | | | 0 | | | |||
Acquisition of subsidiaries, net of cash acquired
|
| | | | (1,395) | | | | | | (11,564) | | | | | | (4,594) | | | |||
Net cash used in investing activities
|
| | | | (11,304) | | | | | | (23,436) | | | | | | (13,256) | | | |||
Net cash from financing activities | | | | | | | | | | | | | | | | | | | | |||
Issuance of share capital
|
| | | | 4,820 | | | | | | 0 | | | | | | 25,590 | | | |||
Proceeds from borrowings
|
| | | | 3,496 | | | | | | 10,400 | | | | | | 2,500 | | | |||
Repayment of borrowings
|
| | | | (4,058) | | | | | | (2,213) | | | | | | (2,761) | | | |||
Interests paid
|
| | | | (1,029) | | | | | | (839) | | | | | | (690) | | | |||
Net cash from financing activities
|
| | | | 3,229 | | | | | | 7,348 | | | | | | 24,639 | | | |||
Net increase/decrease in cash and cash equivalents
|
| | | | (330) | | | | | | (14,862) | | | | | | 18,584 | | | |||
Cash and cash equivalents at the beginning of the year
|
| | | | 13,947 | | | | | | 28,803 | | | | | | 10,213 | | | |||
Effect of exchange rate changes on cash and cash equivalents
|
| | | | (7) | | | | | | 6 | | | | | | 6 | | | |||
Cash and cash equivalents at the end of the year
|
| | | | 13,610 | | | | | | 13,947 | | | | | | 28,803 | | | |||
|
| | | | | F-34 | | | |
| | | |
|
| | ||
| | | | | F-34 | | | |
| | | | | F-34 | | | |
| | | | | F-34 | | | |
| | | | | F-34 | | | |
| | | | | F-38 | | | |
| | | | | F-39 | | | |
| | | | | F-39 | | | |
| | | | | F-40 | | | |
| | | | | F-41 | | | |
| | | | | F-41 | | | |
| | | | | F-42 | | | |
| | | | | F-42 | | | |
| | | | | F-44 | | | |
| | | | | F-44 | | | |
| | | | | F-44 | | | |
| | | | | F-45 | | | |
| | | | | F-45 | | | |
| | | | | F-46 | | | |
| | | | | F-47 | | | |
| | | | | F-48 | | | |
| | | | | F-48 | | | |
| | | | | F-49 | | | |
| | | | | F-49 | | | |
| | | | | F-50 | | | |
| | | | | F-50 | | | |
| | | | | F-50 | | | |
| | | | | F-50 | | | |
| | | | | F-50 | | | |
| | | | | F-50 | | | |
| | | | | F-51 | | | |
| | | | | F-52 | | | |
| | | | | F-52 | | | |
| | | | | F-52 | | | |
| | | | | F-52 | | | |
| | | | | F-53 | | | |
| | | | | F-53 | | | |
| | | | | F-53 | | | |
| | | | | F-54 | | | |
| | | | | F-64 | | | |
| | | | | F-64 | | |
| | | | | F-65 | | | |
| | | | | F-65 | | | |
| | | | | F-66 | | | |
| | | | | F-66 | | | |
| | | | | F-66 | | | |
| | | | | F-66 | | | |
| | | | | F-67 | | | |
| | | | | F-67 | | | |
| | | | | F-69 | | | |
| | | | | F-69 | | | |
| | | | | F-72 | | | |
| | | | | F-73 | | | |
| | | | | F-73 | | | |
| | | | | F-73 | | | |
| | | | | F-73 | | | |
| | | | | F-74 | | | |
| | | | | F-74 | | | |
| | | | | F-75 | | | |
| | | | | F-76 | | | |
| | | | | F-77 | | | |
| | | | | F-78 | | | |
| | | | | F-79 | | | |
| | | | | F-81 | | | |
| | | | | F-82 | | | |
| | | | | F-82 | | | |
| | | | | F-82 | | | |
| | | | | F-85 | | | |
| | | |
|
| |
In KEUR
|
| |
Note
|
| | ||||||||||
Cash | | | | | | | | | | | 10,903 | | | ||
Contingent Consideration
|
| | | | (i) | | | | | | 975 | | | ||
Total consideration transferred
|
| | | | | | | | | | 11,878 | | | ||
|
In KEUR
|
| |
Barnatron
|
| |
Cadisa
|
| |
Total
|
| ||||||||||||
Property, plants and equipment
|
| | | | 2,042 | | | | | | 225 | | | | | | 2,267 | | | |||
Intangible assets
|
| | | | 3,351 | | | | | | 335 | | | | | | 3,686 | | | |||
Inventories | | | | | 105 | | | | | | 48 | | | | | | 153 | | | |||
Trade receivables
|
| | | | 1,455 | | | | | | 769 | | | | | | 2,224 | | | |||
Deferred tax asset
|
| | | | 311 | | | | | | | | | | | | 311 | | | |||
Cash and cash equivalents
|
| | | | 320 | | | | | | 472 | | | | | | 792 | | | |||
Loans and borrowings
|
| | | | (136) | | | | | | | | | | | | (136) | | | |||
Deferred tax liabilities
|
| | | | (1,076) | | | | | | (97) | | | | | | (1,173) | | | |||
Contingent liabilities
|
| | | | (300) | | | | | | | | | | | | (300) | | | |||
Decommissioning Provision
|
| | | | (1,036) | | | | | | | | | | | | (1,036) | | | |||
Trade and other payables
|
| | | | (667) | | | | | | (504) | | | | | | (1,171) | | | |||
Total identifiable net assets acquired
|
| | | | 4,369 | | | | | | 1,248 | | | | | | 5,617 | | | |||
|
In KEUR
|
| | ||||||
Consideration transferred
|
| | | | 11,878 | | | |
Fair value of identifiable net assets
|
| | | | 5,617 | | | |
Goodwill | | | | | 6,261 | | | |
|
In KEUR
|
| | ||||||
Cash | | | | | 3,845 | | | |
Total consideration transferred
|
| | | | 3,845 | | | |
|
In KEUR
|
| | ||||||
Property, plant and equipment
|
| | | | 2,344 | | | |
Deferred tax assets
|
| | | | 119 | | | |
Decommissioning provision
|
| | | | (473) | | | |
Total identifiable net assets acquired
|
| | | | 1,990 | | | |
|
In KEUR
|
| | ||||||
Consideration transferred
|
| | | | 3,845 | | | |
Fair value of identifiable net assets
|
| | | | 1,990 | | | |
Goodwill
|
| | | | 1,855 | | | |
|
In KEUR
|
| |
Note
|
| | | | | | | |||||
Cash
|
| | | | | | | | | | 480 | | | ||
Equity instruments (120,000 ordinary shares of AAA France)
|
| | | | (i) | | | | | | 480 | | | ||
Contingent Consideration
|
| | | | (ii) | | | | | | 239 | | | ||
Total consideration transferred
|
| | | | | | | | | | 1,199 | | | ||
|
In KEUR
|
| | ||||||
Trade receivables
|
| | | | 340 | | | |
Cash and cash equivalents
|
| | | | 163 | | | |
Loans and borrowings
|
| | | | (32) | | | |
Trade and other payables
|
| | | | (129) | | | |
Total identifiable net assets acquired
|
| | | | 343 | | | |
|
In KEUR
|
| | ||||||
Consideration transferred
|
| | | | 1,199 | | | |
Fair value of identifiable net assets
|
| | | | 343 | | | |
Non-Controlling Interests, based on their proportionate interest in the recognized amounts of the assets and liabilities of Umbra Medical AG
|
| | | | (171) | | | |
Goodwill | | | | | 1,027 | | | |
|
In thousands
|
| |
Note
|
| |
ILS
|
| |
EUR
|
| ||||||||||||
Cash | | | | | | | | | | | 26,207 | | | | | | 5,301 | | | |||
Equity instruments (1,650,000 ordinary shares of
AAA France) |
| | | | (i) | | | | | | 32,630 | | | | | | 6,600 | | | |||
Total consideration transferred
|
| | | | | | | | | | 58,837 | | | | | | 11,901 | | | |||
|
In thousands
|
| |
ILS
|
| |
EUR
|
| ||||||||
Property, plant and equipment
|
| | | | 2,382 | | | | | | 482 | | | ||
Intangible assets
|
| | | | 21,476 | | | | | | 4,344 | | | ||
Inventories | | | | | 330 | | | | | | 67 | | | ||
Trade and other receivables
|
| | | | 9,594 | | | | | | 1,940 | | | ||
Cash and cash equivalents
|
| | | | 3,490 | | | | | | 707 | | | ||
Loans and borrowings
|
| | | | (4,331) | | | | | | (877) | | | ||
Deferred tax liabilities
|
| | | | (3,221) | | | | | | (652) | | | ||
Trade and other payables
|
| | | | (6,922) | | | | | | (1,400) | | | ||
Total identifiable net assets acquired
|
| | | | 22,797 | | | | | | 4,611 | | | ||
|
In KEUR
|
| | | | | | | |
Consideration transferred
|
| | | | 11,901 | | | |
Fair value of identifiable net assets
|
| | | | 4,611 | | | |
Goodwill | | | | | 7,290 | | | |
|
Assets acquired
|
| |
Valuation technique
|
|
Property, plant and
equipment |
| | Given the nature of the assets acquired, the valuation model considers mainly the depreciated replacement cost. Depreciated replacement cost reflects adjustments for physical deterioration as well as functional and economic obsolescence. | |
Intangible assets
|
| | Multi-period excess earnings method: The multi-period excess earnings method considers the present value of net cash flows expected to be generated by the customer relationships, by excluding any cash flows related to contributory assets. | |
2011
|
| |
USD
|
| |
CAD
|
| |
ISL
|
| |
CHF
|
| ||||||||||||
Closing Rate
|
| | | | 0.7729 | | | | | | 0.7567 | | | | | | 0.2022 | | | | | | 0.8226 | | |
Average Rate
|
| | | | 0.7180 | | | | | | 0.7269 | | | | | | 0.1994 | | | | | | 0.8103 | | |
2012
|
| |
USD
|
| |
CAD
|
| |
ISL
|
| |
CHF
|
| ||||||||||||
Closing Rate
|
| | | | 0.7251 | | | | | | 0.6816 | | | | | | 0.2089 | | | | | | 0.8146 | | |
Average Rate
|
| | | | 0.7529 | | | | | | 0.7308 | | | | | | 0.2085 | | | | | | 0.8124 | | |
2013
|
| |
USD
|
| |
CAD
|
| |
ISL
|
| |
CHF
|
| ||||||||||||
Closing Rate
|
| | | | 0.7579 | | | | | | 0.7612 | | | | | | 0.2030 | | | | | | 0.8236 | | |
Average Rate
|
| | | | 0.7779 | | | | | | 0.7783 | | | | | | 0.2019 | | | | | | 0.8297 | | |
|
Equity attributable to owners of the company at January 1, 2011 — As previously reported
|
| | | | 37,149 | |
|
Adjustments
|
| | | | (1,101) | |
|
Equity attributable to owners of the company at January 1, 2011 — As restated
|
| | | | 36,048 | |
|
In thousands of Euros
|
| |
12.31.2011
As previously reported |
| |
Adjustments
|
| |
12.31.2011
Restated |
| |||||||||
Sales
|
| | | | 33,864 | | | | | | — | | | | | | 33,864 | | |
Raw materials and consumables used
|
| | | | (4,061) | | | | | | — | | | | | | (4,061) | | |
Personnel cost
|
| | | | (10,617) | | | | | | (40) | | | | | | (10,657) | | |
Other operating expenses
|
| | | | (15,814) | | | | | | (207) | | | | | | (16,021) | | |
Other operating income
|
| | | | 1,457 | | | | | | 63 | | | | | | 1,520 | | |
Depreciation and amortization
|
| | | | (4,447) | | | | | | 105 | | | | | | (4,342) | | |
Operating income
|
| | | | 382 | | | | | | (78) | | | | | | 303 | | |
Finance income
|
| | | | 492 | | | | | | — | | | | | | 492 | | |
Finance Costs
|
| | | | (733) | | | | | | — | | | | | | (733) | | |
Net finance Income / (costs)
|
| | | | (242) | | | | | | — | | | | | | (241) | | |
Income / (loss) before taxes
|
| | | | 140 | | | | | | (78) | | | | | | 62 | | |
Income taxes
|
| | | | (906) | | | | | | 62 | | | | | | (844) | | |
Income / (loss) for the period
|
| | | | (766) | | | | | | (16) | | | | | | (782) | | |
Attributable to: | | | | | |||||||||||||||
Owners of the company
|
| | | | (222) | | | | | | (16) | | | | | | (238) | | |
Non-controlling interests
|
| | | | (544) | | | | | | — | | | | | | (544) | | |
Earnings per share | | | | | |||||||||||||||
Basic (€ per share)
|
| | | | (0.00) | | | | | | (0.00) | | | | | | (0.00) | | |
Diluted (€ per share)
|
| | | | (0.00) | | | | | | (0.00) | | | | | | (0.00) | | |
Net income / (loss) for the year
|
| | | | (766) | | | | | | (16) | | | | | | (782) | | |
Other comprehensive income / (expense): | | | | | |||||||||||||||
Items that will not be reclassified subsequently to profit or loss | | | | | |||||||||||||||
Items that may be reclassified subsequently to profit or loss | | | | | |||||||||||||||
Exchange differences on translating foreign operations
|
| | | | 82 | | | | | | — | | | | | | 82 | | |
Items that will never be reclassified subsequently to profit or loss | | | | | |||||||||||||||
Remeasurement of defined benefit liability
|
| | | | 7 | | | | | | — | | | | | | 7 | | |
Other comprehensive (expense) / income net of tax
|
| | | | 89 | | | | | | — | | | | | | 89 | | |
Total comprehensive income / (loss) for the year
|
| | | | (677) | | | | | | (16) | | | | | | (693) | | |
Total comprehensive income / (loss) attributable to: | | | | | |||||||||||||||
Owner of the company
|
| | | | (134) | | | | | | (16) | | | | | | (149) | | |
Non-controlling interests
|
| | | | (543) | | | | | | — | | | | | | (544) | | |
ASSETS (In thousands of Euros)
|
| |
12.31.2011
As previously reported |
| |
Adjustments
|
| |
12.31.2011
Restated |
| ||||||||||||
Non-current assets
|
| | | | 81,973 | | | | | | (1,516) | | | | | | 80,457 | | | |||
Goodwill
|
| | | | 13,141 | | | | | | — | | | | | | 13,141 | | | |||
Other intangible assets
|
| | | | 33,917 | | | | | | (1,483) | | | | | | 32,434 | | | |||
Property, plant and equipment
|
| | | | 34,360 | | | | | | (33) | | | | | | 34,327 | | | |||
Financial assets
|
| | | | 555 | | | | | | — | | | | | | 555 | | | |||
Current assets
|
| | | | 46,295 | | | | | | — | | | | | | 46,295 | | | |||
Inventories
|
| | | | 1,244 | | | | | | — | | | | | | 1,244 | | | |||
Trade and other receivables
|
| | | | 10,910 | | | | | | — | | | | | | 10,910 | | | |||
Other current assets
|
| | | | 4,351 | | | | | | — | | | | | | 4,351 | | | |||
Cash and cash equivalents
|
| | | | 29,790 | | | | | | — | | | | | | 29,790 | | | |||
TOTAL ASSETS
|
| | | | 128,268 | | | | | | (1,516) | | | | | | 126,752 | | | |||
EQUITY AND LIABILITIES (In thousand of Euros) | | | | | ||||||||||||||||||
Equity attributable to owners of the company
|
| | | | 78,130 | | | | | | (1,117) | | | | | | 77,013 | | | |||
Share capital
|
| | | | 5,210 | | | | | | — | | | | | | 5,210 | | | |||
Share premium
|
| | | | 69,155 | | | | | | — | | | | | | 69,155 | | | |||
Reserves and retained earnings
|
| | | | 3,987 | | | | | | (1,100) | | | | | | 2,887 | | | |||
Net income (loss) for the period
|
| | | | (222) | | | | | | (17) | | | | | | (239) | | | |||
Non-controlling interests
|
| | | | 2,199 | | | | | | — | | | | | | 2,198 | | | |||
Total equity
|
| | | | 80,329 | | | | | | (1,118) | | | | | | 79,211 | | | |||
Non-current liabilities
|
| | | | 28,625 | | | | | | (398) | | | | | | 28,227 | | | |||
Non-current provisions
|
| | | | 3,390 | | | | | | — | | | | | | 3,390 | | | |||
Non-current financial liabilities
|
| | | | 11,789 | | | | | | — | | | | | | 11,789 | | | |||
Deferred tax liabilities
|
| | | | 5,970 | | | | | | (203) | | | | | | 5,767 | | | |||
Other non-current liabilities
|
| | | | 7,476 | | | | | | (195) | | | | | | 7,281 | | | |||
Current liabilities
|
| | | | 19,314 | | | | | | — | | | | | | 19,314 | | | |||
Current provisions
|
| | | | — | | | | | | — | | | | | | — | | | |||
Current financial liabilities
|
| | | | 3,967 | | | | | | — | | | | | | 3,967 | | | |||
Trade and other payables
|
| | | | 7,933 | | | | | | — | | | | | | 7,933 | | | |||
Other current liabilities
|
| | | | 7,414 | | | | | | — | | | | | | 7,414 | | | |||
Total liabilities
|
| | | | 47,939 | | | | | | (398) | | | | | | 47,541 | | | |||
TOTAL EQUITY AND LIABILITIES
|
| | | | 128,268 | | | | | | (1,516) | | | | | | 126,752 | | | |||
|
In thousands of Euros
|
| |
12.31.2011
As previously reported |
| |
Adjustments
|
| |
12.31.2011
As restated |
| ||||||||||||
Cash flows from operating activities | | | | | ||||||||||||||||||
Net income/(loss) for the year
|
| | | | (766) | | | | | | (16) | | | | | | (782) | | | |||
Adjustments: | | | | | ||||||||||||||||||
Depreciation, amortization and impairment of non-current assets
|
| | | | 4,447 | | | | | | (105) | | | | | | 4,342 | | | |||
Share based payment expense
|
| | | | 925 | | | | | | — | | | | | | 925 | | | |||
Gain on disposal of property, plant and equipment
|
| | | | 28 | | | | | | — | | | | | | 28 | | | |||
Financial result
|
| | | | 242 | | | | | | — | | | | | | 242 | | | |||
Income tax expense
|
| | | | 906 | | | | | | (62) | | | | | | 844 | | | |||
Subtotal
|
| | | | 5,782 | | | | | | (183) | | | | | | 5,599 | | | |||
Increase in inventories
|
| | | | (216) | | | | | | — | | | | | | (216) | | | |||
Increase in trade receivables
|
| | | | (3,848) | | | | | | — | | | | | | (3,848) | | | |||
Increase/(decrease) in trade payables
|
| | | | 4,796 | | | | | | — | | | | | | 4,796 | | | |||
Change in other receivables and payables
|
| | | | 869 | | | | | | (62) | | | | | | 807 | | | |||
Increase in provisions
|
| | | | 399 | | | | | | — | | | | | | 399 | | | |||
Change in working capital
|
| | | | 2,000 | | | | | | (62) | | | | | | 1,938 | | | |||
Income tax paid
|
| | | | (336) | | | | | | — | | | | | | (336) | | | |||
Net cash from operating activities
|
| | | | 7,446 | | | | | | (245) | | | | | | 7,201 | | | |||
Cash flows from investing activities | | | | | ||||||||||||||||||
Acquisition of property, plant and equipment
|
| | | | (7,948) | | | | | | — | | | | | | (7,948) | | | |||
Acquisition of intangible assets
|
| | | | (930) | | | | | | 245 | | | | | | (685) | | | |||
Acquisition of financial assets
|
| | | | (29) | | | | | | — | | | | | | (29) | | | |||
Proceeds from disposal of property, plant and equipment
|
| | | | — | | | | | | — | | | | | | — | | | |||
Receipts from government grants
|
| | | | — | | | | | | — | | | | | | — | | | |||
Acquisition of subsidiaries, net of cash acquired
|
| | | | (4,594) | | | | | | — | | | | | | (4,594) | | | |||
Net cash used in investing activities
|
| | | | (13,501) | | | | | | 245 | | | | | | (13,256) | | | |||
Net cash from financing activities | | | | | ||||||||||||||||||
Issuance of share capital
|
| | | | 25,590 | | | | | | — | | | | | | 25,590 | | | |||
Proceeds from borrowings
|
| | | | 2,500 | | | | | | — | | | | | | 2,500 | | | |||
Repayment of borrowings
|
| | | | (2,761) | | | | | | — | | | | | | (2,761) | | | |||
Interests paid
|
| | | | (690) | | | | | | — | | | | | | (690) | | | |||
Net cash from financing activities
|
| | | | 24,639 | | | | | | — | | | | | | 24,639 | | | |||
Net increase / decrease in cash and cash equivalents
|
| | | | 18,584 | | | | | | — | | | | | | 18,584 | | | |||
Cash and cash equivalents at the beginning of the year
|
| | | | 10,213 | | | | | | — | | | | | | 10,213 | | | |||
Effect of exchange rate changes on cash and cash equivalents
|
| | | | 6 | | | | | | — | | | | | | 6 | | | |||
Cash and cash equivalents at the end of the year
|
| | | | 28,803 | | | | | | — | | | | | | 28,803 | | | |||
|
In thousands of Euros
|
| |
12.31.2012
As previously reported |
| |
Adjustments
|
| |
12.31.2012
Restated |
| |||||||||
Sales
|
| | | | 40,834 | | | | | | — | | | | | | 40,834 | | |
Raw materials and consumables used
|
| | | | (6,296) | | | | | | — | | | | | | (6,296) | | |
Personnel cost
|
| | | | (12,970) | | | | | | (289) | | | | | | (13,259) | | |
Other operating expenses
|
| | | | (17,023) | | | | | | (5,009) | | | | | | (22,032) | | |
Other operating income
|
| | | | 2,032 | | | | | | 1,528 | | | | | | 3,560 | | |
Depreciation and amortization
|
| | | | (6,623) | | | | | | 128 | | | | | | (6,495) | | |
Operating income
|
| | | | (46) | | | | | | (3,642) | | | | | | (3,688) | | |
Finance income
|
| | | | 232 | | | | | | — | | | | | | 232 | | |
Finance Costs
|
| | | | (16,512) | | | | | | — | | | | | | (16,512) | | |
Net finance Income / (costs)
|
| | | | (16,280) | | | | | | — | | | | | | (16,280) | | |
Income / (loss) before taxes
|
| | | | (16,326) | | | | | | (3,640) | | | | | | (19,968) | | |
Income taxes
|
| | | | (586) | | | | | | 50 | | | | | | (536) | | |
Income / (loss) for the period
|
| | | | (16,912) | | | | | | (3,590) | | | | | | (20,504) | | |
Attributable to: | | | | | |||||||||||||||
Owners of the company
|
| | | | (16,455) | | | | | | (3,590) | | | | | | (20,045) | | |
Non-controlling interests
|
| | | | (457) | | | | | | — | | | | | | (457) | | |
Earnings per share | | | | | |||||||||||||||
Basic (€ per share)
|
| | | | (0.31) | | | | | | (0.07) | | | | | | (0.38) | | |
Diluted (€ per share)
|
| | | | (0.31) | | | | | | (0.07) | | | | | | (0.38) | | |
Net income / (loss) for the year
|
| | | | (16,912) | | | | | | (3,590) | | | | | | (20,504) | | |
Other comprehensive income / (expense): | | | | | |||||||||||||||
Items that will not be reclassified subsequently to profit or loss | | | | | |||||||||||||||
Items that may be reclassified subsequently to profit or loss | | | | | |||||||||||||||
Exchange differences on translating foreign operations
|
| | | | 150 | | | | | | — | | | | | | 150 | | |
Items that will never be reclassified subsequently to profit or loss | | | | | |||||||||||||||
Remeasurement of defined benefit liability
|
| | | | (52) | | | | | | | | | | | | (52) | | |
Other comprehensive (expense) / income net of tax
|
| | | | 98 | | | | | | — | | | | | | 98 | | |
Total comprehensive income / (loss) for the year
|
| | | | (16,814) | | | | | | (3,590) | | | | | | (20,406) | | |
Total comprehensive income / (loss) attributable to: | | | | | |||||||||||||||
Owner of the company
|
| | | | (16,524) | | | | | | (3,590) | | | | | | (20,116) | | |
Non-controlling interests
|
| | | | (290) | | | | | | — | | | | | | (290) | | |
ASSETS (In thousands of Euros)
|
| |
12.31.2012
As previously reported |
| |
Adjustments
|
| |
12.31.2012
Restated |
| ||||||||||||
Non-current assets
|
| | | | 111,300 | | | | | | (6,687) | | | | | | 104,613 | | | |||
Goodwill
|
| | | | 22,286 | | | | | | — | | | | | | 22,285 | | | |||
Other intangible assets
|
| | | | 40,499 | | | | | | (6,654) | | | | | | 33,845 | | | |||
Property, plant and equipment
|
| | | | 45,794 | | | | | | (32) | | | | | | 45,762 | | | |||
Financial assets
|
| | | | 2,721 | | | | | | — | | | | | | 2,721 | | | |||
Current assets
|
| | | | 38,543 | | | | | | — | | | | | | 38,543 | | | |||
Inventories
|
| | | | 1,833 | | | | | | — | | | | | | 1,833 | | | |||
Trade and other receivables
|
| | | | 15,537 | | | | | | — | | | | | | 15,537 | | | |||
Other current assets
|
| | | | 7,107 | | | | | | — | | | | | | 7,107 | | | |||
Cash and cash equivalents
|
| | | | 14,066 | | | | | | — | | | | | | 14,066 | | | |||
TOTAL ASSETS
|
| | | | 149,843 | | | | | | (6,687) | | | | | | 143,156 | | | |||
EQUITY AND LIABILITIES (In thousand of Euros) | | | | | ||||||||||||||||||
Equity attributable to owners of the company
|
| | | | 63,101 | | | | | | (4,712) | | | | | | 58,389 | | | |||
Share capital
|
| | | | 5,244 | | | | | | — | | | | | | 5,244 | | | |||
Share premium
|
| | | | 69,650 | | | | | | — | | | | | | 69,650 | | | |||
Reserves and retained earnings
|
| | | | 4,662 | | | | | | (1,120) | | | | | | 3,542 | | | |||
Net income (loss) for the period
|
| | | | (16,455) | | | | | | (3,592) | | | | | | (20,047) | | | |||
Non-controlling interests
|
| | | | 2,189 | | | | | | (1) | | | | | | 2,188 | | | |||
Total equity
|
| | | | 65,290 | | | | | | (4,713) | | | | | | 60,577 | | | |||
Non-current liabilities
|
| | | | 58,425 | | | | | | (1,978) | | | | | | 56,447 | | | |||
Non-current provisions
|
| | | | 5,592 | | | | | | — | | | | | | 5,592 | | | |||
Non-current financial liabilities
|
| | | | 21,056 | | | | | | — | | | | | | 21,056 | | | |||
Deferred tax liabilities
|
| | | | 5,640 | | | | | | (254) | | | | | | 5,386 | | | |||
Other non-current liabilities
|
| | | | 26,137 | | | | | | (1,724) | | | | | | 24,413 | | | |||
Current liabilities
|
| | | | 26,128 | | | | | | 4 | | | | | | 26,132 | | | |||
Current provisions
|
| | | | 300 | | | | | | — | | | | | | 300 | | | |||
Current financial liabilities
|
| | | | 4,012 | | | | | | — | | | | | | 4,012 | | | |||
Trade and other payables
|
| | | | 9,857 | | | | | | — | | | | | | 9,857 | | | |||
Other current liabilities
|
| | | | 11,959 | | | | | | 4 | | | | | | 11,963 | | | |||
Total liabilities
|
| | | | 84,553 | | | | | | (1,974) | | | | | | 82,579 | | | |||
TOTAL EQUITY AND LIABILITIES
|
| | | | 149,843 | | | | | | (6,687) | | | | | | 143,156 | | | |||
|
In thousands of Euros
|
| |
12.31.2012
As previously reported |
| |
Adjustments
|
| |
12.31.2012
Restated |
| ||||||||||||
Cash flows from operating activities | | | | | ||||||||||||||||||
Net income/(loss) for the year
|
| | | | (16,912) | | | | | | (3,592) | | | | | | (20,504) | | | |||
Adjustments: | | | | | ||||||||||||||||||
Depreciation, amortization and impairment of non-current assets
|
| | | | 6,623 | | | | | | (127) | | | | | | 6,496 | | | |||
Share based payment expense
|
| | | | 1,249 | | | | | | — | | | | | | 1,249 | | | |||
Gain on disposal of property, plant and equipment
|
| | | | 32 | | | | | | — | | | | | | 32 | | | |||
Financial result
|
| | | | 16,280 | | | | | | — | | | | | | 16,280 | | | |||
Income tax expense
|
| | | | 586 | | | | | | (50) | | | | | | 536 | | | |||
Subtotal
|
| | | | 7,858 | | | | | | (3,769) | | | | | | 4,089 | | | |||
Increase in inventories
|
| | | | (439) | | | | | | — | | | | | | (439) | | | |||
Increase in trade receivables
|
| | | | (2,917) | | | | | | — | | | | | | (2,917) | | | |||
Increase/(decrease) in trade payables
|
| | | | 821 | | | | | | — | | | | | | 821 | | | |||
Change in other receivables and payables
|
| | | | 1,127 | | | | | | (1,529) | | | | | | (402) | | | |||
Increase in provisions
|
| | | | 553 | | | | | | — | | | | | | 553 | | | |||
Change in working capital
|
| | | | (855) | | | | | | (1,529) | | | | | | (2,384) | | | |||
Income tax paid
|
| | | | (479) | | | | | | — | | | | | | (479) | | | |||
Net cash from operating activities
|
| | | | 6,524 | | | | | | (5,298) | | | | | | 1,226 | | | |||
Cash flows from investing activities | | | | | ||||||||||||||||||
Acquisition of property, plant and equipment
|
| | | | (9,934) | | | | | | — | | | | | | (9,934) | | | |||
Acquisition of intangible assets
|
| | | | (5,494) | | | | | | 5,299 | | | | | | (195) | | | |||
Acquisition of financial assets
|
| | | | (2,166) | | | | | | — | | | | | | (2,166) | | | |||
Proceeds from disposal of property, plant and equipment
|
| | | | 178 | | | | | | — | | | | | | 178 | | | |||
Receipts from government grants
|
| | | | 245 | | | | | | — | | | | | | 245 | | | |||
Acquisition of subsidiaries, net of cash acquired
|
| | | | (11,564) | | | | | | — | | | | | | (11,564) | | | |||
Net cash used in investing activities
|
| | | | (28,735) | | | | | | 5,299 | | | | | | (23,436) | | | |||
Net cash from financing activities | | | | | ||||||||||||||||||
Issuance of share capital
|
| | | | — | | | | | | — | | | | | | — | | | |||
Proceeds from borrowings
|
| | | | 10,400 | | | | | | — | | | | | | 10,400 | | | |||
Repayment of borrowings
|
| | | | (2,213) | | | | | | — | | | | | | (2,213) | | | |||
Interests paid
|
| | | | (839) | | | | | | — | | | | | | (839) | | | |||
Net cash from financing activities
|
| | | | 7,348 | | | | | | — | | | | | | 7,348 | | | |||
Net increase / decrease in cash and cash equivalents
|
| | | | (14,863) | | | | | | 1 | | | | | | (14,862) | | | |||
Cash and cash equivalents at the beginning of the year
|
| | | | 28,803 | | | | | | — | | | | | | 28,803 | | | |||
Effect of exchange rate changes on cash and cash equivalents
|
| | | | 6 | | | | | | — | | | | | | 6 | | | |||
Cash and cash equivalents at the end of the year
|
| | | | 13,947 | | | | | | — | | | | | | 13,947 | | | |||
|
In thousands of Euros
|
| |
12.31.2013
As previously reported |
| |
Adjustments
|
| |
12.31.2013
Restated |
| |||||||||
Sales
|
| | | | 53,806 | | | | | | — | | | | | | 53,806 | | |
Raw materials and consumables used
|
| | | | (9,185) | | | | | | — | | | | | | (9,185) | | |
Personnel cost
|
| | | | (15,783) | | | | | | (482) | | | | | | (16,265) | | |
Other operating expenses
|
| | | | (20,930) | | | | | | (3,714) | | | | | | (24,644) | | |
Other operating income
|
| | | | 2,730 | | | | | | 1,247 | | | | | | 3,977 | | |
Depreciation and amortization
|
| | | | (9,672) | | | | | | 128 | | | | | | (9,545) | | |
Operating income
|
| | | | 966 | | | | | | (2,821) | | | | | | (1,856) | | |
Finance income
|
| | | | 387 | | | | | | — | | | | | | 387 | | |
Finance Costs
|
| | | | (10,155) | | | | | | — | | | | | | (10,155) | | |
Net finance Income / (costs)
|
| | | | (9,768) | | | | | | — | | | | | | (9,768) | | |
Income / (loss) before taxes
|
| | | | (8,802) | | | | | | (2,821) | | | | | | (11,624) | | |
Income taxes
|
| | | | (1,059) | | | | | | (99) | | | | | | (1,158) | | |
Income / (loss) for the period
|
| | | | (9,861) | | | | | | (2,921) | | | | | | (12,781) | | |
Attributable to: | | | | | | | | | | | | | | | | | | | |
Owners of the company
|
| | | | (9,231) | | | | | | (2,921) | | | | | | (12,152) | | |
Non-controlling interests
|
| | | | (629) | | | | | | — | | | | | | (629) | | |
Earnings per share | | | | | | | | | | | | | | | | | | | |
Basic (€ per share)
|
| | | | (0.17) | | | | | | (0.05) | | | | | | (0.22) | | |
Diluted (€ per share)
|
| | | | (0.17) | | | | | | (0.05) | | | | | | (0.22) | | |
Net income / (loss) for the year
|
| | | | (9,861) | | | | | | (2,921) | | | | | | (12,781) | | |
Other comprehensive income / (expense): | | | | | | | | | | | | | | | | | | | |
Items that will not be reclassified subsequently to profit or loss | | | | | | | | | | | | | | | | | | | |
Items that may be reclassified subsequently to profit or loss | | | | | | | | | | | | | | | | | | | |
Exchange differences on translating foreign operations
|
| | | | (129) | | | | | | 4 | | | | | | (125) | | |
Items that will never be reclassified subsequently to profit or loss | | | | | | | | | | | | | | | | | | | |
Remeasurement of defined benefit liability
|
| | | | 17 | | | | | | — | | | | | | 17 | | |
Other comprehensive (expense) / income net of tax
|
| | | | (112) | | | | | | 4 | | | | | | (108) | | |
Total comprehensive income / (loss) for the year
|
| | | | (9,973) | | | | | | (2,917) | | | | | | (12,889) | | |
Total comprehensive income / (loss) attributable to: | | | | | | | | | | | | | | | | | | | |
Owner of the company
|
| | | | (9,143) | | | | | | (2,917) | | | | | | (12,061) | | |
Non-controlling interests
|
| | | | (830) | | | | | | (2) | | | | | | (828) | | |
ASSETS (In thousands of Euros)
|
| |
12.31.2013
As previously reported |
| |
Adjustments
|
| |
12.31.2013
Restated |
| ||||||||||||
Non-current assets
|
| | | | 114,202 | | | | | | (10,753) | | | | | | 103,449 | | | |||
Goodwill
|
| | | | 21,252 | | | | | | — | | | | | | 21,252 | | | |||
Other intangible assets
|
| | | | 41,334 | | | | | | (10,753) | | | | | | 30,581 | | | |||
Property, plant and equipment
|
| | | | 49,280 | | | | | | — | | | | | | 49,280 | | | |||
Financial assets
|
| | | | 2,336 | | | | | | — | | | | | | 2,336 | | | |||
Current assets
|
| | | | 40,029 | | | | | | — | | | | | | 40,028 | | | |||
Inventories
|
| | | | 2,278 | | | | | | — | | | | | | 2,278 | | | |||
Trade and other receivables
|
| | | | 16,143 | | | | | | — | | | | | | 16,143 | | | |||
Other current assets
|
| | | | 7,997 | | | | | | — | | | | | | 7,997 | | | |||
Cash and cash equivalents
|
| | | | 13,610 | | | | | | — | | | | | | 13,610 | | | |||
TOTAL ASSETS
|
| | | | 154,231 | | | | | | (10,753) | | | | | | 143,477 | | | |||
EQUITY AND LIABILITIES (In thousands of Euros) | | | | | ||||||||||||||||||
Equity attributable to owners of the company
|
| | | | 63,350 | | | | | | (7,628) | | | | | | 55,723 | | | |||
Share capital
|
| | | | 5,415 | | | | | | — | | | | | | 5,415 | | | |||
Share premium
|
| | | | 76,594 | | | | | | — | | | | | | 76,594 | | | |||
Reserves and retained earnings
|
| | | | (9,427) | | | | | | (4,707) | | | | | | (14,134) | | | |||
Net income (loss) for the period
|
| | | | (9,231) | | | | | | (2,921) | | | | | | (12,152) | | | |||
Non-controlling interests
|
| | | | 1,360 | | | | | | — | | | | | | 1,360 | | | |||
Total equity
|
| | | | 64,710 | | | | | | (7,628) | | | | | | 57,083 | | | |||
Non-current liabilities
|
| | | | 65,178 | | | | | | (3,126) | | | | | | 62,052 | | | |||
Non-current provisions
|
| | | | 6,030 | | | | | | — | | | | | | 6,029 | | | |||
Non-current financial liabilities
|
| | | | 20,359 | | | | | | — | | | | | | 20,359 | | | |||
Deferred tax liabilities
|
| | | | 4,342 | | | | | | (155) | | | | | | 4,187 | | | |||
Other non-current liabilities
|
| | | | 34,448 | | | | | | (2,971) | | | | | | 31,477 | | | |||
Current liabilities
|
| | | | 24,343 | | | | | | — | | | | | | 24,342 | | | |||
Current provisions
|
| | | | 115 | | | | | | — | | | | | | 115 | | | |||
Current financial liabilities
|
| | | | 5,458 | | | | | | — | | | | | | 5,458 | | | |||
Trade and other payables
|
| | | | 9,218 | | | | | | — | | | | | | 9,218 | | | |||
Other current liabilities
|
| | | | 9,552 | | | | | | (1) | | | | | | 9,551 | | | |||
Total liabilities
|
| | | | 89,521 | | | | | | (3,126) | | | | | | 86,394 | | | |||
TOTAL EQUITY AND LIABILITIES
|
| | | | 154,231 | | | | | | (10,753) | | | | | | 143,477 | | | |||
|
In thousands of Euros
|
| |
12.31.2013
As previously reported |
| |
Adjustments
|
| |
12.31.2013
Restated |
| ||||||||||||
Cash flows from operating activities | | | | | ||||||||||||||||||
Net income/(loss) for the year
|
| | | | (9,861) | | | | | | (2,920) | | | | | | (12,781) | | | |||
Adjustments: | | | | | ||||||||||||||||||
Depreciation, amortization and impairment of non-current assets
|
| | | | 9,672 | | | | | | (128) | | | | | | 9,544 | | | |||
Share based payment expense
|
| | | | 2,281 | | | | | | — | | | | | | 2,281 | | | |||
Gain on disposal of property, plant and equipment
|
| | | | (62) | | | | | | — | | | | | | (62) | | | |||
Financial result
|
| | | | 9,768 | | | | | | — | | | | | | 9,768 | | | |||
Income tax expense
|
| | | | 1,059 | | | | | | 99 | | | | | | 1,158 | | | |||
Subtotal
|
| | | | 12,858 | | | | | | (2,950) | | | | | | 9,908 | | | |||
Increase in inventories
|
| | | | (445) | | | | | | — | | | | | | (445) | | | |||
Increase in trade receivables
|
| | | | (606) | | | | | | — | | | | | | (606) | | | |||
Increase/(decrease) in trade payables
|
| | | | (639) | | | | | | — | | | | | | (639) | | | |||
Change in other receivables and payables
|
| | | | 1,184 | | | | | | (1,247) | | | | | | (63) | | | |||
Increase in provisions
|
| | | | 253 | | | | | | — | | | | | | 253 | | | |||
Change in working capital
|
| | | | (253) | | | | | | (1,247) | | | | | | (1,500) | | | |||
Income tax paid
|
| | | | (663) | | | | | | — | | | | | | (663) | | | |||
Net cash from operating activities
|
| | | | 11,942 | | | | | | (4,197) | | | | | | 7,745 | | | |||
Cash flows from investing activities | | | | | ||||||||||||||||||
Acquisition of property, plant and equipment
|
| | | | (9,289) | | | | | | — | | | | | | (9,289) | | | |||
Acquisition of intangible assets
|
| | | | (4,829) | | | | | | 4,195 | | | | | | (634) | | | |||
Acquisition of financial assets
|
| | | | (116) | | | | | | — | | | | | | (116) | | | |||
Proceeds from disposal of property, plant and equipment
|
| | | | 130 | | | | | | — | | | | | | 130 | | | |||
Receipts from government grants
|
| | | | — | | | | | | — | | | | | | — | | | |||
Acquisition of subsidiaries, net of cash acquired
|
| | | | (1,395) | | | | | | — | | | | | | (1,395) | | | |||
Net cash used in investing activities
|
| | | | (15,500) | | | | | | 4,196 | | | | | | (11,304) | | | |||
Net cash from financing activities | | | | | ||||||||||||||||||
Issuance of share capital
|
| | | | 4,820 | | | | | | — | | | | | | 4,820 | | | |||
Proceeds from borrowings
|
| | | | 3,496 | | | | | | — | | | | | | 3,496 | | | |||
Repayment of borrowings
|
| | | | (4,058) | | | | | | — | | | | | | (4,058) | | | |||
Interests paid
|
| | | | (1,029) | | | | | | — | | | | | | (1,029) | | | |||
Net cash from financing activities
|
| | | | 3,229 | | | | | | — | | | | | | 3,229 | | | |||
Net increase / decrease in cash and cash equivalents
|
| | | | (330) | | | | | | — | | | | | | (330) | | | |||
Cash and cash equivalents at the beginning of the year
|
| | | | 13,947 | | | | | | — | | | | | | 13,947 | | | |||
Effect of exchange rate changes on cash and cash equivalents
|
| | | | (7) | | | | | | — | | | | | | (7) | | | |||
Cash and cash equivalents at the end of the year
|
| | | | 13,610 | | | | | | — | | | | | | 13,610 | | | |||
|
Sales by products
|
| | | | | | | | | | | | | | | | | | | |||
In KEUR
|
| |
2013
|
| |
2012
|
| |
2011
|
| ||||||||||||
PET
|
| | | | 41,437 | | | | | | 34,148 | | | | | | 28,077 | | | |||
SPECT
|
| | | | 7,969 | | | | | | 5,849 | | | | | | 5,168 | | | |||
Therapy
|
| | | | 3,262 | | | | | | 655 | | | | | | 0 | | | |||
Other products
|
| | | | 1,138 | | | | | | 182 | | | | | | 619 | | | |||
Total | | | | | 53,806 | | | | | | 40,834 | | | | | | 33,864 | | | |||
|
Sales by country
|
| | | | | | | | | | | | | | | | | | | |||
In KEUR
|
| |
2013
|
| |
2012
|
| |
2011
|
| ||||||||||||
France
|
| | | | 23,263 | | | | | | 18,689 | | | | | | 17,195 | | | |||
Italy
|
| | | | 14,821 | | | | | | 13,718 | | | | | | 12,330 | | | |||
Spain
|
| | | | 6,281 | | | | | | 1,014 | | | | | | 125 | | | |||
Israel
|
| | | | 3,823 | | | | | | 3,262 | | | | | | 1,201 | | | |||
Canada
|
| | | | 160 | | | | | | 126 | | | | | | 248 | | | |||
USA
|
| | | | 3 | | | | | | 5 | | | | | | 20 | | | |||
Other countries
|
| | | | 5,455 | | | | | | 4,020 | | | | | | 2,745 | | | |||
Total
|
| | | | 53,806 | | | | | | 40,834 | | | | | | 33,864 | | | |||
|
Non-current assets by country
|
| | | | | | | | | | | | | | | | | | | |||
In KEUR
|
| |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| ||||||||||||
France
|
| | | | 26,893 | | | | | | 26,950 | | | | | | 21,777 | | | |||
Italy
|
| | | | 17,169 | | | | | | 18,264 | | | | | | 19,434 | | | |||
Spain
|
| | | | 16,962 | | | | | | 17,954 | | | | | | 6,005 | | | |||
USA
|
| | | | 13,365 | | | | | | 13,965 | | | | | | 14,325 | | | |||
Israel
|
| | | | 12,210 | | | | | | 12,339 | | | | | | 12,199 | | | |||
Canada
|
| | | | 5,485 | | | | | | 6,158 | | | | | | 6,123 | | | |||
Other countries
|
| | | | 9,029 | | | | | | 6,262 | | | | | | 39 | | | |||
Total
|
| | | | 101,113 | | | | | | 101,892 | | | | | | 79,902 | | | |||
|
In KEUR
|
| |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| ||||||||||||
Wages and salaries
|
| | | | (10,214) | | | | | | (9,172) | | | | | | (7,131) | | | |||
Social charges
|
| | | | (3,770) | | | | | | (2,837) | | | | | | (2,601) | | | |||
Share-based payments
|
| | | | (2,281) | | | | | | (1,250) | | | | | | (925) | | | |||
Total
|
| | | | (16,265) | | | | | | (13,259) | | | | | | (10,657) | | | |||
|
| | |
2013
|
| |
2012
|
| |
2011
|
| ||||||||||||
Italy
|
| | | | 106 | | | | | | 97 | | | | | | 84 | | | |||
France
|
| | | | 85 | | | | | | 76 | | | | | | 61 | | | |||
Spain
|
| | | | 34 | | | | | | 32 | | | | | | 10 | | | |||
Israel
|
| | | | 13 | | | | | | 13 | | | | | | 10 | | | |||
Germany
|
| | | | 11 | | | | | | 5 | | | | | | — | | | |||
Portugal
|
| | | | 13 | | | | | | 10 | | | | | | 2 | | | |||
Other countries
|
| | | | 13 | | | | | | 5 | | | | | | 5 | | | |||
Total
|
| | | | 275 | | | | | | 238 | | | | | | 172 | | | |||
|
In KEUR
|
| |
2013
|
| |
2012
|
| |
2011
|
| ||||||||||||
Short-term benefits
|
| | | | 1,121 | | | | | | 795 | | | | | | 750 | | | |||
Share-based payments
|
| | | | 322 | | | | | | 241 | | | | | | 288 | | | |||
Post employment defined benefits
|
| | | | 71 | | | | | | 39 | | | | | | 22 | | | |||
Total
|
| | | | 1,514 | | | | | | 1,075 | | | | | | 1,060 | | | |||
|
Grant date
|
| |
06/2009
|
| |
08/2009
|
| |
11/2010
|
| |
12/2011
|
| |
01/2012
|
| |
12/2012
|
| |
08/2013
|
| |||||||||||||||||||||
Number of shares granted
|
| | | | 690,000 | | | | | | 40,000 | | | | | | 370,000 | | | | | | 370,000 | | | | | | 15,000 | | | | | | 562,500 | | | | | | 477,500 | | |
Fair value at grant date (€)
|
| | | | 2.5 | | | | | | 2.5 | | | | | | 2.5 | | | | | | 4.0 | | | | | | 4.0 | | | | | | 4.0 | | | | | | 5.0 | | |
Total fair value (€)
|
| | | | 1,725,000 | | | | | | 100,000 | | | | | | 925,000 | | | | | | 1,480,000 | | | | | | 60,000 | | | | | | 2,250,000 | | | | | | 2,387,500 | | |
Vesting period (in years)
|
| | | | 2 | | | | | | 2 | | | | | | 2 | | | | | | 2 | | | | | | 2 | | | | | | 2 | | | | | | 2 | | |
In KEUR
|
| |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| ||||||||||||
Transport
|
| | | | (7,731) | | | | | | (5,842) | | | | | | (4,933) | | | |||
Consulting and other professional services
|
| | | | (2,286) | | | | | | (1,169) | | | | | | (786) | | | |||
Lease and other administrative expenses
|
| | | | (1,736) | | | | | | (1,425) | | | | | | (1,237) | | | |||
Energy
|
| | | | (986) | | | | | | (720) | | | | | | (631) | | | |||
Travel expenses
|
| | | | (843) | | | | | | (1,095) | | | | | | (671) | | | |||
Telecommunications
|
| | | | (538) | | | | | | (529) | | | | | | (277) | | | |||
Royalties and Licensing fees
|
| | | | (272) | | | | | | (282) | | | | | | (481) | | | |||
Subcontractors
|
| | | | (488) | | | | | | (414) | | | | | | (62) | | | |||
Repairs and maintenance
|
| | | | (2,346) | | | | | | (2,029) | | | | | | (1,322) | | | |||
Taxes
|
| | | | (582) | | | | | | (445) | | | | | | (556) | | | |||
External R&D Services
|
| | | | (5,008) | | | | | | (5,977) | | | | | | (3,327) | | | |||
Allowance for doubtful accounts
|
| | | | (149) | | | | | | (172) | | | | | | 1 | | | |||
Other
|
| | | | (1,679) | | | | | | (1,934) | | | | | | (1,739) | | | |||
Total
|
| | | | (24,644) | | | | | | (22,032) | | | | | | (16,021) | | | |||
|
In KEUR
|
| |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| ||||||||||||
Government subsidies
|
| | | | 3,462 | | | | | | 3,353 | | | | | | 1,392 | | | |||
Net gain/(loss) on disposal of non-current assets
|
| | | | 62 | | | | | | (32) | | | | | | 28 | | | |||
Other
|
| | | | 453 | | | | | | 239 | | | | | | 100 | | | |||
Total
|
| | | | 3,977 | | | | | | 3,560 | | | | | | 1,520 | | | |||
|
In KEUR
|
| |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| ||||||||||||
Impairment of goodwill
|
| | | | (1,015) | | | | | | — | | | | | | — | | | |||
Depreciation and amortization
|
| | | | (8,530) | | | | | | (6,495) | | | | | | (4,342) | | | |||
Total
|
| | | | (9,545) | | | | | | (6,495) | | | | | | (4,342) | | | |||
|
In KEUR
|
| |
2013
|
| |
2012
|
| |
2011
|
| ||||||||||||
Interest expenses
|
| | | | (1,029) | | | | | | (650) | | | | | | (690) | | | |||
Net foreign exchange gain (loss)
|
| | | | (862) | | | | | | 29 | | | | | | 104 | | | |||
Change in fair value of contingent consideration
|
| | | | (7,418) | | | | | | (15,609) | | | | | | 0 | | | |||
Other
|
| | | | (846) | | | | | | (282) | | | | | | 147 | | | |||
Total
|
| | | | (10,155) | | | | | | (16,512) | | | | | | (733) | | | |||
|
In KEUR
|
| |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| ||||||||||||
Current tax
|
| | | | (2,072) | | | | | | (1,411) | | | | | | (1,050) | | | |||
Deferred tax
|
| | | | 915 | | | | | | 875 | | | | | | 206 | | | |||
Total
|
| | | | (1,157) | | | | | | (536) | | | | | | (844) | | | |||
|
In KEUR
|
| |
12.31.2013
(Restated) |
| |
12.31.2012
(Restated) |
| |
12.31.2011
(Restated) |
| ||||||||||||
Net profit (loss) after tax
|
| | | | (12,781) | | | | | | (20,504) | | | | | | (782) | | | |||
Income tax
|
| | | | (1,157) | | | | | | (536) | | | | | | (844) | | | |||
Net profit (loss) before tax
|
| | | | (11,624) | | | | | | (19,968) | | | | | | 62 | | | |||
Theoretical tax rate
|
| | | | 33.33% | | | | | | 33.33% | | | | | | 33.33% | | | |||
Expected tax charge
|
| | | | 3,873 | | | | | | 6,654 | | | | | | (20) | | | |||
Impact of unrecognized losses on overseas subsidiaries
|
| | | | (1,068) | | | | | | (786) | | | | | | (313) | | | |||
Impact of tax rate differences
|
| | | | 531 | | | | | | 309 | | | | | | 193 | | | |||
Impact of unrecognized deferred tax asset on temporary differences
|
| | | | (1,458) | | | | | | (1,672) | | | | | | — | | | |||
impact of permanent differences
|
| | | | (2,668) | | | | | | (4,754) | | | | | | (427) | | | |||
Income tax expense
|
| | | | (790) | | | | | | (249) | | | | | | (567) | | | |||
CVAE & IRAP(1)
|
| | | | (367) | | | | | | (287) | | | | | | (277) | | | |||
Group tax charge
|
| | | | (1,157) | | | | | | (536) | | | | | | (844) | | | |||
|
In KEUR
|
| |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| ||||||||||||
Net deferred tax at the beginning of the year
|
| | | | (5,386) | | | | | | (5,767) | | | | | | (5,231) | | | |||
Deferred tax income
|
| | | | 915 | | | | | | 875 | | | | | | 206 | | | |||
Other comprehensive income
|
| | | | 6 | | | | | | 17 | | | | | | — | | | |||
Change in consolidation scope
|
| | | | — | | | | | | (751) | | | | | | (652) | | | |||
Translation differences
|
| | | | 286 | | | | | | 60 | | | | | | (90) | | | |||
Other changes
|
| | | | (7) | | | | | | 180 | | | | | | — | | | |||
Net deferred tax at the end of the year
|
| | | | (4,186) | | | | | | (5,386) | | | | | | (5,767) | | | |||
|
In KEUR
|
| |
2013
(Restated) |
| |
2012
(Restated) |
| |
2011
(Restated) |
| ||||||||||||
Intangible assets
|
| | | | (6,742) | | | | | | (7,273) | | | | | | (6,415) | | | |||
Carry forward losses
|
| | | | 2,060 | | | | | | 1,705 | | | | | | 1,137 | | | |||
Property, plant and equipment
|
| | | | (868) | | | | | | (912) | | | | | | (888) | | | |||
Other temporary differences
|
| | | | 1,363 | | | | | | 1,094 | | | | | | 399 | | | |||
Deferred liabilities, net
|
| | | | (4,187) | | | | | | (5,386) | | | | | | (5,767) | | | |||
Net deferred tax liabilities | | | | | | | | | | | | | | | | | | | | |||
of which deferred tax assets
|
| | | | — | | | | | | — | | | | | | — | | | |||
of which deferred tax liabilities
|
| | | | (4,187) | | | | | | (5,386) | | | | | | (5,767) | | | |||
|
Acquisition Cost in KEUR
|
| |
Goodwill
|
| |
Acquired
In Process R&D |
| |
Patents and
Licenses |
| |
Customer
relationships |
| |
Total
|
| |||||||||||||||
At 1 January 2011 (Restated)
|
| | | | 5,797 | | | | | | 14,962 | | | | | | 3,019 | | | | | | 2,516 | | | | | | 26,294 | | |
Additions | | | | | — | | | | | | | | | | | | 8,689 | | | | | | — | | | | |
|
8,689
|
| |
Business combinations
|
| | | | 7,258 | | | | | | — | | | | | | | | | | | | 4,345 | | | | |
|
11,603
|
| |
Disposals | | | | | — | | | | | | | | | | | | (6) | | | | | | | | | | |
|
(6)
|
| |
Reclassifications | | | | | — | | | | | | | | | | | | | | | | | | | | | | |
|
—
|
| |
Translation differences
|
| | | | 86 | | | | | | 862 | | | | | | | | | | | | | | | | |
|
948
|
| |
At 31 December 2011 (Restated)
|
| | | | 13,141 | | | | | | 15,824 | | | | | | 11,702 | | | | | | 6,861 | | | | | | 47,528 | | |
Additions
|
| | | | — | | | | | | | | | | | | 210 | | | | | | — | | | | |
|
210
|
| |
Business combinations
|
| | | | 9,143 | | | | | | — | | | | | | 100 | | | | | | 3,586 | | | | |
|
12,829
|
| |
Disposals
|
| | | | — | | | | | | | | | | | | (168) | | | | | | — | | | | |
|
(168)
|
| |
Translation differences
|
| | | | 1 | | | | | | (157) | | | | | | (9) | | | | | | (30) | | | | |
|
(195)
|
| |
At 31 December 2012 (Restated)
|
| | | | 22,285 | | | | | | 15,667 | | | | | | 11,835 | | | | | | 10,417 | | | | | | 60,204 | | |
Additions
|
| | | | — | | | | | | | | | | | | 634 | | | | | | — | | | | |
|
634
|
| |
Disposals
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| |
Translation differences
|
| | | | (19) | | | | | | (1,048) | | | | | | (133) | | | | | | 131 | | | | |
|
(1,069)
|
| |
At 31 December 2013 (Restated)
|
| | | | 22,266 | | | | | | 14,619 | | | | | | 12,336 | | | | | | 10,548 | | | | | | 59,769 | | |
Accumulated amortization and impairment losses in KEUR | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
At 1 January 2011 (Restated)
|
| | | | — | | | | | | — | | | | | | (258) | | | | | | (485) | | | | |
|
(743)
|
| |
Amortization expense
|
| | | | — | | | | | | — | | | | | | (632) | | | | | | (575) | | | | |
|
(1,207)
|
| |
Disposals | | | | | — | | | | | | | | | | | | (3) | | | | | | | | | | |
|
(3)
|
| |
Translation differences
|
| | | | — | | | | | | | | | | | | | | | | | | | | | | |
|
—
|
| |
At 31 December 2011 (Restated)
|
| | | | — | | | | | | — | | | | | | (893) | | | | | | (1,060) | | | | | | (1,953) | | |
Amortization expense
|
| | | | — | | | | | | | | | | | | (1,497) | | | | | | (666) | | | | |
|
(2,163)
|
| |
Disposals
|
| | | | — | | | | | | — | | | | | | 93 | | | | | | — | | | | |
|
93
|
| |
Translation differences
|
| | | | — | | | | | | — | | | | | | (45) | | | | | | (5) | | | | |
|
(50)
|
| |
At 31 December 2012 (Restated)
|
| | | | — | | | | | | — | | | | | | (2,342) | | | | | | (1,731) | | | | | | (4,073) | | |
Amortization expense
|
| | | | — | | | | | | | | | | | | (1,750) | | | | | | (1,128) | | | | |
|
(2,878)
|
| |
Impairment
|
| | | | (1,014) | | | | | | — | | | | | | — | | | | | | — | | | | |
|
(1,014)
|
| |
Reversal
|
| | | | — | | | | | | — | | | | | | — | | | | | | (3) | | | | |
|
(3)
|
| |
Translation differences
|
| | | | — | | | | | | | | | | | | 64 | | | | | | (32) | | | | |
|
32
|
| |
At 31 December 2013 (Restated)
|
| | | | (1,014) | | | | | | — | | | | | | (4,028) | | | | | | (2,894) | | | | | | (7,936) | | |
Carrying amount | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
At 31 December 2011
|
| | | | 13,141 | | | | | | 15,824 | | | | | | 10,809 | | | | | | 5,801 | | | | | | 45,575 | | |
At 31 December 2012
|
| | | | 22,285 | | | | | | 15,667 | | | | | | 9,493 | | | | | | 8,686 | | | | | | 56,130 | | |
At 31 December 2013
|
| | | | 21,252 | | | | | | 14,619 | | | | | | 8,308 | | | | | | 7,654 | | | | | | 51,833 | | |
| | |
12.31.2013 (Restated)
|
| |
12.31.2012 (Restated)
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| | |
Goodwill
|
| |
Acquired
IPR&D |
| |
Accumulated
impairment |
| |
Total
|
| |
Goodwill
|
| |
Acquired
IPR&D |
| |
Accumulated
impairment |
| |
Total
|
| ||||||||||||||||||||||||||||||||
Italy (Gipharma)
|
| | | | 1,947 | | | | | | — | | | | | | — | | | | | | 1,947 | | | | | | 1,947 | | | | | | | | | | | | — | | | | | | 1,947 | | | ||||||||
Canada
|
| | | | 416 | | | | | | 5,064 | | | | | | — | | | | | | 5,480 | | | | | | 501 | | | | | | 5,656 | | | | | | — | | | | | | 6,157 | | | ||||||||
USA
|
| | | | 3,223 | | | | | | 9,555 | | | | | | — | | | | | | 12,778 | | | | | | 3,370 | | | | | | 10,011 | | | | | | — | | | | | | 13,381 | | | ||||||||
Germany
|
| | | | 1,027 | | | | | | — | | | | | | — | | | | | | 1,027 | | | | | | 1,027 | | | | | | — | | | | | | — | | | | | | 1,027 | | | ||||||||
Spain
|
| | | | 6,261 | | | | | | — | | | | | | — | | | | | | 6,261 | | | | | | 6,261 | | | | | | — | | | | | | — | | | | | | 6,261 | | | ||||||||
Israel
|
| | | | 7,500 | | | | | | — | | | | | | — | | | | | | 7,500 | | | | | | 7,286 | | | | | | — | | | | | | — | | | | | | 7,286 | | | ||||||||
Portugal
|
| | | | 1,855 | | | | | | — | | | | | | (1,015) | | | | | | 840 | | | | | | 1,855 | | | | | | — | | | | | | — | | | | | | 1,855 | | | ||||||||
Other countries
|
| | | | 38 | | | | | | | | | | | | — | | | | | | 38 | | | | | | 38 | | | | | | — | | | | | | — | | | | | | 38 | | | ||||||||
Total
|
| | | | 22,267 | | | | | | 14,619 | | | | | | (1,015) | | | | | | 35,871 | | | | | | 22,285 | | | | | | 15,667 | | | | | | — | | | | | | 37,952 | | | ||||||||
|
| | |
12.31.2011 (Restated)
|
| |||||||||||||||||||||||||
| | |
Goodwill
|
| |
Acquired
IPR&D |
| |
Impairment
|
| |
Total
|
| ||||||||||||||||
Italy (Gipharma)
|
| | | | 1,947 | | | | | | | | | | | | — | | | | | | 1,947 | | | ||||
Canada | | | | | 501 | | | | | | 5,577 | | | | | | — | | | | | | 6,078 | | | ||||
USA | | | | | 3,436 | | | | | | 10,247 | | | | | | — | | | | | | 13,683 | | | ||||
Germany | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | ||||
Spain | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | ||||
Israel | | | | | 7,257 | | | | | | | | | | | | — | | | | | | 7,257 | | | ||||
Portugal | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | ||||
Other | | | | | | | | | | | — | | | | | | — | | | | | | — | | | ||||
Total | | | | | 13,141 | | | | | | 15,824 | | | | | | — | | | | | | 28,965 | | | ||||
|
| | |
12.31.2013
|
| |||||||||||||||||||||||||||
CGU
|
| |
Budgeted
EBITDA increase at mid-term (of forecast period)(1) |
| |
Post tax
discount rate |
| |
Pre tax
discount rate |
| |
Terminal
growth rate |
| |
Forecast
period in years |
| |||||||||||||||
Gipharma (Italy)
|
| | | | 12.1% | | | | | | 10.0% | | | | | | 13.8% | | | | | | 2.0% | | | | | | 5 | | |
Canada(2) | | | | | 73.7% | | | | | | 20.0% | | | | | | 23.4% | | | | | | 3.0% | | | | | | 10 | | |
USA | | | | | 341.6% | | | | | | 15.0% | | | | | | 18.7% | | | | | | 0.0% | | | | | | 8 | | |
Germany | | | | | 37.5% | | | | | | 9.0% | | | | | | 12.1% | | | | | | -0.5% | | | | | | 8 | | |
Spain
|
| | | | 23.6% | | | | | | 14.0% | | | | | | 18.0% | | | | | | 0.7% | | | | | | 8 | | |
Israel | | | | | 7.0% | | | | | | 11.0% | | | | | | 12.9% | | | | | | 0.0% | | | | | | 5 | | |
Portugal(3) | | | | | 7.1% | | | | | | 15.0% | | | | | | 17.4% | | | | | | 0.0% | | | | | | 8 | | |
| | |
12.31.2012
|
| |||||||||||||||||||||||||||
CGU
|
| |
Budgeted
EBITDA increase at mid-term (of forecast period)(1) |
| |
Post tax
discount rate |
| |
Pre tax
discount rate |
| |
Terminal
growth rate |
| |
Forecast
period in years |
| |||||||||||||||
Gipharma (Italy)
|
| | | | 13.6% | | | | | | 10.0% | | | | | | 14.1% | | | | | | 2.0% | | | | | | 5 | | |
Canada(2) | | | | | 64.4% | | | | | | 25.0% | | | | | | 28.4% | | | | | | 3.0% | | | | | | 10 | | |
USA | | | | | 73.8% | | | | | | 18.0% | | | | | | 22.1% | | | | | | 2.5% | | | | | | 8 | | |
Germany | | | | | 94.9% | | | | | | 12.0% | | | | | | 15.4% | | | | | | 0.0% | | | | | | 8 | | |
Spain
|
| | | | 19.9% | | | | | | 14.0% | | | | | | 17.9% | | | | | | 2.0% | | | | | | 8 | | |
Israel | | | | | 14.7% | | | | | | 10.0% | | | | | | 13.1% | | | | | | -2.0% | | | | | | 5 | | |
Portugal(3) | | | | | 14.0% | | | | | | 15.0% | | | | | | 17.4% | | | | | | 0.0% | | | | | | 8 | | |
| | |
12.31.2011
|
| |||||||||||||||||||||||||||
CGU
|
| |
Budgeted
EBITDA increase at mid-term (of forecast period)(1) |
| |
Post tax
discount rate |
| |
Pre tax
discount rate |
| |
Terminal
growth rate |
| |
Forecast
period in years |
| |||||||||||||||
Gipharma (Italy)
|
| | | | 14.8% | | | | | | 10.0% | | | | | | 14.0% | | | | | | 2.0% | | | | | | 5 | | |
Canada (2)
|
| | | | 35.5% | | | | | | 25.0% | | | | | | 28.4% | | | | | | 3.0% | | | | | | 10 | | |
USA | | | | | 41.4% | | | | | | 20.0% | | | | | | 24.2% | | | | | | 1.5% | | | | | | 8 | | |
Israel | | | | | 26.6% | | | | | | 10.0% | | | | | | 13.0% | | | | | | -2.0% | | | | | | 5 | | |
| | |
12.31.2013
|
| |
12.13.2012
|
| |
12.13.2011
|
| |||||||||||||||||||||||||||
In percent
|
| |
Change required for carrying amount
to equal recoverable amount |
| |
Change required for carrying amount
to equal recoverable amount |
| |
Change required for carrying amount
to equal recoverable amount |
| |||||||||||||||||||||||||||
CGU
|
| |
Discount rate
|
| |
Budgeted Ebitda
per year |
| |
Discount rate
|
| |
Budgeted Ebitda
per year |
| |
Discount rate
|
| |
Budgeted Ebitda
per year |
| ||||||||||||||||||
Gipharma | | | | | 4 | | | | | | -26 | | | | | | 4.5 | | | | | | -25 | | | | | | 8 | | | | | | -36 | | |
Canada
|
| | | | 3 | | | | | | -31 | | | | | | 3 | | | | | | -35 | | | | | | 3 | | | | | | -34 | | |
USA
|
| | | | 19 | | | | | | -75 | | | | | | 9.5 | | | | | | -50 | | | | | | 2 | | | | | | -19 | | |
Germany
|
| | | | 13 | | | | | | -51 | | | | | | 16 | | | | | | -60 | | | | | | * | | | | | | * | | |
Spain(1) | | | | | 0 | | | | | | 0 | | | | | | 0.5 | | | | | | -4 | | | | | | * | | | | | | * | | |
Israel
|
| | | | 8 | | | | | | -37 | | | | | | 27 | | | | | | -63 | | | | | | 14 | | | | | | -51 | | |
Portugal(1) | | | | | 0 | | | | | | 0 | | | | | | 1 | | | | | | -8 | | | | | | * | | | | | | * | | |
Cost
|
| |
Land
|
| |
Construction
and development |
| |
Equipment
and laboratory material |
| |
Sub-total
financed under lease |
| | |
Land
|
| |
Construction
& equipment in progress |
| |
Equipment
and laboratory material |
| |
Other
tangible assets |
| |
Sub total
|
| | |
TOTAL
|
| ||||||||||||||||||||||||||||||
At 1 January 2011
|
| | |
|
200
|
| | | |
|
7,001
|
| | | |
|
9,248
|
| | | | | 16,449 | | | | | |
|
414
|
| | | |
|
6,299
|
| | | |
|
16,387
|
| | | |
|
2,089
|
| | | | | 25,189 | | | | | | | 41,638 | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Additions | | | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | 30 | | | | | | 4,856 | | | | | | 3,027 | | | | | | 33 | | | | |
|
7,946
|
| | | | |
|
7,946
|
| |
Acquisitions through business combinations
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | | | | | | | | | | | | | 482 | | | | | | | | | | |
|
482
|
| | | | |
|
482
|
| |
Disposals | | | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | | | | | | | — | | | | | | (257) | | | | | | | | | | |
|
(257)
|
| | | | |
|
(257)
|
| |
Reclassifications | | | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | | | | | | | (1,569) | | | | | | 955 | | | | | | 614 | | | | |
|
—
|
| | | | |
|
—
|
| |
Translation differences
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | | | | | | | | | | | | | | | | | | | 4 | | | | |
|
4
|
| | | | |
|
4
|
| |
At 31 December 2011
|
| | | | 200 | | | | | | 7,001 | | | | | | 9,248 | | | | |
|
16,449
|
| | | | | | 443 | | | | | | 9,586 | | | | | | 20,594 | | | | | | 2,740 | | | | |
|
33,363
|
| | | | |
|
49,812
|
| |
Additions
|
| | | | — | | | | | | — | | | | | | 1,250 | | | | |
|
1,250
|
| | | | | | 877 | | | | | | 6,273 | | | | | | 2,711 | | | | | | 377 | | | | |
|
10,238
|
| | | | |
|
11,488
|
| |
Business combinations
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | — | | | | | | 1,183 | | | | | | 3,423 | | | | | | 6 | | | | |
|
4,611
|
| | | | |
|
4,611
|
| |
Disposals
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | — | | | | | | — | | | | | | (153) | | | | | | — | | | | |
|
(153)
|
| | | | |
|
(153)
|
| |
Reclassifications
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | — | | | | | | (6,361) | | | | | | 4,294 | | | | | | 2,067 | | | | |
|
0
|
| | | | |
|
0
|
| |
Translation differences
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | — | | | | | | 0 | | | | | | 8 | | | | | | (134) | | | | |
|
(126)
|
| | | | |
|
(126)
|
| |
At 31 December 2012
|
| | | | 200 | | | | | | 7,001 | | | | | | 10,498 | | | | |
|
17,699
|
| | | | | | 1,320 | | | | | | 10,681 | | | | | | 30,876 | | | | | | 5,056 | | | | |
|
47,934
|
| | | | |
|
65,633
|
| |
Additions
|
| | | | — | | | | | | — | | | | | | 1,717 | | | | |
|
1,717
|
| | | | | | — | | | | | | 6,124 | | | | | | 2,866 | | | | | | 331 | | | | |
|
9,321
|
| | | | |
|
11,038
|
| |
Disposals
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | — | | | | | | (204) | | | | | | (1,950) | | | | | | (7) | | | | |
|
(2,161)
|
| | | | |
|
(2,161)
|
| |
Reclassifications
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | — | | | | | | (128) | | | | | | 2,002 | | | | | | (1,874) | | | | |
|
—
|
| | | | |
|
—
|
| |
Translation differences
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | — | | | | | | — | | | | | | 92 | | | | | | 11 | | | | |
|
103
|
| | | | |
|
103
|
| |
At 31 December 2013
|
| | | | 200 | | | | | | 7,001 | | | | | | 12,215 | | | | | | 19,416 | | | | | | | 1,320 | | | | | | 16,473 | | | | | | 33,886 | | | | | | 3,517 | | | | | | 55,197 | | | | | | | 74,613 | | |
Accumulated amortization and impairment losses in KEUR | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
At 1 January 2011
|
| | | | — | | | | | | 595 | | | | | | (3,161) | | | | |
|
3,756
|
| | | | | | — | | | | | | (1,111) | | | | | | (6,807) | | | | | | (837) | | | | |
|
(8,756)
|
| | | | |
|
(12,511)
|
| |
Amortization expense
|
| | |
|
—
|
| | | |
|
(370)
|
| | | |
|
(724)
|
| | | | | (1,094) | | | | | |
|
—
|
| | | |
|
(249)
|
| | | |
|
(1,677)
|
| | | |
|
(133)
|
| | | | | (2,059) | | | | | | | (3,153) | | |
Disposals | | | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | — | | | | | | — | | | | | | 177 | | | | | | — | | | | |
|
177
|
| | | | |
|
177
|
| |
Translation differences
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | |
|
—
|
| |
At 31 December 2011
|
| | | | — | | | | | | (965) | | | | | | (3,885) | | | | |
|
(4,850)
|
| | | | | | — | | | | | | (1,360) | | | | | | (8,307) | | | | | | (969) | | | | |
|
(10,636)
|
| | | | |
|
(15,486)
|
| |
| | | | | | | | | | | | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Amortization expense
|
| | | | — | | | | | | (338) | | | | | | (1,008) | | | | |
|
(1,346)
|
| | | | | | — | | | | | | (288) | | | | | | (2,303) | | | | | | (394) | | | | |
|
(2,986)
|
| | | | |
|
(4,332)
|
| |
Disposals
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | — | | | | | | — | | | | | | 21 | | | | | | — | | | | |
|
21
|
| | | | |
|
21
|
| |
Translation differences
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | — | | | | | | — | | | | | | (71) | | | | | | (2) | | | | |
|
(73)
|
| | | | |
|
(73)
|
| |
At 31 December 2012
|
| | | | — | | | | | | (1,303) | | | | | | (4,893) | | | | |
|
(6,196)
|
| | | | | | — | | | | | | (1,648) | | | | | | (10,661) | | | | | | (1,366) | | | | |
|
(13,674)
|
| | | | |
|
(19,871)
|
| |
Amortization expense
|
| | | | — | | | | | | (410) | | | | | | (1164) | | | | |
|
(1,574)
|
| | | | | | — | | | | | | (556) | | | | | | (3,130) | | | | | | (400) | | | | |
|
(4,086)
|
| | | | |
|
(5,660)
|
| |
Disposals
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | — | | | | | | 24 | | | | | | 423 | | | | | | 20 | | | | |
|
467
|
| | | | |
|
467
|
| |
Translation differences
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | | | | | — | | | | | | — | | | | | | (266) | | | | | | (3) | | | | |
|
(269)
|
| | | | |
|
(269)
|
| |
At 31 December 2013
|
| | | | — | | | | | | (1,714) | | | | | | (6,057) | | | | | | (7,770) | | | | | | | — | | | | | | (2,180) | | | | | | (13,634) | | | | | | (1,749) | | | | | | (17,563) | | | | | | | (25,333) | | |
Carrying amount | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
At 31 December 2011
|
| | | | 200 | | | | | | 6,036 | | | | | | 5,363 | | | | | | 11,599 | | | | | | | 443 | | | | | | 8,226 | | | | | | 12,287 | | | | | | 1,771 | | | | | | 22,727 | | | | | | | 34,327 | | |
At 31 December 2012
|
| | | | 200 | | | | | | 5,698 | | | | | | 5,605 | | | | | | 11,503 | | | | | | | 1,320 | | | | | | 9,033 | | | | | | 20,215 | | | | | | 3,690 | | | | | | 34,259 | | | | | | | 45,762 | | |
At 31 December 2013
|
| | | | 200 | | | | | | 5,287 | | | | | | 6,158 | | | | | | 11,646 | | | | | | | 1,320 | | | | | | 14,293 | | | | | | 20,253 | | | | | | 1,768 | | | | | | 37,634 | | | | | | | 49,280 | | |
In KEUR
|
| |
12.31.2013
|
| |
12.31.2012
|
| |
12.31.2011
|
| ||||||||||||
Gross value
|
| | | | 16,524 | | | | | | 15,777 | | | | | | 10,925 | | | |||
Allowance for doubtful accounts
|
| | | | (381) | | | | | | (240) | | | | | | (15) | | | |||
Total
|
| | | | 16,143 | | | | | | 15,537 | | | | | | 10,910 | | | |||
|
In KEUR
|
| |
12.31.2013
|
| |
12.31.2012
|
| |
12.31.2011
|
| ||||||||||||
Write-down of allowance for doubtful accounts, beginning of the year
|
| | | | 240 | | | | | | 15 | | | | | | 15 | | | |||
Increase
|
| | | | 149 | | | | | | 225 | | | | | | — | | | |||
Utilized
|
| | | | — | | | | | | — | | | | | | — | | | |||
Reversed
|
| | | | — | | | | | | — | | | | | | — | | | |||
Translation adjustment
|
| | | | (8) | | | | | | — | | | | | | — | | | |||
Write-down of allowance for doubtful accounts, end
of the year |
| | | | 381 | | | | | | 240 | | | | | | 15 | | | |||
|
In KEUR
|
| |
12.31.2013
|
| |
12.31.2012
|
| |
12.31.2011
|
| ||||||||||||
30 – 60 days
|
| | | | 3,975 | | | | | | 3,287 | | | | | | 2,044 | | | |||
Over 60 days
|
| | | | 7,323 | | | | | | 7,412 | | | | | | 4,433 | | | |||
Total
|
| | | | 11,298 | | | | | | 10,699 | | | | | | 6,477 | | | |||
|
In KEUR
|
| |
12.31.2013
|
| |
12.31.2012
|
| |
12.31.2011
|
| ||||||||||||
Raw materials
|
| | | | 2,088 | | | | | | 1,604 | | | | | | 1,154 | | | |||
Other
|
| | | | 199 | | | | | | 234 | | | | | | 90 | | | |||
Total gross value
|
| | | | 2,287 | | | | | | 1,838 | | | | | | 1,244 | | | |||
Write-downs
|
| | | | (9) | | | | | | (5) | | | | | | — | | | |||
Total
|
| | | | 2,278 | | | | | | 1,833 | | | | | | 1,244 | | | |||
|
In KEUR
|
| |
12.31.2013
|
| |
12.31.2012
|
| |
12.31.2011
|
| ||||||||||||
R&D tax credits
|
| | | | 2,562 | | | | | | 2,906 | | | | | | 1,194 | | | |||
Tax receivables (incl. VAT) and other receivables
|
| | | | 4,712 | | | | | | 3,723 | | | | | | 2,971 | | | |||
Prepaid expenses
|
| | | | 723 | | | | | | 478 | | | | | | 186 | | | |||
Other current assets
|
| | | | 7,997 | | | | | | 7,107 | | | | | | 4,351 | | | |||
|
In KEUR
|
| |
12.31.2013
|
| |
12.31.2012
|
| |
12.31.2011
|
| ||||||||||||
Marketable securities(1)
|
| | | | 600 | | | | | | 1,173 | | | | | | 500 | | | |||
Cash
|
| | | | 13,010 | | | | | | 12,893 | | | | | | 29,290 | | | |||
Total
|
| | | | 13,610 | | | | | | 14,066 | | | | | | 29,790 | | | |||
|
| | |
Net profit (loss)
(KEUR) |
| |
Average number
of shares outstanding |
| |
Earnings per
share (EUR) |
| |||||||||
12.31.2013 (Restated)
|
| | | | (12,152) | | | | | | | | | | | | | | |
Basic earnings per share
|
| | | | | | | | | | 54,156,067 | | | | | | (0.22) | | |
Diluted earnings per share
|
| | | | | | | | |
|
54,156,067
|
| | | | | (0.22) | | |
12.31.2012 (Restated)
|
| | | | (20,047) | | | | | | | | | | | | | | |
Basic earnings per share
|
| | | | | | | | | | 52,364,094 | | | | | | (0.38) | | |
Diluted earnings per share
|
| | | | | | | | |
|
52,364,094
|
| | | | | (0.38) | | |
12.31.2011 (Restated)
|
| | | | (239) | | | | | | | | | | | | | | |
Basic earnings per share
|
| | | | | | | | | | 48,054,083 | | | | | | (0.00) | | |
Diluted earnings per share
|
| | | | | | | | | | 48,054,083 | | | | | | (0.00) | | |
| | |
12.31.2013
|
| |
12.31.2012
|
| |
12.31.2011
|
| ||||||||||||||||||||||||||
In KEUR
|
| |
Atreus
Pharmaceuticals Corporation |
| |
Umbra
Medical AG |
| |
Atreus
Pharmaceuticals Corporation |
| |
Umbra
Medical AG |
| |
Atreus
Pharmaceuticals Corporation |
| ||||||||||||||||||||
NCI percentage
|
| | | | 49.9% | | | | | | 49.9% | | | | | | 49.9% | | | | | | 49.9% | | | | | | 49.9% | | | |||||
Non-current assets
|
| | | | 6,768 | | | | | | 1,361 | | | | | | 7,109 | | | | | | 1 | | | | | | 6,699 | | | |||||
Current assets
|
| | | | 472 | | | | | | 409 | | | | | | 617 | | | | | | 536 | | | | | | 394 | | | |||||
Non-current liabilities
|
| | | | (1,783) | | | | | | (1,035) | | | | | | (1,992) | | | | | | (10) | | | | | | (1,968) | | | |||||
Current liabilities
|
| | | | (2,356) | | | | | | (1,109) | | | | | | (1,433) | | | | | | (443) | | | | | | (720) | | | |||||
Net assets
|
| | | | 3,101 | | | | | | (374) | | | | | | 4,301 | | | | | | 84 | | | | | | 4,405 | | | |||||
Carrying amount of NCI
|
| | | | 1,547 | | | | | | (187) | | | | | | 2,146 | | | | | | 42 | | | | | | 2,198 | | | |||||
Revenue
|
| | | | 160 | | | | | | 891 | | | | | | 126 | | | | | | 846 | | | | | | 248 | | | |||||
Total comprehensive income
|
| | | | (1,204) | | | | | | (459) | | | | | | (363) | | | | | | (219) | | | | | | (1,090) | | | |||||
Comprehensive income allocated to NCI
|
| | | | (601) | | | | | | (229) | | | | | | (181) | | | | | | (109) | | | | | | (543) | | | |||||
|
In KEUR
|
| |
12.31.2013
|
| |
12.31.2012
|
| |
12.31.2011
|
| ||||||||||||
Decommissioning obligations
|
| | | | 5,127 | | | | | | 4,903 | | | | | | 2,825 | | | |||
Retirement indemnities and other employee benefits
|
| | | | 843 | | | | | | 657 | | | | | | 469 | | | |||
Other
|
| | | | 60 | | | | | | 32 | | | | | | 96 | | | |||
Total non-current provisions
|
| | | | 6,029 | | | | | | 5,592 | | | | | | 3,390 | | | |||
Other
|
| | | | 115 | | | | | | 300 | | | | | | — | | | |||
Total current provisions
|
| | | | 115 | | | | | | 300 | | | | | | — | | | |||
Total
|
| | | | 6,144 | | | | | | 5,892 | | | | | | 3,390 | | | |||
|
| | |
12.31.2013
|
| |
12.31.2012
|
| |
12.31.2011
|
|
Discount rate
|
| |
3.17%
|
| |
2.69%
|
| |
4.3%
|
|
Future increase in remuneration
|
| |
2%
|
| |
2%
|
| |
2%
|
|
Rate of social charges
|
| |
47%
|
| |
47%
|
| |
47%
|
|
Retirement age
|
| |
Managers: 65 years
Other staff: 62 years |
| |
Managers: 65 years
Other staff: 62 years |
| |
Managers: 65 years
Other staff: 62 years |
|
Mortality table
|
| |
INSEE 2008 – 2010
|
| |
INSEE 2007 – 2009
|
| |
INSEE 2007 – 2009
|
|
|
In KEUR
|
| |
12.31.2013
|
| |
12.31.2012
|
| |
12.31.2011
|
| ||||||||||||
Finance lease obligations(1)
|
| | | | 7,591 | | | | | | 6,988 | | | | | | 6,718 | | | |||
Bank overdrafts
|
| | | | — | | | | | | 119 | | | | | | 987 | | | |||
Loans(1) | | | | | 18,226 | | | | | | 17,961 | | | | | | 8,051 | | | |||
Total | | | | | 25,817 | | | | | | 25,068 | | | | | | 15,756 | | | |||
|
| | |
12.31.2013
|
| |||||||||||||||||||||||||
In KEUR
|
| |
< 1 year
|
| |
1 − 5 years
|
| |
> 5 years
|
| |
Total
|
| ||||||||||||||||
Finance lease obligations
|
| | | | 1,584 | | | | | | 4,281 | | | | | | 1,725 | | | | |
|
7,591
|
| | ||||
Bank overdrafts
|
| | | | — | | | | | | — | | | | | | — | | | | |
|
—
|
| | ||||
Loans
|
| | | | 3,873 | | | | | | 10,993 | | | | | | 3,360 | | | | |
|
18,226
|
| | ||||
Total
|
| | | | 5,458 | | | | | | 15,274 | | | | | | 5,085 | | | | | | 25,817 | | | ||||
|
| | |
12.31.2012
|
| |||||||||||||||||||||||||
In KEUR
|
| |
< 1 year
|
| |
1 − 5 years
|
| |
> 5 years
|
| |
Total
|
| ||||||||||||||||
Finance lease obligations
|
| | | | 1,065 | | | | | | 3,773 | | | | | | 2,150 | | | | |
|
6,988
|
| | ||||
Bank overdrafts
|
| | | | 119 | | | | | | — | | | | | | — | | | | |
|
119
|
| | ||||
Loans
|
| | | | 2,828 | | | | | | 11,711 | | | | | | 3,422 | | | | |
|
17,961
|
| | ||||
Total
|
| | | | 4,012 | | | | | | 15,484 | | | | | | 5,572 | | | | | | 25,068 | | | ||||
|
| | |
12.31.2011
|
| |||||||||||||||||||||||||
In KEUR
|
| |
1 year
|
| |
1 – 5 years
|
| |
> 5 years
|
| |
Total
|
| ||||||||||||||||
Finance lease obligations
|
| | | | 478 | | | | | | 1,752 | | | | | | 4,488 | | | | | | 6,718 | | | ||||
Bank overdrafts
|
| | | | 987 | | | | | | — | | | | | | — | | | | | | 987 | | | ||||
Loans
|
| | | | 1,455 | | | | | | 4,174 | | | | | | 2,422 | | | | | | 8,051 | | | ||||
Total
|
| | | | 2,920 | | | | | | 5,926 | | | | | | 6,910 | | | | | | 15,756 | | | ||||
|
In KEUR
|
| |
average
interest rate |
| |
12.31.2013
|
| |
12.31.2012
|
| |
12.31.2011
|
| ||||||||||||||||
Fixed rates
|
| | | | 3.99% | | | | | | 17,603 | | | | | | 17,879 | | | | | | 13,373 | | | ||||
Floating rates
|
| | | | 2.36% | | | | | | 8,214 | | | | | | 7,189 | | | | | | 2,383 | | | ||||
Total
|
| | | | | | | | | | 25,817 | | | | | | 25,068 | | | | | | 15,756 | | | ||||
|
In KEUR
|
| |
12.31.2013
(Restated) |
| |
12.31.2012
(Restated) |
| |
12.31.2011
(Restated) |
| ||||||||||||
Due to former owners of acquired companies(1)
|
| | | | 29,786 | | | | | | 23,158 | | | | | | 5,912 | | | |||
Government subsidies
|
| | | | 1,690 | | | | | | 1,255 | | | | | | 1,369 | | | |||
Other non-current liabilities
|
| | | | 31,477 | | | | | | 24,413 | | | | | | 7,281 | | | |||
Due to former owners of acquired companies(1)
|
| | | | 2,793 | | | | | | 5,834 | | | | | | 2,638 | | | |||
Tax, personnel and social charges
|
| | | | 3,886 | | | | | | 3,124 | | | | | | 2,291 | | | |||
Other(2) | | | | | 2,873 | | | | | | 3,005 | | | | | | 2,485 | | | |||
Other current liabilities
|
| | | | 9,551 | | | | | | 11,963 | | | | | | 7,414 | | | |||
|
| | |
12.31.2013 (Restated)
|
| ||||||||||||||||||||||||||||||||||||||||||||||
| | |
Carrying amount
|
| |
Fair value
|
| |||||||||||||||||||||||||||||||||||||||||||
In KEUR
|
| |
Note
|
| |
Designated
at fair value |
| |
Loans and
receivables |
| |
Available-
for-sale |
| |
Other
financial liabilities |
| |
Total
|
| | ||||||||||||||||||||||||||||||
Measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Available-for-sale financial assets
|
| | |
|
(3)
|
| | | | | — | | | | | | — | | | | | | 54 | | | | | | — | | | | | | 54 | | | | | | 54 | | | |||||||
Total measured at fair value
|
| | | | | | | | | | — | | | | | | — | | | | | | 54 | | | | | | — | | | | | | 54 | | | | | | 54 | | | |||||||
Not measured at fair value
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Trade receivables and other receivables
|
| | |
|
(1)
|
| | | | | — | | | | | | 16,143 | | | | | | — | | | | | | — | | | | | | 16,143 | | | | | | 16,143 | | | |||||||
Other assets
|
| | |
|
(1)
|
| | | | | — | | | | | | 7,997 | | | | | | — | | | | | | — | | | | | | 7,997 | | | | | | 7,997 | | | |||||||
Guarantee deposits
|
| | |
|
(1)
|
| | | | | — | | | | | | 2,282 | | | | | | — | | | | | | — | | | | | | 2,282 | | | | | | 2,282 | | | |||||||
Cash and cash equivalents
|
| | |
|
(1)
|
| | | | | — | | | | | | 13,610 | | | | | | — | | | | | | — | | | | | | 13,610 | | | | | | 13,610 | | | |||||||
Total not measured at fair value
|
| | | | | | | | | | — | | | | | | 40,032 | | | | | | — | | | | | | — | | | | | | 40,032 | | | | | | 40,032 | | | |||||||
Total financial assets
|
| | | | | | | | | | — | | | | | | 40,032 | | | | | | 54 | | | | | | — | | | | | | 40,086 | | | | | | 40,086 | | | |||||||
Measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Debt due to former owners of
acquired companies |
| | |
|
(2)
|
| | | | | 32,579 | | | | | | — | | | | | | — | | | | | | — | | | | | | 32,579 | | | | | | 32,579 | | | |||||||
Total measured at fair value
|
| | | | | | | | | | 32,579 | | | | | | — | | | | | | — | | | | | | — | | | | | | 32,579 | | | | | | 32,579 | | | |||||||
Not measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Financial liabilities
|
| | |
|
(3)
|
| | | | | — | | | | | | — | | | | | | — | | | | | | 25,817 | | | | | | 25,817 | | | | | | 26,445 | | | |||||||
Trade payables
|
| | |
|
(1)
|
| | | | | — | | | | | | — | | | | | | — | | | | | | 9,218 | | | | | | 9,218 | | | | | | 9,218 | | | |||||||
Other liabilities
|
| | |
|
(1)
|
| | | | | — | | | | | | — | | | | | | — | | | | | | 8,449 | | | | | | 8,449 | | | | | | 8,449 | | | |||||||
Total not measured at fair value
|
| | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | 43,484 | | | | | | 43,484 | | | | | | 44,112 | | | |||||||
Total financial liabilities
|
| | | | | | | | | | 32,579 | | | | | | — | | | | | | — | | | | | | 43,484 | | | | | | 76,063 | | | | | | 76,691 | | | |||||||
|
| | |
12.31.2012 (Restated)
|
| ||||||||||||||||||||||||||||||||||||||||||||||
| | |
Carrying amount
|
| |
Fair value
|
| |||||||||||||||||||||||||||||||||||||||||||
In KEUR
|
| |
Note
|
| |
Designated
at fair value |
| |
Loans and
receivables |
| |
Available-
for-sale |
| |
Other
financial liabilities |
| |
Total
|
| | ||||||||||||||||||||||||||||||
Measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Available-for-sale financial assets
|
| | |
|
(3)
|
| | | | | — | | | | | | — | | | | | | 563 | | | | | | — | | | | | | 563 | | | | | | 563 | | | |||||||
Total measured at fair value
|
| | | | | | | | | | — | | | | | | — | | | | | | 563 | | | | | | — | | | | | | 563 | | | | | | 563 | | | |||||||
Not measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Trade receivables and other receivables
|
| | |
|
(1)
|
| | | | | — | | | | | | 15,537 | | | | | | — | | | | | | — | | | | | | 15,537 | | | | | | 15,537 | | | |||||||
Other assets
|
| | |
|
(1)
|
| | | | | — | | | | | | 7,107 | | | | | | — | | | | | | — | | | | | | 7,107 | | | | | | 7,107 | | | |||||||
Guarantee deposits
|
| | |
|
(1)
|
| | | | | — | | | | | | 2,158 | | | | | | — | | | | | | — | | | | | | 2,158 | | | | | | 2,158 | | | |||||||
Cash and cash equivalents
|
| | |
|
(1)
|
| | | | | — | | | | | | 14,066 | | | | | | — | | | | | | — | | | | | | 14,066 | | | | | | 14,066 | | | |||||||
Total not measured at fair value
|
| | | | | | | | | | — | | | | | | 38,868 | | | | | | — | | | | | | — | | | | | | 38,868 | | | | | | 38,868 | | | |||||||
Total financial assets
|
| | | | | | | | | | — | | | | | | 38,868 | | | | | | 563 | | | | | | — | | | | | | 39,431 | | | | | | 39,431 | | | |||||||
Measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Debt due to former owners of
acquired companies |
| | |
|
(2)
|
| | | | | 28,992 | | | | | | — | | | | | | — | | | | | | — | | | | | | 28,992 | | | | | | 28,992 | | | |||||||
Total measured at fair value
|
| | | | | | | | | | 28,992 | | | | | | — | | | | | | — | | | | | | — | | | | | | 28,992 | | | | | | 28,992 | | | |||||||
Not measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Financial liabilities
|
| | |
|
(3)
|
| | | | | — | | | | | | — | | | | | | — | | | | | | 25,068 | | | | | | 25,068 | | | | | | 25,869 | | | |||||||
Trade payables
|
| | |
|
(1)
|
| | | | | — | | | | | | — | | | | | | — | | | | | | 9,857 | | | | | | 9,857 | | | | | | 9,857 | | | |||||||
Other liabilities
|
| | |
|
(1)
|
| | | | | — | | | | | | — | | | | | | — | | | | | | 7,384 | | | | | | 7,384 | | | | | | 7,384 | | | |||||||
Total not measured at fair value
|
| | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | 42,309 | | | | | | 42,309 | | | | | | 43,110 | | | |||||||
Total financial liabilities
|
| | | | | | | | | | 28,992 | | | | | | — | | | | | | — | | | | | | 42,309 | | | | | | 71,301 | | | | | | 72,102 | | | |||||||
|
| | |
12.31.2011 (Restated)
|
| ||||||||||||||||||||||||||||||||||||||||||||||
| | |
Carrying amount
|
| |
Fair value
|
| |||||||||||||||||||||||||||||||||||||||||||
In KEUR
|
| |
Note
|
| |
Designated
at fair value |
| |
Loans and
receivables |
| |
Available-
for-sale |
| |
Other
financial liabilities |
| |
Total
|
| | | | | | | |||||||||||||||||||||||||
Measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Available-for-sale financial assets
|
| | |
|
(3)
|
| | | | | — | | | | | | — | | | | | | 510 | | | | | | — | | | | | | 510 | | | | | | 510 | | | |||||||
Total measured at fair value
|
| | | | | | | | | | — | | | | | | — | | | | | | 510 | | | | | | — | | | | | | 510 | | | | | | 510 | | | |||||||
Not measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Trade receivables and other receivables
|
| | |
|
(1)
|
| | | | | — | | | | | | 10,910 | | | | | | — | | | | | | — | | | | | | 10,910 | | | | | | 10,910 | | | |||||||
Other assets
|
| | |
|
(1)
|
| | | | | — | | | | | | 4,351 | | | | | | — | | | | | | — | | | | | | 4,351 | | | | | | 4,351 | | | |||||||
Guarantee deposits
|
| | |
|
(1)
|
| | | | | — | | | | | | 45 | | | | | | — | | | | | | — | | | | | | 45 | | | | | | 45 | | | |||||||
Cash and cash equivalents
|
| | |
|
(1)
|
| | | | | — | | | | | | 29,790 | | | | | | — | | | | | | — | | | | | | 29,790 | | | | | | 29,790 | | | |||||||
Total not measured at fair value
|
| | | | | | | | | | — | | | | | | 45,096 | | | | | | — | | | | | | — | | | | | | 45,096 | | | | | | 45,096 | | | |||||||
Total financial assets
|
| | | | | | | | | | — | | | | | | 45,096 | | | | | | 510 | | | | | | — | | | | | | 45,606 | | | | | | 45,606 | | | |||||||
Measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Debt due to former owners of
acquired companies |
| | |
|
(2)
|
| | | | | 8,550 | | | | | | — | | | | | | — | | | | | | — | | | | | | 8,550 | | | | | | 8,550 | | | |||||||
Total measured at fair value
|
| | | | | | | | |
|
8,550
|
| | | | | — | | | | | | — | | | | | | — | | | | | | 8,550 | | | | | | 8,550 | | | |||||||
Not measured at fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |||||||
Financial liabilities
|
| | |
|
(3)
|
| | | | | — | | | | | | — | | | | | | — | | | | | | 15,756 | | | | | | 15,756 | | | | | | 16,683 | | | |||||||
Trade payables
|
| | |
|
(1)
|
| | | | | — | | | | | | — | | | | | | — | | | | | | 7,933 | | | | | | 7,933 | | | | | | 7,933 | | | |||||||
Other liabilities
|
| | |
|
(1)
|
| | | | | — | | | | | | — | | | | | | — | | | | | | 6,145 | | | | | | 6,145 | | | | | | 6,145 | | | |||||||
Total not measured at fair value
|
| | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | 29,834 | | | | | | 29,834 | | | | | | 30,761 | | | |||||||
Total financial liabilities
|
| | | | | | | | | | 8,550 | | | | | | — | | | | | | — | | | | | | 29,834 | | | | | | 38,384 | | | | | | 39,311 | | | |||||||
|
2013 (in KEUR) (Restated) |
| |
Carrying
amount |
| | |
Outstanding
contractual outflows |
| |
Less than
1 year |
| |
From 1 to
5 years |
| |
More than
5 years |
| ||||||||||||||||||||
Finance lease obligations
|
| | | | 7,591 | | | | | |
|
8,672
|
| | | | | 1,810 | | | | | | 4,770 | | | | | | 2,093 | | | |||||
Other loans and financial liabilities
|
| | | | 18,226 | | | | | |
|
19,972
|
| | | | | 4,402 | | | | | | 12,093 | | | | | | 3,477 | | | |||||
Bank overdrafts
|
| | | | — | | | | | |
|
—
|
| | | | | — | | | | | | — | | | | | | — | | | |||||
Trade and other payables
|
| | | | 9,218 | | | | | |
|
9,218
|
| | | | | 9,218 | | | | | | — | | | | | | — | | | |||||
Tax, personnel and social charges
|
| | | | 3,886 | | | | | |
|
3,886
|
| | | | | 3,886 | | | | | | — | | | | | | — | | | |||||
Other
|
| | | | 37,142 | | | | | |
|
72,401
|
| | | | | 5,667 | | | | | | 9,228 | | | | | | 57,506 | | | |||||
Total
|
| | | | 76,063 | | | | | | | 114,149 | | | | | | 24,983 | | | | | | 26,091 | | | | | | 63,076 | | | |||||
|
2012 (in KEUR) (Restated) |
| |
Carrying
amount |
| | |
Outstanding
contractual outflows |
| |
Less than
1 year |
| |
From 1 to
5 years |
| |
More than
5 years |
| ||||||||||||||||||||
Finance lease obligations
|
| | | | 6,988 | | | | | |
|
8,279
|
| | | | | 1,260 | | | | | | 4,498 | | | | | | 2,521 | | | |||||
Other loans and financial liabilities
|
| | | | 17,961 | | | | | |
|
19,778
|
| | | | | 3,362 | | | | | | 12,851 | | | | | | 3,565 | | | |||||
Bank overdrafts
|
| | | | 119 | | | | | |
|
119
|
| | | | | 119 | | | | | | — | | | | | | — | | | |||||
Trade and other payables
|
| | | | 9,857 | | | | | |
|
9,857
|
| | | | | 9,857 | | | | | | — | | | | | | — | | | |||||
Tax, personnel and social charges
|
| | | | 3,124 | | | | | |
|
3,124
|
| | | | | 3,124 | | | | | | — | | | | | | — | | | |||||
Other
|
| | | | 33,252 | | | | | |
|
64,202
|
| | | | | 8,889 | | | | | | 7,490 | | | | | | 47,823 | | | |||||
Total
|
| | | | 71,310 | | | | | | | 105,359 | | | | | | 26,611 | | | | | | 24,839 | | | | | | 53,909 | | | |||||
|
2011 (in KEUR) (Restated) |
| |
Carrying
amount |
| | |
Outstanding
contractual outflows |
| |
Less than
1 year |
| |
From 1 to
5 years |
| |
More than
5 years |
| ||||||||||||||||||||
Financial lease obligations
|
| | | | 6,718 | | | | | | | 8,345 | | | | | | 1,188 | | | | | | 3,820 | | | | | | 3,337 | | | |||||
Other loans and financial liabilities
|
| | | | 8,051 | | | | | | | 9,200 | | | | | | 1,768 | | | | | | 4,878 | | | | | | 2,554 | | | |||||
Bank overdrafts
|
| | | | 987 | | | | | | | 987 | | | | | | 987 | | | | | | — | | | | | | — | | | |||||
Trade and other payables
|
| | | | 7,933 | | | | | | | 7,933 | | | | | | 7,933 | | | | | | — | | | | | | — | | | |||||
Tax, personnel and social charges
|
| | | | 2,291 | | | | | | | 2,291 | | | | | | 2,291 | | | | | | — | | | | | | — | | | |||||
Other
|
| | | | 12,404 | | | | | | | 16,361 | | | | | | 5,721 | | | | | | 4,971 | | | | | | 5,669 | | | |||||
Total
|
| | | | 38,384 | | | | | | | 45,117 | | | | | | 19,888 | | | | | | 13,669 | | | | | | 11,560 | | | |||||
|
Entity
|
| |
Registered office in
|
| |
% Interest
2013 |
| |
% Interest
2012 |
| |
% Interest
2011 |
| ||||||
Advanced Accelerator Applications SA
|
| | France | | | Parent Company |
| | Parent Company |
| | Parent Company |
| ||||||
Advanced Accelerator Applications Unipessoal Lda
|
| | Portugal | | | | | 100% | | | | | | 100% | | | |
100%
|
|
Advanced Accelerator Applications Polska sp zoo
|
| | Poland | | | | | 100% | | | | | | 100% | | | |
N/A
|
|
Advanced Accelerator Applications (Italy) Srl
|
| | Italy | | | | | 100% | | | | | | 100% | | | |
100%
|
|
G.I. Pharma Srl
|
| | Italy | | | | | 100% | | | | | | 100% | | | |
100%
|
|
Advanced Accelerator Applications International SA
|
| | Switzerland | | | | | 100% | | | | | | 100% | | | |
100%
|
|
Umbra Medical AG
|
| | Germany | | | | | 50.1% | | | | | | 50.1% | | | |
N/A
|
|
Advanced Accelerator Applications Iberica
|
| | Spain | | | | | 100% | | | | | | 100% | | | |
100%
|
|
BioSynthema Inc.
|
| | USA | | | | | 100% | | | | | | 100% | | | |
100%
|
|
Marshel (R.R) Investments Ltd
|
| | Israel | | | | | 100% | | | | | | 100% | | | |
100%
|
|
Catalana De Dispensacion
|
| | Spain | | | | | 100% | | | | | | 100% | | | |
N/A
|
|
Barnatron SA
|
| | Spain | | | | | 100% | | | | | | 100% | | | |
N/A
|
|
Advanced Accelerator Applications Canada Inc.
|
| | Canada | | | | | 100% | | | | | | 100% | | | |
100%
|
|
Atreus Pharmaceuticals Corporation
|
| | Canada | | | | | 50.1% | | | | | | 50.1% | | | |
50.1%
|
|
Eifel Property GmbH
|
| | Germany | | | | | 100% | | | | | | 100% | | | |
N/A
|
|
Date
|
| |
Number of
Ordinary Shares Issued |
| |
Price per
Ordinary Share (in Euros) |
| ||||||
05/2011
|
| | | | 2,000,000 | | | | | | 4.0 | | |
06/2011
|
| | | | 1,650,000 | | | | | | 4.0 | | |
02/2012
|
| | | | 120,000 | | | | | | 4.0 | | |
12/2012
|
| | | | 19,377 | | | | | | 2.5 | | |
01/2013
|
| | | | 575,000 | | | | | | 4.0 | | |
Date
|
| |
Number of
Ordinary Shares Issued |
| |
Price per
Ordinary Share (in Euros) |
| ||||||
02/2014
|
| | | | 294,743 | | | | | | 5.0 | | |
03/2014
|
| | | | 241,114 | | | | | | 2.5 | | |
Total Ordinary Shares
|
| | | | 4,900,234 | | | | | | | | |
Date
|
| |
Number of
Ordinary Shares Issued |
| |
Price per
Ordinary Share (in Euros) |
| ||||||
06/2011
|
| | | | 6,397,417 | | | | | | 4.0 | | |
04/2013
|
| | | | 963,086 | | | | | | 5.0 | | |
02/2014
|
| | | | 8,212,295 | | | | | | 5.0 | | |
Total Ordinary Shares
|
| | | | 15,572,798 | | | | | | | | |
|
1.1
|
| | Form of Underwriting Agreement.* | |
|
3.1
|
| | English Translation of By-laws. | |
|
4.1
|
| | Form of Deposit Agreement among Advanced Accelerator Applications S.A., The Bank of New York Mellon, as depositary, and owners and holders of American Depositary Shares (incorporated by reference to our Registration Statement on Form F-6 (File No. 333- ) filed with the SEC on , 2015). | |
|
4.2
|
| | Form of American Depositary Receipt (included in Exhibit 4.1). | |
|
4.3
|
| | Form of Shareholders’ Agreement. | |
|
5.1
|
| | Form of opinion of Davis Polk & Wardwell LLP, counsel to Advanced Accelerator Applications S.A., as to the validity of the ADSs. | |
|
8.1
|
| | Form of opinion of Orrick Rambaud Martel, French tax counsel to Advanced Accelerator Applications S.A., as to French tax matters. | |
|
10.1
|
| | Share Purchase Agreement, dated February 14, 2014, among Advanced Accelerator Applications S.A., Imaging Equipment (Holdings) Limited, Nicholas Stevens, Helen Ruth Stevens, Prabhjeevan Singh Virk, Victor Griffin and Richard Huggins. | |
|
10.2
|
| | Sale and Purchase Agreement, dated May 20, 2010, by and among Advanced Accelerator Applications S.A., BioSynthema Inc., and certain shareholders of BioSynthema Inc. listed in Schedule 1 thereto.† | |
|
10.3
|
| | License Agreement, dated October 10, 2007, by and between Mallinckrodt Inc. and BioSynthema Inc.† | |
|
10.4
|
| | Know How and Trademark License Agreement, dated January 14, 2009, between Advanced Accelerator Applications S.A. and IASON GmbH.† | |
|
10.5
|
| | License Agreement, dated June 12, 2007.† | |
|
10.6
|
| | Service Agreement, dated April 3, 2012, between Advanced Accelerator Applications S.A. and Pierrel Research Italy S.p.A.† | |
|
10.7
|
| | Unanimous Shareholders Agreement dated March 27, 2014, among Advanced Accelerator Applications Canada Inc., 4549694 Canada Inc., 7329563 Canada Inc. and Atreus Pharmaceuticals Corporation.† | |
|
10.8
|
| | Share Purchase Agreement dated December 18, 2014 between 7329563 Canada Inc. and Advanced Accelerator Applications S.A.† | |
|
21.1
|
| | List of subsidiaries. | |
|
23.1
|
| | Consent of KPMG S.A. | |
|
23.2
|
| | Consent of Davis Polk & Wardwell LLP, counsel to Advanced Accelerator Applications S.A. (included in Exhibit 5.1). | |
|
23.3
|
| | Consent of Orrick Rambaud Martel, French tax counsel to Advanced Accelerator Applications S.A. (included in Exhibit 8.1). | |
|
24.1
|
| | Powers of attorney (included on signature page to the registration statement).** | |
| | | | Advanced Accelerator Applications S.A. | | |||
| | | | By: | | | /s/ Stefano Buono | |
| | | | | | |
Name:
Stefano Buono
|
|
| | | | | | |
Title:
Chief Executive Officer
|
|
|
Name
|
| |
Title
|
|
|
/s/ Stefano Buono
Stefano Buono
|
| |
Chief Executive Officer and Director (principal executive officer) |
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/s/ Heinz Mäusli
Heinz Mäusli
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Chief Financial Officer
(principal financial officer and principal accounting officer) |
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*
Claudio Costamagna
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Chairman of the Board
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Muriel de Szilbereky
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Director
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Kapil Dhingra
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Director
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Steve Gannon
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Director
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Yvonne Greenstreet
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Director
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Christian Merle
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Director
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Leopoldo Zambeletti
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Director
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/s/ Jordan Silverstein
Jordan Silverstein
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Authorized Representative in the United States
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*By:
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/s/ Stefano Buono
Stefano Buono
Attorney-in-fact |
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| 1.1 | | | Form of Underwriting Agreement.* | |
| 3.1 | | | English Translation of By-laws. | |
| 4.1 | | | Form of Deposit Agreement among Advanced Accelerator Applications S.A., The Bank of New York Mellon, as depositary, and owners and holders of American Depositary Shares (incorporated by reference to our Registration Statement on Form F-6 (File No. 333- ) filed with the SEC on , 2015). | |
| 4.2 | | | Form of American Depositary Receipt (included in Exhibit 4.1). | |
| 4.3 | | | Form of Shareholders’ Agreement. | |
| 5.1 | | | Form of opinion of Davis Polk & Wardwell LLP, counsel to Advanced Accelerator Applications S.A., as to the validity of the ADSs. | |
| 8.1 | | | Form of opinion of Orrick Rambaud Martel, French tax counsel to Advanced Accelerator Applications S.A., as to French tax matters. | |
| 10.1 | | | Share Purchase Agreement, dated February 14, 2014, among Advanced Accelerator Applications S.A., Imaging Equipment (Holdings) Limited, Nicholas Stevens, Helen Ruth Stevens, Prabhjeevan Singh Virk, Victor Griffin and Richard Huggins. | |
| 10.2 | | | Sale and Purchase Agreement, dated May 20, 2010, by and among Advanced Accelerator Applications S.A., BioSynthema Inc., and certain shareholders of BioSynthema Inc. listed in Schedule 1 thereto.† | |
| 10.3 | | | License Agreement, dated October 10, 2007, by and between Mallinckrodt Inc. and BioSynthema Inc.† | |
| 10.4 | | | Know How and Trademark License Agreement, dated January 14, 2009, between Advanced Accelerator Applications S.A. and IASON GmbH.† | |
| 10.5 | | | License Agreement, dated June 12, 2007.† | |
| 10.6 | | | Service Agreement, dated April 3, 2012, between Advanced Accelerator Applications S.A. and Pierrel Research Italy S.p.A.† | |
| 10.7 | | | Unanimous Shareholders Agreement dated March 27, 2014, among Advanced Accelerator Applications Canada Inc., 4549694 Canada Inc., 7329563 Canada Inc. and Atreus Pharmaceuticals Corporation.† | |
| 10.8 | | | Share Purchase Agreement dated December 18, 2014 between 7329563 Canada Inc. and Advanced Accelerator Applications S.A.† | |
| 21.1 | | | List of subsidiaries. | |
| 23.1 | | | Consent of KPMG S.A. | |
| 23.2 | | | Consent of Davis Polk & Wardwell LLP, counsel to Advanced Accelerator Applications S.A. (included in Exhibit 5.1). | |
| 23.3 | | | Consent of Orrick Rambaud Martel, French tax counsel to Advanced Accelerator Applications S.A. (included in Exhibit 8.1). | |
| 24.1 | | | Powers of attorney (included on signature page to the registration statement).** | |
Exhibit 3.1
ADVANCED ACCELERATOR APPLICATIONS
A limited company with a capital of €6,293,404.10
Registered office: 20, rue Diesel, 01630 Saint Genis Pouilly
BOURG EN BRESSE Trade and Companies Register no. 441 417 110
BY-LAWS
As of January 1, 2015
SECTION I – LEGAL FORM, PURPOSE, CORPORATE NAME, REGISTERED OFFICE AND DURATION | 3 |
Article 1 - Legal form of the company | 3 |
Article 2 - Purpose | 3 |
Article 3 - Corporate name | 4 |
Article 4 - Registered office | 4 |
Article 5 - Duration | 4 |
SECTION II – SHARE CAPITAL AND SHARES | 5 |
Article 6 - Share capital | 5 |
Article 7 - Increasing, reducing and redeeming the share capital | 5 |
Article 8 - Form of the shares | 5 |
Article 9 - Share transfers | 5 |
Article 10 - The rights and obligations attached to shares | 5 |
Article 11 - Paying for shares | 6 |
SECTION III – ADMINISTRATION OF THE COMPANY | 7 |
Article 12 - Board of Directors | 7 |
Article 13 - Decisions taken by the Board of Directors | 9 |
Article 14 - The Board of Directors' powers | 10 |
Article 15 - Method of ensuring the general management of the company | 10 |
Article 16 - General Management | 11 |
Article 17 - Panel of observers | 12 |
Article 18 - Agreements subject to approval | 12 |
Article 19 - Prohibited agreements | 13 |
SECTION IV – GENERAL MEETINGS | 14 |
Article 20 - General Meetings | 14 |
SECTION V – AUDITORS | 16 |
Article 21 - Auditors | 16 |
SECTION VI – PROFITS/LOSSES | 16 |
Article 22 - Financial year | 16 |
Article 23 - Profits – Statutory reserve fund | 17 |
Article 24 - Dividends | 17 |
SECTION VII – WINDING-UP - LIQUIDATION | 18 |
Article 25 - Early winding-up | 18 |
Article 26 - Loss of half of the share capital | 18 |
Article 27 - The effects of winding up the company | 19 |
Article 28 - Appointment of the liquidators - Powers | 19 |
Article 29 - Liquidation - Closure of the liquidation proceedings | 19 |
SECTION VIII – DISPUTES | 20 |
Article 30 - Disputes | 20 |
2 |
SECTION I – LEGAL FORM, PURPOSE, CORPORATE NAME, REGISTERED OFFICE AND DURATION
Article 1 - Legal form of the company
"ADVANCED ACCELERATOR APPLICATIONS" was incorporated in the form of a société à responsabilité limitée (limited liability company) through a private agreement signed on 4 March 2002 in THOIRY, which was registered in BELLEGARDE on 7 March 2002, sheet 92 number 2, and has a capital of €7500.
Its legal form was changed to that of a société anonyme (limited company) by an extraordinary general meeting held on 19 August 2002.
It continues to exist, being owned by the owners of the existing shares and any that may come to be created in the future. It is governed by the laws and regulations in force, and by these Articles of Association.
Article 2 - Purpose
The company's purpose, in France and abroad, is:
- | The sale of products, services and studies in the medical and industrial fields, particle accelerator applications, pharmaceuticals, chemicals, artificial radio-elements and any other similar products. |
- | The production, marketing, distribution, transportation, export, importation and sale of radioactive isotopes for industrial and medical applications. |
- | The production, marketing, distribution, transportation, export, importation and sale of chemicals, pharmaceuticals and medical products and any other similar products. |
- | The production, marketing, distribution, transportation, export, importation and sale of industrial and medical appliances, devices and consumables, and associated services. |
- | The company's participation, by any means, directly or indirectly, in any operations that relate to its purpose, by means of the creation of new companies, contributions, subscriptions, the purchase of corporate securities or rights, mergers, or by other means, the creation, acquisition, leasing, or lease-management of any businesses or establishments; registering, acquiring, exploiting or transferring any processes or patents relating to these activities. |
- | And, in general, any industrial, commercial, financial, non-commercial or real estate operations, or operations concerning movable assets, that directly or indirectly relate to the company's purpose or to any similar or related purpose. |
3 |
Article 3 - Corporate name
The company's corporate name is:
"ADVANCED ACCELERATOR APPLICATIONS".
Its acronym is: AAA.
In all deeds and documents issued by the company and intended for third parties, the corporate name must be stated, immediately preceded or followed by the words "société anonyme" or the letters "S.A.", accompanied by mention of the amount of the share capital.
Article 4 - Registered office
The registered office is established at:
Saint Genis Pouilly (01630) – 20, rue Diesel.
It may be transferred to any other location in the same département or an adjacent département by a decision taken by the Board of Directors, subject to ratification of this decision by the next ordinary general meeting, and transferred anywhere else by a decision taken by a shareholders' extraordinary general meeting.
If transfer of the location of the registered office is decided on by the Board of Directors, it is authorized to amend the Articles of Association and complete the resulting formalities relating to legal notices and filing, on condition that it is indicated that the transfer is subject to the ratification provided for above.
Article 5 - Duration
The company's duration is set at ninety-nine (99) years as from its registration in the Trade and Companies Register, unless it is wound up early or its duration is extended by a decision taken by an extraordinary general meeting.
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*
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SECTION II – SHARE CAPITAL AND SHARES
Article 6 - Share capital
The share capital is set at the sum of SIX MILLION TWO HUNDRED AND NINETY-THREE THOUSAND FOUR HUNDRED AND FOUR EUROS AND TEN CENTIMES (€6,293,404.10), divided into SIXTY-TWO MILLION NINE HUNDRED AND THIRTY-FOUR THOUSAND AND FORTY-ONE (62,934,041) shares with a nominal value of €0.10 each, all fully paid-up and all of the same class.
Article 7 - Increasing, reducing and redeeming the share capital
The share capital may be increased, reduced or redeemed in accordance with the provisions of the legislation in force.
The general meeting may, among other things, decide to reduce the share capital, either by reducing the nominal value of the shares, or by reducing the number of shares.
Article 8 - Form of the shares
The company's shares are registered or bearer shares. The existence of shares results from their registration in the name of the holder(s) in accounts maintained for that purpose by an authorized intermediary duly empowered by the company, under the conditions and in accordance with the procedures provided for by the law.
At the request of any shareholder, a shareholding certificate will be issued to them via the authorized intermediary.
Article 9 - Share transfers
1. All share transfers must take place in accordance with the provisions of the law. All expenses resulting from share transfers will be payable by the transferee. The transmission of shares shall take place by their being transferred from one account to another, in accordance with the procedures stipulated by the legislation and regulations in force.
2. The company's shares are freely transferable.
Article 10 - The rights and obligations attached to shares
1. The rights and obligations attached to each share will remain attached to it regardless of who owns it, and the transfer of a share will include all dividends that are due for payment but have not yet been paid, and all future dividends and also, where applicable, the corresponding share of reserve funds and provisions.
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The ownership of a share entails, ipso facto, approval by the holder of these Articles of Association and an obligation to be bound by decisions taken by shareholders' general meetings.
Except in cases where this conflicts with the provisions of the law, each shareholder has as many voting rights and will have as many votes at general meetings as the number of shares that they hold in respect of which all sums due for payment have been paid. At equal nominal value, each share entitles the holder to one vote.
Each share entitles the holder, in respect of the company's profits and assets and the liquidation profit, to a portion of these that is proportional to the number and nominal value of the shares in existence.
Whenever it is necessary to own several shares or securities in order to exercise any right whatsoever, the shareholders or holders of securities will be personally responsible for grouping together the necessary number of shares or securities.
2. Any natural person or legal entity, acting either alone or in concert, that comes to hold a number of shares representing a proportion of the share capital or voting rights that is equal to or greater than 1% of the share capital or voting rights, or any multiple of this percentage, including any in excess of the declaration thresholds provided for by the legislation and regulations in force, must inform the company of the total number of shares and voting rights that they own, and also inform it of the number of securities giving future access to the capital, and the number of any voting rights that may be attached to these, by means of a letter sent by recorded delivery with return receipt, within a timeframe of ten (10) days as from the time crossing the threshold in question.
This obligation to inform the company also applies whenever a shareholder's holding in the share capital or the voting rights falls below one of the thresholds mentioned in the preceding paragraph.
If not declared in accordance with the provisions of the Articles of Association, shares exceeding the portion which should have been declared will be deprived of their voting right at shareholders' meetings, in accordance with the provisions of the Commercial Code, if, at a meeting, the failure to have made a declaration is noted and one or more shareholders that together hold at least 5% of the share capital request this at this meeting.
Article 11 - Paying for shares
Sums to be paid in payment of cash shares subscribed for on the score of a capital increase will be payable in accordance with the terms decided on by the extraordinary general meeting concerned.
On the occasion of a capital increase, the initial payment cannot be less than one-quarter of the nominal value of the shares plus, where applicable, the whole of the share premium.
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Calls for payment of the balance shall be made by the Board of Directors in one or more stages within a timeframe of five (5) years as from the date of accomplishment of the capital increase.
Sums remaining due in respect of shares to be paid for in cash shall be the subject of calls for payment issued by the Board of Directors, which shall determine the dates and amounts of calls for funds.
Shareholders that do not pay sums due in respect of shares held by them by the due payment date will ipso jure owe the company interest for late payment, calculated daily as from the due payment date and charged at the official interest rate applicable in commercial matters increased by three percentage points, without prejudice to the compulsory enforcement measures provided for by the law.
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SECTION III – ADMINISTRATION OF THE COMPANY
Article 12 - Board of Directors
1. The company shall be administered by a Board of Directors made up of natural persons or legal entities, which shall have between three and eighteen members, that shall be appointed by general meetings.
Legal entities must, at the time of their appointment, appoint a natural person as their permanent representative on the Board of Directors. The duration of the permanent representative's term of office shall be the same as that of the legal entity that they are representing. If a legal entity revokes its permanent representative's appointment, it must replace them immediately. The same provisions will apply in the case of the death or resignation of the permanent representative.
The duration of the term of office of Board members shall be three (3) years, a year being the period which separates two consecutive annual ordinary general meetings. A Board member's term of office will end at the end of the shareholders' ordinary general meeting called to approve the accounts for the previous financial year that is held in the year during which the said Board member's term of office expires.
By way of an exception to this rule, a general meeting may appoint a Board member for a duration of one, two or three years in order to ensure staggered renewal of terms of office.
Board members shall always be eligible for reappointment; they may be removed from office at any time by a decision taken by a shareholders' general meeting.
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If one or more seats on the Board of Directors fall vacant as a result of death or resignation, the Board of Directors may, between two general meetings, make provisional appointments. Board members appointed in replacement of another Board member whose appointed term of office has not yet expired, will only remain in office for the remainder of their predecessor's appointed term of office.
Appointments made by the Board of Directors by virtue of the preceding paragraph will be subject to ratification by the next ordinary general meeting.
If an appointment is not ratified, prior decisions and actions taken by the Board will nonetheless remain valid.
When the number of Board members falls below the legal minimum, the remaining Board members must immediately convene an ordinary general meeting with a view to appointing new Board members.
No natural person who has attained the age of seventy (70) can be appointed as a member of the Board of Directors if their appointment would result in more than one-third of the members of the Board's being aged 70 or more. If, during a Board member's term of office, the number of members of the Board of Directors aged seventy (70) or older becomes more than one-third of the members of the Board, the oldest member of the Board of Directors who has not held a General Management position within the company shall be deemed to have resigned at the end of the next ordinary general meeting following the occurrence of this event.
2. The Board of Directors shall elect a Chairman from among its members, whose remuneration it shall determine. The Chairman, who must be a natural person, shall be appointed for a duration which cannot extend beyond their term of office as a Board member. They shall be eligible for reappointment.
The Board of Directors may be removed from office at any time. Any conflicting provision will be deemed to have not been written.
The Chairman must not have attained the age of seventy (70). When they reach this age, they will automatically be deemed to have resigned. Their term of office will continue however until the next Board of Directors' meeting, during which their successor will be appointed. Subject to this provision, the Chairman of the Board shall always be eligible for reappointment.
The Board of Directors shall appoint from among its members a Board member to be responsible for standing in for the Chairman in the event of their absence, their being temporary unable to fulfil their duties, their resignation or death, or the non-renewal of their appointment. If the Chairman is temporary unable to fulfil their duties, they will stand in for them solely for the duration of this situation; in the other cases, they will stand in for the Chairman until the election of a new Chairman.
3. The Chairman of the Board of Directors organizes and directs the Board's work, and gives an account thereof to general meetings. They ensure the satisfactory operation of the company's various bodies, and in particular ensure that the Board members are in a position to fulfil their mission.
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Article 13 - Decisions taken by the Board of Directors
The Board of Directors shall meet at Board meetings convened by the Chairman as often as the interests of the company renders this necessary. They will be held at the registered office or at the place indicated in the notice of meeting. Meetings shall be convened by any means, even verbally, three (3) days in advance; they may also take place without delay if all the Board members agree to this.
Meetings of the Board of Directors shall be chaired by the Chairman of the Board of Directors. If the Chairman is absent, the Board of Directors shall appoint, for each meeting, one of its members to chair the meeting; if the votes cast to appoint the chairman of the meeting are tied, the meeting shall be chaired by the oldest of the Board members voted for.
If no Board meeting has been held for over two (2) months, at least one-third (1/3) of the members of the Board of Directors may request the Chairman to convene a meeting with a predetermined agenda. The Managing Director may also request the Chairman to convene a Board of Directors' meeting with a predetermined agenda. The Chairman will be obliged to accede to such requests.
If a Works Council exists, its representatives, who shall be appointed in accordance with the provisions of the Labour Code, must be invited to attend all Board of Directors' meetings.
An attendance register shall be kept, and minutes shall be drawn up after each meeting.
Board meetings can only take valid decisions if at least half the members of the Board of Directors are present.
Decisions shall be taken by a majority vote of the members present or represented. In the case of a tied vote, the Chairman will not have a casting vote.
Internal rules adopted by the Board of Directors may, among other things, stipulate that when calculating the quorum and majority, Board members that attend Board meetings by video conferencing or telecommunication means that are compliant with the regulations in force will be deemed to be present.
Any Board member may, even by letter, telegram or fax, give a proxy to another Board member to represent them at a Board meeting, but no Board member may hold more than one proxy at a meeting.
Copies of or excerpts from the minutes of Board of Directors' meetings shall be validly certified as being true copies by the Chairman of the Board of Directors, the Managing Director, the Deputy Managing Directors, the Managing Director temporarily assuming the duties of the Chairman, or a person who has been empowered for that purpose.
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Board members, and anyone attending Board of Directors' meetings, will be obliged to maintain discretion vis-à-vis information of a confidential nature presented as such during a Board meeting.
Article 14 - The Board of Directors' powers
The Board of Directors shall determine the orientations of the company's activity and ensure their implementation. Subject to the powers expressly attributed by law to shareholders' meetings, and within the limits of the company's purpose, it shall deal with all questions concerning the satisfactory running of the company, and through its decisions rule on company matters.
In its relations with third parties, the company is bound by all actions taken by the Board of Directors, even if they do not come within the scope of the company's purpose, unless it can prove that the third party concerned knew that the action in question lay outwith this scope or could not be unaware of it under the circumstances, mere publication of the Articles of Association being insufficient to constitute such proof.
The Board of Directors shall carry out the checks and verifications that it deems appropriate. Each Board member shall receive all the information necessary for them to fulfil their mission, and may have any documents that they deem of utility communicated to them.
The Board shall appoint an Audit Committee, which will act under its responsibility and be responsible for ensuring the follow-up of questions relating to the drawing up and auditing of accounting and financial information, within the limits stipulated by the law. Its mission shall be defined more specifically by the Charter governing it.
The Board may appoint one or more other committees to be responsible for studying questions that the Board or the Chairman refers to them.
In addition, the Board of Directors shall exercise the special powers granted to it by the law.
Article 15 - Method of ensuring the general management of the company
In accordance with the legislation in force, the general management of the company shall be assumed, under their responsibility, either by the Chairman of the Board of Directors, or by another natural person appointed by the Board of Directors, who shall have the title of Managing Director.
The Board of Directors shall choose between these two methods of ensuring the company's general management by a majority vote cast by the Board members present or represented at the time of each appointment of the Chairman of the Board of Directors or the Managing Director or renewal of their appointment. The Board of Directors must inform the shareholders and third parties of their choice in accordance with the legislation in force.
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Changing the method of ensuring the company's general management will not lead to amendment of the Articles of Association.
When the general management of the company is ensured by the Chairman, legislative and regulatory provisions and the provisions of the Article of Association relating to the Managing Director will be applicable to them. They shall have the title of Chairman and Managing Director.
Article 16 - General Management
The Board of Directors shall appoint, either from among its members or outwith them, a Managing Director, who must be a natural person aged under seventy (70). The Managing Director shall have the widest possible powers to act in all circumstances in the name of the company.
They shall exercise their powers within the limits of the company's purpose and subject to the powers that the law expressly attributes to shareholders' meetings and to the Board of Directors. They represent the company in its relations with third parties. The company will be bound even by actions taken by the Managing Director that lie outwith the scope of the company's purpose, unless the company can prove that the third party concerned knew that the action in question lay outwith this scope or could not be unaware of it under the circumstances, mere publication of the Articles of Association being insufficient to constitute such proof.
Decisions taken by the Board of Directors that limit the powers of the Managing Director will not enforceable on third parties.
At the suggestion of the Managing Director, the Board of Directors may appoint one or more natural persons to be responsible for assisting the Managing Director, who shall have the title of Deputy Managing Director. The number of Deputy Managing Directors cannot exceed five.
The Deputy Managing Directors must be aged under seventy (70). In agreement with the Managing Director, the Board of Directors shall determine the scope and duration of the powers granted to the Deputy Managing Director(s). Vis-à-vis third parties, the Deputy Managing Directors shall have the same powers as the Managing Director.
The Managing Director may be removed from office at any time by the Board of Directors. The same applies, at the proposal of the Managing Director, to Deputy Managing Directors. If removal from office is decided on without any valid reason(s) for this, this may result in damages being due, except when the Managing Director is also the Chairman of the Board of Directors.
If the Managing Director ceases to perform or is prevented from performing their duties, the Deputy Managing Directors shall retain their tasks, duties and responsibilities until the appointment of the new Managing Director, unless decided otherwise by the Board.
The Board of Directors shall determine the remuneration of the Managing Director and the Deputy Managing Directors.
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Article 17 - Panel of observers
An ordinary general meeting may, at the proposal of the Board of Directors, appoint observers. The Board of Directors may also appoint observers directly, in which case their appointment will be subject to ratification by the next general meeting.
The observers, whose number cannot exceed two, shall constitute a panel.
They shall be appointed for a period of four (4) years, their appointment coming to an end at the end of the shareholders' ordinary general meeting called to approve the accounts for the preceding financial year. They shall be eligible for reappointment. They shall be removed from office further to a decision taken by an ordinary general meeting.
The panel of observers will study questions that the Board of Directors or its Chairman submits to them for its opinion. The observers will attend Board of Directors' meetings and take part in discussions in an advisory capacity only, without however its being possible for their absence to affect the validity of decisions taken.
They shall be invited to attend Board of Directors' meetings under the same conditions as Board members.
The Board of Directors may remunerate the observers by deducting their remuneration from the directors' fees allocated to the Board members by the general meeting.
Article 18 - Agreements subject to approval
1. Sureties, endorsements and guarantees granted by the company must be authorized by the Board of Directors in accordance with the provisions of the legislation in force.
2. Any agreement concluded directly or via an intermediary between the company and its Managing Director, one of its Deputy Managing Directors, one of its Board members, one of its shareholders holding more than 10% of the voting rights or, in the case of a corporate shareholder, the company controlling it within the meaning of Article L. 233-3 of the Commercial Code, must be submitted to the Board of Directors for prior approval.
The same applies to agreements in which one of the persons listed in the preceding paragraph has an indirect interest.
Also subject to prior approval are agreements concluded between the company and another company or firm, if the Managing Director, one of the Deputy Managing Directors or one of the Board members of the company is its owner, a partner with unlimited liability, its manager, a board member, a member of the Supervisory Board or, in general, the head of the company or firm in question.
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When the Board of Directors gives its prior approval to an agreement it shall state the reasons motivating its approval, indicate the company's inherent interest in the agreement, and in particular specify the financial conditions attached to it. This approval shall be granted in accordance with the provisions of the legislation in force.
The above provisions are not applicable to agreements relating to routine operations concluded under normal conditions or agreements concluded between two companies where, directly or indirectly, all the share capital of one of them is held by the other, where applicable after deducting the minimum number of shares required to meet the requirements of Article 1832 of the Civil Code or Articles L. 225-1 and L. 226-1 of the Commercial Code.
3. Agreements previously approved by the Board of Directors which continued to be performed during the previous financial year shall be made the subject of annual examination by the Board of Directors in accordance with the provisions of the legislation in force.
In addition, the report provided for in Article L. 225-102 of the Commercial Code mentions, apart from agreements relating to routine operations concluded under normal conditions, agreements concluded directly or via an intermediary between, on the one hand one of the members of the Management Board or the Supervisory Board, or the Managing Director, one of the Deputy Managing Directors, one of the Board members or one of its shareholders holding more than 10% of the voting rights in a company, and on the other hand, another company that directly or indirectly owns more than half of the share capital of the said company.
Article 19 - Prohibited agreements
[Note: this provision is not obligatory, as it consists of a summary of the law applicable]
Board members that are not legal entities are prohibited from taking out loans from the company in any form whatsoever, or having an overdraft facility granted to them by the company via a current account or otherwise, or having the company endorse or guarantee their commitments towards third parties.
The same prohibition applies to the Managing Director, the Deputy Managing Directors and the permanent representatives of legal entities that are Board members. It also applies to the spouses, lineal ascendants and descendants of the persons provided for in the present article, and any intermediaries.
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*
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SECTION IV – GENERAL MEETINGS
Article 20 - General Meetings
1. Shareholders' meetings shall be convened by the Board of Directors under the conditions stipulated by law and in accordance with the timeframes stipulated by law.
They shall be held at the registered office or in any place designated by the convenor of the meeting, even outside the registered office or the département in which the registered office is located.
2. Each shareholder has the right to participate in general meetings on presentation of proof of their identity and the registration in the company's accounts of their shares, either in their name or in the name of an intermediary registered on their behalf under the conditions and in accordance with the timeframes provided for by the law.
If not present in person at a meeting, shareholders may choose between one of the following three formulas:
- | they may give a proxy to another shareholder or their spouse, or partner with whom they have concluded a civil solidarity pact; |
- | they may vote by correspondence; or |
- | they may send a proxy form to the company without indicating a proxy holder, in accordance with the provisions of the legislation and regulations in force. |
Even if they have been deprived of their right to vote, bare owners of shares always have the right to be present at general meetings.
The Board of Directors may, in accordance with the provisions of the legislation and regulations in force, organize shareholders' attendance and voting at meetings by video conferencing or by another means of telecommunication enabling their identification.
If the company wishes to convene a meeting by electronic telecommunication means instead of by post, they must first obtain the agreement of the shareholders concerned, that shall indicate their email address.
If the Board of Directors decides to exercise this right for a given meeting, the notice of meeting and/or convocation shall mention this decision taken by the Board of Directors. Shareholders participating in meetings by video conferencing or any of the other means of telecommunication provided for above, as decided on by the Board of Directors, shall be considered to be present at meeting when calculating the quorum and the majority.
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Shareholders that use the electronic voting form available on the website set in place by the meeting's centralizing agent within the stipulated timeframes, shall be considered as shareholders that are present or represented at the meeting. The filling in and signing of the electronic form can be carried out directly on this website using a user ID and a password, in accordance with the first sentence of the second paragraph of Article 1316-4 of the Civil Code.
The proxy or vote thus expressed before the meeting by this electronic means, and the acknowledgement of receipt given, will be considered as irrevocable documents enforceable on all, it being specified that if a share transfer has just taken place and the legal timeframe for verifying that the shares have been duly registered in a share account has not yet elapsed, the company will invalidate or modify the proxy or vote expressed before this date and time accordingly.
3. An attendance sheet shall obligatorily be kept at each meeting. The proxies given to shareholders' representatives and, where applicable, postal voting forms, will be appended to this attendance sheet. Minutes shall be drawn up of the proceedings of each meeting.
Meetings shall be chaired by the Chairman of the Board of Directors or, in their absence, by a Board member designated by the Board of Directors.
The officers of each meeting shall comprise a Chairman and two scrutineers. The role of scrutineer shall be filled by the two shareholders present and accepting this role that both personally and as representatives hold the highest number of votes. The meeting's officers shall appoint a secretary to the meeting, who need not be a shareholder.
4. The voting right attached to each share is proportional to the portion of the share capital that it represents.
5. The competence of ordinary, extraordinary and special meetings is as stipulated by the law.
6. Ordinary general meetings can only take valid decisions if the shareholders present, represented or that voted by correspondence own at least one-fifth of the shares with voting rights. If this is not the case a second meeting must be convened. No quorum will be required at this second meeting.
Subject to the derogations provided for in the case of certain capital increases and changes to the company's legal form, extraordinary general meetings can only take valid decisions if the shareholders present, represented or that voted by correspondence own at least one-quarter of the shares with voting rights at the time of the meetings being first convened or, if a meeting has been convened for a second time, own one-fifth of the voting rights.
Special meetings can only take valid decisions if the shareholders present, represented or that voted by correspondence own at least at least one-quarter of the shares with voting rights at the time of the meeting's being first convened or, if a meeting has been convened for a second time, own one-fifth of the voting rights.
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7. Ordinary general meetings take decisions by a majority of the votes held by the shareholders present or represented or that voted by correspondence. Extraordinary general meetings and special meetings take decisions by a two-thirds majority of the votes held by the shareholders present or represented or that voted by correspondence.
8. Copies of or excerpts from the minutes of meetings shall be validly certified by the Chairman of the Board of Directors, a Board member holding the post of Managing Director, or the secretary of the meeting.
Ordinary and extraordinary general meetings will exercise their respective powers in accordance with the provisions of the legislation in force.
* * *
*
SECTION V – AUDITORS
Article 21 - Auditors
1. Auditing of the company shall be carried out, under the conditions set by the law, by one or more auditors that meet the legal conditions concerning eligibility. When the corresponding legal conditions are met, the company must appoint at least two auditors.
Each auditor shall be appointed by an ordinary general meeting.
An ordinary general meeting shall appoint one or more deputy auditors, whose mission will be to replace the statutory auditors in the event of their refusing to perform their duties or being unable to so, or in the event of their resignation or death.
2. The auditors shall be appointed for a term of office of six (6) years.
* * *
*
SECTION VI – PROFITS/LOSSES
Article 22 - Financial year
Each of the company's financial years will have a duration of twelve months, which will commence on 1 January and end on 31 December each year.
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Article 23 - Profits – Statutory reserve fund
The profit or loss achieved each financial year consists of the difference between the year's revenues and expenses, after the deduction of depreciation and amortization expenses and provisions.
From the profit for the financial year, less where applicable retained losses, a deduction of at least 5% shall obligatorily be made in order to build up the statutory reserve fund. This deduction will cease to be obligatory once the statutory reserve fund has attained one-tenth of the company's share capital. It will be resumed if for any reason whatsoever the reserve fund falls back below this level.
The distributable profit consists of the profit for the financial year less any losses carried forward and the deduction provided for in the preceding paragraph, plus retained earnings.
The ordinary general meeting, at the proposal of the Board of Directors, may decide that all or part of this distributable profit will be carried forward or allocated to one or more general or special reserve accounts.
Article 24 - Dividends
If the accounts for the financial year, as approved by the general meeting, reveal the existence of a distributable profit, the general meeting may decide to allocate it to one or more reserve funds that the meeting is empowered to make allocations to or use, or carry it forward, or distribute it in the form of dividends.
After having noted the existence of any reserves that it is empowered to make use of, the general meeting may decide to distribute sums taken from these reserves. In this case, the decision must expressly indicate the reserve funds from which these deductions are being made. However, dividends must by priority be taken from the distributable profit for the financial year.
The procedures for the payment of dividends shall be determined by the general meeting or, failing this, by the Board of Directors.
However, the payment of dividends must take place within a maximum timeframe of nine months as from the close of the financial year.
The general meeting voting on approval of the accounts for the financial year may grant each shareholder, in respect of all or part of the dividend being distributed, the option to choose between payment of the dividend in cash or in shares.
Likewise, a decision may be taken to distribute an interim dividend to each shareholder, and in this case, in respect of all or part of the interim dividend being distributed, they may be granted the option to choose between payment of the interim dividend in cash or in shares.
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The offer of payment in shares, the price and the conditions governing the share issue and requests for payment in shares, and the conditions governing the carrying out of a capital increase, will be governed by the legislation and regulations in force.
When a balance sheet drawn up during or at the end of the financial year and certified by the auditor(s) shows that since the close of the preceding financial year, after funding the necessary depreciation and amortization expenses and provisions and after deducting, where applicable, losses carried forward and sums to be posted to the reserves in application of the law or the Articles of Association, and taking into account retained earnings, the company has made a profit, the Board of Directors may decide to distribute an interim dividend before the accounts for the financial year have been approved, and set the amount of this dividend and the date on which it will be distributed. The amount of such interim dividends cannot exceed the amount of the profit defined in the preceding paragraph. In this case, the Board of Directors may not make use of the option described in the above paragraphs.
* * *
*
SECTION VII – WINDING-UP - LIQUIDATION
Article 25 - Early winding-up
An extraordinary general meeting may, at any time, decide to wind the company up early.
Article 26 - Loss of half of the share capital
If, on account of losses noted in the accounting records, the company's shareholders' equity has fallen to less than half of the share capital, the Chairman must, within four months of approval of the accounts in which these losses were revealed, convene an extraordinary general meeting for the purpose of deciding whether or not the company should be wound up early.
If it is decided not to wind up the company, the share capital must, at the latest by the close of the second financial year following that in which the losses occurred, and subject to compliance with the provisions of the law relating to minimum share capital requirements for companies whose legal form is that of a société anonyme (limited company), be reduced by an amount equal to the losses which it has not been possible to charge to reserves if, within this timeframe, the shareholders' equity has not been brought back up to a level equal to at least half of the share capital.
18 |
If a general meeting is not held, or if this meeting was unable to take a valid decision, any interested party may request the competent court to have the company wound up.
Article 27 - The effects of winding up the company
The company will be in liquidation as from the time when, for any reason whatsoever, its winding-up is decided on. It will retain its status as a legal entity for the requirements of this liquidation until its completion.
Throughout the entire duration of liquidation, general meetings will retain the same powers as they held during the company's existence.
The company's shares will remain negotiable until the liquidation proceedings have been completed.
Winding up of the company will only product its effects in respect of the company's relations with third parties as from the date on which a notice announcing it is published in the Trade and Companies Register.
Article 28 - Appointment of the liquidators - Powers
On the expiry of the company or in the case of its being wound up early, a general meeting will decide on the method of liquidation and appoint one or more liquidators, whose powers it will determine and who will perform their duties in accordance with the provisions of the law. The appointment of the liquidators terminates the appointments of the Board members, the Chairman, the Managing Director and the Deputy Managing Directors.
Article 29 - Liquidation - Closure of the liquidation proceedings
After payment of the company's liabilities, the balance of the assets will firstly be used to pay to the shareholders the amount of their shares' capital that has been paid up and not been redeemed.
The balance, if any, will be shared out between all the shares.
The shareholders shall be convened at the end of the liquidation proceedings to vote on approval of the definitive accounts, grant discharge to the liquidators for their management and revoke their mandate, and record the completion of liquidation.
A notice announcing the completion of the liquidation procedure will be published in accordance with the provisions of the law.
* * *
*
19 |
SECTION VIII – DISPUTES
Article 30 - Disputes
Any disputes that may arise during the company's lifetime or during its liquidation, either between the shareholders and the company, or between the shareholders themselves, relating to the interpretation or performance of these Articles of Association or, in general, concerning company matters, will be subject to the jurisdiction of the competent courts.
* * *
*
20 |
Exhibit 4.3
Form of Shareholders Agreement
BETWEEN:
OMISSIS ….. (the shareholder list has been eliminated in this copy )
hereinafter together referred to as the “Shareholders” or “Parties”.
WHEREAS:
A. The Parties are all shareholders of Advanced Accelerator Applications S.A, a company incorporated under the laws of France, having its registered office at 20, rue Diesel, 01630 St.Genis-Pouilly, France (hereinafter referred to as the “Company” or “AAA”), represented by the President Director General, with an issued and paid up share capital of € 3,660,000, divided into 36,600,000 shares.,
B. The Shareholders have agreed to enter into this agreement in order to set out the terms governing (i) their relationship in relation to their mutual rights and obligations in case of transfer of shares and other interests in the Company, (ii) certain aspects of the management of the Company and (iii) certain non compete obligations of those Shareholders who are directors of the Company.
IT IS HEREBY AGREED AS FOLLOWS:
TITLE I - PURPOSE – DEFINITIONS –
Article 1 - Definitions
“Other Shareholders” means the Shareholders other that a Shareholder who intends to transfer his Shares.
“Shareholder” means any person, party to the present Agreement, owning Shares of the Company.
“Shares” means any share or other securities issued by the Company including, without limitation, option rights, convertible bonds or any other instrument which may be converted into, or incorporate the right to acquire any shares of the Company.
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“Subsidiary” means, with respect to any Shareholder, a company, partnership, firm association or other entity of which such Shareholder owns more then 50% of the share capital plus one shares.
“Third Party” means any person who is not a party to this Shareholders’ Agreement.
“Transfer” means, with respect to Shares, any disposal or transfer in any manner whatsoever effected whether for consideration or without consideration (including but not limited to any sale, contribution in kind, statutory merger, donation, exchange or other transfer whatsoever and whether in whole or in part).
Article 2 – Purpose of this Agreement
The purpose of this Agreement is to set forth the rights and obligations of the Company’s Shareholders in the event of a proposed Transfer. The present Agreement is however expressly subject to the condition precedent set forth hereinafter in Article 9.
TITLE II – rights and OBLIGATIONS on transfers – terms and conditions
In addition to the pre-emption right (the “Pre-emption Right”) under paragraph 10.3 of the Company’s by-laws (“Paragraph 10.3”), a Share Transfer by a Shareholder must comply with the rights and obligations as described in the present Title.
Article 3 – Free Transfers
Subject to paragraphs 10.3 of the Company’s by-laws, only the Transfers hereinafter set forth may be freely made (the "Free Transfers"), as long as the transferee, if a Third Party, becomes a party to this Agreement:
- transfers to heirs of a Shareholder who is an individual, in the event of death, including succession, of the interests in the equity of the Company;
- donation to heirs of a Shareholder who is an individual, of the interests in the equity of the Company.
Any such Free Transfers shall be notified to the Other Shareholders within 15 days following completion thereof, together with a copy of the Transferee’s agreement, if a Third Party, to become a party to this Agreement, by signing the deed of adherence as provided in article 5 below.
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Article 4 - Tag along
After receipt of a notice by the Company of a Share Transfer by a Shareholder (the “Selling Shareholder”) under Paragraph 10.3, each of the offeree Shareholders may require (save that it wishes to exercise its Pre-emption Right and subject to the exercise of the Pre-emption right by the other shareholders), that the potential purchaser (the “Potential Purchaser”) acquire its Shares (in whole but not in part), upon the same terms and conditions offered to the Selling Shareholder (the “Tag Along Request”). The Tag Along Request shall be made in writing to the Company within the exercise period under Paragraph 10.3, by registered letter return receipt requested.
In case a Tag Along Request is made by one or more Shareholders, the Selling Shareholder shall cause the Potential Purchaser to acquire all the Shares of such Shareholders, provided that, should the Potential Purchaser refuse to purchase such Shares, then the Selling Shareholder shall have the option to either (i) waive to proceed to the sale of its Shares to the Potential Purchaser or (ii) acquire himself or make the other shareholders acquire all of the Shares of the Shareholders which have made a Tag Along Request.
If no Tag Along Request is received by the Company within the exercise period under Paragraph 10.3 (and subject to the other shareholders’ Pre-emption right), then the Selling Shareholder shall be free to sell its Shares to the Potential Purchaser upon the terms and conditions set forth in the notice, provided that such sale occurs within 90 days after the end of the exercise period.
The Selling Shareholder agrees to obtain from the Potential Purchaser (or to undertake himself, as the case may be) the firm and irrevocable commitment in writing to acquire, in the event of completion of the contemplated Transfer, the Shares with respect to which the Other Shareholders wish to exercise their tag along right, on the same terms and conditions and details, at the same time as such completion. Consequently, the Shareholders agree to forego any proposed Transfer, if the Shares of the Other Shareholders exercising their right deriving from the tag along clause have not been acquired as set forth hereinabove.
Article 5 - Adherence of the transferee to this agreement
In any case, the Selling Shareholder shall cause the Potential Purchaser which becomes transferee of the Shares to adhere to this Agreement so that, upon Transfer of the Shares, it assumes the same rights and obligations of the other Shareholders according to this deed. The transferee shall adhere to this agreement and become part hereof by signing the attached deed of adherence and notifying it to the Company and all other shareholders which are parties to this shareholders agreement.
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Article 6 - Infra Group Transfer
The provisions of paragraph 4 above shall not apply to any Transfer to or from any Subsidiary of any of the Shareholders, provided that (i) the transferor Shareholder delivers to the other Shareholders, in advance of the Transfer, full documentary evidence that the transferee is a Subsidiary, (ii) any such transferee continues to be a Subsidiary of such Shareholder, it being understood that if the transferee ceases to be a Subsidiary of the transferor Shareholder, the latter shall purchase back all the Shares from the transferee before the transaction resulting in the transferee ceasing to be a Subsidiary occurs or is agreed, and (iii) the transferor Shareholder remains severally and jointly liable hereunder with any such transferee.
Article 7 - Drag Along
In case Stefano Buono or a group of Shareholders holding more than 66 % of the Shares (the “Main Shareholders”) receive from a Third Party an offer to purchase all of the Shares, subject to the application of the provisions of Paragraph 10.3, the Other Shareholders undertake to sell their Shares upon the same terms and conditions offered to the Main Shareholders, if so required by the Main Shareholders in the notice under Paragraph 10.3, provided that the terms and conditions of the sale be accepted by a number of Shareholders holding at least 66% plus one Shares of the stated share capital.
TITLE III – PROVISIONS REGARDING MANAGEMENT
Article 8– Company’s Board of directors
8.1. Appointment of the board and managing director. The Company’s board of directors shall consist of a maximum of 9 members, among them Stefano Buono. Stefano Buono shall be granted the management powers and related authority to represent the Company as Director General with all the powers foreseen in the company by-laws.
8.2. Managers’ non compete obligations. The Shareholders which are members of the board of directors from time to time (the “Shareholders Directors”), during the whole period in which they shall be members of the board of directors undertake not to:
(a) carry out activities, individually or in association with third parties, on his own account or as employee of third parties, directly or indirectly, in any form whatsoever, in the field of radiopharmaceuticals production and, in any case, in competition with AAA’s activity.
(b) hold participations of more than 2% of the share capital in companies that carry out activities in competition with AAA.
Exemptions from this article require explicit approval of the board by a majority vote.
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TITLE IV – APPLICATION OF THIS AGREEMENT
Article 9 - Condition precedent
The obligations of the Parties hereunder are expressly subject to the condition that the Agreement be signed by Shareholders holding, at least, sixty six (66) per cent of the share capital of the Company.
If the above condition is not fulfilled by 31 December 2008, this Agreement shall be deemed as not reached and never signed by any of the Parties.
Article 10 – Reporting requirements
The Company shall provide the Shareholders with the following data:
(a) | quarterly financial report, within 45 days of the end of each calendar quarter; |
(b) | 6 months balance sheet, income statement and cash flow statement for the Company, its Subsidiaries and on a consolidated basis, within 60 days after the end of each semester; |
(c) | annual report of the Company, within 120 days of the year end; |
(d) | budget for the year including income statement balance sheet and cash flow statements and capital expenditure plans of the Company, its subsidiaries and on a consolidated basis, on or before 31st of January of the same year; |
(e) | if requested by a specific shareholder, a signed copy of the minutes of the Company’s shareholders meetings; |
(f) | if requested in writing by a Shareholder (in which case this information shall be provided only to the requesting Shareholder), a copy of the general and special auditor reports according to articles L225-237 of the French Code de Commerce; |
(g) | if requested in writing by a Shareholder (in which case this information shall be provided only to the requesting Shareholder), a copy of any question of the statutory auditors addressed in writing to the chairman of the board of directors, and relevant answers, as well as the minutes and and resolutions taken according to article L234-1 of the French Code de Commerce; |
(h) | if requested in writing by a Shareholder (in which case this information shall be provided only to the requesting Shareholder), a copy of his or her shareholdings in AAA (as inscribed in the individual shaeholder register) as of December 31 of each year. |
Advanced Accelerator Applications | 5 of 7 |
Article 11 - Termination of previous shareholders agreement, duration and listing
Subject to the condition precedent under article 9 above, this Agreement shall enter into force the earlier of (i) March 1, 2009 and (ii) the date on which it shall been signed by all Parties hereto – superseding any previous shareholders agreement in force at that time - and shall terminate on February 28, 2019 except that, in case of listing of the Company on any stock exchange, it shall automatically terminate on the date of the listing.
Article 12 - Notices
All notices, advises, statements, requests, demands and other communications under this Agreement will be made in the English or French language and will be given or made (unless provided otherwise in this Agreement) in writing by registered mail posted or by facsimile transmission.
The Parties hereby agree to notify the Company immediately any change of address. Failing this, any notices sent to their former address will be considered valid for the purpose of the Agreement.
Article 12 - Law and Jurisdiction
The Agreement is governed by French law.
The Parties agree to endeavor to settle amicably all disputes, which may arise, concerning the Agreement, its application, and the acts entered into for the application of the Agreement.
Should no amicable settlement be reached, the disputing Parties agree to submit any dispute, which may arise regarding the existence, validity, construction or performance of the Agreement, to the Commercial Court of Bourg-en-Bresse (01).
Article 13 – No waiver
Failure by any Shareholder to exercise, or claim, any right of any kind, or waiver thereof, under this Agreement shall in no event be deemed to be a waiver of such right for the future, such waiver to be effective only with respect to the event involved.
Article 14 - Heirs, Successors, and Assigns – Liquidation of community property
This Agreement shall be binding upon, and inure to the benefit of, all heirs, successors, and assigns, as a matter of right, of the parties hereto. They shall then, as a matter of right be bound thereby, without, as the case may be, the need for any notice to be given
Advanced Accelerator Applications | 6 of 7 |
as contemplated by Article 877 of the Civil Code, which each party hereby expressly waives on their behalf.
In addition, each manager agrees that, in the event of the dissolution of his/her community property rights, he/she shall use his/her best efforts to keep personal ownership of the Shares he/she owns.
Article 15 - Validity
The invalidity of the provisions of this Agreement shall not cause the whole agreement to be invalid, and the parties agree to meet to replace, in the same spirit, any provision that proves to be invalid. The Exhibits hereto shall be deemed to be an integral part of this Agreement.
Article 16 - Signing procedure for the Agreement
Given the distance between the Shareholders themselves and the Company, the Agreement cannot be signed by all Shareholders simultaneously. Each Shareholder therefore agrees to (i) sign one copy of the Agreement which will subsequently be countersigned by Mr Stefano Buono and (ii) provide Mr Stefano Buono with a power of attorney empowering him to sign a copy of the Agreement in their name and for their account.
However, in the case that several Parties can meet for the signing of the Agreement, they will collectively sign the same copy of the Agreement. The other Parties unable to do so will sign their own individual copy of the Agreement.
All Parties hereby acknowledge the validity of this procedure and shall not, in anyway, challenge it on these grounds.
OMISSIS ….. (the shareholder signature list has been eliminated in this copy )
New shareholder’s name |
Location and date |
Signature of shareholder
or representative | ||
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Exhibit 5.1
New York Menlo Park Washington DC São Paulo Londres |
Paris Madrid Tokyo Pékin Hong Kong | ||
Davis Polk & Wardwell LLP 121, avenue des Champs-Elysées 75008 Paris |
01 56 59 36 00 tél 01 56 59 37 00 fax |
Toque N° J020 | |
OPINION OF DAVIS POLK & WARDWELL LLP
January 2, 2015
Advanced Accelerator Applications
20, rue Diesel
01630 Saint-Genis-Pouilly
Ladies and Gentlemen,
Advanced Accelerator Applications, a company incorporated under the laws of the Republic of France as a société anonyme, having its registered office at 20, rue Diesel, 01630 Saint-Genis-Pouilly, registered with the Trade and Companies Registry of Bourg-en-Bresse under number 441 417 110 (the “Company”), has filed with the Securities and Exchange Commission a Registration Statement on Form F-1 (the “Registration Statement”) for the purpose of registering under the Securities Act of 1933, as amended (the “Securities Act”), shares of its common stock, par value €0.10 per share (the “Securities”), including additional shares subject to the underwriters’over-allotment option, each described in the Registration Statement.
We, as your counsel, have examined originals or copies of such documents, corporate records, certificates of public officials and other instruments as we have deemed necessary or advisable for the purpose of rendering this opinion.
In rendering the opinion expressed herein, we have, without independent inquiry or investigation, assumed that (i) all documents submitted to us as originals are authentic and complete, (ii) all documents submitted to us as copies conform to authentic, complete originals, (iii) all signatures on all documents that we reviewed are genuine, (iv) all natural persons executing documents had and have the legal capacity to do so, (v) all statements in certificates of public officials and officers of the Company that we reviewed were and are accurate and (vi) all representations made by the Company as to matters of fact in the documents that we reviewed were and are accurate.
Based upon the foregoing, and subject to the additional assumptions and qualifications set forth below, we advise you that, in our opinion, when the price at which the Securities to be sold has been approved by the Board of Directors of the Company in accordance with the resolutions of the Company’s shareholders adopted at the meeting of December 16, 2014 and when the Securities have been issued and delivered against payment therefor in accordance with the terms of the Underwriting Agreement, the Securities will be validly issued, fully paid and non-assessable.
In connection with the opinion expressed above, we have assumed that the Company is a company duly organized, validly existing and incorporated under the laws of France.
We are members of the Paris Bar and the foregoing opinion is limited to the laws of France as in effect on the date hereof as currently construed by the French courts, and does not express any opinion concerning any other law.
We hereby consent to the filing of this opinion as an exhibit to the Registration Statement and further consent to the reference to our name under the caption “Legal Matters” in the Registration Statement. In giving this consent, we do not admit that we are in the category of persons whose consent is required under Section 7 of the Securities Act.
Very truly yours, | |
/s/ Davis Polk & Wardwell LLP | |
Davis Polk & Wardwell LLP |
2 |
EXHIBIT 8.1
![]() | ORRICK RAMBAUD MARTEL |
SOCIETE D’AVOCATS | |
31, AVENUE PIERRE 1er DE SERBIE | |
75782 PARIS CEDEX 16 | |
FRANCE | |
tél +33 (0) 1 53 53 75 00 | |
fax +33
(0) 1 53 53 75 01 | |
WWW.ORRICK.COM | |
Anne-Sophie Kerfant | |
+33 1 5353 7530 | |
akerfant@orrick.com |
January 5, 2015
Advanced Accelerator Applications
20 rue Diesel
01630 Saint-Genis-Pouilly
France
Ladies and Gentlemen:
We have acted as French tax counsel to Advanced Accelerator Applications, a société anonyme incorporated in the French Republic (“AAA”), in connection with the filing of the Form F-1 with the US Securities and Exchange Commission (as amended to the date hereof, the “Registration Statement”) relating to the contemplated issuance and sale of American Depositary Shares (“ADSs”) representing ordinary shares (the “Ordinary Shares”) of AA, nominal value of 0.10 € per share. You have requested our opinion as to French income tax matters relating to the acquisition, ownership and disposition of the ADSs and underlying Ordinary Shares. All capitalized terms used herein, unless otherwise specified, have the meanings assigned to them in the Registration Statement.
In rendering our opinion, we have examined and relied upon the accuracy and completeness of the facts, information, covenants and representations contained in the Registration Statement filed with the US Securities and Exchange Commission relating to the issuance and sale of the ADSs and such other documents and corporate records as we have deemed necessary or appropriate for purposes of this opinion. Our opinion is conditioned on the initial and continuing accuracy of the facts, information, covenants and representations set forth in the documents referred to above. We have no reason to believe that such facts, information, covenants and representations are not true, but have not attempted to verify them independently and expressly disclaim an opinion as to their validity and accuracy.
In our examination, we have assumed the genuineness of all signatures, the legal capacity of natural persons, the authenticity of all documents submitted to us as originals, the conformity to original documents of all documents submitted to us as certified or photostatic copies and the authenticity of the originals of such documents.
The opinion expressed in this letter is based on the provisions of the French Tax Code (Code général des impôts), as amended, final administrative regulations and interpretations thereof (administrative commentaries binding on the French tax authorities pursuant to section L. 80 A of the French Code of Fiscal Procedures (Livre des procédures fiscales) published in the Bulletin Officiel des Finances Publiques-Impôts _BOFIP ) promulgated thereunder, all as in effect as of the date hereof and all of which are subject to change (possibly on a retroactive basis). No ruling
Membre du groupement transnational
avec Orrick, Herrington & Sutcliffe, Solicitors of the Supreme
Court of England and Wales depuis le 1er janvier 2006.
Membre d’une association agréée, le règlement des honoraires par chèque est accepté.
BERLIN BRUXELLES DÜSSELDORF FRANCFORT HONG KONG LONDRES LOS ANGELES MILAN MOSCOU MUNICH NEW YORK ORANGE COUNTY PARIS PEKIN PORTLAND ROME SACRAMENTO SAN FRANCISCO SEATTLE SHANGHAI SILICON VALLEY TAIPEI TOKYO WASHINGTON DC
Advanced Accelerator Applications
January 5, 2015
Page 2
from the French tax authorities has been or will be sought on any issues related to the acquisition, ownership or disposition of the ADSs, and there can be no assurance that the French tax authorities will not take a contrary view. Although our opinion expressed in this letter represents our best judgment as to the matters addressed, our opinion has no binding effect on the French tax authorities or the courts.
Based upon and subject to the foregoing, and subject to the qualifications set forth herein, the discussion under the heading “Taxation — French Tax Consequences” contained in the Registration Statement, insofar as it relates to statements of French tax law and legal conclusions, constitutes our opinion regarding such matters as of the date hereof.
Except as set forth above, we express no opinion to any party as to the tax consequences, whether French or foreign, relating to AAA or the ADSs or of any transactions related to or undertaken in connection with the issuance and sale of the ADSs. We are furnishing this opinion to you solely in connection with the Registration Statement. We consent to the filing of this opinion as an exhibit to the Registration Statement and to the use of and references to our name under the captions “Taxation” and “Legal Matters” in the prospectus included in the Registration Statement. In giving this consent, we do not thereby admit that we are in the category of persons whose consent is required under Section 7 of the Securities Act of 1933, as amended, or the rules and regulations of the US Securities and Exchange Commission promulgated thereunder (collectively, the “Securities Act”), nor do we thereby admit that we are “experts” within the meaning of such term as used in the Securities Act with respect to any part of the Registration Statement, including this opinion letter as an exhibit or otherwise. We disclaim any obligation to update this opinion letter for events occurring or coming to our attention after the date hereof.
Very truly yours, | |
/s/ Orrick Rambaud Martel | |
Orrick Rambaud Martel | |
ASK |
Exhibit 10.1
Dated 14th February 2014
————
Share purchase agreement of Imaging Equipment limited
between
Advanced Accelerator Applications SA
and
Imaging Equipment (Holdings) Limited
and
Mr Nicholas Stevens
and
Mrs Helen Ruth Stevens
and
Mr Prabhjeevan Singh Virk
and
Mr Victor Griffin
and
Mr Richard Huggins
Piper Smith Watton LLP
29 Great Peter Street,
London,
SW1P 3LW
T: 020 7222 9900
F: 020 7222 9901
W: www.pswlaw.co.uk
Ref: SE/A00660.1
Contents
Clause | ||
1. | Interpretation | 1 |
2. | Sale and purchase | 5 |
3. | Purchase price | 6 |
4. | Completion | 8 |
5. | Warranties | 8 |
6. | Limitations on claims | 10 |
7. | Property | 11 |
8. | Tax covenant | 11 |
9. | Indemnities | 11 |
10. | Commitment of Mr Nicholas Stevens and Mr Prabhjeevan Singh Virk | 12 |
11. | Confidentiality and announcements | 12 |
12. | Further assurance | 14 |
13. | Assignment | 15 |
14. | Entire agreement | 15 |
15. | Variation and waiver | 16 |
16. | Costs | 16 |
17. | Notices | 16 |
18. | Interest | 19 |
19. | Severance | 19 |
20. | Agreement survives Completion | 19 |
21. | Third party rights | 19 |
22. | Successors | 20 |
23. | Counterparts | 20 |
24. | Right and remedies | 20 |
25. | Governing law and jurisdiction | 20 |
Schedule | ||
Schedule 1 | Particulars of Warrantors & Liability for Claims | 21 |
Schedule 2 | Particulars of the Company | 22 |
Schedule 3 | Completion | 23 |
Part 1. | What the Seller shall deliver to the Buyer at Completion | 23 |
Part 2. | Matters for the board meetings at Completion | 24 |
Schedule 4 | Warranties | 25 |
Part 1. | General Warranties | 25 |
1. | Power to sell the Sale Shares | 25 |
2. | Shares in the Company | 25 |
3. | Constitutional and corporate documents | 26 |
4. | Information | 27 |
5. | Compliance with laws | 27 |
6. | Licences and consents | 27 |
7. | Insurance | 28 |
8. | Disputes and investigations | 28 |
9. | Defective Products and Services | 29 |
10. | Contracts and trading | 29 |
11. | Effect of sale of the Sale Shares | 30 |
12. | Transactions with the Seller and the Warrantors | 30 |
13. | Finance and guarantees | 31 |
14. | Insolvency | 31 |
15. | Accounts | 32 |
16. | Changes since Accounts Date | 33 |
17. | Assets | 33 |
18. | Financial and other records | 34 |
19. | Plant and Equipment and Stock in Trade | 34 |
20. | Intellectual property | 35 |
21. | Information technology | 35 |
22. | Employment | 36 |
23. | Retirement benefits | 38 |
24. | Property | 38 |
25. | Environment | 42 |
Part 2. | Tax Warranties | 44 |
Schedule 5 | Tax covenant | 49 |
Schedule 6 | Net Financial Position | 63 |
1. | Definitions | 63 |
2. | Accounts | 64 |
3. | Expert determination | 66 |
Schedule 7 | The Properties | 68 |
THIS AGREEMENT is dated 14th February 2014
Parties
(1) | Imaging Equipment (Holdings) Limited, incorporated and registered in England and Wales with company number 8616092 whose registered office is at The Barn Manor Farm, Church Lane, Chilcompton, Radstock, Somerset, BA3 4HP, UK (the Seller) |
(2) | The several persons whose names and addresses are set out in Schedule 1 (the Warrantors). |
(3) | Advanced Accelerator Applications SA incorporated and registered in France with company number 441 417 110 BOURG EN BRESSE TCR whose registered office is at 20 rue Diesel, 01630 Saint Genis Pouilly, France (the Buyer). |
Background
(A) | The Company is a private company limited by shares incorporated in England and Wales. |
(B) | The Company has an issued share capital of £100 divided into 2,000 ordinary shares of £0.05 each. |
(C) | Further particulars of the Company at the date of this agreement are set out in Schedule 2. |
(D) | The Seller is the legal and beneficial owner of the legal and beneficial title to all of Sale Shares as defined below. |
(E) | The Seller has agreed to sell and the Buyer has agreed to buy the Sale Shares subject to the terms and conditions of this agreement. |
(F) | The Warrantors have agreed to enter into the warranties and indemnities set out in this agreement |
Agreed terms
1. | Interpretation |
1.1 | The definitions and rules of interpretation in this clause apply in this agreement. |
Accounts: the financial statements of the Company as at and to the Accounts Date, comprising the individual accounts of the Company including in the balance sheet, profit and loss account together with the notes on them, the cash flow statement and directors' report (a copy of which are included in the Disclosure Bundle).
Accounts Date: 31st December 2013.
Bonus Scheme: the non contractual bonus scheme currently carried out by the Company in respect of its sales employees and consultants
Business: the business carried on by the Company, namely a supplier of medical products.
Business Day: a day other than a Saturday, Sunday or public holiday in England and France when banks in London and Paris are open for business.
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Buyer's Solicitors: Piper Smith Watton LLP, 29 Great Peter Street, London, SW1P 3LW, United Kingdom.
CAA 2001: the Capital Allowances Act 2001.
Claim: a claim for breach of any of the Warranties
Company: Imaging Equipment Limited, a company incorporated and registered in England and Wales with company number 4189193 whose registered office is at The Barn Manor Farm, Church Lane, Chilcompton, Radstock, Somerset, BA3 4HP, UK, further details of which are set out in Schedule 2.
Completion: completion of the sale and purchase of the Sale Shares in accordance with this agreement.
Completion Date: the date of this agreement.
Connected: has, in relation to a person, the meaning given in section 1122 of the CTA 2010.
Consideration Shares: the ordinary shares of in the capital of the Buyer to be allotted and issued to the Seller in accordance with clause 3.1 in consideration for the sale of the Sale Shares.
Control: shall be as defined in section 1124 of the Corporation Tax Act 2010, and the expression change of Control shall be construed accordingly.
CTA 2009: the Corporation Tax Act 2009.
CTA 2010: the Corporation Tax Act 2010.
Director: each person who is a director or shadow director of the Company as set out in Schedule 2.
Disclosed: fairly and fully disclosed (with sufficient details to identify the nature and scope of the matter disclosed) in or under the Disclosure Letter.
Disclosure Bundle: the bundle of documents, in agreed form, annexed to the Disclosure Letter.
Disclosure Letter: the letter from the Seller to the Buyer, in agreed form, with the same date as this agreement that is described as the Disclosure Letter, including the Disclosure Bundle.
Distribution Agreements: the distribution agreements to which the Company is a party to and which are Disclosed.
Employee: has the meaning set out in paragraph 22.1 of Part 1 of Schedule 4.
Employment Contracts: means the employment contracts with the Buyer (in the agreed form) to be entered into by each of Mr Nicholas Stevens, Mrs Helen Ruth Stevens and Mr Prabhjeevan Singh Virk
Encumbrance: any interest or equity of any person (including any right to acquire, option or right of pre-emption) or any sale, mortgage, charge, pledge, lien, assignment, hypothecation, security interest, title retention or any other security agreement or arrangement.
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Group: in relation to a company, that company, any or any Holding Company from time to time of that company, and any Subsidiary from time to time of a Holding Company of that company. Each company in a Group is a member of the Group.
Holding Company: has the meaning given in clause 1.11.
ICTA 1988: the Income and Corporation Taxes Act 1988.
IHTA 1984: the Inheritance Tax Act 1984.
Indemnity Claim: a claim for breach of any of the indemnities in clause 9.
Intellectual Property Rights: has the meaning given in paragraph 20.1 of Part 1 of Schedule 4.
ITA 2007: the Income Tax Act 2007.
ITEPA 2003: the Income Tax (Earnings and Pensions) Act 2003.
Pension Scheme: Scottish Widows Stakeholder Pension Plan (Group Number P000049924.
Previously-owned Land and Buildings: has the meaning given in paragraph 24.1 of Part 1 of Schedule 4.
Properties: has the meaning given in paragraph 24.1 of Part 1 of Schedule 4.
Purchase Price: the consideration for the Sale Shares to be paid by the Buyer on Completion in accordance with clause 3.
Purple Batch Loan: means any sums due and outstanding (including any interest) from the Company to Purple Batch Limited
Sale Shares: 2,000 ordinary shares of £0.05 each in the Company, all of which have been issued and are fully paid, and which comprise the whole of the issued share capital of the Company.
Seller’s Solicitors: Harris + Harris Solicitors of 11 Stony Street, Frome, Somerset, BA11 1BU, United Kingdom.
Share For Share Exchange: the Share for Share Exchange carried out by the Warrantors, the Seller and the Company on 18th July 2013, whereby each of the Warrantors exchanged their shares in the Company for shares in the Seller.
Subsidiary: has the meaning given in clause 1.11.
Subsidiary undertaking: a subsidiary undertaking as defined in section 1162 of the Companies Act 2006.
Substantiated Claim: a Claim that has been:
(a) | agreed in writing by the parties to the Claim, both as to liability and quantum; or |
(b) | finally adjudicated by a court of competent jurisdiction and no right of appeal lies in respect of such adjudication, or the parties are debarred by passage of time or otherwise from making an appeal. |
Tax or Taxation: has the meaning given in paragraph 1.1 of Schedule 5.
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Tax Covenant: the tax covenant set out in Schedule 5.
Tax Warranties: the Warranties set out in Part 2 of Schedule 4.
Taxation Authority: has the meaning given in paragraph 1.1 of Schedule 5.
Taxation Statute: has the meaning given in paragraph 1.1 of Schedule 5.
TCGA 1992: the Taxation of Chargeable Gains Act 1992.
TIOPA 2010: the Taxation (International and Other Provisions) Act 2010.
TMA 1970: the Taxes Management Act 1970.
Transaction: the transaction contemplated by this agreement or any part of that transaction.
VATA 1994: the Value Added Tax Act 1994.
Warranties: the warranties given pursuant to clause 5 and set out in Schedule 4.
Warrantors: those persons whose names are set out in Schedule 1.
1.2 | Clause, Schedule and paragraph headings shall not affect the interpretation of this agreement. |
1.3 | References to clauses and Schedules are to the clauses of and Schedules to this agreement and references to paragraphs are to paragraphs of the relevant Schedule. |
1.4 | The Schedules form part of this agreement and shall have effect as if set out in full in the body of this agreement. Any reference to this agreement includes the Schedules. |
1.5 | A reference to this agreement or to any other agreement or document referred to in this agreement is a reference to this agreement or such other agreement or document as varied or novated in accordance with its terms from time to time. |
1.6 | Unless the context otherwise requires, words in the singular shall include the plural and the plural shall include the singular. |
1.7 | Unless the context otherwise requires, a reference to one gender shall include a reference to the other genders. |
1.8 | A person includes a natural person, corporate or unincorporated body (whether or not having separate legal personality) and that person's personal representatives, successors and permitted assigns. |
1.9 | A reference to a party shall include that party's personal representatives, successors and permitted assigns. |
1.10 | A reference to a company shall include any company, corporation or other body corporate, wherever and however incorporated or established. |
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1.11 | A reference to a Holding Company or a Subsidiary means a holding company or a subsidiary (as the case may be) as defined in section 1159 of the Companies Act 2006 and for the purposes only of the membership requirement contained in sections 1159(1)(b) and (c), a company shall be treated as a member of another company even if its shares in that other company are registered in the name of: |
(a) | another person (or its nominee), by way of security or in connection with the taking of security; or |
(b) | its nominee. |
1.12 | A reference to the Warrantors shall include a reference to each of them. |
1.13 | A reference to writing or written includes fax and e-mail (unless otherwise expressly provided in this agreement). |
1.14 | Any words following the terms including, include, in particular, for example or any similar expression shall be construed as illustrative and shall not limit the sense of the words, description, definition, phrase or term preceding those terms. |
1.15 | Where the context permits, other and otherwise are illustrative and shall not limit the sense of the words preceding them. |
1.16 | A reference to a statute or statutory provision is a reference to it as amended, extended or re-enacted from time to time provided that, as between the parties, no such amendment, extension or re-enactment made after the date of this agreement shall apply for the purposes of this agreement to the extent that it would impose any new or extended obligation, liability or restriction on, or otherwise adversely affect the rights of, any party. |
1.17 | A reference to a statute or statutory provision shall include all subordinate legislation made from time to time under that statute or statutory provision. |
1.18 | Any obligation on a party not to do something includes an obligation not to allow that thing to be done. |
2. | Sale and purchase |
2.1 | On the terms of this agreement, the Seller shall sell and the Buyer shall buy, with effect from Completion, the Sale Shares with full title guarantee, free from all Encumbrances and together with all rights that attach (or may in the future attach) to the Sale Shares including, in particular, the right to receive all dividends and distributions declared, made or paid on or after the Completion Date. |
2.2 | The Buyer is not obliged to complete the purchase of any of the Sale Shares unless the purchase of all the Sale Shares is completed simultaneously. |
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3. | Purchase price |
3.1 | The Purchase Price is calculated as a sum equivalent to three times the Company’s EBITDA for the financial year ended 31st March 2103, being £402,654, giving a Purchase Price of £1,207,962. The Purchase Price shall be satisfied on Completion by the allotment and issue to the Seller, credited as fully paid, of 294,743 Consideration Shares. |
3.2 | In addition to the Purchase Price the Seller shall be entitled to a further payment of a sum equal to the Net Financial Position (as defined in and calculated in accordance with Schedule 6) which will be: |
(a) | a cash amount payable to the Seller where the Net Financial Position is a positive; or |
(b) | a cash amount payable to the Buyer where the Net Financial Position is a negative. |
3.3 | The Purchase Price shall be deemed to be reduced by the amount of any payment made to the Buyer for each and any: |
(a) | Claim; or |
(b) | Indemnity Claim; or |
(c) | claim under the Tax Covenant; or |
(d) | any payment due to the Buyer in the event of a negative Net Financial Position. |
For the avoidance of doubt any repayment due to the Buyer as a result of a Claim, an Indemnity Claim, a claim under the Tax Covenant or a payment due upon a negative Net Financial Position shall be made in cash notwithstanding that Purchase Price is satisfied by the issue of Consideration Shares.
3.4 | All cash payments to be made to the Seller under this agreement shall be made in sterling by electronic transfer of immediately available funds to the Seller’s Solicitors (who are irrevocably authorised by the Seller to receive the same). Payment to the Seller’s Solicitors in accordance with this clause shall be a good and valid discharge of the obligations of the Buyer to pay the sum in question to the Seller, and the Buyer shall not be concerned to see the application of the monies so paid. |
3.5 | For the purposes of clause 3.1, the value of each Consideration Share shall be €5 (Five Euro) and the rate of sterling to Euro conversion is agreed as being £1 to €1.22. |
3.6 | The Seller undertakes to the Buyer that it shall not, during the period of 24 months following Completion (the Lock-in Period), sell, transfer of otherwise dispose of, or create any Encumbrance over, any of the Consideration Shares (or any interest in them), or enter into any agreement to do so, except in accordance with clause 3.7 below |
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3.7 | Nothing in this clause 3 shall prevent the Seller from selling, transferring or otherwise disposing of any Consideration Shares (or any interest in them: with the prior written consent of the Buyer. |
3.8 | In addition each of the Warrantors hereby undertake and covenant that they shall not, for a period of 24 months, sell, transfer, assign or otherwise dispose or create any Encumbrance over the shares that they currently hold in the Seller. |
3.9 | The Buyer acknowledges that the shares held by the Seller in Nuada Medical Limited ("the Nuada Shares") do not form part of this transaction, and that the Company has executed transfers of the Nuada shares from the Company to the Seller but that the transfer of the shares may not have been registered as at the date of Completion. The Buyer agrees that in respect of the Nuada Shares:- |
(a) | they are not covered by the Warranties given by the Seller and the Warrantors in Schedule 4 of this Agreement. |
(b) | that no value is to be attributed to them in the calculation of the Net Financial Provision under Schedule 6 of this Agreement. |
(c) | the Buyer shall allow the Company to promptly execute and deliver such documents and perform such acts as the Seller may reasonably require from time to time for the purpose of giving full effect to the transfer of the Nuada Shares, save that any Stamp Duty or any other tax, duty or levy in respect of the transfer of the Nuada Shares shall be payable by the Seller and / or the Warrantors and neither the Buyer nor the Company shall have any obligations in this regard. |
(d) | The Buyer undertakes to the Seller that, if and for so long as the Company remains the registered holder of any of the Nuada Shares after Completion, it shall procure that the Company: |
i) | holds such Nuada Shares together with all dividends and any other distributions of profits, surplus or other assets in respect of such Nuada Shares and all rights arising out of or in connection with them, in trust for the Seller; |
ii) | at all times after Completion, deal with and dispose of such Nuada Shares, dividends, distributions, assets and rights as the Seller shall direct; |
iii) | exercise all voting rights attached to such Nuada Shares in such manner as the Seller shall direct; and |
iv) | if required by the Seller, execute all instruments of proxy or other documents as may be necessary to enable the Seller to attend and vote at any meeting of the Company. |
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4. | Completion |
4.1 | Completion shall take place on the Completion Date at the offices of the Buyer's Solicitors (or at any other place as may be agreed in writing by the parties). |
4.2 | At Completion: |
(a) | the Seller shall: |
(i) | deliver or cause to be delivered to the Buyer the documents and evidence set out in Part 1 of Schedule 3; |
(ii) | procure that a board meeting of the Company is held at which the matters set out in Part 2 of Schedule 3 are carried out; and |
(iii) | deliver any other documents referred to in this agreement as being required to be delivered by the Seller; and |
(iv) | cause each of Mr Nicholas Stevens, Helen Ruth Stevens and Mr Prabhjeevan Singh Virk to deliver the Employment Contracts. |
(b) | the Buyer shall (subject to the Seller complying with its obligations in clause 4.2(a)) settle the Purchase Price in accordance with clause 3.1 and deliver to the Seller: |
(i) | deliver to the Seller a certified copy of the Board resolutions passed by the Buyer authorising the Transaction and giving general authority to the directors of the Buyer to allot the Consideration Shares on Completion; |
(ii) | deliver to the Seller a share certificate in respect of the Consideration Shares duly executed by the Buyer; and |
(iii) | a signed acknowledgement of the Disclosure Letter. |
4.3 | As soon as possible after Completion, the Seller shall send to the Buyer all records, correspondence, documents, files, memoranda and other papers relating to the Company which are not kept at any of the Properties and which are not required to be delivered at Completion. |
5. | Warranties |
5.1 | The Seller and each of the Warrantors acknowledge that the Buyer is entering into this agreement on the basis of the Warranties. |
5.2 | The Seller and each of the Warrantors warrant to the Buyer that except as Disclosed, each Warranty is true, accurate and not misleading on the date of this agreement. |
5.3 | Without prejudice to the right of the Buyer to claim on any other basis or take advantage of any other remedies available to it, if any Warranty is breached or proves |
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to be untrue or misleading, the Seller and each of the Warrantors shall pay to the Buyer on demand:
(a) | the amount necessary to put the Company into the position they would have been in if the Warranty had not been breached or had not been untrue or misleading; |
(b) | all costs and expenses (including, without limitation, damages, legal and other professional fees and costs, penalties, expenses and consequential losses whether arising directly or indirectly) incurred by the Buyer or the Company as a result of such breach or of the Warranty being untrue or misleading; and |
(c) | any amount necessary to ensure that, after any Taxation of a payment made in accordance with clause 5.3(a) or clause 5.3(b), the Buyer is left with the same amount it would have had if the payment was not subject to Taxation. |
5.4 | Warranties qualified by the expression so far as the Seller or the Warrantors are aware or any similar expression are deemed to be given to the best of the knowledge, information and belief of the Seller and each Warrantor after they have made all reasonable and proper enquiries of: |
(a) | The other Warrantors, directors, company secretary and employees of the Company and Seller |
(b) | The accountants and legal advisers for the Company and the Seller. |
5.5 | Each of the Warranties is separate and, unless otherwise specifically provided, is not limited by reference to any other Warranty or any other provision in this agreement. |
5.6 | Except for the matters Disclosed, no information of which the Buyer, its agents or its advisers has knowledge (in each case whether actual, constructive or imputed), or which could have been discovered (whether by investigation made by the Buyer or on its behalf), shall prejudice or prevent any Claim or reduce the amount recoverable under any Claim. |
5.7 | The Seller agrees that the supply of any information by or on behalf of the Company, or any of its employees, directors, agents or officers (Officers) to the Seller or their advisers in connection with the Warranties, the Disclosure Letter or otherwise shall not constitute a warranty, representation or guarantee as to the accuracy of such information in favour of the Seller. The Seller unconditionally and irrevocably waives all and any rights and claims that it may have against any of the Company, the or the Officers on whom that Seller has, or may have, relied in connection with the preparation of the Disclosure Letter, or agreeing the terms of this agreement, and further undertakes to the Buyer not to make any such claims. |
5.8 | The rights and remedies of the Buyer in respect of any Claim or claim under the Tax Covenant shall not be affected by Completion. |
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6. | Limitations on claims |
6.1 | Save as provided in clause 6.6, the provisions of this clause 6 limit the liability of the Seller and the Warrantors in relation to any Claim and (where specifically provided) |
6.2 | The aggregate liability of the Seller and the Warrantors for all Substantiated Claims shall not exceed an amount equal to the Purchase Price. Notwithstanding that the Purchase Price shall be satisfied by the issue of the Consideration Shares, any Claim shall be settled by the Seller and the Warrantors in cash. |
6.3 | The Seller and the Warrantors shall not be liable for a Claim liability in respect of such Claim (together with any connected Claims) exceeds £5,000. |
For the purposes of this clause 6.3, a Claim is connected with another Claim if the Claims arise from the same or related event or set of circumstances, or relate to the same or similar subject matter.
6.4 | The Seller and the Warrantors shall not be liable for a Claim unless notice in writing summarising the nature of the Claim (in so far as it is known to the Buyer) and, as far as is reasonably practicable, the amount claimed, has been given by or on behalf of the Buyer to the Seller: |
(a) | in the case of a claim made under the Tax Warranties, on or before the seventh anniversary of Completion; or |
(b) | in any other case, prior to the expiry of the period of eighteen ( 18) months commencing on the Completion Date. |
6.5 | The Seller and the Warrantors shall not be liable for a Claim to the extent that the Claim: |
(a) | relates to matters Disclosed; or |
(b) | relates to any matter specifically and fully provided for in the Accounts. |
6.6 | Nothing in this clause 6 applies to exclude or limit the liability of the Seller and the Warrantors: |
(a) | to the extent that a Claim arises or is delayed as a result of dishonesty, fraud, wilful misconduct or wilful concealment by the Seller and / or the Warrantors, their agents or advisers; or |
(b) | in respect of a breach of any of the warranties in paragraph 1.1, paragraph 1.2, paragraph 1.3, paragraph 2.1, paragraph 2.2 or paragraph 2.3 of Part 1 of Schedule 4. |
6.7 | Neither the Seller nor any of the Warrantors shall plead the Limitation Act 1980 in respect of any claims made under the Tax Warranties or Tax Covenant up to seven years after the Completion Date. |
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6.8 | The Warrantors shall be severally liable to any Claim to the extent set out in column 2 of Schedule 1. |
7. | Property |
The provisions of Schedule 7 apply in this agreement in relation to the Properties.
8. | Tax covenant |
The provisions of Schedule 5 apply in this agreement in relation to Taxation.
9. | Indemnities |
9.1 | Each of the Seller and the Warrantors shall indemnify the Buyer and the Company against, and shall pay to the Buyer a sum equal to, all liabilities, costs, expenses, damages and losses (including but not limited to any direct, indirect or consequential losses, loss of profit, loss of reputation and all interest, penalties and legal costs and all other reasonable professional costs and expenses) suffered or incurred by the Buyer or the Company arising out of or in connection with any of the following matters: |
(a) | Any liability to Taxation, fine or penalty together with any loss, damage or costs arising from or related to the Share for Share Exchange and any need for remedial action to be carried out in respect of the same in order to ensure that the Seller has proper legal and beneficial title to the Sale Shares; |
(b) | Any obligation, liability, cost, loss or damage relating to any outstanding amount due and payable in respect of the Purple Batch Loan agreement; |
(c) | Any liability, cost, loss or damage incurred by the Company relating to any Employee or Worker of the Company claiming that the Bonus Scheme is a contractual right in accordance with their terms of employment or engagement with the Company (including without limitation any ongoing obligation of the Company to make payments in accordance with or connected to the Bonus Scheme) and gives them any right or entitlement to a payment for any period after 31st March 2014 in excess of the bonus scheme operated by the Buyer in equivalent business at the date hereof; |
(d) | Any obligation, liability (including any liability to tax or National Insurance Contributions), cost, loss or damage incurred by the Company relating to payments made to any service company of any director, employee or sales person of the Company (including but not limited to Purple Batch Limited and Medtech Consultants Limited) and any failure to disclose these payments as related party transactions by virtue of the Companies Act 2006 (or any other relevant legislation or regulation); and |
(e) | Any liability, cost, loss or damage incurred by the Company relating to the sale or grant of licences of FRACTIONcheck and / or ImagePro software to third parties. |
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9.2 | The Warrantors shall be severally liable to any Claim under 9.1 above to the extent set out in column 2 of Schedule 1. |
9.3 | In addition Mr Nicholas Stevens hereby indemnifies the Buyer with respect to all and any cost, loss or damage relating to a breach by him of his obligations in clause 10.1 below |
9.4 | In addition Mr Prabhjeevan Singh Virk hereby indemnifies the Buyer with respect to all and any cost, loss or damage relating to a breach by him of his obligations in clause 10.1 below. |
9.5 | In addition Mrs Helen Ruth Stevens hereby indemnifies the Buyer with respect to all and any cost, loss or damage relating to a breach by her of her obligations in clause 10.1 below. |
9.6 | Any payment made by the Seller and / or the Warrantors in respect of an Indemnity Claim shall include: |
(a) | an amount in respect of all costs and expenses reasonably incurred by the Buyer and the Company in bringing the relevant Indemnity Claim; and |
(b) | any amount necessary to ensure that, after any Taxation of the payment, the Buyer and the Company (as the case may be) is left with the same amount it would have had if the payment was not subject to Taxation. |
10. | Commitment of Mr Nicholas Stevens, Mrs Helen Ruth Stevens and Mr Prabhjeevan Singh Virk |
10.1 | Each of Mr Nicholas Stevens, Mrs Helen Ruth Stevens and Mr Prabhjeevan Singh Virk hereby agree that it is a material term of this agreement that they each continue to be involved in the management of the Company after Completion. In consideration of the Buyer entering into this agreement each of Mr Nicholas Stevens, Mrs Helen Ruth Stevens and Mr Prabhjeevan Singh Virk hereby separately covenant with the Buyer to continue to carry out the management of the Company for a period of 3 years and 6 months from Completion as may be required by the Buyer. In addition each of Mr Nicholas Stevens, Mrs Helen Ruth Stevens and Mr Prabhjeevan Singh Virk agree that it is a condition of Completion that they enter into the Employment Contracts on Completion. |
11. | Confidentiality and announcements |
11.1 | The Seller and each of the Warrantors separately undertake to each of the Buyer and the Company that he shall: |
(a) | keep confidential the terms of this agreement and all confidential information or trade secrets in his possession concerning the business, affairs, customers, clients or suppliers of the Company or any member of the Buyer's Group; |
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(b) | not disclose any of the information referred in clause 11.1(a) in whole or in part to any third party, except as expressly permitted by this clause 11; and |
(c) | not make any use of any of the information referred in clause 11.1(a), other than to the extent necessary for the purpose of exercising or performing his rights and obligations under this agreement. |
11.2 | Nothing in this agreement shall be construed as imposing on the Buyer an obligation to keep confidential, or restrict its use after Completion, of any information relating to the Company. |
11.3 | Notwithstanding any other provision of this agreement, no party shall be obliged to keep confidential or to restrict its use of any information that: |
(a) | is or becomes generally available to the public (other than as a result of its disclosure by the receiving party or any person to whom it has disclosed the information in accordance with clause 11.4(a) in breach of this agreement); or |
(b) | was, is or becomes available to the receiving party on a non-confidential basis from a person who, to the receiving party's knowledge, is not bound by a confidentiality agreement with the disclosing party or otherwise prohibited from disclosing the information to the receiving party. |
11.4 | Any party may disclose any information that it is otherwise required to keep confidential under this clause 11: |
(a) | to those of its employees, officers, consultants, representatives or advisers who need to know such information to enable them to advise on this agreement, or to facilitate the Transaction, provided that the party making the disclosure informs the recipient of the confidential nature of the information before disclosure and procures that each recipient shall, in relation to any such information disclosed to him, comply with the obligations set out in this clause 11 as if they were that party. The party making a disclosure under this shall, at all times, be liable for the failure of its recipients to comply with the obligations set out in this clause 11; or |
(b) | with the prior consent in writing of all the other parties; or |
(c) | if such information relates to one party only, with the prior consent in writing of that party; or |
(d) | to the extent that the disclosure is required: |
(i) | by the laws of any jurisdiction to which that party is subject; or |
(ii) | by an order of any court of competent jurisdiction, or any regulatory, judicial, governmental or similar body, or any Taxation Authority or securities exchange of competent jurisdiction; or |
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(iii) | to make any filing with, or obtain any authorisation from, a regulatory, governmental or similar body, or any Taxation Authority or securities exchange of competent jurisdiction; or |
(iv) | to protect that party's interest in any legal proceedings, |
PROVIDED that in each case (and to the extent it is legally permitted to do so) the party making the disclosure gives the other parties as much notice of such disclosure as possible and, where notice of disclosure is not prohibited and is given in accordance with this clause, it takes into account the reasonable requests of the other parties in relation to the content of such disclosure.
11.5 | Subject to clause 11.6, clause 11.7 and clause 11.8, no party shall make, or permit any person to make, any public announcement, communication or circular (announcement) concerning this agreement or the Transaction without the prior written consent of the other parties (such consent not to be unreasonably withheld or delayed). |
11.6 | Nothing in clause 11.5 shall prevent any party from making any announcement required by law or any governmental or regulatory authority (including, without limitation, any relevant securities exchange), or by any court or other authority of competent jurisdiction provided that the party required to make the announcement consults with the other parties and takes into account the reasonable requests of the other parties in relation to the content of such announcement before it is made. |
11.7 | The parties shall cooperate and coordinate with each other with regard to the issue of a press release in agreed form immediately after Completion. |
11.8 | The Buyer may, at any time after Completion announce its acquisition of the Sale Shares to any employees, clients, customers or suppliers of the Company or any other member of the Buyer's Group. |
11.9 | The obligations and liability of the Seller and the Warrantors under this clause 11 shall be several and extend only to any loss or damage arising out of their own breaches. |
12. | Further assurance |
12.1 | The Seller and the Warrantors shall (at their own expense) promptly execute and deliver such documents and perform such acts as the Buyer may reasonably require from time to time for the purpose of giving full effect to this agreement. |
12.2 | The Seller undertakes to the Buyer that, if and for so long as it remains the registered holder of any of the Sale Shares after Completion, it shall: |
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(a) | hold such Sale Shares together with all dividends and any other distributions of profits, surplus or other assets in respect of such Sale Shares and all rights arising out of or in connection with them, in trust for the Buyer; |
(b) | at all times after Completion, deal with and dispose of such Sale Shares, dividends, distributions, assets and rights as the Buyer shall direct; |
(c) | exercise all voting rights attached to such Sale Shares in such manner as the Buyer shall direct; and |
(d) | if required by the Buyer, execute all instruments of proxy or other documents as may be necessary to enable the Buyer to attend and vote at any meeting of the Company. |
13. | Assignment |
13.1 | Subject to the further provisions of this clause 13, no party shall assign, transfer, mortgage, charge, declare a trust of, or deal in any other manner with any or all of its rights and obligations under this agreement (or any other document referred to in it). |
13.2 | Each party confirms it is acting on its own behalf and not for the benefit of any other person. |
13.3 | The Buyer may assign or transfer its rights (but not its obligations) under this agreement (or any document referred to in this agreement) to another member of its Group for so long as that company remains a member of the Buyer's Group. The Buyer shall procure that such assignee assigns any rights assigned to it in accordance with this clause 13 back to the Buyer immediately before it ceases to be a member of the Buyer's Group. |
13.4 | If there is an assignment or transfer of the Buyer's rights in accordance with clause 13.3: |
(a) | the Seller and the Warrantors may discharge their obligations under this agreement to the Buyer until they receive notice of the assignment; and |
(b) | the assignee may enforce this agreement as if it were named in this agreement as the Buyer, subject that any liability to an assignee cannot exceed the liability that would have existed to the Buyer and that the benefit of warranties can only be assigned by the Buyer subject to the disclosures and limitations on liability in this Agreement, but the Buyer shall remain liable for any obligations under this agreement. |
14. | Entire agreement |
14.1 | This agreement (together with the documents referred to in it) constitute the entire agreement between the parties and supersede and extinguish all previous discussions, correspondence, negotiations, drafts, agreements, promises, assurances, warranties, |
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representations and understandings between them, whether written or oral, relating to its subject matter.
14.2 | The Buyer acknowledges that in entering into this agreement, and any documents referred to in it, the Buyer does not rely on, and shall have no rights or remedies in respect of, any statement, representation, assurance or warranty (whether made innocently or negligently) that is not set out in this agreement. |
15. | Variation and waiver |
15.1 | No variation of this agreement shall be effective unless it is in writing and signed by the parties (or their authorised representatives). |
15.2 | A waiver of any right or remedy under this agreement or by law is only effective if it is given in writing and is signed by the person waiving such right or remedy. Any such waiver shall apply only to the circumstances for which it is given and shall not be deemed a waiver of any subsequent breach or default. |
15.3 | A failure or delay by any person to exercise any right or remedy provided under this agreement or by law shall not constitute a waiver of that or any other right or remedy, nor shall it prevent or restrict any further exercise of that or any other right or remedy. |
15.4 | No single or partial exercise of any right or remedy provided under this agreement or by law shall prevent or restrict the further exercise of that or any other right or remedy. |
15.5 | A party that waives a right or remedy provided under this agreement or by law in relation to one party, or takes or fails to take any action against that party, does not affect its rights in relation to any other party. |
15.6 | The Buyer may take action against, grant time or other indulgence to, or release or compromise in whole or part the liability of, any one or more of the Seller and the Warrantors in respect of any warranty, indemnity, representation or other obligation under this agreement without affecting the liability of any of the either the Seller or any of the Warrantors who are liable (whether jointly and severally or otherwise) in respect of that warranty, indemnity, representation or other obligation. |
16. | Costs |
Except as expressly provided in this agreement, each party shall pay its own costs and expenses incurred in connection with the negotiation, preparation and execution of this agreement (and any documents referred to in it).
17. | Notices |
17.1 | For the purposes of this clause 17, but subject to clause 17.7, notice includes any other communication. |
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17.2 | A notice given to a party under or in connection with this agreement: |
(a) | shall be in writing and in English; |
(b) | shall be signed by or on behalf of the party giving it; |
(c) | shall be sent to the relevant party for the attention of the contact and to the address or fax number specified in clause 17.3 (as the case may be), or such other address, fax number or person as that party may notify to the others in accordance with the provisions of this clause 17; |
(d) | shall be: |
(i) | delivered by hand; or |
(ii) | sent by fax; or |
(iii) | sent by pre-paid first class post, recorded delivery or special delivery; or |
(iv) | sent by airmail or by reputable international overnight courier (if the notice is to be served by post to an address outside the country from which it is sent); and |
(e) | unless proved otherwise is deemed received as set out in clause 17.5. |
17.3 | The addresses and fax numbers for service of notices on the Seller, the Warrantors and the Buyer are: |
(a) | Seller |
(i) | address: as set out above |
(ii) | for the attention of: Nicholas Stevens |
(iii) | fax number: such fax number as may be supplied from time to time |
(b) | Buyer |
(i) | address: as set out above |
(ii) | for the attention of: Stefano Buono |
(iii) | fax number: +33 450 99 30 89 |
(c) | Mr Nicholas Stevens |
(i) | address: as set out in Schedule 1 |
(ii) | fax number: such fax number as may be supplied from time to time |
(d) | Mrs Helen Ruth Stevens |
(i) | address: as set out in Schedule 1 |
(ii) | fax number: such fax number as may be supplied from time to time |
17 |
(e) | Mr Richard Huggins |
(i) | address: as set out in Schedule 1 |
(ii) | fax number: such fax number as may be supplied from time to time |
(f) | Mr Prabhjeevan Singh Virk |
(i) | address: as set out in Schedule 1 |
(ii) | fax number: such fax number as may be supplied from time to time |
(g) | Mr Victor Griffin |
(i) | address: as set out in Schedule 1 |
(ii) | fax number: such fax number as may be supplied from time to time |
17.4 | A party may change its details for service of notices as specified in clause 17.3 or Schedule 1 (as the case may be) by giving notice to each of the other parties. Any change notified pursuant to this clause shall take effect at 9.00 am on the later of: |
(a) | the date (if any) specified in the notice as the effective date for the change; or |
(b) | five (5) Business Days after deemed receipt of the notice of change. |
17.5 | Delivery of a notice is deemed to have taken place (provided that all other requirements in this clause have been satisfied): |
(a) | if delivered by hand, on signature of a delivery receipt or at the time the notice is left at the address; or |
(b) | if sent by fax, at the time of transmission; or |
(c) | if sent by pre-paid first class post, recorded delivery or special delivery to an address in the UK, at 9.00 am on the second Business Day after posting; or |
(d) | if sent by pre-paid airmail to an address outside the country from which it is sent, at 9.00 am on the fifth Business Day after posting; or |
(e) | if sent by reputable international overnight courier to an address outside the country from which it is sent, on signature of a delivery receipt or at the time the notice is left at the address; or |
(f) | if deemed receipt under the previous paragraphs of this clause 17.5 would occur outside business hours (meaning 9.00 am to 5.30 pm Monday to Friday on a day that is not a public holiday in the place of receipt), at 9.00 am on the day when business next starts in the place of deemed receipt. For the purposes of this clause, all references to time are to local time in the place of deemed receipt. |
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17.6 | To prove service, it is sufficient to prove that: |
(a) | if delivered by hand or by reputable international overnight courier, the notice was delivered to the correct address; or |
(b) | if sent by fax, a transmission report was received confirming that the notice was successfully transmitted to the correct fax number; or |
(c) | if sent by post or by airmail, the envelope containing the notice was properly addressed, paid for and posted. |
17.7 | This clause 17 does not apply to the service of any proceedings or other documents in any legal action or, where applicable, any arbitration or other method of dispute resolution. |
17.8 | A notice given under or in connection with this agreement is not valid if sent by e-mail. |
18. | Interest |
If a party fails to make any payment due to any other party under this agreement by the due date for payment, then the defaulting party shall pay interest on the overdue amount at the rate of 5% per annum above Barclays Bank's base rate from time to time. Such interest shall accrue on a daily basis from the due date until actual payment of the overdue amount, whether before or after judgment. The defaulting party shall pay the interest together with the overdue amount.
19. | Severance |
If any provision or part-provision of this agreement is or becomes invalid, illegal or unenforceable, it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible, the relevant provision or part-provision shall be deemed deleted. Any modification to or deletion of a provision or part-provision under this clause shall not affect the validity and enforceability of the rest of this agreement.
20. | Agreement survives Completion |
This agreement (other than obligations that have already been fully performed) remains in full force after Completion.
21. | Third party rights |
21.1 | Except as expressly provided in clause 21.2, a person who is not a party to this agreement shall not have any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this agreement. |
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21.2 | The following provisions are intended to benefit future buyers of the Sale Shares and (to the extent that they are identified in the relevant clauses as recipients of rights or benefits under that clause), the Company and the Officers (as defined in clause 5.7), and shall be enforceable by each of them to the fullest extent permitted by law: |
(a) | Clause 5(Warranties) and Schedule 4 (subject to clause 6 (Limitations)); |
(b) | Clause 8 (Tax Covenant) and Schedule 5; |
(c) | Clause 9 (Indemnities); |
(d) | Clause 10 (Obligations of Mr Nicholas Stevens, Mrs Helen Ruth Stevens and Mr Prabhjeevan Singh Virk) |
(e) | Clause 11 (Confidentiality and Announcements); and |
(f) | Clause 18 (Interest). |
21.3 | The rights of the parties to terminate, rescind or agree any variation, waiver or settlement under this agreement are not subject to the consent of any other person. |
22. | Successors |
This agreement (and the documents referred to in it) are made for the benefit of the parties and their successors and permitted assigns, and the rights and obligations of the parties under this agreement shall continue for the benefit of, and shall be binding on, their respective successors and permitted assigns.
23. | Counterparts |
This agreement may be executed in any number of counterparts, each of which when executed shall constitute a duplicate original, but all the counterparts shall together constitute the one agreement.
24. | Right and remedies |
Except as expressly provided in this agreement, the rights and remedies provided under this agreement are in addition to, and not exclusive of, any rights or remedies provided by law.
25. | Governing law and jurisdiction |
25.1 | This agreement and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of England and Wales. |
25.2 | Each party irrevocably agrees that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute or claim arising out of or in connection with this agreement or its subject matter or formation (including non-contractual disputes or claims). |
This agreement has been entered into on the date stated at the beginning of it.
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Signed by Nicholas Stevens, a director, IMAGING EQUIPMENT |
/s/ Nicholas Stevens Nicholas Stevens | |
Signed by NICHOLAS STEVENS | /s/ Nicholas Stevens | |
Signed by HELEN RUTH STEVENS | /s/ Helen Ruth Stevens | |
Signed by PRABHJEEVAN SINGH VIRK | /s/ Prabhjeevan Singh Virk | |
Signed by VICTOR GRIFFEN | /s/ Victor Griffen | |
Signed by RICHARD HUGGINS | /s/ Richard Huggins | |
Signed by Stefano Buono, general manager, |
/s/ Stefano Buono Stefano Buono | |
for and on behalf of ADVANCED SA |
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Exhibit 10.2
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
[*] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION.
Execution Version
MAY 20, 2010
BioSynthema Inc. and
Advanced Accelerator Applications, S.A.
SALE AND PURCHASE AGREEMENT
FOR THE ENTIRE ISSUED SHARE CAPITALOF
BIOSYNTHEMA INC.
TABLE OF CONTENTS
Page | ||
1. | Definitions and Interpretation | 1 |
2. | Sale and Purchase | 12 |
3. | Initial Cash Payment; Initial Shares | 12 |
4. | Contingent Cash Consideration; Contingent Shares | 13 |
5. | Royalty Payments and Obligations | 15 |
6. | Conditions | 18 |
7. | Conduct of Business Before Completion | 19 |
8. | Completion | 20 |
9. | Representations and Warranties; Limitations; Cure Period | 20 |
10. | Survival Following Completion | 22 |
11. | Remedies and Waivers | 22 |
12. | Assignment | 23 |
13. | Entire Agreement; Amendment | 23 |
14. | Notices | 23 |
15. | Confidentiality | 24 |
16. | Costs and Expenses | 26 |
17. | Counterparts | 27 |
18. | Termination | 27 |
19. | Dispute Resolution | 28 |
20. | Currency Conversion | 28 |
21. | Severability | 28 |
22. | Choice of Governing Law; Venue; Service of Process and Judgments | 28 |
23. | Press Announcements | 29 |
24. | Further Assurances; Mutual Drafting | 29 |
Schedule 1 - Shareholders | |
Schedule 2 - Conditions to Completion | |
Schedule 3 - Representations and Warranties | |
Schedule 4 - Company Subsidiaries | |
Schedule 5 - Restricted Actions | |
Schedule 6 - Indemnification Obligations | |
Schedule 7 - Accounts as of December 31, 2009· |
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THIS SALE AND PURCHASE AGREEMENT (the "Agreement") is made as of this 20th day of May, 2010
BY AND AMONG:
1. | The several persons whose names are set out in Schedule 1 (the "Shareholders"); and |
2. | Advanced Accelerator Applications, S.A., a limited company (societe anonyme) registered under the laws of France, and whose corporate headquarters is at 20 rue Diesel, 01630 Saint-Genis-Pouilly, France (the "Purchaser"); and |
3. | BioSynthema Inc., a company incorporated under the laws of Missouri, United States of America, whose corporate headquarters is at 4041 Forest Park Boulevard, St. Louis, Missouri 63108, United States of America (the "Company," the Shareholders, the Purchaser and the Company may be referred to herein individually as a "Party" or collectively as the "Parties"). |
WHEREAS:
The Shareholders have each agreed to transfer and sell the Company Shares owned by them and the Purchaser has agreed to purchase and pay for all the Company Shares, in each case on the terms and subject to the conditions of this Agreement.
NOW IT IS HEREBY AGREED as follows:
1.DEFINITIONS AND INTERPRETATION
1.1 In this Agreement, the schedules and the Disclosure Letter, the following terms shall be defined as set forth below:
"Accounts" means the consolidated unaudited financial statements of the Company (comprising a balance sheet, consolidated statement of profit and loss and statement of cash flows for the fiscal year ended on 31 December 2009 with the notes thereto).
"Accounts Date" means December 31,2009.
"Accounts Receivable" has the meaning ascribed thereto in Schedule 3, Part A, and Section 22.
"Action" has the meaning ascribed thereto in Schedule 3, Part A, and Section 5.1.
"Affiliate" means, (i) in respect of any person including an individual, a person that directly, or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with, the person specified, where "control" means the possession,
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directly or indirectly, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by agreement, as trustee or executor, or otherwise, and (ii) in respect of any individual, his or her grandparents and all descendants of those grandparents and (in each case) their spouses or a trust of which any of them is a beneficiary.
"Aggregate Consideration" has the meaning ascribed thereto in Section 2.1.
"Agreement" has the meaning set forth in the first sentence hereof.
"Authorizations" has the meaning ascribed thereto in Schedule 3, Part A, Section 16.
"Benchmark Value" means € 2.50 per Purchaser Share.
"Breaching Party" has the meaning ascribed thereto in Section 9.4.
"Breaching Shareholder" has the meaning ascribed thereto in Schedule 6, Section 2.1.
"Business" means the businesses and activities of the Company and Company Subsidiaries (including businesses as carried on at the date of this Agreement or at any time prior to Completion).
"Business Day" means a day (other than a Saturday or a Sunday) on which financial institutions are open for business in London, England and New York City, New York, United States of America.
"Claim Notice" has the meaning ascribed thereto in Section 2.1 of Schedule 6. "Clinical Trials Target" has the meaning ascribed thereto in Section 4.1. "Code" means the Internal Revenue Code of 1986, as amended.
"Combination Product" means a Product or Substitute Product sold in a finished dosage form containing a Product or Substitute Product in combination with one or more other products or ingredients which are not Products or Substitute Products.
"Common Stock" means the common stock, par value $0.10 of the Company
"Company" has the meaning ascribed thereto in the third recital.
"Company Benefit Plans" has the meaning ascribed thereto in Schedule 3, Part A, Section 7.1.
"Company ERISA Affiliate" has the meaning ascribed thereto in Schedule 3, Part A, and Section 7.1
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"Company Intellectual Property" has the meaning ascribed thereto in Schedule 3, Part A, and Section 21.
"Company Legal Counsel" means Palank & Associates, LLC.
"Company Material Adverse Effect" means such circumstances, event or change that has had a material adverse effect on the business, operations or financial condition of the Company, but shall not include facts, circumstances, event or changes (i) generally affecting the economy or the financial, debt, credit or securities markets, in the United States or elsewhere, (ii) resulting from political conditions or developments in general, (iii) reflecting or resulting from changes or proposed changes in any Law (or interpretations thereof), (iv) resulting from the taking of any action contemplated by this Agreement and the other agreements contemplated hereby, or (v) any facts, circumstances, events or changes that are cured by the Shareholders before the Completion Date.
"Company Material Contract" has the meaning ascribed thereto in Schedule 3, Part A, Section 20.
"Company Obligations" means (i) the loans from Stichting BWE to the Company in the amounts of $300,000 and €250,000, respectively, as each was amended May 1, 2010 and (ii) the $250,000 payable to Mallinckrodt Inc. on or before September 11, 2010, each as further described in the Disclosure Letter.
"Company Organization Documents" has the meaning ascribed thereto in Schedule 3, Part A, Section 1.
"Company Real Property" has the meaning ascribed thereto in Schedule 3, Part A, and Section 9.1.
"Company Shares" means the 5,390,033 shares of Common Stock issued and outstanding as of the date of this Agreement.
"Company Subsidiary" means any Subsidiary of the Company.
"Company Subsidiary Organization Documents" has the meaning ascribed thereto in Schedule 3 Sections 1.
"Completion" means the completion of the sale and purchase of the Company Shares pursuant to the terms of this Agreement.
"Completion Date" means the date of Completion or such other date as the Purchaser and the Majority Shareholders shall agree in writing to be the Completion Date.
"Confidential Material" has the meaning ascribed thereto in Section 15.1.
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Contingent Consideration" means, collectively, the Contingent Cash Consideration and the Contingent Shares.
"Contingent Cash Consideration" has the meaning ascribed thereto in Section 2.1.
"Contingent Shares" has the meaning ascribed thereto in Section 2.1.
"Damages" has the meaning ascribed thereto in Section 2.1 of Schedule 6.
"Deed of Adherence" means a deed of adherence in a form satisfactory to the Purchaser, the Shareholders and the Company.
"Directors" mean Erion and van Rossem.
"Disclosing Party" has the meaning ascribed thereto in Section 15.1.
"Disclosure Letter" means the letter having the same date as this Agreement from the Company to the Purchaser setting forth exceptions to Schedule 3.
"Earn Out" has the meaning ascribed thereto in Section 5.8.
"EMEA” means the European Medicines Agency (or any successor agency).
"Encumbrance" means any mortgage, pledge, security interest, attachment, right of first refusal, option, proxy, voting trust, encumbrance, lien or charge of any kind (including any conditional sale or other title retention agreement or lease in the nature thereof), restrictions (whether on voting, sale, transfer, disposition or otherwise), any subordination arrangement in favor of another person, any filing or agreement to file a financing statement as debtor under the Uniform Commercial Code or any similar statute.
"End Date" means June 30, 2010, or such later date as may be agreed between the Purchaser, the Shareholders and the Company.
"Enforceability Exceptions" has the meaning ascribed thereto in Schedule 3, Part A, and Section 2.1.
"Environmental Laws" means any Law relating to (a) the protection, preservation or restoration of the environment (including air, water vapor, surface water, groundwater, drinking water supply, surface land, subsurface land, plant and animal life or any other natural resource), or (b) the exposure to, or the use, storage, recycling, treatment, generation, transportation, processing, handling, labeling, production, release or disposal of Hazardous Substances, in each case as in effect at the date hereof.
"Erion" means Jack Erion, an individual having an address of 379 Woodmere Nook Court, St. Charles, Missouri 63303.
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"ERISA" has the meaning ascribed thereto in Schedule 3, Part A, and Section 7.1.
"Executory Period" has the meaning ascribed thereto in Schedule 5, Section 1.
"FDA" has the meaning ascribed thereto in Schedule 3, Part A, and Section 16.
"Fifth Year" has the meaning ascribed thereto in Schedule 6, Section 2.2.
"First Commercial Sale" means the initial ‘commercial sale’ of the Product (or the Substitute Product) that has obtained marketing authorization by either the FDA and/or EMEA.
"First Year" has the meaning ascribed thereto in Schedule 6, Section 2.2.
"Fourth Year" has the meaning ascribed thereto in Schedule 6, Section 2.2.
"GEP-NET" means Gastro-entero-pancreatic Neuroendocrine Tumor.
"Gross Profit Margin" shall mean, for any fiscal year of the Company, the quotient of (x) Net Sales less the sum of (i) direct production costs plus (ii) distribution payments to any distributor or agent divided by (y) Net Sales.
"Governmental Entity" any nation or government, any state or other political subdivision thereof, any entity, authority or body exercising executive, legislative, judicial, regulatory or administrative functions of or pertaining to government, including any governmental or regulatory authority, agency, department, board, commission, administration or instrumentality, any court, tribunal or arbitrator or any self-regulatory organization.
"Hazardous Substance"means any substance listed, defined, designated or classified as hazardous, toxic, radioactive or dangerous or as a pollutant or contaminant under any environmental Law. Hazardous Substances include any substance to which exposure is regulated by any Governmental Entity or any Environmental Law, including (a) petroleum or any derivative or byproduct thereof, toxic mold, asbestos or asbestos containing material or polychlorinated biphenyls and (b) all substances defined as Hazardous Substances,Oils, Pollutants or Contaminants in the National and Hazardous Substances Contingency Plan, 40 C.F.R. Section 300.5.
"Indebtedness" means (i) all indebtedness for borrowed money or for the deferred purchase price of property or services (other than expenses and current trade liabilities incurred in the ordinary course of business and payable in accordance with customary practices), (ii) any other indebtedness that is evidenced by a note, bond, debenture, and credit agreement or similar instrument, (iii) all obligations under financing leases, (iv) all obligations in respect of acceptances issued or created, (v) al1 1iabilities secured by an Encumbrance on any property and (vi) all guarantee obligations.
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"Indemnification Obligations" has the meaning ascribed thereto in Section 1 of Schedule 6.
"Initial Cash Payment" has the meaning ascribed thereto in Section 2.1.
"Initial Shares" has the meaning ascribed thereto in Section 2.1.
"Intellectual Property" means (i) United States, international and foreign patents and patent applications, including divisionals, continuations, continuations-in-part, reissues, reexaminations and extensions thereof and counterparts claiming priority therefrom; utility models; invention disclosures; and statutory invention registrations and certificates; (ii) United States and foreign registered, pending and unregistered trademarks, service marks, trade dress, logos, trade names, corporate names and other source identifiers, domain names, Internet sites and web pages; and registrations and applications for registration for any of the foregoing, together with all of the goodwill associated therewith; (iii) United States and foreign registered and unregistered copyrights, and registrations and applications for registration thereof; and copyrightable works; (iv) all inventions and design rights (whether patentable or unpatentable) and all categories of trade secrets as defined in the Uniform Trade Secrets Act, including business, technical and financial information; and (v) confidential and proprietary information, including know-how.
"Key Employees and Consultants" means Jack L. Erion, President and CEO, and consultants: Jeanine Boesen through Boesen BV, Henk van Rossem and Mary Palank.
"Knowledge" or "Company Knowledge" means the actual awareness of a given matter by the Key Employees and Consultants or any of them.
"Law" or "Laws" means any foreign, federal, state or local Order, statute, law, rule, regulation, ordinance, principle of common law, constitution, treaty enacted, or any writ, arbitration award, injunction, directive, judgment, or decree, promulgated, issued, enforced or entered by any Governmental Entity.
"Licensed Intellectual Property" has the meaning ascribed thereto in Schedule 3, Part A, and Section 21.
"Majority Shareholders" has the meaning ascribed thereto in Section 18.1.
"Management Accounts" mean the unaudited consolidated financial statements (comprising a balance sheet, consolidated statement of profit and loss, statement of cash flows and statement of shareholders' equity) of the Company and Company Subsidiaries from the Accounts Date through the Completion Date, each in the agreed form.
"Market Authorization Target" has the meaning ascribed thereto in Section 4.1.
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Market Value" means the most recent price per Purchaser Share at which the Purchaser or the Purchaser's shareholders last sold its shares to bona fide purchasers in bona fide stock sale transactions (including by way of subscription of increase of capital of the Company), excluding: (i) any gift or other issuance for no or nominal value, (ii) transfer made following exercise of the pre-emption right provided in the bylaws of the Purchaser, (iii) permitted transfers under the Shareholders' Agreement or (iv) any issuances, exercises or purchases pursuant to any stock option, bonus or similar employee compensation plan of the Purchaser.
"Net Sales" means, with respect to the commercial sale (as defined by the FDA or the EMEA) of the Product (or the Substitute Product, as the case may be), during the prior completed fiscal year, the gross amount invoiced and effectively collected by or on behalf of the Purchaser (or the Company) and their Subsidiaries (or Affiliates) for the Product (or Substitute Product) in bona fide, arm's-length transactions plus any royalties received by Purchaser (or the Company) and their Subsidiaries from licensees or sublicensees from commercial sales of the Product (or Substitute Product), less the following customary deductions, determined in accordance with US GAAP, to the extent included in the gross invoiced commercial sales price of any Product or Substitute Product or otherwise directly paid or incurred by the Purchaser, the Company or their Subsidiaries (and Affiliates) with respect to the commercial sale of such Product or Substitute Product:
(i) normal and customary trade and quantity discounts actually allowed and properly taken directly with respect to commercial sales of the Product or Substitute Product;
(ii) amounts actually repaid or credited by reason of defects, rejection recalls, returns, rebates and allowances of goods;
(iii) charge-backs and other amounts paid on commercial sales or dispensing of such Product;
(iv) rebate amounts payable resulting from governmental mandated rebate programs;
(v) tariffs, duties, excise, sales, value-added and other taxes (other than taxes based on income);
(vi) Customary cash discounts for timely payment; (vii) delayed ship order credits;
(viii) discounts pursuant to indigent patient programs and patient discount programs and coupon discounts;
(ix) All freight, postage and insurance included in the invoice price;
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(x) all payments made to distributors, consultants or agents in connection with the sale of the Product (or Substitute Product);
(xi) all royalties (including royalties to Mallinckrodt) paid or other payments made to licensors in connection with the sale of the Product (or Substitute Product).
Commercial sales by the Purchaser and/or the Company to (i) any of their Affiliates, Subsidiaries, licensees or sublicensees or (ii) for clinical trial use shall be disregarded for purposes of calculating Net Sales. Any of the items set forth above that would otherwise be deducted from the invoice price in the calculation of the amount Net Sales but which are separately charged to third parties shall not be deducted from the invoice price in the calculation of the amount Net Sales.
In the case of any commercial sale or other disposal for value, such as barter or counter- trade, of the Product, or part thereof, other than in an arm's-length transaction exclusively for money, the amount of Net Sales shall be calculated by the Company as above on the value of the non-cash consideration received or the fair market price (if higher) of the Product or Substitute Product in the country of sale or disposal.
Net Sales from Combination Products shall be determined in accordance with Section 5.3 by replacing the introduction to Section 5.3 as follows: "For the purpose of determining the Royalty Payments with respect to sales of Combination Products" shall be replaced with "For the purpose of determining Net Sales with respect to sales of Combination Products."
"Net Sales Target" has the meaning ascribed to such term in Section 4.1.
"Officers" mean each of Erion and Palank.
"Order" has the meaning ascribed thereto in Schedule 3, Part A, Section 5.1.
"Other Product" has the meaning ascribed thereto in Section 5.3.
"Palank" means Mary Palank, an individual having an address of 1034 S. Brentwood Blvd., Suite 1630, St. Louis, Missouri 63117, USA.
"Participating Member State" means any member state of the European Union that adopts or has adopted the Euro as its lawful currency in accordance with legislation of the European Union relating to Economic and Monetary Union.
"Party" or "Parties" has the meaning ascribed thereto in the description of the parties to this Agreement on page 1 hereof.
"Plan" means that certain Restricted Stock Bonus Plan of the Company, as approved December 29, 2004.
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"Press Announcement" means the press announcement to be issued by the Company and the Purchaser in the agreed form upon Completion.
"Proceedings" means any legal proceedings or action arising out of or in connection with this Agreement or any other document referred to herein.
"Product" means, either: (i) the 177-leutitum radiolabeled compound for radiotherapeutic or radiodiagnostic use in final dosage form and ready for infusion into the patient, with "compound" meaning, the somatostatin peptide analogue, DOTAO-Tyr3-octreotate)o, r (ii) the vial containing frozen or lyophilized material comprised of the compound plus other additives necessary for a commercially stable formulation to which a 177-leutium solution is added to make the Product.
"Purchaser" has the meaning ascribed thereto in the description of the parties to this Agreement on page 1 hereof.
"Purchaser General Indemnification Claim" has the meaning ascribed thereto in Schedule 6, Section 2.2.
"Purchaser General Indemnification Notice" has the meaning ascribed thereto in Schedule 6, Section 2.2.
"Purchaser Indemnified Party" has the meaning ascribed thereto in Section 2.1 of Schedule 6.
"Purchaser Shares" means shares of common stock of the Purchaser, nominal value of € 0.10 each;
"Purchaser Share" shall be construed accordingly.
"Purchaser Survival Period" has the meaning ascribed thereto in Section 1 of Schedule 6.
"Purchaser's Legal Counsel" means Ellenoff Grossman & Schole LLP.
"Receiving Party" has the meaning ascribed thereto in Section 15.1.
"Representatives" means, in relation to a party, its respective Affiliates and the directors, officers, employees, agents, external legal advisers, accountants, consultants and financial advisers of that party and/or of its respective Affiliates.
"Restricted Actions" means the actions listed in Schedule 5.
"Royalty Payment" has the meaning ascribed thereto in Section 5.1.
"Royalty Payment Objection Period" has the meaning ascribed thereto in Section 5.5
"Royalty Statement" has the meaning ascribed thereto in Section 5.5.
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"Sale of the Company" means, following the Completion of this Agreement, the acquisition, whether effected directly or indirectly or in one or a series of transactions, by a third person not affiliated with the Purchaser of the capital stock or assets of the Company (other than a sale, exchange or transfer to one or more entities where the Purchaser retains, directly or indirectly, at least a majority of the beneficial interest in the voting stock of the entity or entities to which the assets were transferred), for an aggregate amount exceeding the Aggregate Consideration (excluding any Royalty Payments) multiplied by three (3).
"Second Year" has the meaning ascribed thereto in Schedule 6, Section 2.2.
"Securities Act" means the Securities m Act of 1933, as amended.
"Shareholder Agreement" means that certain Shareholders Agreement by and among all of the shareholders of the Purchaser effective as of March 1, 2009, as amended on April 8, 2009.
"Shareholder Indemnification Cap" has the meaning ascribed thereto in Schedule 6, Section 2.2(d).
"Shareholders" mean the holders of Common Stock whose names and addresses are set out in Part 1 of Schedule 1.
"Side Letter" means that certain side letter dated May 20 2010 pursuant to which van Rossem and Palank agree to certain non-competition and non-solicitation provisions.
"Subsidiary" or "Subsidiaries" means any corporation, a majority of the outstanding voting power of which, or any partnership, joint venture, limited liability company or other entity a majority of the total equity interests of which, is directly or indirectly (either alone or through or together with any other subsidiary) owned by such specified person.
"Substitute Product" means a molecule different from Lutate for treatment of GEP-NET (including carcinoid), for which the Purchaser or its Subsidiary or Affiliate achieves Net Sales in lieu of the Product.
"Survival Period" has the meaning ascribed thereto in Section 1 of Schedule 6.
"Surviving Provisions" means Sections 5, 11, 14, 15, 22 and Schedule 6.
"Target" or "Targets" means: (i) the Clinical Trials Target, (ii) the Market Authorization Target or (iii) the Net Sales Target, as applicable, and as such terms are defined in Section 4.1.
"Tax" or "Taxes" means any tax, custom, duty, governmental fee or other like assessment or charge of any kind whatsoever. Imposed by any Governmental Entity (including any
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federal, state, local, foreign or provincial income, gross receipts, property, sales, use, net worth, premium, license, excise, franchise, employment, payroll, social security, workers compensation, unemployment compensation, alternative or added minimum, ad valorem, transfer or excise tax) together with any interest, addition or penalty imposed thereon.
"Tax Returns" has the meaning ascribed thereto in Schedule 3, Part A, and Section 8.1.
"Tenant Leases" has the meaning ascribed thereto in Schedule 3, Part A, and Section 9.1.
"Third Party Claim" has the meaning ascribed thereto in Section 3 of Schedule 6.
"Third Year" has the meaning ascribed thereto in Schedule 6, Section 2.2.
"Transaction Documents" has the meaning ascribed thereto in Section 13.1.
"Uniform Commercial Code" means the Uniform Commercial Code as in effect from time to time in the State of Missouri.
"US GAAP" means the generally accepted accounting principles of the United States.
"van Rossem" means Hendrik van Rossem, an individual having an address of Wihelminaplantsoen 13, 1601 LS Enkhuizen, The Netherlands.
"€" and "Euro" means the single currency of the Participating Member States.
"$" and "US Dollar" means the single currency of the United States of America.
1.2 In this Agreement, unless otherwise specified:
(a) a reference to any Law shall be construed as a reference to the same as it may have been, or may from time to time be, amended, modified or re-enacted except to the extent that any amendment or modification made or coming into effect of any Law after the date of this Agreement would increase or alter the liability of any of the Company, the Shareholders or the Purchaser under this Agreement; and
(b) references to a "company" shall be construed so as to include any company, corporation or other body corporate, wherever and however incorporated or established; and
(c) references to a "person" shall be construed so as to include any individual, firm, company, Governmental Entity or any joint venture, association or partnership (whether or not having separate legal personality); and
(d) use of any gender inc1udesthe other gender; and
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(e) references to writing shall include any modes of reproducing words in a legible and non transitory form; and
(f) headings to Sections and Schedules are for convenience only and do not affect the interpretation of this Agreement; and
(g) the Recitals and Schedules form part of this Agreement and shall have the same force and effect as if expressly set out in the body of this Agreement, and any reference to this Agreement shall include the Recitals and the Schedules; and
(h) references to "including" shall be construed as "including without limitation."
2. SALE AND PURCHASE
2.1 At Completion and subject to the terms and conditions set forth herein, each of the Shareholders shall irrevocably sell, free from all Encumbrances and with full title guarantee, the Company Shares and the Purchaser shall purchase all of the Company Shares together with all rights attached or accruing to them, for the following consideration (the "Aggregate Consideration"): (i) € 375,000 in cash (the "Initial Cash Payment"); (ii) that certain number of Purchaser Shares having an aggregate Market Value of € 2,300,000 (the "Initial Shares"); (iii) up to € 1,125,000 in cash subject to the provisions of Section 4 (the "Contingent Cash Consideration"); (iv) that certain number of Purchaser Shares having up to an aggregate Market Value of € 6,900,000 (the "Contingent Shares"); (v) the right to receive the Royalty Payment; and (vi) the assumption of the Company Obligations; provided, however, the Contingent Consideration may be reduced in accordance with the Indemnification Obligations.
2.2 With effect from the Completion Date and by executing this Agreement, each of the Shareholders irrevocably waives any and all rights over any of the Company Shares any of them ever had, now have or hereafter can, shall or may have, from the beginning of the world to the end of time.
3. INITIAL CASH PAYMENT; INITIAL SHARES
3.1 At Completion and upon receipt of the duly endorsed certificates representing the Company Shares, the Purchaser (or its agent) shall: (i) distribute the Initial Cash Payment and (ii) issue the Initial Shares, with each of (i) and (ii) being paid or issued, respectively, to the Shareholders pro rata in accordance with their percentage ownership of the Company Shares set forth on Schedule 1; provided, however, each Shareholder acknowledges that becoming a party to the Shareholder Agreement is an unwaivable condition precedent to receipt of any Initial Shares due such Shareholder and that such Shareholder shall not be treated as a stockholder of Purchaser, shall not appear on the records of the Purchaser as a shareholder and shall have no right, title or interest to
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the Initial Shares until such Shareholder has executed the Shareholder Agreement.The aggregate number of Initial Shares to be issued shall be 920,000.
3.2 Payment of the Initial Cash Payment shall be made by wire transfer of funds in Euro to each of the Shareholders in accordance with Schedule 1.
3.3 A certificate evidencing each Shareholder's pro rata portion of the Initial Shares shall be sent to the address set forth opposite each Shareholder's name in Schedule 1 by Federal Express (or similar courier). Each of the Shareholders agrees that upon receipt of such certificate, such Shareholder will not effect any sale, transfer, assignment, hypothecation, pledge or other Encumbrance of the Initial Shares, unless such sale, transfer, assignment, hypothecation, pledge or other Encumbrance is made in accordance with (i) French securities Laws (as evidenced by an opinion of counsel) or an applicable exemption therefrom and (ii) the Shareholder Agreement
4. CONTINGENT CASH CONSIDERATION;
CONTINGENT SHARES
4.1 At such time that (i) clinical trials approved by the FDA and EMEA begin with respect to the Product (or Substitute Product) (the "Clinical Trials Target"), (ii) marketing authorization is granted with respect to the Product (or Substitute Product) by both the FDA and EMEA (the "Market Authorization Target") or (iii) aggregate Net Sales of the Product (or Substitute Product) exceed € 10,000,000 in the aggregate (the "Net Sales Target"); then upon and subject to the satisfaction of each such Target: (a) one-third (1/3) of the Contingent Cash Consideration and (b) Contingent Shares having a Market Value equal to one-third (1/3) of the € 6,900,000 (as calculated pursuant to Section 4.2 and adjusted pursuant to Section 4.3) shall be paid or issued, as applicable, to the Shareholders in accordance with Sections 4.3 and 4.4; provided, however, no Contingent Shares shall be issued to any Shareholder who is in material violation of, or breach with respect to the Shareholders' Agreement, or to any Officer or Director who is in material violation of, or breach with respect to any employment, non-compete or other agreement between such person and the Purchaser or the Company (or any Subsidiary of either), the fact of such material violation or breach to be determined in the reasonable, good faith, discretion of Purchaser and disputed in accordance with Section 19.
4.2 The Contingent Shares issuable upon the satisfaction of any Target shall be the quotient of the following:
Contingent Shares = portion of Euro 6,900,000 payable upon satisfaction of such Target or Targets
Market Value
provided that if the Market Value of such Contingent Shares is less than the Benchmark Value, then: (i) the number of Contingent Shares to be issued shall be equal to that portion of € 6,900,000 payable upon satisfaction of such Target or Targets divided by the Benchmark Value and (ii) the difference between the Benchmark Value and Market Value (per Contingent Share) shall be paid in cash (Euros), in accordance with Section 4.4
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The Contingent Cash Consideration and/or the Contingent Shares may be reduced from time to time by all or a portion of the Indemnification Obligations in accordance with Schedule 6, Section 2.2.
4.3 Within sixty (60) days after the satisfaction of a Target, any Contingent Cash Consideration due the Shareholders shall be paid by wire transfer of immediately available funds denominated in Euros to the Shareholders in accordance with Schedule 1. Any such payments of Contingent Cash Consideration shall include interest accruing at two percent (2%) per annum, calculated on the basis of a 365 day year; from the date of Completion to the date such payment is made.
4.4 A certificate evidencing the Contingent Shares due with respect to satisfaction of a Target shall be sent by the Purchaser (or its transfer agent) to each respective Shareholder in accordance with Schedule 1 within sixty (60) days of satisfaction of such Target.
4.5 Prior to the Sale of the Company, the payment of all unpaid Contingent Cash Consideration and the issuance of any then unissued Contingent Shares (less any amounts withheld in accordance with the provisions set forth in Schedule 6, Section 2.2) shall automatically be accelerated such that the Purchaser shall, immediately prior to consummation of such Sale of the Company, pay all unpaid Contingent Cash Consideration and issue all unissued Contingent Shares as set forth herein.
4.6 As soon as practicable, but no later than the thirtieth (30th) day after the applicable Target is satisfied, the Purchaser (or its agent) shall prepare in good faith and deliver to the Shareholders a statement setting forth in reasonable detail (a) the Target achieved and (b) the Contingent Consideration due as a result thereof.
4.7 Until the expiration of the Survival Period, each of the Shareholders hereby covenants and agrees that such Shareholder shall remain both the record and beneficial holder of all such Contingent Shares in a given year subject to the Indemnification Obligations held by such Shareholder and shall not sell, transfer, assign, hypothecate, pledge or otherwise encumber such Contingent Shares except in accordance with the Laws of descent and distribution upon the death of such Shareholder; provided, however that in all cases such Contingent Shares shall remain subject to this Section 4.7 and provided, further, that upon the expiration of the Survival Period, such Shareholder shall only effect a sale, transfer, assignment, hypothecation, pledge or other Encumbrance of such Contingent Shares in accordance with (i) French securities Laws (as evidenced by an opinion of counsel) or an applicable exemption therefrom and (ii) the Shareholder Agreement.
4.8 Unless and until the Contingent Shares become due pursuant to this Section 4, the Shareholders shall have no rights, title or interest in any securities or other property received by Shareholders of the Purchaser as a result of any stock split or combination of the Purchaser, payment of a stock dividend or other stock distribution in
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or on Purchaser Shares, or change of Purchaser Shares into any other securities pursuant to or as a part of a merger, consolidation, acquisition of property or stock, reorganization or liquidation involving the Purchaser.
4.9 No fractional Contingent Shares shall be issued and no certificates or scrip for any such fractional Contingent Shares shall be issued. Any Shareholder who would otherwise be entitled to receive a fraction of a Contingent Share shall, in lieu of such fraction, be paid in cash the amount in Euro (rounded up to the nearest whole Euro cent) determined by multiplying such fraction of a Contingent Share by the greater of (i) the Market Value or (ii) the Benchmark Price.
4.10 The Purchaser shall use commercially reasonable efforts to extend or renew all corporate approvals and authorizations necessary to issue the Contingent Shares in accordance with the terms of this Agreement. If (i) the approvals and authorizations to issue the Contingent Shares have not been renewed or extended by the end of the twenty- sixth (26th) full month following the Completion Date or (ii) if any extensions to the corporate approvals or authorizations are not subsequently extended prior to the expiration of the approvals or authorizations then in effect to issue the Contingent Shares, then subject to Section 4.3, the Purchaser agrees that all Contingent Shares shall immediately be deemed to have been fully earned and shall be issued as soon as practicable (but in any event prior to the expiration of the approvals and authorizations) to each Shareholder in accordance with Schedule 1. The Purchaser shall also provide notice to the Shareholders, in a commercially reasonable manner, following any non-renewal of the approvals and authorizations necessary to issue the Contingent Shares.
5. ROYALTY PAYMENTS AND OBLIGATIONS.
5.1 In further consideration of the transaction contemplated hereby, the Purchaser .hereby agrees to pay to the shareholders a portion of the annual Net Sales of the Product or any Substitute Product (if Purchaser commercializes such Substitute Product in lieu of the Product) during the period set forth in Section 5.4 hereof (the "Royalty Payment"). All Royalty Payments shall be made to the Shareholders in accordance with Schedule 1 within ninety (90) days of such Royalty Payment becoming due and payable. Royalty Payments being due in one year shall not be indicative of, or infer that, Royalty Payments shall be due in subsequent years.
5.2 Provided the Gross Profit Margin in a given year with respect to the relevant Net Sales is in excess of thirty percent (30%), then Purchaser shall make Royalty Payments in accordance with the following: (i) with respect to Net Sales from 0 to $50,000,000, the Shareholders shall be entitled to a Royalty Payment equal to [*] ([*]%) of such Net Sales, (ii)
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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with respect to Net Sales from $50,000,000 to $100,000,000, the Shareholders shall be entitled to a Royalty Payment equal to [*] percent ([*]%) of such Net Sales, and (iii) with respect to Net Sales equal to or in excess of $100,000,000, the Shareholders shall be entitled to a Royalty Payment equal to [*] percent ([*]%) of such Net Sales. For the avoidance of doubt, in all cases where the Gross Profit Margin is less than thirty percent (30%) of the Net Sales, no Royalty Payments shall be due from Purchaser to the Shareholders in connection with such Net Sales. For purposes of this Section 5.2, any sales reflected in Euros shall be converted to US Dollars in accordance with Section 20.
5.3 For the purpose of determining the Royalty Payments with respect to sales of Combination Products, Net Sales will be determined by multiplying the Net Sales of the Combination Product by a fraction, the numerator of which shall be the per unit retail selling price of the Product included in the Combination Product sold as a separate stand-alone item, and the denominator of which shall be the per unit retail selling price of the Combination Product. If there is no established current retail selling price for the Product or Substitute Product sold separately, but there is an established current retail selling price for the other products sold in combination with the Product or Substitute Product (the "Other Product"), then the Net Sales price of the Product or Substitute Product sold in such Combination Product will be (i) the Net Sales of the Combination Product less (ii) the Net Sales of the Combination Product multiplied by a fraction, the numerator of which shall be the per unit retail selling price of the Other Product sold separately, and the denominator of which shall be the per unit retail selling price of the Combination Product. If there is no established per unit retail selling price for the Product or the Other Product, then, the Net Sales price of the Product or Substitute Product included in such Combination Product will be determined by the Purchaser in good faith using commercially reasonable methods in accordance with generally accepted cost accounting principles consistently applied.
5.4 The Purchaser's obligation with respect to the Royalty Payments shall commence on the earlier of the date of the First Commercial Sale of the Product or Substitute Product by the Company, a Subsidiary or any of their Affiliates. Royalty Payments will be paid by Purchaser hereunder until the earlier of (i) ten (10) years following the First Commercial Sale of the Product or (ii) ten (10) years following the First Commercial Sale of any Substitute Product. For the purposes of clarity, the Shareholders shall only receive Royalty Payments with respect to either the Product or the Substitute Product, which shall be determined as the first to consummate a First Commercial Sale.
5.5 Royalty Payments shall be calculated as of the end of each calendar quarter in Euro, with Net Sales in any foreign currency to be converted into Euro at the conversion rate set forth in the Financial Times (London Edition) during such quarter. Royalty Payments shall be paid to the Shareholders in Euro within ninety (90) days following the end of each fiscal
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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year. As soon as practicable, but in no event later than the sixtieth (60th) day following the end of Purchaser's fiscal year during which Royalty Payments are due, the Purchaser shall deliver to the Shareholders a statement (the "Royalty Statement") setting forth the Net Sales for the fiscal year pursuant to which the Royalty Payment is being made, and setting forth: (i) the total number of units of the Product or Substitute Product sold by country, (ii) the gross sales of the Product or Substitute Product in the local currency and the Euro conversion and (iii) an analysis of the manner in which the Royalty Payment was calculated. Unless the Majority Shareholders deliver a written objection to the Purchaser within thirty (30) days following its receipt of the Royalty Statement (the "Royalty Payment Objection Period"), the Royalty Payments set forth on the Royalty Statement shall be deemed final and binding on the Shareholders. Any notice of objection by the Majority Shareholders must be timely and specify the items or calculations with which such Majority Shareholders reasonably takes issue. If the Majority Shareholders object in accordance with the previous sentence, Purchaser and the Majority Shareholders shall settle such dispute in accordance with the provisions set forth in Section 19 below, with such resolution applying pro rata to all Shareholders.
5.6 The Purchaser shall maintain and shall require its Subsidiaries, licensees, and sublicensees (if applicable) to maintain accurate books and accounts of record in connection with the sale by or for it of the Product or Substitute Product and any Combination Product in sufficient detail to permit accurate determination of all figures necessary for verification of the Royalty Payments. Such records shall be maintained for a period of five (5) years from the end of each year in which sales occurred. To ensure that the proper Royalty Payment is made, the Majority Shareholders shall have the right, at their own expense, to cause qualified certified public accountants of its choice to audit the Purchaser's books and records pertaining solely to Net Sales of the Product or any Substitute Product. Such audits shall take place during Purchaser's normal business hours and not more frequently than once per calendar year. Prior to conducting an audit, the Majority Shareholders will provide at least ten (10) days written notice to Purchaser. If any such audit reveals that a shortfall in Royalty Payments has occurred, then Purchaser shall promptly following (i) the receipt of notice of a shortfall by the Majority Shareholders in the event that Purchaser does not dispute the audit results or (ii) the resolution of any such dispute, pay to the Shareholders the amount of such shortfall plus interest accrued thereon at the average prime rate announced by Citibank, N .A. during the period from the date the Royalty Payment was originally due and ending on the date that the shortfall and interest is paid. If the parties have a good faith dispute regarding the results of the audit, they shall first seek to amicably resolve the dispute through discussion. If the parties are unable to resolve the dispute, they shall jointly appoint an independent certified public accountant to resolve the dispute and will abide by the decision reached by such independent certified public accountant. If the parties are unable to agree on the selection of an independent certified public accountant, they shall each appoint one such firm, and the two so selected shall chose a third independent certified public accountant who shall resolve the dispute and whose decision shall be binding on the parties. The parties will share equally the fees and expenses of any independent certified public accountant engaged to resolve any dispute pursuant to this Section 5.6; provided, however, that if (a) the
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independent certified public accountant selected in accordance with the immediately preceding sentence determines the existence of a Net Sales deficiency that is greater than or equal to five percent (5%) of the Net Sales originally reported by the Purchaser, the Purchaser shall pay all fees and expenses of the independent certified public accountant engaged to resolve such dispute or (b) that the independent certified public accountant confirms the Net Sales originally reported by the Purchaser or determines the existence of a Net Sales surplus of the Net Sales originally reported by the Purchaser, the Majority Shareholders shall pay all fees and expenses of the independent certified public accountant engaged to resolve such dispute.
5.7 Any Tax that Purchaser is required to withhold under applicable Law and pay on behalf of the Shareholders hereunder with respect to any Royalty Payment shall be deducted from and offset against said Royalty Payment prior to remittance; provided, however, that in regard to any Tax so deducted, Purchaser shall give or cause to be given to the Shareholders such assistance as may reasonably be necessary to enable the Shareholders to claim exemption therefrom or credit therefor, and in each case shall furnish the Shareholders of proper evidence of Taxes paid on behalf of the Shareholders. If a Tax treaty is applicable or in effect and the Majority Shareholders request Purchaser utilize such treaty, the Purchaser shall use reasonable efforts in complying with the treaty and each Shareholder shall give or cause to be given to Purchaser such assistance as may be reasonably necessary to enable Purchaser to utilize such treaty.
5.8 From the Completion Date through the entirety of the period when any Royalty Payments and/or Contingent Consideration (collectively, the "Earn Out") may be or become payable by the Purchaser to the Shareholders in accordance with this Agreement, the Purchaser shall: (i) for the purpose of protecting the rights of the Shareholders to receive the Earn Out under the terms of this Agreement, use commercially reasonable efforts to avoid taking any action or permitting any omission which is intended to deter the Shareholders' ability to earn the Earn Out; and (ii) use commercially reasonable efforts to collect all Net Sales in a timely manner.
6. CONDITIONS
6.1 The sale and purchase of the Company Shares and the completion of the other transactions contemplated by this Agreement and the Transaction Documents are in all respects conditional upon those matters listed in Schedule 2, provided that: (i) the Purchaser may, in its sole and absolute discretion, waive any of the conditions precedent which must be satisfied by the Shareholders and Company set forth on Schedule 2A by written notice to the Shareholders, (ii) the Shareholders may, in their sole and absolute discretion, waive any of the conditions precedent which must be satisfied by the Purchaser set forth on Schedule 2B by written notice to the Purchaser, and (iii) in no instance may any party hereto waive the conditions set forth on Schedule 2C.
6.2 The Company and the Shareholders covenant and agree to use commercially reasonable efforts to cause the conditions set forth in Schedule 2 (and applicable to such party) to be fulfilled as soon as possible after the date of this Agreement (to the reasonable
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satisfaction of the Purchaser); and the Purchaser covenants and agrees to use commercially reasonable efforts to cause the conditions set out in Schedule 2 (and applicable to such party) to be fulfilled as soon as possible after the date of this Agreement.
6.3 None of Purchaser, the Company or the Shareholders may rely on the failure of any condition set forth in Schedule 2 to be satisfied if such failure was caused by such party's failure to comply with or perform any of its covenants or obligations set forth in this Agreement.
7. CONDUCT OF BUSINESS BEFORE COMPLETION
7.1 The Shareholders shall take all reasonable actions within their power to procure, and the Company shall procure, that the Business is conducted in the ordinary course during the period from the date of this Agreement to Completion. Without limitation to the generality of the foregoing, the Shareholders shall take all commercially reasonable actions within their power to procure, and the Company shall use its best efforts to procure, that between the date of this Agreement and Completion neither the Company nor any Company Subsidiary will undertake any of the Restricted Actions without the prior written consent of the Purchaser.
7.2 Sub-Section 7.1 shall not operate so as to restrict or prevent:
(i) any matter reasonably undertaken by the Company or Company Subsidiary in an emergency or disaster situation with the intention of minimizing any material adverse effect thereof (and of which the Purchaser will be notified in advance, where such advance notice is commercially practicable, failing which the Purchaser shall be notified promptly thereafter) only for so long as such emergency or disaster situation continues and/or solely to the extent the Company reasonably considers necessary to mitigate the effects of such emergency or disaster situation; or
(ii) the completion or performance of any obligations undertaken in the ordinary course of business pursuant to or matters contemplated by any agreement or arrangement entered into by the Company or Company Subsidiary prior to the date of this Agreement which does not in the aggregate exceed $10,000; or
(iii) any matter contemplated in this Agreement; or
(iv) any matter undertaken with the prior written approval of the Purchaser.
7.3 From the date of this Agreement until Completion, the Shareholders shall use commercially reasonable efforts to procure and the Company shall use its best efforts to procure that each of the Company and Company Subsidiaries shall give the Purchaser and its authorized representatives reasonable access to books, records, accounts, documents, personnel and offices of the Company and Company Subsidiaries.
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7.4 Neither the Shareholders nor the Company shall be obliged to grant access pursuant to Section 7.3 to the extent that such access materially interferes with the ability of the Company or Company Subsidiaries to conduct the Business.
7.5 From the date of this Agreement until Completion, the Company shall use its best efforts to provide the Purchaser and its authorized representatives with notice of any enquiry or investigation of, or any material communication, material correspondenceor material request received from, a Governmental Entity in relation to the Business, the Company or any Company Subsidiary within twenty-four (24) hours of becoming aware, or at such time it should reasonably be aware thereof.
8. COMPLETION
8.1 Completion shall take place on the Completion Date at the offices of Ellenoff Grossman & Schole LLP, 150 East 42nd Street, New York, NY 10017, or at such other venue as may be agreed in writing between the Majority Shareholders and the Purchaser.
8.2 Except with respect to any condition on Schedule 2C which shall not be waived, each of the conditions to Completion set forth on Schedule 2A and 2B shall have been satisfied or waived by the party benefiting from such condition.
8.3 If the respective obligations of the Company, Shareholders and/or the Purchaser pursuant to Schedule 2 have not been satisfied or waived by the Completion Date the Purchaser or the Company, as the case may be, shall have the following options: (i) defer Completion, (ii) proceed to Completion as far as practicable (without limiting the parties' respective rights under this Agreement), or (iii) in the event that Completion has not occurred by the End Date, terminate this Agreement by notice in writing to the other parties hereto, provided that the reason Completion has not occurred by the End Date is not attributable to any act or omission by the party giving such notice.
9. Representations And Warranties; Limitations; Cure Period
9.1 Unless such representation or warranty is limited therein, each of the representations and warranties set forth on Schedule 3 shall survive until the expiration of the Survival Period.
9.2 The representations and warranties set out in separate paragraphs of Schedule 3 shall be separate and independent and (except as expressly provided otherwise in this Agreement) no representation or warranty shall be limited by reference to any other representation or warranty.
9.3 The representations and warranties are qualified by and are subject to any facts and circumstances fairly disclosed in this Agreement or the Disclosure Letter with sufficient detail to allow a reasonably sophisticated person to evaluate such matter.
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9.4 If there has been a breach by any Shareholder of the representations and warranties set forth in Section 17.2 of Schedule 3, then, and only if such breach is curable, such Shareholder shall have twenty (20) calendar days to cure such breach, provided such Shareholder exercises commercially reasonable best efforts to cure such breach. Notwithstanding any cure by the Shareholder or the effectuation of a cure by the Shareholder, the Purchaser may seek indemnification pursuant to the Indemnification Obligations for any Damages incurred by Purchaser as a result of such breach during the cure period.
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10. SURVIVAL FOLLOWING COMPLETION
10.1 Any provision of this Agreement which is capable of being performed in accordance with the terms of this Agreement after Completion, but which has not been performed at or before Completion, the representations and warranties and all covenants and other undertakings contained in or entered into pursuant to this Agreement that are intended to be performed after Completion shall remain in full force and effect notwithstanding Completion, subject to the provisions contained in Schedule 6.
11. REMEDIES AND WAIVERS
11.1 Except as otherwise expressly provided in this Agreement, no delay or omission by any party to this Agreement in exercising any right, power or remedy provided by Law or under this Agreement or any other documents referred to in it shall affect that right, power or remedy or operate as a waiver thereof.
11.2 Except as otherwise expressly provided in this Agreement, the single or partial exercise of any right, power or remedy provided by Law or under this Agreement shall not preclude any other or further exercise of it or the exercise of any other right, power or remedy.
11.3 Except as otherwise expressly provided in this Agreement, the rights, powers and remedies provided in this Agreement are cumulative and not exclusive of any rights, powers and remedies provided by Law.
11.4 The Purchaser shall be entitled, in addition to any other remedy to which it may be entitled at Law or in equity, to seek injunctive relief and/or to compel specific performance to prevent breaches by any Shareholder and/or Company of any covenant or agreement contained in this Agreement. Accordingly, the Shareholders and the Company hereby agree the Purchaser is entitled to an injunction prohibiting any conduct by the Shareholders and/or the Company in violation of this Agreement and the Shareholders or the Company, as the case may be, shall not seek the posting of any bond in connection with such request for an injunction. All costs and expenses, including reasonable attorneys' and experts' fees incurred by the parties in connection with any action for enforcement pursuant to this Section 11.4 shall be borne by the non-prevailing party or parties.
11.5 The Shareholders shall be entitled, in addition to any other remedy to which they may be entitled at Law or in equity, to seek injunctive relief and/or to compel specific performance to prevent breaches by the Purchaser of any covenant or agreement contained in this Agreement. Accordingly, the Purchaser hereby agrees the Shareholders are entitled to an injunction prohibiting any conduct by the Purchaser in violation of this Agreement 'and Purchaser shall not seek the posting of any bond in connection with such request for an injunction. All costs and expenses, including reasonable attorneys' and
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experts' fees incurred by the parties in connection with any action for enforcement pursuant to this Section 11.5 shall be borne by the non-prevailing party or parties.
12. ASSIGNMENT
12.1 Neither the Company nor the Shareholders shall assign, or purport to assign, all or any part of the benefit of, or its rights or benefits under, this Agreement or any causes of action arising hereunder without the prior written consent of the Purchaser, other than an assignment or transfer by operation of descent and distribution. The Purchaser may assign the benefit of all or any of the Company or Shareholder obligations under this Agreement and/or any other benefit to the Purchaser arising under or out of this Agreement, subject to the provisions contained in Section 4.5 above.
12.2 This Agreement shall be binding upon, inure to the benefit of and be enforceable by the parties and their respective successors in title and permitted assigns.
13. ENTIRE AGREEMENT; AMENDMENT
13.1 This Agreement and the documents or instruments referred to herein, including any exhibits attached hereto and the Schedules referred to herein, which exhibits and Schedules are incorporated herein by reference, the Disclosure Letter, the Shareholder Agreement, the Side Letter and the Deed of Adherence (collectively, the "Transaction Documents"), constitute the whole and only agreement among the parties relating to subject matter provided for herein and supersede all prior agreements and the understandings among the parties with respect to such subject matter. The parties acknowledge and agree they have not entered into this Agreement or any of the other documents or agreements referred to herein in reliance or any representation or warranty except for those set forth in the Transaction Documents.
13.2 Prior to Completion, this Agreement may only be amended in writing signed by or on behalf of the Purchaser and the Company. Beginning at Completion, this Agreement may only be amended in writing signed by or on behalf of the Purchaser and the Majority Shareholders.
14. NOTICES
14.1 All notices, statements or other documents which are required or contemplated by this Agreement shall be: (i) in writing and delivered personally or sent by first class registered or certified mail, overnight courier service or facsimile transmission to the address designated in writing, (ii) by facsimile to the number most recently provided to such party or such other address or fax number as may be designated in writing by such party and (iii) by electronic mail, to the electronic mail address most recently provided to such party or such other electronic mail address as may be designated in writing by such party. Any notice or other communication so transmitted shall be deemed to have been given on the day of delivery, if delivered personally, on the business day following receipt of written confirmation, if sent by facsimile transmission
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or email, one (1) business day after delivery to an overnight courier service or five (5) days after mailing if sent by mail.
14.2 Notices under this Agreement shall be sent to:
(a) if to a Shareholder, at the address and/or facsimile number set forth on such Shareholder's signature page
(b) if to the Company:
BioSynthema, Inc.
4041 Forest Park Avenue
S1.Louis, MO 63108
Attn: General Counsel
Fax: (314) 615-6901
with a copy to (which shall not constitute notice):
Palank & Associates
1034 S. Brentwood Blvd., Suite 1630
S1.Louis, MO 63117
Attn: Mary A. Palank, Esq.
Fax: (314) 863-3301
(c) if to the Purchaser:
Advanced Accelerator Applications, S.A.
20, rue Diesel
01630 Saint Genis Pouilly, France
Fax: (33)-4-50-99-3070
with a copy to (which shall not constitute notice):
Ellenoff Grossman & Schole LLP
150 East 42nd Street, 11th Floor
New York, NY 10017
Attn: Douglas S. Ellenoff, Esq.
Fax: (212) 370-7889
15. CONFIDENTIALITY
15.1 Each party to this Agreement shall (and shall procure that each of its Representatives shall) treat as confidential all information (whether written or transferred or obtained orally, visually, electronically or by any other means) obtained in connection with the preparation for and negotiation of the sale and purchase of the Company Shares or as a result of entering into or performing this Agreement (or, with respect to
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confidential information relating to the Business, the Company and Company Subsidiaries known by any Shareholder, obtained in connection with the Business, the Company and Company Subsidiaries prior to Completion) which relates to:
(a) (in relation to the obligations of the Purchaser under this Section 15) any confidential information received or held by the Purchaser (or any of its Representatives) where such information relates to the Shareholders or any of them or, prior to (but not after) Completion, the Company or any Company Subsidiary;
(b) the provisions of this Agreement;
(c) the negotiations relating to this Agreement;
(d) the subject matter of this Agreement; or
(e) (in relation to the obligations of each of the Shareholders, this Section 15) any confidential information received or held by such Shareholder (or any of their Representatives) where such confidential information relates to the Purchaser or, following Completion, the Company, any Company Subsidiary or the Business including any confidential Intellectual Property owned by the Purchaser, the Company or any Company Subsidiary or any Licensed Intellectual Property (as defined in Schedule 3)
(the abovementioned items of information shall, for the purposes of this Section 15, be referred to herein as "Confidential Material"). Notwithstanding the foregoing, Confidential Material shall not include any information of the disclosing party or its Affiliates (the "Disclosing Party") that (i) is already known to the receiving party or its Affiliates (the "Receiving Party") at the time of its disclosure; (ii) is or becomes publicly known through no wrongful act of the Receiving Party; (iii) is independently developed by the Receiving Party without use or access to the Disclosing Party's Confidential Material; (iv) is communicated to a third party with the express written consent of the Disclosing Party unless such third party is bound by a confidentiality agreement among the parties hereto; or (v) is communicated to the Receiving Party by a third party who is not under an obligation not to disclose the information.
15.2 Notwithstanding the other provisions of this Section 15, any party to this Agreement and any of such party's Representatives may disclose Confidential Material:
(a) if and to the extent that such party or such Representative, as the case may be, can demonstrate that disclosure is required by Law in any applicable jurisdiction;
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(b) if and to the extent that such party or such Representative, as the case may be, can demonstrate that disclosure is required by any securities exchange or Governmental Entity to which that party is subject wherever situated;
(c) for the purpose of any Proceedings;
(d) to its Representatives on a need to know basis provided that each person to whom disclosure is made is advised of the confidentiality obligations under this Agreement and agrees to be bound thereby;
(e) if and to the extent that the Shareholders (in respect of disclosure by the Purchaser or its Representatives, including the Company, following Completion) or the Purchaser (in respect of disclosure by any Shareholder or their respective Representatives and the Company prior to Completion) has given prior written consent to the disclosure; or
(f) to an insurer under an insurance policy taken out or intended to be taken out to benefit the Company or any Company Subsidiary, to the extent that such disclosure is required to determine the terms of that insurance policy.
Any information to be disclosed pursuant to paragraphs (a) or (b) of this Section 15.2 shall be disclosed only after consultation with the other parties to this Agreement to whom such information is relevant and the party intending to disclose the Confidential Material shall take into account the reasonable comments or requests of such other party.
15.4 The restrictions contained in this Section 15 shall continue to apply after Completion or termination of this Agreement for a period of five (5) years.
15.5 Each party to this Agreement shall use commercially reasonable efforts to procure that its respective Representatives also comply with the provisions of Sections 15.1 and 15.2, mutatis mutandis. Each party to this Agreement shall be responsible for breach of the above confidentiality undertaking by it or its Representatives.
15.6 Each party to this Agreement shall only use (or permit the use by its Representatives of) the Confidential Material received or held by it or its Representatives for the purposes of performing the obligations under this Agreement or for the purposes of establishing a defense in the course of any Proceedings.
16. COSTS AND EXPENSES
16.1 All expenses incurred in connection with the preparation, negotiation and execution of this Agreement and the transactions contemplated hereby shall be paid by the party incurring such expenses, whether or not the sale and purchase of the Company Shares or any other related transaction is completed
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17. COUNTERPARTS
17.1 This Agreement may be executed in any number of counterparts, and by the parties to it on separate counterparts, but shall not be effective until each party has executed at least one counterpart.
17.2 Each counterpart shall constitute an original of this Agreement, but all the counterparts shall together constitute but one and the same instrument.
18. TERMINATION
18.1 This Agreement may be terminated at any time prior to Completion as follows:
(a) by mutual written consent of the parties as duly authorized by the Purchaser's board of directors, the holders of at least 2/3 of the outstanding Company Shares as of the date hereof (the "Majority Shareholders") and the Company's board of directors;
(b) by either the Purchaser or the Company if Completion has not occurred by the End Date (and all conditions set forth on Schedule 2 have been satisfied);
(c) by written notice of the Purchaser, if there has been a breach by the Company or any Shareholder of any of their respective representations, warranties, covenants or agreements contained in this Agreement, or if any representation or warranty of the Company or any Shareholder shall have become untrue or inaccurate; provided, however, the Company, or the Shareholder, as the case may be, shall have thirty (30) calendar days to cure such breach from their receipt of notice by the Purchaser;
(d) by written notice by the Majority Shareholders, if there has been a breach by the Purchaser of any of its respective representations, warranties, covenants or agreements contained in this Agreement, or if any representation or warranty of the Purchaser shall have become untrue or inaccurate; provided, however, the Purchaser shall have thirty (30) calendar days to cure such breach from their receipt of notice by the Majority Shareholders; and
(e) in accordance with Section 8.3.
18.2 In the event of the termination of this Agreement in accordance with Section 18.1(a) or 18.1(b), this Agreement shall forthwith become void, and there shall he no liability on the part of any party hereto or any of their respective Affiliates or the directors, officers, partners, members, managers, employees, agents or any other person related to each of them, and all rights and obligations of each party hereto shall cease, except for the Surviving Provisions.
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19. DISPUTE RESOLUTION
19.1 The Parties shall attempt to resolve any dispute arising out of or relating to this Agreement, promptly by good faith negotiation among representatives who have authority to resolve the controversy. If such dispute is not resolved, any Party may give the other applicable Parties written notice of such dispute and within twenty (20) calendar days after delivery of such notice, each receiving Party shall submit to the other applicable Parties a written response. The notice and the response shall include (i) a statement of the applicable Party's concerns and perspectives on the dispute, (ii) a summary of supporting facts and circumstances and (iii) the identity of the representative who will represent such Party. Within forty-five (45) calendar days after delivery of the original notice, the representatives of the applicable Parties shall confer, either in person, telephonically, by videoconference or otherwise, at a mutually acceptable time and place, and thereafter as often as they reasonably deem necessary, for the purposes of resolving such dispute. If such dispute remains unresolved following thirty (30) calendar days, then each party shall have the option of appointing an independent advisor reasonably considered an expert in the area of the dispute. Such independent advisors shall meet with the Parties at a mutually agreed upon time and place for the purpose of resolving the dispute (within thirty (30) calendar days of the period described above). All negotiations pursuant to this subsection are confidential and shall be treated as compromise and settlement negotiations for purposes of applicable rules of evidence.
20. CURRENCY CONVERSIONS
20.1 Notwithstanding anything to the contrary contained in this Agreement, all conversions between currencies shall be in accordance with the standard currency conversion policies and procedures of the Purchaser, as recommended by Purchaser's auditors.
21. SEVERABILITY
21.1 If any provision of this Agreement is held to be invalid or unenforceable, then such provision shall (so far as it is invalid or unenforceable) be given no effect and shall be deemed not to be included in this Agreement but without invalidating any of the remaining provisions of this Agreement.
22. CHOICE OF GOVERNING LAW; VENUE; SERVICE OF PROCESS AND JUDGMENTS
22.1 The terms of this Agreement and the relations between the parties hereto shall be governed by and are subject to the laws of France, without regard to conflicts of law principles. Each of the Parties hereby irrevocably submits to the jurisdiction of the courts located in France or first in the United States District Court for the Eastern District of Missouri and thereafter (and only if dismissed or transferred by the United States Court for the Eastern District of Missouri for lack of jurisdiction) in any court of competent jurisdiction in St. Louis, Missouri, in any action, suit or proceeding brought against any party hereto under
- 28 - |
or in connection with this Agreement, and hereby irrevocably waives; to the fullest extent each of them may effectively do so, any defense based on improper jurisdiction or venue including, without limitation, defenses based on forum non-conveniens. The Parties further agree that a judgment against such party in France, the United States District Court for the Eastern District of Missouri or, as applicable, any court of competent jurisdiction located in St. Louis, Missouri, shall be conclusive and binding upon it and may be enforced in any other jurisdiction to the fullest extent applicable.
23. PRESS ANNOUNCEMENTS
24.1 Purchaser, the Company and the Shareholders agree that no Press Announcement shall be issued by any party or any of their Affiliates without the prior written consent of the other of them (which consent shall not be unreasonably withheld, conditioned or delayed); provided, that the consent of the Majority Shareholders shall constitute the consent of the Shareholders, except as such release or announcement may be required by applicable Law, in which case the applicable party shall use reasonable efforts to allow the other of them reasonable time to comment on such release or announcement in advance of such issuance; provided, however, that either Purchaser or the Company may make any public statement in response to specific questions by the press, analysts, investors or those attending industry conferences or financial analyst conference calls, so long as any such statements are not inconsistent with previous Press Announcements.
24. FURTHER ASSURANCES; MUTUAL DRAFTING
25.1 Each party agrees to cooperate fully with the other parties and to execute such further instruments, documents and agreements and to give such further written assurances as may be reasonably requested by any other party to evidence and reflect the transactions described herein and contemplated hereby and to carry into effect the intents and purposes of this Agreement.
25.2 This Agreement is the joint product of the Company, the Shareholders and the Purchaser and each provision hereof has been subject to the mutual consultation, negotiation and agreement of such parties and shall not be construed for or against any party hereto
[Signature Page Follows]
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In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
ADVANCED ACCELERATOR APPLICATIONS, S. A. | |
By: /s/ Stefano Buono | |
Name: Stefano Buono | |
Title: Chairman and Chief Executive Officer |
BIOSYNTHEMA INC. |
By: /s/ Jack L. Erion |
Name: Jack L. Erion |
Title: Chief Executive Officer and President |
Company and Purchaser Signature Page to Stock Purchase Agreement
- 30 - |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: W. Bakker | ||
/s/ W.H. Bakker | W.H. Bakker | |
Name: | Signature | Print name |
Title: | Director | |
Date: | May 27, 2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
31 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: Boesen B.V | ||||
/s/ J.G.R Boesen | /s/ J.J.B. Boesen | J.G.R Boesen | J.J.B. Boesen | |
Name: | Signature | Print name | ||
Title: | Director | Managing Director | ||
Date: | 28 May 2010 | May 28, 2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
32 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: W. Breeman | ||
/s/ W. Breeman | W. Breeman | |
Name: | Signature | Print name |
Title: | PhD | |
Date: | May 28, 2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
33 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: B. D. Burleigh | ||
/s/ Bruce D. Burleigh | Bruce D. Burleigh | |
Name: | Signature | Print name |
Title: | ||
Date: | 25 May 2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
34 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: Center for Emerging Technologies | ||
/s/ William B. Simon | William B. Simon | |
Name: | Signature | Print name |
Title: | VP/COO for Center for Emerging Technologies | |
Date: | 5/25/2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
35 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: M. de Jong | ||
/s/ M. de Jong | M. de Jong | |
Name: | Signature | Print name |
Title: | Professor | |
Date: | May 30, 2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
36 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: J. Erion | ||
/s/ Jack L. Erion | Jack L. Erion | |
Name: | Signature | Print name |
Title: | President & CEO | |
Date: | 5/24/2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
37 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: Four Marks Development B.V. | ||
/s/ H. van Rossem | H. van Rossem | |
Name: | Signature | Print name |
Title: | Principal | |
Date: | May 26, 2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
38 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: B. Gallagher | ||
/s/ Brendan Gallagher | Brendan Gallagher | |
Name: | Signature | Print name |
Title: | ||
Date: | 5/29/2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
39 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: A. G. Harris | ||
/s/ Alan Harris | Alan Harris | |
Name: | Signature | Print name |
Title: | ||
Date: | 28 May 2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
40 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: E. Krenning | ||
/s/ EP Krenning | Prof. Dr. EP Krenning | |
Name: | Signature | Print name |
Title: | MD, PhD, FRCP | |
Date: | 29 May 2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
41 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: L. Kvols | ||
/s/ Larry Kvols | Larry Kvols | |
Name: | Signature | Print name |
Title: | ||
Date: | 6-1-2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
42 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: D. Kwekkeboom | ||
/s/ D. J. Kwekkeboom | D. J. Kwekkeboom | |
Name: | Signature | Print name |
Title: | Dr | |
Date: | 29./5/2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
43 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: S. Pauwels | ||
/s/ S. Pauwels | S. Pauwels | |
Name: | Signature | Print name |
Title: | MD, PhD | |
Date: | 28 May 2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
44 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: J. Reubi | ||
/s/ J. C. Reubi | J. C. Reubi | |
Name: | Signature | Print name |
Title: | Professor and Head of Division | |
Date: | June 3rd 2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
45 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: F. Sorenson | ||
/s/ Ferril M. Sorenson | Ferril M. Sorenson | |
Name: | Signature | Print name |
Title: | ||
Date: | May 31, 2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
46 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: J. Spronk | ||
/s/ Jacob Spronk | Jacob Spronk | |
Name: | Signature | Print name |
Title: | Prof. Dr. | |
Date: | 29 May 2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
47 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: A. van Dulmen | ||
/s/ Aad van Dulmen | Aad van Dulmen | |
Name: | Signature | Print name |
Title: | Shareholder | |
Date: | May 27, 2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
48 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: H. van Rooij | ||
/s/ Hans H. van Rooij | Hans H. van Rooij | |
Name: | Signature | Print name |
Title: | PhD | |
Date: | 2010/05/27 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
49 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: T. Visser | ||
/s/ Theo J. Visser | Theo J. Visser | |
Name: | Signature | Print name |
Title: | Professor | |
Date: | May 30, 2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
50 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: R. Wolfangel | ||
/s/ Robert G. Wolfangel | Robert G. Wolfangel | |
Name: | Signature | Print name |
Title: | Regulatory Consultant | |
Date: | 5-29-2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
51 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: H. Maecke | ||
/s/ Helmut Maecke | Helmut Maecke | |
Name: | Signature | Print name |
Title: | Professor | |
Date: | 31-05-2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
52 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: Mallinckrodt Inc.
By: | /s/ Joe Wuestner |
Name: | Joe Wuestner | |
Title: | VP and Assistant Secretary |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
53 |
In witness whereof, the parties hereto have caused this Agreement to be executed and delivered as of the date first set forth above.
Shareholder: RRL76, LLC | ||
/s/ Mary A. Palank | Mary A. Palank | |
Name: | Signature | Print name |
Title: | ||
Date: | 5/26/2010 |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
54 |
Exhibit 10.3
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
[*] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION.
License Agreement
between
Mallinckrodt Inc.
and
BioSynthema Inc.
TABLE OF CONTENTS
Article 1 | |
Definitions | 4 |
Article 2 | |
License | 11 |
Article 3 | |
Development and Commercialization | 11 |
Article 4 | |
Manufacture | 12 |
Article 5 | |
Consideration | 12 |
Article 6 | |
Commercialization Option | 14 |
Article 7 | |
Intellectual Property | 14 |
Article 8 | |
Representations and Warranties | 17 |
Article 9 | |
Confidentiality | 19 |
Article 10 | |
Announcement and Publicity | 20 |
Article 11 | |
Term and Termination | 20 |
Article 12 | |
Indemnification and Insurance | 23 |
Article 13 | |
Information on Clinical Safety and Epidemiology | 25 |
Article 14 | |
Governing Law and Jurisdiction | 25 |
Article 15 | |
Miscellaneous Provisions | 25 |
2 |
License Agreement
BioSynthema Inc. / Mallinckrodt Inc.
This License Agreement dated the 10th day of October, 2007 (the “Effective Date”), is entered into by and between Mallinckrodt Inc., a corporation organized and existing under the laws of the State of Delaware and having its principal offices at 675 McDonnell Blvd., Hazelwood, MO 63042 (referred to as “Mallinckrodt”), and BioSynthema Inc., a corporation organized and existing under the laws of Missouri, with an office at 4041 Forest Park Avenue, Saint Louis, MO 63108, and its Affiliates (BioSynthema Inc. and its Affiliates are hereafter referred to as “BI”).
INTRODUCTION
WHEREAS, BI has entered into an agreement with Dr. [*], referred to as the [*] License Agreement (as defined in Article 1) to obtain certain rights in and to inventions relating to radiolabeled somatostatin analogues covered in the Generic Patents (as defined in Article 1);
WHEREAS, BI has entered into an agreement with the Erasmus Hospital Medical Centre (hereinafter “Erasmus”) in Rotterdam, The Netherlands, referred to as the Erasmus License Agreement (as defined in Article 1) providing for the transfer of certain clinical data to BI;
WHEREAS, BI has accepted delivery of and has certain exclusive rights to the commercial use of clinical data relevant to the Product (as defined in Article 1) pursuant to the Erasmus License Agreement;
WHEREAS, Mallinckrodt owns certain rights to the Mallinckrodt Patents (as defined in Article 1);
WHEREAS, BI has, prior to the Effective Date, performed Development (as defined in Article 1) work on the Product in an effort toward ultimately obtaining Marketing Authorization (as defined in Article 1) for the Product; and
WHEREAS, BI wishes to obtain and Mallinckrodt agrees to convey certain licenses to the Mallinckrodt Patents, for the purpose of permitting BI to Develop, manufacture and Commercialize the Product.
NOW, THEREFORE, in consideration of the mutual promises, covenants and agreements hereinafter set forth, the sufficiency of which is hereby acknowledged, the Parties to this Agreement mutually agree as follows:
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
3 |
ARTICLE 1
DEFINITIONS
For purposes of this Agreement the terms defined in this Article shall have the meanings specified below:
1.1 | “Accounting Standards” shall mean GAAP (Generally Accepted Accounting Principles), consistently applied by the respective Party so utilizing such Accounting Standards. |
1.2 | “Affiliate” shall mean any entity that directly or indirectly controls or is controlled by or is under common control with a Party to this Agreement. For purposes of this definition, “control” or “controlled” means ownership directly or through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interest in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity, or the ability to cause the direction of the management or policies of a corporation or other entity. |
1.3 | “Agreement” shall mean this License Agreement together with all exhibits, schedules, and appendices attached to this Agreement, all as respectively amended, modified or supplemented by the Parties in accordance with the terms of this Agreement. |
1.4 | “Applicable Laws” shall mean all laws, regulations, ordinances, rules or standards applicable to the conduct, performance or obligations of either Party hereunder and imposed by a governmental, quasi-governmental authority or Regulatory Authority having jurisdiction in the respective portion of the Territory, including by way of illustration and not limitation, the U.S. Food, Drug and Cosmetic Act and the Good Manufacturing Practices promulgated by FDA or other Regulatory Authorities. |
1.5 | “BI Early Termination License” shall have the meaning as set forth in Section 11.4(c). |
1.6 | “BI Intellectual Property” shall mean BI’s rights (only to the extent they relate to the Product, the Product Components and the Compound) in and to: (1) the Generic Patents; (2) any patents licensed or otherwise acquired from a Third Party (including those listed on Exhibit 2) necessary or useful in the Development, manufacture or Commercialization of the Product; (3) the Erasmus clinical patient data as granted under the Erasmus License Agreement as of the Effective Date; (4) other clinical patient data from medical facilities and other non-clinical data under any Other Data Agreements; (5) any BI New Intellectual Property; (6) any BI Know-How; and (7) any intellectual property rights licensed or otherwise acquired from any Third Party which include the right to sublicense to Mallinckrodt or its Affiliates as set out in Exhibit 2. |
1.7 | “BI Know-How” shall mean any proprietary or non-proprietary information only to the |
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extent related to the Product, the Product Components and the Compound including, but not limited to research, development, manufacture and production methods and processes, use, inventions, discoveries, formulation, specifications (including raw material, component and product specifications), processes, trade secrets, expertise, developments and regulatory information Controlled by BI, whether or not protected under patent, trademark, copyright or other legal principles, to which BI has rights. | |
1.8 | “BioSynthema License Rights” shall have the meaning as set forth in Section 2.1 below. |
1.9 | “BI New Intellectual Property” shall mean: (1) any BI Intellectual Property, (2) any BI Know-How, (3) any improvements, enhancements, new discoveries, inventions, applications and further know-how conceived, made or acquired by BI and related to the Product, the Product Components and Compound, its formulation or the manufacture thereof, (4) any BI rights in the clinical patient data under the Erasmus License Agreement, (5) any BI rights to any data arising under the Other Data Agreements and (6) any BI interests in any co-owned intellectual property right pertaining to the Product only to the extent that any of the foregoing arises from the Development and/or the manufacture of the Product, the Product Components and the Compound from and after the Effective Date hereof. BI New Intellectual Property shall include any and all intellectual property rights in the foregoing, including all patents and trademarks, including domain names that BI uses in relation to the Compound, the Product Components and/or Product. |
1.10 | “Calendar Quarter” shall mean any period of three consecutive calendar months during a Calendar Year commencing with the first day of any January, April, July or October. |
1.11 | “Calendar Year” shall mean the calendar year, starting on January 1 and ending on December 31, in which the first First Commercial Sale of the Product occurs and each successive calendar year. |
1.12 | “Combination Product” shall mean the Product when sold in a finished dosage form containing the Product in combination with one or more other active ingredients. |
1.13 | “Commercialization” or “Commercialize” shall mean all activities conducted by a Party either directly, by its Affiliates or through a Third Party and directed to marketing, promoting, distributing, importing, exporting, offering for sale or selling a Product in the Field, which may include pre-launch market preparation, whether undertaken by a Party alone or with a partner or a Sublicensee. When used as a verb, “Commercialize” means to engage in Commercialization. |
1.14 | “Commercialization Agreement” shall have the meaning as set forth in Section 6.2(c). |
1.15 | “Commercialization Exercise” shall have the meaning as set forth in Section 6.2. |
1.16 | “Commercialization Option ” shall have the meaning as set forth in Section 6.1. |
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1.17 | “Commercially Reasonable Effort” shall mean reasonable efforts and resources customarily used in the nuclear medicine pharmaceutical industry in the United States for radiopharmaceutical oncology products with equivalent sales potential to the Product. |
1.18 | “Compound” shall mean the somatostatin peptide analogue, DOTAº-Tyr³-octreotate, as shown in Exhibit 3. |
1.19 | “Confidential Information” shall mean and include any and all know-how, data and information, not in the public domain, including without limitation information relating to the Compound, the Product Component and/or the Product, or the business, marketing, research and development activities, results of clinical trials, regulatory proceedings, finances, contractual relationships and operations of the Parties or their Affiliates. |
1.20 | “Controlled” or “Controls”, when used in reference to intellectual property, shall mean the legal authority or right of a Party hereto (or any of its Affiliates) to make, have made, use, sell, or offer for sale Compound, the Product Components and/or the Product, or to grant a license or sub-license of intellectual property rights to another party or to otherwise disclose proprietary or trade secret information to such other Party, without: (i) breaching the terms of any agreement with a Third Party; (ii) infringing upon the intellectual property rights of a Third Party; or (iii) misappropriating the proprietary or trade secret information of a Third Party. |
1.21 | “Damages” shall mean any and all losses, costs, claims, liabilities, fines, penalties, damages, expenses, court costs, interest, and reasonable fees of counsel, consultants, and expert witnesses, but shall not include consequential damages or lost profits of a Party, its Affiliates or its Sublicensees or subcontractors. |
1.22 | “Develop” or “Development” shall mean all activities conducted by BI, either directly or through a Sublicensee, as are necessary or useful toward successful application for Marketing Authorization. |
1.23 | “Development Costs” shall mean all costs and expenses as solely determined by BI and incurred by BI in connection with the Development of the Product. |
1.24 | “Dollars” or “USD” shall mean the lawful currency of the United States of America. |
1.25 | “Effective Date” shall mean the date provided in the Preamble to this Agreement. |
1.26 | “EMEA” shall mean the European Medicines Evaluation Agency or any successor agency responsible for review and approval of marketing applications for human drugs or diagnostics in the EU. |
1.27 | “Erasmus License Agreement” means the agreement between Erasmus Hospital and BI which grants to BI rights in clinical data on approximately five hundred (500) patients treated with the Product, including data on safety, efficacy and outcome, for inclusion in |
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a New Drug Application for submission to Regulatory Authorities to obtain Marketing Authorization for the Commercialization of the Product. | |
1.28 | “EU” shall mean the European Union, as it may be constituted from time to time. |
1.29 | “FDA” shall mean the U.S. Food and Drug Administration or its successor agency responsible for review and approval of marketing applications for human drugs or diagnostics in the US. |
1.30 | “Field” shall mean human oncology. |
1.31 | “First Commercial Sale” shall mean the first arms’ length sale of a Product to a Third Party in a country in the Territory following applicable Marketing Authorization for one or more indication(s) of such Product in such country, excluding for use in a clinical trial. |
1.32 | “Force Majeure” shall mean failure or delay by any Party in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from fire, floods, embargoes, government regulations, prohibitions or interventions, war, acts of war (whether war be declared or not), acts of terrorism, insurrections, riots, civil commotions, strikes, lockouts, Third Party supplier failures, including unscheduled shut down of a reactor which is integral for the performance of BI’s obligations hereunder, or any other cause beyond the reasonable control of the affected Party. |
1.33 | “Generic Patents” shall mean Patent Case 100-7382 and Patent Case 118-7595 (additional use patent), and any corresponding patent applications or patents including any and all substitutions, extensions, re-examination, or supplementary protection certificates, reissues, renewals, divisions, continuations or continuations-in-part thereof, provisional patents, patents of addition, or registrations of any kind, including but not limited to those set out in Exhibit 1a. For reference purposes, and not by way of limitation, the foregoing Generic Patents relate to labeled somatostatin analogues. |
1.34 | “Good Clinical Practice” or “GCP” shall mean the internationally recognized ethical and scientific standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity and confidentiality of the trial subjects are protected. |
1.35 | “Good Manufacturing Practices” or “GMP” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Regulatory Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory pursuant to its regulations, guidelines or otherwise. |
1.36 | “Interest” shall mean a rate per annum equal to LIBOR (London Interbank Offered Rate) plus one percent (1%) at the time such payment is due, and for the time period until payment is received by the Party entitled to receive such Interest |
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1.37 | “[*]” shall mean Dr. [*] of Rotterdam, The Netherlands. |
1.38 | “[*] License Agreement” shall mean the sublicense agreement entered into by and between [*] and BI, dated June 12, 2007 granting BI rights to the Generic Patents. |
1.39 | “MAA” shall mean a Marketing Authorization Application filed with the EMEA or any regulatory authority in any other country other than the US that is responsible for review and approval of marketing applications for human drugs or diagnostics. |
1.40 | “Mallinckrodt Early Termination License” shall have the meaning as set forth in Section 11.4(a). |
1.41 | “Mallinckrodt Milestone Payments” shall mean the milestone payments due from BI as set forth under Sections 5.2 and 5.3. |
1.42 | “Mallinckrodt Patents” shall mean any issued patent and any pending patent application owned or Controlled by Mallinckrodt during the Term of this Agreement with a claim encompassing the Compound, the Product, or any claims or formulations related to the Product and Compound, processes, uses and intermediates for the foregoing and shall include any continuations, continuations-in-part, divisions, provisionals, substitutions, patents of addition, reissues, re-examinations, renewals or extensions thereof (including any supplemental patent certificates) and any confirmation patent or registration patent and all foreign counterparts of any of the foregoing, including but not limited to those set out in Exhibit 1b. |
1.43 | “Mallinckrodt Royalties” shall mean the royalty payments due from BI as set forth under Section 5.4. |
1.44 | “Marketing Authorization” shall mean, with respect to a country in the Territory, the approval by the appropriate Regulatory Authority necessary for the Commercialization of the Product in that country. For the sake of clarity, Marketing Authorization shall not include the reimbursement approval. |
1.45 | “NDA” or “New Drug Application” shall mean a new drug application and all amendments and supplements thereto filed with the FDA (as more fully defined in 21 C.F.R. 314.5 et seq.), or the equivalent application filed with any equivalent Regulatory Authority outside the US (including any supra-national agency such as EMEA) requiring such filing, including all documents, data and other information concerning the Product which are necessary for gaining Marketing Authorization. |
1.46 | “NDA Acceptance” shall mean the date upon which the Product NDA submitted by BI is accepted for filing by FDA or the equivalent dossier is accepted for review by any |
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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other country’s respective Regulatory Authority, such as, for example, a Common Technical Document (“CTD”) submitted to the EMEA. | |
1.47 | “Net Sales” shall mean, with respect to the Product, the gross amount invoiced by or on behalf of the relevant Party or its Affiliates or Sublicensees for sales of the Product, during the Term hereof as set forth in Article 11, to Third Parties in bona fide, arms’-length transactions, less the following customary deductions, each determined in accordance with the Accounting Standards: |
(i) | normal and customary trade and quantity discounts actually allowed and properly taken directly with respect to sales of the Product; |
(ii) | amounts actually repaid or credited by reason of defects, rejection, recalls, returns, rebates and allowances of goods; |
(iii) | chargebacks and other amounts paid on sale or dispensing of Product; |
(iv) | amounts payable resulting from governmental mandated rebate programs; |
(v) | tariffs, duties, excise, sales, value- added and other taxes (other than taxes based on income); |
(vi) | retroactive price reductions specifically identifiable to the Product that are actually allowed or granted; |
(vii) | customary cash discounts for timely payment; |
(viii) | delayed ship order credits; all freight, postage and insurance included in the invoice price; |
(ix) | pharmacy service fees for services such as compounding fees for the preparation of radiopharmaceuticals and fees for the preparation of unit doses; and |
(x) | discounts pursuant to indigent patient programs and patient discount programs. |
In the event the Product is sold as a Combination Product, the Net Sales of the Product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales (as defined above in this Section) of the Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average sale price in a particular country of the Product when sold separately in finished form and B is the weighted average sale price in that country of the other product(s) sold separately in finished form. In the event that such average sale price cannot be determined for both the Product and the other product(s) in combination, Net Sales for purposes of determining royalty payments shall be negotiated in good faith and agreed upon by the Parties based on the relative value contributed by each component.
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1.48 | “Other Data Agreements” shall mean any agreement(s) between a Third Party and BI, other than the Erasmus License Agreement, which grant to BI rights in data relating to the Compound, the Product Components or the Product, including without limitation clinical data on patients treated with the Product, data on safety, efficacy and outcome, stability or manufacturing data of the Compound, the Product Components or the Product for inclusion in a New Drug Application for submission to Regulatory Authorities to obtain Marketing Authorization. |
1.49 | “Party” or “Parties” shall mean BI or Mallinckrodt, or BI and Mallinckrodt, whichever the context admits. |
1.50 | “Person” shall mean any individual or legal entity, including a corporation, partnership, association, joint-stock company, trust, unincorporated organization or government or political subdivision thereof. |
1.51 | “Product” shall mean the lutetium-177 radiolabeled Compound for radio-therapeutic and dosimetric use in final therapy dosage form and ready for infusion into the patient by the customer. |
1.52 | “Product Components” shall mean the lutetium Lu 177 chloride sterile solution, the Product Reaction Vial and such other elements comprising the Product as defined in the NDA which are combined to form the lutetium-177 labeled Compound. As used in the preceding sentence, “lutetium Lu 177 chloride sterile solution” shall mean the sterile radiochemical solution of the lutetium-177 radioisotope in a hydrochloric acid solution. |
1.53 | “Product Reaction Vial” shall mean the vial containing frozen or lyophilized material comprised of the Compound plus other additives necessary for a commercially stable formulation to which a lutetium-177 solution is added to make the Product. |
1.54 | “Regulatory Authority” shall mean the FDA or any foreign counterpart or additional governmental or regulatory agency in the Territory responsible for applicable Marketing Authorization pharmacovigilance, reimbursement or other subject matters contemplated in this Agreement. |
1.55 | [Deleted pursuant to terms of Termination and Amendment attached hereto as Annex A.1]. |
1.56 | “Specifications” shall mean the written standards for the Product and the Product Components as set forth in the NDA approved by a Regulatory Authority in connection with the Marketing Authorization of the Product or as set forth in a separate DMF. |
1.57 | “Sublicensee” shall mean a Third Party to which either Party may grant a right or license to the Product or the Compound under all or part of the BI Intellectual Property or the Mallinckrodt Patents in the Territory, or delegate an obligation hereunder. |
1.58 | “Term” shall have the meaning as set forth in Section 11.1. |
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1.59 | “Territory” shall mean all the countries and territories of the world. |
1.60 | “Third Party” shall mean any Person other than BI, Mallinckrodt, their respective Affiliates or permitted Sublicensees hereunder. |
1.61 | “US” shall mean the United States of America, including the District of Columbia, the Commonwealth of Puerto Rico and all other places under the jurisdiction thereof. |
ARTICLE 2
LICENSE
2.1 | Grant to BI. In consideration of the payments provided for in this Agreement, and subject to the provisions of this Agreement, Mallinckrodt hereby grants to BI an exclusive, worldwide, royalty-bearing license in the Field under the Mallinckrodt Patents, with the right to grant sublicenses as provided below to Develop and Commercialize the Product and exercise its rights under this Agreement (“BioSynthema License Rights”). |
2.2 | Sublicense. Under the BioSynthema License Rights, BI shall have the right to grant sublicenses to Third Parties including but not limited to sublicenses for the manufacturing of the Product, provided that the terms and conditions of a sublicense agreement shall be consistent with the terms of this Agreement. BI shall remain directly liable to Mallinckrodt for its obligations hereunder and shall be deemed a guarantor of each Sublicensee’s performance of BI’s obligations under this Agreement. BI shall strictly enforce each Sublicensee’s performance of BI’s obligations under this Agreement. Any sublicense by BI shall not waive any of BI’s obligations to Mallinckrodt, nor waive any of Mallinckrodt’s rights under this Agreement. Any reference to the obligations, performance, requirements or duties of BI hereunder shall be deemed applicable to and enforceable by either Party against any BI Sublicensee. In the event that BI assigns any of BI’s rights or obligations under this Agreement to a Sublicensee, then BI shall promptly notify Mallinckrodt of that fact and of the extent of the involvement of the Sublicensee with regard to this Agreement. BI shall provide Mallinckrodt with such additional information regarding any such Sublicensee as may be reasonably requested by Mallinckrodt. |
2.3 | Limitations of Rights. No license is granted by Mallinckrodt to BI other than the license expressly granted by the provisions of Section 2.1. Mallinckrodt retains all other rights under the Mallinckrodt Patents. |
ARTICLE 3
BioSynthema shall utilize Commercially Reasonable Efforts to Develop and Commercialize the Product.
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ARTICLE 4
MANUFACTURE
4.1 | Manufacturing Responsibility. BI shall be responsible, at its expense, for: (i) procuring all necessary materials required to manufacture the Compound, the Product Components and the Product; (ii) obtaining all licenses, permits or approvals required to manufacture the Compound, the Product Components and the Product; and (iii) manufacturing the Product in accordance with GMP to meet the requirements of the Development work hereunder, the requirements for patient use from and after the First Commercial Sale and in accordance with the Product Specifications as approved in each country in which the Product has Marketing Authorization. |
ARTICLE 5
CONSIDERATION
5.1 | [Deleted pursuant to terms of Termination and Amendment attached hereto as Annex A.1] |
5.2 | [Deleted pursuant to terms of Termination and Amendment attached hereto as Annex A.1] |
5.3 | [Deleted pursuant to terms of Termination and Amendment attached hereto as Annex A.1] |
5.4 | [Deleted pursuant to terms of Termination and Amendment attached hereto as Annex A.1] |
(a) | [Deleted pursuant to terms of Termination and Amendment attached hereto as Annex A.1] |
(b) | Royalty Term. Royalties shall be payable within sixty (60) days of the end of each Calendar Quarter from the First Commercial Sale of the Product until 2020. Notwithstanding the foregoing, the royalties hereunder shall cease to be payable in a country to the extent that the Mallinckrodt Patents are held to be invalid by a court of competent jurisdiction in that country. |
(c) | [Deleted pursuant to terms of Termination and Amendment attached hereto as Annex A.1] |
5.5 | Sales Reports. After the first First Commercial Sale of Product, BI shall have the following sales report obligations: |
(a) | Substance of Reports. Within sixty (60) days following the close of each Calendar Quarter, BI shall furnish to Mallinckrodt a written report showing the Net Sales in each country in the Territory. |
(b) | Records. BI shall keep accurate records in sufficient detail to enable the amounts |
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due hereunder to be determined and to be verified by an independent certified public accountant mutually agreed upon by the Parties pursuant to Section 5.5(d). | ||
(c) | Currency Exchange. All payments shall be made in U.S. Dollars. The U.S. Dollar equivalent of Net Sales invoiced in a currency other than U.S. Dollars shall be calculated in the same manner and using the same exchange rate as Mallinckrodt’s ultimate parent company (Covidien) uses to translate its consolidated income statements into U.S. Dollars. The methodology employed by Covidien to translate its consolidated income statements into U.S. Dollars shall be in accordance with Accounting Standards. |
(d) | Record Retention and Inspection. Royalty payments shall be made to the address and to the Affiliate as Mallinckrodt may designate from time to time. |
(i) | BI shall keep for two (2) years from the date of each payment of royalties complete and accurate records of sales by BI of Product in sufficient detail to allow the accruing royalties to be determined accurately. |
(ii) | Mallinckrodt shall have the right for a period of one (1) year after receiving any report or statement with respect to royalties due and payable to appoint an independent certified public accountant reasonably acceptable to BI to inspect the relevant records of BI and/or its Sublicensees (directly) to verify such report or statement. Mallinckrodt may exercise this right once with respect to the prior year’s Net Sales. If the right is not exercised during the one (1) year period described, the report shall be deemed accepted. Mallinckrodt may exercise this right only once in any Calendar Year. |
(iii) | BI shall make its records available for inspection by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon reasonable notice from Mallinckrodt, solely to verify the accuracy of the reports and payments. The results of each inspection, if any, shall be binding on both Parties. |
(iv) | Mallinckrodt agrees to hold in strict confidence and use only for the purpose described in this Article 5 all information concerning royalty payments and reports, and all information learned in the course of any audit or inspection (and not to make copies of such reports and information), except to the extent necessary for Mallinckrodt to reveal such information in order to enforce its rights under this Agreement in a court of competent jurisdiction or if disclosure is required by law, regulation or judicial order or to Novartis Pharma AG (“Novartis”) as may be necessary for Mallinckrodt to comply with any contractual obligations to Novartis. |
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(v) | Mallinckrodt shall pay for such inspections, except that in the event there is any upward adjustment in aggregate royalties payable for any year shown by such inspection of more than [*] percent ([*]%) of the amount paid, BI shall pay for such inspection. BI shall immediately pay Mallinckrodt the amount of any underpayment revealed by the inspection; any overpayments shall be fully creditable against amounts payable in subsequent payment periods, or fully refunded by Mallinckrodt to BI in the event there are no further sales of Product. |
(vi) | BI shall include in each Sublicense entered into by it pursuant to this Agreement a provision requiring the Sublicensee to keep and maintain adequate records of sales made pursuant to such sublicense and to grant BI access to such records for the purpose of BI inspecting such records for verification of Net Sales. |
5.6 | Withholding Taxes. In the event BI is required by law to make any deduction or withholding of taxes from any payment due to Mallinckrodt or its Affiliate under this Agreement, BI is authorized to withhold such taxes from the payments made under this Agreement at the applicable rate, taking into account any reduced rate of tax that Mallinckrodt or its Affiliate may be eligible for under applicable treaty or other applicable tax law; provided, however, Mallinckrodt shall provide to BI all necessary documentation establishing its eligibility for either (i) treaty benefits under an applicable treaty, or (ii) a reduction in or exemption from taxes under other applicable tax law. |
5.7 | Interest Due. All payments due by BI to Mallinckrodt, if not paid as specified in this Agreement shall accrue Interest until all such payments and Interest are paid. |
ARTICLE 6
[Deleted pursuant to terms of Termination and Amendment attached hereto as Annex A.1]
ARTICLE 7
INTELLECTUAL PROPERTY
7.1 | Mallinckrodt Patents During the Term of this Agreement, Mallinckrodt shall be responsible for the prosecution and maintenance of Mallinckrodt Patents. |
7.2 | Infringement Claims by Third Parties. |
(a) | Notice. If the manufacture, use, marketing, promotion, importation, offer for sale, distribution or sale of Compound or Product results in a claim or a threatened claim by a Third Party against a Party hereto for patent infringement or for inducing or contributing to patent infringement (“Infringement Claim”), the Party first having notice of an Infringement Claim shall promptly notify the other |
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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in writing. The notice shall set forth the facts of the Infringement Claim in reasonable detail. Failure to give notice shall not constitute a defense, in whole or in part, to any claim by any indemnified person hereunder except to the extent the rights of the indemnifier are materially prejudiced by such failure to give notice. |
(b) | Litigation. The Parties will promptly meet to discuss the lawsuit. BI shall defend any such infringement suit and will pay all losses, damages, costs, and expenses, including attorney's fees, that may be incurred by BI in the defense or settlement of the litigation. Mallinckrodt will cooperate fully, at BI’s expense, with BI in defending any such litigation for patent infringement. If BI should decide to settle any such litigation, it will notify Mallinckrodt of the proposed terms of any such proposed settlement and Mallinckrodt may agree to such proposed settlement or Mallinckrodt will assume the prosecution of the litigation and assume complete responsibility for all subsequent expenses, damages and judgments. If any settlement of the litigation results in an obligation on the part of BI to pay license fees or royalties to a Third Party, BI shall not reduce the royalty rate otherwise owed to Mallinckrodt. In addition, the Party not controlling such defense will have the right to be represented in any such action by counsel of its choosing at its own expense. The Party controlling such defense shall keep the other Party advised of the status of such action and shall consider recommendations made by the other Party in respect thereto. |
7.3 | Infringement Claims Against Third Parties |
(a) | Notice. If either Party becomes aware that any Third Party is (or is reasonably likely to be) infringing any Mallinckrodt Patents, or BI Intellectual Property, the Party to this Agreement first having knowledge of such infringement, or knowledge of a reasonable probability of such infringement, shall promptly notify the other in writing. The notice shall set forth the facts of such infringement in reasonable detail. |
(b) | Institution of Proceedings. Mallinckrodt shall have the right, but not the obligation, to institute, prosecute, and control with its own counsel at its own expense any action or proceeding with respect to infringement of the claims of the Mallinckrodt Patents. BI shall have the right, but not the obligation, to institute, prosecute, and control with its own counsel at its own expense any action or proceeding with respect to infringement of the claims of the BI Intellectual Property. In the event the respective Party does not take any action with respect to any such infringement within 120 days after receiving notice of such infringement thereof, the other Party may at its own discretion and at its own expense undertake such prosecution thereof. The Party undertaking the prosecution shall have the sole charge and direction of the prosecution of any such suit or action and the other Party shall, at its own expense, have the right, but not the obligation, to be represented in such action by its own counsel acting in an advisory but not controlling capacity. Each Party agrees to cooperate fully in the prosecution of any such suit or action undertaken hereunder by the other Party and to provide all evidence in its reasonable control. The Party controlling any |
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such legal proceedings shall, at the request of the other Party and to the extent permitted by law, direct its counsel to provide the other Party copies of all pleadings, discovery, and any other filings made or received in such legal proceedings. In addition, the Party controlling such legal proceedings may name the other Party as a party plaintiff as required by law and, if so required, shall pay the reasonable costs of representation solely for the purposes of prosecuting the lawsuit.
(c) | Division of Settlement / Damages Award. Each Party shall recover their respective actual out-of-pocket expenses, or equitable proportions thereof, associated with any litigation or settlement thereof from any recovery made by any Party. Any excess amount allocated as a damage award or settlement recovery shall be shared equally between the Parties. |
(d) | Settlement Status. The Parties shall keep each other informed of the status of, and of their respective activities regarding, any litigation or settlement thereof concerning the Compound and/or Product; provided, however, that no settlement or consent judgment or other voluntary final disposition of a suit under this Article 7 may be undertaken without the consent of the other Party if such settlement would require the other Party to be subject to an injunction or to make a monetary payment or would otherwise adversely affect the other Party’s rights under this Agreement. |
7.4 | Patent Term Extensions. The Parties shall cooperate in good faith with each other in procuring a patent term extension, wherever applicable, to the Mallinckrodt Patents. In the event that Mallinckrodt, which is responsible for prosecution and maintenance of the Mallinckrodt Patents, elects not to file for an extension, Mallinckrodt shall (i) inform BI of its intention not to file and (ii) cooperate with BI to file for such extension if the law requires such filing be made by Mallinckrodt or grant BI the right to file for such extension. |
7.5 | BI Intellectual Property. During the Term of this Agreement, BI New Intellectual Property shall be owned by BI and BI shall at its discretion be responsible for the filing, prosecution and maintenance of any patents or patent applications granted/filed on inventions or discoveries made by BI during the Development of the Compound and the Product. BI will disclose promptly to Mallinckrodt, in writing, all such inventions and discoveries made or conceived by BI personnel/representatives, and any such new patent applications filed. Such written disclosures shall include the names of all inventor(s) and/or developer(s). Such written disclosures shall be held in confidence by Mallinckrodt and BI. BI shall provide Mallinckrodt copies of drafts of such patent applications and copies of all prosecution documents in a timely manner prior to its filing in order to permit Mallinckrodt a reasonable time period to review such patent applications or prosecution documents and, at Mallinckrodt’s discretion, provide BI reasonable technical assistance in the preparation and prosecution of such patent applications. |
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ARTICLE 8
REPRESENTATIONS AND WARRANTIES
8.1 | Mallinckrodt Representations and Warranties. Mallinckrodt represents and warrants to BI as follows with respect to Mallinckrodt’s performance of its obligations under this Agreement: |
(a) | This Agreement has been duly executed and delivered by Mallinckrodt and constitutes the valid and binding obligation of Mallinckrodt, enforceable against Mallinckrodt in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles. The execution, delivery and performance of this Agreement have been duly authorized by all necessary action on the part of Mallinckrodt, its officers and directors. |
(b) | Mallinckrodt is the owner of, or Controls, and it will maintain during the Term, the entire right, title and interest in and to the Mallinckrodt Patents and it has the right to grant the licenses described in the License Agreement and as described herein and the grant of such licenses will not result in a breach of any agreement, contract or other understanding of any nature whatsoever to which Mallinckrodt is a party. |
(c) | Having no duty to conduct due diligence, Mallinckrodt has no knowledge as of the date of this Agreement of any patent applications, valid issued patents or other intellectual property rights owned by any Third Party which adversely affects Mallinckrodt’s obligations under this Agreement, the licenses granted hereunder, the Mallinckrodt Patents, and specifically, Mallinckrodt does not have any knowledge that practicing the Mallinckrodt Patents will constitute an infringement of any Third Party’s valid and enforceable rights. |
(d) | Having no duty to conduct due diligence, Mallinckrodt does not have any knowledge of any prior art, public use, prior offering for sale, presentation, publication or any other act that would adversely affect the validity of, or limit the scope of, any pending or issued claims of, the Mallinckrodt Patents. |
(e) | Mallinckrodt is not currently a Party to, and during the Term of this Agreement will not enter into, any agreements, oral or written, that are inconsistent with its obligations under this Agreement. |
(f) | Mallinckrodt is duly organized and validly existing under the laws of the State of Delaware and has full legal power and authority to enter into this Agreement. |
(g) | Mallinckrodt is not subject to any order, decree or injunction by a court of competent jurisdiction which prevents or materially delays the consummation of the transactions contemplated by this Agreement. |
8.2 | BI Representations and Warranties. BI represents and warrants to Mallinckrodt as follows with respect to the performance of its obligations under this Agreement: |
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(a) | This Agreement has been duly executed and delivered by BI and constitutes the valid and binding obligation of BI, enforceable against BI in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles. The execution, delivery and performance of this Agreement have been duly authorized by all necessary action on the part of BI, its officers and directors. |
(b) | BI is not currently a Party to, and during the Term of this Agreement will not enter into, any agreements, oral or written, that are inconsistent with its obligations under this Agreement. |
(c) | BI is duly organized and validly existing under the laws of the State of Missouri and has full legal power and authority to enter into this Agreement. |
(d) | BI is not subject to any order, decree or injunction by a court of competent jurisdiction which prevents or materially delays the consummation of the transactions contemplated by this Agreement. |
(e) | BI has entered into the [*] License Agreement and has thereby acquired valid and enforceable rights to the Generic Patents (listed in Exhibit 1a). A true and correct copy of the [*] License Agreement has been delivered to Mallinckrodt prior to the Effective Date hereof, with financial information redacted. BI represents and warrants that it has the right to enforce, or the right to cause to be enforced, the Generic Patents and the patents licensed under any Third Party license agreements that are listed in Exhibit 2 against a Third Party infringer. |
(f) | BI has entered the Erasmus License Agreement and the Other Data Agreements and has thereby acquired valid and enforceable right, title and interest in and to all of the clinical data described therein. A true and correct copy of the Erasmus License Agreement and the Other Data Agreements has been delivered to Mallinckrodt prior to the Effective Date hereof, with financial information redacted. |
(g) | BI has the right, under the [*] License Agreement, the Erasmus License Agreement and any Other Data Agreements, to sublicense the BI Intellectual Property to Mallinckrodt during the Term hereof, and shall have the right to sublicense to Mallinckrodt under any BI New Intellectual Property during the Term. |
8.3 | THE LIMITED WARRANTIES CONTAINED IN THIS ARTICLE ARE THE SOLE WARRANTIES GIVEN BY THE PARTIES AND ARE MADE EXPRESSLY IN LIEU OF AND EXCLUDE ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, |
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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INFRINGEMENT OR OTHERWISE, AND ALL OTHER EXPRESS OR IMPLIED REPRESENTATIONS AND WARRANTIES PROVIDED BY COMMON LAW, STATUTE OR OTHERWISE ARE HEREBY DISCLAIMED BY BOTH PARTIES.
ARTICLE 9
CONFIDENTIALITY
9.1 | Confidentiality. Subject to the exercise of the licenses granted in Article 2, during the Term of this Agreement, and for a period of five (5) years thereafter each Party hereto will maintain in confidence all Confidential Information generated under this Agreement as well as any Confidential Information disclosed by the other Party hereto. Neither Party shall use, disclose or grant use of such Confidential Information except as required under this Agreement. Each Party shall use the same standard of care as it uses to protect its own Confidential Information to ensure that its and its Affiliates’ employees, agents, consultants, Sublicensee(s) and clinical investigators only make use of Confidential Information for the purpose of this Agreement and do not disclose or make any unauthorized use of such Confidential Information. Each Party shall promptly notify the other upon discovery of any unauthorized use or disclosure of Confidential Information. Confidential Information shall not include any information which and to the extent: |
(a) | was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the other Party; |
(b) | was generally available to the public or otherwise part of the public domain at the time of its disclosure to the other Party; |
(c) | becomes generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; |
(d) | was disclosed to the receiving Party, by a Third Party who had no obligation to the other Party not to disclose such information; or |
(e) | was independently developed by the receiving Party without reference to the disclosure by the other Party. |
9.2 | The Parties agree that the financial terms of the Agreement and the reports described in Section 3.1.2 shall be considered Confidential Information of both Parties. |
9.3 | Each Party may disclose the Confidential Information to the extent such disclosure is reasonably necessary in filing or prosecuting patent applications, prosecuting or defending litigation, or complying with any applicable statute or governmental regulation provided such Party has given the disclosing Party prompt written notice allowing it to limit such disclosure. In addition, either Party may disclose Confidential Information to |
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its Affiliates and to its Sublicensees; provided, however, in connection with any such disclosure the disclosing Party shall secure the same obligations of confidential treatment of such Confidential Information, as required in this Article 9. BI may disclose all the terms of this Agreement and the License Agreement to a Third Party for the purpose of seeking financial assistance and investment, and shall obligate such Third Parties to treat such information as Confidential in accordance with this Article 9.
9.4 | The Parties shall undertake to ensure that all their employees who have access to Confidential Information of the other Party are under obligations of confidentiality fully consistent with those provided in this Article. |
9.5 | BI agrees that the terms, including but not limited to the financial terms, may be disclosed by Mallinckrodt to Novartis without further notice, provided Novartis shall be subject to the same confidentiality obligations as set forth herein. |
ARTICLE 10
ANNOUNCEMENT AND PUBLICITY
10.1 | Except upon agreement of both Parties, neither Party hereto shall make any disclosure to any Third Party, including press releases, concerning the terms of this Agreement. The restrictions on disclosure specified herein shall not apply to announcements required by law or regulations or stock exchange rules, including announcements required by law, regulations or stock exchange rules to be made by either Party to their respective shareholders. It is, however, the Parties’ intent that they will coordinate to such extent as may be reasonably possible with respect to the wording of any such announcements and that the financial terms of this Agreement shall not be made public. |
10.2 | Except with Mallinckrodt’s prior written permission, BI shall not use and shall prohibit its Sublicensees from using Mallinckrodt’s or its Affiliates’ name, symbols and any other marks in any form of publicity. |
ARTICLE 11
TERM AND TERMINATION
11.1 | Term. Unless otherwise terminated as provided under this Article 11 or under Section 15.2 (Force Majeure), the term of the Agreement shall commence as of the Effective Date and shall remain in full force and effect through January 1, 2020 (“Term”). |
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11.2 | Termination For Insolvency. Either Party may terminate this Agreement immediately upon delivery of written notice to the other Party (a) upon a finding of insolvency, receivership or bankruptcy by a competent court, for the settlement of the other Party's debts, (b) upon the other Party's making an assignment for the benefit of creditors, or (c) upon the other Party's dissolution or ceasing to do business. |
11.3 | Material Breach. If either Party is in breach of any material obligation hereunder and, in the case of a breach capable of remedy, it shall not h ave been remedied by the defaulting Party within ninety (90) days of written notice specifying the breach and requiring its remedy, the Party not in breach of the material obligation may forthwith terminate this Agreement by notice without prejudice to the accrued rights of either Party, with rights to each Party as set forth in Section 11.4 below. |
11.4 | Effect Of Termination. |
(a) | Termination by Mallinckrodt. Upon early termination pursuant to Section 11.2, 11.3 or 15.2, if Mallinckrodt is the terminating Party, all of Mallinckrodt’s rights in the Mallinckrodt Patents shall revert to Mallinckrodt and Mallinckrodt shall automatically be granted a perpetual, worldwide, royalty-bearing, exclusive license, with the right to sub-license, in and to the BI Intellectual Property, except expressly excluding the Generic Patents, to Develop, make, have made, use, offer to sell, import and sell the Compound, the Product Components and the Product in the Territory in the Field. BI shall assign to Mallinckrodt all of BI’s rights in and to any Third Party Sublicenses granted to BI in connection with its performance of the obligations hereunder. At Mallinckrodt’s election, BI shall transfer to Mallinckrodt upon Mallinckrodt’s request all its stock of Compound, Product Reaction Vials, Product labeling, package inserts and packaging at cost, and will immediately transfer ownership of all Marketing Authorizations to Mallinckrodt and to the extent possible, shall give Mallinckrodt and its Sublicensees an access right to all clinical development, regulatory and manufacturing data of the Product, as well as to all other relevant information Controlled by BI regarding the Compound, the Product Reaction Vials and the Product, as necessary to Develop, manufacture and Commercialize the Product (the foregoing rights and assets are collectively referred to herein as the “Mallinckrodt Early Termination License”). In addition, BI shall provide at Mallinckrodt’s request, the reasonable assistance of appropriate BI personnel in connection with the transfer therewith. The royalty rate payable by Mallinckrodt to BI for the Mallinckrodt Early Termination License shall be as follows: |
(A) | [*] percent ([*]%) of the annual Net Sales of the Product for a period of time and upon terms as set forth in Section 5.4. |
(b) | Mallinckrodt’s Right of First Offer on BI’s Product Manufacturing Assets. |
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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(i) | If Mallinckrodt terminates this Agreement under Article 11 or under Section 15.2, then, in addition to the Mallinckrodt Early Termination License, Mallinckrodt shall have ninety (90) days after the date of such termination to provide a written offer to BI (the “Mallinckrodt Proposal”). The Mallinckrodt Proposal shall contain material terms for a transaction to acquire ownership of, or a license to, all of the assets of BI used in the manufacture of the Product, including the BI Intellectual Property related thereto, not otherwise acquired by or licensed to Mallinckrodt under the Mallinckrodt Early Termination License (the “Product Manufacture Assets”). |
(ii) | If the Mallinckrodt Proposal is not received within the ninety (90) day response period or if Mallinckrodt notifies BI in writing that Mallinckrodt declines to extend such an offer, then BI shall have the unrestricted and irrevocable right thereafter to pursue an option to sell or license the Product Manufacture Assets to a Third Party. |
(iii) | If Mallinckrodt does provide a Mallinckrodt Proposal within the ninety (90) day response period, then BI and Mallinckrodt shall have a further sixty (60) days to negotiate exclusively and in good faith the terms of a business arrangement with respect to the Product Manufacture Assets. |
(iv) | If BI and Mallinckrodt are unable to reach an agreement within such sixty (60) day period, then BI shall so notify Mallinckrodt, and BI shall have the right thereafter to negotiate with (but not disclose the terms of the Mallinckrodt Proposal to) any Third Party and consider such proposal from a Third Party containing the material terms on which the Third Party proposes to enter into a business arrangement with respect to the Product Manufacture Assets. In the event of any such Third Party proposal which is acceptable to BI and which is received by BI within twelve (12) months of the date of termination as provided in subparagraph (i) above (the “Third Party Proposal”), BI shall give written notice thereof to Mallinckrodt and Mallinckrodt shall have thirty (30) days thereafter to offer to BI in writing terms that are in BI’s sole, good faith determination better terms than that offered in the Third Party Proposal. |
(v) | If BI accepts Mallinckrodt’s offer for the Product Manufacture Assets, then BI and Mallinckrodt shall negotiate in good faith within thirty (30) days thereafter with the intent of entering into a binding agreement to execute such transaction and all necessary documents. |
(vi) | If BI and Mallinckrodt do not enter into a binding agreement as provided in subparagraph (v) above, then BI shall have no further obligation to Mallinckrodt for the sale of the Product Manufacturing Assets under this Agreement |
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(c) | Termination by BI. Upon early termination by BI pursuant to Section 11.2 or 11.3, BI shall be granted a perpetual, worldwide, royalty-bearing, exclusive license, with the right to sub-license in and to the Mallinckrodt Patents existing as of the date of such termination to make, have made, use, offer to sell, import and sell Product in the Territory in the Field (the “BI Early Termination License”). The royalty rate payable by BI for the BI Early Termination License shall be as follows: |
(A) | The applicable percentage as set forth in Section 5.4, reduced by [*] percent ([*]%) and payable upon the same terms and conditions as set forth in Section 5.4. |
ARTICLE 12
INDEMNIFICATION AND INSURANCE
12.1 | BI will indemnify, defend and hold Mallinckrodt harmless from and against any and all Damages incurred or suffered by Mallinckrodt arising out of or resulting from: (i) BI’s breach of a material term of this Agreement; (ii) BI’s breach of any of its representations or warranties hereunder; (iii) BI’s performance of its obligations hereunder, including the Development, manufacture, handling, use, marketing, sale or other disposition, of Compound, Product Component and/or Product by any of BI, its Sublicensees, and their contractors; (iv) any actual or alleged bodily injury, illness or death sustained in connection with the use of the Product; or (v) BI’s breach of any of its obligations under the [*] License Agreement, the Erasmus License Agreement, any Third Party license agreement(s) or any Other Data Agreement(s), except to the extent that such Damages are due to Mallinckrodt’s or Mallinckrodt’s directors’, officers’, or employees’ negligence or willful misconduct. |
12.2 | Mallinckrodt will indemnify, defend and hold BI harmless from and against any and all Damages incurred or suffered by BI arising out of or resulting from: (i) Mallinckrodt’s breach of a material term of this Agreement; (ii) Mallinckrodt’s breach of any of its representations or warranties hereunder, or (iii) Mallinckrodt’s breach of any its obligations with Novartis; except to the extent that such Damages are due to BI’s or BI’s directors’, officers’, or employees’ negligence or willful misconduct. |
12.3 | The Parties agree as follows: |
(a) | Each Party shall give the other Party prompt written notice of any claim or threat of claim it receives with respect to any matter for which it may be entitled to indemnification, and the indemnifier shall thereafter defend or settle (subject to the terms of this Section 12.3) any such claim at the indemnifier’s sole expense, with counsel selected by the indemnifier. In the defense or settlement of any such |
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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claim, the indemnified Party shall cooperate with and assist the indemnifier to the extent reasonably possible, but the indemnifier shall bear and pay any and all expenses incurred by the indemnified Party in providing such cooperation and assistance, either directly or upon request of the indemnified Party who has incurred such expense. Failure to give notice shall not constitute a defense, in whole or in part, to any claim by any indemnified person hereunder except to the extent the rights of the indemnifier are materially prejudiced by such failure to give notice.
(b) | Notwithstanding the foregoing, upon any claim being made by a person not a Party to this Agreement (and not an Affiliate of a Party) with respect to any matter to which the foregoing indemnities relate, the indemnified Party may make settlement of such claim on not less than thirty (30) days prior written notice of the proposed terms thereof to the indemnifier; provided, however, that if within said thirty (30) day period the indemnifier shall have requested the indemnified Party not to settle such claim and to deny such claim, the indemnified Party will promptly comply and the indemnifier shall have the right to defend the claim at the indemnifier’s sole expense and with counsel reasonably acceptable to the indemnified Party. In the event that the indemnifier has not responded to such notice within such 30-day period, such absence of response shall be deemed a written consent to the proposed settlement. |
(c) | Notwithstanding that the indemnifier has assumed the defense of any claim with counsel selected by the indemnifier, the indemnified Party shall have the right to employ its own counsel, at its sole expense. If, in good faith, an indemnified Party concludes that there are specific defenses available to the indemnified Party which are different from or in addition to those available to the indemnifier with respect to the scope of the foregoing indemnities, then such indemnified Party shall have the right to direct the defense of any such defense of any such claim and each Party shall pay all its Damages. |
(d) | Neither Party will conduct itself in a way that could prejudice the defense of any such claims or threats. |
12.4 | References in this Article 12 to a Party that may be entitled to indemnification shall also include its Affiliates and its and their officers, directors, employees and agents. |
12.5 | The Parties agree to maintain insurance, including but not limited to product liability insurance and clinical trial insurance in the case of BI, with respect to their activities hereunder. Such insurance shall be in such amounts and subject to such deductibles based upon standards prevailing in the industry at the time. Mallinckrodt may satisfy its obligations under this Article through self-insurance to the same extent. BI shall, upon request by Mallinckrodt from time to time, produce a certificate of insurance evidencing such insurance coverage. |
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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12.6 | Neither Party nor its Affiliates shall have any liability for any special, incidental, or consequential damages, including, but not limited to the loss of opportunity, revenue or profit, in connection with or arising out of this Agreement, even if it shall have been advised of the possibility of such damages. |
ARTICLE 13
INFORMATION ON CLINICAL SAFETY AND EPIDEMIOLOGY
13.1 | BI shall be fully responsible for ensuring compliance with all pharmacovigilance obligations, including the holding and maintaining of the global safety database for the Product. |
ARTICLE 14
GOVERNING LAW AND JURISDICTION
14.1 | The construction, validity and performance of this Agreement will be governed in all respects by Missouri Law. All disputes arising out of or affecting this Agreement which cannot be resolved amicably shall be submitted to the exclusive jurisdiction of the State courts of Missouri (County of St. Louis) or (at the option of either Party) Federal District Court for the Eastern District of Missouri. |
ARTICLE 15
MISCELLANEOUS PROVISIONS
15.1 | Waiver. The failure on the part of BI or Mallinckrodt to exercise or enforce any rights conferred upon it hereunder shall not be deemed to be a waiver of any such rights nor operate to bar the exercise or enforcement thereof at any time or times thereafter. The observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively) by the Party entitled to enforce such term, but any such waiver shall be effective only if in writing signed by the waiving Party. |
15.2 | Force Majeure. Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement, other than an obligation to make a payment, when such failure or delay is caused by reason of Force Majeure. If a Force Majeure circumstance persists for more than six (6) consecutive months, the Party not claiming the delay shall be entitled to terminate this Agreement effective upon the |
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expiration of such six (6) month period, provided that the terminating Party provide at least thirty (30) days prior written notice before the effective date of such termination.
15.3 | Severability. The Parties shall comply with all Applicable Laws, domestic or foreign in connection with the performance of their respective obligations hereunder. In the event that any provision of this Agreement, or any part hereof, is found invalid or unenforceable, the remainder of this Agreement will be binding on the Parties hereto, and will be construed as if the invalid or unenforceable provision or part thereof had been deleted, and the Agreement shall be deemed modified to the extent necessary to render the surviving provisions enforceable to the fullest extent permitted by law. |
15.4 | Assignment. This Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party; provided, however, that either Party may assign this Agreement, without the consent of the other Party, (i) to any of its Affiliates, if the assigning Party guarantees the full performance of its Affiliates’ obligations hereunder or (ii) in connection with the transfer or sale of all or substantially all of its assets or business to which this Agreement pertains or in the event of its merger or consolidation with another company. In all cases the assigning Party shall provide the other Party with prompt notice of any such assignment. Any purported assignment in contravention of this Article shall, at the option of the non assigning Party, be null and void and of no effect. No assignment shall release either Party from responsibility for the performance of any accrued obligation of such Party hereunder. |
15.5 | Counterparts. This Agreement may be executed in two copies, both of which shall be deemed to be originals, and both of which shall constitute one and the same Agreement. |
15.6 | No Agency. Nothing herein contained shall be deemed to create an agency, joint venture, amalgamation, partnership or similar relationship between Mallinckrodt and BI. Notwithstanding any of the provisions of this Agreement, neither Party shall at any time enter into, incur, or hold itself out to Third Parties as having authority to enter into or incur, on behalf of the other Party, any commitment, expense, or liability whatsoever, and all contracts, expenses and liabilities undertaken or incurred by one Party in connection with or relating to the Development, manufacture or Commercialization of Compound or Product shall be undertaken, incurred or paid exclusively by that Party, and not as an agent or representative of the other Party. |
15.7 | Notice. All communications between the Parties with respect to any of the provisions of this Agreement will be sent to the addresses set out below, or to other addresses as designated by one Party to the other by notice pursuant hereto, by internationally recognized courier or by prepaid certified, air mail (which shall be deemed received by the other Party on the seventh day following deposit in the mails), or by facsimile transmission or other electronic means of communication (which shall be deemed received when transmitted), with confirmation by letter given by the close of business on or before the next following day: |
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If to Mallinckrodt, at:
Mallinckrodt Inc.
675 McDonnell Blvd
St. Louis, MO 63042
Attn: President, Imaging Solutions
With a copy to:
Mallinckrodt Inc.
675 McDonnell Blvd.
St. Louis, MO 63042
Attn: Vice President, Chief Corporate Counsel, Imaging Solutions
If to BI at:
Jack L. Erion
President & CEO
BioSynthema Inc.
4041 Forest Park Avenue
St. Louis, MO 63108
Attn: President, BioSynthema
With a copy to:
BioSynthema Inc.
Mary A. Palank, Esq.
Vice President & General Counsel
BioSynthema Inc.
Palank & Associates LLC
1034 S. Brentwood Blvd., Suite 1630
St. Louis, Missouri 63117
15.8 | Survival. Except where explicitly provided elsewhere herein, termination of this Agreement for any reason, or expiration of this Agreement, will not affect: (i) obligations, including the payment of any sums which have accrued as of the date of termination or expiration, and (ii) rights and obligations which, from the context thereof, are intended to survive termination or expiration of this Agreement. |
15.9 | Headings. The paragraph headings are for convenience only and will not be deemed to affect in any way the language of the provisions to which they refer. |
15.10 | Entire Agreement. This Agreement together with its Exhibits shall supersede any prior agreement between the Parties and constitutes the entire understanding of the Parties relating to the matters referred to herein, and may only be amended by a written document, duly executed on behalf of the respective Parties. However the terms of this Agreement shall prevail over any conflicting terms contained in any of the Exhibits. |
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15.11 | Interpretation. In this Agreement unless the context requires otherwise: |
(a) | the singular includes the plural and vice versa; |
(b) | a gender includes the other genders; |
(c) | a reference to a document includes the document as modified from time to time and any document replacing it; |
(d) | if something is to be done on a day which is not a Business Day then that thing must be done on the next or following Business Day; |
(e) | "month" means calendar month and "year" means 12 months; |
(f) | "in writing" includes any communication sent by letter, facsimile transmission or email; |
(g) | a reference to any statute, proclamation, rule, regulation or ordinance includes any amendment, consolidation, modification, re-enactment or reprint of it or any statute, proclamation, rule, regulation or ordinance replacing it. A reference to a specified section, clause, paragraph, schedule or item of any statute, proclamation, rule, regulation or ordinance means a reference to the equivalent section of the statute, proclamation, rule, regulation or ordinance which is for the time being in force; |
(h) | "including" and similar expressions are not words of limitation; and |
(h) | a reference to any agency or body, if that agency or body ceases to exist or is reconstituted, renamed or replaced or has its powers or functions removed (defunct body), means the agency or body which performs most closely the functions of the defunct body. |
ARTICLE 16
PAYMENTS
All payments due to a Party hereunder shall be invoiced to the other Party within sixty (60) days following the Calendar Quarter that such payment is due and owing, and the invoiced Party shall pay all undisputed invoices within sixty (60) days of the date of invoice by wire transfer pursuant to the instructions on the invoicing Party’s invoice statement. All payments due by either Party under this Agreement, if not received as specified in this Agreement, shall accrue Interest until all such payments and Interest are paid.
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ARTICLE 17
SALES AND USE TAX
The payments hereunder exclude any sales and use or similar taxes imposed by any state or local government in the US which taxes, if any, Mallinckrodt will bear. BI agrees to collect and remit any such tax, if required to do so under the laws of any state or local jurisdictions. Each Party shall cooperate with the other Party and take any action reasonably requested (which does not cause such Party to incur any material cost or inconvenience) in order to minimize any taxes payable, including providing sales and use tax exemption certificates or other documentation necessary to support sales or use tax exemptions. Mallinckrodt and BI agree to provide each other information and data that they may from time to time reasonably request and otherwise fully cooperate with each other in connection with (i) the reporting of any sales or use taxes payable; (ii) any sales or use tax audit; and (iii) any assessment, refund claim or proceeding relating to taxes payable.
ARTICLE 18
DISPUTE RESOLUTION
If either Party disagrees with the other Party regarding the adequacy of performance of a Party’s obligations or any payments owing hereunder, then the Parties agree to meet and negotiate such matter(s) in good faith toward a mutually acceptable resolution.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
Mallinckrodt Inc. | |||
By: | /s/ Steven J. Hanley | ||
Name: | Steven J. Hanley | ||
Title: | President, Imaging Solutions | ||
BioSynthema Inc. | |||
By: | /s/ Jack L. Erion | ||
Name: | Jack L. Erion | ||
Title: | President and CEO |
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Annex A.1
Amending Provisions
from Termination of Commercialization Agreement and Amendment
to License Agreement, dated March 12, 2010, between BioSynthema
Inc. (“BI”) and
Mallinckrodt Inc. (“Mallinckrodt”)
Section 1.2.
Except as expressly provided herein, the terms of the Commercialization Agreement governing the exercise and effect of early termination shall continue to apply in full force and effect. Without limiting the generality of the foregoing, the terms of Section 13.2(d) and 13.4(a) of the Commercialization Agreement shall apply and govern as written (including without limitation the grant of the BI Early Termination License and BI's corresponding [*] percent ([*]%) royalty obligation through January 1, 2020 as set forth therein). Further, the following terms of the Commercialization Agreement shall be incorporated in their entirety as additional terms of the License Agreement:
1.2.1 Section 14.1, (Payments), shall be the new Article 16 of the License Agreement, and
1.2.2 Section 14.14(a), (Sales and Use Tax), shall be the new Article 17 of the License Agreement, and
1.2.3 Section 14.18, (Dispute Resolution), shall be the new Article 18 of the License Agreement, and
1.2.4 Section 11.2, (Permitted Disclosures), shall replace Section 9.3 of the License Agreement in its entirety. For clarification, the Parties agree that BI may disclose all of the terms of the License Agreement to a Third Party for the purpose of seeking financial assistance and investment subject to and in accordance with the terms, conditions and stipulations of new Section 11.2, of the License Agreement. Except for disclosures expressly permitted under Article 9 of the License Agreement (e.g., disclosure for the purpose of seeking financial assistance and investment), the terms of Article 10 of the License Agreement require that both Parties must agree prior to any disclosure to any Third Party, including press releases, concerning the terms of this Agreement.
Section 2.2.
The following provisions of the License Agreement are hereby amended as follows:
2.2.1 Articles 1, 2 and 4 of the License Agreement shall remain in full force and effect.
2.2.2 Article 3 of the License Agreement is hereby deleted in its entirety and replaced with the following: "BioSynthema shall utilize Commercially Reasonable Efforts to Develop and Commercialize the Product."
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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2.2.3 Article 5, Sections 5.1 through 5.4 (a), (b) and (c) of the License Agreement are hereby deleted in their entirety. Sections 5.5 and 5.6 shall survive and govern as written.
2.2.4 New Section 5.4(b) of the License Agreement shall read in its entirety: “Royalties shall be payable within sixty (60) days of the end of each Calendar Quarter from the First Commercial Sale of the Product until 2020. Notwithstanding the foregoing, the royalties hereunder shall cease to be payable in a country to the extent that the Mallinckrodt Patents are held to be invalid by a court of competent jurisdiction in that country.”
2.2.5 Article 6 of the License Agreement is hereby deleted.
2.2.6 Articles 7 and 8 of the License Agreement shall survive and govern as written.
2.2.7 Articles 10 through 15 of the License Agreement along with all exhibits shall remain in full force and effect as written.
2.2.8 Section 1.55 of the License Agreement, (Royalty Term) shall be deleted in its entirety.
2.2.9 Section 11.1 of the License Agreement (Term) shall be deleted in its entirety and shall be replaced as follows: “11.1 Term. Unless otherwise terminated as provided under this Article 11 or under Section 15.2 (Force Majeure), the term of the Agreement shall commence as of the Effective Date and shall remain in full force and effect through January 1, 2020 (“Term”).”
Section 3.
Except as otherwise provided for in this Termination and Amendment, the terms and conditions of the License Agreement remains in full force and effect. To the extent that any of the terms of the License Agreement vary or conflict in any respect with the terms of this Termination and Amendment, then the terms of this Termination and Amendment shall control.
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Annex A.2
Relevant Provisions
of Commercialization Agreement dated February 5, 2008,
between Mallinckrodt Inc. and BioSynthema Inc., incorporated into License
Agreement
Section 11.2
Permitted Disclosures. Each Party may disclose the Confidential Information to the extent such disclosure is reasonably necessary in filing or prosecuting patent applications, prosecuting or defending litigation, or complying with any applicable statute or governmental regulation provided such Party has given the disclosing Party prompt written notice allowing it to limit such disclosure. In addition, either Party may disclose Confidential Information to its Affiliates and to its Sublicensees; provided, however, in connection with any such disclosure the disclosing Party shall secure the same obligations of confidential treatment of such Confidential Information, as required in this Article 11. BI may disclose all the terms of this Agreement and the License Agreement to a Third Party for the purpose of seeking financial assistance and investment, and shall obligate such Third Parties to treat such information as Confidential in accordance with this Article 11.
Section 13.2(d)
Termination Without Cause. Either Party may terminate this Agreement without cause upon twelve (12) months prior written notice to the other Party. BI may exercise such right only if BI (i) warrants to Mallinckrodt in writing that BI shall discontinue all manufacturing of the Compound, the Product Components, and the Product, whether for Mallinckrodt or otherwise, and (ii) agrees in writing to terminate all of the rights of BI under the License Agreement. MI may exercise such right only if Mallinckrodt warrants to BI that, it shall discontinue all marketing and sales of the Product.
Section 13.4(a)
Termination by Mallinckrodt. Upon early termination of this Agreement by Mallinckrodt pursuant to Section 13.2(d) (Termination Without Cause), the License Agreement shall nonetheless remain in full force and effect, BI shall automatically be granted the BI Early Termination License and all obligations of BI to pay Mallinckrodt Milestones and Royalties as set forth in Article 5 of the License Agreement shall be irrevocably waived. The royalty rate payable by BI for the BI Early Termination License under this paragraph (a) shall be as follows:
(A) [*] percent ([*]%) of the annual Net Sales of the Product to be paid in accordance with the terms of Section 14.1 for the stated Term of this Agreement.
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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Annex A.2
Section 14.1
Payments. All payments due to a Party hereunder shall be invoiced to the other Party within sixty (60) days following the Calendar Quarter that such payment is due and owing, and the invoiced Party shall pay all undisputed invoices within sixty (60) days of the date of invoice by wire transfer pursuant to the instructions on the invoicing Party’s invoice statement. All payments due by either Party under this Agreement, if not received as specified in this Agreement, shall accrue Interest until all such payments and Interest are paid.
All royalty payments owing for the sale of Products (as contemplated in Sections 4.8(b), 5.1(b), 5.4, 13.3 and 13.4), whether owing during the Term, or to be paid after termination of this Agreement, shall be paid (without invoice or notice) by wire transfer by the Party owing such royalty within sixty (60) days following the Calendar Quarter in which the sales generating such royalty payment occurred.
All payments, including any late payment as set forth in this Section 14.1, shall be made in U.S. Dollars. The U.S. Dollar equivalent of Net Sales invoiced in a currency other than U.S. Dollars shall be calculated in the same manner and using the same exchange rate as Mallinckrodt’s ultimate parent company (Covidien) uses to translate its consolidated income statements into U.S. Dollars. The methodology employed by Covidien to translate its consolidated income statements into U.S. Dollars shall be in accordance with Accounting Standards.
Section 14.14(a)
Sales and Use Tax. The payments hereunder exclude any sales and use or similar taxes imposed by any state or local government in the US which taxes, if any, Mallinckrodt will bear. BI agrees to collect and remit any such tax, if required to do so under the laws of any state or local jurisdictions. Each Party shall cooperate with the other Party and take any action reasonably requested (which does not cause such Party to incur any material cost or inconvenience) in order to minimize any taxes payable, including providing sales and use tax exemption certificates or other documentation necessary to support sales or use tax exemptions. Mallinckrodt and BI agree to provide each other information and data that they may from time to time reasonably request and otherwise fully cooperate with each other in connection with (i) the reporting of any sales or use taxes payable; (ii) any sales or use tax audit; and (iii) any assessment, refund claim or proceeding relating to taxes payable.
Section 14.18
If either Party disagrees with the other Party regarding the adequacy of performance of a Party’s obligations or any payments owing hereunder, then the Parties agree to meet and negotiate such matter(s) in good faith toward a mutually acceptable resolution.
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Exhibit 10.4
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
[*] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION.
KNOW HOW and TRADEMARK LICENCE AGREEMENT
BETWEEN:
IASON GmbH a company organised and existing under the laws of Austria, whose registered office is at Feldkirchner Straße 4, A-8054 Graz-Seiersberg represented by Mr Mag. Christoph Artner in his capacity of CEO, (hereinafter “LICENSOR”)
- on the one hand -
AND :
Advanced Accelerator Applications S.A., a company organised and existing under the laws of France, whose registered office is at 20 rue Diesel 01630 Saint Genis Pouilly (France), represented by Stefano Buono, in his capacity of President and General Director (hereinafter the “LICENSEE”)
- on the other hand -
WHEREAS:
A. | LICENSOR has developed the formulation of the pharmaceutical Product(s) described in Schedule A hereto (« the Product(s) ») and owns a body of scientific, technical and marketing information and know-how relating to the Product(s). |
B. | LICENSOR is the registered owner of the trademark(s) shown in Schedule B hereto which is/are registered in different countries as given in Schedule B. |
C. | LICENSOR has obtained from the competent authorities the Marketing Authorisation according to pharmaceutical legal rules to sell and market the Product in the countries given in Schedule C. |
D. | LICENSOR as the Marketing Authorisation Holder (MAH), is responsible for all aspects of the Product, including quality and compliance with the conditions of marketing authorisation. |
E. | LICENSOR wishes to grant LICENSEE the right to manufacture the Product(s) by using the LICENSOR’s know-how and the right to sell and to promote the sales of the Product(s) in France, Spain, Belgium, Luxembourg, The Netherlands, French Cantons of Switzerland, and the following regions of Italy: Valle d´Aosta, Piemonte, Liguria, WesternPart of the regions of Lombardia and Emilia Romagna, including the city of Parma, according to the map attached hereto as Schedule D (the “Territory”). The city of |
Parma is belonging to LICENSEE´s region. For Southern Italy, LICENSOR intends to grant LICENSEE this right under a special agreement to be defined within the year 2009.
F. | Except for the equipments mentioned under letter G below, LICENSEE has all necessary industrial equipment and commercial resources for manufacturing and selling the Product(s) in the Territory and is willing to do so in its own name and on its own account. |
G. | LICENSOR will supply and install all necessary technical equipments (Technical Equipment as specified in Schedule H) as better specified in this agreement and upon the terms and conditions set forth under paragraph 3.1. and Schedule E of this contract. |
IT WAS THEREFORE AGREED AS FOLLOWS:
1. | DEFINITIONS |
In this Agreement:
« Affiliate » means any company, firm, partnership or other legal entity which (a) directly or indirectly owns or controls, or (b) is owned or controlled by, or (c) is under common control or ownership with, either party.
« Authorities » means the competent authorities which authorise the importation and/or sale of the Product(s) in the Territory.
« Effective Date » means the date of first production of LICENSOR´s Product on LICENSEE´s site after having accomplished Variation Type II for LICENSEE´s site for first Product under this agreement.
« Execution Date » means the date of signature of this Agreement by both parties as set out at the top of page 1.
« Force Majeure » means any circumstances beyond the reasonable control of either party including, without limitation, any decision of the Authorities or other governemental bodies, strike, lock-out or other form of industrial action.
«Improvement» means any development or enhancement of the Know-How which would make the Product(s) cheaper, more effective, more useful or more valuable, or which would in any other way render the Product(s) preferable in commerce when compared to other competitive Product(s).
«Inventing Party» has the meaning set out in clause 6.1(a).
«Know-How» means any methods, techniques, processes, discoveries or inventions, whether patentable or not, specifications, recipes, formulae, designs, plans, drawings, data or other technical, scientific or marketing information.
«LICENSOR’s Know-How » means any Know-How relating to the Product(s), their manufacture and their marketing, which has been developed or acquired by the LICENSOR
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on or before the date of this Agreement, or which shall be developed or acquired by the LICENSOR after such date, including but not limited to :
- | the methods of manufacturing, |
- | the technical specifications and formula, |
- | the methods of quality control, |
- | the design and get-up of the packaging and labelling including the LICENSOR’s logo, |
- | the methods of marketing, advertising and sales promotion, |
- | all scientific and medical data, including all data contained in the Registration Dossier. |
«LICENSOR’s Corporate Design Guidelines» means the LICENSOR’s guidelines relating to the use of LICENSOR’s corporate Logo and Trademark on packagings and advertising materials.
“Module 3”is the section of any Marketing Authorisation concerning the industrial process for production of the Product to which the Marketing Authorisation refers.
« Product(s)» means the pharmaceutical Product(s) in its/their finished form as described in Schedule A.
« Production Sites» are the sites within the Territory, where the LICENSEE envisages to manufacture the Products as listed in Schedule A, and any further production site that the LICENSEE may add to the attached list from time to time (“New Production Sites”), by written notice to the LICENSOR.
« Product Licence(s) » means the authorisation(s) issued by the Authorities to manufacture and/or import and/or market the Product(s) in the Territory, including any Variation Type II filed by the LICENSOR with reference to any of the LICENSEE’s Production Sites.
« Territory » has the meaning ascribed to it in letter E of the premises..
« Trademark(s) » means the LICENSOR’s registered and not registered trademark(s) as set out in Schedule B hereto and, except where the context otherwise requires, any copyright or other intellectual property rights of the LICENSOR in respect of the get-up of the Product(s) and the design of the packaging and labelling of the Product(s).
“Variation Type II” means the authorisation by the Authorities of the “variation” of the Marketing Authorisation, which is necessary in order to include a new production site in the Marketing Authorisation and, thus, produce and market the Product(s) from such production site.
2. | LICENCE AND ROYALTIES |
2.1. | Under the terms and conditions hereinafter set out, the LICENSOR hereby grants LICENSEE and LICENSEE hereby accepts the grant of : |
(a) | an exclusive licence to use the LICENSOR’s Know-How for the purpose of manufacturing and selling the Product(s) in the Territory and |
(b) | an exclusive licence to use the Trademark(s) in relation thereto. |
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2.2. | As a result of the rights granted under clause 2.1, the LICENSOR shall not, during the term of this Agreement, grant any third party the right to use the LICENSOR’s Know How and/or the Trademark(s), neither for manufacturing the Product(s) for sale in the Territory nor for selling or promoting the sales of the Product(s) in the Territory. |
2.3. | As a result of the rights granted under clause 2.1, LICENSEE shall not, during the term of this Agreement, except with the LICENSOR’s prior written consent: |
(a) | assign, transfer or sub-license any of its rights or sub-contract or otherwise delegate any of its obligations under this Agreement to any third party ; |
(b) | manufacture the Product for sale outside the Territory or sell the Product(s) outside the Territory. |
2.4. | As remuneration of the rights granted under clause 2.1 above, in full consideration of all benefits afforded under this Agreement,
LICENSEE shall pay the LICENSOR a royalty according to Schedule E. |
2.5. | Royalty payments shall be made every 3 months. LICENSEE shall provide the LICENSOR by the 30th day after each three-month period with a written report showing all necessary data, mainly production amounts (no. of batches performed) of the Product(s) during the immediately preceding three-month period and calculation of the due royalties according to paragraph 2.4 above. LICENSOR will then issue an invoice to LICENSEE for the amount of said royalties and LICENSEE will then pay the invoice within 30 days of receipt. Payment shall be made to LICENSOR to the following bank account, or any other bank account subsequently and timely communicated from LICENSOR to LICENSEE in writing. |
Steiermärkische Bank und Sparkassen AG
BIC: [•]
IBAN : [•]
2.6. | LICENSEE shall give LICENSOR access to the LICENSEE’s production records and pharmaceutical documentation concerning the Products under this agreement, in order to verify the declared no. of batches produced. |
2.7. | In case of a disagreement between the parties as to the no. of batches produced, the LICENSOR will also have access to all sale records of the Product(s), in order to be able to verify correlation between net sales figures of Product(s) and no of batches declared. |
2.8. | The rights under 2.6. and 2.7. can be exercised on a quarterly basis. |
3. | PRODUCT LICENCE(S) |
3.1 | As soon as possible after the Execution Date, the LICENSOR shall, at its own cost provide LICENSEE with: |
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(a) one copy of the Marketing Authorisation for each Product, together with all necessary pharmaceutical and technical information and documentation, which is necessary for the LICENSEE to start the production under this contract. The Qualified persons of both parties have agreed upon such documentation as described in Schedule F.
(b) any and all LICENSOR’s Know-How in order to enable LICENSEE to prepare and finalise in due time and under the LICENSOR´s guidance all documents, forms, reports, records, studies, protocols, product information and any other information required or useful to file and or obtain LICENSOR´s Variation Type II for each of the LICENSEE’S Production Site in relation to each Product and any other Product Licence(s) possibly required in order for the LICENSEE to manufacture, import and/or market the Products in the Territory.
(c) installation of the necessary technical equipment for production of the Products under this agreement, as specifically identified in Schedule H to this agreement (the “Technical Equipment”). The Technical equipment shall comply with the specifications detailed in Schedule H and shall be supplied and installed at each Production Site according to the time schedule shown in Schedule H. The LICENSOR shall also provide the LICENSEE with the after sale service in relation to the Technical Equipment supplied to LICENSEE, as provided in Schedule H. Supply, installation and after sale service of the Technical Equipment shall be entirely remunerated by the LICENSEE with the “basis fee” provided in Schedule E, per each Production Site. LICENSEE has to provide the necessary technical installation to produce the needed nuclide in the target (see schedule H). If additional equipment has to be ordered from a third party, LICENSOR will do that on the account of LICENSEE after prior consensus of the latter about the items and services to be ordered. LICENSEE will in no case order equipment from a third party to avoid disagreement between the parties as to the responsibility for the quality of the technical equipment installed by LICENSOR.
3.2 | LICENSOR shall in its name and at its own cost: |
(a) Perform all necessary validation works on the site of the LICENSEE, which are basis for production of the necessary site specific documents as described in 3.1.a. under responsibility of the LICENSOR on the LICENSEE´s production site.
(b) file an application for obtaining the Variation Type II for each Product and for each LICENSEE’S Production Site and any other Product Licence(s) with the Authorities as soon as practically possible after signing this Agreement or, in case of New Production Sites, as soon as practically possible after the reception of the GMP authorisation delivered by the competent Authorities;
(c) take any other action that may be required by the Authorities for granting the Variation Type II or other Product Licences possibly required in order for the LICENSEE to manufacture, import and/or market the Products in the Territory.
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3.3 | As soon as the Variation Type II or any other Product Licence(s) is/are issued by the Authorities, LICENSOR shall inform LICENSEE in writing and shall provide the LICENCEE with one copy thereof. |
4. | CONFIDENTIALITY |
4.1. | During the term of this Agreement and after its termination, LICENSEE shall not, except as provided by sub-clause 4.2, disclose to any third party or use for any purpose other than contemplated by this Agreement, any part of the LICENSOR’s Know-How or any other information which has been or will be disclosed by the LICENSOR to LICENSEE under or pursuant to this Agreement, which is marked in writing as confidential (“LICENSOR’s Confidential Information”). |
4.2. | Any LICENSOR’s Confidential Information may be : |
(a) | disclosed by LICENSEE to (i) the Authorities or (ii) any other person, to the extent required by applicable laws; or |
(b) | disclosed by LICENSEE to any of its own employees or to employees of its own Affiliates to the extent necessary for the manufacture and sale of the Product(s), subject to LICENSEE imposing upon such employees a written undertaking to comply with obligations identical to those set out in sub-clause 4.1. |
4.3. | The obligation of secrecy and non-use shall not apply to such LICENSOR’s Confidential Information which the LICENSEE has provided to the LICENSOR in writing that: |
(a) | is or becomes in the public domain without violation of this Agreement, or |
(b) | has been legitimally received from a third party, without violation of this Agreement. |
4.4. | Upon termination of this Agreement the LICENSEE shall be obliged to promptly return to the LICENSOR, without being requested to do so, all samples, documents, electronic records, data carriers and other storage media which the LICENSOR hands over to the LICENSEE within the scope of the cooperation under this Agreement or makes available to the LICENSEE in any other way. With respect to this obligation, the LICENSEE hereby waives any right of retention irrespective of ots legal basis. Furthermore, the LICENSEE undertakes not to make any copies, electronic storage or any other records of the documents handed over and to promptly and completely destroy and/or delete any that have necessarily been made, and to confirm this in writing at the LICENSOR’s request. |
5. | DISCLOSURE OF THE LICENSOR’s KNOW-HOW and TECHNICAL ASSISTANCE |
5.1. | As soon as practicable after the Execution Date, the LICENSOR shall disclose the LICENSOR’s Know-How to LICENSEE in sufficient detail to enable LICENSEE to manufacture the Product(s) on an industrial basis. Thereafter, the LICENSOR shall, |
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during the term of this Agreement, disclose to LICENSEE any modification to the LICENSOR’s Know-How.
5.2. | The LICENSOR represents and warrants to the LICENSEE that: |
- | the LICENSOR is the owner of the LICENSOR’s Know-How and of the Trademark(s) and has full right and authority to give and grant all rights and licences for the use of the LICENSOR’s Know-How and Trademark(s) in the Territory in connection with the manufacture and sale of the Product(s); |
- | the use by the LICENSEE of the LICENSOR’s Know-How and of the Trademark(s) in the Territory does not infringe any third party’s right; |
- | the performance by LICENSOR of its obligations under this Agreement does not contravene any provision of law, regulation, judgment, order, certificate of incorporation, by-laws, agreement or other instruments to which the LICENSOR or any of its property is subject. |
5.3. | Nothing in this Agreement shall be construed as imposing any obligation upon the LICENSOR to engage in any scientific or technical study relating to the Product(s). |
5.4. | During a period of 2 months from the Execution Date: |
(a) | LICENSEE shall be entitled, at its own cost, to send to the LICENSOR’s premises where the Product(s) is/are manufactured suitably qualified employees of LICENSEE for training in the manufacture of the Product(s) and use of the LICENSOR’s Know-How; |
(b) | the LICENSOR shall, if so requested by LICENSEE, make available to LICENSEE, at LICENSEE’s cost and for a period not exceeding 5 man days in any quarter, the services of suitably qualified employees of the LICENSOR to provide technical assistance at LICENSEE’s premises in relation to the manufacture of the Product(s) and the use of the LICENSOR’s Know-How in relation thereto; |
(c) | the number of employees of each party who shall visit the other party’s premises pursuant to paragraphs (a) and (b) above and the time and duration of such visits shall be agreed in advance by mutual consent of both parties ; |
(d) | Any employees of either party who shall visit the other party’s premises pursuant to paragraphs (a) and (b) above shall remain employed by the party which sends them and this party shall : |
(i) | ensure that each such employee complies with all security, health and safety and other regulations in force at the premises visited and |
(ii) | Indemnify the other party against any damage to this other party’s property or any personal injury to any individual which is caused by the negligent act or omission of any such employee at the other party’s premises. |
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6. | IMPROVEMENTS |
6.1. | If any time during the term of this Agreement, either party makes, devises or otherwise acquires any Improvement, it shall, as soon as reasonably practicable, disclose the Improvement to the other party in the same conditions as those set out in sub-clause 5.1 and 5.2 above, provided however that such obligation shall not apply to the extent that or for so long as : |
(a) | the party which makes or acquires the Improvement (« the Inventing Party ») is precluded from doing so by law or any obligation owed to any third party, or |
(b) | the disclosure of the Improvement would prejudice the ability of the Inventing Party to obtain a patent or any other intellectual property protection in respect of the Improvement. |
6.2. | Whenever the LICENSOR is the Inventing Party, any Improvement which is disclosed by the LICENSOR to LICENSEE pursuant to sub-clause 6.1 shall be deemed to be included in the definition of the LICENSOR’s Know-How and LICENSEE shall have the same rights upon such Improvement as those granted by the LICENSOR upon the LICENSOR’s Know-How under this Agreement. |
6.3. | Whenever LICENSEE is the Inventing Party, any Improvement which is disclosed by LICENSEE to the LICENSOR pursuant to sub-clause 6.1 (« LICENSEE’s Improvement ») shall belong to LICENSEE and shall be subject to the following conditions : |
(a) | LICENSEE shall be entitled, without the LICENSOR’s prior consent, to: |
- | apply at its own cost for any patent upon any LICENSEE’s Improvement; |
- | use any LICENSEE’s Improvement for manufacturing or selling the Product(s) or for any other purpose, including granting any license thereupon to any third party; provided that such LICENSEE’s Improvement is separable from, and not dependent upon, the LICENSOR’s Know-How. |
(b) | LICENSEE shall be entitled, without the LICENSOR’s prior consent, to use any LICENSEE’s Improvement for manufacturing or selling the Product(s) or for any other purpose, including granting any license thereupon to any third party provided however that (i) such LICENSEE’s Improvement is separable from, and not dependent upon, the LICENSOR’s Know-How and (ii) such license does not involve any disclosure of THE LICENSOR’s Know-How ; |
(c) | In any case the LICENSOR shall be entitled to manufacture, use, sell or otherwise deal in any Product(s) manufactured through the use of any LICENSEE’s Improvement by way of a non-exclusive, worldwide, perpetual and royalty-free licence; |
7. | MANUFACTURE AND PACKAGING of the PRODUCT(S) |
During the term of this Agreement, LICENSEE shall:
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(a) | manufacture and pack the Product(s) in conformity with : |
(i) | the LICENSOR’s Know-How and all other written instructions from THE LICENSOR, in conformity with the Registration Dossier and/or the Product Licence, and |
(ii) | all applicable legal and regulatory requirements ; |
(b) | ensure that all packagings and labellings for the Product(s) comply with all applicable legal and regulatory requirements in the Territory and with the LICENSOR’s Corporate Design Guidelines |
(c) | permit the LICENSOR’s authorised representatives, at any time during normal working hours and on reasonable advance notice (not shorter than two weeks) to enter the premises of LICENSEE where the Product(s) is/are manufactured, packed or stored, in order to check exclusively their conformity with the above provisions, provided a date for the visit is agreed at least 2 weeks in advance; |
(d) | permit the LICENSOR´s authorised persons to perform regular audits in the following fields: |
compliance with GMP-rules
production files of Products under this contract
provided that a date for the audit is agreed at least 2 weeks in advance;
(e) | permit the LICENSOR´s authorised persons to perform Audits on emergency occasion in the following fields, with a prior
notice of at least 3 working days: fields listed under (d) radiation protection packing and shipping in compliance with ADR and IATA. |
8. | MARKETING and SALE of the PRODUCT(S) |
8.1. | During the term of this Agreement, LICENSEE shall: |
(a) | Use its best commercial endeavours to promote the sales of the Product(s) throughout the Territory; |
(b) | sell and market the Product(s) in the Territory only in packagings and labellings conforming with the provisions of sub-clause 7 (b) ; |
(c) | refrain from (i) using the Trademark(s) for any other purpose than as permitted under this Agreement; |
(d) | notify the LICENSOR in writing of any serious adverse reaction to the Product(s). |
For the purpose of this paragraph, a serious adverse reaction shall mean any medical occurrence following the use of the Product(s) which (i) results in patient’s death or (ii) requires the patient to be hospitalised or to prolong hospitalisation or (iii) results in a
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persistent or significant disability or incapacity or (iv) is life threatening or (v) involves a malignancy or congenital anomaly;
Install a Documentation Management for all type of customer claims, starting from low-level complaints upon delivery delays, logistic failures, etc. on a quarterly base.
(e) | inform the LICENSOR as soon as it becomes aware of (i) the introduction in the Territory of any Competitive Product or (ii) any infringement to the Trademark(s) or (iii) any decision from the Authorities to suspend or discontinue the sale of the Product (s) in the Territory and/or to recall from the Customers the Product(s) already delivered to them; |
8.2. | Any production and distribution of Products under this contract as free samples for the customers and/or members of the medical profession in the Territory can be done by LICENSEE on his own decision and costs. Nevertheless LICENSEE shall pay to LICENSOR the royalty according to Schedule E without any reduction. |
9. | PROTECTION OF THE LICENSOR’s KNOW-HOW and OF THE TRADEMARK |
9.1. | LICENSOR shall, at its own cost : |
(a) | obtain, maintain and renew all existing and future registrations of the Trademark(s) in the Territory, |
(b) | take all actions which the LICENSOR shall deem advisable to protect and defend the Trademark(s) against illicit copy, imitation or infringement by any third party in the Territory. |
9.2. | LICENSEE shall inform the LICENSOR of: |
(a) | any claim threatened or made against LICENSEE by any person alleging that the use of the LICENSOR’s Know-How or the Trademark(s) infringes any intellectual property right or other rights of third parties, |
(b) | any illicit copy, imitation or infringement by any person in the Territory of the Trademark(s) or the get-up of the Product(s) or the packaging or labelling thereof of which LICENSEE officially becomes aware; |
provided however that LICENSEE shall take no action in relation thereto except as LICENSOR may reasonably require pursuant to sub-clauses 9.4.
9.3 | LICENSEE shall take all such steps as LICENSOR may reasonably require to assist the LICENSOR in: |
(a) | maintaining the validity or enforceability of LICENSOR’s rights on LICENSOR’s Know-How or the Trademark(s) in the Territory or |
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(b) | taking actions for illicit copy, imitation or infringement of the Trademark(s) in the Territory. |
9.4 | LICENSEE shall be obliged, to provide the contractual Product’s manufactured by the LICENSEE or by order of the LICENSEE with serial numbers and mark them as given in the SPC (Summary of Product Characteristics) after having achieved the Variation Type II under French authorithies guidance. A proposal for the labelling to be proposed at Variation Type II application is attached as Schedule G. |
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10. | TERM and TERMINATION |
10.1 | This Agreement shall enter into force on the Execution Date and shall continue for an initial period of [*] from the Effective Date and thereafter for successive periods of [*] each, until and unless terminated by either party pursuant to any of the following clauses. |
10.2 | Either party may terminate this Agreement by the end of the initial period or of any subsequent period, subject to giving the other party notice to that effect not less than 9 months in advance. In case of termination of this contract by the LICENSOR prior to the initial period of [*], the LICENSOR is obliged to buy back the equipment (schedule H) bought by the LICENSEE at book value. The equipment will be depreciated by the LICENSEE in a linear way over [*]. For compensation of its investments in the contract period, the LICENSOR will pay an additional fee representing [*]% of the total license fee (this excludes the basis fee as defined in schedule A). Beyond [*] (i.e. the initial period), the LICENSOR will pay [*]% of the latest annual license fees. |
10.3 | Without prejudice to any claim for damages against the breaching party, either party shall be entitled to terminate this Agreement forthwith upon giving notice to the other party if this other party commits any breach of this Agreement and fails to remedy such breach at the end of a period of 30 (thirty) days after being given a notice containing full particulars of the breach and requiring it to be remedied. |
10.4 | Upon termination of this Agreement for any reason, LICENSEE shall : |
(a) | be entitled, for a period not exceeding a maximum of 6 months after the date of expiry of this Agreement (“the Expiry Date”), (i) to manufacture the Product(s) to the extent necessary to satisfy contractual obligations as given by contracts or orders with customers and accepted by LICENSEE prior to the Expiry Date. |
(b) | subject to paragrph (a) above, cease forthwith (i) to use the Trademark(s) and the Product Licence(s) and (ii) to use or otherwise exploit in any way, directly or indirectly, LICENSOR’s Know-How, except to the extent that LICENSOR’s Know-How is, at the date of termination or at any time thereafter becomes public knowledge, otherwise than through any fault or negligence of LICENSEE; |
(c) | ensure that, as soon as practically possible after termination, any reference to the Trademark(s) and/or LICENSOR’s Logo on its premises, vehicles, business documents and advertising materials is removed and that any of its advertisements and advertising materials containing such reference ceases to be used; |
10.5 | After the Expiry Date, neither party shall be under any obligation to the other under this Agreement, except that the provisions of clauses 3.5, 4, 6.3 and 11 shall continue in force in accordance with their terms, notwithstanding termination of this Agreement. |
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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Furthermore the LICENSOR shall be entitled to terminate this Agreement forthwith, by serving written notice, with immediate effect (without giving any prior notice period) if the LICENSEE
10.5.1 | files a nullity suit against a contractual Property Right. |
10.5.2 | does not achieve the agreed minimum quantities, as provided in paragraph 12.2 below; |
10.5.3 | has lost the legal basis for pharmaceutical production, e.g. loss of production licence, GMP/certification; |
10.5.4 | does not fullfill essential obligations of this Agreement despite a warning in writing, as provided in paragraph 10.3 above; or |
10.5.5 | if insolvency proceedings have been initiated against the LICENSEE assets. |
11. | GOVERNING LAW and SETTLEMENT OF DISPUTES |
11.1 | This Agreement shall be governed exclusively by the substantive laws of the Republic of Austria excluding any conflict of law provisons. This shall also apply to the ssue of the Conclusion of this Agreement as well as to the legal consequences of its after-effet. |
11.2 | All disputes arising out of this contract or related to its violation, termination or nullity shall be, unless it is settled amicably within 60 (sixty) days from the date of either party’s claim against the other, finally settled under the Rules of Arbitration and Conciliation of the International Arbitral Centre of the Austrian Federal Economic Chamber in Vienna (Vienna Rules) by one or more arbitrators appointed in accordance with these Rules. The number of arbitrators shall be three. The language to be used in the arbitral proceedings shall be English. The place of arbitration shall be Vienna/Austria. |
12. | OBLIGATION TO USE |
12.1. | The LICENSEE shall use its best efforts to exercise the license right, to start production without delay and to carry out the appropriate advertising and marketing activities to promote the sales of the contracutal Product(s). |
12.2. | Unless the LICENSEE produces the quantities shown in Schedule E (in the line “no Batches”) per each solar year - to be considered as minimum quantities – the LICENSOR shall be entitled to terminate this Agreement forthwith, by serving written notice, with immediate effect (without giving any prior notice period), within [90] days after the end of the solar year in which the relevant minimum quantities have not been achieved. |
“It is hereby agreed and understood that the above right of the LICENSOR to terminate this agreement shall exhaust any and all LICENSOR’s remedies against the LICENSEE in case the latter does not reach the agreed minimum quantities and the LICENSOR shall not be entitled to any compensation for damages.”
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13. | NO-CONTEST CLAUSE |
The LICENSEE undertakes not to contest the LICENSOR’s Know-How either by an invalidity suit, opposition or otherwise, not to assist Third Parties directly or indirectly in contesting the LICENSOR’s Know-How. The scope of protection of this provision sall also cover the contracutal Know-How.
14. | MISCELLANEOUS |
14.1 | This Agreement and its Schedules constitute the entire agreement between the parties in relation to the manufacture and sale of the Product(s) and the use of the Trademark(s) in the Territory and supersede all prior verbal or written agreements between the parties, if any, relating to the same subject matter. No change to this Agreement and/or any of its Schedules shall be binding upon the parties unless it is made in a written document signed by authorised representatives of both parties or of their legal successors. |
14.2 | Any notice required or permitted under this Agreement may be sent aither by certified mail, return receipt requested, or by fax or by mail to the following addresses and numbers of the Parties: |
If to LICENSOR:
Feldkirchnerstraße 4
A -8054 Seiersberg
Fax +43 316 28 43 00 14
Email: christoph.artner@iason.eu
If to LICENSEE:
20 rue Diesel
01630 Saint Genis Pouilly, France
Fax: +33-4-50 99 30 71
email: gerard.ber@adacap.com
14.3 | Any notice required or permitted to be given concerning this Agreement shall be effective upon receipt by the Party to whom it is addressed as certified by the return recipt (in case of certified mail) or by confirmation of dispatch (in case of fax) or by the massage from the adress confirming receipt (in case of email). |
14.4 | Should any provision of this Agreement become unvalid or unenforceable under applicable laws, this shall not invalidate or render any other provision unenforceable. The invalidated or unenforceable provision shall be deleted and replaced, by mutual consent of both parties, by a valid or enforceable provision having an objective or similar to the objective of the deleted provision. |
14.5 | Neither party shall be deemed to be in breach of this Agreement, or otherwise liable to the other, by reason of the non-performance or of any delay in the performace, of any of its obligations hereunder, to the extent that such delay or non-performance is due to any Force Majeure, provided that the party which is so prevented from, or delayed in, |
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the performance of any of its obligations under this Agreement shall (a) notify forthwith the other party of the occurrence and likely duration and effect of any such Force Majeure, (b) use its best endeavours to resolve promptly or cure any matter under its own control and (c) resume performance as soon as the Force Majeure has ceased or has been removed.
14.6 | Failure by either party, either permanently or temporarily, to enforce any of its rights hereunder or to require performance by the other party of any of its obligations hereunder shall not constitute, or be deemed to constitute, any waiver of this party’s rights under this Agreement. |
14.7 | This Agreement is a licence agreement and nothing in this Agreement shall create, or be deemed to create, any partnership, or any relationship of principal and agent, between the parties. |
14.8 | Except as otherwise provided in this Agreement, each party shall bear its own costs relating to the preparation, execution and implementation of this Agreement and all taxes relating thereto. |
14.9 | Except with the other Party’s prior written consent, Paties shall not disclose to any third party (except to the Authorities if required by applicable laws) or make any public announcement concerning the existence or content of this Agreement. |
14.10 | Both parties agree that this Agreement complies with the provisions EU Regulation 772/2004 of April 27, 2004 on technology transfer agreements and is therefore exempted from prior notification to the EU Commission. |
Made in 2 copies, January 14, 2009
LICENSOR | LICENSEE |
/s/ Christoph Artner | /s/ Gérard Ber |
Christoph Artner | Gérard Ber |
for Stefano Buono |
List of the Schedules:
A.: The Products
B.: Trade Marks
C.: C2 Marketing Authorization; C2 projected Marketing Authorization
D.: The Terrritory; Details on Italy
E.: Royalties, Base Fees, After-Sales Service
F.: Lists of Documents according to 3.1.a
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G.: Proposal for Labelling
H.: Technical Equipment
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Exhibit 10.5
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
[*] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION.
LICENSE AGREEMENT
BETWEEN
[*]
AND
BIOSYNTHEMA INC.
LICENSE AGREEMENT
This Agreement, executed this 12th day of June, 2007, ("the Effective Date") is made by and between [*]("[*]"), and BioSynthema Inc., a corporation organized under the laws of the State of Missouri, USA, and having its principal place of business 4041 Forest Park Blvd., S1. Louis, Missouri, 63108 USA ("BioSynthema"), and hereafter referred to as the "Agreement". For the purpose of the Agreement, BioSynthema shall include a sublicensee to the Agreement.
INTRODUCTION
1. WHEREAS, [*] has made inventions relating to labelled somatostatin analogues covered in the patent case 100-7382 and patent case 118-7595, as set out in Schedule I annexed hereto (the "Patent") as set out in Schedules I and Ia, which were assigned to Novartis PharmaAG;
2. WHEREAS, Novartis Pharma AG of Basle, Switzerland, has entered into a License Agreement with [*] signed on December 21, 2006 granting [*] a non-exclusive, royalty-bearing right to the Patent, with the right to sublicense (the "[*] License");
3. WHEREAS, BioSynthema is the successor of certain intellectual property and related assets of Mallinckrodt Inc., to expand BioSynthema's research, development and commercialization of radiopharmaceutical products in the field of oncology, and
4. WHEREAS, [*] is willing to grant to BioSynthema certain sublicense rights under the [*] License, subject to the terms of the Agreement;
NOW THEREFORE, in consideration of the premises and the mutual covenants herein contained, the Parties mutually agree as follows: -
ARTICLE 1.
DEFINITIONS
As used in the Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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"Affiliate" an entity shall be deemed to be an "Affiliate" of BioSynthema whether a corporation or other business entity, that is controlling, controlled by or under common control with BioSynthema.
"Agreement" means this agreement together with all exhibits, schedules, or appendices, as may be attached, all as respectively amended, modified or supplemented by the Parties in accordance with the terms of the Agreement.
"BioSynthema License Rights" means the right to all of [*]'s interests in the [*] License and as defined in Section 4.1.1.
"BioSynthema Non-Exclusive Sublicense" means the non-exclusive sublicense granted by BioSynthema to a Third Party.
"Commercialization" means activities conducted by a Party either by itself or through a Third Party and directed to marketing, promoting, distributing, importing, exporting, offering for sale or selling a Licensed Product, which may include pre-launch market preparation, whether undertaken by a Party alone or with a partner or a sublicensee. When used as a verb, "Commercialize" means to engage in Commercialization.
"Control" means the direct or indirect ownership of more than fifty percent (50%) of the equity interest in such corporation or business entity, or the ability in fact to control the management decisions of such corporation or business entity.
"Cover" (including the variations such as "Covered", "Coverage" or "Covering") when applied to a patent means that the making, using, offering for sale, selling or importing of a given product would infringe a Valid Claim of a patent in the absence of a license under such patent. The determination of whether a product is Covered by a particular patent shall be made on a country-by-country basis.
"Diagnostic Field" means the use of Licensed Product for diagnostic purposes.
"Dollars" (including "U.S. Dollars" and the abbreviation "USD") means the lawful currency of the United States of America.
"Effective Date" means the date set forth at the outset of this Agreement.
"Euros" means the lawful currency of the European Union.
"Expiration Date" means, in relation to [*]'s rights and obligations and BioSynthema's rights and obligations under the Agreement, the date calculated on a country-by-country basis, upon which the Parties payment obligations shall expire.
"FDA" means thereto. the United Stares Food and Drug Administration and any successor agency
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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"First Commercial Sales" means the first shipment of a Licensed Product to an independent Third Party, by BioSynthema or its sublicensee, in a country following applicable Marketing Authorization of Licensed Product in such country, excluding for use in a clinical trial.
"[*] Designee" or "Designee" means an individual, corporation, partnership, association, joint-stock company, trust, which is designated by [*] pursuant to lawful purposes as the beneficiary of [*] considerations defined under Article 4.
"[*] License Agreement" means the Agreement dated and signed by [*] on December 21, 2006 by which Novartis grants [*] a non-exclusive license to develop, test, make, have made, use, sell, have sold, offer for sale, distribute, export or import a Licensed Product.
"Licensed Product" means any product in the Diagnostic or Therapeutic Field Covered by a Valid Patent Claim, excluding OctreoScan and OctreoTher, and shall include products, 1) unlabelled in combination with a radioisotope product, or 2) radiolabelled compound, or 3) an unlabelled compound, sold in a small quantity to be labelled by or for the customer on-site or locally with a generator isotope for diagnostic purposes.
"Marketing Authorization" means, with respect to a specific country or region in the Territory, the approval by the appropriate authority necessary for the Commercialization of a Licensed Product in that country or region. For the sake of clarity, Marketing Authorization shall not include the reimbursement approval by an appropriate authority.
"Net Sales" means, with respect to the Licensed Product (hereinafter collectively referred to as "Product"), the gross amount invoiced by or on behalf of the relevant Party and its Affiliates, its licensees or sublicensees for the Product sold to Third Parties other than licensees or sub- licensees in bona fide, arm's-length transactions, less the following customary deductions, determined in accordance with General Accounting Principles (GAP) as generally and consistently applied by that Party, to the extent included in the gross invoiced sales price of any Product or otherwise directly paid or incurred by such Party, its Affiliates or sublicensees with respect to the sale of such Product:
(i) | normal and customary trade and quantity discounts actually allowed and properly taken directly with respect to sales of the Product; | |
(ii) | amounts actually repaid or credited by reasons of defects, rejection recalls, returns, rebates and allowances of goods; | |
(iii) | charge-backs and other amounts paid on sale or dispensing of such Product; | |
(iv) | rebate amounts payable resulting from governmental mandated rebate programs; | |
(v) | tariffs, duties, excise, sales, value-added and other taxes (other than taxes based on income); | |
(vi) | customary cash discounts for timely payment; (vii) delayed ship order credits; | |
(viii) | discounts pursuant to indigent patient programs and patient discount programs and coupon discounts; and | |
(ix) | all freight, postage and insurance included in the invoice price. |
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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Sales from a Party to its Affiliates, its licensees or sublicensee for the Product sold shall be disregarded for purposes of calculating Net Sales. Any of the items set forth above that would otherwise be deducted from the invoice price in the calculation of Net Sales but which are separately charged to Third Parties shall not be deducted from the invoice price in the calculation of Net Sales.
a) | In the case of any sale or other disposal of the Product between or among a Party and its Affiliates or sublicensees for resale, Net Sales shall be calculated as above only on the value charged or invoiced on the first arm's-length sale thereafter to a Third Party; | |
b) | In the case of any sale which is not invoiced or is delivered before invoice, Net Sales shall be calculated at the time of shipment or when the Product is paid for, if paid for before shipment or invoice; | |
c) | In the case of any sale or other disposal for value, such as barter or counter-trade, of any Licensed Product, or part thereof, other than in an arm's-length transaction exclusively for money, Net Sales shall be calculated as above on the value of the non-cash consideration received or the fair market price (if higher) of the Product in the country of sale or disposal. |
In the event the Product is sold in a finished dosage form containing a Licensed Product in combination with one or more other active ingredients (a "Combination Product"), the Net Sales of the Product, for the purposes of calculating proposed royalty payments, shall be determined by multiplying the Net Sales (as defined above in this Article) of the Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average sale price in a particular country of the Product when sold separately in finished form and B is the weighted average sale price in that country of the other product(s) sold separately in finished form. Net Sales for purposes of determining royalty payments shall be agreed by the Parties based on the relative value contributed by each component, such agreement shall not be unreasonably delayed or withheld.
"Party" means each of [*] and BioSynthema, and "Parties" means both together.
"Patent" means the patents and patent applications set out in Schedule I, all patents issuing in the future on said patent applications and any divisions, continuations and continuations-in-part, reexaminations, reissues, additions, extensions, supplementary certificates, and foreign counterparts thereof. Schedule I will specifically include the list of patents/patent applications corresponding to patent cases 100-7382 and 118-7595.
"Royalty Term" shall be as defined in Section 4.1.2.
"Sublicensee" means a third party granted certain license rights from BioSynthema for Licensed Product.
"Territory" means all countries and territories in the world.
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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"Therapeutic Field" means the use of the Licensed Product for therapeutic purposes.
"Third Party" means a person or entity other than (i) BioSynthema, it's Affiliates, distributors or agents, or (ii) [*] or any of his designees or agents.
"Valid Patent Claim" means on a country-by-country basis a granted claim within the Patent, which has not been held invalid and/or unenforceable in a decision of a patent office, court or other government agency of competent jurisdiction, unappealable or unappealed within the time frame allowed for appeal.
ARTICLE 2.
LICENSE GRANT BY [*]
2.1 License.
Subject to the terms and conditions of this Agreement, [*] grants to BioSynthema all of [*]'s rights and interests to a worldwide, irrevocable, non-exclusive license, including the right to grant sublicenses, to develop, test, make, have made, use, sell, have sold, offer for sale, distribute, export or import a Licensed Product from the Effective Date of this Agreement and ending with the Expiration Date, after having the terms of the Patent extended due to regulatory delay where possible under the applicable law ("BioSynthema License Rights").
2.2 Sublicense.
2.2.1 [*] shall have the right to disapprove and block a proposed sublicense by BioSynthema of BioSynthema's License Rights to a third party, in which event [*] and BioSynthema shall meet to discuss the proposed sublicense by BioSynthema with the intent to resolve any issues that may arise for the purpose of BioSynthema executing such sublicense with a third party. Notwithstanding the above, [*] has approved BioSyntbema's right to enter into a sublicense agreement with Mallinckrodt Inc., for the license of BioSynthema's sublicense rights for the licensed product referred to as Lutate.
2.2.2 | In the event that [*] is unable to act for the purpose of this provision, for any reason, including that of incapacity or the death of [*], [*] herein designates that Hendrik van Rossell, residing in Enkhuizen, the Netherlands, shall act in his place at all times for the purpose of approving a sublicense of BioSynthema to the license rights granted to BioSynthema by [*] herein. |
2.2.2 Any sublicensee of BioSynthema shall be obligated to [*] to the same extent that BioSynthema is obligated to [*] under the Agreement, (including without limitation with respect to all restrictions, exceptions, royalty obligations, maintenance and availability for inspection of books and records, reports, termination
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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provisions and other provisions applicable to a sublicense), and any sublicense shall not relieve BioSynthema of any of its responsibilities under the Agreement and BioSynthema shall be :fully responsible and liable for all acts and omissions of its sublicensees.
2.2.3 BioSynthema shall have the right to negotiate a sublicense to the Agreement, as applicable, with a Third Party without notice to [*], and BioSynthema will in good faith negotiate reasonable and customary terms for such sublicense.
ARTICLE 3.
SUBLICENSE & AUDITS
3.1 Considerations.
In the event that a Third Party agrees to enter into a sublicense agreement with BioSynthema, the sublicense agreement will include specific provisions on payments to [*], including but not be limited to license and sublicense fees, royalty, Patent costs, and any other payments in kind (the "Proceeds"). In the event there is a conflict between the terms of the [*] License Agreement and a sublicense agreement, the terms of the [*] License Agreement shall prevail, at no costs to [*] and no financial compensation to BioSynthema by [*] related to a conflict between the terms of the [*] License Agreement and this Agreement, for general or specific damages.
3.2 Auditing Rights.
3.2.1 Upon the written request of [*] and not more than once in each calendar year, BioSynthema shall permit an independent certified public accounting firm of nationally recognized standing, selected by [*] and reasonably acceptable to BioSynthema, at [*]'s expense, to have access during normal business hours to such records of BioSynthema as may be reasonably necessary to verify the accuracy of the royalty reports hereunder for any years ending not more than twenty-four (24) months prior to the date of such request. The accounting firm shall disclose to [*] only whether the records are correct or not and the specific details concerning any discrepancies. All other confidential information of the accounting firm, including working papers, shall be shared exclusively with the legal counsel representing [*], and its subcontractors, for the purpose of analysis and verification, on a confidential basis, such that information provided by the accounting firm shall not be disclosed to [*].
3.2.2 If such accounting firm concludes that additional royalties were owed during such period, BioSynthema shall pay the additional royalties within thirty (30) days of the date of delivery by [*] to BioSynthema of such accounting firm's written report so concluding. The fees charged by such accounting firm shall be paid by
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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BioSynthema, provided however, that if the audit discloses that the royalties payable by BioSynthema for the audited period are more than one hundred and five percent (105%) of the royalties actually paid for such period, then [*] shall pay the reasonable and direct fees and expenses charged by such accounting firm. Any overpayment determined pursuant to this provision shall be credited to the next payment due hereunder from BioSynthema. If no further payments by BioSynthema will be due hereunder then a refund of any such overpayment will be made within thirty (30) days of the delivery of a detailed written accountants' report to the Parties hereto.
3.3. Underpayment.
If at any time during the Term of the Agreement and thereafter, it is determined that BioSynthema or its Exclusive Licensee underreported sales to [*], then any royalty payments related to such under reporting of sales shall be reported and paid to [*] within sixty (60) days of BioSynthema or its Exclusive Licensee's first knowledge of such underpaymentwith Interest.
ARTICLE 4.
CONSIDERATION TO [*]
4.1 Royalty.
4.1.1 Royalty Rate. As a consideration for the license of all of [*]'s rights under the [*] License Agreement to BioSynthema, BioSynthema agrees to pay to [*] or [*] Designee a royalty on Net Sales of Licensed Product or, if and where BioSynthema License Rights are licensed to a Third Party, to cause its Sublicensee to pay such royalty on the Territory annual Net Sales of such Licensed Product during the- Royalty Term according to the following rate:
4.1.1.1 | annual Net Sales up to USD fifty million ($ 50,000,000), [*] percent ([*]%) |
4.1.1.2 | incremental annual Net Sales from USD fifty million ($50,000,000) through USD one hundred million ($100,000,000), [*] percent ([*]%) |
4.1.1.3 | incremental annual Net Sales above USD one hundred million ($100,000,000), [*] percent ([*]%) |
Payments to [*] by BioSynthema shall be made in Euros for all Net Sales invoiced in Euros by BioSynthema or its Sublicensee, without currency conversion, and in US Dollars for all other Net Sales. Such payments will be non-refundable and will not be subject to any claims by BioSynthema, its Sublicensee, or any Third party, for any reason.
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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4.1.2 Royalty Term. The duration of the royalty obligation shall be determined on a country-by-country basis. Royalties shall be payable quarterly from the First Commercial Sales of the Licensed Product in a country (i) for the period such Licensed Product's use or sale is Covered by a Valid Patent in such country, or (ii) for a period of ten (10) years from First Commercial Sales; and if both (i) and (ii) are applicable, for the longer of either.
4.1.3 Report. BioSynthema sha11generate a report for [*] within sixty (60) days of the end of each calendar quarter and BioSynthema shall make payment in full to [*] the amount due [*] for the previous calendar quarter within sixty (60) days of issuing such report. The report shall set forth by country, (i) the Net Sales of Licensed Product, (ii) the number of units of Licensed Product sold and the royalties payable hereunder, (iii) the withholding taxes, if any, required by law to be deducted in respect of such sales, (iv) the date of the First Commercial Sales of the Licensed Product in each country during the reporting period, and (v) the exchange rates used in determining the amount of US Dollars, for such payments that are to be made in US Dollars. With respect to sales of the Licensed Product invoiced in Euros, the Net Sales, and royalties payable shall be expressed in Euros. ' With respect to sales of the Licensed Product invoiced in a currency other than Euros, the Net Sales and amounts due to [*] hereunder will be expressed in the US Dollars equivalent calculated on a monthly basis in the currency of the country of sale and converted to their US Dollar equivalent using the following method:
The Net Sales in each country in the Territory at each quarterly period shall be calculated by translating the Net Sales in local currency in each country in the Territory into those in Euros using the exchange rate mechanism in accordance with General Accounting Practice (GAP) as generally and consistently applied by U.S. Commercial Pharmaceutical Companies, for such currency calculations.
4.1.4 Interest. Payments due by BioSynthema under the Agreement, when overdue, shall bear interest at a rate per annum equal to LIBOR (London Interbank Offered Rate) plus one percent (1%) at the time such payment is due, and for the time period until payment is received by [*].
4.1.5 Confidential Financial Information. [*] shall treat all financial information subject to review under this Article 4 as confidential and shall cause his accounting firm to retain all such financial information in confidence, subject to Section 9.2.5.
4.1.6 Payment Method. Royalty, License Fee and Interest payments by BioSynthema under the Agreement shall be paid in US Dollars and/or in Euros as provided for in Section 4.1.2, by bank wire transfer or bank check in immediately available funds to such accounts as [*] shall designate before such payment is due.
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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4.1.7 Exchange Control. If at any time legal restrictions prevent the prompt remittance of part or all royalties with respect to any country where Licensed Product is sold, payment shall be made through such lawful means or methods as BioSynthema shall reasonably determine after consultation with [*].
4.1.8 Royalty Accrual. There shall be no obligation to pay [*] royalties on a reasonable amount of samples lawfully used in the Territory and on Licensed Product used (and not sold) during pre-clinical or clinical testing, or for physician preference testing, teaching or experimental purposes, or for any other similar pre-commercial uses of Licensed Product.
4.2 Designee.
4.2.1 [*] shall be entitled to assign his consideration rights during the term of the Agreement to a Designee, upon three months notice to BioSynthema or its Sublicensee and to cancel such assignment upon a three months prior notice to BioSynthema or its Sublicensee.
4.2.2 BioSynthema's payment to Designee shall relieve BioSynthema of any same payment to [*]. BioSynthema shall not be liable for any additional tax or costs that such Third Party beneficiary payment may cause.
ARTICLE 5.
PATENTS AND OWNERSHIP OF INTELLECTUAL PROPERTY
5.1 Patent Prosecution and Maintenance.
5.1.1 Pursuant to the [*] License, Novartis shall have the first responsibility to draft, file, extend, prosecute (including conducting opposition proceedings), and maintain (including conducting opposition proceedings) the Patent, and any and all of its substitutions, extensions, or supplementary protection certificates, reissues, renewals, divisions, patents of addition, or registrations of any kind, in the Territory.
5.1.2 All costs associated with filing, prosecution, maintenance, and term extension associated with regulatory delay of Patents shall be borne by Novartis .
5.1.3 Cooperation. [*] will keep BioSynthema informed of any notice from Novartis, of Novartis making any major decision relating to the maintenance of the Patent, and [*] shall provide written notification of such change no less than ninety (90) days prior to any change relating to the maintenance of the Patents in a country.
5.1.4 Should Novartis decide to abandon the Patent in one or several countries [*] assigns all of his rights to maintain the Patent under the [*] License to
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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BioSynthema. [*] shall provide written notice to BioSynthema thereof no less than five (5) days from receipt of notice from Novartis of its intent to abandon the Patent, and eighty (80) days prior to the final date for filing a response or submitting a payment to the relevant governmental office regarding such Patent after which the Patent would become abandoned. After receiving such notice, BioSynthema may, but is not obligated to, elect to continue preparation, filing and prosecution or maintenance of the discontinued Patent at its sole expense. Ownership of any such abandoned Patents by Novartis shall at the request of BioSynthema be fully assigned by [*] to BioSynthema. BioSynthema shall promptly prepare and execute such documents and perform such acts as may be reasonably necessary for assigning such sole ownership to BioSynthema at BioSynthema's sole expense and at no cost to [*].
5.1.5 Upon abandonment by Novartis of the Patents and election by BioSynthema to maintain said Patents [*] shall provide reasonable assistance to BioSynthema and cooperate in the defense of the Patents at the reasonable request of BiuSynthema, at BioSynthema's sole expense. BioSynthema or its Sublicensee shall also provide to [*] upon abandonment of the Patents that BioSynthema elects to continue, all relevant documentation of Patents filings including, but not limited to, records pertaining to the preparation, filing and maintenance of the Patents, at BioSynthema's or its Sublicensee's sole expense.
5.2 Infringement Claims Against Third Parties.
5.2.1 Cooperation. Each Party shall promptly provide written notice to the other Party during the Agreement Term of any known infringement or suspected infringement of the Patents by a Third Party's commercial making, using, offering for sale, selling, or importing Licensed Product.
5.2.2 Under the [*] License, Novartis shall have the first right, but not the obligation, to take, institute and prosecute legal proceedings of Patent infringements. In the event that Novartis elects not to take, institute and prosecute legal proceedings of Patent infringement by a Third Party, BioSynthema shall have the right, but Dot the obligation to take such action, without the approval of [*]. Any such action taken under this Section 5.2.2 shall be at BicSynthema's or its Sublicensee's sole - costs and benefits.
ARTICLE
6.
TRADEMARKS
BioSynthema shall have the sole right to select a trademark for Licensed Product ("BioSynthema Trademarks)
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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ARTICLE 7.
SUPPLY OF LICENSED PRODUCT FOR RESEARCH
Erasmus Pricing for Licensed Product Used for Research. In the event that Licensed Product is approved for patient use by Erasmus, BioSynthema agrees, and shall cause its Sublicensees, if any, to agree to supply Licensed Product to [*] and to Erasmus for all of Erasmus' Product needs at the best price the Product is sold in the European Union.
ARTICLE 8.
REPRESENTATIONS, WARRANTIES AND COVENANTS
8.1 Representations and Warranties of Both Parties. Each Party warrants and represents to the other Party that it has the full right and authority to enter into the Agreement and that to the best of its knowledge it is not aware of any reason which would inhibit its ability to perform the terms and conditions imposed on it by the Agreement.
8.2 Representations and Warranties of [*].
No Material Misstatements. [*] has not intentionally failed to disclose any information actually known to it which would be material to BioSynthema entering into this Agreement, and to the best of his knowledge such information does not contain any untrue statement of material fact or omit to state a material fact.
8.3 Representations and Warranties of BioSynthema.
8.3.1 BioSynthema is duly organized and validly existing under the Laws of Missouri, USA and has fun legal power and authority to enter into the Agreement.
8.3.2 BioSynthema is not subject to any order, decree or injunction by any court of competent jurisdiction which prevents or materially delays the consummation of the transaction contemplated by the Agreement.
8.3.3 No Material Misstatements. BioSynthema (i) has fully disclosed to [*]; (ii) has not intentionally failed to disclose any information actually known to it which would be material to [*] entering into the Agreement, and to the best of its knowledge such information does not contain any untrue statement of material fact or omit to state a material fact.
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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ARTICLE
9.
CONFIDENTIAL INFORMATION
9.1 | Treatment of Confidential Information. In carrying out rights and obligations under the Agreement, the Parties may share proprietary information, but shall not be required to share proprietary information, which shall include any information in any form, whether disclosed orally, or in writing, of any nature, including, without limitation all: writings, reports, trade secrets, discoveries, ideas, inventions, know-how, business plans, business opportunities, future projects or products, projects or products under consideration, information related to [mances, costs, prices ("Confidential Information") with each other. Except as permitted by this Agreement, each Party shall and shall cause its/his Affiliates and/or licensees/sublicensees to treat Confidential Information received from the other Party as it treats its own proprietary information. In particular, it shall not disclose, divulge or otherwise communicate such Confidential Information to Third Parties, or use it for any purpose except pursuant to and in order to carry out its obligations under the Agreement during the Agreement Term; provided that, each Party (i) may disclose the Confidential Information to such of its directors, officers, employees, Affiliates, consultants, subcontractors, licensees, sublicensees, agents to the extent reasonably necessary to carry out its obligations under the Agreement and so far as disclosure is made to each individual on a need to know basis and each individual is bound by obligations of confidentiality at least as strict as those contained within the Agreement, and (ii) hereby agrees to exercise every reasonable precaution to prevent and restrain the unauthorized disclosure or use of Confidential Information. |
9.2 | Release from Restrictions. The provisions of this Article 9 shall not apply to any Confidential Information which: |
9.2.1 was known or used by the receiving Party or its Affiliates prior to its date of disclosure to the receiving Party or its Affiliates by the disclosing Party or its Affiliates, as evidenced by the prior written records of the receiving Party or its Affiliates; or
9.2.2 either before or after the date of the disclosure to the receiving Party or its Affiliates, is lawfully disclosed to the receiving party or its Affiliates by a Third Party rightfully in possession of the Confidential Information and not in breach of any obligation of confidentiality to the disclosing Party; or
9.2.3 either before or after the date of the disclosure to the receiving Party or its Affiliates, becomes published or generally known to the public through no fault or omission on the part of the receiving Party or its Affiliates, but such inapplicability applies only after such information is published or becomes generally known; or
9.2.4 is independently developed by or on behalf of the receiving Party or its Affiliates without reference to or reliance upon any Confidential Information of the disclosing Party or its Affiliates; or
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9.2.5 is reasonably determined to be required to be disclosed by the receiving Party or its Affiliates to comply with applicable securities or other laws, to defend or prosecute litigation or to comply with governmental regulations; the receiving Party or its Affiliates shall provide prior written notice within twenty (20) days of such disclosure to the disclosing Party or its Affiliates and shall take reasonable and lawful actions to prevent such disclosure and/or minimize the degree of such disclosure.
9.3 Exceptions. The restrictions set forth in this Article 9 shall not prevent either Party from (i) preparing, filing, prosecuting or maintaining a patent application or its resulting patents related to a Licensed Product in accordance with the terms of the Agreement; (ii) disclosing Confidential Information to governmental agencies to the extent required or desirable to secure government approval for the development or marketing of a Licensed Product; or (iii) disclosing all the necessary information to potential Third Party licensees or sublicensees, respectively, provided such Third Party is bound by confidentiality provisions at least as strict as the ones contained herein. In particular, [*] expressly authorizes BioSynthema to disclose the relevant terms of this Agreement to a potential sublicensee of Licensed Product. Such exception to the Confidentiality provisions does not allow BioSynthema to disclose any of the terms of the Agreement to other third parties without the approval of [*].
ARTICLE 10.
TERM AND REMEDIES FOR BREACH
10.1 Agreement Term. The Agreement Term shall commence on the Effective Date and end, unless earlier terminated pursuant to Section 10.2.1 on the Expiration Date under the Agreement.
10.2 Termination for Breach.
10.2.1 Either Party shall have the right to terminate the Agreement at any time with immediate effect by giving written notice to the other in the event that the other Party should willfully breach its obligation under the Agreement and should fail or be unable to rectify that breach either (i) within ninety (90) days of receipt of written notice specifying the breach, or (ii) within such additional time as may be reasonably necessary to rectify the breach.
10.2.2 In all other cases of breach, the exclusive remedy to a non-breaching Party for any material breach of the Agreement by the other Party shall be solely for monetary damages plus interest; no other remedies available by law or otherwise shall apply for a breach of the Agreement. The non-breaching Party shall have the right to demand monetary damages for alleged breach of the Agreement by the other Party, at any time with immediate effect, by giving written notice to the other Party in the event that the other Party should commit an alleged material breach of the terms of the Agreement and should fail or be unable to rectify that breach either (i) within sixty (60) days of receipt of
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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written notice specifying the breach, or (ii) within such additional time as may be reasonably necessary to rectify the breach. For the sake of clarity, neither Party shall be entitled to terminate the Agreement for material breach by the other Party, except as provided under 10.2.1.
10.3 Termination for Bankruntcy. Only if required by applicable law, shall a Party have the right to terminate the Agreement in the event that the other Party becomes insolvent, makes assignment for the benefit of the creditors, is the subject of proceedings in voluntary or involuntary bankruptcy instituted on behalf of or against such Party (except for involuntary bankruptcies which are dismissed within ninety (90) days), or has a receiver or trustee appointed for substantially all of its property. In the event of the insolvency of a Party, the other Party shall seek only monetary remedies through the applicable courts, and shall not seek termination of the Agreement. All remedies granted the Party not seeking court administration of its agreements and or operations, by a court of competent jurisdiction in insolvency and bankruptcy matters, shall be the sale remedies available to the other Party. In case of termination required by law: (i) due to BioSynthema's insolvency, all the rights shall revert to [*], or (ii) due to [*]'s insolvency, BioSynthema shall have a non-exclusive, perpetual, fully paid-up, royalty-free license under the Remaining Interests, with the right to sublicense and an exclusive perpetual, fully paid-up, royalty-free license, with the right to sublicense, under BioSynthema Exclusive Rights. Termination of the Agreement will not release the non-insolvent Party from any obligation to make any payments to the other Party which were accrued prior to and including the effective date of termination or expiration.
10.4 Effect of Termination.
10.4.1 Upon early termination of this Agreement by BioSynthema due to [*]'s willful and material breach of his obligations under the Agreement in accordance with Section 10.2.1, BioSynthema shall be entitled to the full proceeds due from any sublicensee or licensee under a non-exclusive license or sublicense as set forth in Article 3, including the portion of payments that should have normally been paid to [*]. In addition, BioSynthema shall have a sale, perpetual, fully paid-up, royalty- free license under the Remaining Interests, with the right to sublicense, as well as an exclusive perpetual, fully paid-up, royalty-free license, with the right to sublicense.
10.4.2 Upon early termination by [*] due to BioSynthema's willful and material breach of its obligations under the Agreement in accordance with Section 10.2.1, all the rights granted by [*] hereunder shall revert to [*]. In addition, [*] shall be entitled to the full Proceeds due from any of sublicensee or licensee as set forth in Article 3.
10.5 Survival. Any other provision and any definitions used in such Sections or Article which, by its terms, is understood to survive the termination or expiration of the Agreement shall survive the expiration or termination of this Agreement.
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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ARTICLE 11.
INDEMNIFICATION
11.1 Indemnification by the Parties.
11.1.1 [*] agrees to indemnify and hold BioSynthema and its directors, officers, employees and agents (the "BioSynthema Indemnified Parties") harmless from and against any claims, losses, costs, damages, fees or expenses arising out of or otherwise relating to (i) the gross negligence or willful misconduct of [*] or (ii) a breach by [*] of any of his representations, warranties, covenants or agreements ("BioSynthema Losses"). The foregoing indemnification shall not apply to BioSynthema Losses to the extent that they are caused by the gross negligence or willful misconduct of BioSynthema.
11.1.2 BioSynthema agrees to indemnify and hold harmless [*] from and against any claims, losses, costs, damages, fees and expenses arising out of or otherwise relating to (i) the development, manufacture, if applicable, labelling, use, offer for sale, sale or other disposition of Licensed Product, (ii) the gross negligence or willful misconduct of BioSynthema or its sublicensee(s), or (iii) a breach by BioSynthema of any of its representations, warranties, covenants or agreements ("[*] Losses"). The foregoing indemnification shall not apply to [*] Losses to the extent that they are caused by the gross negligence or willful misconduct of [*].
ARTICLE 12.
MISCELLANEOUS
12.1 Publicity. Neither party shall originate any publicity, news release or other public announcement, written or oral, relating to the Agreement, including its terms, without the prior - approval of the other Party. Any such approval shall not be unreasonably withheld or delayed. Each Party shall to the extent consistent with applicable laws and regulations limit the disclosure of the financial terms set forth in this Agreement (such as by requesting confidential treatment of such terns in documents required to be filed with the U.S. Securities and Exchange Commission).
12.2 Force Majeure. Neither Party to the Agreement shall be responsible to the other Party for non performance or delay in performance of the terms or conditions of the Agreement due to acts of governments, war, riots, strikes, accidents in transportation, or other causes beyond the reasonable control of such Party, but such force majeure shall toll any and all obligations and time periods for so long as such force majeure continues.
12.3 Governing Law. The Agreement shall be governed by and interpreted in accordance with the laws of the Netherlands without giving effect to principles of conflicts of law. Any dispute which cannot be solved amicably shall be submitted to the exclusive
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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jurisdiction of the courts of Amsterdam, the Netherlands, should [*] be the defendant, and of the courts of the City of St. Louis, Missouri, should BioSynthema be the defendant.
12.4 Waiver. The waiver by a Party of a breach or a default of any provision of the Agreement by the other Party shall not be construed as a waiver of any succeeding breach of the same or any other provision, nor shall any delay or omission on the part of a Party to exercise or avail itself of any right, power or privilege that it has or may have hereunder operate as a waiver of any right, power or privilege by such Party.
12.5 Notices. Any notice or other communication in connection with the Agreement must be in writing and may be given by any of the following methods: (i) personal delivery against a signed receipt; (ii) registered or certified mail, postage prepaid, return receipt requested; (iii) by overnight delivery service which obtains a signed receipt; or (iv) by facsimile transmission with confirmation of delivery. Notice shall be effective when delivered to the addressee at the address listed below or such other address as the addressee shall have specified in a written notice actually received by the addresser.
If to [*]:
[*]
[*]
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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If to BioSynthema:
Jack L. Erion
President
4041 Forest Park Blvd.
St. Louis, Missouri 63108
USA
With a copy to BioSynthema General Counsel:
Mary A. Palank
Palank & Associates LLC
1034 S. Brentwood Blvd., Suite 1630
St. Louis, Missouri 63117
USA
12.6 Payments. All payments to be made by either Party to the other Party shall be made to the bank account of the receiving Party as directed in writing by the receiving Party at the time payment is to be made.
12.7 No Agency. Nothing herein shall be deemed to constitute an agency, joint venture, amalgamation, partnership or other similar relationship between BioSynthema and [*]. Each Party shall be an independent contractor, not an employee or partner of the other Party. Each Party shall be responsible for the conduct of activities and for any liabilities resulting therefrom. Neither Party shall be responsible for the acts or omissions of the other Party, nor will either Party have the authority to speak for, represent or obligate the other Party in any way without prior written authority from the other Party.
12.8 Entire Agreement. The Agreement and Schedules hereto (which Schedules are deemed to be a part of the Agreement for all purposes) contain the full understanding of the- Parties with respect to the subject matter hereof and supersede, cancel and annul any prior written or oral understandings and agreements relating thereto. No waiver, alteration or modification of any of the provisions hereof shall be binding unless made in writing and signed by the Parties.
12.9 Headings. The headings contained in the Agreement are for convenience of reference only and shall not be considered in construing the Agreement.
12.10 Severability. In the event that any provision of the Agreement is held by a court of competent jurisdiction to be unenforceable because it is invalid or in conflict with any law of any relevant jurisdiction, the validity of the remaining provisions shall not be affected, and the Parties shall negotiate a substitute provision that, to the extent possible, accomplishes the original business purpose. During the period of such negotiation, and thereafter if no substituted provision is agreed upon, any such provision which is enforceable in part but not in whole shall
be enforced to the maximum extent permitted by law.
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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12.11 Assignment. Neither the Agreement nor any of the rights or obligations hereunder may be assigned by either Party without the prior written consent of the other Party, except to an Affiliate of the assigning Party and such assignment shall only remain effective as long as such Affiliate remains an Affiliate of the assigning Party or to any other Third Party who acquires all or substantially all of the business to which the Agreement relates of the assigning Party by merger, sale of assets or otherwise, so long as such Affiliate or Third Party agrees in writing to be bound by the terms of the Agreement. In all cases the assigning Party shall provide the other Party with prompt notice of any such assignment.
12.12 Successors and Assigns. Except as otherwise provided herein, the Agreement shall be binding upon and inure to the benefit of the Parties hereto and their successors and permitted assigns under Section 12.11.
12.13 Counterparts. The Agreement may be executed in any number of counterparts, each of which shall be deemed an original but all of such together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the Parties hereto have caused the Agreement to be executed in their names by their properly and duly authorized officers or representatives as of the dates below written.
[*] | BIOSYNTHEMA Inc. |
Date: June 12th 2007 | Date: June 12th 2007 |
/s/ Hendrik van Rossem | |||
By: | Hendrik van Rossem | ||
Title: | Chairman |
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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SCHEDULE 1 — 1. Patent (Case 100-7382)
Country | Grant Date | Patent n° | Exp. Date | |||
Australia | 04.06.93 | 633859 | 04.12.09 | |||
Austria | 09.12.97 | 403476 | 30.11.09 | |||
Belgium | 20.11.90 | 1002296 | 05.12.09 | |||
Canada | 22.02.00 | 2004532 | 04.12.09 | |||
Cyprus | 01.12.95 | 1893 | 01.12.09 | |||
Denmark | 30.08.04 | 175338 | 05.12.09 | |||
Finland | 30.09.98 | 101967 | 11.07.14 | |||
Finland | 31.12.98 | 102540 | 04.12.09 | |||
France | 21.04.95 | 8915993 | 04.12.09 | |||
Germany | 20.04.06 | 3991505 | 30.11.09 | |||
Great Britain | 20.01.93 | 2225579 | 01.12.09 | |||
Greece | 26.11.96 | 1002475 | 05.12.09 | |||
Hong Kong | 21.12.95 | 1899/95 | 01.12.09 | |||
Hungary | 20.09.95 | 211468 | 01.12.09 | |||
Ireland | 05.12.94 | 62091 | 04.12.09 | |||
Israel | 25.09.94 | 92534 | 04.12.09 | |||
Italy | 19.10.93 | 1239285 | 05.12.09 | |||
Japan | 10.06.05 | 3686503 | 04.12.09 | |||
Japan | 05.12.97 | 2726320 | 04.12.09 | |||
Korea South | 22.07.98 | 156541 | 22.07.13 | |||
Luxemburg | 18.09.91 | 87633 | 05.12.09 | |||
Malaysia | 31.03.95 | 106120 | 31.03.10 | |||
Netherland | 03.04.03 | 194828 | 04.12.09 | |||
New Zealand | 20.01.94 | 231623 | 04.12.09 | |||
Nigeria | 13.04.93 | 10732 | 05.12.09 | |||
Pakistan | 21.03.92 | 132014 | 05.12.09 | |||
Philippines | 07.05.96 | 29649 | 07.05.13 | |||
Poland | 28.09.93 | 163432 | 04.12.09 | |||
Portugal | 20.10.95 | 92487 | 20.10.10 | |||
Saudi Arabia* | 01.01.09 | |||||
Singapore | 15.04.97 | 38709 | 01.12.09 | |||
South Africa | 28.08.91 | 89/9285 | 05.12.09 | |||
Spain | 22.11.91 | 2023533 | 05.12.09 | |||
Sweden | 09.11.98 | 8904087-7 | 04.12.09 | |||
Switzerland | 30.08.91 | 678329-6 | 30.12.09 | |||
Tanganyida | 30.09.97 | 2533 | 01.12.09 | |||
Trinidad+Tabago | 14.11.95 | 78/95 | 01.12.09 | |||
USA | 19.05.98 | 5753627 | 06.06.15 |
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Country | Grant Date | Patent n° | Exp. Date | |||
USA | 07.07.98 | 5776894 | 07.07.15 |
*Saudi Arabia: patent application still pending, filing number 95160495
SCHEDULE Ia — Additional Patent (Case 100-7774)
Country | Grant Date | Patent n° | Exp. Date | |||
Belgium | 09.08.00 | 515313 | 20.05.12 | |||
Canada | 07.01.03 | 2069154 | 21.05.12 | |||
France | 09.08.00 | 515313 | 20.05.12 | |||
Germany | 09.08.00 | 515313 | 20.05.12 | |||
Great Britain | 09.08.00 | 515313 | 20.05.12 | |||
Italy | 09.08.00 | 515313 | 20.05.12 | |||
Japan | 14.02.03 | 3397338 | 22.05.12 | |||
Netherlands | 09.08.00 | 515313 | 20.05.12 | |||
Switzerland | 09.08.00 | 515313 | 20.05.12 |
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Exhibit 10.6
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
[*] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION.
CLINICAL SERVICES AGREEMENT
THIS CLINICAL SERVICES AGREEMENT (together with all corresponding Exhibits, "AGREEMENT") is entered into as the 1st of November 2011 by and between Advanced Accelerator Applications, with registered office in Saint-Genis-Pouilly, 20 rue Diesel, France ("SPONSOR"), and Pierrel Research Italy Spa ("CRO"), with registered office in Via Pietro Mascagni 14, Milan, Italy and operational offices in Italy, in Sesto S. Giovanni (MI), Via Alberto Falck 15 and in Cantù (CO), Via Como 5.
WHEREAS, SPONSOR requires various clinical research services in support of the clinical trial “A multicenter, stratified, open, randomized, comparator-controlled parallel groups phase III study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in patients with inoperable, progressive , somatostatin receptor positive midgut carcinoid tumours ” (“Project” or “Study”) to be conducted in various clinical institutions according to the protocol synopsis which is set forth in Exhibit A to this Agreement (“Protocol”);
WHEREAS, CRO is properly qualified by the competent regulatory authorities and engaged in the business of providing such services;
WHEREAS, CRO has been approved by The French Ministry of Higher Education and Research, as an organization carrying out R&D activities for the account of private companies (see Exhibit B) and said approval is needed in order to enable AAA to benefit of the so called “Credit d’impôt recherché (CIR)”;
WHEREAS, SPONSOR and CRO entered into a Letter of Intent dated 01 May 2011 and following First Extension and Amendment of the Letter of intent dated 01 September 2011, concerning some preliminary clinical research services linked to the clinical services of this Agreement (“Start-up Agreement”);
WHEREAS, pursuant to the Start-up Agreement CRO has invoiced to SPONSOR the overall amount of Euro 178.375,50 for CRO services activities, Euro 3.576,00 for CRO Operational Costs and Euro 23.290,00 for Pass-Through Costs.
NOW, THEREFORE, for good and valuable consideration, and intending to be legally bound, SPONSOR and CRO hereby agree as follows:
1. SCOPE OF AGREEMENT
1.1 The specific responsibilities, tasks and obligations to be performed by CRO with respect to the Project, as set forth in the Protocol, and relevant timing (the "Services") are expressly set forth in Exhibits C attached to this Agreement, which, together with the Exhibits attached hereto, are incorporated by reference herein. The responsibility for the Services is being transferred to CRO in accordance with the applicable provisions of law concerning the CRO activity.
Execution copy
Sponsor authorises the CRO to conduct the Services, to submit on its behalf the Protocol as well as any subsequent amendment, previously shared and agreed with SPONSOR, to all Competent Authorities for approval.
Without prejudice of the of paragraph 2.1 below, Parties agree that the agreements with the jointly selected central laboratories for the purpose of the implementation and execution of the Project will be signed directly by CRO in the exclusive interest of Sponsor.
Without prejudice of the provision of paragraph 1.3 below, Parties agree that the agreements with Public Institutions (hospitals) in USA and in Switzerland for the purpose of the implementation and execution of the Project will be signed directly by CRO in the exclusive interest of Sponsor and will be in line with the budgeted costs. Payments under said agreements shall be invoiced by the USA and Swiss Public Institutions to Pierrel and Pierrel will pay the invoiced amount to them. Said pass-through cost shall be charged to AAA according to paragraph 2.5.2) below, provided that SPONSOR may require that CRO invoices the Pass-Through Costs relevant to USA Public Institutions be charged and invoiced to SPONSOR’s USA affiliate and, upon SPONSOR’s request, CRO shall invoice as required by SPONSOR.
The agreements with Public Institutions (hospitals) in EU countries will be signed by Sponsor, being agreed between the Parties that the CRO will take care of the negotiation and managing of the agreements (contact with the institution, negotiation and finalization of the agreement), and will help SPONSOR to manage the payments: EU Public Institutions will invoice SPONSOR for any payment under their agreements and SPONSOR will directly pay the amount so invoiced and CRO shall timely check all invoices issued by the EU Public Institutions to ensure that the relevant amounts are effectively due under the relevant agreements.
The Services regulated by this agreement include the sub-study in Protocol N° AAA-III-01/FINAL version 1.0, November 14th, 2011, Par. 6.6 Dosimetry, Pharmacokinetics and ECG (from page 64 to page 70) - and related appendices. If SPONSOR requires CRO to make additional sub-studies, CRO shall provide SPONSOR with a budget proposal that, if and when accepted by SPONSOR, will be regulated as an addendum to the present agreement.
1.2 CRO agrees to provide the Services in accordance with this Agreement and its Exhibits and: (a) all applicable laws and regulations, including without limitations the Declaration of Helsinki, the ICH-Guideline of Good Clinical Practice (CPMP/ICH/135/1995), Directives 2001/20/EC and 2005/28/EC and the laws and regulations implementing said directives in each territory where the Project is performed; (b) the relevant provisions regulating the ethic committee activity and taking into account the peculiarity of the clinical institutions involved. CRO will use (i) appropriately qualified and trained personnel, (ii) standard operating procedures, ensuring a full compliance with the above mentioned guidelines and regulations and, in general (iii) the standard of care that are customary required in the performance of the type of services as the Services.
1.3. CRO will take all reasonable steps to ensure that personnel it uses to perform its obligations under this Agreement are appropriately trained and qualified to conduct the Study in accordance with the terms of this Agreement.
CRO shall promptly deliver general terms and conditions of any agreement which CRO is negotiating with clinical institutions (including Public Institutions – hospitals - in USA) or subcontractors for the performance of any of the Services. SPONSOR is committed to give its feedback on the received documents as soon as possible and in any case in no more than 5 working days (i.e. days when banks are open both in France and in Italy) and CRO shall take it in due consideration.
Upon SPONSOR request, CRO shall deliver any executed agreement between CRO and clinical institutions or subcontractors.
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Execution copy
For the avoidance of doubt, any subcontractor of the Services (in whole or in part) must be previously approved by SPONSOR.
In case any of the Services is subcontracted, CRO shall remain fully responsible for its performance under this Agreement.
As far as subcontracting with external laboratories is concerned, SPONSOR shall be responsible jointly with CRO for those contractual obligations - referred to the CRO in the agreements signed between CRO and external laboratories - that involve SPONSOR’s actions or responsibilities.
1.4 CRO warrants its full cooperation with the SPONSOR in pursuing the completion of the Project. To this purpose, CRO undertakes to submit to SPONSOR for approval the necessary and appropriate documentation for the start-up, conduct and reporting of the Study. CRO shall upon SPONSOR request and in any case at least monthly report to SPONSOR on the progress (activities, results and timing) of the Project and Services and provide to SPONSOR all requested documents and details in relation thereto.
1.5 In the event the position of any person dedicated to the Project remains for any reason vacant during the performance of the relevant Service, CRO shall immediately notify SPONSOR of such event and, subject to SPONSOR’s written consent which shall not be unreasonably withheld, shall appoint without delay another qualified person in order to ensure the continuity of the performance of such a Service without any interruption.
2. PAYMENT
2.1 In consideration of the Services, SPONSOR shall pay to CRO the Service Fees and Pass-Through Costs provided in Exhibit C (except for the amount of the “Investigator Grant” for the EU countries, which shall be paid directly by SPONSOR as provided in paragraph 1.1. above), provided that the relevant price/cost per unit are definitively agreed (without prejudice of the provision of paragraph2.4), but the aggregate amount of the Service Fees and Pass-Through Costs may change in case the number of units vary. The amount chargeable by CRO to SPONSOR under the term of this Agreement, excluding the preliminary clinical research services performed by CRO pursuant to the Start-up Agreement, is estimated in Euro 3.102.181,00 for Service Fees (the amount includes “CRO Services Fees” and “CRO Operational Costs”) and Euro 4.196.140,00 for Pass-Through Costs (all as better described and detailed in Exhibit C and except for the amount of the “Investigator Grant” for the EU countries), unless otherwise agreed in writing by both SPONSOR and CRO.
2.2 In the Pass-Through Costs amount are not included the Pass-Through Costs related to external laboratories (KEOSYS-QUALIM and INTERLAB) and related to insurance coverage (if any) for DSMB members; these Pass-through costs will be in any case regulated by this Agreement – provided that they are previously agreed with the SPONSOR - and will be subject to the same billing as the Pass-Through Cost detailed in Exhibit C, that is as indicated in article 2.5.2): the relevant amount shall be ascribed to the upfront payment under article 2.5.2)(a) until the same is reached and will thereafter invoiced by CRO to SPONSOR “at cost”. Any agreement with external laboratories (KEOSYS-QUALIM and INTERLAB or others) or related to insurance coverage, which is not included in the above estimate must be negotiated with the participation of SPONSOR and its execution and any future amendment must be previously approved by SPONSOR.
2.3 As used in this Agreement, the term "Pass-Through Costs" means all investigator’s grants, ethics committee fees, shipping costs, external vendors costs (if applicable), or other applicable pass-through costs actually incurred by CRO under this Agreement or the Exhibit(s)
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in order to expedite successful completion of the Project, which costs are normal and routine to studies similar to such Project.
2.4 CRO hereby represents to SPONSOR that the Service Fees and Pass Through Costs provided in Exhibit C have been determined and made after due and careful inquiry. It is also agreed that Starting 1st of May, 2012, and each May for the following years, a % service price increase based on the Official European CPI (Consumer Price Index) of the previous year, will be applied to the Services Fees provided in Exhibit C .
2.5 The payments will be regulated as follow:
1) | Payments for Service Fees will be made accordingly to the following (see also Exhibit D): |
(a) within January 2012, CRO shall invoice to SPONSOR Euro 277.336,50 as upfront payment for Service Fees in Europe and Euro 187.990,65 as upfront Payment for Service Fees in USA
(b) every subsequent month, for 40 months (from February 2012 till May 2015 included), CRO shall invoice to Sponsor fixed instalments of Euro 39.289,34 for Service Fees in Europe and Euro 26.632,01 for Service Fees in USA.
With the monthly instalments, CRO shall also invoice the amounts indicated in Exhibit C with the wording: “as required/if required/at cost”, if any and after Sponsor approval.
As far as the instalments related to USA are concerned, the art. 2.7 will be applied.
2) | Payments for Pass-Through Costs will be made accordingly to the following: |
(a) Within January 2012, CRO shall invoice to SPONSOR Euro 200.000,00 as upfront payment for pass-through costs in Europe and Euro 80.000,00 as upfront Payment for Pass-through costs in USA.
(b) When, with the incurred Pass-Through Costs, the amount of the upfront payments will be reached, CRO will start issuing monthly invoices to SPONSOR for the amount of Pass-Through Costs effectively incurred in the preceding month (in excess of the upfront payment under letter (a) above), including also the “at cost” Pass-Through Costs, if any.
In the event that SPONSOR requires detailed information relating to any Pass Through Cost (excluding the ones where a flat rate/fixed cost has been agreed), SPONSOR may, at its option visit CRO facilities pursuant to Section 8 contained herein or promptly receive by CRO the relevant documents evidencing the incurred Pass-Through Costs.
As far as the invoices related to USA are concerned, the art. 2.7 will be applied.
2.6 Sponsor shall make all payment to CRO in Euro and accordingly CRO shall invoice SPONSOR in said currency.
As far as the upfront payments are concerned (see 2.5.1.a and 2.5.2.a), SPONSOR shall pay by bank transfer the amount undisputed and invoiced to it by the CRO in Euro at the receipt of the invoices; for the subsequent invoices Sponsor shall pay by bank transfer the amount undisputed and invoiced to it by the CRO in Euro within 30 days from the end of the month of the invoice.
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Following are the wire transfer instructions for CRO, provided that, even if CRO designates new wire transfer instructions from time to time during the Term by written notice to SPONSOR, CRO’s bank accounts shall be always in the EU.
All payments to CRO shall be made to:
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Bank [*]
Account Name [*]
Account Number [*]
IBAN [*]
Swift Code [*]
The CRO shall submit all invoices to the SPONSOR at the address listed below:
Advanced Accelerator Applications, 20 Rue Diesel, 01630 Saint-Genis-Pouilly, France.
2.7 As far as USA is concerned, the parties agree not to mitigate for fluctuations in the exchange rate if the closing daily euro/USD exchange rate on the date of invoice for the rendered services and pass-through costs (as reported in the Wall Street Journal) is equal to or between 1,45 and 1,15 euro to the USD, but (i) if such exchange rate is greater than 1,45 euros to the US Dollar for more than 60 consecutive days, then the price for the services and pass-through costs in Euro will be decreased in the same proportion as the ratio of (a) 80% of the average increase in the closing daily euro/USD exchange rate during those 60 days to (b) 1,45; and (ii) if such exchange rate is less than 1,15 euros to the US Dollar for more than 60 consecutive days, then the price for the services and pass-through costs in euros will be increased in the same proportion as the as the ratio of (a) 80% of the average decrease of the closing daily euro/USD exchange rate during those 60 days to (b) 1,15.
By way of example, if the average closing daily euro/USD exchange rate during a period of 60 consecutive days in which the exchange rate exceed 1,45 equals 1,60 euros to the UD Dollars, then the price for the service will be reduced as follows:
80% (1,60 euro minus 1,45 euro) / 1,45 euro = 0,08
1000,00 euro minus (1000,00 euro X 0,08) = 920,00 euro (new price)
By way of example, if the average closing daily euro/USD exchange rate during a period of 60 consecutive days in which the exchange rate is below 1,15 equals 1,00 euros to the UD Dollars, then the price for the service will be increased as follows:
80% (1,15 euro minus 1,00 euro) / 1,15 euro = 0,10
1000,00 euro plus (1000 euro X 0,10) = 1100,00 euro (new price)
2.8. The cost, fee and budget estimates specified in Exhibit C with respect to the STUDY are subject to a number of general and specific assumptions. The general assumptions (collectively, the “ ASSUMPTIONS”) are as follows:
· | There are no material changes to Exhibits A ; |
· | CRO and SPONSOR will each execute all of their obligations under this Agreement in a timely fashion; |
· | CRO and SPONSOR will fully cooperate with each other in the performance of their obligations under this Agreement and refrain from any actions or inactions which prevent each from timely or properly performing its obligations hereunder and there under, respectively; and |
· | No event outside of CRO’s control occurs (that is events related to safety, IMP supply issues, force majeure events - see also art. 11- and events under direct Sponsor’s responsibility. |
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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In the event that SPONSOR desires to modify or deviate from any of the ASSUMPTION, or CRO reasonably determines and evidences that the STUDY objectives cannot be fulfilled, based on the ASSUMPTIONS, (each a “DEVIATION”) then the budget, fees, costs and time estimates for such STUDY as specified in Exhibit C shall be modified in accordance with the terms of this Section.
In the event a DEVIATION is identified, the identifying party shall notify the other party of such DEVIATION. Within 15 working days from the receipt by CRO or from sending of such DEVIATION notice, CRO shall provide SPONSOR with an estimate of the modification to the timeline, costs and fees and overall budget (whether an increase or decrease) arising from such DEVIATION, if any, provided that said costs and fees shall be in line with costs and fees agreed in Exhibit C. SPONSOR shall have 15 working days to approve such modification estimates.
If SPONSOR does not, in its reasonable discretion, approve the modification estimates and has not terminated the Study but prefer the STUDY to be modified to take in account the DEVIATION, then CRO and SPONSOR shall use their commercially reasonable efforts to agree on modification estimates that are mutually acceptable.
Once the DEVIATION is approved by SPONSOR and the modification estimates are agreed, the services and activities included in the DEVIATION shall be considered Services under this Agreement and the Study and Project accordingly amended.
During the DEVIATION ASSESSMENT PERIOD (defined below), CRO shall continue work on the STUDY if practicable but shall not implement the modification representing the DEVIATION unless approved by SPONSOR.
For purposes of this Agreement, “DEVIATION ASSESSMENT PERIOD” means the time from the date CRO sends or receives a notice of DEVIATION pursuant to this Section and the date SPONSOR either accepts or rejects CRO’s modification estimates as specified in this Section.
2.9 The following bonus/malus is agreed between the Parties:
a) In case CRO will reach the target of final draft report within 43 months from the start of the activities (that is from 1st of November, 2011), SPONSOR will pay to CRO, in addition to the full contract value (i.e. the overall amount of the Service Fees and Pass Through Costs under this Agreement), a BONUS of Euro 400.000,00.
b) If CRO will not deliver the final draft report within 43 months from the start of the activities (that is from 1st of November, 2011) and the reason for such a delay is other than safety, IMP supply issues, force majeure events (see also art. 11) and events under direct Sponsor’s responsibility, CRO will continue the study activities on its own charge and expense for Service Fees up to a value of Euro 400.000,00.
3. CONFIDENTIALITY
3.1 In connection with the performance of the Services, SPONSOR shall provide to CRO, and CRO shall have access to, SPONSOR's Confidential Information. As used in this Agreement, "SPONSOR’s Confidential Information" means any: (a) information provided by, or developed for, SPONSOR within the framework of this Agreement, the Start-up Agreement, the Exhibit(s) or the Project; or (b) data collected or developed during the Project.
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3.2 In connection with this Agreement, SPONSOR will have access to, or become acquainted with, CRO's Confidential Information. As used in this Agreement, "CRO's Confidential Information" means any: (a) information generated or obtained in connection with CRO's pricing, proposals or contracts; (b) CRO's procedures, programs, guidelines or policies (including, without limitation, its Standard Operating Procedures).
3.3 Neither SPONSOR's Confidential Information nor CRO's Confidential Information (collectively, "CONFIDENTIAL INFORMATION") shall include any information that:
(a) was known by the receiving party at the time of disclosure to it by the disclosing party, or that is independently developed or discovered by the receiving party, after disclosure by the disclosing party, without the aid, application or use of any item of the disclosing party's Confidential Information, as evidenced by written records;
(b) is now or subsequently becomes, through no act or failure to act on the part of the receiving party, generally known or available;
(c) is disclosed to the receiving party by a third party authorized to disclose it; or
(d) is required by law or by court or administrative order to be disclosed; provided, that the receiving party shall have first given prompt notice to the other party of such required disclosure.
3.4 Each party shall exercise due care to prevent the unauthorized use or disclosure of the other party's Confidential Information, and shall not, without the other party's prior written consent: (a) use the other party's Confidential Information for any purpose other than performing its obligations under this Agreement and the Exhibit(s); or (b) disclose or otherwise make available, directly or indirectly, any item of the other party's Confidential Information to any person or entity other than those employees, independent contractors, agents or investigators of such party and/or its affiliated entities (collectively, "Representatives") who reasonably need to know the same in the performance of such party's obligations under this Agreement (including the Exhibit(s)), or in order to make decisions or render advice in connection therewith. Each party shall advise its Representatives who have access to the other party's Confidential Information of the confidential nature thereof, and agrees that such Representatives will be bound by terms of confidentiality and restrictions on use with respect thereto that are at least as restrictive as the terms of this Section 3 (it being understood that each Party shall remain responsible to the other for any breach by the respective Representatives of the confidentiality obligations under this Agreement).
3.5 The provisions of this Section 3 shall survive until the information remains Confidential Information and, in any event, for a period of ten (10) years from the date of any expiration or termination of this Agreement, however caused.
4. PERSONAL DATA
4.1 The Parties, duly informed with reference to the relevant legislative provisions on privacy and data protection, express their reciprocal consent and authorization for the processing and communication of their personal data which is necessary for any specific accounting and tax requirements and also for execution and management of relationship and contractual obligations between themselves.
4.2 With regard to all patients’ personal and sensitive data processing that are caused by performance of the SERVICES, the Parties agree that SPONSOR is the data controller and CRO is the data processor. For this purpose the parties shall enter into an appointment of
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“data processor”. CRO commits to comply with all applicable laws and regulations concerning personal data protection and treatment, including collecting all required authorizations and appointing the persons in charge of the processing where required.
4.3 All information provided under this Agreement by CRO to SPONSOR, final report, Case Report Forms and SAS datasets included, will be made available only under coded data format or in aggregated form, as appropriate, without any identifiable personal data. The Project will be therefore conducted by CRO in a way to prevent disclosure of any identifiable patient personal data to any SPONSOR’s employee according to the ICH, to applicable law, regulation and guidelines (including but not limited to the Italian Data Protection Authority’s “Guidelines for Data Processing within the Framework of Clinical Drug Trials”) . Any knowledge or treatment of such patient personal data by CRO and its employees or collaborators will be made in strict compliance with applicable laws and regulations on personal data, provided any prior express consent and authorization is duly obtained.
5. PROPERTY OF SPONSOR
5.1 All (a) of SPONSOR's Confidential Information (including, without limitation, all original Project records and reports), (b) unused clinical supplies provided by SPONSOR, and (c) complete and incomplete Case Report Forms, which in any case are in CRO's possession, shall be and remain SPONSOR's property.
5.2 All inventions, improvements, know-how, new uses, processes and compounds involving or however concerning the Study, drug(s) and/or product(s) covered by this Agreement and/or the Exhibit(s) and /or the Project that are conceived or reduced to practice or however result from the Study or the Services under this Agreement (including any work performed by clinical institutions, external laboratories or subcontractors) ("Results") shall be and remain the sole property of SPONSOR. CRO shall cooperate fully with SPONSOR in obtaining, at SPONSOR's sole cost and expense, any patent protection as may be available for the Results, and shall execute all documents reasonably deemed necessary by SPONSOR for purposes of procuring such patent protection. CRO agrees that it shall endeavour to ensure contractually the prompt disclosure to SPONSOR by any investigator, employee or other individual retained by CRO for the Project of any Results, as well as the cooperation of such persons in securing patent protection as set forth herein.
5.3 Notwithstanding the foregoing, SPONSOR acknowledges that CRO and its professional staff currently possess certain inventions, processes, know-how, trade' secrets, methods, approaches, analyses, improvements, other intellectual properties and other assets including, but not limited to, clinical trial management analyses, analytical methods, procedures and techniques, computer technical expertise and proprietary software, and technical and conceptual expertise in the area of conducting clinical trials, all of which have been developed independently by CRO without the benefit of any information provided by SPONSOR (collectively, "CRO Property"). SPONSOR agrees that any CRO Property which is used, improved, modified or developed by CRO under or during the term of this Agreement shall be and remain the sole and exclusive property of CRO.
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6. RESTRICTIONS ON ANNOUNCEMENTS
CRO shall not make any announcement, oral presentation or publication relating to the Project without SPONSOR's prior written consent (which consent shall not be unreasonably withheld), except as required by law or by court or administrative order. The Parties shall coordinate the wordings of such announcement, oral presentation or publication. Neither party shall employ or use the name of the other party in any publication or promotional material or in any form for public distribution, without the prior written consent of the other party, except as required by law or by court or administrative order.
7. INSPECTIONS
In the event that CRO receives a notice of inspection (a "Notice") from any authority entitled to do so which relates to the Project, CRO shall: (a) notify SPONSOR promptly of such Notice; (b) keep SPONSOR informed of the progress of the inspection; and (c) provide to SPONSOR a copy of any documents produced to the inspecting authority pursuant to such Notice. SPONSOR acknowledges that it is CRO's obligation to respond to a Notice directed to CRO. CRO ensures the attendance of one of its representatives, to be previously agreed upon with the Sponsor, during all the inspection operations.
SPONSOR shall have the right to perform co-monitoring visits or audit at the CRO/subcontractor facilities or at the investigator’s sites with respect to the services provided for the STUDY with reasonable prior written notice and with normal business hours. In such a case, the CRO will assist and cooperate with the SPONSOR.
8. ACCESS TO FACILITIES
SPONSOR's authorized representatives may visit CRO's site and facilities at reasonable times and with reasonable frequency during normal business hours and upon reasonable advance written notice, to observe the progress of any Services.
9. INDEMNIFICATION AND WARRANTIES
9.1 CRO shall defend, indemnify and hold harmless SPONSOR, its affiliated entities, and their respective trustees, officers, agents and employees from any and all losses, costs, expenses, liabilities, claims, actions and damages, directly and objectively attributable to the responsibility of CRO in the conduction of the Project and/or performance of the Services including without limitations, the failure to strictly comply with the Protocol, with good clinical practices, with Service timelines, with SPONSOR's written recommendations and instructions relative to the conduct of the Project, or with any applicable law, regulations or authority’s requirements, subject to the restrictions set forth in articles 9.2 and 9.3 below.
9.2 The above obligation of CRO shall not apply nor shall CRO be liable for any indemnification or expenses, and in fact, SPONSOR shall defend, indemnify, and hold harmless CRO, for actions or claims in any way arising from or caused by the wilful misconduct or gross negligence of SPONSOR or arising from or caused by any of its failures to comply with this Agreement.
9.3 The obligation of the indemnifying party hereunder, in connection with a third party claim or suit, shall apply only if the other party provides prompt written notification upon receipt of notice of any claim or suit (provided, however, that neither party shall be released
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from its obligations under this Section 9 if the failure to promptly notify the other party does not materially prejudice the defence of any claim), permits the indemnifying party and its attorneys and personnel to handle and control the defence of such claims or suits, including pre-trial, trial or settlement, and the indemnified party fully cooperates and assists in such defence. The indemnified party further agrees that it will not settle or compromise any such claim or suit without the prior written consent of the indemnifying party.
9.4 The parties shall secure and maintain in full force and effect through the performance of the Project (and following termination of the applicable Study to cover any claims arising from the applicable Study) insurance coverage in amounts appropriate to the conduct of the Project and the Services contemplated by the applicable Project, and shall provide evidence of insurance coverage in an acceptable form upon request.
9.5 In the event any breach or default by any of the Party of this Agreement with respect to its obligations under this Agreement, the respective Party’s damage liability to the other Party for such breach or default shall be limited to emerging damages (i.e. “danno emergente” under Italian law), except in case of losses sought or awarded for death or bodily injury for which such limitation shall not apply.
9.6 CRO represents and warrants that this Agreement will be performed in material compliance with all applicable laws and regulations, including without limitation, laws and regulations relating to health, safety and environment, fair labour practices, unlawful discrimination.
9.7 CRO shall maintain/extend/renew, for the entire duration of this Agreement, the approval by the French Ministry of Higher Education and Research mentioned in the premises of this agreement (the “French Ministry Approval”).
Without limitation of the foregoing, CRO shall make all filings and take all actions needed in order to maintain/extend/renew the French Ministry Approval and use its best effort thereto.
In case the French Ministry Approval is not maintained/extended/renewed for the entire duration of the Agreement, due to responsibility directly and objectively attributable to CRO, CRO shall pay to SPONSOR – also by way of set off with any amount due by SPONSOR to CRO under this agreement - as forfeiture (“penale” under Italian law), per each year in which the French Ministry Approval is not maintained/extended/renewed, 30% of the Services Fees invoiced in the reference year.
The above is provided that, in case the French Ministry Approval is not maintained/extended/renewed due to changes in the applicable legislation that prevent CRO to obtain it, the above provided forfeiture shall not apply.
10. DURATION AND TERMINATION
10.1 Without prejudice of the Parties’ rights in case of breach of this Agreement by the other Party, this Agreement is applicable to all Services rendered or to be rendered by CRO with respect to the Project, in accordance with Exhibit C, from 1st of November, 2011 until May 2015 (43 months).
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In case art. 2.9 b) shall apply, the duration is extended until completion of the Services or up to the € 400.000,00 value stated therein (whatever occurs first)
10.2 Without prejudice of any other remedy available, SPONSOR will be entitled to terminate this Agreement at any time by registered letter upon serious breach by CRO of its obligations not remedied, provided remediation is possible, within the term set out by SPONSOR.
10.3 SPONSOR shall have the right at any time to terminate the Agreement at will, serving thirty (30) days written notice to CRO.
10.4 In the event the Agreement is terminated by SPONSOR pursuant to article 10.3 above, SPONSOR shall pay to CRO all Service Fees due and owed in relation to conforming Services completed and Pass-through costs incurred through the effective date of termination, provided that they are duly documented.
Also SPONSOR shall pay an additional amount corresponding to the 15% of the Service Fees relating to the Services not performed, due to the termination; in the amount of the Services Fees relating to the Services not performed the bonus must be also considered if (i) the timing of the Services as provided in Exhibit C was respected up to termination and, if not respected, (ii) the reason for such a delay is force majeure events (see also art. 11) or safety, IMP supply issues and other events under direct Sponsor’s responsibility.
10.5 Upon receipt of a termination note, CRO shall over a ninety (90) days period cease performing any work not necessary for the orderly closeout of the Project or for the fulfilment of regulatory requirements. CRO shall use its best efforts to minimize any expenses resulting from any such early termination.
Except as provided above, CRO shall not be entitled to any other compensation nor indemnification in case of termination of this Agreement under the above article 10.3.
10.6 Any funds or advance payments held by CRO which by contract are deemed unearned shall be returned to SPONSOR within 30 (thirty) days after expiration or termination of this Agreement.
10.7 Following termination of this Agreement or the finalization of the Clinical Study Report, CRO shall forward, within 60 (sixty) days all original Project records and reports (including any CONFIDENTIAL INFORMATION) to SPONSOR (or to a repository designated by SPONSOR in writing), SPONSOR being the owner of all Project documentation, information and results. Thereafter, CRO shall retain only the documentation related to such Project that is required according to ICH regulation or local regulations on retention and destruction of records.
11. FORCE MAJEURE
If either party's performance of this Agreement or any Exhibit is prevented, restricted or delayed (either totally or in part) by reason of any cause beyond the reasonable control of the parties, such as acts of God, explosion, disease, weather, war, insurrection, civil strike, riot or power failure, the party so affected shall, upon giving notice thereof to the other party, be excused from such performance to the extent of such prevention, restriction or delay; PROVIDED, that the affected party shall use its commercially reasonable efforts to avoid or remove such causes of non-performance.
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12. NO CONFLICT
Each party represents and warrants that it is authorized to enter into this Agreement and that the terms hereof are not inconsistent with or a violation of any contractual or other legal obligation to which it is subject.
13. LABOR LAWS
CRO shall take care at its own charge of any and all obligations towards its employees and collaborators arising from applicable labour and social security laws and regulations. Working condition for CRO’s employees rendering the Services under this Agreement will not be less than those stated in applicable national collective employment agreements. CRO will provide SPONSOR with evidence of compliance of above obligations and will permit and shall cause that any CRO’s collaborators permit SPONSOR any inspection.
14. INDEPENDENT CONTRACTOR
The status of the parties under this Agreement is that of independent contractors, and, except as specifically set forth herein, or in the Exhibit(s), neither party has any authority to bind or act on behalf of the other party without its express written consent. All contracts, expenses and liabilities undertaken or incurred by CRO in connection with or relating to this Agreement shall be undertaken, incurred or paid exclusively by CRO and not as an agent or representative of SPONSOR.
15. NOTICES
Apart from the ordinary business communications related to the conduct of the Study, which may be given also by informal means, any relevant notices, requests or other communications given under this Agreement (i.e. related to a modification, termination, indemnification procedure) shall be in writing and shall be given by personal delivery, or sent by (a) facsimile transmission (with message confirmed during normal business hours); (b) first class mail, postage prepaid; or (c) Federal Express (or equivalent nationally recognized overnight delivery service), delivery charges prepaid. All notices shall be given to a party at its respective address set forth below, or at such other address as such party from time to time may specify by notice in accordance with this Section 15. A notice shall be deemed given when actually received, PROVIDED, that if any facsimile notice is received after 5:00 P.M. local time at the place of receipt, it shall be deemed to have been given as of the next following business day.
If to CRO:
Pierrel Research Italy Spa
Via Alberto Falck 15
20099 Sesto S. Giovanni (MI)
Attention: Mr. Luigi Visani
fax: 0224862994.; E-mail: l.visani@pierrel-research.com
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If to SPONSOR:
Advanced Accelerator Application
Via Ribes, 5
10010 Colleretto Giacosa (TO)
Italy
Attention Mrs. Paola Santoro
Fax: +39 0125561212; E-mail paola.santoro@adacap.com
16. ENTIRE AGREEMENT
This Agreement, together with all corresponding Exhibits, Amendments or Deviation, constitutes the entire agreement between SPONSOR and CRO with respect to the subject matter hereof, and replaces and supersedes any and all prior and contemporaneous agreements and/or understandings, whether oral or written, between SPONSOR and CRO with respect to the subject matter hereof. This Agreement (including the Exhibit(s)) may be amended or modified only by a written instrument executed by a duly authorized officer of each party.
17. CONSTRUCTION OF AGREEMENT
The descriptive headings of the Sections of this Agreement are for convenience only and shall not affect the meaning or construction of any of the provisions of this Agreement. The failure of either party to enforce any provision of this Agreement (including Exhibit(s)) shall not be construed as a waiver or limitation of that party's subsequent rights to enforce and compel strict compliance with every provision of this Agreement. To the extent any provision of this Agreement or the application thereof is found by a proper authority to be invalid or unenforceable, it shall be considered deleted herefrom, and the remainder of this Agreement shall continue in full force and effect.
18. APPLICABLE LAW AND JURISDICTION
This Agreement shall be governed by and construed in accordance with the laws of Italy, without regard to provisions of conflicts of law. Any lawsuit arising from or related to this Agreement shall be brought exclusively before the Court of Milano, and each party hereby consents to the jurisdiction of such court.
19. ASSIGNMENT
Neither SPONSOR nor CRO may assign this Agreement or any rights hereunder or delegate the performance of any duties hereunder without the prior written approval of the other party, which approval shall not be unreasonably delayed or withheld; it is therefore agreed between the Parties that CRO shall subcontract the Services, in whole or in part, to the subsidiaries and/or affiliates of Pierrel Research without prejudice to CRO liability vis-à-vis SPONSOR for the fulfilment of the obligations set forth by this Agreement.
Also, without CRO consent, SPONSOR may assign this Agreement to its affiliated companies (directly or indirectly controlled). Subject to the foregoing, this Agreement shall be binding
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upon, inure to the benefit of and be enforceable by the parties and their respective successors and permitted assigns.
20. SURVIVAL
Sections 3 and all other provisions that expressly or by their nature survive (including, without limitation, Section 2, 4, 5, 8, 9, and this Section 20), will survive the termination or expiration of this Agreement.
21. SIGNATORIES
This Agreement may be executed in counterparts, each of which, when executed and delivered, shall be deemed to be an original, and all of which, when joined, shall together constitute one and the same agreement.
***
IN WITNESS WHEREOF, the parties have executed this Agreement by their duly authorized officers as of the date first above written.
Advanced Accelerator Applications | PIERREL RESEARCH ITALY S.p.A. | |
Saint-Genis-Poully | Sesto S. Giovanni (MI) | |
/s/ Stefano Buono | /s/ Luigi Visani | |
Stefano Buono | Luigi Visani | |
Chief Executive Officer | Chief Executive Officer | |
09/02/2012 | 16/02/2012 | |
Date | Date |
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EXIBIT A: PROTOCOL / PROTOCOL SYNOPSIS
EXIBIT B: APPROVAL by FRENCH MINISTRY OF HIGHER EDUCATION and RESEARCH
EXIBIT C: ASSUMPTIONS and COST PROPOSAL BY CRO
EXHIBIT D: PAYMENT SCHEDULE FOR CRO SERVICES AND OPERATIONAL COSTS
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Exhibit 10.7
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
[*] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION.
UNANIMOUS SHAREHOLDERS AGREEMENT
This Agreement dated as of the 27th day of March, 2014.
AMONG:
ADVANCED ACCELERATOR APPLICATIONS CANADA INC., a corporation incorporated under the laws of Canada
(Hereinafter called “AAA Holdco")
OF THE FIRST PART;
- and-
4549694 CANADA INC., a corporation incorporated under the laws of Canada
(Hereinafter called “Exchangeco")
OF THE SECOND PART;
- and-
7329563 CANADA INC., a corporation incorporated under the laws of Canada
(Hereinafter called “Atreus Holdco")
OF THE THIRD PART;
- and-
ATREUS PHARMACEUTICALS CORPORATION, a Corporation incorporated under the laws of Canada
(Hereinafter called the "Corporation")
OF THE FOURTH PART.
WHEREAS:
1. | The authorized capital of the Corporation consists of an unlimited number of common shares, of which 1,000 common shares are issued and outstanding and held by the shareholders set out in Schedule A hereto; |
2. | The parties wish to enter into this Agreement to provide for the conduct of the business and affairs of the Corporation, to provide for restrictions on the transfer and ownership of their shares of the Corporation and to govern their relationship as shareholders of the Corporation. |
NOW THEREFORE THIS AGREEMENT WITNESSES THAT, in consideration of the mutual covenants and agreement herein contained and other good and valuable consideration, the parties hereto agree as follows:
ARTICLE 1
INTERPRETATION
1.1 | Definitions |
Unless the subject matter or context otherwise requires:
(a) | "Act" means the Canada Business Corporations Act and any statute that may be substituted therefore, as from time to time amended, and the regulations thereto and any regulations that may be substituted therefore, as from time to time amended; |
(b) | "Affiliate" has the meaning assigned to such term in the Act; |
(c) | "thisAgreement"the"Agreement","hereto","hereof',"herein","hereby","hereunder" and similar expressions mean or refer to this Agreement as amended , from time to time, any indenture, agreement or instrument supplemental or ancillary hereto or in the implementation hereof, and the expressions "Section", "subsection" and "paragraph" followed by a number or letter refer to the specified section, subsection or paragraph of this Agreement; |
(d) | "Annual Budget" means the detailed financial and cash budget of the projected business activities and operations of the Corporation, including estimates of proposed and committed operating and capital expenditures and the subject matter of each expenditure and all sources of revenue, cash and financing of the Corporation for the subject period; |
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(e) | "Articles” means the articles of incorporation of the Corporation, as amended from time to time; |
(f) | "Board of Directors” means the board of directors of the Corporation which shall be constituted in accordance with the provisions of subsection 2.2 hereof |
(g) | "Business Day" means any day other than a Saturday, Sunday or statutory holiday in the Province of Ontario or France; |
(h) | "Common Shares" means the common shares in the capital of the Corporation and any other shares that may henceforth be issued having the same rights, privileges and restrictions as such common shares; |
(i) | "Control” has the meaning assigned to such term in the Act; |
(j) | "Fiscal Year" means the fiscal year of the Corporation which ends on December31 in each year; |
(k) | "Milestone" means the Corporation obtaining the IND by the FDA to proceed with a clinical trial with Tc-Annexin, for the indication on Rheumatoid Arthritis; |
(1) | "Person" means any individual, company, corporation, partnership, firm, trust, sole proprietorship, government or entity howsoever designated or constituted; |
(m) | "Public Offering" means an underwritten public offering of its Common Shares pursuant to a registration statement that has been declared effective under the United States Securities Act of 1933 or a prospectus filed under applicable Canadian securities laws in respect of which a (final) receipt has been obtained, accompanied by the listing of the Common Shares on the Toronto Stock Exchange and/or the Nasdaq National Market and/or the New York Stock Exchange and/or any other stock exchange or market approved by Special Shareholder Approval; |
(n | "Share" means any share in the capital of the Corporation; |
(0) | "Shareholder” means any party to this Agreement who is a holder of Shares; and |
(p) | "Special Shareholder Approval" means the approval of the holders of Shares representing not less than sixty-six and two-thirds percent (66 2/3%) of the votes attaching to the outstanding shares in the Corporation. |
1.2 | Schedules |
The following are the schedules attached to and forming part of this Agreement
Schedule A - Shareholders and Issued Capital of the Corporation
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1.3 | Extended Meanings |
Words importing the singular number include the plural and vice versa and words importing the masculine gender include the feminine and neuter genders and vice versa.
1.4 | Interpretation Not Affected by Headings |
The division of this Agreement into sections and insertion of headings are for convenience of reference only and shall not affect the construction or Interpretation of this Agreement.
1.5 | Applicable Law |
This Agreement shall be interpreted in accordance with and be governed by the laws of Ontario and the laws of Canada applicable therein.
1.6 | Entire Agreement |
This Agreement constitutes the entire agreement among the parties with respect to the subject matter hereof and contains all the representations, undertakings and agreements of the respective parties.
1.7 | Funds |
All dollar amounts referred to in this Agreement are in the lawful money of the United States of America.
1.8 | Paramountcy |
If any provision of this Agreement conflicts with the Articles or by-laws of the Corporation or any agreement among the Corporation and/or any of the Shareholders and/or any officers or directors of the Corporation concerning matters which are the subject matter of this Agreement, the provisions of this Agreement shall prevail.
1.9 | Invalidity |
If any provision of this Agreement shall be held invalid or unenforceable in any jurisdiction, such invalidity or unenforceability shall attach only to such provision such jurisdiction and shall not in any manner affect or render invalid or unenforceable such provision 111 any other jurisdiction or any other provision of this Agreement in any jurisdiction.
1.10 | Calculation of Time |
Where in this Agreement a period of time is given for the doing of any act following the giving of a notice the date on which the notice is given shall be excluded from the calculation of the time period. When any period of time for the performance of any act expires on a Saturday, Sunday or a national statutory holiday the period shall be deemed to expire on the next following Business Day. Notwithstanding anything herein contained to the contrary, the Corporation shall have the right, at its sole option, to postpone any date provided for herein to a date not exceeding three Business days after such date.
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1.11 | Privity |
This Agreement shall be binding upon all Persons executing these presents, and all Persons who subsequently become holders of Shares, each of whom shall execute a counterpart of this Agreement. Any agreement to be bound hereby and any other agreement among the parties hereto with respect to the Corporation or the Shares may be effectively delivered by one party to each of the others by delivery of an executed counterpart of this Agreement to the Corporation.
ARTICLE 2
CONDUCT OF THE AFFAIRS OF THE CORPORATION
2.1 | Business and Affairs of the Company |
The Shareholders shall cause such meeting to be held, votes to be cast, resolutions to be passed, by-laws to be made and confirmed, documents to be executed and all other things and acts to be done to ensure that, at all times, the following provisions are in effect or are complied with, or with respect to any provision which is not entirely within the control or power of the Shareholders to cause compliance therewith, the Shareholders .shall use their best efforts to cause such compliance to occur.
2.2 | Directors of the Corporation |
(a) The Shareholders, by majority vote, will determine from time to time the number of directors to be elected.
(b) The Shareholders will from time to time so act and vote (to the extent that each is able to do so on account of its respective shareholdings or otherwise) so that the board of directors (the "Board") of the Corporation shall consist of at least one nominee of AAA Holdco and at least one nominee of Atreus Holdco; provided that, such right shall terminate in respect of each such Shareholder if AAA Holdco and Exchangeco, on the one hand, or Atreus Holdco, on the other hand, shall cease to hold Shares in the capital of the Corporation representing at least 5% of the votes attaching to the outstanding shares in the Corporation.
(c) Each of AAA Holdco and Atreus Holdco shall be entitled at any time to require the removal of any director nominated by it and to provide for a successor nominee by written notice to the Corporation and to the other Shareholders. No Shareholder other than a shareholder having nomination rights shall use its voting rights to remove a director who is a nominee of AAA Holdco or Atreus Holdco. If a director nominated by AAA Holdco or Atreus Holdco ceases to be a director for any reason, the Shareholders shall, if necessary, fill the
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vacancy thereby created by appointing, as soon as reasonably possible, the individual who is nominated by AAA Holdco or Atreus Holdco, as the case may be.
(d) A quorum for a meeting of directors of the Corporation shall be a nominee of each of the Shareholders; provided that, if a nominee is not able to attend two (2) successive properly called board meetings, then the next meetings may proceed without such nominee being present, so long as a majority of directors are present.
(e) Notice of meetings of the Board shall be accompanied by an agenda together with copies of documents to be considered at such meetings. AAA Holdco and Atreus Holdco shall make best efforts to convene board meetings at least [quarterly] during the year. Each of AAA Holdco and Atreus Holdco may bring one observer to board meetings, but such observer shall have no right to vote. Any additional observers shall require the approval of the other board members.
(f) The Board shall appoint a Chairperson (who shall not have a casting vote in the event of an equality of votes on any matter among members of the Board), who shall initially be ■.
2.3 | Directors' Compensation and Indemnity |
The Corporation will pay all reasonable out-of pocket expenses incurred by the directors to attend meetings of the Board of Directors. Directors shall be indemnified by the Corporation with respect to their actions as directors to the maximum extent, and subject to the limitations, permitted by law. The Board will determine what, if any, compensation will be paid to any external director
2.4 | Shareholders' Right of Inspection and Inquiry |
The Corporation shall permit Persons designated by the Shareholders to visit and inspect any properties of the Corporation, to examine the books and financial records of the Corporation and to discuss with management its affairs, finances and accounts all during normal business hours and as often as may be reasonably requested, with prior notice and at times reasonably convenient to management. The Persons designated pursuant to this provision may include accountants (including the auditors of the Corporation) or management consultants or others appointed to examine all or any aspect of the operations of the Corporation, and the Corporation agrees to cause management to answer fully and fairly and to the best of their ability any reasonable inquiries which such Persons may have. The Corporation agrees that such Persons may, in the course of their investigations, discuss the business and affairs of the Corporation with the officers and directors and with the auditors of the Corporation.
2.5 | Annual Financial Statements |
Within 90 days after the end of the Fiscal Year, the Corporation shall prepare and furnish or cause to be prepared and furnished to the Shareholders unaudited consolidated financial statements in respect of the Corporation, including a balance sheet and statements of changes in financial position and profit and loss, together with a comparison of the actual
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budgeted results, each of the end of such Fiscal Year and prepared in accordance with Canadian generally accepted accounting principles applied on a consistent basis from time to time and certified by the President of the Corporation. The Shareholders agree to waive the right to receive audited financial statements as permitted in the Act; provided however, that a Shareholder may retract such waiver in respect of a fiscal year of the Corporation and prior to the commencement of such fiscal year if (i) such Shareholder agrees to pay the full incremental costs of conducting such audit; and (ii) such audit can be completed without unduly interfering with the business operations of the Corporation.
2.6 | Additional Financial Reporting |
The Corporation shall provide the Shareholders with the following data:
(a) Quarterly financial report, within 30 days of the end of each calendar quarter;
(b) 6 months balance sheet, income statement and cash flow statement for the Corporation, its Subsidiaries and on a consolidated basis, within 40 days after the end of each semester; and
(c) budget for the year including income statement balance sheet and cash flow statements and capital expenditure plans of the Corporation, its subsidiaries and on a consolidated basis, within thirty (30) days of the end of each fiscal year of the Corporation.
2.7 | Board of Directors Consent/Special Shareholder Approval Respecting Certain Matters |
Save and except as expressly provided in this Agreement, no action shall be taken by the Corporation in respect of any of the matters described below without prior Special Shareholder Approval, which approval shall be in addition to any other approvals that may be required by the Act;
(a) the approval of the Corporation's annual budget;
(b) any significant deviation from the Corporation's current business plan;
(c) any redemption or repurchase of Shares not effected on a pro-rata basis.
2.8 | Licensing of IP Almexin rights in the USA and Japan |
Any decisions with respect to the licensing of IP Annexin rights in the USA and Japan shall be on terms determined by Atreus Holdco; provided that:
(i) Atreus Holdco shall consult with AAA Holdco prior to any such agreement being entered into;
(ii) Atreus Holdco shall provide an execution copy of the proposed license agreement to AAA Holdco not less than fifteen (15) days prior to the execution of any such agreement, during which time AAA Holdco shall have the right to provide a written opinion thereon which shall be considered in good faith by Atreus Holdco; and
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(iii) The terms of such license agreement shall be commercially reasonable and consistent with the fiduciary obligations of the directors of the Corporation.
ARTICLE 3
RESTRICTIONS ON TRANSFER OF SHARES
3.1 | Restrictions on Transfer of Shares |
No Shareholder shall, except as expressly provided herein, directly or indirectly, sell assign or otherwise transfer or encumber by pledge, assignment, mortgage, charge or otherwise, any Shares from time to time held by it. Any attempted sale, assignment, transfer or other disposition of Shares in violation of this Agreement shall be void and of no force and effect and the Corporation shall not recognize any such attempted disposition.
A transfer of a controlling interest in AAA Holdco or Atreus Holdco shall be subject to the provisions of this Article 3.
3.2 | Pledge of Shares |
Each of the Shareholders may mortgage, hypothecate, pledge or charge its Shares to a commercial lending institution as security for an operating or term loan provided by that institution to the Corporation, provided that each of the Shareholders consents in advance to such transaction and provided further that the Person to whom such Shares are mortgage, hypothecated, pledge or charged agrees in writing to be bound by the provision of this Agreement with respect to such Shares and, in the event of the realization on such Shares, such Person shall become a party to this Agreement.
3.3 | Permitted Transfers |
Notwithstanding the terms of this Agreement, a Shareholder shall be entitled to sell, assign, transfer or otherwise dispose of all or any shares in the capital of the Corporation beneficially owned by such Shareholder to an Affiliate, provided that, prior to the completion of such sale, assignment, transfer or other disposition, the transferee agrees to be bound by the terms of this Agreement.
3.4 | Piggyback/ Drag-Along |
(a) | Offer - If an independent third party (the "Third Party") shall make a bona fide offer (the "Offer") to purchase all or a majority of the Shares of the Corporation which the holders of not less than sixty-six and two-thirds (66 2/3rds) of the Shares (the "Super Majority") wish to accept, then, the Super Majority shall give notice (the "Notice of Sale") to the other Shareholders (the "Other Shareholder(s)") specifying therein the number of Shares which Super Majority desires to sell (the "Offered Shares") and the terms upon which and the price at which it desires to sell the Offered Shares, including the identity of the proposed purchaser (the "Selling Price"). |
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(b) | Rejection, Third Party Sale and Piggyback - The Super Majority may, at any time and from time to time during the period of 90 days next following the delivery of the Notice of Sale, sell the Offered Shares to the Third Party at a price which is not less than the Selling Price and on terms not less favourable to the Super Majority than those set out in the Notice of Sale, provided that the Third Party shall have offered by notice given to each of the Other Shareholders to purchase from each of the Other Shareholders all the Shares owned by such of the Other Shareholders at the price and upon the terms and conditions set forth in the offer from the Third Party. |
(c) | Time for Sale - If the Super Majority does not effect a sale to the Third Party during the 90-day period referred to in paragraph (b), then the foregoing provisions hereof shall again apply thereto and so on from time to time. |
(d) | Drag-Along - In the event that any of the Other Shareholders do not wish to accept the Third Party offer under paragraph (b) above, the Super Majority may, if the Third Party Offer is an offer to acquire all of the Shares, by notice in writing given to the Other Shareholders who do not wish to sell at any time ten (l0) days or more prior to the expiry of the Offer, require the Other Shareholders to sell their Shares pursuant to the Offer at the same price specified in the Offer: |
Notwithstanding the foregoing, no Shareholder is required to comply with the terms of this Section 3.4 if:
(i) | consideration under the Offer is not payable in cash or securities of a publicly traded entity (or shares exchangeable into shares of a publicly traded entity); |
(ii) | the liability of such Shareholder under the purchase agreement in respect of the Offer (including, without limitation, liability for a breach of representation or warranty or for a claim under an indemnity) exceeds with respect to such Shareholder the lesser of such Shareholder's (A.) pro rata share of any claim; and (B,) the purchase price payable to such Investor; or |
(iii) | any representation and warranty to be given by a Shareholder is to be given on a joint and several basis. |
(e) | Power of Attorney - Each of the Other Shareholders hereby appoints, in the event that circumstances give rise to this Section 3.4, the President of the Corporation as the Shareholder's attorney, with full power of substitution, in the name of the Shareholder, to execute and deliver all deeds, transfers, assignments and assurances necessary to effectively transfer the interest being sold in the Corporation under this Section 3.4.Such appointment, being coupled with an interest, is irrevocable by each |
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Shareholder and shall not be revoked by the insolvency, bankruptcy, death incapacity, dissolution, liquidation or other termination of the existence of the Shareholder and the Shareholder agrees to ratify and confirm all that the Corporation may do or cause to be done pursuant to the foregoing. The Shareholder consents to any transfer of shares made pursuant to the foregoing.
3.5 | Right of First Refusal |
(a) | Unless the provisions of Section 3.4(d) apply, in the event that any Shareholder (hereinafter in this Section 3.5 referred to as the "Selling Shareholder") receives a bona fide offer from a person, firm or corporation dealing at arm's length with such Shareholder (including another Shareholder) (hereinafter in this Section 3 referred to as the "Offer") to purchase any or all of the Shares owned or controlled by the Selling Shareholder, which the Selling Shareholder is prepared to accept, then the Selling Shareholder shall forthwith give to the Corporation and to each of the other Shareholders who owns more than one percent (1%) of the outstanding Common Shares (hereinafter in this Section 3.5 referred to as the "Offeree Shareholders") notice in writing of its desire or intention to sell such Shares accompanied by a copy of the entire Offer which, without limiting the generality of the foregoing, shall fully identify the offeror. |
(b) | Such notice shall provide that the Corporation shall be entitled to purchase any or all of the offered Shares and each Offeree Shareholder shall be entitled to purchase such number of the offered Shares not purchased by the Corporation as nearly as may be in proportion to the number of Shares of the class of offered Shares held by it at the date of the Offer on the same terms as specified in the Offer and shall also state that any Offeree Shareholder who desires to purchase a number of Shares so offered in excess of its proportion shall in its reply state how many Shares in excess of its proportion it desires to purchase. Such notice shall also provide that if the Corporation or Offeree Shareholder do not accept such offer from the Selling Shareholder within thirty (30) days after the date of notice of the Offer, it will be deemed to have been declined. The Corporation shall notify the Selling Shareholder and each Offeree Shareholder within fifteen (15) days of receipt of notice of the Offer whether it intends to purchase any of the Shares. |
(c) | If all the Offeree Shareholders do not claim their respective proportions, the unclaimed Shares so offered shall be used for satisfying the claims of Offeree Shareholders for Shares in excess of their proportions and if the claims in excess are more than sufficient to exhaust such unclaimed Shares, the unclaimed Shares shall be divided pro rata among the Offeree Shareholders desiring excess Shares in proportion to their existing holdings of Shares of the class of offered Shares; provided that no Offeree Shareholder shall be bound to take any Shares in excess of the amount which it desires. |
(d) | If any Shares shall not be capable of being offered to or divided among the Offeree Shareholders in proportion to their existing holdings of Shares without |
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division into fractions of shares, the same shall be offered to or divided among the Offeree Shareholders as nearly as may be in proportion to the number of Shares of the class of offered Shares held by them respectively at the date of such Offer as may be determined by the Board.
(e) | If by the time limited by the Offer, the Corporation and the Offeree Shareholders have not agreed to purchase all the Shares offered thereby on the terms specified in the Offer, the Selling Shareholder shall be under no obligation to sell any Shares to the Corporation and the Offeree Shareholders or any of them and the Selling Shareholder may, within ninety (90) days from the date of the Offer, sell all and not less than all of the Shares specified in the Offer pursuant to the provisions of this Section 3.5 to the bona fide purchaser at a price not less than the share price set out in the Offer and on the other terms and conditions set out in the Offer; provided that such person or persons to whom the Selling Shareholder sells the Shares, contemporaneously with the purchase of such Shares, shall covenant and agree with all the other Shareholders to be bound by the terms and conditions of this Agreement as if it were an original party thereto by signing an acknowledgment to become bound by the terms of this Agreement. After the expiration of the said ninety (90) days, no sale of Shares shall be made except without again complying with the provisions of this Section 3.5. |
ARTICLE 4
ADDITIONAL ISSUE OF SHARES
4.1 | Pre-Emptive Right |
Subject to the provisions of Section 4.2 hereof, in the event the Corporation wishes at any time to issue any Shares (except for the granting of options to employees not to exceed 10% of the issued and outstanding shares of the Corporation) it shall offer them for purchase by the Shareholders by notice given to each Shareholder. Such notice shall be given within 10 days of the approval of the Board of Directors of a proposal to issue Shares to raise funds and shall set forth a description of the Shares to be offered, the purchase price and the purchase date which shall be a date not earlier than twenty (20) days after the date of such notice. Upon receipt of such notice, each such Shareholder shall have the right to subscribe for and purchase a number of such Shares determined by multiplying the total number of Share offered by a fraction, the numerator of which shall be the number of Common Shares owned by such Shareholder at the date of such notice and the denominator of which shall be the total number of Conunon Shares outstanding as at the date of such notice. Such right shall be exercised by the Shareholder by giving notice of acceptance to the Corporation within twenty (20) days after the receipt of the notice from the Corporation. In the event that the Shareholder does exercise such right it shall subscribe, purchase and pay for such Shares on the purchase date set forth in the notice of the Corporation. If all the Shareholders do not subscribe for their respective proportions, the unsubscribed Shares shall be used to satisfy the subscriptions of such Shareholders for Shares in excess of their proportion and,
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if the subscriptions in excess are more than sufficient to exhaust such unsubscribed Shares, the unsubscribed Shares shall be divided pro rata among the Shareholders desiring Shares as nearly as may be in proportion to the number of Common Shares held by them respectively at the date of such notice, but no Shareholder shall be bound to take any such Shares in excess of the amount it desires. It shall be a condition to the issuance of any new shares that the new Shareholder become party to this Agreement or, if agreed by the Board, another shareholder or share restriction agreement approved by the Board.
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4.2 | Right of AAA Holdco to Increase Shareholdings |
Notwithstanding the provisions of Section 4,1 hereof, and provided AAA Holdco and Exchangeco together own more than 50% of the Shares in Atreus and have no obligation to return Shares to the Corporation that would leave it with less than 50% of the Shares, AAA Holdco shall have the right, exercisable by a written offer to the Corporation, with a copy to Atreus Holdco, any time after the day which is eighteen (18) months after the date of this Agreement, to subscribe for such number of additional Common Shares to permit it to reach up to a 65% shareholding in the Corporation, at a price per share determined in AAA Holdco's sole discretion (the "AAA Holdco Offer"). In case such an offer is made in writing to the Corporation, the Corporation, and Atreus Holdco, shall have the right to find investors to subscribe to substantially the same amount of shares that are the subject matter of the AAA Holdco Offer at a price [*] higher than the price offered by AAA Holdco (the "Higher Price"), within [*] months from receipt by the Corporation of the AAA Holdco Offer. Atreus Holdco shall be permitted to disclose relevant information about the Corporation to prospective investors considering making an investment in the Corporation based on the AAA Holdco Offer, subject to the execution of a confidentiality and non-disclosure agreement in a form approved by AAA Holdco.
In case one or more investors place a bona fide binding offer at a Higher Price as set out above within the above mentioned [*] months period, then the investors' offer will be deemed accepted and the offering investor shall have the obligation to subscribe to the offered shares at a Higher Price and AAA Holdco shall have the right, but not the obligation, to subscribe to the same amount of shares that are the subject matter of the AAA Holdco Offer, at the Higher Price. In any case, AAA Holdco shall have the right to subscribe for additional shares at the Higher Price in order to maintain majority.
In case the Corporation and Atreus Holdco do not find other investors within the above mentioned [*] months period, then AAA Holdco shall have the right to complete the AAA Holdco Offer within [*] ([*]) days after the expiry of such [*] month period, and the Corporation shall fully cooperate in order to complete such transaction.
ARTICLE 5
PAYMENT AND CLOSING PROVISIONS
5.1 | Payment and Closing Provisions |
In the event of the sale of Shares as provided in Article 3 hereof, the party selling shall in this subsection 5.1 be called the "Vendor" and the party purchasing shall be in this subsection 5.1 be called the "Purchaser" and the following provisions shall apply:
Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.
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(a) Payment of Purchase Price and Delivery of Certificates - The purchase price shall be paid in such a manner as the Vendor and the Purchaser may agree or as specified pursuant to the relevant provision of this Agreement, as the case may be, against receipt by the Purchaser of the share certificate or certificates representing the Shares being purchased and sold, duly endorsed in blank for transfer together with signed and dated resignations by the Vendor or its nominee as a director and officer of the Corporation.
(b) Closing - closing shall take place at 10:00 a.m. on the closing date at the office of the solicitors for the Corporation.
(c) Title - The Vendor shall warrant that it has good and marketable title to the Shares being sold subject only to the terms of this Agreement, and shall deliver to the Purchaser all such documents, instruments and releases and shall take all such steps and do all such acts and things as may be necessary or desirable to vest title in the Shares to the Purchaser and the Purchaser shall be bound by all the terms of this Agreement as if he had been a party hereto.
(d) Failure to Complete Sale - If on the date of closing the Vendor shall have failed, neglected or refused to complete the sale, the Purchaser shall have the right to deposit the purchase price for the account of the Vendor in the Corporation's bank and thereafter to execute and deliver such deeds, transfers of share certificates, resignations, releases and other documents that may be necessary or desirable in order to complete the transaction with respect to such purchase; and the Purchaser is hereby irrevocably constituted and appointed as the attorney of the Vendor to so execute and deliver.
(e) Vendor Indebted to Corporation - If at the time of such sale the Vendor shall be indebted to the Corporation, the Purchaser shall at the Vendor's option pay, satisfy and discharge such indebtedness out of the purchase price payable for the Shares.
(f) Assignment of Indebtedness - If at the time of sale the Corporation shall be indebted to the Vendor, the Purchaser shall, at the Vendor's option, upon the closing of such sale, purchase from the Vendor that proportion of the indebtedness that the number of Shares to be sold bears to the total number of Shares held by the Vendor for a price equal to the amount thereof and shall pay such price to the Vendor on closing by certified cheque against the delivery of a valid assignment to the Purchaser of such indebtedness. Alternatively, if the Purchaser and the non-selling Shareholders if any agree, the Purchaser may cause the Corporation to repay such indebtedness or portion thereof to the Vendor.
(g) Liability as Guarantor - If at the time of sale, the Vendor shall be liable or responsible as a guarantor for any debts, liabilities or obligations of the Corporation, the Purchaser shall use its best efforts to cause any and all such guarantees to be released on or before the date of closing and, in the event that the Purchaser shall be unable to deliver up such guarantees, the Purchaser shall indemnify and save harmless the Vendor from all claims arising out of such guarantees.
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(h) Payment of Declared Dividends - Prior to the closing of any sale of Shares any declared and unpaid dividends in respect of the Shares to be sold shall be paid in full to the Vendor
ARTICLE 6
CONFIDENTIALITY
6.1 | Confidentiality |
For so long as the Corporation carries on business, each Shareholder shall keep confidential any trade secret, patent, know-how or secret, technical expertise, customer list or non-public information of any sort relating to the business carried on by the Corporation, as may from time to time be acquired by it by virtue of being a Shareholder, officer, agent, director or employee of the Corporation, and shall use its best efforts to prevent communication of such information to others, even after such Shareholder ceases to own, directly or indirectly, Shares, provided that a party's obligations to disclose information requested pursuant to applicable laws shall supersede its obligations pursuant to this provision. The provisions hereof are in addition to and not in substitution for any confidentiality agreement executed by any party hereto.
ARTICLE 7
GENERAL
7.1 | Share Certificates |
All certificates representing Shares shall have endorsed thereon the following notation:
"The shares represented by this certificate are subject to the terms of a Shareholders Agreement dated ■ as amended from time to time, among the shareholders of the Corporation and the Corporation and others. Such shares may not be sold, transferred, pledged, hypothecated or otherwise disposed of except in accordance with the provisions thereof herewith."
7.2 | Assignment and Enurement |
This Agreement is not assignable by any party except insofar as its benefit and burden pass with the Shares transferred in accordance with the provisions of this Agreement. This Agreement shall enure to the benefit of and be binding upon the successors and permitted assigns of the parties hereto.
7.3 | Notices |
Any instrument, notice, consent, request or election required or permitted to be given under this Agreement shall be in writing and delivered personally or transmitted by telecopier or other form of recorded communication or, except in the event of disruption or threatened disruption of postal service, mailed by prepaid registered mail addressed to the party to whom it is to be given at his address as shown below and such notice shall be deemed to have been given on the next day after delivery or transmission or on the fourth business day after mailing as aforesaid, as the case may be,
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if to AAA Holdco or Exchangeco: | ■ | |
■ | ||
Attention: | ■ | |
Fax: | ■ | |
if to Atreus Holdco: | ■ | |
■ | ||
Attention: | ■ | |
Fax: | ■ | |
if to the Corporation: | ||
Attention: | ■ | |
Fax | ■ |
Notice of change of address may be given to any party in the same manner.
7.4 | Time of Essence |
Time shall be of the essence of this Agreement.
7.5 | Further Assurances |
The parties hereto hereby' agree to execute or cause to be executed such other documents, instruments and certificates as may be required to effectively carry out the terms and conditions of this Agreement.
7.6 | CounterpaIis |
This Agreement may be executed in one or more counterparts each of which shall be deemed to be an original and such counterparts together shall constitute but one and the same instrument.
7.7 | Waivers - In this Agreement: |
(a) Not a Waiver of Other Rights - A waiver by any party of its rights hereunder or of the performance by any other party of any of its obligations hereunder shall be without prejudice to all or any of the other rights hereunder of the party so waiving and shall not constitute a waiver of any other such rights or, in any other instances, of the rights so waived or a waiver of performance by the party of any of its other obligations hereunder or the performance, in any other instance, of the obligations so waived.
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(b) In Writing - No waiver on behalf of any party of the breach of any of the covenants, conditions and provisions herein contained shall be effective or binding upon such other party unless the same shall be expressed in writing.
7.8 | Termination |
This Agreement terminates upon the first to occur of:
(a) the date this Agreement is terminated by the written approval by Shareholders holding at least sixty-six and two-thirds percent (66 2/3%) of the outstanding shares of the Corporation;
(b) the date that is immediately prior to a Public Offering by the Corporation;
(c) the date that the Corporation is wound-up, liquidated or dissolved, whether voluntarily or involuntarily; and
(d) that date that one Person becomes the beneficial owner of all of the Shares.
7.9 | Amendment |
No amendment, supplement or modification of this Agreement and, unless otherwise specified, no waiver, consent or approval by any Party, is binding unless approved by the Board, and approved in writing by Shareholders holding at least sixty-six and two-thirds percent (66 2/3 %) of the outstanding shares of the Corporation and any amendment, supplement, modification, waiver, consent or approval so approved shall be binding upon each of the Parties, but only if no Shareholder, without its consent, is materially and adversely affected by any such amendment, supplement, modification, waiver, consent or approval in any maimer in which the other Shareholders are not likewise adversely affected.
7.10 | Facsimile Delivery |
This Agreement may be delivered upon the provision of telefaxed execution pages provided that the party delivering such telefaxed execution pages shall as soon as practicable thereafter deliver to the other parties an originally executed execution page.
[The remainder of this page has been left blank intentionally}
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IN WITNESS WHEREOF the parties hereto have executed this Agreement on the date set out above.
ADVANCED ACCELERATOR | ||
APPLICATIONS CANADA INC. | ||
By: | /s/ Stefano Buono | |
Name: | Stefano Buono | |
Title: | President |
4549694 CANADA INC. | ||
By: | /s/ Stefano Buono | |
Name: | Stefano Buono | |
Title: | President |
7329563 CANADA INC. | ||
By: | /s/ William J. Dickie |
Name: William J. Dickie | ||
Title: Director | ||
ATREUS PHARMACEUTICALS | ||
CORPORATION |
By: | /s/ William J. Dickie |
Name: William J. Dickie | ||
Title: Director |
~ 18 ~ |
Exhibit 10.8
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
[*] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION.
SHARE PURCHASE AGREEMENT
|
Made as of December 18, 2014
TABLE OF CONTENTS
Article 1 INTERPRETATION | 1 | |
1.1 | General Definitions | 1 |
1.2 | Headings, etc. | 7 |
1.3 | Number, etc. | 7 |
1.4 | Currency | 7 |
1.5 | Accounting Principles | 7 |
1.6 | Additional Rules of Interpretation | 7 |
1.7 | Knowledge | 8 |
1.8 | Schedules | 8 |
1.9 | Taxes | 8 |
Article 2 PURCHASE AND SALE | 8 | |
2.1 | Agreement of Purchase and Sale | 8 |
2.2 | Purchase Price | 8 |
2.3 | Payment of Purchase Price | 8 |
2.4 | Determination and Payment of Royalty Amounts | 9 |
2.5 | Anniversary Payments | 11 |
2.6 | Manner of Payments | 11 |
2.7 | Termination | 11 |
Article 3 REPRESENTATIONS AND WARRANTIES OF THE SELLER AND RELATING TO THE CORPORATION | 12 | |
3.1 | Seller’s Representations and Warranties | 12 |
3.2 | Representations and Warranties relating to the Corporation | 13 |
3.3 | Non-Waiver | 18 |
Article 4 PURCHASER’S REPRESENTATIONS AND WARRANTIES | 19 | |
4.1 | Purchaser’s Representations and Warranties | 19 |
4.2 | Non-Waiver | 20 |
Article 5 INDEMNIFICATION | 20 | |
5.1 | Non-Merger and Exclusive Remedy | 20 |
5.2 | Indemnification by Seller | 20 |
5.3 | Indemnification by the Purchaser | 20 |
5.4 | Time Limitations | 21 |
5.5 | Limitations on Amount | 22 |
5.6 | Limited Recourse | 22 |
5.7 | Notice of Third Party Claims | 22 |
5.8 | Defence of Third Party Claims | 22 |
5.9 | Assistance for Third Party Claims | 23 |
5.10 | Settlement of Third Party Claims | 23 |
5.11 | Direct Claims | 23 |
5.12 | Failure to Give Timely Notice | 24 |
5.13 | Set-off | 24 |
5.14 | Reductions and Subrogation | 24 |
5.15 | Tax Effect | 24 |
5.16 | Additional Rules and Procedures | 24 |
Article 6 CLOSING ARRANGEMENTS | 25 | |
6.1 | Date, Place and Time of Closing | 25 |
6.2 | Closing Deliveries of the Seller | 25 |
6.3 | Closing Deliveries of the Purchaser | 26 |
Article 7 GENERAL | 26 | |
7.1 | Further Assurances | 26 |
7.2 | Costs and Expenses | 26 |
7.3 | Public Announcements | 26 |
7.4 | Assignment | 26 |
7.5 | Notices | 27 |
7.6 | Governing Law | 28 |
7.7 | Benefit of Agreement | 28 |
7.8 | Amendment and Waiver | 28 |
7.9 | Entire Agreement | 28 |
7.10 | Severability | 28 |
7.11 | Counterparts and Execution by Electronic Means | 29 |
2 |
SHARE PURCHASE AGREEMENT
THIS SHARE PURCHASE AGREEMENT is made as of the 18th day of December, 2014 between 7329563 Canada Inc. (the “Seller”), a corporation incorporated under the Canada Business Corporations Act, and Advanced Accelerator Applications International S.A. (the “Purchaser”), a corporation incorporated under the laws of Switzerland and Advanced Accelerator Applications S.A. (“Parent”), a corporation incorporated under the laws of France.
RECITALS:
WHEREAS Atreus Pharmaceuticals Corporation (the “Corporation”) is a corporation incorporated under the Canada Business Corporations Act;
AND WHEREAS the Seller is the owner of 499 Common Shares in capital of the Corporation (the “Purchased Shares”);
AND WHEREAS members of the Purchaser Group (as hereinafter defined) are the owners of 501 Common Shares in the capital of the Corporation;
AND WHEREAS the Seller wishes to sell and the Buyer wishes to buy from the Seller the Purchased Shares;
AND WHEREAS the Parties desire to make certain representations, warranties and agreements in connection with the transactions contemplated by this Agreement;
NOW THEREFORE THIS AGREEMENT WITNESSES that in consideration of the premises and the mutual covenants and agreements herein contained the Parties hereto covenant and agree as follows:
Article 1
INTERPRETATION
1.1 | General Definitions |
In this Agreement (including the recitals hereto), unless something in the subject matter or context is inconsistent therewith, the following terms have the following meanings:
(a) | “Accounting Firm” has the meaning set forth in Section 2.4(c); |
(b) | “Affiliate” has the meaning given to that term in the Canada Business Corporations Act; |
(c) | “Agreement” means this agreement and all Schedules annexed hereto, as amended from time to time; |
(d) | “Annexin” means all forms of annexin developed and marketed by the Corporation or, from and after the date hereof, any other member of the Purchaser Group from time to time; |
(e) | “Annexin Sales” shall mean, with respect to the applicable period, all gross revenue actually received by the Corporation and the Purchaser Group |
(determined on a consolidated basis) from Annexin, determined in accordance with IFRS, but shall not include the following items (to the extent that they pertain to the making, using, importing or selling of Annexin, are otherwise included in gross revenue, and are separately billed):
(i) | import, export, excise and sales taxes, and custom duties; |
(ii) | costs of insurance, packing and transportation from the place of manufacture to the customer's premises; and |
(iii) | credit for returns, allowances or trades; |
(f) | “Anniversary Payment” has the meaning set forth in Section 2.5; |
(g) | “Annual Financial Statements” means the unaudited financial statements of the Corporation as, at and for the financial year ended December 31, 2013, a copy of which are attached hereto as Schedule “A”; |
(h) | “Annual Royalty Amount” has the meaning set forth in Section 2.4(c); |
(i) | “Approval Date” means the earlier of the First Milestone Approval Date and the Second Milestone Approval Date; |
(j) | “Benefit Plan” means any plan providing for profit sharing, deferred compensation, incentives, health, dental, welfare, bonuses, retirement, unemployment compensation, insurance, severance, sick leave or vacation, or any other employee benefit plan of a similar nature, that is sponsored or maintained by or contributed to or required to be contributed to by the Corporation for the benefit of any of its employees, former employees or beneficiaries of any of them, whether or not insured (except, that, the term “Benefit Plan” shall not include any statutory plans with which the Corporation is required to comply, including the Canada/Quebec Pension Plan or plans administered pursuant to applicable provincial health tax, workers’ compensation, workers’ safety and insurance or employment insurance legislation); |
(k) | “Business” when used in relation to the Corporation means the business of developing and selling Annexin-based imaging agents; |
(l) | “Business Day” means any day except Saturday, Sunday or any statutory holiday in the Province of Ontario; |
(m) | “Claim” means any act, omission or state of facts, and any legal proceeding, assessment, judgment, settlement or compromise relating thereto, which may give rise to a right to indemnification under Article 5; |
(n) | “Closing Date” means the date hereof; |
(o) | “Closing Date Payment” means CHF 318,955; |
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(p) | “Closing Time” means 1:00 p.m. in the City of Ottawa on the Closing Date or such other time on the Closing Date as the Parties may agree in writing that the Closing will take place; |
(q) | “Contract” means any written, oral, implied or other agreement, contract, understanding, instrument, note, guarantee, indemnity, representation, warranty, deed, assignment, power of attorney, certificate, commitment, covenant, assurance or undertaking of any nature; |
(r) | “Corporation” has the meaning set forth in the recitals; |
(s) | “Defending Party” has the meaning set forth in Section 5.9; |
(t) | “Direct Claim” has the meaning set forth in Section 5.11; |
(u) | “Disclosure Schedule” means the schedule of exceptions annexed hereto as Schedule “C”; |
(v) | “EMA” means the European Medicines Agency; |
(w) | “Encumbrance” means any mortgage, charge, easement, encroachment, lien, adverse claim, restrictive covenant, assignment by way of security, security interest of any nature, servitude, pledge, hypothecation, security agreement, title retention agreement, right of occupation, option or privilege or any agreement to create any of the foregoing; |
(x) | “FDA” means the U.S. Food and Drug Administration; |
(y) | “Final Fiscal Year” has the meaning set forth in Section 2.4(c); |
(z) | “Financial Statements” means, collectively, the Annual Financial Statements and the Interim Financial Statements; |
(aa) | “First Milestone Amount” has the meaning set forth in Section 2.3(b); |
(bb) | “First Milestone Approval Date” means the date upon which the Corporation satisfies the First Milestone Condition; |
(cc) | “First Milestone Condition” means the Corporation obtaining first indication market approval for Annexin in the United States by the FDA; |
(dd) | “Fourth Milestone Amount” has the meaning set forth in Section 2.3(e); |
(ee) | “Fourth Milestone Condition” means the Corporation obtaining second indication market approval for Annexin across Europe by the EMA; |
(ff) | “Fundamental Representations” has the meaning set forth in Section 5.4(b)(i); |
(gg) | “Governmental Authority” means any domestic or foreign government, whether federal, provincial, state, territorial or municipal; and any governmental agency, |
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ministry, department, Tribunal, commission, bureau, board or other similar instrumentality;
(hh) | “IFRS” means International Financial Reporting Standards in effect at the applicable date of determination; |
(ii) | “Income Tax Act” means, collectively, the Income Tax Act, R.S.C. 1985, c. 1 (5th Supp.), the Income Tax Application Rules, R.S.C. 1985, c. 2 (5th Supp.), and the Income Tax Regulations, C.R.C., c. 945, in each case as amended from time to time; |
(jj) | “Indemnitee” means any Party entitled to indemnification under Article 5 of this Agreement; |
(kk) | “Indemnitor” means any Party obligated to provide indemnification under Article 5 of this Agreement; |
(ll) | “Indemnity Payment” has the meaning set forth in Section 5.14; |
(mm) | “Initial Royalty Amount” has the meaning set forth in Section 2.4(b)(i); |
(nn) | “Insiders” of a corporation means directors, officers, holders of more than 5% of the corporation’s shares, or employees of the corporation, or any other person not dealing at arm’s length (as such term is defined in the Income Tax Act) with the corporation or any Affiliate or associate (as such terms is defined in the Canada Business Corporations Act) of any of the foregoing; |
(oo) | “Intellectual Property” means any and all of the following and all proprietary, intellectual property and other rights in, arising out of or associated with: |
(i) all patents and utility models and applications therefor (including without limitation provisionals) and all equivalent or similar rights anywhere in the world in inventions and discoveries including without limitation, invention disclosures;
(ii) all registered and unregistered trade-marks, service marks, trade names, trade dress, logos, business, corporate and product names and slogans and registrations and applications for registration thereof (including intent-to-use applications);
(iii) all copyrights in copyrightable works, and all other rights of authorship, worldwide, and all applications, registrations and renewals in connection therewith;
(iv) all maskworks, maskwork registrations and applications therefor, and any equivalent or similar rights in semiconductor masks, layouts, architectures or topologies;
(v) all design patents, design registrations, pending patent and design applications and rights to file applications for the designs,
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including all rights of priority and rights in continuations, continuations-in-part, divisions, reexaminations, reissues and other derivative applications and patents; and
(vi) all Internet or World Wide Web addresses, domain names and sites and applications and registrations therefor;
(pp) | “Interim Financial Statements” means the unaudited interim financial statements of the Corporation as, at and for the period ending September 30, 2014; provided that if Closing has not occurred by January 15, 2015, the Interim Financial Statements will be prepared as, at and for the period ending December 31, 2014, a copy of which are attached hereto as Schedule “B”; |
(qq) | “Interim Financial Statement Date” means the date of the Interim Financial Statements; |
(rr) | “Investment Date” means February 12, 2010, being the effective date of a purchase agreement by and among the Corporation, the Seller, the Parent and other parties; |
(ss) | “Loss” means any loss, liability, damage, cost, expense, charge, fine, penalty or assessment, resulting from or arising out of any Claim, including the costs and expenses of any legal proceeding, assessment, judgment, settlement or compromise relating thereto and all interest, punitive damages, fines and penalties and reasonable legal fees and expenses incurred in connection therewith; |
(tt) | “Material Adverse Change” in relation to the Corporation means a change in the business, operations, capital, properties, assets, prospects or condition, financial or otherwise, of the Corporation that materially and adversely affects or could reasonably be expected to have a material and adverse effect on the Corporation, the Business or the value of the securities of the Corporation; |
(uu) | “Milestone Amounts” means collectively, the First Milestone Amount, the Second Milestone Amount, the Third Milestone Amount and the Fourth Milestone Amount; |
(vv) | “Notice Period” has the meaning set forth in Section 5.8; |
(ww) | “Parties” means the Purchaser and the Seller collectively, and “Party” means any one of them; |
(xx) | “Purchase Price” has the meaning set forth in Section 2.2; |
(yy) | “Purchased Shares” has the meaning set forth in the recitals; |
(zz) | “Purchaser” has the meaning set forth in the preamble; |
(aaa) | “Purchaser Group” means the Purchaser and its Affiliates; |
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(bbb) | “Royalty Amount” has the meaning set forth in Section 2.4; |
(ccc) | “Royalty Period End Date” means the tenth (10th) anniversary of the later of the First Milestone Approval Date and the Second Milestone Approval Date; |
(ddd) | “Royalty Report” has the meaning set forth in Section 2.4(c); |
(eee) | “Second Milestone Amount” has the meaning set forth in Section 2.3(c); |
(fff) | “Second Milestone Approval Date” means the date upon which the Corporation satisfies the Second Milestone Condition; |
(ggg) | “Second Milestone Condition” means the Corporation obtaining first indication market approval for Annexin across Europe by the EMA; |
(hhh) | “Seller” has the meaning set forth in the preamble; |
(iii) | “Shareholders Agreement” has the meaning set forth in Section 6.2(f); |
(jjj) | “Stanford Agreement” means the License Agreement effective June 1, 2008 between the Board of Trustees of the Leland Stanford Junior University and the Corporation, as amended by Amendment No. 1 effective as of December 17, 2009, as further amended by Amendment No. 2 effective as of August 17, 2010 and as further amended by Amendment No. 3 effective as of November 20, 2013 between the same parties; |
(kkk) | “Subsequent Royalty Amount” has the meaning set forth in Section 2.4(b)(ii); |
(lll) | “Tax Legislation” means collectively, the Income Tax Act, the United States Internal Revenue Code of 1986, as amended, and all federal, provincial, state, municipal, county, territorial or other tax statutes including all treaties, conventions, case law, interpretation bulletins, circulars and releases, rules, regulations, orders and decrees of any jurisdiction; |
(mmm) | “Tax Returns” means all reports, elections, returns and other documents required to be filed under the provisions of any applicable Tax Legislation and any tax forms required to be filed, whether in connection with a tax return or not, under any provisions of any applicable Tax Legislation; |
(nnn) | “Tax” or “Taxes” means all taxes, assessments, charges, dues, duties, rates, fees, imposts, levies and similar charges of any kind lawfully levied, assessed or imposed by any Governmental Authority under any applicable Tax Legislation, including, Canadian federal, provincial, territorial, municipal and local, foreign or other income, capital, goods and services, sales, use, consumption, excise, value-added, business, real property, personal property, transfer, franchise, withholding, payroll, or employer health taxes, customs, import, anti-dumping or countervailing duties, Canada Pension Plan contributions, provincial pension plan contributions, employment insurance premiums, and provincial workers’ compensation payments, including any interest, penalties and fines associated therewith; |
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(ooo) | “Third Milestone Amount” has the meaning set forth in Section 2.3(d); |
(ppp) | “Third Milestone Condition” means the Corporation obtaining second indication market approval for Annexin in the United States by the FDA; |
(qqq) | “Third Party Claim” has the meaning set forth in Section 5.6; |
(rrr) | “Tribunal” means any court (including a court of equity), arbitrator or arbitration panel and any other Governmental Authority, stock exchange, professional or business organization or association or other body exercising adjudicative, regulatory, judicial or quasi-judicial powers. |
1.2 | Headings, etc. |
The division of this Agreement into Articles, Sections, subsections, paragraphs, subparagraphs and clauses and the insertion of headings are for the convenience of reference only and shall not affect the construction or interpretation of this Agreement. The terms “this Agreement”, “hereof”, “hereunder” and similar expressions refer to this Agreement and not to any particular Article, Section, subsection, paragraph, subparagraph, clause or other portion hereof and include any agreement or instrument supplemental or ancillary hereto.
1.3 | Number, etc. |
Words importing the singular number only shall include the plural and vice versa, and words importing the masculine gender shall include the feminine and neutral genders and vice versa.
1.4 | Currency |
Unless otherwise indicated all dollar amounts referred to in this Agreement, including the symbol “CHF”, refer to Swiss Francs.
1.5 | Accounting Principles |
Wherever in this Agreement reference is made to “generally accepted accounting principles” or “GAAP”, such reference shall be to the generally accepted accounting principles in effect in Canada at the date of determination as recommended in Part II – Accounting Standards for Private Enterprises of the Handbook of Chartered Professional Accountants of Canada and consistently applied.
1.6 | Additional Rules of Interpretation |
(a) | Persons - Unless the context otherwise requires, references in this Agreement to a “person” are to be broadly interpreted and shall include an individual (whether acting as an executor, administrator, legal representative or otherwise), body corporate, unlimited liability company, partnership, limited liability partnership, joint venture, trust, unincorporated association, unincorporated syndicate, any Governmental Authority and any other legal or business entity. |
(b) | Trade Meanings - Unless otherwise defined herein, words or abbreviations that have well-known trade meanings are used herein with those meanings. |
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1.7 | Knowledge |
Where any representation, warranty or other statement in this Agreement is expressed to be made by a Party to its knowledge or is otherwise expressed to be limited in scope to matters known to such Party or of which such Party is aware, it shall mean such knowledge as is actually known to the officers or employees of such Party who have overall responsibility for or knowledge of the matters relevant to such statement, and such Party hereby confirms that it has made reasonable inquiries of such officers and employees.
1.8 | Schedules |
The following are the Schedules annexed hereto and incorporated in this Agreement by reference and deemed to be part hereof:
Schedule “A” | - | Annual Financial Statements |
Schedule “B” | - | Interim Financial Statements |
Schedule “C” | - | Disclosure Schedule |
1.9 | Taxes |
Subject to any taxes required to be withheld by the Purchaser, in accordance with applicable laws, from the Purchase Price Payments to be made hereunder, the Purchaser shall not deduct any non-Canadian taxes from the Purchase Price payments hereunder due to the Seller.
Article 2
PURCHASE AND SALE
2.1 | Agreement of Purchase and Sale |
Subject to the terms and conditions of this Agreement, at the Closing Time the Seller shall sell to the Purchaser, and the Purchaser shall purchase from the Seller, all of the Purchased Shares.
2.2 | Purchase Price |
The aggregate consideration to be paid for the Purchased Shares (the “Purchase Price”) shall be an amount equal to (i) the Closing Date Payment, plus (ii) the aggregate of all Anniversary Payments (if any) made pursuant to Section 2.5, plus (iii) the Milestone Amounts (if any), plus (iv) the Initial Royalty Amount (if any), plus (v) the Subsequent Royalty Amount (if any).
2.3 | Payment of Purchase Price |
The Purchaser shall pay and satisfy the Purchase Price as follows:
(a) | at the Closing Time, the Purchaser shall pay to the Seller the Closing Date Payment; |
(b) | within ten (10) Business Days of the satisfaction of the First Milestone Condition by the Corporation, the Purchaser shall pay to the Seller, by wire transfer of immediately available funds to an account designated in writing by the Seller at least two (2) Business Days prior to such payment, an amount equal to CHF |
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387,303 less the aggregate of the Closing Date Payment and any Anniversary Payments previously paid by the Purchaser to the Seller and not previously deducted from the payment of the Second Milestone Amount (the “First Milestone Amount”);
(c) | within ten (10) Business Days of the satisfaction of the Second Milestone Condition by the Corporation, the Purchaser shall pay to the Seller, by wire transfer of immediately available funds to an account designated in writing by the Seller at least two (2) Business Days prior to such payment, an amount equal to CHF 387,303 less the aggregate of the Closing Date Payment and any Anniversary Payments previously paid by the Purchaser to the Seller and not previously deducted from the payment of the First Milestone Amount (the “Second Milestone Amount”); |
(d) | within ten (10) Business Days of the satisfaction of the Third Milestone Condition by the Corporation, the Purchaser shall pay to the Seller, by wire transfer of immediately available funds to an account designated in writing by the Seller at least two (2) Business Days prior to such payment, an amount equal to CHF 592,345 less the aggregate of the Closing Date Payment and any Anniversary Payments previously paid by the Purchaser to the Seller and not previously deducted from the payment of the First Milestone Amount and/or the Second Milestone Amount and/or the Fourth Milestone Amount (the “Third Milestone Amount”); |
(e) | within ten (10) Business Days of the satisfaction of the Fourth Milestone Condition by the Corporation, the Purchaser shall pay to the Seller, by wire transfer of immediately available funds to an account designated in writing by the Seller at least two (2) Business Days prior to such payment, an amount equal to CHF 592,345 less the aggregate of the Closing Date Payment and any Anniversary Payments previously paid by the Purchaser to the Seller and not previously deducted from the payment of the First Milestone Amount, the Second Milestone Amount and/or the Third Milestone Amount (the “Fourth Milestone Amount”); |
(f) | the Purchaser shall pay to the Seller, in accordance with Section 2.4, the Initial Royalty Amount, if any, less the aggregate of any Anniversary Payments previously paid by the Purchaser to the Seller and not deducted from the payment of the Milestone Amounts; and |
(g) | the Purchaser shall pay to the Seller, in accordance with Section 2.4, the Subsequent Royalty Amount, if any, less the aggregate of any Anniversary Payments previously paid by the Purchaser to the Seller and not deducted from the payment of the Milestone Amounts. |
2.4 | Determination and Payment of Royalty Amounts |
The Purchaser shall make payment to the Seller in an aggregate amount (the “Royalty Amount”), calculated, if any, as follows:
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(a) | Following the Approval Date, the Purchaser shall determine the amount, if any, of the Royalty Amount, based on the cumulative Annexin Sales as follows: |
(i) | the Purchaser shall pay a royalty to the Seller on all Annexin Sales in the United States of America from the First Milestone Approval Date until the tenth (10th) anniversary of the First Milestone Approval Date; |
(ii) | the Purchaser shall pay a royalty to the Seller on all Annexin Sales in Europe from the Second Milestone Date until the tenth (10th) anniversary of the Second Milestone Approval Date; and |
(iii) | the Purchaser shall pay a royalty to the Seller on all Annexin Sales worldwide (excluding the United States and the European Union) from the Approval Date to the tenth (10th) anniversary of the Approval Date. |
(b) | The Royalty Amount shall be equal to: |
(i) | an amount equal to [*]% of the first cumulative CHF 91.13 million of Annexin Sales, determined in accordance with Section 2.3(a), following the Approval Date, to a maximum of CHF [*] (the “Initial Royalty Amount”); plus |
(ii) | an amount equal to [*]% of all Annexin Sales, determined in accordance with Section 2.3(a), in excess of CHF 91.13 million in aggregate, if any, until the Royalty Period End Date (the “Subsequent Royalty Amount”). |
(c) | Within ninety (90) days of the end of each fiscal year of the Corporation, commencing with the fiscal year in which the Approval Date occurs and ending with the fiscal year in which the Royalty Period End Date occurs (the “Final Fiscal Year”), the Purchaser shall provide the Seller with a report setting forth the number, description and aggregate Annexin Sales during the most recently completed fiscal year of the Corporation, or in the case of the Final Fiscal Year the Annexin Sales from January 1 of the Final Fiscal Year to the Royalty Period End Date (in each case a “Royalty Report”) for purposes of establishing any amounts to be paid in accordance with this Section 2.4, together with an amount equal to the Purchaser’s determination of the amount of the Royalty Amount to be paid for the particular fiscal year (the “Annual Royalty Amount”). The Purchaser shall cause the Corporation and any other member of the Purchaser Group to maintain its records relating to its determination of an Annual Royalty Amount for a period of three years from the date of the applicable Royalty Report. |
(d) | In the event the Seller objects to the Annual Royalty Amount, the Seller shall deliver written notice of such objection to Purchaser within thirty (30) days of the Seller’s receipt of a Royalty Report. If the Seller does not notify the Purchaser of any dispute within such thirty (30) day period, the Annual Royalty Amount set forth in the Royalty Report shall be deemed to binding on the Parties. The Seller and the Purchaser shall attempt in good faith to resolve any such dispute as promptly as practicable. If the Seller and Purchaser are unable to resolve any dispute regarding the calculation of the Annual Royalty Amount |
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within ten (10) days (or such longer period as the Purchaser and the Seller shall mutually agree in writing) of the Seller’s notice of a dispute, the Parties shall engage a mutually agreeable nationally-recognized accounting firm (the “Accounting Firm”) to resolve all issues having a bearing on such dispute and such resolution shall be final and binding on the Parties. The Accounting Firm shall deliver a statement setting forth its own calculation of the Annual Royalty Amount (determined in accordance with this Agreement) to the Parties within thirty (30) days of the submission of the matter to such firm. The fees and expenses of the Accounting Firm in resolving such dispute shall be borne by the Seller, unless the Accounting Firm determination of the Annual Royalty Amount is greater than 105% of the Purchaser’s determination of the Annual Royalty Amount, in which case the fees and expenses of the Accounting Firm shall be borne by the Purchaser.
(e) | Within ten (10) Business Days after the final determination of an Annual Royalty Amount in accordance with Section 2.4(d) the Purchaser shall pay to the Seller the excess of the Annual Royalty Amount as finally determined over the payment made in Section 2.4(c), if any, or the Seller shall pay to the Purchaser the excess of the payment made in Section 2.4(c) over the Annual Royalty Amount as finally determined, if any, as the case may be, by wire transfer of immediately available funds to an account designated in writing by the payee at least two (2) Business Days prior to such payment. |
2.5 | Anniversary Payments |
On each anniversary of the Closing Date and prior to the Approval Date, the Purchaser shall pay the Seller an amount equal to CHF 318,955 (each such payment being an “Anniversary Payment”).
2.6 | Manner of Payments |
All payments required to be made by the Purchaser to or to the order of the Seller under this Article 2 shall be made in Swiss Francs.
2.7 | Termination |
If the Purchaser Group abandons the development and marketing of Annexin and provides written evidence of such abandonment, this Agreement may be terminated at any time thereafter, in the sole and absolute discretion of the Purchaser, by providing thirty (30) days’ prior written notice to the Seller. In the event that the Purchaser exercises its right to terminate this Agreement the Parties will be discharged from any further obligations under this Agreement except that:
(a) | all Purchase Price payments due to the date of termination shall become immediately due and payable by the Purchaser to the Seller; provided that if the Approval Date has not yet occurred when this Agreement is terminated the Purchaser shall not be required to pay a pro rata amount of the upcoming Anniversary Payment; |
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(b) | the Purchaser shall cause the Corporation to use its commercially reasonable efforts to assign all of its rights and obligations under the Stanford Agreement to the Seller; |
(c) | the Purchaser shall cause the Corporation to deliver all materials, regulatory documents, protocols and any other property of the Corporation pertaining to the development of Annexin to the Seller and all Intellectual Property of the Corporation or the Purchaser Group pertaining to Annexin; and |
(d) | each Party’s respective obligations under Section 7.2 and Section 7.3 will continue indefinitely. |
Article 3
REPRESENTATIONS AND WARRANTIES OF THE SELLER AND RELATING TO THE CORPORATION
3.1 | Seller’s Representations and Warranties |
The Seller represents and warrants to the Purchaser as follows, and acknowledges that the Purchaser is relying on such representations and warranties in connection with the transactions contemplated herein, including, without limitation, the purchase of the Purchased Shares:
(a) | Incorporation of the Seller. |
The Seller is duly incorporated, organized and subsisting under the laws of Canada . No proceedings have been taken or authorized by the Seller or by any other person with respect to the bankruptcy, insolvency, liquidation, dissolution or winding up of the Seller or with respect to any amalgamation, merger, consolidation, arrangement or reorganization of, or relating to, the Seller nor, to the knowledge of the Seller, have any such proceedings been threatened by any other person.
(b) | Authorization of Transaction by Seller. |
The Seller has the corporate power, authority and capacity to execute and deliver this Agreement, to hold the Purchased Shares and to perform its other obligations hereunder. The execution and delivery of this Agreement and the completion of the transactions herein contemplated have been duly and validly authorized by all necessary action on behalf of the Seller and this Agreement has been duly and validly executed and delivered by the Seller and is a valid and binding obligation of the Seller enforceable against the Seller in accordance with its terms. There is no litigation, action, suit, investigation, hearing, claim, complaint, grievance, arbitration proceeding or other proceeding, including any appeal or review and any application for same, in progress, pending, or, to the knowledge of the Seller, threatened against or affecting the Seller or affecting the title of the Seller to any of the Purchased Shares at law or in equity or before or by any Tribunal and, to the knowledge of the Seller, there are no grounds on which any such legal proceeding might be commenced with any reasonable likelihood of success nor is there any order outstanding against or affecting the Seller which, in any such case, affects adversely or might affect adversely the ability of the Seller to enter into this Agreement or to perform its obligations hereunder. Seller has obtained all authorizations, consents or approvals required to be obtained or performed by the Seller in order to complete the transactions contemplated by this Agreement.
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(c) | Title to Purchased Shares. |
The Seller is the registered and beneficial owner of the Purchased Shares to be sold by the Seller to the Purchaser hereunder. The Seller has good and marketable title to such Purchased Shares, free and clear of all Encumbrances. No person has, or has any right capable of becoming, any agreement, option, understanding or commitment for the purchase or other acquisition from the Seller of any of the Purchased Shares.
(d) | Residence of Seller. |
The Seller is not a “non-resident” of Canada within the meaning of the Income Tax Act.
(e) | No Finders’ Fee. |
No broker, finder, agent or similar intermediary has acted on behalf of the Seller in connection with this Agreement or the transactions contemplated hereby, and there is no brokerage commission, finders’ fee or similar fee payable by the Corporation or the Purchaser in connection therewith.
3.2 | Representations and Warranties relating to the Corporation |
The Seller represents and warrants to the Purchaser and acknowledges that the Purchaser is relying on such representations and warranties in connection with the transactions contemplated herein, including, without limitation, the purchase of the Purchased Shares:
(a) | Incorporation and Organization of the Corporation. |
The Corporation is a corporation duly incorporated, organized and validly subsisting under the laws of Canada, and is in good standing under the laws of such jurisdiction.
(b) | Qualification. |
To the Seller’s knowledge, the Corporation is duly qualified or licensed to carry on business in every jurisdiction in which the nature of the Business or the property owned or leased by the Corporation makes such qualification or license necessary, except where the failure to be so in any such case or taken together would not have a material adverse effect on the Corporation.
(c) Shareholder Agreements. Other than as set forth in the Shareholders Agreement and the articles of the Corporation, as amended, the Seller is not a party to any Contract that relates to or affects the management of the Corporation or restricts the ability of the Corporation to issue securities or the ability of shareholders of the Corporation to freely transfer or alienate any outstanding securities of the Corporation or securities of the Corporation that may hereafter be issued, or that creates a voting trust, voting agreement, pooling agreement, drag-along, right of first refusal, pre-emptive right or proxy with respect to any of the outstanding securities of the Corporation or securities of the Corporation that hereafter may be issued.
(d) | Conflicting Instruments. |
To the knowledge of the Seller, the consummation of the transactions contemplated herein will not conflict with, or result in the violation of, or a default under, any applicable law, rule or
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regulation, any of the terms and provisions of the articles or by-laws of the Corporation or of any Contract to which the Corporation is a party or by which it is bound, or cause the rights of any party (including any right to the vesting of purchase rights with respect to any outstanding securities or securities which hereafter may be issued) to any such Contract to accelerate according to the terms of such Contract.
(e) | Subsidiaries and Other Interests. |
To the knowledge of the Seller, the Corporation has no subsidiaries, is not and has not been a partner in a partnership, is not and has not participated in any joint venture, and does not own, and has not agreed or become bound to acquire any securities issued by, or acquire any equity or ownership interest in, any other business or person. To the knowledge of the Seller, the Corporation is not subject to any obligation or requirement to provide funds to or to make any investment in any business or person by way of loan, capital contribution or otherwise.
(f) | Minute Books. |
To the knowledge of the Seller, the minute books of the Corporation have been made available to the Purchaser or counsel to the Purchaser and contain all articles, by-laws and resolutions and a complete and accurate record of all meetings and actions of directors (and committees thereof) and shareholders of the Corporation since the Investment Date, and reflect all transactions referred to in such proceedings accurately up until the Closing Time. The share ledgers and registers of the Corporation are complete and reflect all issuances, transfers, repurchases and cancellations of shares in the capital of the Corporation.
(g) | Financial Statements. |
The Financial Statements have been prepared in accordance with generally accepted accounting principles applied on a basis consistent with prior periods and completely and accurately presents the financial position of the Corporation as at December 31, 2013 in respect of the Annual Financial Statements and as at the Interim Financial Statement Date in respect of the Interim Financial Statements, including, without limiting the generality of the foregoing, all liabilities of the Corporation of every nature and kind whether contingent, deferred or otherwise, including but not limited to all liabilities or provision for Taxes of any and every kind due or to become due as at such date. The Financial Statements are in all respects in accordance with the books and records of the Corporation. The books and records of the Corporation completely and accurately record all financial transactions of the Corporation in accordance with sound business and financial practice. There has not been, since December 31, 2013, any:
(i) | payment or satisfaction of any obligation or liability, absolute or contingent, other than current liabilities or obligations disclosed in the Financial Statements and current liabilities or obligations incurred since the Interim Financial Statement Date in the ordinary course of the business of the Corporation or in connection with the transactions contemplated by this Agreement; |
(ii) | declaration, setting aside or payment of any dividend, redemption or repurchase of any outstanding shares, or any distribution by the Corporation of its properties or assets to its shareholders, other than salaries paid in the ordinary course; |
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(iii) | material loss, destruction or damage to any property of the Corporation, whether or not insured; |
(iv) | material change in any of the Corporation’s personnel or their terms and conditions of employment; |
(v) | waiver of any valuable right, claim or debt owed to the Corporation; |
(vi) | acquisition or disposition of any material asset (or any Contract or arrangement therefor) in excess of $100,000, or any other material transaction by the Corporation; |
(vii) | authorization, agreement or commitment to do any of the foregoing; or |
(viii) | to the knowledge of the Seller, Material Adverse Change. |
(h) | Business in the Ordinary Course. |
To the knowledge of the Seller, the Corporation has not carried on any business other than the Business since the Investment Date. To the knowledge of the Seller, the operations and Business of the Corporation between the Investment Date and the date hereof have been carried on in the ordinary course and, except as set forth in the Financial Statements, the Corporation has not incurred any obligation or liability out of the ordinary course.
(i) | Compliance With Laws. |
To the knowledge of the Seller, the Corporation is conducting the Business in compliance in all material respects with all applicable laws, rules and regulations of each jurisdiction in which the Business is carried on, and is not in breach in any material respect of any such laws, rules or regulations except where the failure to be so in any such case or taken together would not have a material adverse effect on the Corporation.
(j) | Tax Matters. |
The Corporation has duly filed all Tax Returns required to be filed by it. All such Tax Returns, and all materials accompanying such Tax Returns, are true, correct and complete in all material respects and contain accurate disclosure. The Corporation has paid all Taxes which are due and payable by it on or prior to the date hereof, and all governmental or municipal charges or levies, penalties, interest and fines in respect of such Taxes due and payable by it on or prior to the date hereof; to the extent required, adequate provisions have been made for all such Taxes, charges, levies, penalties, interest and fines payable for the current year for which Tax Returns are not yet filed; there is no action, suit, proceeding, investigation or claim pending or, to the knowledge of the Corporation, threatened, against the Corporation in respect of Taxes, governmental or municipal charges, levies or assessment, nor are there any matters under discussion with any governmental or municipal authority relating to Taxes, governmental or municipal charges, levies or assessment asserted by any such authority. The Corporation has withheld from each payment made to any of its officers, directors, employees, shareholders, creditors or other persons, all amounts which it is required by law to withhold or deduct and has duly remitted all amounts so withheld or deducted to the proper recipients thereof within the time periods and in the manner required by such laws.
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(k) | Property & Assets. |
The Corporation has good and marketable title, or valid leasehold title pursuant to the leases described in Schedule 3.2(k) of the Disclosure Schedule, to all of its properties and assets, free and clear of all Encumbrances. All machinery and equipment included in such properties and assets is in good condition and repair except for reasonable wear and tear, and all leases of real or personal property to which the Corporation is a Party are fully effective and afford the Corporation peaceful and undisturbed possession of the subject matter of the lease. To the knowledge of the Seller, the Corporation is not in violation of any zoning, building or safety ordinance, regulation or requirement or other law or regulation applicable to the operation of owned or leased properties that is likely to impede the normal operation of the Business. The Corporation does not own any real property.
(l) | Liabilities and Debt Instruments. |
Except as set forth in the Financial Statements or as may exist between the Corporation and members of the Purchaser Group, the Corporation does not have any liabilities, obligations or commitments (including, without limitation, indebtedness, Tax liabilities, guarantees, indemnifications, surety or similar obligations), whether accrued, absolute, contingent or otherwise. To the knowledge of the Seller, the Corporation is not a party to or bound by or subject to: (i) any bond, debenture, promissory note, credit facility or other Contract evidencing indebtedness for borrowed money; or (ii) any agreement, Contract to create, assume or issue any of the foregoing. To the knowledge of the Seller, the Corporation is not in default under any obligation (contingent or otherwise) in respect of borrowed money or pursuant to any Contract referred to above, and none of the Corporation’s debts or liabilities is guaranteed by any other person.
(m) | Employee Benefits. |
The Corporation does not maintain any Benefit Plans.
(n) | Environmental, Health and Safety Matters. |
To the knowledge of the Seller, the operations of the Corporation (as well as any property or assets of the Corporation whether or not used in carrying on of the Business) are not in, and have not been in, violation of any applicable laws, regulations, permits, licences, approvals, policies, guidelines or orders of any governmental or municipal authority relating to environmental, health or safety matters, including the release of hazardous substances.
(o) | Litigation. |
To the knowledge of the Seller, there is no claim, action, law suit, proceeding, complaint, charge or investigation pending or threatened against the Corporation. The foregoing includes, without limitation, actions pending or, to the knowledge of the Seller, threatened, involving the prior employment or engagement, as applicable, of any of the employees or independent contractors of the Corporation, their use in connection with the Business of the Corporation of any information, creations or techniques allegedly proprietary to any of their former employers or other persons, or their obligations under any Contracts with prior employers or other persons. Neither the Corporation nor any of its employees, independent contractors, officers or directors, is a party to, or subject to the provisions of, any order, writs, injunction, judgment or decree of any court or governmental agency or instrumentality relating to the Corporation or the Business. The Corporation is not and has not been since the Investment Date engaged in any dispute with any present or former
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officers, directors, employees, independent contractors or shareholders. There is no action, suit or proceeding by the Corporation currently pending or, to the knowledge of the Seller, which the Corporation presently intends to initiate.
(p) | Stanford Agreement. |
The Stanford Agreement: (i) is valid and binding upon the Corporation and, to the knowledge of the Seller, the other parties thereto; (ii) is in full force and effect; and (iii) has not been breached by the Corporation or, to the knowledge of the Seller, any other party thereto, nor is there any event or condition which, with the passage of time would constitute a material default or a material breach by the Corporation or any third party. No party to the Stanford Agreement has indicated to the Corporation, nor does the Seller have any reasonable basis to believe that any party to the Stanford Agreement shall indicate, that it intends to cancel, withdraw, modify or amend any of same. There is no consent or approval required from any party to the Stanford Agreement in order to complete the transactions contemplated by this Agreement. A true and complete copy of the Stanford Agreement has been delivered to the Purchaser or counsel for the Purchaser.
(q) | Insiders. |
Except as set forth in Schedule 3.2(q) of the Disclosure Schedule, there are no Contracts between the Corporation and any of the Seller’s Insiders (other than Contracts of employment and share subscription agreements entered into in the ordinary course). Except for usual compensation paid in the ordinary course of business, consistent with past practice, the Corporation has not made any payment or loan to, or borrowed any monies from or is otherwise indebted to, any of the Seller’s Insiders.
(r) | Employees. |
(i) | The Corporation has no employees and only 1 independent contractor, who is Bill Dickie. The agreement governing the terms of the independent contractor’s services has been provided to the Purchaser. There has not been and there is not currently any material disagreement or other difficulties with any of the Corporation’s present or former employees or independent contractors. To the knowledge of the Seller, no officer or key employee of the Corporation has any present intention of terminating his or her services to the Corporation nor to the knowledge of the Seller does the Corporation have any present intention of terminating the service of any such person in each case, other than as contemplated herein. |
(ii) | To the knowledge of the Seller, since the Investment Date no present or former employee or independent contractor of the Corporation is a party to or has violated any term of any employment contract, consulting agreement, non-competition or non-solicitation agreement, patent or other proprietary information agreement or similar Contract with, or any fiduciary duty in favour of, a former employer of such employee or independent contractor or any other third party. The Corporation has not received any notice from any third party alleging that such a violation has occurred. To the knowledge of the Seller, the |
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continued employment or engagement by the Corporation of its present employees or contractors shall not result in any such violation.
(iii) | Since the Investment Date, there have been no claims of wrongful dismissal, or complaints, inquiries or claims made against the Corporation resulting from the violation or alleged violation of any applicable employment law or regulation, including any employment equity, human rights, health or safety law or regulation, or any agreement or arrangement with respect to Benefit Plans. |
(iv) | Since the Investment Date, the Corporation has complied with all applicable federal, provincial, state and any other applicable laws and regulations respecting employment and employment practices, terms and conditions of employment, wages and hours and other laws related to employment, and there are no arrears in the payments of wages, withholding Taxes, Canada Pension Plan premiums, employment insurance premiums or other similar obligations. |
(v) | The Corporation is not a party to any collective bargaining agreement and, to the Corporation’s knowledge, no organizational efforts to establish a collective bargaining or similar arrangement are presently being made with respect to any of its employees. |
(vi) | The Corporation is not a party to and is not bound by any Contract for the: (A) employment of any employee that cannot be terminated without cause on provisions of notice limited to the minimum notice requirements under the Employment Standards Act, 2000 (Ontario), as amended; or (B) engagement of any independent contractor or consultant that cannot be terminated on less than sixty (60) days’ notice. |
(s) | Material Information. |
No representation or warranty by the Seller contained in this Agreement contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements therein, in light of the circumstances in which they were made, not false or misleading.
3.3 | Non-Waiver |
The Purchaser and the Purchaser Group shall not have any recourse against the Seller in respect of facts or circumstances that are reflected in public filings of any member of the Purchaser Group or in respect of facts or circumstances of which any member of the Purchaser Group other than the Corporation had knowledge.
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Article 4
PURCHASER’S REPRESENTATIONS AND WARRANTIES
4.1 | Purchaser’s Representations and Warranties |
The Purchaser represents and warrants to the Seller as follows and acknowledges that the Seller is relying on such representations and warranties in connection with the transactions contemplated herein:
(a) | Incorporation of the Purchaser |
The Purchaser is duly incorporated, organized and subsisting under the laws of its jurisdiction of incorporation and is in good standing under the laws of such jurisdiction. No proceedings have been taken or authorized by the Purchaser or by any other person with respect to the bankruptcy, insolvency, liquidation, dissolution or winding up of the Purchaser or with respect to any amalgamation, merger, consolidation, arrangement or reorganization of, or relating to, the Purchaser nor, to the knowledge of the Purchaser, have any such proceedings been threatened by any other person.
(b) | Authorization. |
The Purchaser has all the necessary corporate or other power, authority and capacity to (i) own and operate its properties and assets; (ii) carry on its business as presently conducted and proposed to be conducted; (iii) purchase or acquire the Purchased Shares; and (iv) execute and deliver this Agreement and to perform all of its obligations hereunder. The execution and delivery of this Agreement, and the consummation of the transactions herein contemplated, has been duly authorized by all necessary corporate or other action of the Purchaser.
(c) | Charter Documents and By-laws, etc. |
The execution, delivery and performance of this Agreement, and the consummation of the transactions herein contemplated, shall not conflict with or constitute a default under or result in the breach of: (i) any provision of the constating documents or any resolution of the directors or shareholders of the Purchaser (if applicable); or (ii) any statute, law or regulation of any jurisdiction as such statute, law or regulation relates to the Purchaser.
(d) | Binding Obligation. |
Upon due execution by the Seller and the Purchaser, this Agreement will constitute a legally valid and binding obligation of the Purchaser enforceable in accordance with its respective terms except as limited by applicable bankruptcy, insolvency, reorganization, moratorium or other similar laws affecting creditors’ rights generally.
(e) | No Finders’ Fee. |
The Purchaser has carried on all negotiations relating to this Agreement and the transactions contemplated by this Agreement without intervention on its behalf of any other party in such a manner as to give rise to any valid claim for a brokerage commission, finder’s fee or other like payment against the Seller.
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4.2 | Non-Waiver |
No investigation made by or on behalf of the Seller at any time shall waive, diminish the scope of or otherwise affect any representation or warranty made by the Purchaser in this Agreement.
Article 5
INDEMNIFICATION
5.1 | Non-Merger and Exclusive Remedy |
The representations, warranties, covenants and other obligations contained in this Agreement and in any agreement, certificate, affidavit, statutory declaration or other document delivered or given pursuant to this Agreement shall not merge on Closing and, notwithstanding the Closing or any investigation made by any Party with respect thereto, shall continue in full force and effect until the dates specified in Section 5.4 hereof. All claims by any Party after the Closing in respect of such representations and warranties (but not, for greater certainty, any of such covenants and other obligations (which are intended to be continuing in nature)) shall be subject to the conditions and limitations set forth in this Article 5 and the rights of indemnity in this Article 5 shall be the sole and exclusive remedy of each Party in respect of such claims.
5.2 | Indemnification by Seller |
Subject to the limitations in Sections 5.4(a) and 5.4(b), the Seller shall indemnify, defend and save harmless the Purchaser from and against any and all Losses suffered or incurred by the Purchaser, as a direct or indirect result of, or arising in connection with or related in any manner whatever to:
(a) | any misrepresentation or breach of warranty made or given by the Seller in this Agreement or in any agreement, certificate, affidavit, statutory declaration or other document delivered or given pursuant to this Agreement; or |
(b) | any failure by the Seller to observe or perform any covenant or obligation contained in this Agreement or in any agreement, certificate, affidavit, statutory declaration or other document delivered or given pursuant to this Agreement. |
5.3 | Indemnification by the Purchaser |
Subject to limitations in Section 5.4(c), the Purchaser and Parent shall jointly and severally indemnify, defend and save harmless the Seller from and against any and all Losses suffered or incurred by it, as a direct or indirect result of, or arising in connection with or related in any manner whatsoever to:
(a) | any misrepresentation or breach of any warranty made or given by the Purchaser in this Agreement; |
(b) | any misrepresentation or breach in any agreement, certificate, affidavit, statutory declaration or other document delivered or given pursuant to this Agreement; or |
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(c) | any failure by the Purchaser to observe or perform any covenant or obligation contained in this Agreement or in any agreement, certificate, affidavit, statutory declaration or other document delivered or given pursuant to this Agreement, including any failure to pay any portion of the Purchase Price. |
5.4 | Time Limitations |
(a) | Subject to Section 5.4(b), the Seller shall have no liability to the Purchaser for any Loss arising from any Claim relating to a breach of any representation or warranty by the Seller contained in this Agreement or in any agreement, certificate, affidavit, statutory declaration or other document delivered or given pursuant to this Agreement unless the Purchaser gives notice to the Seller specifying in reasonable detail the factual basis of the Claim and a reasonable estimate of the amount thereof on or before that date which is two (2) years after the Closing Date. |
(b) | Despite the provisions of Section 5.4(a): |
(i) | notice with respect to Claims relating to Section 3.1(a) (Incorporation of the Seller.), Section 3.1(b) (Authorization of Transaction by Seller.), Section 3.1(c) (Title to Purchased Shares.) and Section 3.1(e) (No Finders’ Fee.) (collectively, the “Fundamental Representations”) may be given at any time after the Closing Date and prior to the 30th day following the expiration of all applicable statute of limitation periods (including all extensions thereof); |
(ii) | the period to give notice with respect to Claims relating to Section 3.1(d) (Residence of Seller.) and 3.2(j) (Tax Matters.) shall be the date which is sixty (60) days following the expiration of the period during which an assessment, reassessment or other form of recognized document assessing liability for tax, interest or penalties under applicable Tax Legislation in respect of any taxation year to which such representations and warranties extend could be issued (after giving effect to any extensions or waivers thereof), |
except in the case of claims for fraud, in which case, such representations and warranties shall not terminate and shall survive indefinitely; provided, any representation or warranty in respect of which indemnity may be sought under this Article 5, and the indemnity with respect thereto, shall survive the time at which it would otherwise terminate pursuant to this Section 5.4 if notice of the inaccuracy or breach or potential inaccuracy or breach thereof giving rise to such right or alleged right of indemnity shall have been given to the Party against whom such indemnity may be sought prior to such time.
(c) | The Purchaser and Parent shall have no liability to the Seller for any Loss arising from any Claim relating to a breach of any representation or warranty contained in this Agreement or in any agreement, certificate, affidavit, statutory declaration or other document delivered or given pursuant to this Agreement unless the Seller gives notice to the Purchaser or Parent specifying in reasonable |
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detail the factual basis of the Claim and a reasonable estimate of the amount thereof on or before that date which is two (2) years after the Closing Date.
(d) | The covenants of each Party in this Agreement shall survive the Closing and, notwithstanding such Closing, shall continue in full force and effect for the benefit of the other Party in accordance with the terms hereof. |
5.5 | Limitations on Amount |
(a) | The Seller shall not have any liability under Section 5.2(a) unless and until the aggregate of the Losses collectively, in respect of all Claims at any time asserted by the Purchaser pursuant to this Article 5, exceeds CHF 45,565, in which event the amount of all such Losses including such CHF 45,565 amount may be asserted. |
(b) | The Seller shall not have any liability under Section 5.2(a) for any Claim resulting solely from any action or inaction on the part of any member of the Purchaser Group. |
(c) | The Purchaser shall not have any liability under Section 5.3(a) unless and until the aggregate of the Losses in respect of all Claims at any time asserted by the Seller pursuant to this Article 5 exceeds CHF 45,565, in which event the amount of all such Losses including such CHF 45,565 amount may be asserted. |
5.6 | Limited Recourse |
The aggregate liability of the Seller under Section 5.2(a) (other than with respect to a misrepresentation involving fraud) shall be limited to the Purchase Price paid or otherwise payable by the Purchaser to the Seller hereunder.
5.7 | Notice of Third Party Claims |
If an Indemnitee receives notice of the commencement or assertion of any Claim asserted against the Indemnitee that is paid or payable to, or claimed by, any person who is not a Party to this Agreement (a “Third Party Claim”), the Indemnitee shall give the Indemnitor reasonably prompt notice thereof, but in any event no later than thirty (30) days after receipt of such notice of such Third Party Claim. Such notice to the Indemnitor shall describe the Third Party Claim in reasonable detail and shall indicate, if reasonably practicable, the estimated amount of the Loss that has been or may be sustained by the Indemnitee.
5.8 | Defence of Third Party Claims |
The Indemnitor may participate in or assume the defence of any Third Party Claim by giving notice to that effect to the Indemnitee not later than thirty (30) days after receiving notice of that Third Party Claim (the “Notice Period”). The Indemnitor’s right to do so shall be subject to the rights of any insurer or other Party who has potential liability in respect of that Third Party Claim. The Indemnitor shall pay all of its own expenses of participating in or assuming such defence. The Indemnitee shall co-operate in good faith in the defence of each Third Party Claim, even if the defence has been assumed by the Indemnitor and may participate in such defence assisted by counsel of its own choice at its own expense. If the Indemnitee has not received notice within the Notice Period that the Indemnitor has
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elected to assume the defence of such Third Party Claim, the Indemnitee may, at its option, elect to settle or compromise the Third Party Claim or assume such defence, assisted by counsel of its own choosing and the Indemnitor shall be liable for all reasonable costs and expenses paid or incurred in connection therewith and any Loss suffered or incurred by the Indemnitee with respect to such Third Party Claim. If the Indemnitor elects to assume the defence of a Third Party Claim under this Section 5.8 or fails to assume the defence, the Indemnitor shall not have the right thereafter to contest its liability for such claim.
5.9 | Assistance for Third Party Claims |
The Indemnitor and the Indemnitee will use all reasonable efforts to make available to the person that is undertaking and controlling the defence of any Third Party Claim (the “Defending Party”),
(a) | those employees and other persons whose assistance, testimony or presence is necessary to assist the Defending Party in evaluating and in defending any Third Party Claim; and |
(b) | all documents, records and other materials in the possession of such Party reasonably required by the Defending Party for its use in defending any Third Party Claim, |
and shall otherwise cooperate with the Defending Party. The Indemnitor shall be responsible for all reasonable expenses associated with making such documents, records and materials available and for all reasonable expenses of any employees or other persons made available by the Indemnitee to the Indemnitor hereunder, which expense shall not exceed the actual cost to the Indemnitee associated with such employees and other persons.
5.10 | Settlement of Third Party Claims |
If an Indemnitor elects to assume the defence of any Third Party Claim as provided in Section 5.8, the Indemnitor shall not be liable for any legal expenses subsequently incurred by the Indemnitee in connection with the defence of such Third Party Claim following the receipt by the Indemnitee of notice of such assumption. However, if in the opinion of the Indemnitee, acting reasonably, there is a conflict between the interests of the Indemnifying Party and the interests of the Indemnitee with respect to such Third Party Claim, or if the Indemnitor fails to take reasonable steps necessary to defend diligently such Third Party Claim within thirty (30) days after receiving notice from the Indemnitee that the Indemnitee believes on reasonable grounds that the Indemnitor has failed to take such steps, the Indemnitee may, at its option, elect to assume the defence of and to negotiate, settle or compromise the Third Party Claim assisted by counsel of its own choosing and the Indemnitor shall also be liable for all reasonable costs and expenses paid or incurred in connection therewith. The Indemnitor shall not, without the prior written consent of the Indemnitee, enter into any compromise or settlement of a Third Party Claim, which would lead to liability or create any other obligation, financial or otherwise, on the Indemnitee.
5.11 | Direct Claims |
Any Claim other than a Third Party Claim (a “Direct Claim”) shall be asserted by giving the Indemnitor reasonably prompt written notice thereof, but in any event not later than sixty (60) days after the Indemnitee becomes aware of such Direct Claim. The Indemnitee shall make available to the
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Indemnitor the information relied upon by the Indemnitee to substantiate its right to be indemnified hereunder, together with such other information as the Indemnitor may reasonably request. The Indemnitor shall then have a period of thirty (30) days within which to respond in writing to such Direct Claim. If the Indemnitor does not so respond within such thirty (30) day period (or any mutually agreed upon extension thereof), the Indemnitor shall be deemed to have rejected such Direct Claim, and in such event the Indemnitee shall be free to pursue such remedies as may be available to the Indemnitee.
5.12 | Failure to Give Timely Notice |
A failure to give timely notice as provided in this Article 5 shall not affect the rights or obligations of any Party except and only to the extent that, as a result of such failure, any Party which was entitled to receive such notice was deprived of its right to recover any payment under its applicable insurance coverage or was otherwise directly and materially damaged as a result of such failure.
5.13 | Set-off |
The Purchaser shall be entitled to set-off the amount of any Loss for which indemnification is sought under Section 5.2 once finally determined in accordance with this Article 5 as damages or by way of indemnification against any other amounts payable by the Purchaser to the Seller pursuant to this Agreement.
5.14 | Reductions and Subrogation |
If the amount of any Loss at any time subsequent to the making of any payment on account of any Loss required to paid pursuant to this Article 5 (an “Indemnity Payment”) in respect of that Loss is reduced by any recovery, settlement or otherwise under or pursuant to any insurance coverage, or pursuant to any claim, recovery, settlement or payment by or against any other person, the amount of such reduction (less any costs, expenses (including Taxes) or premiums incurred in connection therewith), shall promptly be repaid by the Indemnitee to the Indemnitor. Upon making a full Indemnity Payment, the Indemnitor shall, to the extent of such Indemnity Payment, be subrogated to all rights of the Indemnitee against any third party that is not an affiliate of the Indemnitee in respect of the Loss to which the Indemnity Payment relates. Until the Indemnitee recovers full payment of its Loss, any and all claims of the Indemnitor against any such third party on account of such Indemnity Payment shall be postponed and subordinated in right of payment to the Indemnitee’s rights against such third party. Without limiting the generality or effect of any other provision hereof, the Indemnitee and Indemnitor shall duly execute upon request all instruments reasonably necessary to evidence and perfect such postponement and subordination.
5.15 | Tax Effect |
If any Indemnity Payment received by an Indemnitee would constitute taxable income or be subject to a tax benefit to such Indemnitee, the Indemnitor shall pay to the Indemnitee at the same time and on the same terms, as to interest and otherwise, as the Indemnity Payment an additional or lesser amount, as the case may be, to place the Indemnitee in the same after-tax position as it would have been if the Indemnity Payment had been received without the tax deduction or benefit.
5.16 | Additional Rules and Procedures |
The Indemnitee and the Indemnitor shall co-operate fully with each other with respect to Third Party Claims, shall keep each other fully advised with respect thereto (including supplying
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copies of all relevant documentation promptly as it becomes available) and shall each designate a senior officer who shall keep himself informed about and be prepared to discuss the Third Party Claim with his counterpart and with counsel at all reasonable times.
Article 6
CLOSING ARRANGEMENTS
6.1 | Date, Place and Time of Closing |
The Closing shall take place at the offices of Dentons Canada LLP, located at Suite 1420, 99 Bank Street, Ottawa, Ontario K1P 1H4 at the Closing Time on the Closing Date, or at such other place, on such other date and at such other time as may be agreed upon in writing by the Parties.
6.2 | Closing Deliveries of the Seller |
At the Closing Time, the Seller shall deliver or cause to be delivered to the Purchaser, the following:
(a) | a transfer by the Seller to the Purchaser (or as the Purchaser may otherwise direct) of the Purchased Shares, or certificates representing the Purchased Shares duly endorsed for transfer to the Purchaser (or as the Purchaser may otherwise direct); |
(b) | all documentation and other evidence reasonably requested by the Purchaser in order to establish the due authorization and completion of the transactions contemplated by this Agreement, including the taking of all corporate proceedings by the boards of directors and shareholders of the Seller and the Corporation required to effectively carry out the obligations of the Seller pursuant to this Agreement; |
(c) | duly executed resignation effective as at the Closing Time of each resigning Seller nominee director of the Corporation; |
(d) | releases from the Seller and Bill Dickie of all Claims they may have against the Corporation as at the Closing Time in a form acceptable to the Seller, acting reasonably; |
(e) | a consulting agreement between the Corporation and WJD Associates Inc., in form and substance satisfactory to the Purchaser signed by Bill Dickie on behalf of WJD Associates Inc.; |
(f) | written consent of the Seller to the termination of that certain Unanimous Shareholders Agreement made as of December 6, 2010, as amended (the “Shareholders Agreement”). |
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6.3 | Closing Deliveries of the Purchaser |
At the Closing Time, the Purchaser shall deliver or cause to be delivered to the Seller, the following:
(a) | all documentation and other evidence reasonably requested by the Seller in order to establish the due authorization and completion of the transactions contemplated by this Agreement, including the taking of all corporate proceedings by the board of directors and shareholders of the Purchaser and the Corporation required to effectively carry out the obligations of the Purchaser pursuant to this Agreement; |
(b) | the consulting agreement between the Corporation, Bill Dickie and WJD Associates Inc., signed by the Corporation; and |
(c) | documentation, satisfactory to the Seller, evidencing the termination of the Shareholders Agreement. |
Article 7
GENERAL
7.1 | Further Assurances |
Each Party shall execute and deliver such further documents, instruments of conveyance and transfer and take such additional action as the other Parties may reasonably request to confirm or evidence the transfer of the Purchased Shares or to otherwise carry out or better evidence or perfect the full intent and meaning of this Agreement.
7.2 | Costs and Expenses |
Unless otherwise specified, each Party shall be responsible for all costs and expenses (including the fees and disbursements of legal counsel, bankers, investment bankers, accountants, brokers and other advisors) incurred by it in connection with this Agreement and the transactions contemplated by it.
7.3 | Public Announcements |
No public announcement or press release concerning the purchase and sale of the Purchased Shares shall be made by the Purchaser or the Seller without the consent and approval of the other Party; provided, however, that each of the Parties shall be permitted to disclose the transactions contemplated by this Agreement to each of such Party’s direct or indirect shareholders, members or partners, as applicable, to the extent required by law or in a manner consistent with such Party’s past practices.
7.4 | Assignment |
Except as provided in this Section 7.4, neither this Agreement nor any of the rights, benefits or obligations under this Agreement are assignable or transferable by either Party without the prior written consent of the other Party which consent shall not be unreasonably withheld. The Purchaser may assign its rights, benefits and obligations under this Agreement, in whole or in part, to
26 |
any person that acquires all or substantially all of the assets of the Purchaser or acquires a majority of the Purchaser’s issued and outstanding voting securities, whether by way of take-over bid, amalgamation, arrangement, merger or otherwise.
7.5 | Notices |
Any demand, notice or other communication to be made or given in connection with this Agreement shall be made or given in writing and may be made or given by personal delivery, by courier or by transmittal by fax or e-mail addressed as follows:
(a) | if to the Purchaser, to: |
20 rue Diesel
01630 Saint Genis Pouilly,
France
Facsimile: | +33 4 50 99 30 71 |
Attention: | Stefano Buono, CEO of AAA |
E-Mail: | stefano.buono@adacap.com |
with a copy to:
Dentons Canada LLP
99 Bank Street, Suite 1420
Ottawa ON K1P 1H4
Facsimile: | (613) 783-9690 |
Attention: | Thomas A. Houston |
E-Mail: | tom.houston@dentons.com |
(b) | if to the Seller, to: |
9 Hansen Avenue,
Kanata, Ontario K2K 2L9
Facsimile: | (613) 212-8990 |
Attention: | Chief Executive Officer |
E-Mail: | bdickie@atreuspharma.com |
with a copy to:
LaBarge Weinstein LLP
800-515 Legget Drive
Ottawa ON K2K 3G4
27 |
Facsimile: | (613) 599-0018 |
Attention: | Estelle Duez |
E-Mail: | eduez@lwlaw.com |
or to such other address, fax number, e-mail address or individual as may be designated by notice by any Party to the others. Any demand, notice or other communication made or given by personal delivery shall be conclusively deemed to have been given on the day of actual delivery thereof and, if made or given by courier, on the second (2nd) business day following the deposit thereof with the courier and, if made or given by fax or e-mail, on the day of transmittal thereof or if the day of transmittal is not a business day, the next business day following the date of transmittal thereof (provided the original copy is immediately forwarded by courier).
7.6 | Governing Law |
This Agreement shall be governed by and construed in accordance with the laws of the Province of Ontario, without regard to the province’s conflict of law provisions, and each of the Parties hereto irrevocably agrees to submit to the exclusive jurisdiction of the courts of such province located in Ottawa, Ontario for and in connection with any proceedings relating to this Agreement.
7.7 | Benefit of Agreement |
This Agreement shall enure to the benefit of and be binding upon the Parties and their respective successors and permitted assigns.
7.8 | Amendment and Waiver |
This Agreement may not be amended, supplemented or otherwise modified in any respect except by written agreement signed by the Parties. Any waiver of any of the provisions of this Agreement will be binding only if it is in writing and signed by the Party to be bound by it, and only in the specific instance and for the specific purpose for which it has been given. The failure or delay of any Party in exercising any right under this Agreement will not operate as a waiver of that right. No single or partial exercise of any right will preclude any other or further exercise of that right or the exercise of any other right, and no waiver of any of the provisions of this Agreement will constitute a waiver of any other provision (whether or not similar).
7.9 | Entire Agreement |
This Agreement constitutes the entire agreement between the Parties hereto with respect to the subject matter hereof and cancels and supersedes any prior understandings and agreements between the Parties hereto with respect thereto. There are no representations, warranties, terms, conditions, undertakings or collateral agreements, express, implied or statutory, between the Parties other than as expressly set forth or contemplated in this Agreement.
7.10 | Severability |
If any provision of this Agreement is determined to be invalid or unenforceable in whole or in part, such invalidity or unenforceability shall attach only to such provision or part thereof and the remaining part of such provision and all other provisions hereof shall continue in full force and effect.
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7.11 | Counterparts and Execution by Electronic Means |
This Agreement may be executed by the Parties in separate counterparts, each of which, when so executed and delivered, shall be deemed to constitute an original, but all of which together shall constitute one and the same agreement. This Agreement may be executed by facsimile or PDF and the delivery by facsimile or PDF of signed copies of this Agreement shall constitute and be deemed to be delivery of the original signatures of the Parties.
The remainder of this page is intentionally left blank.
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IN WITNESS WHEREOF the Parties have executed this Agreement on and as of the day first above written.
AAA INTERNATIONAL S.A. | ||
By: | /s/ Gérard Ber | |
Name: Gérard Ber | ||
Title: Chief Executive Officer |
ADVANCED ACCELERATOR APPLICATIONS S.A. | ||
By: | /s/ Stefano Buono | |
Name: Stefano Buono | ||
Title: Chief Executive Officer |
7329563 CANADA INC. | ||
By: | /s/ William J. Dickie | |
Name: William J. Dickie | ||
Title: Director |
[SIGNATURE PAGE TO SHARE PURCHASE AGREEMENT]
SCHEDULE “A”
Annual Financial Statements
See attached.
SCHEDULE “B”
Interim Financial Statements
See attached.
SCHEDULE “C”
Disclosure Schedule
See attached.
Exhibit 21.1
SUBSIDIARIES OF THE REGISTRANT
The following is the significant subsidiary of Advanced Accelerator Applications S.A.
Name | Jurisdiction of Incorporation |
Advanced Accelerator Application (Italy) S.R.L. | Italy |
Exhibit 23.1
KPMG Audit | Téléphone : | +33 (0)4 37 64 76 00 |
51 rue de Saint Cyr | Télécopie : | +33 (0)4 37 64 76 09 |
CS 60409 | Site internet : | www.kpmg.fr |
69338 Lyon Cedex 9 | ||
France |
Consent of Independent Registered Public Accounting Firm
The Board of Directors
Advanced Accelerator Applications S.A.
We consent to the use of our report included herein and to the references to our firm under the headings “Experts”, “Summary Financial and Other Information”, “Presentation of Financial and Other Information” and “Selected Financial and Other Information” in the prospectus.
Our report refers to the restatement of the consolidated financial statements as of December 31, 2013, 2012 and 2011 and for each of the years in the three-year period ended December 31, 2013.
Lyon, January 5, 2015
KPMG Audit
Department of KPMG S.A.
/s/ Stéphane Devin
Stéphane Devin
Partner
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