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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) |
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John G. Crowley, Esq. Davis Polk & Wardwell LLP 450 Lexington Avenue New York, NY 10017 |
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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 |
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Ordinary shares, €0.10 nominal value per share, in the form of ADSs |
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$ |
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$ |
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Per ADS |
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Total |
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Public offering price |
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$ |
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$ |
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Underwriting discounts and commissions |
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$ |
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$ |
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Proceeds, before expenses, to us |
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$ |
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$ |
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Citigroup |
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Jefferies |
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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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---|---|---|---|---|---|---|---|---|---|---|---|
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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) |
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PET tracer for oncology, cardiology, neurology and infectious/inflammatory diseases |
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Gluscan: Belgium, France, Italy, Luxembourg, Switzerland |
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Gluscan 500: France, Germany, Poland, Portugal, Spain |
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Barnascan: Spain |
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IASOflu |
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Our licensed brand name for Sodium Fluoride-18 |
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PET tracer used as a bone imaging agent in defining areas of altered osteogenic activity |
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Belgium, France, Germany, Italy, Luxembourg, Poland |
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IASOdopa |
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Our licensed brand name for 6-fluoro-(18F)-L-DOPA, a DOPA analogue |
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PET tracer for diagnostic use, with key applications in neurology and oncology |
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France, Germany, Italy |
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IASOcholine |
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Our licensed brand name for 18F-choline (FCH) |
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PET tracer for detecting metastasis of prostate cancer and hepatocellular carcinoma (liver cancer) |
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Belgium, France, Germany, Italy, Luxembourg, Poland |
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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 |
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MIBITEC: Austria, France, Germany, Luxembourg, Poland, Slovenia |
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Adamibi: Greece, Italy |
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Leukokit |
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Medical device for the separation and labeling of autologous leukocytes |
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Identifies sites of infection or inflammation in the body |
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CE mark: can be commercialized throughout Europe |
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Year Ended December 31, |
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Six Months Ended June 30, |
| ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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2013 |
|
|
2012 |
|
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2014 |
|
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2013 |
| ||||||||||||||||||||||||||||||
|
|
|
|
US$(1) |
|
|
Euro |
|
|
Euro |
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US$(1) |
|
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Euro |
|
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Euro |
| ||||||||||||||||||||||||
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(Dollars and Euros in thousands unless otherwise noted except share and per share amounts) |
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Consolidated Statements of Income: |
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|
|
|
|
|
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|
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|
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|
|
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|
|
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| | | | | | | | |||||
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Sales |
|
|
|
|
73,660 |
|
|
|
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|
53,806 |
|
|
|
|
|
40,834 |
|
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|
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|
45,491 |
|
|
|
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|
33,229 |
|
|
|
|
|
26,285 |
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| ||||||
|
Raw materials and consumables used |
|
|
|
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(12,574 |
) |
|
|
|
|
|
(9,185 |
) |
|
|
|
|
|
(6,296 |
) |
|
|
|
|
|
(8,491 |
) |
|
|
|
|
|
(6,202 |
) |
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|
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(4,606 |
) |
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Personnel costs |
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|
(21,607 |
) |
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|
|
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|
(15,783 |
) |
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|
|
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|
(12,970 |
) |
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|
|
|
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(12,064 |
) |
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|
|
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(8,812 |
) |
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|
|
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(7,706 |
) |
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Other operating expenses |
|
|
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(28,653 |
) |
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|
|
|
|
(20,930 |
) |
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|
|
|
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(17,023 |
) |
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|
|
|
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(17,459 |
) |
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|
|
|
|
(12,753 |
) |
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|
|
|
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(10,045 |
) |
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Other operating income |
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3,737 |
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2,730 |
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2,032 |
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1,826 |
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1,334 |
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1,539 |
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Depreciation and amortization |
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(13,241 |
) |
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(9,672 |
) |
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|
|
|
(6,623 |
) |
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(6,422 |
) |
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(4,691 |
) |
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(4,193 |
) |
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Operating income (loss) |
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1,322 |
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|
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|
966 |
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(46 |
) |
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2,881 |
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2,105 |
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|
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|
1,274 |
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Finance income |
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|
530 |
|
|
|
|
|
387 |
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|
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|
232 |
|
|
|
|
|
90 |
|
|
|
|
|
66 |
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|
|
|
|
105 |
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Finance costs |
|
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|
(13,902 |
) |
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|
|
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|
(10,155 |
) |
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(16,512 |
) |
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(2,908 |
) |
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(2,124 |
) |
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(2,117 |
) |
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Net finance costs |
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(13,372 |
) |
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|
|
|
|
(9,768 |
) |
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|
|
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|
(16,280 |
) |
|
|
|
|
|
(2,818 |
) |
|
|
|
|
|
(2,058 |
) |
|
|
|
|
|
(2,012 |
) |
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Loss before income taxes |
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|
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|
(12,050 |
) |
|
|
|
|
|
(8,802 |
) |
|
|
|
|
|
(16,326 |
) |
|
|
|
|
|
63 |
|
|
|
|
|
47 |
|
|
|
|
|
(738 |
) |
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|
Income taxes |
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|
|
|
(1,450 |
) |
|
|
|
|
|
(1,059 |
) |
|
|
|
|
|
(586 |
) |
|
|
|
|
|
(1,433 |
) |
|
|
|
|
|
(1,047 |
) |
|
|
|
|
|
(362 |
) |
|
|
|
Net loss for the period |
|
|
|
|
(13,450 |
) |
|
|
|
|
|
(9,861 |
) |
|
|
|
|
|
(16,912 |
) |
|
|
|
|
|
(1,370 |
) |
|
|
|
|
|
(1,000 |
) |
|
|
|
|
|
(1,100 |
) |
|
|
|
Attributable to owners of the company |
|
|
|
|
(12,637 |
) |
|
|
|
|
|
(9,231 |
) |
|
|
|
|
|
(16,455 |
) |
|
|
|
|
|
(713 |
) |
|
|
|
|
|
(521 |
) |
|
|
|
|
|
(844 |
) |
|
|
|
Non-controlling interests |
|
|
|
|
(861 |
) |
|
|
|
|
|
(629 |
) |
|
|
|
|
|
(457 |
) |
|
|
|
|
|
(656 |
) |
|
|
|
|
|
(479 |
) |
|
|
|
|
|
(256 |
) |
|
|
|
Loss per share: |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Basic (US$ and € per share) |
|
|
|
|
(0.23 |
) |
|
|
|
|
|
(0.17 |
) |
|
|
|
|
|
(0.31 |
) |
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
(0.02 |
) |
|
|
|
Diluted (US$ and € per share) |
|
|
|
|
(0.23 |
) |
|
|
|
|
|
(0.17 |
) |
|
|
|
|
|
(0.31 |
) |
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
(0.02 |
) |
|
|
| | | | | | | | | | | | | | | | | | | | |
|
|
|
|
At December 31, |
|
|
At June 30, |
| |||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
2013 |
|
|
2012 |
|
|
2014 |
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|
|
|
|
US$(1) |
|
|
Euro |
|
|
Euro |
|
|
US$(1) |
|
|
Euro |
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|
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|
|
(Dollars and Euros in thousands) |
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Consolidated Statements of Financial Position: |
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|
|
|
|
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|
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|
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Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
Non-current assets |
|
|
|
|
157,359 |
|
|
|
|
|
114,202 |
|
|
|
|
|
111,300 |
|
|
|
|
|
164,710 |
|
|
|
|
|
120,314 |
|
| |||||
|
Goodwill |
|
|
|
|
29,283 |
|
|
|
|
|
21,252 |
|
|
|
|
|
22,286 |
|
|
|
|
|
29,688 |
|
|
|
|
|
21,686 |
|
| |||||
|
Other intangible assets |
|
|
|
|
56,954 |
|
|
|
|
|
41,334 |
|
|
|
|
|
40,499 |
|
|
|
|
|
62,117 |
|
|
|
|
|
45,374 |
|
| |||||
|
Property, plant and equipment |
|
|
|
|
67,903 |
|
|
|
|
|
49,280 |
|
|
|
|
|
45,794 |
|
|
|
|
|
70,230 |
|
|
|
|
|
51,300 |
|
| |||||
|
Financial assets |
|
|
|
|
3,219 |
|
|
|
|
|
2,336 |
|
|
|
|
|
2,721 |
|
|
|
|
|
2,675 |
|
|
|
|
|
1,954 |
|
| |||||
|
Current assets |
|
|
|
|
55,156 |
|
|
|
|
|
40,029 |
|
|
|
|
|
38,543 |
|
|
|
|
|
112,177 |
|
|
|
|
|
81,941 |
|
| |||||
|
Inventories |
|
|
|
|
3,139 |
|
|
|
|
|
2,278 |
|
|
|
|
|
1,833 |
|
|
|
|
|
4,733 |
|
|
|
|
|
3,457 |
|
| |||||
|
Trade and other receivables |
|
|
|
|
22,243 |
|
|
|
|
|
16,143 |
|
|
|
|
|
15,537 |
|
|
|
|
|
26,074 |
|
|
|
|
|
19,046 |
|
| |||||
|
Other current assets |
|
|
|
|
11,019 |
|
|
|
|
|
7,997 |
|
|
|
|
|
7,107 |
|
|
|
|
|
11,231 |
|
|
|
|
|
8,204 |
|
| |||||
|
Cash and cash equivalents |
|
|
|
|
18,753 |
|
|
|
|
|
13,610 |
|
|
|
|
|
14,066 |
|
|
|
|
|
70,139 |
|
|
|
|
|
51,234 |
|
| |||||
|
Total assets |
|
|
|
|
212,515 |
|
|
|
|
|
154,231 |
|
|
|
|
|
149,843 |
|
|
|
|
|
276,887 |
|
|
|
|
|
202,255 |
|
| |||||
|
Equity and liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
Equity attributable to owners of the company |
|
|
|
|
87,290 |
|
|
|
|
|
63,350 |
|
|
|
|
|
63,101 |
|
|
|
|
|
145,920 |
|
|
|
|
|
106,589 |
|
| |||||
|
Share capital |
|
|
|
|
7,461 |
|
|
|
|
|
5,415 |
|
|
|
|
|
5,244 |
|
|
|
|
|
8,615 |
|
|
|
|
|
6,293 |
|
| |||||
|
Share premium |
|
|
|
|
105,539 |
|
|
|
|
|
76,594 |
|
|
|
|
|
69,650 |
|
|
|
|
|
162,162 |
|
|
|
|
|
118,453 |
|
| |||||
|
Reserves and retained earnings |
|
|
|
|
(12,989 |
) |
|
|
|
|
|
(9,427 |
) |
|
|
|
|
|
4,662 |
|
|
|
|
|
(24,144 |
) |
|
|
|
|
|
(17,636 |
) |
|
| |
|
Net loss for the year |
|
|
|
|
(12,719 |
) |
|
|
|
|
|
(9,231 |
) |
|
|
|
|
|
(16,455 |
) |
|
|
|
|
|
(713 |
) |
|
|
|
|
|
(521 |
) |
|
|
|
Non-controlling interests |
|
|
|
|
1,874 |
|
|
|
|
|
1,360 |
|
|
|
|
|
2,189 |
|
|
|
|
|
1,387 |
|
|
|
|
|
1,013 |
|
| |||||
|
Total equity |
|
|
|
|
89,164 |
|
|
|
|
|
64,710 |
|
|
|
|
|
65,290 |
|
|
|
|
|
147,307 |
|
|
|
|
|
107,602 |
|
| |||||
|
Non-current liabilities |
|
|
|
|
89,809 |
|
|
|
|
|
65,178 |
|
|
|
|
|
58,425 |
|
|
|
|
|
90,273 |
|
|
|
|
|
65,941 |
|
| |||||
|
Non-current provisions |
|
|
|
|
8,309 |
|
|
|
|
|
6,030 |
|
|
|
|
|
5,592 |
|
|
|
|
|
9,897 |
|
|
|
|
|
7,229 |
|
| |||||
|
Non-current financial liabilities |
|
|
|
|
28,053 |
|
|
|
|
|
20,359 |
|
|
|
|
|
21,056 |
|
|
|
|
|
25,511 |
|
|
|
|
|
18,635 |
|
| |||||
|
Deferred tax liabilities |
|
|
|
|
5,983 |
|
|
|
|
|
4,342 |
|
|
|
|
|
5,640 |
|
|
|
|
|
5,759 |
|
|
|
|
|
4,207 |
|
| |||||
|
Other non-current liabilities |
|
|
|
|
47,466 |
|
|
|
|
|
34,448 |
|
|
|
|
|
26,137 |
|
|
|
|
|
49,106 |
|
|
|
|
|
35,870 |
|
| |||||
|
Current liabilities |
|
|
|
|
33,542 |
|
|
|
|
|
24,343 |
|
|
|
|
|
26,128 |
|
|
|
|
|
39,306 |
|
|
|
|
|
28,712 |
|
| |||||
|
Current provisions |
|
|
|
|
158 |
|
|
|
|
|
115 |
|
|
|
|
|
300 |
|
|
|
|
|
187 |
|
|
|
|
|
137 |
|
| |||||
|
Current financial liabilities |
|
|
|
|
7,521 |
|
|
|
|
|
5,458 |
|
|
|
|
|
4,012 |
|
|
|
|
|
8,057 |
|
|
|
|
|
5,885 |
|
| |||||
|
Trade and other payables |
|
|
|
|
12,701 |
|
|
|
|
|
9,218 |
|
|
|
|
|
9,857 |
|
|
|
|
|
16,264 |
|
|
|
|
|
11,880 |
|
| |||||
|
Other current liabilities |
|
|
|
|
13,162 |
|
|
|
|
|
9,552 |
|
|
|
|
|
11,959 |
|
|
|
|
|
14,799 |
|
|
|
|
|
10,810 |
|
| |||||
|
Total liabilities |
|
|
|
|
123,351 |
|
|
|
|
|
89,521 |
|
|
|
|
|
84,553 |
|
|
|
|
|
129,580 |
|
|
|
|
|
94,653 |
|
| |||||
|
Total Equity and liabilities |
|
|
|
|
212,515 |
|
|
|
|
|
154,231 |
|
|
|
|
|
149,843 |
|
|
|
|
|
276,887 |
|
|
|
|
|
202,255 |
|
| |||||
| | | | | | | | | | | | | | | | | |
|
|
|
|
Year Ended December 31, |
|
|
Six Months Ended June 30, |
| |||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
2013 |
|
|
2012 |
|
|
2014 |
| ||||||||||||||||||||||||||
|
|
|
|
US$(1) |
|
|
Euro |
|
|
Euro |
|
|
US$(1) |
|
|
Euro |
| ||||||||||||||||||||
|
|
|
|
(Dollars and Euros in thousands) |
| ||||||||||||||||||||||||||||||||
|
Adjusted EBITDA(2) |
|
|
|
|
14,653 |
|
|
|
|
|
10,638 |
|
|
|
|
|
6,577 |
|
|
|
|
|
9,304 |
|
|
|
|
|
6,796 |
|
| |||||
|
Adjusted EBITDA margin(3) |
|
|
|
|
19.8 |
% |
|
|
|
|
|
19.8 |
% |
|
|
|
|
|
16.1 |
% |
|
|
|
|
|
20.5 |
% |
|
|
|
|
|
20.5 |
% |
|
|
| | | | | | | | | | | | | | | | | |
|
|
|
|
Six Months Ended June 30, |
|
|
Year Ended December 31, |
| |||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
2014 |
|
|
2013 |
|
|
2012 |
| ||||||||||||||||||||||||||
|
|
|
|
US$(1) |
|
|
Euro |
|
|
US$(1) |
|
|
Euro |
|
|
Euro |
| ||||||||||||||||||||
|
|
|
|
(Dollars and Euros in thousands) |
| ||||||||||||||||||||||||||||||||
|
Net loss for the year |
|
|
|
|
(1,369 |
) |
|
|
|
|
|
(1,000 |
) |
|
|
|
|
|
(13,499 |
) |
|
|
|
|
|
(9,861 |
) |
|
|
|
|
|
(16,912 |
) |
|
|
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
Finance income |
|
|
|
|
(90 |
) |
|
|
|
|
|
(66 |
) |
|
|
|
|
|
(529 |
) |
|
|
|
|
|
(387 |
) |
|
|
|
|
|
(232 |
) |
|
|
|
Finance costs |
|
|
|
|
2,908 |
|
|
|
|
|
2,124 |
|
|
|
|
|
13,902 |
|
|
|
|
|
10,155 |
|
|
|
|
|
16,512 |
|
| |||||
|
Income taxes |
|
|
|
|
1,433 |
|
|
|
|
|
1,047 |
|
|
|
|
|
1,449 |
|
|
|
|
|
1,059 |
|
|
|
|
|
586 |
|
| |||||
|
Depreciation and amortization |
|
|
|
|
6,422 |
|
|
|
|
|
4,691 |
|
|
|
|
|
13,241 |
|
|
|
|
|
9,672 |
|
|
|
|
|
6,623 |
|
| |||||
|
Adjusted EBITDA |
|
|
|
|
9,304 |
|
|
|
|
|
6,796 |
|
|
|
|
|
14,563 |
|
|
|
|
|
10,638 |
|
|
|
|
|
6,577 |
|
| |||||
|
Sales |
|
|
|
|
45,491 |
|
|
|
|
|
33,229 |
|
|
|
|
|
73,660 |
|
|
|
|
|
53,806 |
|
|
|
|
|
40,834 |
|
| |||||
|
Adjusted EBITDA margin |
|
|
|
|
20.5 |
% |
|
|
|
|
|
20.5 |
% |
|
|
|
|
|
19.8 |
% |
|
|
|
|
|
19.8 |
% |
|
|
|
|
|
16.1 |
% |
|
|
| | | | | | | | | | | | | | | | | |
|
|
|
|
June 30, 2014 (unaudited) |
| |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
Actual |
|
|
As Adjusted |
|
|
Actual |
|
|
As Adjusted |
| ||||||||||||||||
|
|
|
|
(in thousands of US$(1)) |
|
|
(in thousands of Euros) |
| ||||||||||||||||||||||
|
Cash and cash equivalents |
|
|
|
|
70,139 |
|
|
|
|
|
|
|
|
|
|
15,234 |
|
|
|
|
|
|
| ||||||
|
Non-current financial liabilities |
|
|
|
|
25,511 |
|
|
|
|
|
|
|
|
|
|
|
18,635 |
|
|
|
|
|
|
|
| ||||
|
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 |
|
|
|
|
8,615 |
|
|
|
|
|
|
|
|
|
|
|
6,293 |
|
|
|
|
|
|
|
| ||||
|
Share premium |
|
|
|
|
162,162 |
|
|
|
|
|
|
|
|
|
|
|
118,453 |
|
|
|
|
|
|
|
| ||||
|
Reserves and retained earnings |
|
|
|
|
(24,142 |
) |
|
|
|
|
|
|
|
|
|
|
|
(7,636 |
) |
|
|
|
|
|
|
|
| ||
|
Net loss for the year |
|
|
|
|
(713 |
) |
|
|
|
|
|
|
|
|
|
|
|
(521 |
) |
|
|
|
|
|
|
|
| ||
|
Non-controlling interests in equity |
|
|
|
|
2,043 |
|
|
|
|
|
|
|
|
|
|
|
1,492 |
|
|
|
|
|
|
|
| ||||
|
Non-controlling interests in net loss for the year |
|
|
|
|
(656 |
) |
|
|
|
|
|
|
|
|
|
|
|
(479 |
) |
|
|
|
|
|
|
|
| ||
|
Total equity(2) |
|
|
|
|
147,307 |
|
|
|
|
|
|
|
|
|
|
|
107,602 |
|
|
|
|
|
|
|
| ||||
|
Total capitalization(2)(3) |
|
|
|
|
172,818 |
|
|
|
|
|
|
|
|
|
|
|
126,237 |
|
|
|
|
|
|
|
| ||||
| | | | | | | | | | | | | | |
|
Net tangible book value per ADS at June 30, 2014 |
|
|
|
€ |
0.64 |
|
| |
|
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: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
2009 |
|
|
|
|
1.4332 |
|
|
|
|
|
1.3955 |
|
|
|
|
|
1.2547 |
|
|
|
|
|
1.5100 |
|
| ||||
|
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 September 19, 2014) |
|
|
|
|
1.2835 |
|
|
|
|
|
1.3518 |
|
|
|
|
|
1.2835 |
|
|
|
|
|
1.3927 |
|
| ||||
|
Quarter Ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
September 30, 2013 |
|
|
|
|
1.3535 |
|
|
|
|
|
1.3338 |
|
|
|
|
|
1.2774 |
|
|
|
|
|
1.3537 |
|
| ||||
|
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 |
|
| ||||
|
Month Ended: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
January 31, 2014 |
|
|
|
|
1.3500 |
|
|
|
|
|
1.3618 |
|
|
|
|
|
1.3500 |
|
|
|
|
|
1.3682 |
|
| ||||
|
February 28, 2014 |
|
|
|
|
1.3806 |
|
|
|
|
|
1.3665 |
|
|
|
|
|
1.3507 |
|
|
|
|
|
1.3806 |
|
| ||||
|
March 31, 2014 |
|
|
|
|
1.3777 |
|
|
|
|
|
1.3828 |
|
|
|
|
|
1.3731 |
|
|
|
|
|
1.3927 |
|
| ||||
|
April 31, 2014 |
|
|
|
|
1.3870 |
|
|
|
|
|
1.3810 |
|
|
|
|
|
1.3704 |
|
|
|
|
|
1.3898 |
|
| ||||
|
May 31, 2014 |
|
|
|
|
1.3640 |
|
|
|
|
|
1.3739 |
|
|
|
|
|
1.3596 |
|
|
|
|
|
1.3924 |
|
| ||||
|
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 (through September 19, 2014) |
|
|
|
|
1.2835 |
|
|
|
|
|
1.2959 |
|
|
|
|
|
1.2835 |
|
|
|
|
|
1.3136 |
|
| ||||
| | | | | | | | | | | | | |
|
|
|
|
Year Ended December 31, |
|
|
Six Months Ended June 30, |
| ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
2013 |
|
|
2012 |
|
|
2014 |
|
|
2013 |
| ||||||||||||||||||||||||||||||
|
|
|
|
US$(1) |
|
|
Euro |
|
|
Euro |
|
|
US$(1) |
|
|
Euro |
|
|
Euro |
| ||||||||||||||||||||||||
|
|
|
|
(Dollars and Euros in thousands unless otherwise noted except share and per share amounts) |
| |||||||||||||||||||||||||||||||||||||||
|
Consolidated Statements of Income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| | | | | | | | | | | | | | | | | | | | | | |||
|
Sales |
|
|
|
|
73,660 |
|
|
|
|
|
53,806 |
|
|
|
|
|
40,834 |
|
|
|
|
|
45,491 |
|
|
|
|
|
33,229 |
|
|
|
|
|
26,285 |
|
| ||||||
|
Raw materials and consumables used |
|
|
|
|
(12,574 |
) |
|
|
|
|
|
(9,185 |
) |
|
|
|
|
|
(6,296 |
) |
|
|
|
|
|
(8,491 |
) |
|
|
|
|
|
(6,202 |
) |
|
|
|
|
|
(4,606 |
) |
|
|
|
Personnel costs |
|
|
|
|
(21,607 |
) |
|
|
|
|
|
(15,783 |
) |
|
|
|
|
|
(12,970 |
) |
|
|
|
|
|
(12,064 |
) |
|
|
|
|
|
(8,812 |
) |
|
|
|
|
|
(7,706 |
) |
|
|
|
Other operating expenses |
|
|
|
|
(28,653 |
) |
|
|
|
|
|
(20,930 |
) |
|
|
|
|
|
(17,023 |
) |
|
|
|
|
|
(17,459 |
) |
|
|
|
|
|
(12,753 |
) |
|
|
|
|
|
(10,045 |
) |
|
|
|
Other operating income |
|
|
|
|
3,737 |
|
|
|
|
|
2,730 |
|
|
|
|
|
2,032 |
|
|
|
|
|
1,826 |
|
|
|
|
|
1,334 |
|
|
|
|
|
1,539 |
|
| ||||||
|
Depreciation and amortization |
|
|
|
|
(13,241 |
) |
|
|
|
|
|
(9,672 |
) |
|
|
|
|
|
(6,623 |
) |
|
|
|
|
|
(6,422 |
) |
|
|
|
|
|
(4,691 |
) |
|
|
|
|
|
(4,193 |
) |
|
|
|
Operating income (loss) |
|
|
|
|
1,322 |
|
|
|
|
|
966 |
|
|
|
|
|
(46 |
) |
|
|
|
|
|
2,881 |
|
|
|
|
|
2,105 |
|
|
|
|
|
1,274 |
|
| |||||
|
Finance income |
|
|
|
|
530 |
|
|
|
|
|
387 |
|
|
|
|
|
232 |
|
|
|
|
|
90 |
|
|
|
|
|
66 |
|
|
|
|
|
105 |
|
| ||||||
|
Finance costs |
|
|
|
|
(13,902 |
) |
|
|
|
|
|
(10,155 |
) |
|
|
|
|
|
(16,512 |
) |
|
|
|
|
|
(2,908 |
) |
|
|
|
|
|
(2,124 |
) |
|
|
|
|
|
(2,117 |
) |
|
|
|
Net finance costs |
|
|
|
|
(13,372 |
) |
|
|
|
|
|
(9,768 |
) |
|
|
|
|
|
(16,280 |
) |
|
|
|
|
|
(2,818 |
) |
|
|
|
|
|
(2,058 |
) |
|
|
|
|
|
(2,012 |
) |
|
|
|
Loss before income taxes |
|
|
|
|
(12,050 |
) |
|
|
|
|
|
(8,802 |
) |
|
|
|
|
|
(16,326 |
) |
|
|
|
|
|
64 |
|
|
|
|
|
47 |
|
|
|
|
|
(738 |
) |
|
| ||
|
Income taxes |
|
|
|
|
(1,450 |
) |
|
|
|
|
|
(1,059 |
) |
|
|
|
|
|
(586 |
) |
|
|
|
|
|
(1,433 |
) |
|
|
|
|
|
(1,047 |
) |
|
|
|
|
|
(362 |
) |
|
|
|
Net loss for the year |
|
|
|
|
(13,450 |
) |
|
|
|
|
|
(9,861 |
) |
|
|
|
|
|
(16,912 |
) |
|
|
|
|
|
(1,370 |
) |
|
|
|
|
|
(1,000 |
) |
|
|
|
|
|
(1,100 |
) |
|
|
|
Attributable to |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| | | | | | | | | | | | | | | | | | | | | | |||
|
Owners of the company |
|
|
|
|
(12,637 |
) |
|
|
|
|
|
(9,231 |
) |
|
|
|
|
|
(16,455 |
) |
|
|
|
|
|
(713 |
) |
|
|
|
|
|
(521 |
) |
|
|
|
|
|
(844 |
) |
|
|
|
Non-controlling interests |
|
|
|
|
(861 |
) |
|
|
|
|
|
(629 |
) |
|
|
|
|
|
(457 |
) |
|
|
|
|
|
(656 |
) |
|
|
|
|
|
(479 |
) |
|
|
|
|
|
(256 |
) |
|
|
|
Loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| | | | | | | | | | | | | | | | | | | | | | |||
|
Basic (US$ and € per share) |
|
|
|
|
(0.23 |
) |
|
|
|
|
|
(0.17 |
) |
|
|
|
|
|
(0.31 |
) |
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
(0.02 |
) |
|
|
|
Diluted (US$ and € per share) |
|
|
|
|
(0.23 |
) |
|
|
|
|
|
(0.17 |
) |
|
|
|
|
|
(0.31 |
) |
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
(0.02 |
) |
|
|
| | | | | | | | | | | | | | | | | | | | |
|
|
|
|
At June 30, 2014 |
|
|
At December 31, 2013 |
| |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
US$(1) |
|
|
Euro |
|
|
Euro |
| ||||||||||||
|
|
|
|
(Dollars and Euros in thousands) |
| ||||||||||||||||||
|
Consolidated Statements of Financial Position: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Assets |
| | | | | | | | | | | | | | | | | | | | | |
|
Non-current assets |
|
|
|
|
164,710 |
|
|
|
|
|
120,314 |
|
|
|
|
|
114,202 |
|
| |||
|
Goodwill |
|
|
|
|
29,688 |
|
|
|
|
|
21,686 |
|
|
|
|
|
21,252 |
|
| |||
|
Other intangible assets |
|
|
|
|
62,117 |
|
|
|
|
|
45,374 |
|
|
|
|
|
41,334 |
|
| |||
|
Property, plant and equipment |
|
|
|
|
70,230 |
|
|
|
|
|
51,300 |
|
|
|
|
|
49,280 |
|
| |||
|
Financial assets |
|
|
|
|
2,675 |
|
|
|
|
|
1,954 |
|
|
|
|
|
2,336 |
|
| |||
|
Current assets |
|
|
|
|
112,177 |
|
|
|
|
|
81,941 |
|
|
|
|
|
40,029 |
|
| |||
|
Inventories |
|
|
|
|
4,733 |
|
|
|
|
|
3,457 |
|
|
|
|
|
2,278 |
|
| |||
|
Trade and other receivables |
|
|
|
|
26,074 |
|
|
|
|
|
19,046 |
|
|
|
|
|
16,143 |
|
| |||
|
Other current assets |
|
|
|
|
11,231 |
|
|
|
|
|
8,204 |
|
|
|
|
|
7,997 |
|
| |||
|
Cash and cash equivalents |
|
|
|
|
70,139 |
|
|
|
|
|
51,234 |
|
|
|
|
|
13,610 |
|
| |||
|
Total assets |
|
|
|
|
276,887 |
|
|
|
|
|
202,255 |
|
|
|
|
|
154,231 |
|
| |||
|
Equity and liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Equity attributable to owners of the company |
|
|
|
|
145,920 |
|
|
|
|
|
106,589 |
|
|
|
|
|
63,350 |
|
| |||
|
Share capital |
|
|
|
|
8,615 |
|
|
|
|
|
6,293 |
|
|
|
|
|
5,415 |
|
| |||
|
Share premium |
|
|
|
|
162,162 |
|
|
|
|
|
118,453 |
|
|
|
|
|
76,594 |
|
| |||
|
Reserves and retained earnings |
|
|
|
|
(24,144 |
) |
|
|
|
|
|
(17,636 |
) |
|
|
|
|
|
(9,427 |
) |
|
|
|
Net loss for the year |
|
|
|
|
(713 |
) |
|
|
|
|
|
(521 |
) |
|
|
|
|
|
(9,231 |
) |
|
|
|
Non-controlling interests |
|
|
|
|
1,387 |
|
|
|
|
|
1,013 |
|
|
|
|
|
1,360 |
|
| |||
|
Total equity |
|
|
|
|
147,307 |
|
|
|
|
|
107,602 |
|
|
|
|
|
64,710 |
|
| |||
|
Non-current liabilities |
|
|
|
|
90,273 |
|
|
|
|
|
65,941 |
|
|
|
|
|
65,178 |
|
| |||
|
Non-current provisions |
|
|
|
|
9,897 |
|
|
|
|
|
7,229 |
|
|
|
|
|
6,030 |
|
| |||
|
Non-current financial liabilities |
|
|
|
|
25,511 |
|
|
|
|
|
18,635 |
|
|
|
|
|
20,359 |
|
| |||
|
Deferred tax liabilities |
|
|
|
|
5,759 |
|
|
|
|
|
4,207 |
|
|
|
|
|
4,342 |
|
| |||
|
Other non-current liabilities |
|
|
|
|
49,106 |
|
|
|
|
|
35,870 |
|
|
|
|
|
34,448 |
|
| |||
|
Current liabilities |
|
|
|
|
39,306 |
|
|
|
|
|
28,712 |
|
|
|
|
|
24,343 |
|
| |||
|
Current provisions |
|
|
|
|
188 |
|
|
|
|
|
137 |
|
|
|
|
|
115 |
|
| |||
|
Current financial liabilities |
|
|
|
|
8,057 |
|
|
|
|
|
5,885 |
|
|
|
|
|
5,458 |
|
| |||
|
Trade and other payables |
|
|
|
|
16,264 |
|
|
|
|
|
11,880 |
|
|
|
|
|
9,218 |
|
| |||
|
Other current liabilities |
|
|
|
|
14,799 |
|
|
|
|
|
10,810 |
|
|
|
|
|
9,552 |
|
| |||
|
Total liabilities |
|
|
|
|
129,580 |
|
|
|
|
|
94,653 |
|
|
|
|
|
89,521 |
|
| |||
|
Total Equity and liabilities |
|
|
|
|
276,887 |
|
|
|
|
|
202,255 |
|
|
|
|
|
154,231 |
|
| |||
| | | | | | | | | | | |
|
|
|
|
Year Ended December 31, |
|
|
Six Months Ended June 30, |
| ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
2013 |
|
|
2012 |
|
|
2014 |
|
|
2013 |
| ||||||||||||||||||||||||||||||
|
|
|
|
US$(1) |
|
|
Euro |
|
|
Euro |
|
|
US$(1) |
|
|
Euro |
|
|
Euro |
| ||||||||||||||||||||||||
|
|
|
|
(Dollars and Euros in thousands except percentages) |
| |||||||||||||||||||||||||||||||||||||||
|
Financial metrics |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| | | | | | | | | | | | | | | | | | | | | | |||
|
Sales |
|
|
|
|
73,660 |
|
|
|
|
|
53,806 |
|
|
|
|
|
40,834 |
|
|
|
|
|
45,491 |
|
|
|
|
|
33,229 |
|
|
|
|
|
26,285 |
|
| ||||||
|
Year-over-year percentage increase |
|
|
|
|
|
|
|
|
|
|
31.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26.8 |
% |
|
|
|
|
|
|
|
| ||||
|
Operating income/(loss) |
|
|
|
|
1,322 |
|
|
|
|
|
966 |
|
|
|
|
|
(46 |
) |
|
|
|
|
|
2,882 |
|
|
|
|
|
2,105 |
|
|
|
|
|
1,274 |
|
| |||||
|
Net loss for the year |
|
|
|
|
(13,450 |
) |
|
|
|
|
|
(9,861 |
) |
|
|
|
|
|
(16,912 |
) |
|
|
|
|
|
(1,369 |
) |
|
|
|
|
|
(1,000 |
) |
|
|
|
|
|
(1,100 |
) |
|
|
|
Adjusted EBITDA(2) |
|
|
|
|
14,653 |
|
|
|
|
|
10,638 |
|
|
|
|
|
6,577 |
|
|
|
|
|
9,304 |
|
|
|
|
|
6,796 |
|
|
|
|
|
5,467 |
|
| ||||||
|
Adjusted EBITDA margin(2) |
|
|
|
|
19.8 |
% |
|
|
|
|
|
19.8 |
% |
|
|
|
|
|
16.1 |
% |
|
|
|
|
|
20.5 |
% |
|
|
|
|
|
20.5 |
% |
|
|
|
|
|
20.8 |
% |
|
|
|
Net cash from operating activities |
|
|
|
|
16,349 |
|
|
|
|
|
11,942 |
|
|
|
|
|
6,524 |
|
|
|
|
|
9,665 |
|
|
|
|
|
7,455 |
|
|
|
|
|
1,048 |
|
| ||||||
|
Cash and cash equivalents |
|
|
|
|
18,632 |
|
|
|
|
|
13,610 |
|
|
|
|
|
14,066 |
|
|
|
|
|
70,139 |
|
|
|
|
|
51,234 |
|
|
|
|
|
15,264 |
|
| ||||||
| | | | | | | | | | | | | | | | | | | | |
|
|
|
|
For the six months ended June 30, |
| |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
2014 |
|
|
2014 |
|
|
2013 |
|
|
% Change from prior period |
| ||||||||||||||||
|
|
|
|
US$(1) |
|
|
Euro |
|
|
Euro |
|
|
| |||||||||||||||||
|
|
|
|
(Dollars and Euros in thousands except percentages) |
| |||||||||||||||||||||||||
|
Consolidated Statements of Income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
Sales |
|
|
|
$ |
45,491 |
|
|
|
|
€ |
33,229 |
|
|
|
|
€ |
26,285 |
|
|
|
|
|
26 |
% |
|
| |||
|
Raw materials and consumables used |
|
|
|
|
(8,491 |
) |
|
|
|
|
|
(6,202 |
) |
|
|
|
|
|
(4,606 |
) |
|
|
|
|
|
35 |
% |
|
|
|
Personnel costs |
|
|
|
|
(12,064 |
) |
|
|
|
|
|
(8,812 |
) |
|
|
|
|
|
(7,706 |
) |
|
|
|
|
|
14 |
% |
|
|
|
Other operating expenses |
|
|
|
|
(17,459 |
) |
|
|
|
|
|
(12,753 |
) |
|
|
|
|
|
(10,045 |
) |
|
|
|
|
|
27 |
% |
|
|
|
Other operating income |
|
|
|
|
1,826 |
|
|
|
|
|
1,334 |
|
|
|
|
|
1,539 |
|
|
|
|
|
(13 |
%) |
|
| |||
|
Depreciation and amortization |
|
|
|
|
(6,422 |
) |
|
|
|
|
|
(4,691 |
) |
|
|
|
|
|
(4,193 |
) |
|
|
|
|
|
12 |
% |
|
|
|
Operating income (loss) |
|
|
|
|
2,881 |
|
|
|
|
|
2,105 |
|
|
|
|
|
1,274 |
|
|
|
|
|
65 |
% |
|
| |||
|
Finance costs |
|
|
|
|
(2,908 |
) |
|
|
|
|
|
(2,124 |
) |
|
|
|
|
|
(2,117 |
) |
|
|
|
|
|
0 |
% |
|
|
|
Finance income |
|
|
|
|
90 |
|
|
|
|
|
66 |
|
|
|
|
|
105 |
|
|
|
|
|
(37 |
%) |
|
| |||
|
Net finance costs |
|
|
|
|
(2,818 |
) |
|
|
|
|
|
(2,058 |
) |
|
|
|
|
|
(2,012 |
) |
|
|
|
|
|
0 |
% |
|
|
|
Loss before income taxes |
|
|
|
|
64 |
|
|
|
|
|
47 |
|
|
|
|
|
(738 |
) |
|
|
|
|
|
(106 |
%) |
|
| ||
|
Income taxes |
|
|
|
|
(1,433 |
) |
|
|
|
|
|
(1,047 |
) |
|
|
|
|
|
(362 |
) |
|
|
|
|
|
189 |
% |
|
|
|
Net loss for the period |
|
|
|
|
(1,370 |
) |
|
|
|
|
|
(1,000 |
) |
|
|
|
|
|
(1,100 |
) |
|
|
|
|
|
(9 |
%) |
|
|
|
Attributable to owners of the company |
|
|
|
|
(713 |
) |
|
|
|
|
|
(521 |
) |
|
|
|
|
|
(844 |
) |
|
|
|
|
|
(38 |
%) |
|
|
|
Non-controlling interests |
|
|
|
|
(656 |
) |
|
|
|
|
|
(479 |
) |
|
|
|
|
|
(256 |
) |
|
|
|
|
|
87 |
% |
|
|
|
Loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
Basic (US$ and € per share) |
|
|
|
|
(0.01 |
) |
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
(0.02 |
) |
|
|
|
|
|
|
|
| |
|
Diluted (US$ and € per share) |
|
|
|
|
(0.01 |
) |
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
(0.02 |
) |
|
|
|
|
|
|
|
| |
| | | | | | | | | | | | | | |
|
|
|
|
For the year ended December 31, |
| |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
2013 |
|
|
2013 |
|
|
2012 |
|
|
% Change from prior year |
| ||||||||||||||||
|
|
|
|
US$(1) |
|
|
Euro |
|
|
Euro |
|
|
| |||||||||||||||||
|
|
|
|
(Dollars and Euros in thousands except percentages) |
| |||||||||||||||||||||||||
|
Consolidated Statements of Income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
Sales |
|
|
|
$ |
73,660 |
|
|
|
|
€ |
53,806 |
|
|
|
|
€ |
40,834 |
|
|
|
|
|
31.8 |
|
| ||||
|
Raw materials and consumables used |
|
|
|
|
(12,574 |
) |
|
|
|
|
|
(9,185 |
) |
|
|
|
|
|
(6,296 |
) |
|
|
|
|
|
45.9 |
|
| |
|
Personnel costs |
|
|
|
|
(21,607 |
) |
|
|
|
|
|
(15,783 |
) |
|
|
|
|
|
(12,970 |
) |
|
|
|
|
|
21.7 |
|
| |
|
Other operating expenses |
|
|
|
|
(28,653 |
) |
|
|
|
|
|
(20,930 |
) |
|
|
|
|
|
(17,023 |
) |
|
|
|
|
|
23.0 |
|
| |
|
Other operating income |
|
|
|
|
3,737 |
|
|
|
|
|
2,730 |
|
|
|
|
|
2,032 |
|
|
|
|
|
34.4 |
|
| ||||
|
Depreciation and amortization |
|
|
|
|
(13,241 |
) |
|
|
|
|
|
(9,672 |
) |
|
|
|
|
|
(6,623 |
) |
|
|
|
|
|
46.0 |
|
| |
|
Operating income (loss) |
|
|
|
|
1,322 |
|
|
|
|
|
966 |
|
|
|
|
|
(46 |
) |
|
|
|
|
|
— |
|
| |||
|
Finance costs |
|
|
|
|
(13,902 |
) |
|
|
|
|
|
(10,155 |
) |
|
|
|
|
|
(16,512 |
) |
|
|
|
|
|
(38.5 |
) |
|
|
|
Finance income |
|
|
|
|
530 |
|
|
|
|
|
387 |
|
|
|
|
|
232 |
|
|
|
|
|
66.8 |
|
| ||||
|
Net finance costs |
|
|
|
|
(13,372 |
) |
|
|
|
|
|
(9,768 |
) |
|
|
|
|
|
(16,280 |
) |
|
|
|
|
|
(40.0 |
) |
|
|
|
Loss before income taxes |
|
|
|
|
(12,050 |
) |
|
|
|
|
|
(8,802 |
) |
|
|
|
|
|
(16,326 |
) |
|
|
|
|
|
(46.1 |
) |
|
|
|
Income taxes |
|
|
|
|
(1,450 |
) |
|
|
|
|
|
(1,059 |
) |
|
|
|
|
|
(586 |
) |
|
|
|
|
|
80.7 |
|
| |
|
Net loss for the year |
|
|
|
|
(13,450 |
) |
|
|
|
|
|
(9,861 |
) |
|
|
|
|
|
(16,912 |
) |
|
|
|
|
|
(41.7 |
) |
|
|
|
Attributable to owners of the company |
|
|
|
|
(12,637 |
) |
|
|
|
|
|
(9,231 |
) |
|
|
|
|
|
(16,455 |
) |
|
|
|
|
|
(43.9 |
) |
|
|
|
Non-controlling interests |
|
|
|
|
(861 |
) |
|
|
|
|
|
(629 |
) |
|
|
|
|
|
(457 |
) |
|
|
|
|
|
37.6 |
|
| |
|
Loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
Basic (US$ and € per share) |
|
|
|
|
(0.23 |
) |
|
|
|
|
|
(0.17 |
) |
|
|
|
|
|
(0.31 |
) |
|
|
|
|
|
(45.2 |
) |
|
|
|
Diluted (US$ and € per share) |
|
|
|
|
(0.23 |
) |
|
|
|
|
|
(0.17 |
) |
|
|
|
|
|
(0.31 |
) |
|
|
|
|
|
(45.2 |
) |
|
|
| | | | | | | | | | | | | | |
|
|
|
|
For the Six Months Ended June 30, |
|
|
For the Years Ended December 31, |
| ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
2014 |
|
|
2013 |
|
|
2013 |
|
|
2012(2) |
| ||||||||||||||||||||||||||||||
|
|
|
|
US$(1) |
|
|
Euro |
|
|
Euro |
|
|
US$(1) |
|
|
Euro |
|
|
Euro |
| ||||||||||||||||||||||||
|
|
|
|
(Dollars and Euros in thousands) |
| |||||||||||||||||||||||||||||||||||||||
|
Net cash from operating activities |
|
|
|
$ |
10,206 |
|
|
|
|
€ |
7,455 |
|
|
|
|
€ |
1,048 |
|
|
|
|
$ |
16,349 |
|
|
|
|
€ |
11,942 |
|
|
|
|
€ |
6,524 |
|
| ||||||
|
Net cash used in investing activities |
|
|
|
|
(11,422 |
) |
|
|
|
|
|
(8,343 |
) |
|
|
|
|
|
(5,529 |
) |
|
|
|
|
|
(21,220 |
) |
|
|
|
|
|
(15,500 |
) |
|
|
|
|
|
(28,735 |
) |
|
|
|
Net cash from financing activities |
|
|
|
|
52,623 |
|
|
|
|
|
38,439 |
|
|
|
|
|
(5,699 |
) |
|
|
|
|
|
4,421 |
|
|
|
|
|
3,229 |
|
|
|
|
|
7,348 |
|
| |||||
|
Net increase/(decrease) in cash and cash equivalents |
|
|
|
|
51,407 |
|
|
|
|
|
37,551 |
|
|
|
|
|
1,218 |
|
|
|
|
|
(452 |
) |
|
|
|
|
|
(330 |
) |
|
|
|
|
|
(14,863 |
) |
|
| |||
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
|
|
100 |
|
|
|
|
|
73 |
|
|
|
|
|
69 |
|
|
|
|
|
(10 |
) |
|
|
|
|
|
(7 |
) |
|
|
|
|
|
6 |
|
| ||||
|
Cash and cash equivalents at the end of the period |
|
|
|
$ |
70,139 |
|
|
|
|
€ |
51,234 |
|
|
|
|
€ |
15,264 |
|
|
|
|
$ |
18,632 |
|
|
|
|
€ |
13,610 |
|
|
|
|
€ |
13,977 |
|
| ||||||
| | | | | | | | | | | | | | | | | | | | |
|
Contractual Obligations |
|
|
Less than 1 year |
|
|
Between 1 and 3 years |
|
|
Between 1 and 5 years |
|
|
More than 5 years |
|
|
Total |
| ||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
(amounts in thousands of Euros) |
| ||||||||||||||||||||||||||||||||
|
Finance lease obligations(1) |
|
|
|
|
1,671 |
|
|
|
|
|
2,767 |
|
|
|
|
|
1,484 |
|
|
|
|
|
1,719 |
|
|
|
|
|
7,640 |
|
| |||||
|
Other loans and financial liabilities(1) |
|
|
|
|
4,584 |
|
|
|
|
|
6,771 |
|
|
|
|
|
5,121 |
|
|
|
|
|
2,527 |
|
|
|
|
|
19,003 |
|
| |||||
|
Total |
|
|
|
€ |
6,255 |
|
|
|
|
€ |
9,538 |
|
|
|
|
€ |
6,605 |
|
|
|
|
€ |
4,246 |
|
|
|
|
€ |
26,643 |
|
| |||||
| | | | | | | | | | | | | | | | | |
|
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 |
|
|
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 |
|
|
Description |
|
|
Applications |
|
|
Marketing Authorizations |
|
---|---|---|---|---|---|---|---|---|---|---|---|
|
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 |
|
|
56 |
|
|
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 |
|
|
55 |
|
|
Director |
|
|
2014 |
|
|
Steve Gannon |
|
|
52 |
|
|
Director |
|
|
2014 |
|
|
Yvonne Greenstreet |
|
|
52 |
|
|
Director |
|
|
2014 |
|
|
Christian Merle |
|
|
61 |
|
|
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 |
|
|
|
|
1,390,600 |
|
|
|
|
|
2.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Heinz Mäusli |
|
|
|
|
701,050 |
|
|
|
|
|
1.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Claude Hariton |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
All directors and senior management as a group (13 persons)(1) |
|
|
|
|
8,619,950 |
|
|
|
|
|
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. |
|
|
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. |
|
| | | | | |
|
|
|
|
France |
|
|
Delaware |
|
---|---|---|---|---|---|---|---|---|
|
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. |
|
|
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, |
|
|
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. |
|
| | | | | |
|
|
|
|
France |
|
|
Delaware |
|
---|---|---|---|---|---|---|---|---|
|
|
|
|
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). |
|
|
|
|
|
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. |
|
|
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. |
|
| | | | | |
|
|
|
|
France |
|
|
Delaware |
|
---|---|---|---|---|---|---|---|---|
|
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 or the By-laws. |
|
|
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. |
|
|
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:
•
•
|
|
|
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. |
|
| | | | | |
|
|
|
|
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;
•
•
•
|
|
|
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. |
|
| | | | | |
|
|
|
|
France |
|
|
Delaware |
|
---|---|---|---|---|---|---|---|---|
|
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:
•
•
|
|
|
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:
•
•
|
|
|
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:
•
•
|
|
| | | | | |
|
|
|
|
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:
•
•
•
|
|
| | | | | |
|
|
|
|
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:
•
•
|
|
|
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 |
|
|
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: |
|
---|---|---|---|---|---|
|
•
•
•
•
|
|
|
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 |
|
|
|
|
|
|
| |
|
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. |
| |||||||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
| | | | | |
|
In thousands of Euros |
|
|
Notes |
|
|
06.30.2014 |
|
|
06.30.2013 |
| ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sales |
|
|
|
|
4.1 |
|
|
|
|
|
33,229 |
|
|
|
|
|
26,285 |
|
| |||
|
Raw materials and consumables used |
|
|
|
|
|
|
|
|
|
|
(6,202 |
) |
|
|
|
|
|
(4,606 |
) |
|
| |
|
Personnel costs |
|
|
|
|
4.2 |
|
|
|
|
|
(8,812 |
) |
|
|
|
|
|
(7,706 |
) |
|
| |
|
Other operating expenses |
|
|
|
|
|
|
|
|
|
|
(12,753 |
) |
|
|
|
|
|
(10,045 |
) |
|
| |
|
Other operating income |
|
|
|
|
|
|
|
|
|
|
1,334 |
|
|
|
|
|
1,539 |
|
| |||
|
Depreciation and amortization |
|
|
|
|
|
|
|
|
|
|
(4,691 |
) |
|
|
|
|
|
(4,193 |
) |
|
| |
|
Operating income |
|
|
|
|
|
|
|
|
|
|
2,105 |
|
|
|
|
|
1,274 |
|
| |||
|
Finance income |
|
|
|
|
|
|
|
|
|
|
66 |
|
|
|
|
|
105 |
|
| |||
|
Finance costs |
|
|
|
|
4.3 |
|
|
|
|
|
(2,124 |
) |
|
|
|
|
|
(2,117 |
) |
|
| |
|
Net finance costs |
|
|
|
|
|
|
|
|
|
|
(2,058 |
) |
|
|
|
|
|
(2,012 |
) |
|
| |
|
Income/(loss) before income taxes |
|
|
|
|
|
|
|
|
|
|
47 |
|
|
|
|
|
(738 |
) |
|
| ||
|
Income taxes |
|
|
|
|
4.4 |
|
|
|
|
|
(1,047 |
) |
|
|
|
|
|
(362 |
) |
|
| |
|
Loss for the period |
|
|
|
|
|
|
|
|
|
|
(1,000 |
) |
|
|
|
|
|
(1,100 |
) |
|
| |
|
Attribuable to: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Owners of the company |
|
|
|
|
|
|
|
|
|
|
(521 |
) |
|
|
|
|
|
(844 |
) |
|
| |
|
Non-controlling interests |
|
|
|
|
|
|
|
|
|
|
(479 |
) |
|
|
|
|
|
(256 |
) |
|
| |
|
Earnings per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Basic (€ per share) |
|
|
|
|
|
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
(0.02 |
) |
|
| |
|
Diluted (€ per share) |
|
|
|
|
|
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
(0.02 |
) |
|
| |
| | | | | | | | | | | |
|
In thousands of Euros |
|
|
06.30.2014 |
|
|
06.30.2013 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Loss for the period |
|
|
|
|
(1,000 |
) |
|
|
|
|
|
(1,100 |
) |
|
|
|
Other comprehensive income: |
| | | | | | | | | | | | | | |
|
Items that may be reclassified subsequently to profit or loss |
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
Exchange differences on translating foreign operations |
|
|
|
|
604 |
|
|
|
|
|
804 |
|
| ||
|
Items that will never be reclassified subsequently to profit or loss |
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
Remeasurement of defined benefit liability |
|
|
|
|
7 |
|
|
|
|
|
12 |
|
| ||
|
Other comprehensive income net of tax(1) |
|
|
|
|
612 |
|
|
|
|
|
816 |
|
| ||
|
Total comprehensive income/(loss) for the period |
|
|
|
|
(388 |
) |
|
|
|
|
|
(284 |
) |
|
|
|
Total comprehensive income/(loss) attributable to: |
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
Owners of the company |
|
|
|
|
83 |
|
|
|
|
|
(71 |
) |
|
| |
|
Non-controlling interests |
|
|
|
|
(471 |
) |
|
|
|
|
|
(213 |
) |
|
|
| | | | | | | | |
|
(In thousands of Euros) |
|
|
Notes |
|
|
06.30.2014 |
|
|
12.31.2013 |
| ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Non-current assets |
|
|
|
|
|
|
|
|
|
|
120,314 |
|
|
|
|
|
114,202 |
|
| |||
|
Goodwill |
|
|
|
|
5.3 |
|
|
|
|
|
21,686 |
|
|
|
|
|
21,252 |
|
| |||
|
Other intangible assets |
|
|
|
|
5.3 |
|
|
|
|
|
45,374 |
|
|
|
|
|
41,334 |
|
| |||
|
Property, plant and equipment |
|
|
|
|
5.4 |
|
|
|
|
|
51,300 |
|
|
|
|
|
49,280 |
|
| |||
|
Financial assets |
|
|
|
|
|
|
|
|
|
|
1,954 |
|
|
|
|
|
2,336 |
|
| |||
|
Current assets |
|
|
|
|
|
|
|
|
|
|
81,941 |
|
|
|
|
|
40,029 |
|
| |||
|
Inventories |
|
|
|
|
|
|
|
|
|
|
3,457 |
|
|
|
|
|
2,278 |
|
| |||
|
Trade and other receivables |
|
|
|
|
|
|
|
|
|
|
19,046 |
|
|
|
|
|
16,143 |
|
| |||
|
Other current assets |
|
|
|
|
|
|
|
|
|
|
8,204 |
|
|
|
|
|
7,997 |
|
| |||
|
Cash and cash equivalents |
|
|
|
|
5.5 |
|
|
|
|
|
51,234 |
|
|
|
|
|
13,610 |
|
| |||
|
TOTAL ASSETS |
|
|
|
|
|
|
|
|
|
|
202,255 |
|
|
|
|
|
154,231 |
|
| |||
|
EQUITY AND LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Equity attribuable to owners of the company |
|
|
|
|
|
|
|
|
|
|
106,589 |
|
|
|
|
|
63,350 |
|
| |||
|
Share capital |
|
|
|
|
|
|
|
|
|
|
6,293 |
|
|
|
|
|
5,415 |
|
| |||
|
Share premium |
|
|
|
|
|
|
|
|
|
|
118,453 |
|
|
|
|
|
76,594 |
|
| |||
|
Reserves and retained earnings |
|
|
|
|
|
|
|
|
|
|
(17,636 |
) |
|
|
|
|
|
(9,427 |
) |
|
| |
|
Net loss for the period |
|
|
|
|
|
|
|
|
|
|
(521 |
) |
|
|
|
|
|
(9,231 |
) |
|
| |
|
Non-controlling interests |
|
|
|
|
|
|
|
|
|
|
1,013 |
|
|
|
|
|
1,360 |
|
| |||
|
Total equity |
|
|
|
|
5.5 |
|
|
|
|
|
107,602 |
|
|
|
|
|
64,710 |
|
| |||
|
Non-current liabilities |
|
|
|
|
|
|
|
|
|
|
65,941 |
|
|
|
|
|
65,178 |
|
| |||
|
Non-current provisions |
|
|
|
|
|
|
|
|
|
|
7,229 |
|
|
|
|
|
6,030 |
|
| |||
|
Non-current financial liabilities |
|
|
|
|
5.7 |
|
|
|
|
|
18,635 |
|
|
|
|
|
20,359 |
|
| |||
|
Deferred tax liabilities |
|
|
|
|
|
|
|
|
|
|
4,207 |
|
|
|
|
|
4,342 |
|
| |||
|
Other non-current liabilities |
|
|
|
|
5.8 |
|
|
|
|
|
35,870 |
|
|
|
|
|
34,448 |
|
| |||
|
Current liabilities |
|
|
|
|
|
|
|
|
|
|
28,712 |
|
|
|
|
|
24,343 |
|
| |||
|
Current provisions |
|
|
|
|
|
|
|
|
|
|
137 |
|
|
|
|
|
115 |
|
| |||
|
Current financial liabilities |
|
|
|
|
5.7 |
|
|
|
|
|
5,885 |
|
|
|
|
|
5,458 |
|
| |||
|
Trade and other payables |
|
|
|
|
|
|
|
|
|
|
11,880 |
|
|
|
|
|
9,218 |
|
| |||
|
Other current liabilities |
|
|
|
|
5.8 |
|
|
|
|
|
10,810 |
|
|
|
|
|
9,552 |
|
| |||
|
Total liabilities |
|
|
|
|
|
|
|
|
|
|
94,653 |
|
|
|
|
|
89,521 |
|
| |||
|
TOTAL EQUITY AND LIABILITIES |
|
|
|
|
|
|
|
|
|
|
202,255 |
|
|
|
|
|
154,231 |
|
| |||
| | | | | | | | | | | |
|
|
|
|
Attribuable to the company |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
In thousands of Euros |
|
|
Share capital |
|
|
Share premium |
|
|
Translation reserve |
|
|
Income/ (loss) for the period |
|
|
Group reserves |
|
|
Total attribuable to owners of the Company |
|
|
Non- controlling interests |
|
|
TOTAL |
| ||||||||||||||||||||||||||||||||
|
At December 31, 2013 |
|
|
|
|
5,415 |
|
|
|
|
|
76,594 |
|
|
|
|
|
(435 |
) |
|
|
|
|
|
(9,231 |
) |
|
|
|
|
|
(8,992 |
) |
|
|
|
|
|
63,350 |
|
|
|
|
|
1,360 |
|
|
|
|
|
64,710 |
|
| |||||
|
Comprehensive income/(loss) for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
|
Net income/(loss) for the period |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(521 |
) |
|
|
|
|
|
— |
|
|
|
|
|
(521 |
) |
|
|
|
|
|
(479 |
) |
|
|
|
|
|
(1,000 |
) |
|
| ||||
|
Other comprehensive income/(loss) for the period |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
597 |
|
|
|
|
|
— |
|
|
|
|
|
7 |
|
|
|
|
|
604 |
|
|
|
|
|
8 |
|
|
|
|
|
612 |
|
| ||||||||
|
Total comprehensive income/(loss) |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
597 |
|
|
|
|
|
(521 |
) |
|
|
|
|
|
7 |
|
|
|
|
|
83 |
|
|
|
|
|
(471 |
) |
|
|
|
|
|
(388 |
) |
|
| |||||
|
Transactions with owners of the company |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
|
Issue of ordinary shares(1) |
|
|
|
|
878 |
|
|
|
|
|
41,859 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(603 |
) |
|
|
|
|
|
42,134 |
|
|
|
|
|
— |
|
|
|
|
|
42,134 |
|
| |||||||
|
Appropriation of 2013 net income/(loss) |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
9,231 |
|
|
|
|
|
(9,231 |
) |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
| |||||||
|
Equity-settled share-based payments |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,112 |
|
|
|
|
|
1,112 |
|
|
|
|
|
— |
|
|
|
|
|
1,112 |
|
| ||||||||
|
Transactions between shareholders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(90 |
) |
|
|
|
|
|
(90 |
) |
|
|
|
|
|
124 |
|
|
|
|
|
34 |
|
| ||||||
|
Total transactions with owners of the company |
|
|
|
|
878 |
|
|
|
|
|
41,859 |
|
|
|
|
|
— |
|
|
|
|
|
9,231 |
|
|
|
|
|
(8,812 |
) |
|
|
|
|
|
43,156 |
|
|
|
|
|
124 |
|
|
|
|
|
43,280 |
|
| |||||||
|
At June 30, 2014 |
|
|
|
|
6,293 |
|
|
|
|
|
118,453 |
|
|
|
|
|
162 |
|
|
|
|
|
(521 |
) |
|
|
|
|
|
(17,797 |
) |
|
|
|
|
|
106,589 |
|
|
|
|
|
1,013 |
|
|
|
|
|
107,602 |
|
| ||||||
| | | | | | | | | | | | | | | | | | | | | | | | | | |
|
|
|
|
Attribuable to the company |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
In thousands of Euros |
|
|
Share capital |
|
|
Share premium |
|
|
Translation reserve |
|
|
Income/ (loss) for the period |
|
|
Group reserves |
|
|
Total attribuable to owners of the Company |
|
|
Non- controlling interests |
|
|
TOTAL |
| ||||||||||||||||||||||||||||||||
|
Balance as at December 31, 2012 |
|
|
|
|
5,244 |
|
|
|
|
|
69,650 |
|
|
|
|
|
(507 |
) |
|
|
|
|
|
(16,455 |
) |
|
|
|
|
|
5,167 |
|
|
|
|
|
63,101 |
|
|
|
|
|
2,189 |
|
|
|
|
|
65,290 |
|
| ||||||
|
Comprehensive income/(loss) for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
|
Net income/(loss) for the period |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(844 |
) |
|
|
|
|
|
— |
|
|
|
|
|
(844 |
) |
|
|
|
|
|
(256 |
) |
|
|
|
|
|
(1,100 |
) |
|
| ||||
|
Other comprehensive income for the year |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
761 |
|
|
|
|
|
— |
|
|
|
|
|
12 |
|
|
|
|
|
773 |
|
|
|
|
|
43 |
|
|
|
|
|
816 |
|
| ||||||||
|
Total comprehensive income/(loss) |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
761 |
|
|
|
|
|
(844 |
) |
|
|
|
|
|
12 |
|
|
|
|
|
(71 |
) |
|
|
|
|
|
(213 |
) |
|
|
|
|
|
(284 |
) |
|
| ||||
|
Transactions with owners of the company |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
|
Issue of ordinary shares |
|
|
|
|
152.84 |
|
|
|
|
|
6,961.95 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
7,115 |
|
|
|
|
|
— |
|
|
|
|
|
7,115 |
|
| ||||||||
|
Appropriation of 2012 net income/(loss) |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
16,456 |
|
|
|
|
|
(16,456 |
) |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
| |||||||
|
Equity-settled share-based payments |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
917 |
|
|
|
|
|
917 |
|
|
|
|
|
— |
|
|
|
|
|
917 |
|
| ||||||||
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
|
Total transactions with owners of the company |
|
|
|
|
153 |
|
|
|
|
|
6,962 |
|
|
|
|
|
— |
|
|
|
|
|
16,456 |
|
|
|
|
|
(15,539 |
) |
|
|
|
|
|
8,031 |
|
|
|
|
|
— |
|
|
|
|
|
8,031 |
|
| |||||||
|
Balance as at June 30, 2013 |
|
|
|
|
5,397 |
|
|
|
|
|
76,612 |
|
|
|
|
|
254 |
|
|
|
|
|
(843 |
) |
|
|
|
|
|
(10,362 |
) |
|
|
|
|
|
71,062 |
|
|
|
|
|
1,976 |
|
|
|
|
|
73,038 |
|
| ||||||
| | | | | | | | | | | | | | | | | | | | | | | | | | |
|
In thousands of Euros |
|
|
Notes |
|
|
06.30.2014 |
|
|
06.30.2013 |
| ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Net income/(loss) for the period |
|
|
|
|
|
|
|
|
|
|
(1,000 |
) |
|
|
|
|
|
(1,100 |
) |
|
| |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Depreciation, amortization and impairment of non-current assets |
|
|
|
|
|
|
|
|
|
|
4,691 |
|
|
|
|
|
4,193 |
|
| |||
|
Share-based payment expense |
|
|
|
|
|
|
|
|
|
|
1,112 |
|
|
|
|
|
917 |
|
| |||
|
Gain on disposal of property, plant and equipment |
|
|
|
|
|
|
|
|
|
|
26 |
|
|
|
|
|
(23 |
) |
|
| ||
|
Financial result |
|
|
|
|
|
|
|
|
|
|
2,058 |
|
|
|
|
|
2,012 |
|
| |||
|
Income tax expense |
|
|
|
|
|
|
|
|
|
|
1,047 |
|
|
|
|
|
362 |
|
| |||
|
|
|
|
|
|
|
|
|
|
|
|
7,934 |
|
|
|
|
|
6,361 |
|
| |||
|
Increase in inventories |
|
|
|
|
|
|
|
|
|
|
(1,179 |
) |
|
|
|
|
|
(328 |
) |
|
| |
|
Increase in trade receivables |
|
|
|
|
|
|
|
|
|
|
(2,903 |
) |
|
|
|
|
|
(133 |
) |
|
| |
|
Increase/(decrease) in trade payables |
|
|
|
|
|
|
|
|
|
|
2,319 |
|
|
|
|
|
(1,664 |
) |
|
| ||
|
Change in other receivable and other payables |
|
|
|
|
|
|
|
|
|
|
1,773 |
|
|
|
|
|
(2,741 |
) |
|
| ||
|
Change in working capital requirements |
|
|
|
|
|
|
|
|
|
|
10 |
|
|
|
|
|
(4,867 |
) |
|
| ||
|
Income tax paid |
|
|
|
|
|
|
|
|
|
|
(489 |
) |
|
|
|
|
|
(446 |
) |
|
| |
|
Net cash from operating activities |
|
|
|
|
|
|
|
|
|
|
7,455 |
|
|
|
|
|
1,048 |
|
| |||
|
Cash flows from investing activities |
| | | | | | | | | | | | | | | | | | | | | |
|
Acquisition of property, plant and equipment |
|
|
|
|
|
|
|
|
|
|
(4,930 |
) |
|
|
|
|
|
(4,142 |
) |
|
| |
|
Acquisition of intangible assets |
|
|
|
|
|
|
|
|
|
|
(3,735 |
) |
|
|
|
|
|
(1,416 |
) |
|
| |
|
Repayment of financial assets |
|
|
|
|
|
|
|
|
|
|
390 |
|
|
|
|
|
0 |
|
| |||
|
Proceeds from disposal of property, plant and equipment |
|
|
|
|
|
|
|
|
|
|
0 |
|
|
|
|
|
29 |
|
| |||
|
Acquisition of subsidiaries, net of cash acquired |
|
|
|
|
5.1 |
|
|
|
|
|
(68 |
) |
|
|
|
|
|
0 |
|
| ||
|
Net cash used in investing activities |
|
|
|
|
|
|
|
|
|
|
(8,343 |
) |
|
|
|
|
|
(5,529 |
) |
|
| |
|
Cash flows from financing activities |
| | | | | | | | | | | | | | | | | | | | | |
|
Payment of deferred and contingent liabilities to former owners of acquired subsidiaries |
|
|
|
|
|
|
|
|
|
|
(394 |
) |
|
|
|
|
|
— |
|
| ||
|
Issuance of share capital |
|
|
|
|
5.5 |
|
|
|
|
|
40,666 |
|
|
|
|
|
4,820 |
|
| |||
|
Proceeds from borrowings |
|
|
|
|
|
|
|
|
|
|
1,025 |
|
|
|
|
|
2,600 |
|
| |||
|
Repayment of borrowings |
|
|
|
|
|
|
|
|
|
|
(2,507 |
) |
|
|
|
|
|
(1,313 |
) |
|
| |
|
Interests paid |
|
|
|
|
|
|
|
|
|
|
(351 |
) |
|
|
|
|
|
(408 |
) |
|
| |
|
Net cash from financing activities |
|
|
|
|
|
|
|
|
|
|
38,439 |
|
|
|
|
|
5,699 |
|
| |||
|
Net increase in cash and cash equivalents |
|
|
|
|
|
|
|
|
|
|
37,551 |
|
|
|
|
|
1,218 |
|
| |||
|
Cash and cash equivalents at the beginning of the period |
|
|
|
|
|
|
|
|
|
|
13,610 |
|
|
|
|
|
13,977 |
|
| |||
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
|
|
|
|
|
|
|
|
73 |
|
|
|
|
|
69 |
|
| |||
|
Cash and cash equivalents at the end of the period |
|
|
|
|
|
|
|
|
|
|
51,234 |
|
|
|
|
|
15,264 |
|
| |||
| | | | | | | | | | | |
|
|
|
|
|
F-9 |
|
| ||
|
|
|
|
|
F-9 |
|
| ||
|
|
|
|
|
F-9 |
|
| ||
|
|
|
|
|
F-9 |
|
| ||
|
|
|
|
|
F-9 |
|
| ||
|
|
|
|
|
F-10 |
|
| ||
|
|
|
|
|
F-10 |
|
| ||
|
|
|
|
|
F-10 |
|
| ||
|
|
|
|
|
F-10 |
|
| ||
|
|
|
|
|
F-10 |
|
| ||
|
|
|
|
|
F-11 |
|
| ||
|
|
|
|
|
F-11 |
|
| ||
|
|
|
|
|
F-11 |
|
| ||
|
|
|
|
|
F-11 |
|
| ||
|
|
|
|
|
F-12 |
|
| ||
|
|
|
|
|
F-12 |
|
| ||
|
|
|
|
|
F-13 |
|
| ||
|
|
|
|
|
F-13 |
|
| ||
|
|
|
|
|
F-13 |
|
| ||
|
|
|
|
|
F-14 |
|
| ||
|
|
|
|
|
F-14 |
|
| ||
|
|
|
|
|
F-14 |
|
| ||
|
|
|
|
|
F-15 |
|
| ||
|
|
|
|
|
F-15 |
|
| ||
|
|
|
|
|
F-15 |
|
| ||
|
|
|
|
|
F-16 |
|
| ||
|
|
|
|
|
F-16 |
|
| ||
|
|
|
|
|
F-17 |
|
| ||
|
|
|
|
|
F-18 |
|
| ||
|
|
|
|
|
F-19 |
|
| ||
| | | | | |
|
Sales by products |
|
|
|
|
| ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
In KEUR |
|
|
06.30.2014 |
|
|
06.30.2013 |
| ||||||||
|
Product PET |
|
|
|
|
22,808 |
|
|
|
|
|
20,459 |
|
| ||
|
Product SPECT – Diagnostic |
|
|
|
|
4,367 |
|
|
|
|
|
4,033 |
|
| ||
|
Product – Therapy |
|
|
|
|
2,504 |
|
|
|
|
|
1,272 |
|
| ||
|
Other products |
|
|
|
|
3,550 |
|
|
|
|
|
520 |
|
| ||
|
Total |
|
|
|
|
33,229 |
|
|
|
|
|
26,285 |
|
| ||
| | | | | | | |
|
Sales by country |
|
|
|
|
| ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
In KEUR |
|
|
06.30.2014 |
|
|
06.30.2013 |
| ||||||||
|
France |
|
|
|
|
12,435 |
|
|
|
|
|
11,106 |
|
| ||
|
Abroad |
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
Italy |
|
|
|
|
8,943 |
|
|
|
|
|
7,309 |
|
| ||
|
Spain |
|
|
|
|
3,106 |
|
|
|
|
|
3,285 |
|
| ||
|
Israel |
|
|
|
|
1,255 |
|
|
|
|
|
2,049 |
|
| ||
|
Canada |
|
|
|
|
5 |
|
|
|
|
|
164 |
|
| ||
|
United States |
|
|
|
|
— |
|
|
|
|
|
3 |
|
| ||
|
Other countries |
|
|
|
|
7,486 |
|
|
|
|
|
2,370 |
|
| ||
|
Total |
|
|
|
|
33,229 |
|
|
|
|
|
26,285 |
|
| ||
| | | | | | | |
|
Non current assets by country |
|
|
|
|
| ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
In KEUR |
|
|
06.30.2014 |
|
|
12.31.2013 |
| ||||||||
|
France |
|
|
|
|
43,460 |
|
|
|
|
|
37,646 |
|
| ||
|
Abroad |
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
Italy |
|
|
|
|
16,233 |
|
|
|
|
|
17,169 |
|
| ||
|
Spain |
|
|
|
|
16,308 |
|
|
|
|
|
16,962 |
|
| ||
|
Israel |
|
|
|
|
12,240 |
|
|
|
|
|
12,210 |
|
| ||
|
Canada |
|
|
|
|
5,674 |
|
|
|
|
|
5,485 |
|
| ||
|
United States |
|
|
|
|
13,633 |
|
|
|
|
|
13,365 |
|
| ||
|
Other countries |
|
|
|
|
10,813 |
|
|
|
|
|
9,029 |
|
| ||
|
Total |
|
|
|
|
118,360 |
|
|
|
|
|
111,866 |
|
| ||
| | | | | | | |
|
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 |
|
|
06.30.2014 |
|
|
06.30.2013 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Interest expenses |
|
|
|
|
(452 |
) |
|
|
|
|
|
(408 |
) |
|
|
|
Net foreign exchange (loss) |
|
|
|
|
(73 |
) |
|
|
|
|
|
(416 |
) |
|
|
|
Other(1) |
|
|
|
|
(1,598 |
) |
|
|
|
|
|
(1,293 |
) |
|
|
|
Total |
|
|
|
|
(2,124 |
) |
|
|
|
|
|
(2,117 |
) |
|
|
| | | | | | | |
|
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 |
|
| ||
| | | | | | | |
|
|
|
|
06.30.2014 |
| |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
Goodwill |
|
|
Other intangible assets not yet available for use |
|
|
Accumulated impairment |
|
|
Total |
| ||||||||||||||||
|
France |
|
|
|
|
— |
|
|
|
|
|
13,339 |
|
|
|
|
|
— |
|
|
|
|
|
13,339 |
|
| ||||
|
Italy (Gipharma) |
|
|
|
|
1,947 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,947 |
|
| ||||
|
Canada |
|
|
|
|
572 |
|
|
|
|
|
5,101 |
|
|
|
|
|
— |
|
|
|
|
|
5,673 |
|
| ||||
|
USA |
|
|
|
|
3,312 |
|
|
|
|
|
9,670 |
|
|
|
|
|
— |
|
|
|
|
|
12,982 |
|
| ||||
|
Germany |
|
|
|
|
1,027 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,027 |
|
| ||||
|
Spain |
|
|
|
|
6,261 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
6,261 |
|
| ||||
|
Israel |
|
|
|
|
7,688 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
7,688 |
|
| ||||
|
Portugal |
|
|
|
|
1,855 |
|
|
|
|
|
— |
|
|
|
|
|
(1,015 |
) |
|
|
|
|
|
840 |
|
| |||
|
Others |
|
|
|
|
38 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
38 |
|
| ||||
|
Total |
|
|
|
|
22,701 |
|
|
|
|
|
28,110 |
|
|
|
|
|
(1,015 |
) |
|
|
|
|
|
49,796 |
|
| |||
| | | | | | | | | | | | | |
|
|
|
|
12.31.2013 |
| |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
Goodwill |
|
|
Other intangible assets not yet available for use |
|
|
Accumulated impairment |
|
|
Total |
| ||||||||||||||||
|
France |
|
|
|
|
— |
|
|
|
|
|
9,911 |
|
|
|
|
|
— |
|
|
|
|
|
9,911 |
|
| ||||
|
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 |
|
| |||
|
Others |
|
|
|
|
38 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
38 |
|
| ||||
|
Total |
|
|
|
|
22,267 |
|
|
|
|
|
24,546 |
|
|
|
|
|
(1,015 |
) |
|
|
|
|
|
45,798 |
|
| |||
| | | | | | | | | | | | | |
|
|
|
|
Net income (loss) (KEUR) |
|
|
Average number of shares outstanding |
|
|
Earning per share (EUR) |
| ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
30.06.2014 |
|
|
|
|
(521 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
Earning per basic share |
|
|
|
|
|
|
|
|
|
|
61,308,227 |
|
|
|
|
|
(0.01 |
) |
|
| ||
|
Earning per diluted share |
|
|
|
|
|
|
|
|
|
|
61,308,227 |
|
|
|
|
|
(0.01 |
) |
|
| ||
|
30.06.2013 |
|
|
|
|
(844 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
Earning per basic share |
|
|
|
|
|
|
|
|
|
|
53,850,491 |
|
|
|
|
|
(0.02 |
) |
|
| ||
|
Earning per diluted share |
|
|
|
|
|
|
|
|
|
|
53,850,491 |
|
|
|
|
|
(0.02 |
) |
|
| ||
| | | | | | | | | | |
|
KEUR |
|
|
06.30.2014 |
|
|
12.31.2013 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Finance lease obligations(1) |
|
|
|
|
6,823 |
|
|
|
|
|
7,591 |
|
| ||
|
Loans(1) |
|
|
|
|
17,697 |
|
|
|
|
|
18,226 |
|
| ||
|
Total |
|
|
|
|
24,520 |
|
|
|
|
|
25,817 |
|
| ||
| | | | | | | |
|
|
|
|
2014 |
| |||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
KEUR |
|
|
< 1 year |
|
|
1 – 5 years |
|
|
> 5 years |
|
|
Total |
| ||||||||||||||||||||||||||||||
|
Finance lease obligations |
|
|
|
|
1,501 |
|
|
|
|
|
3,854 |
|
|
|
|
|
1,468 |
|
|
|
|
|
6,823 |
|
| | | | | | | | | | | | | | | ||||
|
Loans |
|
|
|
|
4,383 |
|
|
|
|
|
10,898 |
|
|
|
|
|
2,414 |
|
|
|
|
|
17,697 |
|
| | | | | | | | | | | | | | | ||||
|
Total |
|
|
|
|
5,884 |
|
|
|
|
|
14,752 |
|
|
|
|
|
3,882 |
|
|
|
|
|
24,520 |
|
| | | | | | | | | | | | | | | ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
| | | | | | | | | | | | | | | | | | | |
|
|
|
|
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 |
|
|
06.30.2014 |
|
|
12.31.2013 |
| ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Fixed rates |
|
|
|
|
3.47 |
% |
|
|
|
|
|
16,975 |
|
|
|
|
|
17,603 |
|
| ||
|
Floating rates |
|
|
|
|
2.28 |
% |
|
|
|
|
|
7,545 |
|
|
|
|
|
8,214 |
|
| ||
|
Total |
|
|
|
|
|
|
|
|
|
|
24,520 |
|
|
|
|
|
25,817 |
|
| |||
| | | | | | | | | | |
|
KEUR |
|
|
06.30.2014 |
|
|
12.31.2013 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Due to former owners of acquired companies(1) |
|
|
|
|
31,221 |
|
|
|
|
|
29,786 |
|
| ||
|
Government subsidies |
|
|
|
|
4,649 |
|
|
|
|
|
4,661 |
|
| ||
|
Other non-current liabilities |
|
|
|
|
35,870 |
|
|
|
|
|
34,448 |
|
| ||
|
Due to former owners of acquired companies(1) |
|
|
|
|
2,399 |
|
|
|
|
|
2,793 |
|
| ||
|
Tax, personnel and social charges |
|
|
|
|
4,478 |
|
|
|
|
|
3,886 |
|
| ||
|
Other debts(2) |
|
|
|
|
3,933 |
|
|
|
|
|
2,874 |
|
| ||
|
Other current liabilities |
|
|
|
|
10,810 |
|
|
|
|
|
9,552 |
|
| ||
| | | | | | | |
|
|
|
|
06.30.2014 |
| ||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
62 |
|
|
|
|
|
|
|
|
|
|
|
62 |
|
|
|
|
|
62 |
|
| |||||||
|
Total measured at fair value |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
62 |
|
|
|
|
|
— |
|
|
|
|
|
62 |
|
|
|
|
|
62 |
|
| |||||||
|
Not measured at fair value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
|
Trade receivables and other receivables |
|
|
|
|
(1) |
|
|
|
|
|
|
|
|
|
|
|
19,046 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19,046 |
|
|
|
|
|
19,046 |
|
| |||||||
|
Other assets |
|
|
|
|
(1) |
|
|
|
|
|
|
|
|
|
|
|
8,204 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,204 |
|
|
|
|
|
8,204 |
|
| |||||||
|
Guarantee deposits |
|
|
|
|
(1) |
|
|
|
|
|
|
|
|
|
|
|
1,892 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,892 |
|
|
|
|
|
1,892 |
|
| |||||||
|
Cash and cash equivalent |
|
|
|
|
(1) |
|
|
|
|
|
|
|
|
|
|
|
51,234 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
51,234 |
|
|
|
|
|
51,234 |
|
| |||||||
|
Total not measured at fair value |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
80,376 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
80,376 |
|
|
|
|
|
80,376 |
|
| |||||||
|
Total financial assets |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
80,376 |
|
|
|
|
|
62 |
|
|
|
|
|
— |
|
|
|
|
|
80,438 |
|
|
|
|
|
80,438 |
|
| |||||||
|
Measured at fair value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
|
Debt due to former owners of acquired companies |
|
|
|
|
(2) |
|
|
|
|
|
33,619 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33,619 |
|
|
|
|
|
33,619 |
|
| |||||||
|
Total measured at fair value |
|
|
|
|
|
|
|
|
|
|
33,619 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
33,619 |
|
|
|
|
|
33,619 |
|
| |||||||
|
Not measured at fair value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
|
Financial liabilities |
|
|
|
|
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,520 |
|
|
|
|
|
24,520 |
|
|
|
|
|
24,924 |
|
| |||||||
|
Trade payables |
|
|
|
|
(1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,537 |
|
|
|
|
|
11,537 |
|
|
|
|
|
11,537 |
|
| |||||||
|
Other liabilities |
|
|
|
|
(1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,040 |
|
|
|
|
|
13,040 |
|
|
|
|
|
13,040 |
|
| |||||||
|
Total not measured at fair value |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
49,097 |
|
|
|
|
|
49,097 |
|
|
|
|
|
49,844 |
|
| |||||||
|
Total financial liabilities |
|
|
|
|
|
|
|
|
|
|
33,619 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
49,097 |
|
|
|
|
|
82,716 |
|
|
|
|
|
83,463 |
|
| |||||||
| | | | | | | | | | | | | | | | | | | | | | |
|
|
|
|
12.31.2013 |
| ||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,421 |
|
|
|
|
|
11,421 |
|
|
|
|
|
11,421 |
|
| |||||||
|
Total not measured at fair value |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
46,456 |
|
|
|
|
|
46,456 |
|
|
|
|
|
47,084 |
|
| |||||||
|
Total financial liabilities |
|
|
|
|
|
|
|
|
|
|
32,579 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
46,456 |
|
|
|
|
|
79,035 |
|
|
|
|
|
79,663 |
|
| |||||||
| | | | | | | | | | | | | | | | | | | | | | |
|
In thousands of Euros |
|
|
Notes |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sales |
|
|
|
|
4.1 |
|
|
|
|
|
53,806 |
|
|
|
|
|
40,834 |
|
| |||
|
Raw materials and consumables used |
|
|
|
|
|
|
|
|
|
|
(9,185 |
) |
|
|
|
|
|
(6,296 |
) |
|
| |
|
Personnel costs |
|
|
|
|
4.2 |
|
|
|
|
|
(15,783 |
) |
|
|
|
|
|
(12,970 |
) |
|
| |
|
Other operating expenses |
|
|
|
|
4.4 |
|
|
|
|
|
(20,930 |
) |
|
|
|
|
|
(17,023 |
) |
|
| |
|
Other operating income |
|
|
|
|
4.5 |
|
|
|
|
|
2,730 |
|
|
|
|
|
2,032 |
|
| |||
|
Depreciation and amortization |
|
|
|
|
4.6 |
|
|
|
|
|
(9,672 |
) |
|
|
|
|
|
(6,623 |
) |
|
| |
|
Operating income |
|
|
|
|
|
|
|
|
|
|
966 |
|
|
|
|
|
(46 |
) |
|
| ||
|
Finance income |
|
|
|
|
|
|
|
|
|
|
387 |
|
|
|
|
|
232 |
|
| |||
|
Finance costs |
|
|
|
|
4.7 |
|
|
|
|
|
(10,155 |
) |
|
|
|
|
|
(16,512 |
) |
|
| |
|
Net finance costs |
|
|
|
|
|
|
|
|
|
|
(9,768 |
) |
|
|
|
|
|
(16,280 |
) |
|
| |
|
Loss before income taxes |
|
|
|
|
|
|
|
|
|
|
(8,802 |
) |
|
|
|
|
|
(16,326 |
) |
|
| |
|
Income taxes |
|
|
|
|
4.8 |
|
|
|
|
|
(1,059 |
) |
|
|
|
|
|
(586 |
) |
|
| |
|
Loss for the year |
|
|
|
|
|
|
|
|
|
|
(9,861 |
) |
|
|
|
|
|
(16,912 |
) |
|
| |
|
Attributable to: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Owners of the company |
|
|
|
|
|
|
|
|
|
|
(9,231 |
) |
|
|
|
|
|
(16,455 |
) |
|
| |
|
Non-controlling interests |
|
|
|
|
5.9 |
|
|
|
|
|
(629 |
) |
|
|
|
|
|
(457 |
) |
|
| |
|
Earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Basic (€ per share) |
|
|
|
|
|
|
|
|
|
|
(0.17 |
) |
|
|
|
|
|
(0.31 |
) |
|
| |
|
Diluted (€ per share) |
|
|
|
|
|
|
|
|
|
|
(0.17 |
) |
|
|
|
|
|
(0.31 |
) |
|
| |
| | | | | | | | | | | |
|
In thousands of Euros |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Loss for the year |
|
|
|
|
(9,861 |
) |
|
|
|
|
|
(16,912 |
) |
|
|
|
Other comprehensive income/(expense): |
| | | | | | | | | | | | | | |
|
Items that may be reclassified subsequently to profit or loss |
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
Exchange differences on translating foreign operations |
|
|
|
|
(129 |
) |
|
|
|
|
|
150 |
|
| |
|
Items that will never be reclassified subsequently to profit or loss |
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
Remeasurement of defined benefit liability |
|
|
|
|
17 |
|
|
|
|
|
(52 |
) |
|
| |
|
Other comprehensive income/(expense) net of tax(1) |
|
|
|
|
(112 |
) |
|
|
|
|
|
98 |
|
| |
|
Total comprehensive income/(loss) for the year |
|
|
|
|
(9,973 |
) |
|
|
|
|
|
(16,814 |
) |
|
|
|
Total comprehensive income/(loss) attributable to: |
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
Owners of the company |
|
|
|
|
(9,143 |
) |
|
|
|
|
|
(16,524 |
) |
|
|
|
Non-controlling interests |
|
|
|
|
(830 |
) |
|
|
|
|
|
(290 |
) |
|
|
| | | | | | | | |
|
(In thousands of Euros) |
|
|
Notes |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Non-current assets |
|
|
|
|
|
|
|
|
|
|
114,202 |
|
|
|
|
|
111,300 |
|
| |||
|
Goodwill |
|
|
|
|
5.1 |
|
|
|
|
|
21,252 |
|
|
|
|
|
22,286 |
|
| |||
|
Other intangible assets |
|
|
|
|
5.1 |
|
|
|
|
|
41,334 |
|
|
|
|
|
40,499 |
|
| |||
|
Property, plant and equipment |
|
|
|
|
5.2 |
|
|
|
|
|
49,280 |
|
|
|
|
|
45,794 |
|
| |||
|
Financial assets |
|
|
|
|
5.3 |
|
|
|
|
|
2,336 |
|
|
|
|
|
2,721 |
|
| |||
|
Current assets |
|
|
|
|
|
|
|
|
|
|
40,029 |
|
|
|
|
|
38,543 |
|
| |||
|
Inventories |
|
|
|
|
5.5 |
|
|
|
|
|
2,278 |
|
|
|
|
|
1,833 |
|
| |||
|
Trade and other receivables |
|
|
|
|
5.4 |
|
|
|
|
|
16,143 |
|
|
|
|
|
15,537 |
|
| |||
|
Other current assets |
|
|
|
|
5.6 |
|
|
|
|
|
7,997 |
|
|
|
|
|
7,107 |
|
| |||
|
Cash and cash equivalents |
|
|
|
|
5.7 |
|
|
|
|
|
13,610 |
|
|
|
|
|
14,066 |
|
| |||
|
TOTAL ASSETS |
|
|
|
|
|
|
|
|
|
|
154,231 |
|
|
|
|
|
149,843 |
|
| |||
|
EQUITY AND LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
Equity attributable to owners of the company |
|
|
|
|
|
|
|
|
|
|
63,350 |
|
|
|
|
|
63,101 |
|
| |||
|
Share capital |
|
|
|
|
|
|
|
|
|
|
5,415 |
|
|
|
|
|
5,244 |
|
| |||
|
Share premium |
|
|
|
|
|
|
|
|
|
|
76,594 |
|
|
|
|
|
69,650 |
|
| |||
|
Reserves and retained earnings |
|
|
|
|
|
|
|
|
|
|
(9,427 |
) |
|
|
|
|
|
4,662 |
|
| ||
|
Net loss for the year |
|
|
|
|
|
|
|
|
|
|
(9,231 |
) |
|
|
|
|
|
(16,455 |
) |
|
| |
|
Non-controlling interests |
|
|
|
|
5.9 |
|
|
|
|
|
1,360 |
|
|
|
|
|
2,189 |
|
| |||
|
Total equity |
|
|
|
|
5.8 |
|
|
|
|
|
64,710 |
|
|
|
|
|
65,290 |
|
| |||
|
Non-current liabilities |
|
|
|
|
|
|
|
|
|
|
65,178 |
|
|
|
|
|
58,425 |
|
| |||
|
Non-current provisions |
|
|
|
|
5.10 |
|
|
|
|
|
6,030 |
|
|
|
|
|
5,592 |
|
| |||
|
Non-current financial liabilities |
|
|
|
|
5.11 |
|
|
|
|
|
20,359 |
|
|
|
|
|
21,056 |
|
| |||
|
Deferred tax liabilities |
|
|
|
|
4.8 |
|
|
|
|
|
4,342 |
|
|
|
|
|
5,640 |
|
| |||
|
Other non-current liabilities |
|
|
|
|
5.12 |
|
|
|
|
|
34,448 |
|
|
|
|
|
26,137 |
|
| |||
|
Current liabilities |
|
|
|
|
|
|
|
|
|
|
24,343 |
|
|
|
|
|
26,128 |
|
| |||
|
Current provisions |
|
|
|
|
5.10 |
|
|
|
|
|
115 |
|
|
|
|
|
300 |
|
| |||
|
Current financial liabilities |
|
|
|
|
5.11 |
|
|
|
|
|
5,458 |
|
|
|
|
|
4,012 |
|
| |||
|
Trade and other payables |
|
|
|
|
|
|
|
|
|
|
9,218 |
|
|
|
|
|
9,857 |
|
| |||
|
Other current liabilities |
|
|
|
|
5.12 |
|
|
|
|
|
9,552 |
|
|
|
|
|
11,959 |
|
| |||
|
Total liabilities |
|
|
|
|
|
|
|
|
|
|
89,521 |
|
|
|
|
|
84,553 |
|
| |||
|
TOTAL EQUITY AND LIABILITIES |
|
|
|
|
|
|
|
|
|
|
154,231 |
|
|
|
|
|
149,843 |
|
| |||
| | | | | | | | | | | |
|
|
|
|
Attributable to the company |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
In thousands of Euros |
|
|
Share capital |
|
|
Share premium |
|
|
Translation reserve |
|
|
Income/ (loss) for the year |
|
|
Group reserves |
|
|
Total attributable to owners of the Company |
|
|
Non- controlling interests |
|
|
TOTAL |
| ||||||||||||||||||||||||||||||||
|
At December 31, 2012 |
|
|
|
|
5,244 |
|
|
|
|
|
69,650 |
|
|
|
|
|
(507 |
) |
|
|
|
|
|
(16,455 |
) |
|
|
|
|
|
5,167 |
|
|
|
|
|
63,101 |
|
|
|
|
|
2,189 |
|
|
|
|
|
65,290 |
|
| ||||||
|
Comprehensive income/(loss) for the year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
|
Loss for the year |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(9,231 |
) |
|
|
|
|
|
— |
|
|
|
|
|
(9,231 |
) |
|
|
|
|
|
(629 |
) |
|
|
|
|
|
(9,861 |
) |
|
| ||||
|
Other comprehensive income for the year |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
72 |
|
|
|
|
|
— |
|
|
|
|
|
17 |
|
|
|
|
|
89 |
|
|
|
|
|
(201 |
) |
|
|
|
|
|
(112 |
) |
|
| ||||||
|
Total comprehensive income/(loss) |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
72 |
|
|
|
|
|
(9,231 |
) |
|
|
|
|
|
17 |
|
|
|
|
|
(9,143 |
) |
|
|
|
|
|
(830 |
) |
|
|
|
|
|
(9,973 |
) |
|
| ||||
|
Transactions with owners of the company |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
|
Issue of ordinary shares(1) |
|
|
|
|
171 |
|
|
|
|
|
6,944 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
7,114 |
|
|
|
|
|
— |
|
|
|
|
|
7,114 |
|
| ||||||||
|
Appropriation of 2012 net loss |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(16,455 |
) |
|
|
|
|
|
(16,455 |
) |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
| ||||||
|
Equity-settled share-based payments |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
2,280 |
|
|
|
|
|
2,280 |
|
|
|
|
|
— |
|
|
|
|
|
2,280 |
|
| ||||||||
|
Total transactions with owners of the company |
|
|
|
|
171 |
|
|
|
|
|
6,944 |
|
|
|
|
|
— |
|
|
|
|
|
(16,455 |
) |
|
|
|
|
|
(14,175 |
) |
|
|
|
|
|
9,394 |
|
|
|
|
|
— |
|
|
|
|
|
9,394 |
|
| ||||||
|
At December 31, 2013 |
|
|
|
|
5,415 |
|
|
|
|
|
76,594 |
|
|
|
|
|
(435 |
) |
|
|
|
|
|
(9,231 |
) |
|
|
|
|
|
(8,992 |
) |
|
|
|
|
|
63,350 |
|
|
|
|
|
1,360 |
|
|
|
|
|
64,710 |
|
| |||||
| | | | | | | | | | | | | | | | | | | | | | | | | | |
|
|
|
|
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 |
|
|
Attributable to owners of the Company |
|
|
Non- controlling interests |
|
|
TOTAL |
| ||||||||||||||||||||||||||||||||
|
At January 1, 2012 |
|
|
|
|
5,210 |
|
|
|
|
|
69,155 |
|
|
|
|
|
(490 |
) |
|
|
|
|
|
(222 |
) |
|
|
|
|
|
4,478 |
|
|
|
|
|
78,130 |
|
|
|
|
|
2,199 |
|
|
|
|
|
80,329 |
|
| ||||||
|
Comprehensive income/(loss) for the year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
|
Net income/loss for the year |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(16,455 |
) |
|
|
|
|
|
— |
|
|
|
|
|
(16,455 |
) |
|
|
|
|
|
(457 |
) |
|
|
|
|
|
(16,912 |
) |
|
| ||||
|
Other comprehensive income for the year |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(16 |
) |
|
|
|
|
|
— |
|
|
|
|
|
(52 |
) |
|
|
|
|
|
(69 |
) |
|
|
|
|
|
167 |
|
|
|
|
|
99 |
|
| |||||
|
Total comprehensive income/(loss) |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(16 |
) |
|
|
|
|
|
(16,455 |
) |
|
|
|
|
|
(52 |
) |
|
|
|
|
|
(16,524 |
) |
|
|
|
|
|
(290 |
) |
|
|
|
|
|
(16,814 |
) |
|
| ||
|
Transactions with owners of the company |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
|
Issue of ordinary shares |
|
|
|
|
34 |
|
|
|
|
|
495 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
529 |
|
|
|
|
|
— |
|
|
|
|
|
529 |
|
| ||||||||
|
Appropriation of 2011 net income/(loss) |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
222 |
|
|
|
|
|
(222 |
) |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
| |||||||
|
Equity-settled share-based payments |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,249 |
|
|
|
|
|
1,249 |
|
|
|
|
|
— |
|
|
|
|
|
1,249 |
|
| ||||||||
|
Transactions between shareholders |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(289 |
) |
|
|
|
|
|
(289 |
) |
|
|
|
|
|
282 |
|
|
|
|
|
(7 |
) |
|
| |||||
|
Total transactions with owners of the company |
|
|
|
|
34 |
|
|
|
|
|
495 |
|
|
|
|
|
— |
|
|
|
|
|
222 |
|
|
|
|
|
740 |
|
|
|
|
|
1,491 |
|
|
|
|
|
282 |
|
|
|
|
|
1,773 |
|
| ||||||||
|
At December 31, 2012 |
|
|
|
|
5,244 |
|
|
|
|
|
69,650 |
|
|
|
|
|
(507 |
) |
|
|
|
|
|
(16,455 |
) |
|
|
|
|
|
5,167 |
|
|
|
|
|
63,101 |
|
|
|
|
|
2,189 |
|
|
|
|
|
65,290 |
|
| ||||||
| | | | | | | | | | | | | | | | | | | | | | | | | | |
|
In thousands of Euros |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
Net income/(loss) for the year |
|
|
|
|
(9,861 |
) |
|
|
|
|
|
(16,912 |
) |
|
|
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
Depreciation, amortization and impairment of non-current assets |
|
|
|
|
9,672 |
|
|
|
|
|
6,623 |
|
| ||
|
Share-based payment expense |
|
|
|
|
2,281 |
|
|
|
|
|
1,249 |
|
| ||
|
Gain on disposal of property, plant and equipment |
|
|
|
|
(62 |
) |
|
|
|
|
|
32 |
|
| |
|
Financial result |
|
|
|
|
9,768 |
|
|
|
|
|
16,280 |
|
| ||
|
Income tax expense |
|
|
|
|
1,059 |
|
|
|
|
|
586 |
|
| ||
|
|
|
|
|
|
12,858 |
|
|
|
|
|
7,858 |
|
| ||
|
Increase in inventories |
|
|
|
|
(445 |
) |
|
|
|
|
|
(439 |
) |
|
|
|
Increase in trade receivables |
|
|
|
|
(606 |
) |
|
|
|
|
|
(2,917 |
) |
|
|
|
Increase (decrease) in trade payables |
|
|
|
|
(639 |
) |
|
|
|
|
|
821 |
|
| |
|
Change in other receivables and payables |
|
|
|
|
1,184 |
|
|
|
|
|
1,127 |
|
| ||
|
Increase in provisions |
|
|
|
|
253 |
|
|
|
|
|
553 |
|
| ||
|
Change in working capital |
|
|
|
|
(253 |
) |
|
|
|
|
|
(855 |
) |
|
|
|
Income tax paid |
|
|
|
|
(663 |
) |
|
|
|
|
|
(479 |
) |
|
|
|
Net cash from operating activities |
|
|
|
|
11,942 |
|
|
|
|
|
6,524 |
|
| ||
|
Cash flows from investing activities |
| | | | | | | | | | | | | | |
|
Acquisition of property, plant and equipment |
|
|
|
|
(9,289 |
) |
|
|
|
|
|
(9,934 |
) |
|
|
|
Acquisition of intangible assets |
|
|
|
|
(4,829 |
) |
|
|
|
|
|
(5,494 |
) |
|
|
|
Acquisition of financial assets |
|
|
|
|
(116 |
) |
|
|
|
|
|
(2,166 |
) |
|
|
|
Proceeds from disposal of property, plant and equipment |
|
|
|
|
130 |
|
|
|
|
|
178 |
|
| ||
|
Receipts from government grants |
|
|
|
|
0 |
|
|
|
|
|
245 |
|
| ||
|
Acquisition of subsidiaries, net of cash acquired |
|
|
|
|
(1,395 |
) |
|
|
|
|
|
(11,564 |
) |
|
|
|
Net cash used in investing activities |
|
|
|
|
(15,500 |
) |
|
|
|
|
|
(28,735 |
) |
|
|
|
Net cash from financing activities |
| | | | | | | | | | | | | | |
|
Issuance of share capital |
|
|
|
|
4,820 |
|
| | | | | | | | |
|
Proceeds from borrowings |
|
|
|
|
3,496 |
|
|
|
|
|
10,400 |
|
| ||
|
Repayment of borrowings |
|
|
|
|
(4,058 |
) |
|
|
|
|
|
(2,213 |
) |
|
|
|
Interest paid |
|
|
|
|
(1,029 |
) |
|
|
|
|
|
(839 |
) |
|
|
|
Net cash from financing activities |
|
|
|
|
3,229 |
|
|
|
|
|
7,348 |
|
| ||
|
Net decrease in cash and cash equivalents |
|
|
|
|
(330 |
) |
|
|
|
|
|
(14,863 |
) |
|
|
|
Cash and cash equivalents at the beginning of the year |
|
|
|
|
13,947 |
|
|
|
|
|
28,803 |
|
| ||
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
|
|
(7 |
) |
|
|
|
|
|
6 |
|
| |
|
Cash and cash equivalents at the end of the year |
|
|
|
|
13,610 |
|
|
|
|
|
13,947 |
|
| ||
| | | | | | | | |
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
| | | | | |
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
|
|
|
|
|
|
| |||
| | | | | |
|
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 |
|
| |
| | | | |
|
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. |
|
| | | |
|
2012 |
|
|
USD |
|
|
CAD |
|
|
ISL |
|
|
CHF |
| ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Closing rate |
|
|
|
|
0.7579 |
|
|
|
|
|
0.7612 |
|
|
|
|
|
0.203 |
|
|
|
|
|
0.8236 |
|
| ||||
|
Average rate |
|
|
|
|
0.7779 |
|
|
|
|
|
0.7783 |
|
|
|
|
|
0.2019 |
|
|
|
|
|
0.8297 |
|
| ||||
| | | | | | | | | | | | | |
|
2013 |
|
|
USD |
|
|
CAD |
|
|
ISL |
|
|
CHF |
| ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Closing rate |
|
|
|
|
0.7251 |
|
|
|
|
|
0.6816 |
|
|
|
|
|
0.2089 |
|
|
|
|
|
0.8146 |
|
| ||||
|
Average rate |
|
|
|
|
0.7529 |
|
|
|
|
|
0.7308 |
|
|
|
|
|
0.2085 |
|
|
|
|
|
0.8124 |
|
| ||||
| | | | | | | | | | | | | |
|
Sales by Products |
|
|
|
|
| ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
In KEUR |
|
|
2013 |
|
|
2012 |
| ||||||||
|
PET |
|
|
|
|
41,438 |
|
|
|
|
|
34,148 |
|
| ||
|
SPECT |
|
|
|
|
7,969 |
|
|
|
|
|
5,849 |
|
| ||
|
Therapy |
|
|
|
|
3,262 |
|
|
|
|
|
655 |
|
| ||
|
Other products |
|
|
|
|
1,138 |
|
|
|
|
|
182 |
|
| ||
|
Total |
|
|
|
|
53,806 |
|
|
|
|
|
40,834 |
|
| ||
| | | | | | | |
|
Sales by country |
|
|
|
|
| ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
In KEUR |
|
|
2013 |
|
|
2012 |
| ||||||||
|
France |
|
|
|
|
23,263 |
|
|
|
|
|
18,688 |
|
| ||
|
Italy |
|
|
|
|
14,821 |
|
|
|
|
|
13,718 |
|
| ||
|
Spain |
|
|
|
|
6,281 |
|
|
|
|
|
1,014 |
|
| ||
|
Israel |
|
|
|
|
3,823 |
|
|
|
|
|
3,262 |
|
| ||
|
Canada |
|
|
|
|
160 |
|
|
|
|
|
126 |
|
| ||
|
USA |
|
|
|
|
3 |
|
|
|
|
|
5 |
|
| ||
|
Other countries |
|
|
|
|
5,455 |
|
|
|
|
|
4,020 |
|
| ||
|
Total |
|
|
|
|
53,806 |
|
|
|
|
|
40,834 |
|
| ||
| | | | | | | |
|
Non-current assets by country |
|
|
|
|
| ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
In KEUR |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||
|
France |
|
|
|
|
37,646 |
|
|
|
|
|
33,636 |
|
| ||
|
Italy |
|
|
|
|
17,169 |
|
|
|
|
|
18,264 |
|
| ||
|
Spain |
|
|
|
|
16,962 |
|
|
|
|
|
17,954 |
|
| ||
|
USA |
|
|
|
|
13,365 |
|
|
|
|
|
13,965 |
|
| ||
|
Israel |
|
|
|
|
12,210 |
|
|
|
|
|
12,339 |
|
| ||
|
Canada |
|
|
|
|
5,485 |
|
|
|
|
|
6,158 |
|
| ||
|
Other countries |
|
|
|
|
9,029 |
|
|
|
|
|
6,262 |
|
| ||
|
Total |
|
|
|
|
111,866 |
|
|
|
|
|
108,578 |
|
| ||
| | | | | | | |
|
In KEUR |
|
|
2013 |
|
|
2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Wages and salaries |
|
|
|
|
(9,732 |
) |
|
|
|
|
|
(8,884 |
) |
|
|
|
Social charges |
|
|
|
|
(3,770 |
) |
|
|
|
|
|
(2,837 |
) |
|
|
|
Share-based payments |
|
|
|
|
(2,281 |
) |
|
|
|
|
|
(1,249 |
) |
|
|
|
Total |
|
|
|
|
(15,783 |
) |
|
|
|
|
|
(12,970 |
) |
|
|
| | | | | | | |
|
|
|
|
2013 |
|
|
2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Italy |
|
|
|
|
106 |
|
|
|
|
|
97 |
|
| ||
|
France |
|
|
|
|
85 |
|
|
|
|
|
76 |
|
| ||
|
Spain |
|
|
|
|
34 |
|
|
|
|
|
32 |
|
| ||
|
Israel |
|
|
|
|
13 |
|
|
|
|
|
13 |
|
| ||
|
Germany |
|
|
|
|
11 |
|
|
|
|
|
5 |
|
| ||
|
Portugal |
|
|
|
|
13 |
|
|
|
|
|
10 |
|
| ||
|
Other countries |
|
|
|
|
13 |
|
|
|
|
|
5 |
|
| ||
|
Total |
|
|
|
|
275 |
|
|
|
|
|
238 |
|
| ||
| | | | | | | |
|
In KEUR |
|
|
2013 |
|
|
2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Short-term benefits |
|
|
|
|
1,121 |
|
|
|
|
|
795 |
|
| ||
|
Share-based payments |
|
|
|
|
322 |
|
|
|
|
|
241 |
|
| ||
|
Post-employment defined benefits |
|
|
|
|
71 |
|
|
|
|
|
39 |
|
| ||
|
Total |
|
|
|
|
1,514 |
|
|
|
|
|
1,075 |
|
| ||
| | | | | | | |
|
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 |
|
|
2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Transport |
|
|
|
|
(7,731 |
) |
|
|
|
|
|
(5,842 |
) |
|
|
|
Consulting and other professional services |
|
|
|
|
(2,286 |
) |
|
|
|
|
|
(1,169 |
) |
|
|
|
Lease and other administrative expenses |
|
|
|
|
(1,736 |
) |
|
|
|
|
|
(1,425 |
) |
|
|
|
Energy |
|
|
|
|
(986 |
) |
|
|
|
|
|
(720 |
) |
|
|
|
Travel expenses |
|
|
|
|
(843 |
) |
|
|
|
|
|
(1,095 |
) |
|
|
|
Telecommunications |
|
|
|
|
(538 |
) |
|
|
|
|
|
(529 |
) |
|
|
|
Royalties and licensing fees |
|
|
|
|
(272 |
) |
|
|
|
|
|
(282 |
) |
|
|
|
Subcontractors |
|
|
|
|
(488 |
) |
|
|
|
|
|
(414 |
) |
|
|
|
Repairs and maintenance |
|
|
|
|
(2,346 |
) |
|
|
|
|
|
(2,029 |
) |
|
|
|
Taxes |
|
|
|
|
(582 |
) |
|
|
|
|
|
(445 |
) |
|
|
|
External R&D services |
|
|
|
|
(1,294 |
) |
|
|
|
|
|
(968 |
) |
|
|
|
Allowance for doubtful accounts |
|
|
|
|
(149 |
) |
|
|
|
|
|
(172 |
) |
|
|
|
Other |
|
|
|
|
(1,679 |
) |
|
|
|
|
|
(1,935 |
) |
|
|
|
Total |
|
|
|
|
(20,930 |
) |
|
|
|
|
|
(17,023 |
) |
|
|
| | | | | | | |
|
In KEUR |
|
|
2013 |
|
|
2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Government subsidies |
|
|
|
|
2,214 |
|
|
|
|
|
1,825 |
|
| ||
|
Net gain/(loss) on disposal of non-current assets |
|
|
|
|
62 |
|
|
|
|
|
(32 |
) |
|
| |
|
Other |
|
|
|
|
454 |
|
|
|
|
|
239 |
|
| ||
|
Total |
|
|
|
|
2,730 |
|
|
|
|
|
2,032 |
|
| ||
| | | | | | | |
|
In KEUR |
|
|
2013 |
|
|
2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Impairment of goodwill |
|
|
|
|
(1,015 |
) |
|
|
|
|
|
— |
|
| |
|
Depreciation and amortization |
|
|
|
|
(8,657 |
) |
|
|
|
|
|
(6,623 |
) |
|
|
|
Total |
|
|
|
|
(9,672 |
) |
|
|
|
|
|
(6,623 |
) |
|
|
| | | | | | | |
|
In KEUR |
|
|
2013 |
|
|
2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Interest expenses |
|
|
|
|
(1,029 |
) |
|
|
|
|
|
(650 |
) |
|
|
|
Net foreign exchange gain (loss) |
|
|
|
|
(862 |
) |
|
|
|
|
|
29 |
|
| |
|
Other |
|
|
|
|
(8,264 |
) |
|
|
|
|
|
(15,891 |
) |
|
|
|
Total |
|
|
|
|
(10,155 |
) |
|
|
|
|
|
(16,512 |
) |
|
|
| | | | | | | |
|
In KEUR |
|
|
2013 |
|
|
2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Current tax |
|
|
|
|
(2,072 |
) |
|
|
|
|
|
(1,411 |
) |
|
|
|
Deferred tax |
|
|
|
|
1,013 |
|
|
|
|
|
825 |
|
| ||
|
Total |
|
|
|
|
(1,059 |
) |
|
|
|
|
|
(586 |
) |
|
|
| | | | | | | |
|
In KEUR |
|
|
2013 |
|
|
2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Net loss after tax |
|
|
|
|
(9,861 |
) |
|
|
|
|
|
(16,912 |
) |
|
|
|
Income tax |
|
|
|
|
(1,059 |
) |
|
|
|
|
|
(586 |
) |
|
|
|
Net loss before tax |
|
|
|
|
(8,802 |
) |
|
|
|
|
|
(16,326 |
) |
|
|
|
Theoretical tax rate |
|
|
|
|
33.33 |
% |
|
|
|
|
|
33.33 |
% |
|
|
|
Expected tax charge |
|
|
|
|
2,934 |
|
|
|
|
|
5,441 |
|
| ||
|
Impact of unrecognized losses on overseas subsidiaries |
|
|
|
|
(1,068 |
) |
|
|
|
|
|
(786 |
) |
|
|
|
Impact of tax rate differences |
|
|
|
|
531 |
|
|
|
|
|
309 |
|
| ||
|
Impact of permanent differences |
|
|
|
|
(3,088 |
) |
|
|
|
|
|
(5,263 |
) |
|
|
|
Income tax expense |
|
|
|
|
(690 |
) |
|
|
|
|
|
(299 |
) |
|
|
|
CVAE & IRAP(1) |
|
|
|
|
(369 |
) |
|
|
|
|
|
(287 |
) |
|
|
|
Group tax charge |
|
|
|
|
(1,059 |
) |
|
|
|
|
|
(586 |
) |
|
|
| | | | | | | |
|
In KEUR |
|
|
2013 |
|
|
2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Net deferred tax at the beginning of the year |
|
|
|
|
(5,640 |
) |
|
|
|
|
|
(5,970 |
) |
|
|
|
Deferred tax income |
|
|
|
|
1,013 |
|
|
|
|
|
825 |
|
| ||
|
Other comprehensive income |
|
|
|
|
6 |
|
|
|
|
|
17 |
|
| ||
|
Change in consolidation scope |
|
|
|
|
— |
|
|
|
|
|
(751 |
) |
|
| |
|
Translation differences |
|
|
|
|
286 |
|
|
|
|
|
60 |
|
| ||
|
Other changes |
|
|
|
|
(6 |
) |
|
|
|
|
|
179 |
|
| |
|
Net deferred tax at the end of the year |
|
|
|
|
(4,341 |
) |
|
|
|
|
|
(5,640 |
) |
|
|
| | | | | | | |
|
In KEUR |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Intangible assets |
|
|
|
|
(6,896 |
) |
|
|
|
|
|
(7,527 |
) |
|
|
|
Carry forward losses |
|
|
|
|
2,060 |
|
|
|
|
|
1,705 |
|
| ||
|
Property, plant and equipment |
|
|
|
|
(868 |
) |
|
|
|
|
|
(912 |
) |
|
|
|
Other temporary differences |
|
|
|
|
1,363 |
|
|
|
|
|
1,094 |
|
| ||
|
Deferred liabilities, net |
|
|
|
|
(4,341 |
) |
|
|
|
|
|
(5,640 |
) |
|
|
|
Net deferred tax liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
of which deferred tax assets |
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
of which deferred tax liabilities |
|
|
|
|
(4,341 |
) |
|
|
|
|
|
(5,640 |
) |
|
|
| | | | | | | |
|
Acquisition cost in KEUR |
|
|
Goodwill |
|
|
Development expenditure |
|
|
Patents & Licenses |
|
|
Customer relationships |
|
|
Total |
| ||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
At January 1, 2012 |
|
|
|
|
13,141 |
|
|
|
|
|
19,476 |
|
|
|
|
|
9,930 |
|
|
|
|
|
6,861 |
|
|
|
|
|
49,408 |
|
| |||||
|
Additions |
|
|
|
|
— |
|
|
|
|
|
5,400 |
|
|
|
|
|
108 |
|
|
|
|
|
— |
|
|
|
|
|
5,508 |
|
| |||||
|
Business combinations |
|
|
|
|
9,143 |
|
|
|
|
|
— |
|
|
|
|
|
100 |
|
|
|
|
|
3,586 |
|
|
|
|
|
12,829 |
|
| |||||
|
Disposals |
|
|
|
|
— |
|
|
|
|
|
(168 |
) |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(168 |
) |
|
| |||
|
Translation differences |
|
|
|
|
2 |
|
|
|
|
|
(156 |
) |
|
|
|
|
|
(9 |
) |
|
|
|
|
|
(30 |
) |
|
|
|
|
|
(193 |
) |
|
| |
|
At December 31, 2012 |
|
|
|
|
22,286 |
|
|
|
|
|
24,552 |
|
|
|
|
|
10,129 |
|
|
|
|
|
10,417 |
|
|
|
|
|
67,384 |
|
| |||||
|
Additions |
|
|
|
|
— |
|
|
|
|
|
4,684 |
|
|
|
|
|
145 |
|
|
|
|
|
— |
|
|
|
|
|
4,829 |
|
| |||||
|
Disposals |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
| |||||
|
Translation differences |
|
|
|
|
(19 |
) |
|
|
|
|
|
(1,024 |
) |
|
|
|
|
|
(133 |
) |
|
|
|
|
|
131 |
|
|
|
|
|
(1,045 |
) |
|
| |
|
At December 31, 2013 |
|
|
|
|
22,267 |
|
|
|
|
|
28,212 |
|
|
|
|
|
10,141 |
|
|
|
|
|
10,548 |
|
|
|
|
|
71,168 |
|
| |||||
|
Accumulated amortization and impairment losses in KEUR |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
At January 1, 2012 |
|
|
|
|
— |
|
|
|
|
|
(799 |
) |
|
|
|
|
|
(491 |
) |
|
|
|
|
|
(1,060 |
) |
|
|
|
|
|
(2,350 |
) |
|
| |
|
Amortization expense |
|
|
|
|
— |
|
|
|
|
|
(512 |
) |
|
|
|
|
|
(1,113 |
) |
|
|
|
|
|
(666 |
) |
|
|
|
|
|
(2,291 |
) |
|
| |
|
Disposals |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
93 |
|
|
|
|
|
— |
|
|
|
|
|
93 |
|
| |||||
|
Translation differences |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(45 |
) |
|
|
|
|
|
(5 |
) |
|
|
|
|
|
(50 |
) |
|
| ||
|
At December 31, 2012 |
|
|
|
|
— |
|
|
|
|
|
(1,311 |
) |
|
|
|
|
|
(1,557 |
) |
|
|
|
|
|
(1,731 |
) |
|
|
|
|
|
(4,598 |
) |
|
| |
|
Amortization expense |
|
|
|
|
— |
|
|
|
|
|
(787 |
) |
|
|
|
|
|
(1,083 |
) |
|
|
|
|
|
(1,128 |
) |
|
|
|
|
|
(2,998 |
) |
|
| |
|
Impairment |
|
|
|
|
(1,015 |
) |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(1,015 |
) |
|
| |||
|
Reversal |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(3 |
) |
|
|
|
|
|
(3 |
) |
|
| |||
|
Translation differences |
|
|
|
|
— |
|
|
|
|
|
62 |
|
|
|
|
|
2 |
|
|
|
|
|
(32 |
) |
|
|
|
|
|
32 |
|
| ||||
|
At December 31, 2013 |
|
|
|
|
(1,015 |
) |
|
|
|
|
|
(2,036 |
) |
|
|
|
|
|
(2,638 |
) |
|
|
|
|
|
(2,894 |
) |
|
|
|
|
|
(8,582 |
) |
|
|
|
Carrying amount |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
At December 31, 2012 |
|
|
|
|
22,286 |
|
|
|
|
|
23,241 |
|
|
|
|
|
8,572 |
|
|
|
|
|
8,686 |
|
|
|
|
|
62,785 |
|
| |||||
|
At December 31, 2013 |
|
|
|
|
21,252 |
|
|
|
|
|
26,176 |
|
|
|
|
|
7,504 |
|
|
|
|
|
7,654 |
|
|
|
|
|
62,586 |
|
| |||||
| | | | | | | | | | | | | | | | | |
|
|
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
Goodwill |
|
|
Other intangible assets not yet available for use |
|
|
Accumulated impairment |
|
|
Total |
|
|
Goodwill |
|
|
Other intangible assets not yet available for use |
|
|
Accumulated impairment |
|
|
Total |
| ||||||||||||||||||||||||||||||||
|
France |
|
|
|
|
— |
|
|
|
|
|
9,911 |
|
|
|
|
|
— |
|
|
|
|
|
9,911 |
|
|
|
|
|
— |
|
|
|
|
|
5,911 |
|
|
|
|
|
— |
|
|
|
|
|
5,911 |
|
| ||||||||
|
Italy (Gipharma) |
|
|
|
|
1,947 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,947 |
|
|
|
|
|
1,947 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,947 |
|
| ||||||||
|
Canada |
|
|
|
|
416 |
|
|
|
|
|
5,064 |
|
|
|
|
|
— |
|
|
|
|
|
5,480 |
|
|
|
|
|
501 |
|
|
|
|
|
5,656 |
|
|
|
|
|
— |
|
|
|
|
|
6,157 |
|
| ||||||||
|
USA |
|
|
|
|
3,223 |
|
|
|
|
|
9,571 |
|
|
|
|
|
— |
|
|
|
|
|
12,794 |
|
|
|
|
|
3,370 |
|
|
|
|
|
10,004 |
|
|
|
|
|
— |
|
|
|
|
|
13,374 |
|
| ||||||||
|
Germany |
|
|
|
|
1,027 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,027 |
|
|
|
|
|
1,027 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,027 |
|
| ||||||||
|
Spain |
|
|
|
|
6,261 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
6,261 |
|
|
|
|
|
6,261 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
6,261 |
|
| ||||||||
|
Israel |
|
|
|
|
7,500 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
7,500 |
|
|
|
|
|
7,287 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
7,287 |
|
| ||||||||
|
Portugal |
|
|
|
|
1,855 |
|
|
|
|
|
— |
|
|
|
|
|
(1,015 |
) |
|
|
|
|
|
840 |
|
|
|
|
|
1,855 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,855 |
|
| |||||||
|
Other countries |
|
|
|
|
38 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
38 |
|
|
|
|
|
38 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
38 |
|
| ||||||||
|
Total |
|
|
|
|
22,267 |
|
|
|
|
|
24,546 |
|
|
|
|
|
(1,015 |
) |
|
|
|
|
|
45,798 |
|
|
|
|
|
22,286 |
|
|
|
|
|
21,571 |
|
|
|
|
|
— |
|
|
|
|
|
43,857 |
|
| |||||||
| | | | | | | | | | | | | | | | | | | | | | | | | | |
|
|
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
CGU |
|
|
Budgeted Ebitda increase at mid-term (of forecast period)(1) |
|
|
Discount rate |
|
|
Terminal growth rate |
|
|
Forecast period in years |
|
|
Budgeted Ebitda increase at mid-term (of forecast period)(1) |
|
|
Discount rate |
|
|
Terminal growth rate |
|
|
Forecast period in years |
| ||||||||||||||||||||||||||||||||
|
France |
|
|
|
|
43.9 |
% |
|
|
|
|
|
10.0 |
% |
|
|
|
|
|
-0.7 |
% |
|
|
|
|
|
8 |
|
|
|
|
|
24.8 |
% |
|
|
|
|
|
10.0 |
% |
|
|
|
|
|
1.9 |
% |
|
|
|
|
|
8 |
|
| ||
|
Italy (incl. Gipharma) |
|
|
|
|
12.1 |
% |
|
|
|
|
|
10.0 |
% |
|
|
|
|
|
2.0 |
% |
|
|
|
|
|
5 |
|
|
|
|
|
13.6 |
% |
|
|
|
|
|
10.0 |
% |
|
|
|
|
|
2.0 |
% |
|
|
|
|
|
5 |
|
| ||
|
Canada(2) |
|
|
|
|
73.7 |
% |
|
|
|
|
|
20.0 |
% |
|
|
|
|
|
3.0 |
% |
|
|
|
|
|
10 |
|
|
|
|
|
64.4 |
% |
|
|
|
|
|
25.0 |
% |
|
|
|
|
|
3.0 |
% |
|
|
|
|
|
10 |
|
| ||
|
USA |
|
|
|
|
341.6 |
% |
|
|
|
|
|
15.0 |
% |
|
|
|
|
|
0.0 |
% |
|
|
|
|
|
8 |
|
|
|
|
|
73.8 |
% |
|
|
|
|
|
18.0 |
% |
|
|
|
|
|
2.5 |
% |
|
|
|
|
|
8 |
|
| ||
|
Germany |
|
|
|
|
37.5 |
% |
|
|
|
|
|
9.0 |
% |
|
|
|
|
|
-0.5 |
% |
|
|
|
|
|
8 |
|
|
|
|
|
94.9 |
% |
|
|
|
|
|
12.0 |
% |
|
|
|
|
|
0.0 |
% |
|
|
|
|
|
8 |
|
| ||
|
Spain |
|
|
|
|
23.6 |
% |
|
|
|
|
|
14.0 |
% |
|
|
|
|
|
0.7 |
% |
|
|
|
|
|
8 |
|
|
|
|
|
19.9 |
% |
|
|
|
|
|
14.0 |
% |
|
|
|
|
|
2.0 |
% |
|
|
|
|
|
8 |
|
| ||
|
Israel |
|
|
|
|
7.0 |
% |
|
|
|
|
|
11.0 |
% |
|
|
|
|
|
0.0 |
% |
|
|
|
|
|
5 |
|
|
|
|
|
14.7 |
% |
|
|
|
|
|
10.0 |
% |
|
|
|
|
|
-2.0 |
% |
|
|
|
|
|
5 |
|
| ||
|
Portugal(3) |
|
|
|
|
7.1 |
% |
|
|
|
|
|
15.0 |
% |
|
|
|
|
|
0.0 |
% |
|
|
|
|
|
8 |
|
|
|
|
|
14.0 |
% |
|
|
|
|
|
15.0 |
% |
|
|
|
|
|
0.0 |
% |
|
|
|
|
|
8 |
|
| ||
| | | | | | | | | | | | | | | | | | | | | | | | | | |
|
|
|
|
12.31.2013 |
|
|
12.13.2012 |
| ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
In percent |
|
|
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 |
| ||||||||||||||||
|
France |
|
|
|
|
17 |
|
|
|
|
|
-66 |
|
|
|
|
|
11 |
|
|
|
|
|
-56 |
|
| ||||
|
Italy (incl. Gipharma) |
|
|
|
|
4 |
|
|
|
|
|
-26 |
|
|
|
|
|
4.5 |
|
|
|
|
|
-25 |
|
| ||||
|
Canada |
|
|
|
|
3 |
|
|
|
|
|
-31 |
|
|
|
|
|
3 |
|
|
|
|
|
-35 |
|
| ||||
|
USA |
|
|
|
|
19 |
|
|
|
|
|
-75 |
|
|
|
|
|
9.5 |
|
|
|
|
|
-50 |
|
| ||||
|
Germany |
|
|
|
|
13 |
|
|
|
|
|
-51 |
|
|
|
|
|
16 |
|
|
|
|
|
-60 |
|
| ||||
|
Spain(1) |
|
|
|
|
0 |
|
|
|
|
|
0 |
|
|
|
|
|
0.5 |
|
|
|
|
|
-4 |
|
| ||||
|
Israel |
|
|
|
|
8 |
|
|
|
|
|
-37 |
|
|
|
|
|
27 |
|
|
|
|
|
-63 |
|
| ||||
|
Portugal(1) |
|
|
|
|
0 |
|
|
|
|
|
0 |
|
|
|
|
|
1 |
|
|
|
|
|
-8 |
|
| ||||
| | | | | | | | | | | | | | |
|
|
|
|
On finance lease |
|
|
Not on finance lease |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Acquisition cost in KEUR |
|
|
Land |
|
|
Buildings |
|
|
Laboratory equipment |
|
|
Sub-total |
|
|
Land |
|
|
Buildings and construction in progress |
|
|
Laboratory equipment |
|
|
Other |
|
|
Sub-total |
|
|
TOTAL |
| ||||||||||||||||||||||||||||||||||||||||
|
At January 1, 2012 |
|
|
|
|
200 |
|
|
|
|
|
7,001 |
|
|
|
|
|
9,248 |
|
|
|
|
|
16,449 |
|
|
|
|
|
443 |
|
|
|
|
|
9,586 |
|
|
|
|
|
20,596 |
|
|
|
|
|
2,751 |
|
|
|
|
|
33,376 |
|
|
|
|
|
49,825 |
|
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
| ||||||||||
|
Additions |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,250 |
|
|
|
|
|
1,250 |
|
|
|
|
|
877 |
|
|
|
|
|
6,273 |
|
|
|
|
|
2,711 |
|
|
|
|
|
396 |
|
|
|
|
|
10,258 |
|
|
|
|
|
11,508 |
|
| ||||||||||
|
Business combinations |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,183 |
|
|
|
|
|
3,423 |
|
|
|
|
|
6 |
|
|
|
|
|
4,611 |
|
|
|
|
|
4,611 |
|
| ||||||||||
|
Disposals |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(153 |
) |
|
|
|
|
|
— |
|
|
|
|
|
(153 |
) |
|
|
|
|
|
(153 |
) |
|
| |||||||
|
Reclassifications |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(6,361 |
) |
|
|
|
|
|
4,294 |
|
|
|
|
|
2,067 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
| |||||||||
|
Translation differences |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
0 |
|
|
|
|
|
8 |
|
|
|
|
|
(134 |
) |
|
|
|
|
|
(126 |
) |
|
|
|
|
|
(126 |
) |
|
| |||||||
|
At December 31, 2012 |
|
|
|
|
200 |
|
|
|
|
|
7,001 |
|
|
|
|
|
10,498 |
|
|
|
|
|
17,699 |
|
|
|
|
|
1,320 |
|
|
|
|
|
10,681 |
|
|
|
|
|
30,879 |
|
|
|
|
|
5,086 |
|
|
|
|
|
47,966 |
|
|
|
|
|
65,664 |
|
| ||||||||||
|
Additions |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
1,717 |
|
|
|
|
|
1,717 |
|
|
|
|
|
— |
|
|
|
|
|
6,124 |
|
|
|
|
|
2,866 |
|
|
|
|
|
300 |
|
|
|
|
|
9,289 |
|
|
|
|
|
11,007 |
|
| ||||||||||
|
Disposals |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(204 |
) |
|
|
|
|
|
(1,950 |
) |
|
|
|
|
|
(7 |
) |
|
|
|
|
|
(2,161 |
) |
|
|
|
|
|
(2,161 |
) |
|
| |||||
|
Reclassifications |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
(128 |
) |
|
|
|
|
|
2,002 |
|
|
|
|
|
(1,874 |
) |
|
|
|
|
|
0 |
|
|
|
|
|
0 |
|
| ||||||||
|
Translation differences |
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
92 |
|
|
|
|
|
11 |
|
|
|
|
|
103 |
|
|
|
|
|
103 |
|
| ||||||||||
|
At December 31, 2013 |
|
|
|
|
200 |
|
|
|
|
|
7,001 |
|
|
|
|
|
12,215 |
|
|
|
|
|
19,416 |
|
|
|
|
|
1,320 |
|
|
|
|
|
16,472 |
|
|
|
|
|
33,889 |
|
|
|
|
|
3,516 |
|
|
|
|
|
55,197 |
|
|
|
|
|
74,613 |
|
| ||||||||||
|
Accumulated amortization and impairment losses in KEUR |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
At January 1, 2012 |
|
|
|
|
— |
|
|
|
|
|
(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 December 31, 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 December 31, 2013 |
|
|
|
|
— |
|
|
|
|
|
(1,714 |
) |
|
|
|
|
|
(6,057 |
) |
|
|
|
|
|
(7,770 |
) |
|
|
|
|
|
— |
|
|
|
|
|
(2,180 |
) |
|
|
|
|
|
(13,634 |
) |
|
|
|
|
|
(1,749 |
) |
|
|
|
|
|
(17,563 |
) |
|
|
|
|
|
(25,333 |
) |
|
| ||
|
Carrying amount |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
At December 31, 2012 |
|
|
|
|
200 |
|
|
|
|
|
5,697 |
|
|
|
|
|
5,605 |
|
|
|
|
|
11,503 |
|
|
|
|
|
1,320 |
|
|
|
|
|
9,033 |
|
|
|
|
|
20,218 |
|
|
|
|
|
3720 |
|
|
|
|
|
34,291 |
|
|
|
|
|
45,794 |
|
| ||||||||||
|
At December 31, 2013 |
|
|
|
|
200 |
|
|
|
|
|
5,287 |
|
|
|
|
|
6,159 |
|
|
|
|
|
11,646 |
|
|
|
|
|
1,320 |
|
|
|
|
|
14,292 |
|
|
|
|
|
20,255 |
|
|
|
|
|
1,767 |
|
|
|
|
|
37,634 |
|
|
|
|
|
49,280 |
|
| ||||||||||
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
In KEUR |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gross value |
|
|
|
|
16,524 |
|
|
|
|
|
15,777 |
|
| ||
|
Allowance for doubtful accounts |
|
|
|
|
(381 |
) |
|
|
|
|
|
(240 |
) |
|
|
|
Total |
|
|
|
|
16,143 |
|
|
|
|
|
15,537 |
|
| ||
| | | | | | | |
|
In KEUR |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Write-down of allowance for doubtful accounts, beginning of year |
|
|
|
|
240 |
|
|
|
|
|
15 |
|
| ||
|
Increase |
|
|
|
|
149 |
|
|
|
|
|
225 |
|
| ||
|
Utilized |
|
|
|
|
— |
|
|
|
|
|
— |
|
| ||
|
Reversed |
|
|
|
|
— |
|
|
|
|
|
— |
|
| ||
|
Translation adjustment |
|
|
|
|
(8 |
) |
|
|
|
|
|
— |
|
| |
|
Write-down of allowance for doubtful accounts, end of year |
|
|
|
|
381 |
|
|
|
|
|
240 |
|
| ||
| | | | | | | |
|
In KEUR |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
30 – 60 days |
|
|
|
|
3,975 |
|
|
|
|
|
3,287 |
|
| ||
|
Over 60 days |
|
|
|
|
7,323 |
|
|
|
|
|
7,412 |
|
| ||
|
Total |
|
|
|
|
11,298 |
|
|
|
|
|
10,699 |
|
| ||
| | | | | | | |
|
In KEUR |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Raw materials |
|
|
|
|
2,088 |
|
|
|
|
|
1,604 |
|
| ||
|
Other |
|
|
|
|
199 |
|
|
|
|
|
234 |
|
| ||
|
Total gross value |
|
|
|
|
2,287 |
|
|
|
|
|
1,838 |
|
| ||
|
Write-downs |
|
|
|
|
(9 |
) |
|
|
|
|
|
(5 |
) |
|
|
|
Total |
|
|
|
|
2,278 |
|
|
|
|
|
1,833 |
|
| ||
| | | | | | | |
|
In KEUR |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
R&D tax credits |
|
|
|
|
2,562 |
|
|
|
|
|
2,906 |
|
| ||
|
Tax receivables (incl. VAT) and other receivables |
|
|
|
|
4,712 |
|
|
|
|
|
3,723 |
|
| ||
|
Prepaid expenses |
|
|
|
|
723 |
|
|
|
|
|
478 |
|
| ||
|
Other current assets |
|
|
|
|
7,997 |
|
|
|
|
|
7,107 |
|
| ||
| | | | | | | |
|
In KEUR |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Marketable securities(1) |
|
|
|
|
600 |
|
|
|
|
|
1,173 |
|
| ||
|
Cash |
|
|
|
|
13,010 |
|
|
|
|
|
12,893 |
|
| ||
|
Total |
|
|
|
|
13,610 |
|
|
|
|
|
14,066 |
|
| ||
| | | | | | | |
|
|
|
|
Net income (loss) (KEUR) |
|
|
Average number of shares outstanding |
|
|
Earnings per share (EUR) |
| ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
12.31.2013 |
|
|
|
|
(9,231 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
Basic earnings per share |
|
|
|
|
|
|
|
|
|
|
54,156,067 |
|
|
|
|
|
(0.17 |
) |
|
| ||
|
Diluted earnings per share |
|
|
|
|
|
|
|
|
|
|
54,156,067 |
|
|
|
|
|
(0.17 |
) |
|
| ||
|
12.31.2012 |
|
|
|
|
(16,455 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||
|
Basic earnings per share |
|
|
|
|
|
|
|
|
|
|
52,364,094 |
|
|
|
|
|
(0.31 |
) |
|
| ||
|
Diluted earnings per share |
|
|
|
|
|
|
|
|
|
|
52,364,094 |
|
|
|
|
|
(0.31 |
) |
|
| ||
| | | | | | | | | | |
|
|
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
In KEUR |
|
|
Atreus Pharmaceuticals Corporation |
|
|
Umbra Medical AG |
|
|
Atreus Pharmaceuticals Corporation |
|
|
Umbra Medical AG |
| ||||||||||||||||
|
NCI percentage |
|
|
|
|
49.9 |
% |
|
|
|
|
|
49.9 |
% |
|
|
|
|
|
49.9 |
% |
|
|
|
|
|
49.9 |
% |
|
|
|
Non-current assets |
|
|
|
|
6,768 |
|
|
|
|
|
1,361 |
|
|
|
|
|
7,109 |
|
|
|
|
|
1 |
|
| ||||
|
Current assets |
|
|
|
|
472 |
|
|
|
|
|
409 |
|
|
|
|
|
617 |
|
|
|
|
|
536 |
|
| ||||
|
Non-current liabilities |
|
|
|
|
(1,783 |
) |
|
|
|
|
|
(1,035 |
) |
|
|
|
|
|
(1,992 |
) |
|
|
|
|
|
(10 |
) |
|
|
|
Current liabilities |
|
|
|
|
(2,356 |
) |
|
|
|
|
|
(1,109 |
) |
|
|
|
|
|
(1,433 |
) |
|
|
|
|
|
(443 |
) |
|
|
|
Net assets |
|
|
|
|
3,101 |
|
|
|
|
|
(374 |
) |
|
|
|
|
|
4,301 |
|
|
|
|
|
84 |
|
| |||
|
Carrying amount of NCI |
|
|
|
|
1,547 |
|
|
|
|
|
(187 |
) |
|
|
|
|
|
2,146 |
|
|
|
|
|
42 |
|
| |||
|
Revenue |
|
|
|
|
160 |
|
|
|
|
|
891 |
|
|
|
|
|
126 |
|
|
|
|
|
846 |
|
| ||||
|
Total comprehensive income |
|
|
|
|
(1,204 |
) |
|
|
|
|
|
(459 |
) |
|
|
|
|
|
(363 |
) |
|
|
|
|
|
(219 |
) |
|
|
|
Comprehensive income allocated to NCI |
|
|
|
|
(601 |
) |
|
|
|
|
|
(229 |
) |
|
|
|
|
|
(181 |
) |
|
|
|
|
|
(109 |
) |
|
|
| | | | | | | | | | | | | |
|
In KEUR |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Decommissioning obligations |
|
|
|
|
5,127 |
|
|
|
|
|
4,903 |
|
| ||
|
Retirement indemnities and other employee benefits |
|
|
|
|
843 |
|
|
|
|
|
657 |
|
| ||
|
Other |
|
|
|
|
60 |
|
|
|
|
|
32 |
|
| ||
|
Total non-current provisions |
|
|
|
|
6,030 |
|
|
|
|
|
5,592 |
|
| ||
|
Other |
|
|
|
|
115 |
|
|
|
|
|
300 |
|
| ||
|
Total current provisions |
|
|
|
|
115 |
|
|
|
|
|
300 |
|
| ||
|
Total |
|
|
|
|
6,145 |
|
|
|
|
|
5,892 |
|
| ||
| | | | | | | |
|
|
|
|
12.31.2013 |
|
|
12.31.2012 |
|
---|---|---|---|---|---|---|---|---|
|
Discount rate |
|
|
3.17% |
|
|
2.69% |
|
|
Future increase in remuneration |
|
|
2% |
|
|
2% |
|
|
Rate of social charges |
|
|
47% |
|
|
47% |
|
|
Retirement age |
|
|
Managers: 65 years Other staff: 62 years |
|
|
Managers: 65 years Other staff: 62 years |
|
|
Mortality table |
|
|
INSEE 2008 – 2010 |
|
|
INSEE 2007 – 2009 |
|
| | | | | |
|
In KEUR |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Finance lease obligations(1) |
|
|
|
|
7,591 |
|
|
|
|
|
6,988 |
|
| ||
|
Bank overdrafts |
|
|
|
|
— |
|
|
|
|
|
119 |
|
| ||
|
Loans(1) |
|
|
|
|
18,226 |
|
|
|
|
|
17,961 |
|
| ||
|
Total |
|
|
|
|
25,817 |
|
|
|
|
|
25,068 |
|
| ||
| | | | | | | |
|
|
|
|
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 |
|
| ||||
| | | | | | | | | | | | | |
|
In KEUR |
|
|
Average interest rate |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Fixed rates |
|
|
|
|
3.99 |
% |
|
|
|
|
|
17,603 |
|
|
|
|
|
17,879 |
|
| ||
|
Floating rates |
|
|
|
|
2.36 |
% |
|
|
|
|
|
8,214 |
|
|
|
|
|
7,189 |
|
| ||
|
Total |
|
|
|
|
|
|
|
|
|
|
25,817 |
|
|
|
|
|
25,068 |
|
| |||
| | | | | | | | | | |
|
In KEUR |
|
|
12.31.2013 |
|
|
12.31.2012 |
| ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Due to former owners of acquired companies(1) |
|
|
|
|
29,786 |
|
|
|
|
|
23,158 |
|
| ||
|
Government subsidies |
|
|
|
|
4,661 |
|
|
|
|
|
2,979 |
|
| ||
|
Other non-current liabilities |
|
|
|
|
34,448 |
|
|
|
|
|
26,137 |
|
| ||
|
Due to former owners of acquired companies(1) |
|
|
|
|
2,793 |
|
|
|
|
|
5,834 |
|
| ||
|
Tax, personnel and social charges |
|
|
|
|
3,886 |
|
|
|
|
|
3,124 |
|
| ||
|
Other(2) |
|
|
|
|
2,874 |
|
|
|
|
|
3,001 |
|
| ||
|
Other current liabilities |
|
|
|
|
9,552 |
|
|
|
|
|
11,959 |
|
| ||
| | | | | | | |
|
|
|
|
12.31.2013 |
| ||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
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) |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
11,421 |
|
|
|
|
|
11,421 |
|
|
|
|
|
11,421 |
|
| |||||||
|
Total not measured at fair value |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
46,456 |
|
|
|
|
|
46,456 |
|
|
|
|
|
47,084 |
|
| |||||||
|
Total financial liabilities |
|
|
|
|
|
|
|
|
|
|
32,579 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
46,456 |
|
|
|
|
|
79,035 |
|
|
|
|
|
79,663 |
|
| |||||||
| | | | | | | | | | | | | | | | | | | | | | |
|
|
|
|
12.31.2012 |
| ||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
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) |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
9,104 |
|
|
|
|
|
9,104 |
|
|
|
|
|
9,104 |
|
| |||||||
|
Total not measured at fair value |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
44,029 |
|
|
|
|
|
44,029 |
|
|
|
|
|
44,830 |
|
| |||||||
|
Total financial liabilities |
|
|
|
|
|
|
|
|
|
|
28,992 |
|
|
|
|
|
— |
|
|
|
|
|
— |
|
|
|
|
|
44,029 |
|
|
|
|
|
73,021 |
|
|
|
|
|
73,822 |
|
| |||||||
| | | | | | | | | | | | | | | | | | | | | | |
|
2013 (in KEUR) |
|
|
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 |
|
|
|
|
40,114 |
|
|
|
|
|
75,373 |
|
|
|
|
|
5,667 |
|
|
|
|
|
12,200 |
|
|
|
|
|
57,506 |
|
| |||||
|
Total |
|
|
|
|
79,035 |
|
|
|
|
|
117,121 |
|
|
|
|
|
24,983 |
|
|
|
|
|
29,063 |
|
|
|
|
|
63,076 |
|
| |||||
| | | | | | | | | | | | | | | | | |
|
2012 (in KEUR) |
|
|
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 |
|
|
|
|
34,972 |
|
|
|
|
|
65,922 |
|
|
|
|
|
8,889 |
|
|
|
|
|
9,210 |
|
|
|
|
|
47,823 |
|
| |||||
|
Total |
|
|
|
|
73,021 |
|
|
|
|
|
107,079 |
|
|
|
|
|
26,611 |
|
|
|
|
|
26,559 |
|
|
|
|
|
53,909 |
|
| |||||
| | | | | | | | | | | | | | | | | |
|
Entity |
|
|
Registered office in |
|
|
% Interest 2013 |
|
|
% Interest 2012 |
|
---|---|---|---|---|---|---|---|---|---|---|---|
|
Advanced Accelerator Applications SA |
|
|
France |
|
|
Parent Company |
|
|
Parent Company |
|
|
Advanced Accelerator Applications Unipessoal Lda |
|
|
Portugal |
|
|
100% |
|
|
100% |
|
|
Advanced Accelerator Applications Polska sp zoo |
|
|
Poland |
|
|
100% |
|
|
100% |
|
|
Advanced Accelerator Applications (Italy) Srl |
|
|
Italy |
|
|
100% |
|
|
100% |
|
|
G.I. Pharma Srl |
|
|
Italy |
|
|
100% |
|
|
100% |
|
|
Advanced Accelerator Applications International SA |
|
|
Switzerland |
|
|
100% |
|
|
100% |
|
|
Umbra Medical AG |
|
|
Germany |
|
|
50.1% |
|
|
50.1% |
|
|
Advanced Accelerator Applications Iberica |
|
|
Spain |
|
|
100% |
|
|
100% |
|
|
BioSynthema Inc. |
|
|
USA |
|
|
100% |
|
|
100% |
|
|
Marshel (R.R) Investments Ltd |
|
|
Israel |
|
|
100% |
|
|
100% |
|
|
Catalana De Dispensacion |
|
|
Spain |
|
|
100% |
|
|
100% |
|
|
Barnatron SA |
|
|
Spain |
|
|
100% |
|
|
100% |
|
|
Advanced Accelerator Applications Canada Inc. |
|
|
Canada |
|
|
100% |
|
|
100% |
|
|
Atreus Pharmaceuticals Corporation |
|
|
Canada |
|
|
50.1% |
|
|
50.1% |
|
|
Eifel Property GmbH |
|
|
Germany |
|
|
100% |
|
|
100% |
|
| | | | | | | |
|
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 |
|
| ||
|
09/2012 |
|
|
|
|
575,000 |
|
|
|
|
|
4.0 |
|
| ||
|
12/2012 |
|
|
|
|
19,377 |
|
|
|
|
|
2.5 |
|
| ||
| | | | | | | |
|
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 , 2014).* |
|
|
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.† |
|
|
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: |
|
|
|
|
|
|
|
|
|
|
|
Name:
|
|
|
|
|
|
|
|
|
Title:
|
|
| | | | | |
|
Name |
|
|
Title |
|
---|---|---|---|---|---|
|
Stefano Buono |
|
|
Chief Executive Officer and Director (principal executive officer) |
|
|
Heinz Mäusli |
|
|
Chief Financial Officer (principal financial officer and principal accounting officer) |
|
|
Claudio Costamagna |
|
|
Chairman of the Board |
|
|
Muriel de Szilbereky |
|
|
Director |
|
|
Kapil Dhingra |
|
|
Director |
|
|
Steve Gannon |
|
|
Director |
|
|
Yvonne Greenstreet |
|
|
Director |
|
|
Christian Merle |
|
|
Director |
|
|
Leopoldo Zambeletti |
|
|
Director |
|
|
Donald J. Puglisi |
|
|
Authorized Representative in the United States |
|
| | | |
|
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 , 2014).* |
|
|
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.† |
|
|
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 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· |
i |
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
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
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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.
Shareholder: Mallinckrodt Inc.
By: | /s/ Joe Wuestner |
Name: | Joe Wuestner | |
Title: | VP and Assistant Secretary |
BiosSynthema Inc. Shareholder Signature Page to Stock Purchase Agreement
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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.
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
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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.
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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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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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Execution copy
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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Execution copy
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.
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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: |
Name: | ||
Title | ||
ATREUS PHARMACEUTICALS | ||
CORPORATION |
By: |
Name: | ||
Title: |
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