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ý
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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75-2402409
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(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.)
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4400 Biscayne Blvd.
Miami, FL 33137 (Address of Principal Executive Offices) (Zip Code) |
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(305) 575-4100
(Registrant’s Telephone Number, Including Area Code) |
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Large accelerated filer
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x
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Accelerated filer
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¨
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Non-accelerated filer
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¨
(Do not check if a smaller reporting company)
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Smaller reporting company
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¨
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Page
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EX-31.1
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Section 302 Certification of CEO
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EX-31.2
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Section 302 Certification of CFO
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EX-32.1
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Section 906 Certification of CEO
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EX-32.2
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Section 906 Certification of CFO
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EX-101.INS
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XBRL Instance Document
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EX-101.SCH
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XBRL Taxonomy Extension Schema Document
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EX-101.CAL
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XBRL Taxonomy Extension Calculation Linkbase Document
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EX-101.DEF
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XBRL Taxonomy Extension Definition Linkbase Document
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EX-101.LAB
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XBRL Taxonomy Extension Label Linkbase Document
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EX-101.PRE
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XBRL Taxonomy Extension Presentation Linkbase Document
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•
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We have a history of operating losses and we do not expect to become profitable in the near future.
|
•
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Our technologies are in an early stage of development and are unproven.
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•
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Our business is substantially dependent on our ability to develop, launch and generate revenue from our pharmaceutical and diagnostic programs.
|
•
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Our research and development activities, or that of our investees, may not result in commercially viable products.
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•
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The timing and expenditures associated with the build-up of pre-launch inventory and capacity expansion.
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•
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The results of previous clinical trials may not be predictive of future results, and our current and planned clinical trials may not satisfy the requirements of the United States (“U.S.”) Food and Drug Administration (“FDA”) or other non-U.S. regulatory authorities.
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•
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We may require substantial additional funding, which may not be available to us on acceptable terms, or at all.
|
•
|
We may finance future cash needs primarily through public or private offerings, debt financings or strategic collaborations, which may dilute your stockholdings in the Company.
|
•
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If our competitors develop and market products that are more effective, safer or less expensive than our future product candidates, our commercial opportunities will be negatively impacted.
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•
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The regulatory approval process is expensive, time consuming and uncertain and may prevent us or our collaboration partners from obtaining approvals for the commercialization of some or all of our product candidates.
|
•
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Failure to complete the proposed merger with Bio-Reference Laboratories, Inc. ("Bio-Reference"), or to successfully integrate Bio-Reference with our business, could have a negative impact on our financial condition, results of operations, cash flows and stock price.
|
•
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Failure to recruit and enroll patients for clinical trials may cause the development of our product candidates to be delayed.
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•
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Even if we obtain regulatory approvals for our product candidates, the terms of approvals and ongoing regulation of our products may limit how we manufacture and market our product candidates, which could materially impair our ability to generate anticipated revenues.
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•
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We may not meet regulatory quality standards applicable to our manufacturing and quality processes.
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•
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Even if we receive regulatory approval to market our product candidates, the market may not be receptive to our products.
|
•
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The loss of Phillip Frost, M.D., our Chairman and Chief Executive Officer, could have a material adverse effect on our business and product development.
|
•
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If we fail to attract and retain key management and scientific personnel, we may be unable to successfully develop or commercialize our product candidates.
|
•
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In the event that we successfully evolve from a company primarily involved in development to a company also involved in commercialization, we may encounter difficulties in managing our growth and expanding our operations successfully.
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•
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If we fail to acquire and develop other products or product candidates, at all or on commercially reasonable terms, we may be unable to diversify or grow our business.
|
•
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We have no experience manufacturing our pharmaceutical product candidates other than at one of our Israel facilities and one of our Irish facilities, and at our Mexican and Spanish facilities, and we have no experience in manufacturing our diagnostic product candidates. We will therefore likely rely on third parties to manufacture and supply our pharmaceutical and diagnostics product candidates, and we would need to meet various standards to satisfy FDA regulations in order to manufacture on our own.
|
•
|
We currently have no pharmaceutical or diagnostic marketing, sales or distribution capabilities other than in Chile, Mexico, Spain, and Uruguay for sales in those countries and our active pharmaceutical ingredients (“APIs”) business in Israel, and the sales force for our laboratory business based in Nashville, Tennessee. If we are unable to develop our sales and marketing and distribution capability on our own or through collaborations with marketing partners, we will not be successful in commercializing our pharmaceutical and diagnostic product candidates.
|
•
|
Certain elements of our business are dependent on the success of ongoing and planned phase 3 clinical trials for
Alpharen
(Fermagate Tablets), and hGH-CTP.
|
•
|
Independent clinical investigators and contract research organizations that we engage to conduct our clinical trials may not be diligent, careful or timely.
|
•
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The success of our business is dependent on the actions of our collaborative partners.
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•
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Our exclusive worldwide agreement with Pfizer Inc. (“Pfizer”) is important to our business. If we do not successfully develop hGH-CTP and/or Pfizer does not successfully commercialize hGH-CTP, our business could be adversely affected.
|
•
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Our license agreement with TESARO, Inc. (“TESARO”) is important to our business. If TESARO does not successfully develop and commercialize rolapitant, our business could be adversely affected.
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•
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If we are unable to obtain and enforce patent protection for our products, our business could be materially harmed.
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•
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If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.
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•
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We rely heavily on licenses from third parties.
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•
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We license patent rights to certain of our technology from third-party owners. If such owners do not properly maintain or enforce the patents underlying such licenses, our competitive position and business prospects will be harmed.
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•
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Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties.
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•
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Adverse results in material litigation matters or governmental inquiries could have a material adverse effect upon our business and financial condition.
|
•
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If our products have undesirable effects on patients, we could be subject to litigation or product liability claims that could impair our reputation and have a material adverse effect upon our business and financial condition.
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•
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Medicare prescription drug coverage legislation and future legislative or regulatory reform of the health care system may adversely affect our ability to sell our products or provide our services profitably.
|
•
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Failure to obtain and maintain regulatory approval outside the U.S. will prevent us from marketing our product candidates abroad.
|
•
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We may not have the funding available to pursue acquisitions.
|
•
|
Acquisitions may disrupt our business, distract our management, may not proceed as planned, and may also increase the risk of potential third party claims and litigation.
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•
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We may encounter difficulties in integrating acquired businesses.
|
•
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Non-U.S. governments often impose strict price controls, which may adversely affect our future profitability.
|
•
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Political and economic instability in Europe and Latin America and political, economic, and military instability in Israel or neighboring countries could adversely impact our operations.
|
•
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We are subject to fluctuations in currency exchange rates in connection with our international businesses.
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•
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We have a large amount of goodwill and other intangible assets as a result of acquisitions and a significant write-down of goodwill and/or other intangible assets would have a material adverse effect on our reported results of operations and net worth.
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•
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Our business may become subject to legal, economic, political, regulatory and other risks associated with international operations.
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•
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The market price of our Common Stock may fluctuate significantly.
|
•
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The conversion and redemption features of our January 2013 convertible senior notes due in 2033 are classified as embedded derivatives and may continue to result in volatility in our financial statements, including having a material impact on our result of operations and recorded derivative liability.
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•
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Directors, executive officers, principal stockholders and affiliated entities own a significant percentage of our capital stock, and they may make decisions that you may not consider to be in your best interests or in the best interests of our stockholders.
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•
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Compliance with changing regulations concerning corporate governance and public disclosure may result in additional expenses.
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•
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If we are unable to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as they apply to us, or our internal controls over financial reporting are not effective, the reliability of our financial statements may be questioned and our Common Stock price may suffer.
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•
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We may be unable to maintain our listing on the New York Stock Exchange (“NYSE”), which could cause our stock price to fall and decrease the liquidity of our Common Stock.
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•
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Future issuances of Common Stock and hedging activities may depress the trading price of our Common Stock.
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•
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Provisions in our charter documents and Delaware law could discourage an acquisition of us by a third party, even if the acquisition would be favorable to you.
|
•
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We do not intend to pay cash dividends on our Common Stock in the foreseeable future.
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|
June 30, 2015
(1)
|
|
December 31, 2014
(1)
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
221,217
|
|
|
$
|
96,907
|
|
Accounts receivable, net
|
26,980
|
|
|
19,969
|
|
||
Inventory, net
|
20,519
|
|
|
16,604
|
|
||
Prepaid expenses and other current assets
|
9,623
|
|
|
9,389
|
|
||
Total current assets
|
278,339
|
|
|
142,869
|
|
||
Property, plant, equipment, and investment properties, net
|
23,405
|
|
|
16,411
|
|
||
Intangible assets, net
|
94,247
|
|
|
62,649
|
|
||
In-process research and development
|
812,446
|
|
|
793,152
|
|
||
Goodwill
|
289,607
|
|
|
224,292
|
|
||
Investments, net
|
21,434
|
|
|
22,453
|
|
||
Other assets
|
6,013
|
|
|
5,838
|
|
||
Total assets
|
$
|
1,525,491
|
|
|
$
|
1,267,664
|
|
LIABILITIES AND EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
16,039
|
|
|
$
|
8,744
|
|
Accrued expenses
|
149,843
|
|
|
60,912
|
|
||
Current portion of lines of credit and notes payable
|
14,599
|
|
|
13,455
|
|
||
Total current liabilities
|
180,481
|
|
|
83,111
|
|
||
2033 Senior Notes, net of discount and estimated fair value of embedded derivatives
|
109,203
|
|
|
131,454
|
|
||
Other long-term liabilities, principally deferred revenue and deferred tax liabilities
|
408,821
|
|
|
217,358
|
|
||
Total long-term liabilities
|
518,024
|
|
|
348,812
|
|
||
Total liabilities
|
698,505
|
|
|
431,923
|
|
||
Equity:
|
|
|
|
||||
Common Stock - $0.01 par value, 750,000,000 shares authorized; 464,567,632 and 433,421,677
shares issued at June 30, 2015 and December 31, 2014, respectively
|
4,646
|
|
|
4,334
|
|
||
Treasury Stock - 1,120,367 and 1,245,367 shares at June 30, 2015 and December 31, 2014,
respectively
|
(3,645
|
)
|
|
(4,051
|
)
|
||
Additional paid-in capital
|
1,687,389
|
|
|
1,529,096
|
|
||
Accumulated other comprehensive income (loss)
|
(18,880
|
)
|
|
(12,392
|
)
|
||
Accumulated deficit
|
(834,721
|
)
|
|
(674,843
|
)
|
||
Total shareholders’ equity attributable to OPKO
|
834,789
|
|
|
842,144
|
|
||
Noncontrolling interests
|
(7,803
|
)
|
|
(6,403
|
)
|
||
Total shareholders’ equity
|
826,986
|
|
|
835,741
|
|
||
Total liabilities and equity
|
$
|
1,525,491
|
|
|
$
|
1,267,664
|
|
(1)
|
As of
June 30, 2015
and
December 31, 2014
, total assets include
$7.1 million
and
$7.6 million
, respectively, and total liabilities include
$12.7 million
and
$12.1 million
, respectively, related to SciVac Ltd (“SciVac”), now known as SciVac Therapeutics, Inc., a consolidated variable interest entity. SciVac’s consolidated assets are owned by SciVac and SciVac’s consolidated liabilities have no recourse against us. Refer to Note 5.
|
|
For the three months ended June 30,
|
|
For the six months ended June 30,
|
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Revenues:
|
|
|
|
|
|
|
|
||||||||
Products
|
$
|
22,848
|
|
|
$
|
21,392
|
|
|
$
|
38,334
|
|
|
$
|
41,219
|
|
Revenue from services
|
1,908
|
|
|
2,153
|
|
|
3,977
|
|
|
4,123
|
|
||||
Revenue from transfer of intellectual property
|
17,673
|
|
|
—
|
|
|
30,202
|
|
|
476
|
|
||||
Total revenues
|
42,429
|
|
|
23,545
|
|
|
72,513
|
|
|
45,818
|
|
||||
Costs and expenses:
|
|
|
|
|
|
|
|
||||||||
Costs of revenues
|
14,434
|
|
|
12,565
|
|
|
24,755
|
|
|
24,955
|
|
||||
Selling, general and administrative
|
20,937
|
|
|
14,874
|
|
|
38,382
|
|
|
28,686
|
|
||||
Research and development
|
29,570
|
|
|
16,234
|
|
|
55,072
|
|
|
37,227
|
|
||||
In-process research and development
|
—
|
|
|
10,055
|
|
|
—
|
|
|
10,055
|
|
||||
Contingent consideration
|
(339
|
)
|
|
1,876
|
|
|
4,836
|
|
|
4,486
|
|
||||
Amortization of intangible assets
|
3,236
|
|
|
2,826
|
|
|
5,901
|
|
|
5,569
|
|
||||
Grant repayment (Note 12)
|
—
|
|
|
—
|
|
|
25,889
|
|
|
—
|
|
||||
Total costs and expenses
|
67,838
|
|
|
58,430
|
|
|
154,835
|
|
|
110,978
|
|
||||
Operating loss
|
(25,409
|
)
|
|
(34,885
|
)
|
|
(82,322
|
)
|
|
(65,160
|
)
|
||||
Other income and (expense), net:
|
|
|
|
|
|
|
|
||||||||
Interest income
|
5
|
|
|
7
|
|
|
12
|
|
|
48
|
|
||||
Interest expense
|
(986
|
)
|
|
(4,685
|
)
|
|
(3,551
|
)
|
|
(8,171
|
)
|
||||
Fair value changes of derivative instruments, net
|
(16,556
|
)
|
|
10,967
|
|
|
(66,344
|
)
|
|
594
|
|
||||
Other income (expense), net
|
760
|
|
|
2,990
|
|
|
(748
|
)
|
|
4,666
|
|
||||
Other income and (expense), net
|
(16,777
|
)
|
|
9,279
|
|
|
(70,631
|
)
|
|
(2,863
|
)
|
||||
Loss before income taxes and investment losses
|
(42,186
|
)
|
|
(25,606
|
)
|
|
(152,953
|
)
|
|
(68,023
|
)
|
||||
Income tax benefit (provision)
|
(251
|
)
|
|
(101
|
)
|
|
(5,760
|
)
|
|
(714
|
)
|
||||
Loss before investment losses
|
(42,437
|
)
|
|
(25,707
|
)
|
|
(158,713
|
)
|
|
(68,737
|
)
|
||||
Loss from investments in investees
|
(804
|
)
|
|
(370
|
)
|
|
(2,565
|
)
|
|
(2,426
|
)
|
||||
Net loss
|
(43,241
|
)
|
|
(26,077
|
)
|
|
(161,278
|
)
|
|
(71,163
|
)
|
||||
Less: Net loss attributable to noncontrolling interests
|
(475
|
)
|
|
(597
|
)
|
|
(1,400
|
)
|
|
(1,137
|
)
|
||||
Net loss attributable to common shareholders
|
$
|
(42,766
|
)
|
|
$
|
(25,480
|
)
|
|
$
|
(159,878
|
)
|
|
$
|
(70,026
|
)
|
Loss per share, basic and diluted:
|
|
|
|
|
|
|
|
||||||||
Net loss per share
|
$
|
(0.09
|
)
|
|
$
|
(0.06
|
)
|
|
$
|
(0.35
|
)
|
|
$
|
(0.17
|
)
|
Weighted average number of common shares outstanding, basic and diluted
|
462,253,161
|
|
|
413,339,679
|
|
|
454,361,137
|
|
|
413,125,932
|
|
|
For the three months ended June 30,
|
|
For the six months ended June 30,
|
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Net loss
|
$
|
(43,241
|
)
|
|
$
|
(26,077
|
)
|
|
$
|
(161,278
|
)
|
|
$
|
(71,163
|
)
|
Other comprehensive income (loss), net of tax:
|
|
|
|
|
|
|
|
||||||||
Change in foreign currency translation and other comprehensive income (loss) from equity investments
|
(694
|
)
|
|
188
|
|
|
(4,547
|
)
|
|
(1,613
|
)
|
||||
Available for sale investments:
|
|
|
|
|
|
|
|
||||||||
Change in unrealized gain (loss), net of tax
|
(682
|
)
|
|
(1,283
|
)
|
|
(1,941
|
)
|
|
(948
|
)
|
||||
Less: reclassification adjustments for (gains) losses included in net loss, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
(553
|
)
|
||||
Comprehensive loss
|
(44,617
|
)
|
|
(27,172
|
)
|
|
(167,766
|
)
|
|
(74,277
|
)
|
||||
Less: Comprehensive loss attributable to noncontrolling interest
|
(475
|
)
|
|
(597
|
)
|
|
(1,400
|
)
|
|
(1,137
|
)
|
||||
Comprehensive loss attributable to common shareholders
|
$
|
(44,142
|
)
|
|
$
|
(26,575
|
)
|
|
$
|
(166,366
|
)
|
|
$
|
(73,140
|
)
|
|
For the six months ended June 30,
|
||||||
|
2015
|
|
2014
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net loss
|
$
|
(161,278
|
)
|
|
$
|
(71,163
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
7,685
|
|
|
7,591
|
|
||
Non-cash interest on 2033 Senior Notes
|
1,681
|
|
|
3,557
|
|
||
Amortization of deferred financing costs
|
895
|
|
|
1,807
|
|
||
Losses from investments in investees
|
2,565
|
|
|
2,426
|
|
||
Equity-based compensation – employees and non-employees
|
14,090
|
|
|
6,993
|
|
||
(Recovery of) provision for bad debts
|
626
|
|
|
(68
|
)
|
||
Provision for inventory obsolescence
|
710
|
|
|
583
|
|
||
Revenue from receipt of equity
|
(120
|
)
|
|
(120
|
)
|
||
Realized gain on sale of equity securities
|
(216
|
)
|
|
(1,274
|
)
|
||
(Gain) loss on conversion of 3.00% convertible senior notes
|
291
|
|
|
(2,668
|
)
|
||
Change in fair value of derivative instruments
|
66,344
|
|
|
(594
|
)
|
||
In-process research and development
|
—
|
|
|
10,055
|
|
||
Change in fair value of contingent consideration
|
4,836
|
|
|
4,486
|
|
||
Changes in assets and liabilities, net of the effects of acquisitions:
|
|
|
|
||||
Accounts receivable
|
(4,812
|
)
|
|
(4,321
|
)
|
||
Inventory
|
(3,257
|
)
|
|
(1,413
|
)
|
||
Prepaid expenses and other current assets
|
1,142
|
|
|
3,466
|
|
||
Other assets
|
(512
|
)
|
|
3,911
|
|
||
Accounts payable
|
7,101
|
|
|
(3,308
|
)
|
||
Foreign currency measurement
|
300
|
|
|
(824
|
)
|
||
Deferred revenue
|
263,926
|
|
|
(846
|
)
|
||
Accrued expenses and other liabilities
|
2,741
|
|
|
(2,817
|
)
|
||
Net cash provided by (used in) operating activities
|
204,738
|
|
|
(44,541
|
)
|
||
Cash flows from investing activities:
|
|
|
|
||||
Investments in investees
|
(2,345
|
)
|
|
(500
|
)
|
||
Proceeds from sale of equity securities
|
—
|
|
|
1,331
|
|
||
Acquisition of businesses, net of cash
|
(94,674
|
)
|
|
(1,695
|
)
|
||
Capital expenditures
|
(1,439
|
)
|
|
(2,467
|
)
|
||
Net cash used in investing activities
|
(98,458
|
)
|
|
(3,331
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Proceeds from the exercise of Common Stock options and warrants
|
17,366
|
|
|
2,747
|
|
||
Cash from non-controlling interest
|
100
|
|
|
—
|
|
||
Contingent consideration payments
|
—
|
|
|
(6,435
|
)
|
||
Borrowings on lines of credit
|
11,038
|
|
|
14,258
|
|
||
Repayments of lines of credit
|
(10,022
|
)
|
|
(14,571
|
)
|
||
Net cash provided by financing activities
|
18,482
|
|
|
(4,001
|
)
|
||
Effect of exchange rate on cash and cash equivalents
|
(452
|
)
|
|
85
|
|
||
Net increase (decrease) in cash and cash equivalents
|
124,310
|
|
|
(51,788
|
)
|
||
Cash and cash equivalents at beginning of period
|
96,907
|
|
|
185,798
|
|
||
Cash and cash equivalents at end of period
|
$
|
221,217
|
|
|
$
|
134,010
|
|
SUPPLEMENTAL INFORMATION:
|
|
|
|
||||
Interest paid
|
$
|
1,724
|
|
|
$
|
2,771
|
|
Income taxes paid, net
|
$
|
757
|
|
|
$
|
796
|
|
Pharmsynthez common stock received
|
$
|
—
|
|
|
$
|
6,264
|
|
Non-cash financing:
|
|
|
|
||||
Shares issued upon the conversion of:
|
|
|
|
||||
2033 Senior Notes
|
$
|
92,172
|
|
|
$
|
95,665
|
|
Common Stock options and warrants, surrendered in net exercise
|
$
|
14,239
|
|
|
$
|
3,493
|
|
Issuance of capital stock to acquire:
|
|
|
|
||||
OPKO Health Europe
|
$
|
1,813
|
|
|
$
|
—
|
|
OPKO Uruguay Ltda.
|
$
|
—
|
|
|
$
|
159
|
|
Inspiro
|
$
|
—
|
|
|
$
|
8,566
|
|
EirGen Pharma Limited
|
$
|
33,569
|
|
|
$
|
—
|
|
(In thousands)
|
June 30,
2015 |
|
December 31,
2014 |
||||
Accounts receivable, net
|
|
|
|
||||
Accounts receivable
|
$
|
29,045
|
|
|
$
|
21,875
|
|
Less: allowance for doubtful accounts
|
(2,065
|
)
|
|
(1,906
|
)
|
||
|
$
|
26,980
|
|
|
$
|
19,969
|
|
Inventories, net
|
|
|
|
||||
Finished products
|
$
|
13,830
|
|
|
$
|
12,116
|
|
Work in-process
|
1,619
|
|
|
1,011
|
|
||
Raw materials
|
5,782
|
|
|
4,116
|
|
||
Less: inventory reserve
|
(712
|
)
|
|
(639
|
)
|
||
|
$
|
20,519
|
|
|
$
|
16,604
|
|
Prepaid expenses and other current assets
|
|
|
|
||||
Prepaid supplies
|
$
|
1,441
|
|
|
$
|
1,123
|
|
Prepaid insurance
|
613
|
|
|
968
|
|
||
Other receivables
|
1,107
|
|
|
669
|
|
||
Taxes recoverable
|
3,074
|
|
|
2,417
|
|
||
Other
|
3,388
|
|
|
4,212
|
|
||
|
$
|
9,623
|
|
|
$
|
9,389
|
|
Intangible assets, net:
|
|
|
|
||||
Technologies
|
$
|
52,287
|
|
|
$
|
52,508
|
|
Customer relationships
|
55,750
|
|
|
22,108
|
|
||
Product registrations
|
8,088
|
|
|
8,763
|
|
||
Trade names
|
3,411
|
|
|
3,483
|
|
||
Covenants not to compete
|
8,620
|
|
|
8,639
|
|
||
Other
|
4,889
|
|
|
1,079
|
|
||
Less: accumulated amortization
|
(38,798
|
)
|
|
(33,931
|
)
|
||
|
$
|
94,247
|
|
|
$
|
62,649
|
|
Accrued expenses:
|
|
|
|
||||
Taxes payable
|
$
|
2,592
|
|
|
$
|
77
|
|
Deferred revenue
|
75,159
|
|
|
4,185
|
|
||
Clinical trials
|
8,534
|
|
|
8,643
|
|
||
Professional fees
|
1,724
|
|
|
1,860
|
|
||
Employee benefits
|
5,456
|
|
|
4,127
|
|
||
Contingent consideration
|
41,146
|
|
|
27,352
|
|
||
Other
|
15,232
|
|
|
14,668
|
|
||
|
$
|
149,843
|
|
|
$
|
60,912
|
|
|
|
|
|
(In thousands)
|
June 30,
2015 |
|
December 31,
2014 |
||||
Other long-term liabilities:
|
|
|
|
||||
Contingent consideration – OPKO Renal
|
$
|
19,183
|
|
|
$
|
36,529
|
|
Contingent consideration – OPKO Health Europe
|
225
|
|
|
254
|
|
||
Contingent consideration – OPKO Diagnostics
|
13,342
|
|
|
6,992
|
|
||
Contingent consideration – CURNA
|
433
|
|
|
440
|
|
||
Mortgages and other debts payable
|
2,148
|
|
|
2,434
|
|
||
Deferred tax liabilities
|
172,458
|
|
|
167,153
|
|
||
Deferred revenue
|
197,279
|
|
|
2,526
|
|
||
Other
|
3,753
|
|
|
1,030
|
|
||
|
$
|
408,821
|
|
|
$
|
217,358
|
|
|
2015
|
||||||||||||||
(In thousands)
|
Balance at January 1st
|
|
Acquisitions
|
|
Foreign exchange
|
|
Balance at June 30th
|
||||||||
Pharmaceuticals
|
|
|
|
|
|
|
|
||||||||
CURNA
|
$
|
4,827
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,827
|
|
OPKO Mexico
|
100
|
|
|
—
|
|
|
(5
|
)
|
|
95
|
|
||||
OPKO Chile
|
5,283
|
|
|
—
|
|
|
(243
|
)
|
|
5,040
|
|
||||
OPKO
Health Europe
|
8,013
|
|
|
—
|
|
|
(699
|
)
|
|
7,314
|
|
||||
FineTech
|
11,698
|
|
|
—
|
|
|
—
|
|
|
11,698
|
|
||||
SciVac
|
1,553
|
|
|
—
|
|
|
49
|
|
|
1,602
|
|
||||
OPKO Renal
|
2,069
|
|
|
—
|
|
|
—
|
|
|
2,069
|
|
||||
OPKO Biologics
|
139,784
|
|
|
—
|
|
|
—
|
|
|
139,784
|
|
||||
EirGen Pharma Ltd
|
—
|
|
|
66,823
|
|
|
(610
|
)
|
|
66,213
|
|
||||
Diagnostics
|
|
|
|
|
|
|
|
||||||||
OPKO Diagnostics
|
17,977
|
|
|
—
|
|
|
—
|
|
|
17,977
|
|
||||
OPKO Lab
|
32,988
|
|
|
—
|
|
|
—
|
|
|
32,988
|
|
||||
|
$
|
224,292
|
|
|
$
|
66,823
|
|
|
$
|
(1,508
|
)
|
|
$
|
289,607
|
|
(In thousands)
|
|
EirGen
|
||
Current assets
(1)
|
|
$
|
11,795
|
|
Intangible assets:
|
|
|
||
IPR&D assets
|
|
19,597
|
|
|
Customer relationships
|
|
34,155
|
|
|
Currently marketed products
|
|
3,919
|
|
|
Total intangible assets
|
|
57,671
|
|
|
Goodwill
|
|
66,823
|
|
|
Property, plant and equipment
|
|
8,117
|
|
|
Other assets
|
|
1,232
|
|
|
Accounts payable and other liabilities
|
|
(6,254
|
)
|
|
Deferred tax liability
|
|
(5,618
|
)
|
|
Total purchase price
|
|
$
|
133,766
|
|
|
For the three months ended June 30,
|
|
For the six months ended June 30,
|
||
(In thousands)
|
2015
|
2014
|
|
2015
|
2014
|
Revenues
|
$43,848
|
$25,659
|
|
$76,769
|
$50,185
|
Net loss
|
(43,420)
|
(28,356)
|
|
(162,331)
|
(75,879)
|
Net loss attributable to common shareholders
|
(42,945)
|
(27,759)
|
|
(160,931)
|
(74,742)
|
Basic and diluted net loss per share
|
$(0.09)
|
$(0.07)
|
|
$(0.35)
|
$(0.18)
|
(In thousands)
|
June 30,
2015 |
|
December 31,
2014
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
21
|
|
|
$
|
393
|
|
Accounts receivable, net
|
304
|
|
|
316
|
|
||
Inventories, net
|
1,433
|
|
|
1,649
|
|
||
Prepaid expenses and other current assets
|
774
|
|
|
718
|
|
||
Total current assets
|
2,532
|
|
|
3,076
|
|
||
Property, plant and equipment, net
|
1,791
|
|
|
1,725
|
|
||
Intangible assets, net
|
843
|
|
|
875
|
|
||
Goodwill
|
1,602
|
|
|
1,553
|
|
||
Other assets
|
368
|
|
|
384
|
|
||
Total assets
|
$
|
7,136
|
|
|
$
|
7,613
|
|
Liabilities
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
900
|
|
|
$
|
445
|
|
Accrued expenses
|
4,476
|
|
|
4,446
|
|
||
Notes payable
|
5,409
|
|
|
5,189
|
|
||
Total current liabilities
|
10,785
|
|
|
10,080
|
|
||
Other long-term liabilities
|
1,884
|
|
|
2,042
|
|
||
Total liabilities
|
$
|
12,669
|
|
|
$
|
12,122
|
|
(In thousands)
|
Embedded conversion option
|
|
2033 Senior Notes
|
|
Discount
|
|
Total
|
||||||||
Balance at December 31, 2014
|
$
|
65,947
|
|
|
$
|
87,642
|
|
|
$
|
(22,135
|
)
|
|
$
|
131,454
|
|
Amortization of debt discount
|
—
|
|
|
—
|
|
|
1,680
|
|
|
1,680
|
|
||||
Change in fair value of embedded derivative
|
67,950
|
|
|
—
|
|
|
—
|
|
|
67,950
|
|
||||
Conversion
|
(60,346
|
)
|
|
(41,442
|
)
|
|
9,907
|
|
|
(91,881
|
)
|
||||
Balance at June 30, 2015
|
$
|
73,551
|
|
|
$
|
46,200
|
|
|
$
|
(10,548
|
)
|
|
$
|
109,203
|
|
|
June 30, 2015
|
Stock price
|
$16.08
|
Conversion Rate
|
141.4827
|
Conversion Price
|
$7.07
|
Maturity date
|
February 1, 2033
|
Risk-free interest rate
|
1.19%
|
Estimated stock volatility
|
41%
|
Estimated credit spread
|
1,133 basis points
|
(In thousands)
|
June 30, 2015
|
||
Fair value of 2033 Senior Notes:
|
|
||
With the embedded derivatives
|
$
|
107,743
|
|
Without the embedded derivatives
|
$
|
34,192
|
|
Estimated fair value of the embedded derivatives
|
$
|
73,551
|
|
(Dollars in thousands)
|
|
|
|
|
|
Balance Outstanding
|
||
Lender
|
|
Interest rate on
borrowings at June 30, 2015
|
|
Credit line
capacity
|
|
June 30,
2015 |
|
December 31,
2014
|
Itau Bank
|
|
6.00%
|
|
$1,800
|
|
$1,171
|
|
$965
|
Bank of Chile
|
|
5.50%
|
|
2,250
|
|
1,572
|
|
1,410
|
BICE Bank
|
|
6.16%
|
|
2,300
|
|
1,088
|
|
1,249
|
BBVA Bank
|
|
5.00%
|
|
2,300
|
|
1,552
|
|
795
|
Penta Bank
|
|
7.58%
|
|
1,200
|
|
631
|
|
1,008
|
Security Bank
|
|
6.16%
|
|
940
|
|
305
|
|
361
|
Estado Bank
|
|
5.30%
|
|
2,800
|
|
2,039
|
|
1,870
|
BBVA Bank
|
|
4.75%
|
|
277
|
|
—
|
|
—
|
Total
|
|
|
|
$13,867
|
|
$8,358
|
|
$7,658
|
(In thousands)
|
June 30,
2015 |
|
December 31,
2014
|
||||
Current portion of notes payable
|
$
|
832
|
|
|
$
|
608
|
|
Other long-term liabilities
|
2,393
|
|
|
2,435
|
|
||
Total mortgage notes and other debt
|
$
|
3,225
|
|
|
$
|
3,043
|
|
(In thousands)
|
Foreign
currency
|
|
Unrealized
gain (loss) in
Accumulated
OCI
|
|
Total
|
||||||
Balance at December 31, 2014
|
$
|
(6,717
|
)
|
|
$
|
(5,675
|
)
|
|
$
|
(12,392
|
)
|
Other comprehensive income before reclassifications, net of tax
|
(4,547
|
)
|
|
(1,941
|
)
|
|
(6,488
|
)
|
|||
Amounts reclassified from accumulated other comprehensive income, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|||
Net other comprehensive loss
|
(4,547
|
)
|
|
(1,941
|
)
|
|
(6,488
|
)
|
|||
Balance at June 30, 2015
|
$
|
(11,264
|
)
|
|
$
|
(7,616
|
)
|
|
$
|
(18,880
|
)
|
|
As of June 30, 2015
|
||||||||||||||||||
(In thousands)
|
Amortized
Cost
|
|
Gross
unrealized
gains in
Accumulated
OCI
|
|
Gross
unrealized
losses in
Accumulated
OCI
|
|
Gain/(Loss)
in
Accumulated
Deficit
|
|
Fair
value
|
||||||||||
Common stock investments, available for sale
|
$
|
11,479
|
|
|
$
|
898
|
|
|
$
|
(7,119
|
)
|
|
$
|
(1,442
|
)
|
|
$
|
3,816
|
|
Common stock options/warrants
|
3,925
|
|
|
—
|
|
|
—
|
|
|
6,044
|
|
|
9,969
|
|
|||||
Total assets
|
$
|
15,404
|
|
|
$
|
898
|
|
|
$
|
(7,119
|
)
|
|
$
|
4,602
|
|
|
$
|
13,785
|
|
|
As of December 31, 2014
|
||||||||||||||||||
(In thousands)
|
Amortized
Cost
|
|
Gross
unrealized
gains in
Accumulated
OCI
|
|
Gross
unrealized
losses in
Accumulated
OCI
|
|
Gain/(Loss)
in
Accumulated
Deficit
|
|
Fair
value
|
||||||||||
Common stock investments, available for sale
|
$
|
11,479
|
|
|
$
|
293
|
|
|
$
|
(4,573
|
)
|
|
$
|
(1,441
|
)
|
|
$
|
5,758
|
|
Common stock options/warrants
|
1,425
|
|
|
216
|
|
|
—
|
|
|
4,673
|
|
|
6,314
|
|
|||||
Total assets
|
$
|
12,904
|
|
|
$
|
509
|
|
|
$
|
(4,573
|
)
|
|
$
|
3,232
|
|
|
$
|
12,072
|
|
|
Fair value measurements as of June 30, 2015
|
||||||||||||||
(In thousands)
|
Quoted
prices in
active
markets for
identical
assets
(Level 1)
|
|
Significant
other
observable
inputs
(Level 2)
|
|
Significant
unobservable
inputs
(Level 3)
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
52,563
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
52,563
|
|
Common stock investments, available for sale
|
3,816
|
|
|
—
|
|
|
—
|
|
|
3,816
|
|
||||
Common stock options/warrants
|
—
|
|
|
9,969
|
|
|
—
|
|
|
9,969
|
|
||||
Forward contracts
|
—
|
|
|
115
|
|
|
—
|
|
|
115
|
|
||||
Total assets
|
$
|
56,379
|
|
|
$
|
10,084
|
|
|
$
|
—
|
|
|
$
|
66,463
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Embedded conversion option
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
73,551
|
|
|
$
|
73,551
|
|
Contingent consideration:
|
|
|
|
|
|
|
|
||||||||
CURNA
|
—
|
|
|
—
|
|
|
433
|
|
|
433
|
|
||||
OPKO Diagnostics
|
—
|
|
|
—
|
|
|
13,342
|
|
|
13,342
|
|
||||
OPKO Renal
|
—
|
|
|
—
|
|
|
60,090
|
|
|
60,090
|
|
||||
OPKO Health Europe
|
—
|
|
|
—
|
|
|
464
|
|
|
464
|
|
||||
Total liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
147,880
|
|
|
$
|
147,880
|
|
|
Fair value measurements as of December 31, 2014
|
||||||||||||||
(In thousands)
|
Quoted
prices in
active
markets for
identical
assets
(Level 1)
|
|
Significant
other
observable
inputs
(Level 2)
|
|
Significant
unobservable
inputs
(Level 3)
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
71,286
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
71,286
|
|
Common stock investments, available for sale
|
5,758
|
|
|
—
|
|
|
—
|
|
|
5,758
|
|
||||
Common stock options/warrants
|
—
|
|
|
6,314
|
|
|
—
|
|
|
6,314
|
|
||||
Forward contracts
|
—
|
|
|
36
|
|
|
—
|
|
|
36
|
|
||||
Total assets
|
$
|
77,044
|
|
|
$
|
6,350
|
|
|
$
|
—
|
|
|
$
|
83,394
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Embedded conversion option
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
65,947
|
|
|
$
|
65,947
|
|
Contingent consideration:
|
|
|
|
|
|
|
|
||||||||
CURNA
|
—
|
|
|
—
|
|
|
440
|
|
|
440
|
|
||||
OPKO Diagnostics
|
—
|
|
|
—
|
|
|
13,578
|
|
|
13,578
|
|
||||
OPKO Renal
|
—
|
|
|
—
|
|
|
55,780
|
|
|
55,780
|
|
||||
OPKO Health Europe
|
—
|
|
|
—
|
|
|
1,769
|
|
|
1,769
|
|
||||
Total liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
137,514
|
|
|
$
|
137,514
|
|
|
June 30, 2015
|
||||||||||||||||||
(In thousands)
|
Carrying
Value
|
|
Total
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||||
2033 Senior Notes
|
$
|
35,652
|
|
|
$
|
34,192
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
34,192
|
|
|
June 30, 2015
|
|||||||
(In thousands)
|
Contingent
consideration
|
|
|
Embedded
conversion
option
|
||||
Balance at December 31, 2014
|
$
|
71,567
|
|
|
|
$
|
65,947
|
|
Total losses (gains) for the period:
|
|
|
|
|
||||
Included in results of operations
|
4,836
|
|
|
|
67,950
|
|
||
Foreign currency impact
|
(261
|
)
|
|
|
—
|
|
||
Payments
|
(1,813
|
)
|
|
|
—
|
|
||
Conversion
|
—
|
|
|
|
(60,346
|
)
|
||
Balance at June 30, 2015
|
$
|
74,329
|
|
|
|
$
|
73,551
|
|
(In thousands)
|
Balance Sheet Component
|
|
June 30,
2015 |
|
December 31,
2014 |
||||
Derivative financial instruments:
|
|
|
|
|
|
||||
Common Stock options/warrants
|
Investments, net
|
|
$
|
9,969
|
|
|
$
|
6,314
|
|
Embedded conversion option
|
2033 Senior Notes, net of discount and estimated fair value of embedded derivatives
|
|
$
|
73,551
|
|
|
$
|
65,947
|
|
Forward contracts
|
Unrealized gains on forward contracts are recorded in Prepaid expenses and other current assets. Unrealized losses on forward contracts are recorded in Accrued expenses.
|
|
$
|
115
|
|
|
$
|
36
|
|
|
Three months ended June 30,
|
|
Six months ended June 30,
|
||||||||||||
(In thousands)
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Derivative gain (loss):
|
|
|
|
|
|
|
|
||||||||
Common Stock options/warrants
(1)
|
$
|
(2,446
|
)
|
|
$
|
(860
|
)
|
|
$
|
1,425
|
|
|
$
|
(263
|
)
|
2033 Senior Notes
|
(14,220
|
)
|
|
11,882
|
|
|
(67,950
|
)
|
|
770
|
|
||||
Forward contracts
|
110
|
|
|
(55
|
)
|
|
181
|
|
|
87
|
|
||||
Total
|
$
|
(16,556
|
)
|
|
$
|
10,967
|
|
|
$
|
(66,344
|
)
|
|
$
|
594
|
|
(1)
|
Amount for 2014 includes the Pharmsynthez Note Receivable and the Purchase Option.
|
(In thousands)
Days until maturity
|
|
Contract value
|
|
Fair value at
June 30, 2015
|
|
Effect on income (loss)
|
||||||
0 to 30
|
|
$
|
1,414
|
|
|
$
|
1,466
|
|
|
$
|
52
|
|
31 to 60
|
|
324
|
|
|
336
|
|
|
12
|
|
|||
61 to 90
|
|
939
|
|
|
981
|
|
|
42
|
|
|||
91 to 120
|
|
180
|
|
|
188
|
|
|
8
|
|
|||
More than 120
|
|
31
|
|
|
32
|
|
|
1
|
|
|||
Total
|
|
$
|
2,888
|
|
|
$
|
3,003
|
|
|
$
|
115
|
|
(In thousands)
Days until maturity
|
|
Contract value
|
|
Fair value at
December 31, 2014
|
|
Effect on income (loss)
|
||||||
0 to 30
|
|
$
|
750
|
|
|
$
|
780
|
|
|
$
|
30
|
|
31 to 60
|
|
90
|
|
|
93
|
|
|
3
|
|
|||
61 to 90
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
91 to 120
|
|
68
|
|
|
71
|
|
|
3
|
|
|||
121 to 180
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
More than 180
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total
|
|
$
|
908
|
|
|
$
|
944
|
|
|
$
|
36
|
|
|
For the three months ended June 30,
|
|
For the six months ended June 30,
|
||||||||||||
(In thousands)
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Product revenues:
|
|
|
|
|
|
|
|
||||||||
Pharmaceuticals
|
$
|
22,848
|
|
|
$
|
21,392
|
|
|
$
|
38,334
|
|
|
$
|
41,219
|
|
Diagnostics
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Corporate
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
$
|
22,848
|
|
|
$
|
21,392
|
|
|
$
|
38,334
|
|
|
$
|
41,219
|
|
Revenue from services:
|
|
|
|
|
|
|
|
||||||||
Pharmaceuticals
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Diagnostics
|
1,848
|
|
|
2,093
|
|
|
3,857
|
|
|
4,003
|
|
||||
Corporate
|
60
|
|
|
60
|
|
|
120
|
|
|
120
|
|
||||
|
$
|
1,908
|
|
|
$
|
2,153
|
|
|
$
|
3,977
|
|
|
$
|
4,123
|
|
Revenue from transfer of intellectual property:
|
|
|
|
|
|
|
|
||||||||
Pharmaceuticals
|
$
|
17,673
|
|
|
$
|
—
|
|
|
$
|
30,202
|
|
|
$
|
285
|
|
Diagnostics
|
—
|
|
|
—
|
|
|
—
|
|
|
191
|
|
||||
Corporate
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
$
|
17,673
|
|
|
$
|
—
|
|
|
$
|
30,202
|
|
|
$
|
476
|
|
Operating (loss) income:
|
|
|
|
|
|
|
|
||||||||
Pharmaceuticals
|
$
|
(4,660
|
)
|
|
$
|
(20,368
|
)
|
|
$
|
(42,584
|
)
|
|
$
|
(36,941
|
)
|
Diagnostics
|
(7,098
|
)
|
|
(6,805
|
)
|
|
(15,575
|
)
|
|
(13,882
|
)
|
||||
Corporate
|
(12,905
|
)
|
|
(7,038
|
)
|
|
(22,882
|
)
|
|
(13,174
|
)
|
||||
Less: Operating loss attributable to noncontrolling interests
|
(746
|
)
|
|
(674
|
)
|
|
(1,281
|
)
|
|
(1,163
|
)
|
||||
|
$
|
(25,409
|
)
|
|
$
|
(34,885
|
)
|
|
$
|
(82,322
|
)
|
|
$
|
(65,160
|
)
|
Depreciation and amortization:
|
|
|
|
|
|
|
|
||||||||
Pharmaceuticals
|
$
|
2,371
|
|
|
$
|
2,287
|
|
|
$
|
4,138
|
|
|
$
|
4,135
|
|
Diagnostics
|
1,754
|
|
|
1,716
|
|
|
3,501
|
|
|
3,408
|
|
||||
Corporate
|
27
|
|
|
24
|
|
|
46
|
|
|
48
|
|
||||
|
$
|
4,152
|
|
|
$
|
4,027
|
|
|
$
|
7,685
|
|
|
$
|
7,591
|
|
Net loss from investment in investees:
|
|
|
|
|
|
|
|
||||||||
Pharmaceuticals
|
$
|
(804
|
)
|
|
$
|
(370
|
)
|
|
$
|
(2,565
|
)
|
|
$
|
(2,426
|
)
|
Diagnostics
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Corporate
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
$
|
(804
|
)
|
|
$
|
(370
|
)
|
|
$
|
(2,565
|
)
|
|
$
|
(2,426
|
)
|
Revenues:
|
|
|
|
|
|
|
|
||||||||
United States
|
$
|
2,525
|
|
|
$
|
2,153
|
|
|
$
|
5,019
|
|
|
$
|
4,599
|
|
Ireland
|
19,376
|
|
|
—
|
|
|
31,480
|
|
|
—
|
|
||||
Chile
|
8,698
|
|
|
7,852
|
|
|
15,150
|
|
|
15,136
|
|
||||
Spain
|
4,920
|
|
|
5,666
|
|
|
8,857
|
|
|
11,815
|
|
||||
Israel
|
5,942
|
|
|
6,307
|
|
|
10,155
|
|
|
10,853
|
|
||||
Mexico
|
968
|
|
|
1,546
|
|
|
1,852
|
|
|
3,377
|
|
||||
Other
|
—
|
|
|
21
|
|
|
—
|
|
|
38
|
|
||||
|
$
|
42,429
|
|
|
$
|
23,545
|
|
|
$
|
72,513
|
|
|
$
|
45,818
|
|
(In thousands)
|
June 30,
2015 |
|
December 31,
2014 |
||||
Assets:
|
|
|
|
||||
Pharmaceuticals
|
$
|
1,290,366
|
|
|
$
|
1,064,498
|
|
Diagnostics
|
104,487
|
|
|
108,072
|
|
||
Corporate
|
130,638
|
|
|
95,094
|
|
||
|
$
|
1,525,491
|
|
|
$
|
1,267,664
|
|
Goodwill:
|
|
|
|
||||
Pharmaceuticals
|
$
|
238,642
|
|
|
$
|
173,327
|
|
Diagnostics
|
50,965
|
|
|
50,965
|
|
||
Corporate
|
—
|
|
|
—
|
|
||
|
$
|
289,607
|
|
|
$
|
224,292
|
|
|
For the three months ended June 30,
|
||||||
|
2015
|
|
2014
|
||||
External expenses:
|
|
|
|
||||
Phase 3 clinical trials
|
$
|
3,707
|
|
|
$
|
3,399
|
|
CMC expense for biological products
|
7,748
|
|
|
718
|
|
||
Earlier-stage programs
|
1,706
|
|
|
1,869
|
|
||
Research and development employee-related expenses
|
6,984
|
|
|
5,429
|
|
||
Other unallocated internal research and development expenses
|
9,916
|
|
|
5,326
|
|
||
Third-party grants and funding from collaboration agreements
|
(491
|
)
|
|
(507
|
)
|
||
Total research and development expenses
|
$
|
29,570
|
|
|
$
|
16,234
|
|
|
For the six months ended June 30,
|
||||||
|
2015
|
|
2014
|
||||
External expenses:
|
|
|
|
||||
Phase 3 clinical trials
|
$
|
6,989
|
|
|
$
|
6,446
|
|
CMC expense for biological products
|
14,101
|
|
|
6,183
|
|
||
Earlier-stage programs
|
4,472
|
|
|
3,579
|
|
||
Research and development employee-related expenses
|
15,191
|
|
|
11,268
|
|
||
Other unallocated internal research and development expenses
|
15,276
|
|
|
10,763
|
|
||
Third-party grants and funding from collaboration agreements
|
(957
|
)
|
|
(1,012
|
)
|
||
Total research and development expenses
|
$
|
55,072
|
|
|
$
|
37,227
|
|
Contractual obligations
(In thousands)
|
|
Remaining Six Months ending December 31,
2015 |
|
2016
|
|
2017
|
|
2018
|
|
2019
|
|
Thereafter
|
|
Total
|
||||||||||||||
Open purchase orders
|
|
$
|
16,911
|
|
|
$
|
676
|
|
|
$
|
676
|
|
|
$
|
485
|
|
|
$
|
199
|
|
|
$
|
298
|
|
|
$
|
19,245
|
|
Operating leases
|
|
1,673
|
|
|
2,728
|
|
|
1,774
|
|
|
1,346
|
|
|
743
|
|
|
1,000
|
|
|
9,264
|
|
|||||||
2033 Senior Notes
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
46,200
|
|
|
—
|
|
|
46,200
|
|
|||||||
Mortgages and other debts payable
(1)
|
|
443
|
|
|
329
|
|
|
298
|
|
|
249
|
|
|
240
|
|
|
1,209
|
|
|
2,768
|
|
|||||||
Lines of credit
|
|
8,358
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
8,358
|
|
|||||||
Interest commitments
|
|
828
|
|
|
1,463
|
|
|
1,452
|
|
|
1,441
|
|
|
278
|
|
|
50
|
|
|
5,512
|
|
|||||||
Total
|
|
$
|
28,213
|
|
|
$
|
5,196
|
|
|
$
|
4,200
|
|
|
$
|
3,521
|
|
|
$
|
47,660
|
|
|
$
|
2,557
|
|
|
$
|
91,346
|
|
(1)
|
Excludes
$5.4 million
of consolidated liabilities related to SciVac, as to which there is no recourse against us.
|
•
|
Unit of account – Most intangible assets are valued as single global assets rather than multiple assets for each jurisdiction or indication after considering the development stage, expected levels of incremental costs to obtain additional approvals, risks associated with further development, amount and timing of benefits expected to be derived in the future, expected patent lives in various jurisdictions and the intention to promote the asset as a global brand.
|
•
|
Estimated useful life – The asset life expected to contribute meaningful cash flows is determined after considering all pertinent matters associated with the asset, including expected regulatory approval dates (if unapproved), exclusivity periods and other legal, regulatory or contractual provisions as well as the effects of any obsolescence, demand, competition, and other economic factors, including barriers to entry.
|
•
|
Probability of Technical and Regulatory Success (“PTRS”) Rate – PTRS rates are determined based upon industry averages considering the respective programs development stage and disease indication and adjusted for specific information or data known at the acquisition date. Subsequent clinical results or other internal or external data obtained could alter the PTRS rate and materially impact the estimated fair value of the intangible asset in subsequent periods leading to impairment charges.
|
•
|
Projections – Future revenues are estimated after considering many factors such as initial market opportunity, pricing, sales trajectories to peak sales levels, competitive environment and product evolution. Future costs and expenses are estimated after considering historical market trends, market participant synergies and the timing and level of additional development costs to obtain the initial or additional regulatory approvals, maintain or further enhance the product. We generally assume initial positive cash flows to commence shortly after the receipt of expected regulatory approvals which typically may not occur for a number of years. Actual cash flows attributed to the project are likely to be different than those assumed since projections are subjected to multiple factors including trial results and regulatory matters which could materially change the ultimate commercial success of the asset as well as significantly alter the costs to develop the respective asset into commercially viable products.
|
•
|
Tax rates – The expected future income is tax effected using a market participant tax rate. Our recent valuations typically use a U.S. tax rate (and applicable state taxes) after considering the jurisdiction in which the intellectual property is held and location of research and manufacturing infrastructure. We also considered that any repatriation of earnings would likely have U.S. tax consequences.
|
•
|
Discount rate – Discount rates are selected after considering the risks inherent in the future cash flows; the assessment of the asset’s life cycle and the competitive trends impacting the asset, including consideration of any technical, legal, regulatory, or economic barriers to entry, as well as expected changes in standards of practice for indications addressed by the asset.
|
Exhibit 2.1
+
|
Agreement for the Sale and Purchase of Shares in EirGen Pharma Limited, dated May 5, 2015 by and among OPKO Ireland Limited, OPKO Health, Inc. and the Sellers named therein.
|
Exhibit 2.2
+
|
Form of Additional Agreement for the Sale and Purchase of Shares in EirGen Pharma Limited, dated May 5, 2015 by and among OPKO Ireland Limited and the Sellers named therein.
|
Exhibit 3.1
(1)
|
Amended and Restated Certificate of Incorporation.
|
Exhibit 3.2
(2)
|
Amended and Restated By-Laws.
|
Exhibit 3.3
(3)
|
Certificate of Designation of Series D Preferred Stock.
|
Exhibit 4.3
(4)
|
Indenture, dated as of January 30, 2013, between OPKO Health, Inc. and Wells Fargo Bank, National Association.
|
Exhibit 31.1
|
Certification by Phillip Frost, Chief Executive Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the quarterly period ended June 30, 2015.
|
Exhibit 31.2
|
Certification by Adam Logal, Chief Financial Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the quarterly period ended June 30, 2015.
|
Exhibit 32.1
|
Certification by Phillip Frost, Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 for the quarterly period ended June 30, 2015.
|
Exhibit 32.2
|
Certification by Adam Logal, Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 for the quarterly period ended June 30, 2015.
|
Exhibit 101.INS
|
XBRL Instance Document
|
Exhibit 101.SCH
|
XBRL Taxonomy Extension Schema Document
|
Exhibit 101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
Exhibit 101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
Exhibit 101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
Exhibit 101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
+
|
Certain confidential material contained in the document has been omitted and filed separately with the Securities and Exchange Commission.
|
(1)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2013 for the Company’s three month period ended September 30, 2013, and incorporated herein by reference.
|
(2)
|
Filed with the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2008, and incorporated herein by reference.
|
(3)
|
Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 24, 2009, and incorporated herein by reference.
|
(4)
|
Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 5, 2013, and incorporated herein by reference.
|
Date: August 5, 2015
|
|
OPKO Health, Inc.
|
|
|
|
|
|
/s/ Adam Logal
|
|
|
Adam Logal
|
|
|
Senior Vice President, Chief Financial Officer,
|
|
|
Chief Accounting Officer and Treasurer
|
Exhibit Number
|
Description
|
|
|
Exhibit 2.1
+
|
Agreement for the Sale and Purchase of Shares in EirGen Pharma Limited, dated May 5, 2015 by and among OPKO Ireland Limited, OPKO Health, Inc. and the Sellers named therein.
|
|
|
Exhibit 2.2
+
|
Form of Additional Agreement for the Sale and Purchase of Shares in EirGen Pharma Limited, dated May 5, 2015 by and among OPKO Ireland Limited and the Sellers named therein.
|
|
|
Exhibit 31.1
|
Certification by Phillip Frost, Chief Executive Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the quarterly period ended June 30, 2015.
|
|
|
Exhibit 31.2
|
Certification by Adam Logal, Chief Financial Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the quarterly period ended June 30, 2015.
|
|
|
Exhibit 32.1
|
Certification by Phillip Frost, Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 for the quarterly period ended June 30, 2015.
|
|
|
Exhibit 32.2
|
Certification by Adam Logal, Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 for the quarterly period ended June 30, 2015.
|
|
|
Exhibit 101.INS
|
XBRL Instance Document
|
|
|
Exhibit 101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
|
Exhibit 101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
Exhibit 101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
Exhibit 101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
Exhibit 101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
+
|
Certain confidential material contained in the document has been omitted and filed separately with the Securities and Exchange Commission.
|
(1)
|
THE PERSONS
whose names and addresses are set out in Schedule 1 (together the “
Sellers
”, and each a “
Seller
”);
|
(2)
|
OPKO IRELAND LIMITED
, a company registered in Ireland under number 530936 and having its registered office at Citywest Business Campus, 3013 Lake Drive, Dublin 24, Ireland (“
OPKO Irl
”); and
|
(3)
|
OPKO HEALTH, INC.,
a company formed under the laws of Delaware, and having its registered office at 4400 Biscayne Boulevard, Miami, Florida 33137, USA (the “
OPKO Inc
”),
|
(A)
|
EirGen Pharma Limited (the “
Company
”) is a private limited company incorporated in Ireland under registration number 398605. Further particulars of the Company and of its Subsidiary are set out in Parts 1 and 2 of Schedule 2.
|
(B)
|
The Sellers are the owners of the numbers of Shares set opposite their respective names in column 3 of Part 1 of Schedule 1 (the “
Sellers’ Shares
”).
|
(C)
|
OPKO Inc is the indirect owner of 100% of the issued share capital in OPKO Irl.
|
(D)
|
The Sellers have agreed to sell and the Buyer has agreed to buy, the Sellers’ Shares on the terms and subject to the conditions of this Agreement.
|
(E)
|
The Shareholders other than the Sellers have respectively agreed to sell, and OPKO Irl has agreed to buy, the Remaining Shares, subject to the conditions of the Ancillary Share Purchase Agreements.
|
1.
|
Interpretation
|
1.1
|
Definitions
|
(a)
|
the marketing of goods or services, including customer names and lists and other details of customers, sales targets, sales statistics, market share statistics, prices market research reports and surveys and advertising or other promotional materials;
|
(b)
|
product information, know-how, formulas, compositions, manufacturing and production processes and techniques, technical data, designs, plans, drawings, specifications and blueprints;
|
(c)
|
future projects, business development or planning, commercial relationships and negotiations; or
|
(d)
|
any information in relation to which a Group Company is bound by an obligation of confidence to a third party,
|
(a)
|
any dividend, distribution or other return of assets, profits or capital or any payments in lieu of any such dividend, distribution or other return of assets, profits or capital declared, paid or made by a member of the Group to, for the benefit of, or at the direction of, a Shareholder or any member of such Shareholder’s Group;
|
(b)
|
any payments made, future benefits granted or assets transferred to or from, or liabilities assumed by, indemnified or incurred for the ultimate benefit of, any of the Shareholders or any of their Related Persons by any Group Company;
|
(c)
|
any payments made or agreed to be made by any Group Company to any of the Shareholders or any of their respective Related Persons in respect of any share capital or other securities of any Group Company being issued, redeemed, purchased or repaid, or any other return of capital;
|
(d)
|
the waiver, deferral or release by any member of the Group of any amount, right, value or benefit owed to any member of the Group by a Shareholder or any member of such Shareholder’s Group;
|
(e)
|
any Encumbrance created over any of the assets of a member of the Group to or for the benefit of a Shareholder or any member of such Shareholder’s Group;
|
(f)
|
the payment by any member of the Group of Transaction-related or other bonuses or amounts to a Shareholder, any member of such Shareholder’s Group, any employees of such Shareholder or such Shareholder’s Group or any employees of any member of the Group;
|
(g)
|
any other payments made (whether in cash or in kind) by any member of the Group to a Shareholder or any member of such Shareholder’s Group, and whether or not purporting to be for value received;
|
(h)
|
any agreement to do or pay any of the foregoing; and
|
(i)
|
any Tax to the extent becoming payable by any member of the Group as a consequence of any of the foregoing;
|
(j)
|
all payments:
|
(i)
|
of salary, fees, benefits, bonuses and expenses to or for the benefit of any of the Shareholders as employees or directors of, or investors in or consultants of, any member of the Group, provided that any element of any bonus which is related to the sale of the Shares pursuant to this Agreement and/or the Ancillary Share Purchase Agreements shall not be Permitted Leakage and will be deemed Leakage;
|
(ii)
|
in respect of the cost of any directors and officers liability insurance and maintaining any run off cover in respect of the same;
|
(iii)
|
to Enterprise Ireland in respect of the redemption of the 8% cumulative redeemable preference shares of €1.00 each held by Enterprise Ireland in the capital of the Company;
|
(iv)
|
to Glopec International Inc pursuant to the supply agreement dated 10 March 2015 between Glopec International Inc and the Company and the consultancy agreement dated 13 August 2012 between Glopec International Inc and the Company (as amended);
|
(v)
|
to Q1 Scientific Limited pursuant to the technical agreement between Q1 Scientific Limited and the Company (details of which were provided in the Data Room) and the service agreement dated 1 February 2013 between Q1 Scientific Limited and the Company;
|
(vi)
|
to Martina Ryan (trading as MRA) pursuant to the terms of business dated 15 June 2006 entered into between the Company and Martina Ryan (trading as MRA);
|
(vii)
|
to Clarnwood Capital Limited pursuant to the consultancy agreement dated 1 July 2013 between Clanwood Capital Limited and the Company; and
|
(viii)
|
any Tax to the extent becoming payable by any member of the Group as a result of the foregoing;
|
(a)
|
pricing or reimbursement approval in such country;
|
(b)
|
pre- and post-approval marketing authorizations;
|
(c)
|
labelling approval; and
|
(d)
|
technical, medical and scientific licenses;
|
(e)
|
in the case of a person which is a body corporate, any subsidiary or holding company of that person and any subsidiary of any such parent company, and any trustee or nominee acting on its behalf, in each case from time to time; and
|
(f)
|
in the case of a person which is an individual, a person Connected to that individual;
|
(a)
|
corporation tax (including any surcharge), advance corporation tax, income tax (including tax or amounts on account of tax required to be deducted or withheld from or accounted for in respect of any payment), capital gains tax, inheritance tax, gift tax, capital acquisition tax, value added
|
(b)
|
all other taxes on gross or net income, profits or gains, distributions, receipts, sales, use, occupation, franchise, value added and personal property;
|
(c)
|
all taxes, levies, imposts, duties, charges or withholdings of any nature whatsoever chargeable and/or collectable by any Tax Authorities in any Relevant Jurisdiction; and
|
(d)
|
any payment whatsoever which a Group Company may be or become bound to make to any person as a result of the discharge by that person of any tax which a Group Company has failed to discharge;
|
(d)
|
a Fundamental Warranty Claim; or
|
(e)
|
a General Warranty Claim.
|
1.2
|
Construction
|
(a)
|
use of the singular includes the plural and vice versa;
|
(b)
|
a reference to one gender includes a reference to each other gender;
|
(c)
|
the headings are inserted for convenience of reference only and shall not in any way form part of, or affect the construction or interpretation of, this Agreement;
|
(d)
|
the provisions of the Schedules to this Agreement form an integral part of this Agreement and have as full effect as if they were incorporated in the body of this Agreement and the expressions “
this Agreement
” and “
the Agreement
” shall be deemed to include the Schedules to this Agreement;
|
(e)
|
a reference to a person (including a party to this Agreement) includes a reference to that person’s legal personal representatives, successors and permitted assigns;
|
(f)
|
a reference to a document is a reference to that document as from time to time amended, supplemented or varied (in each case, other than in breach of the provisions of this Agreement);
|
(g)
|
any reference to any statute or statutory provision shall include:
|
(i)
|
any statute or statutory provision which:
|
(A)
|
amends, extends, consolidates, re-enacts or replaces any statute or statutory provision; or
|
(B)
|
has been amended, extended, consolidated, re-enacted or replaced (whether before or after the date of this Agreement) by any statute or statutory provision; and
|
(ii)
|
any orders, regulations, instruments or other subordinate legislation made under the relevant statute;
|
(h)
|
words and phrases the definitions of which are contained or referred to in the Companies Acts shall be construed as having the meanings attributed to them in such Acts;
|
(i)
|
a reference to any clause, sub-clause, paragraph, or Schedule shall be a reference to the clause, sub-clause, paragraph, or Schedule of this Agreement unless the context otherwise requires;
|
(j)
|
any reference to a “
person
” shall be construed as a reference to any individual, firm, company, corporation, undertaking, government, state, agency of a state, association, partnership, organisation, foundation or trust (whether or not having separate legal personality);
|
(k)
|
reference to a “
company
” shall be construed so as to include any company, corporation or body corporate, whenever and however established or incorporated;
|
(l)
|
all references to costs, charges and expenses include any irrevocable value added tax or similar tax charged or chargeable in respect thereof;
|
(m)
|
references to any tax in respect of income or profits or gains or chargeable gains earned, accrued or received on or before a particular date or in respect of a particular period shall include any tax in respect of income or profits or gains deemed for Tax purposes to have been or treated as earned, accrued or received on or before that date or in respect of that period;
|
(n)
|
any phrase introduced by the terms “
including
”,
“
include
” and “
in particular
” or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms;
|
(o)
|
the rule known as ‘
contra proferentum
” shall not apply; and
|
(p)
|
any reference to an Irish legal term for any action, remedy, method of judicial proceeding, legal document, legal status, court, official or any legal concept or thing shall, in respect of any
|
2.
|
Sale of Shares
|
2.1
|
Subject to the terms of this Agreement, each Seller severally shall sell, and OPKO Irl shall buy, the number of Sellers’ Shares set opposite each Seller’s name in column 2 of Part 2 of Schedule 1, with effect from immediately following execution of this Agreement.
|
2.2
|
Subject to the terms of this Agreement, each Seller severally shall sell, and OPKO Inc shall buy, the number of Sellers’ Shares set opposite each Seller’s name in column 3 of Part 2 of Schedule 1, with effect from immediately following the sale and purchase referred to in clause 2.1.
|
2.3
|
The Sellers’ Shares shall be sold free from all Encumbrances together with all other rights attached or accruing to the Sellers’ Shares, including the right to receive all dividends or distributions of whatever nature declared, paid or made in respect of any period on or after the Completion Date.
|
2.4
|
Each Seller severally waives any rights of pre-emption or other restriction on transfer to which it is entitled by virtue of the articles of association of the Company or otherwise in respect of the sale of the entire issued share capital of the Company to the Buyer on or about the date hereof.
|
3.
|
Consideration
|
(a)
|
in the case of the sale and purchase at clause 2.1, the Elected Cash Consideration Amount for each Seller (other than BD) payable in cash to the Sellers’ Solicitors’ Account; and
|
(b)
|
in the case of the sale and purchase at clause 2.2, the Elected Share Consideration Amount for each Seller to be satisfied by the issuance of the OPKO Consideration Shares.
|
4.
|
Completion Payment
|
4.1
|
Subject to clause 4.2 and 4.3, on the Completion Date, the Consideration shall be paid to the Sellers in accordance with columns 5 and 6 of Part 1 of Schedule 1 by the payment of cash by OPKO Irl and/or the issue and allotment of OPKO Consideration Shares by OPKO Inc credited as fully paid (the “
Completion Payment
”).
|
4.2
|
At Completion, the Escrow Amount shall be paid to the Escrow Account in the form of the Escrow Consideration Shares and in accordance with clause 9.2.
|
4.3
|
The number of OPKO Consideration Shares to be issued and allotted to a Seller pursuant to clause 4.1 shall be that number of OPKO Common Stock having an aggregate value equal to such Seller’s Elected Share Consideration Amount , and shall be calculated by dividing such Seller’s Elected Share Consideration Amount by the Average Common Stock Trading Price.
|
5.
|
Completion
|
5.1
|
Completion of the sales and purchases referred to in clauses 2.1 and 2.2 shall take place at the offices of the Buyer’s Solicitors immediately following the execution of this Agreement.
|
5.2
|
At Completion the Sellers and the Buyer shall do all those things respectively required of them in Schedule 4.
|
5.3
|
The Buyer shall not be obliged to complete this Agreement unless:
|
(a)
|
the Sellers comply with all of their obligations in Schedule 4; and
|
(b)
|
the purchase of the Remaining Shares pursuant to the Ancillary Share Purchase Agreements is completed at the same time as the sale and purchase referred to in clause 2.1.
|
5.4
|
The Sellers shall not be obliged to complete this Agreement unless the Buyer comply with all of their respective obligations in Schedule 4.
|
5.5
|
Each of the Sellers appoints the Buyer to be that Seller's attorney for the purposes set out in this clause 5.5 from Completion until the Sellers’ Shares of that Seller are registered in the Buyer's name and on the following terms:
|
(a)
|
the Buyer may do the following in the name of such Seller:
|
(i)
|
exercise any rights, including rights to appoint a proxy or representative and voting rights, attaching to such Sellers’ Shares; and
|
(ii)
|
receive any dividend or other entitlement paid or credited to such Seller on or after Completion in respect of such Sellers’ Shares;
|
(b)
|
all acts and things done by the Buyer in exercising powers under this power of attorney will be as valid as if they had been done by such Seller; and
|
(c)
|
on registration of such Sellers’ Shares in the Buyer's name, the powers conferred on the Buyer under this clause 5.5 in respect of such Sellers’ Shares and such Seller immediately cease; and
|
(d)
|
the Buyer shall indemnify such Seller against any loss, liability and cost which it may incur as a result of or in connection with the exercise by the Buyer of the power conferred on the Buyer under this clause.
|
6.
|
Sellers’ Warranties
|
6.1
|
[***] warrants and undertakes to the Buyer that each of the Fundamental Warranties is, at the date of this Agreement, true and accurate, provided that the warranty and undertaking in respect of paragraphs 1.1. 1.2, 1.3(b), 1.4 and 1.5 of Part 1 of Schedule 5 is provided solely in respect of that Seller and its Seller’s Shares.
|
6.2
|
[***] warrants and undertakes to the Buyer that each of the Fundamental Warranties (other than the Fundamental Warranties at paragraphs 1.3(c), 1.3(d) and 1.5 of Part 1 of Schedule 5) is, at the date of this Agreement true and accurate in respect of him and his Seller Shares.
|
6.3
|
[***] warrants and undertakes to the Buyer that each of the General Warranties is, at the date of this Agreement, true, and accurate.
|
6.4
|
Each Seller agrees and acknowledges that the Buyer is entering into this Agreement in reliance on each Warranty.
|
6.5
|
The Warranties (other than the Fundamental Warranties) are qualified by the information and circumstances Disclosed in the Disclosure Letter.
|
6.6
|
Subject to the terms of this Agreement and the Tax Deed, no information of which the Buyer or its agents or advisers has knowledge (actual or constructive) and no investigation by or on behalf of the Buyer prevents any claim made by the Buyer under the Warranties and the Tax Deed or operates to reduce any liability of the Sellers or the amount recoverable by the Buyer from the Sellers (other than, in the case of the General Warranties, the information Disclosed in the Disclosure Letter). The Sellers shall not invoke the knowledge of the Buyer or its agents or advisers (actual or constructive) of a fact or circumstance which might make a Warranty untrue or inaccurate as a defence to a claim for breach of clause 6.1, 6.2, 6.3 or the Tax Deed (other than, in the case of the General Warranties, the information Disclosed in the Disclosure Letter). The Buyer confirms that none of [***] are at the date hereof actually aware of a
|
6.7
|
Notwithstanding any other provision of this Agreement, the Disclosure Letter shall not limit the liability of the Sellers for any claims under the Fundamental Warranties or Tax Deed.
|
6.8
|
Any General Warranty that refers to the knowledge, information, belief or awareness of the Management Sellers shall be deemed to include the knowledge, information or belief which such Management Seller would have if such Management Seller had made all reasonable enquiries of the Specified Employees and the Management Sellers warrant that such enquiries have been made.
|
6.9
|
Each Warranty is independent and is not limited by a provision of this Agreement or by another Warranty (except where this Agreement provides otherwise).
|
6.10
|
Each Warranty shall continue in full force and effect notwithstanding Completion.
|
6.11
|
Each Seller [***] undertakes not to make a claim against any Group Company and/or a director, officer or employee of any Group Company which they may have in respect of a misrepresentation, inaccuracy or omission in or from information or advice provided by any Group Company, or a director, officer or employee of any Group Company for the purposes of assisting the Sellers to make a representation, give a Warranty or in the case of the Management Sellers only, prepare the Disclosure Letter.
|
6.12
|
The Management Sellers agree with the Buyer that, in the event of a breach of any of the warranties contained in paragraph 11.7 of Part 11 Schedule 5 {stamp duty}, they will pay to the Buyer by way of liquidated damages an amount equal to the unpaid stamp duty concerned together with any interest and penalties payable in relation thereto. The Management Sellers and the Buyer agree that such amount represents their genuine pre-estimate of the loss likely to be suffered by the Buyer in the event of such a breach.
|
6.13
|
The Buyer acknowledges and agrees that:
|
(a)
|
this Agreement and the other documents to be delivered by the Seller to the Buyer at Completion or pursuant to this Agreement contain the only Assurances given by the Sellers in relation to the Transaction; and
|
(b)
|
it has not relied, in relation to the purchase of the Shares and in relation to any other matters contemplated by this Agreement and the other documents to be delivered by the Sellers to the Buyer at Completion or pursuant to this Agreement on any other Assurances.
|
6.14
|
References to “Company” in Schedule 5 (other than paragraph 1.3(a) and 1.3(c) of Part 1 of Schedule 5) shall be deemed to include references to each Group Company.
|
7.
|
Limitations on the Sellers’ liability
|
7.1
|
The liability of the Sellers in respect of all Claims shall be limited as set out in Schedule 6.
|
7.2
|
The liability of each Management Seller in respect of all Tax Deed Claims shall be limited as set out in the Tax Deed.
|
8.
|
Indemnification
|
8.1
|
Subject to clause 7.1 and Schedule 6, from and after Completion, [***] shall [***] indemnify and keep indemnified the Buyer from, against and in respect of, the full amount of all Losses incurred by the Buyer, each member of the Buyer’s Group, their respective affiliates and their respective directors, officers, employees and agents in respect of:
|
(a)
|
any Fundamental Warranty warranted and undertaken to be true and accurate by that Seller pursuant to clauses 6.1 or 6.1 being untrue or inaccurate; or
|
(b)
|
any fraud or wilful breach of this Agreement or any other Transaction Document (excluding the Disclosure Letter) by that Seller.
|
8.2
|
Subject to clause 7.1 and Schedule 6, from and after Completion, [***] shall [***] indemnify and keep indemnified the Buyer from, against and in respect of, the full amount of all Losses incurred by the Buyer, each member of the Buyer’s Group, their respective affiliates and their respective directors, officers, employees and agents, in respect of any General Warranty, warranted and undertaken to be true and accurate pursuant to clause 6.3, being untrue or inaccurate.
|
8.3
|
Subject to clause 13.3 from and after Completion, each Buyer shall indemnify and keep indemnified the Sellers from, against and in respect of, the full amount of all Losses incurred by a Seller, a member of such Seller’s Group, their respective affiliates and their respective directors, officers, employees and agents, in respect of:
|
(a)
|
any warranty warranted to be true and accurate by that Buyer under clause 13 being untrue or inaccurate; or
|
(b)
|
any fraud or wilful breach of this Agreement or any other Transaction Document by that Buyer.
|
8.4
|
The indemnifying party under this clause 8 shall have the right to contest any third party claim that may result in a Loss. In no event shall any indemnitee under this clause 8 consent to the entry of any judgment or enter into any settlement with respect to such claim without obtaining the prior written consent of the indemnifying party not to be unreasonably withheld or delayed. In any event, the indemnifying party and the indemnitee may participate in the contest of such claim at their own expense. The indemnifying party and the indemnitee shall cooperate fully with each other as to all such claims, shall make available to each other as reasonably requested all information, records, and documents relating to such claims, and shall preserve all such information, records and documents until the termination or resolution of any such claim.
|
9.
|
Seller Indemnity Escrow
|
9.1
|
At Completion, the Buyer, the Management Sellers’ and the Escrow Agent shall enter into the Escrow Agreement in order to provide for the Escrow Account to secure and to serve as a fund in respect of the indemnification obligations of the Management Sellers under and subject to the conditions of this Agreement and the Tax Deed.
|
9.2
|
At Completion, OPKO Inc shall deposit the Escrow Consideration Shares with the Escrow Agent to be held in the Escrow Account pursuant to the terms of the Escrow Agreement. No certificates or scrip or shares of OPKO Common Stock representing fractional shares of OPKO Common Stock or book-entry credit of the same shall be issued as part of the Escrow Consideration Shares.
|
9.3
|
Except with respect to Escrow Consideration Shares that have been distributed from the Escrow Account to the Buyer pursuant to the Escrow Agreement, and except with respect to pending Claims made against the Management Sellers in accordance with clause 8.1(a) or 8.2 of this Agreement and/or the Tax Deed on or before the expiry of the Escrow Period, the Escrow Agreement will provide that all Escrow Consideration Shares in the Escrow Account shall be distributed to the Management Sellers in accordance with the Escrow Agreement on the fifth Business Day after the expiration of the Escrow Period; provided, that with respect to any such pending Claim, promptly following resolution of such pending Claim, the amount, if any, of such pending Claim which has not been paid, which is not payable to any Claimant pursuant to clause 8.1(a) or 8.2 of this Agreement and/or the Tax Deed and/or which is not required to remain in the Escrow Account to satisfy other pending Claims made against the Management Sellers in accordance with clause 8.1(a) or 8.2 of this Agreement and/or the Tax Deed, shall be paid to the Management Sellers.
|
10.
|
Restrictions on sale of OPKO Consideration Shares
|
10.1
|
Each Seller acknowledges that:
|
(a)
|
the OPKO Consideration Shares are “restricted securities” as defined by Rule 144 promulgated under the Securities Act, are not registered under the Securities Act or any applicable securities Laws and are being issued by the Parent to such Seller in reliance upon Regulation S promulgated under the Securities Act for offers and sales of securities outside the United States;
|
(b)
|
any sale, transfer or disposition by any Seller of any OPKO Consideration Shares into the United States may only be made:
|
(i)
|
pursuant to an effective registration statement under the Securities Act; or
|
(ii)
|
in accordance with Rule 144 of the Securities Act or another exemption from the registration requirements of the Securities Act and any other applicable securities Laws;
|
(c)
|
the OPKO Consideration Shares shall bear a restrictive legend; and
|
(d)
|
in order to remove the restrictive legend on the OPKO Consideration Shares, in connection with any sale, transfer or disposition by any Seller of any OPKO Consideration Shares, the Parent may require an opinion of counsel reasonably acceptable to it to the effect that such sale, transfer or disposition is exempt from the registration requirements of the Securities Act and any other applicable securities Laws.
|
11.
|
The Buyer’s remedies
|
11.1
|
The rights and remedies of the Buyer in respect of a breach of any of the Warranties or in respect of any claim under the Tax Deed or in respect of any breach of this Agreement shall not be affected by Completion except by a specific and duly authorised written waiver or release by the Buyer.
|
12.
|
Sellers’ Representative
|
12.1
|
Subject to clause 12.5, each Seller irrevocably appoints the Sellers’ Representative as its agent to act for and on its behalf in respect of the Transaction Documents.
|
12.2
|
Each Seller shall (to the extent within its power of procurement) procure that the Sellers’ Representative shall take such action as is required to be taken by the Sellers’ Representative as set out in the Transaction Documents.
|
12.3
|
The Sellers agree that any decision and/or action taken by the Sellers’ Representative under the Transaction Documents shall be binding on the Sellers.
|
12.4
|
The Sellers acknowledge that the Sellers’ Representative shall, on behalf of all of the Sellers , have full and irrevocable power and authority to take any action, give any consent and do or omit to do anything pursuant to the powers and authorities vested in him or contemplated by the Transaction Documents (including, as the case may be, without limitation, disputing or settling any Claim and instructing the Escrow Agent to release any amount from the Escrow Account as he shall in his absolute discretion decide).
|
12.5
|
The Sellers agree that the Sellers representing together a majority of the Sellers’ Shares sold pursuant to this Agreement may replace the designated Sellers’ Representative on the same terms of this clause 12.5 by giving 5 Business Days’ notice in writing served upon the Buyer and the Sellers’ Representative.
|
12.6
|
The Sellers acknowledge that the Sellers’ Representative shall have no liability to the Sellers (or any of them) in respect of any action taken by him or any omission to take action by him pursuant to the Transaction Documents or otherwise, except to the extent that he has acted fraudulently.
|
13.
|
Buyer Warranties
|
13.1
|
OPKO Irl warrants and undertakes to each of the Sellers that each of the following warranties is true and accurate:
|
(a)
|
it is a company duly incorporated and validly existing under the laws of the jurisdiction of its incorporation;
|
(b)
|
it has all requisite corporate power and authority to enter into this Agreement to which it is a party and to perform its obligations under the Transaction Documents;
|
(c)
|
the signature (and, where relevant, execution and delivery) of, and the performance by it of its obligations under this Agreement will not:
|
(i)
|
result in a breach of any provision of its articles of association; or
|
(ii)
|
result in a breach of, constitute a default or require a consent under, or violate any instrument or agreement to which it is a party or any Laws or any other restrictions of any kind by which it is bound; and
|
(d)
|
this Agreement has been duly and validly authorised and executed by it and constitutes its legal, valid and binding obligations, enforceable in accordance with its terms and conditions.
|
13.2
|
OPKO Inc warrants and undertakes to each of the Sellers that each of the following warranties is true and accurate:
|
(a)
|
it is a company duly incorporated and validly existing under the laws of the jurisdiction of its incorporation;
|
(b)
|
it has all requisite corporate power and authority to enter into this Agreement to which it is a party and to perform its obligations under the Transaction Documents;
|
(c)
|
the signature (and, where relevant, execution and delivery) of, and the performance by it of its obligations under this Agreement, including the issuance of the OPKO Consideration Shares, will not:
|
(i)
|
result in a breach of any provision of its articles of association (or equivalent constitutional documents); or
|
(ii)
|
result in a breach of, constitute a default or require a consent under, or violate any instrument or agreement to which it is a party or any Laws or any other restrictions of any kind by which it is bound;
|
(d)
|
this Agreement has been duly and validly authorised and executed by it and constitutes its legal, valid and binding obligations, enforceable in accordance with its terms and conditions;
|
(e)
|
the OPKO Consideration Shares will, when issued and delivered in accordance with the terms of this Agreement for the consideration expressed herein, be duly and validly issued, fully paid and non-assessable, and will be free and clear of any Encumbrances, other than restrictions on resale under the Securities Act and any other applicable securities Laws;
|
(f)
|
OPKO Inc has filed with the SEC all periodic reports and other documents required to be filed by it under the Exchange Act including, and since the date of, its Annual Report on Form 10-K for the fiscal year ended 31 December, 2014 (collectively the “
Public Reports
”). As of their respective dates, the Public Reports were prepared in accordance with the requirements of the Exchange Act and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading and there have been no material changes in the business or affairs of OPKO Irl or OPKO Inc since the date of such Public Reports;
|
(g)
|
neither it, OPKO Irl nor any of their affiliates nor any person acting on their behalf has engaged or will engage in any directed selling efforts (as defined in Regulation S under the Securities Act) in connection with the offering of the OPKO Consideration Shares, and they have complied
|
(h)
|
the number of outstanding capital shares of OPKO Inc, with respect to each class of capital shares and in the aggregate, has not changed by more than 5% from the information reflected in the OPKO Inc’s Form 10K for the fiscal year ended 31 December 2014 and any subsequent reports filed prior to the date of this Agreement; and
|
(i)
|
OPKO Inc has not experienced any change in or effect on the business of it or its subsidiaries that is, or could reasonably be expected to be, materially adverse to the business, assets (including intangible assets), liabilities (contingent or otherwise), condition (financial or otherwise), prospects or results of OPKO Inc or its subsidiaries taken as a whole, from the information reflected in the OPKO Inc’s Form 10-K for the fiscal year ended 31 December, 2014 and any subsequent reports filed prior to the date of this Agreement.
|
13.3
|
Except for claims against OPKO Inc for breach of the warranty at clause 13.2(e), no claim may be brought against OPKO Irl or OPKO Inc for breach of their respective warranties and undertakings in clause 13.1 or 13.2 respectively unless notice of the claim is served on OPKO Irl, or OPKO Inc, as the case may be, within 12 months of Completion.
|
14.
|
Protection of Goodwill
|
14.1
|
In this clause the following definitions apply:
|
14.2
|
Each of the Sellers (except [***]) severally undertakes with the Buyer for its own benefit and as trustee for the benefit of each Group Company to procure that he shall not (save in the course of his employment or engagement by a Group Company), either alone or jointly with others, in any capacity:
|
(a)
|
during the Restricted Period, employ or engage any person (except [***]) who at the date of this Agreement is an employee or officer of a Group Company, or who has been an employee or officer of a Group Company in the [***] immediately preceding Completion;
|
(b)
|
during the Restricted Period, solicit to employ or engage any person who at the date of this Agreement is an employee or officer of a Group Company or who has been an employee or officer of a Group Company in the [***] immediately preceding Completion;
|
(c)
|
during the Restricted Period, intentionally do or say anything which is harmful to the goodwill (as subsisting at the date of this Agreement) of a Group Company or which is reasonably likely to lead a person who has dealt with a Group Company at any time during the [***] prior to the date of this Agreement to cease to deal with the Group Company on substantially equivalent terms to those previously offered or at all; or
|
(d)
|
at any time after the Completion Date, use in the course of business:
|
(i)
|
the name EirGen;
|
(ii)
|
any trade mark, business or domain name, design or logo which on or before the Completion Date was or had been used by the Group; or
|
(iii)
|
anything which is, in the reasonable opinion of the Buyer, capable of confusion with such mark, names, design or logo.
|
14.3
|
[***] undertakes with the Buyer for its own benefit and as trustee for the benefit of each Group Company to procure that for the Restricted Period he shall not (save in the course of his employment or engagement by a Group Company) solicit to employ anyone who is an employee of a Group Company or who has been such an employee in the [***] immediately preceding Completion.
|
14.4
|
Subject to clause 14.5 each of the Management Sellers undertakes with the Buyer for its own benefit and as trustee for the benefit of each Group Company to procure that he shall not, either alone or jointly with others in any capacity (save, where relevant, in the course of his employment or engagement by a Group Company),
|
(a)
|
during the Restricted Period and within the Restricted Territory, carry on or participate or assist or be engaged or concerned or interested in any Restricted Business provided that this restriction shall not prevent the Management Sellers from holding in aggregate no more than 5% of shares or debentures of a company listed on a recognised stock exchange;
|
(b)
|
during the Restricted Period and in a manner competitive to the Restricted Business, solicit or endeavour to entice away or adversely interfere with the custom of any person, firm or company who, or which is currently, or who or which has, during the [***] immediately preceding the Completion Date been, a customer of a Group Company; or
|
(c)
|
during the Restricted Period, contract or seek to contract with any person who has been contracted with or engaged to manufacture, assemble or supply or deliver goods or services to a Group Company during the [***] prior to the Completion Date, in such a way that has the effect of adversely affecting the business of a Group Company.
|
14.5
|
The Buyer acknowledges and agrees that the [***] may [***] provided that the [***] of the [***] in any [***] does not [***] and [***] in any such case without the prior written consent of the Buyer.
|
14.6
|
Each of the undertakings in clauses 14.2, 14.3 and 14.4 is considered fair and reasonable by the Buyer and Sellers, but if any restriction is found to be unenforceable, but would be valid if any part of it were deleted or the period or territory of application reduced, the restriction shall apply with such modifications as may be necessary to make it valid and enforceable.
|
14.7
|
Each of the undertakings in clauses 14.2 and 14.3 and 14.4 shall be construed and take effect independently of the others.
|
15.
|
Confidentiality
|
15.1
|
Subject to clause 15.2, the Sellers undertakes to the Buyer not at any time to disclose or cause to be disclosed to any person or use for any purpose any Confidential Information. This restriction shall not apply to the Management Sellers in the necessary course of their employment by a Group Company. The Buyer undertakes to each Seller to keep the terms of the Transaction Documents confidential.
|
15.2
|
A Seller may disclose Confidential Information, and the Buyer may disclose the terms of the Transaction Documents, to the extent that:
|
(a)
|
disclosure is required by the law of any Relevant Jurisdiction or pursuant to an order of a court of competent jurisdiction;
|
(b)
|
disclosure is required by any securities exchange or regulatory or governmental body to which either party or its holding company is subject, wherever situated, whether or not the requirement for information has the force of law;
|
(c)
|
the information has come into the public domain through (i) no fault of the Sellers or any member of the Seller’s Group or (ii) no fault of the Buyer or any member of the Buyer’s Group
|
(d)
|
the information was in the possession of the person receiving it before such disclosure was made; or
|
(e)
|
the information was obtained by the Sellers from a third party who was free to divulge it;
|
(i)
|
inform the other of the full circumstances of the disclosure and the information that will be disclosed, and take all such steps as may be reasonable and practicable in the circumstances to agree the content of such disclosure with the other party before making the disclosure;
|
(ii)
|
consult with the other as to possible steps to avoid or limit disclosure and take those steps where they would not result in significant adverse consequences to the other party; and
|
(iii)
|
where the disclosure is by way of public announcement, agree the wording with the party in advance.
|
15.3
|
The restrictions contained in this clause 15 shall apply at all times after the date of this Agreement, notwithstanding the termination or expiration of this Agreement.
|
15.4
|
The parties are entering into this Agreement in consideration of the other parties’ undertakings to comply with clauses 14.2, 14.3, 14.4 and 15. If any breach or violation of any of the provisions of clauses 14.2, 14.3, 14.4 and 15 occurs, the parties agree that damages would not be an adequate relief for such breach or violation and that injunctive relief would be reasonable and essential to safeguard the legitimate interests of the parties. Accordingly, each Seller and the Buyer acknowledges to the other that the other will be entitled to seek injunctive relief in respect of any actual or threatened breach of clauses 14.2, 14.3, 14.4 and 15 (in addition to any other remedies) by the other party and each such other party shall not object to the appropriateness of such relief being sought.
|
16.
|
Announcements
|
16.1
|
No party shall make any statement to the press or to the employees of the Group or make any other public announcement in connection with any matters referred to in this Agreement without the prior consent in writing of each other party which consent shall not be unreasonably withheld or delayed.
|
16.2
|
Clause 16.1 does not apply to a public announcement, communication or circular to be made or sent by a party if it is required by law, a regulation of a stock exchange or by any regulatory body which that party is a member of or is otherwise regulated by or subject to.
|
17.
|
Payments under this Agreement
|
17.1
|
If any payment required to be made by the Sellers under this Agreement is not made by the due date for payment, that payment shall carry interest from that due date until the date when payment is actually made at a rate of 5 per cent over Euribor.
|
17.2
|
Any payment or delivery to the Sellers’ Solicitors by or on behalf of the Buyer shall be an absolute discharge of any obligation to make such a payment or delivery to the Sellers (or any of them) and a receipt from the Sellers’ Solicitors in respect of any payments made by the Buyer shall be a good and complete discharge to the Buyer who shall not be concerned as to the distribution of such payment to the Sellers by the Sellers’ Solicitors.
|
17.3
|
Any sum payable by the Sellers under this Agreement or the Tax Deed shall be treated as a reduction in the Consideration.
|
18.
|
Notices
|
18.1
|
Notices or other communications (a “
Notice
”) given in connection with this Agreement shall be:
|
(a)
|
in writing;
|
(b)
|
delivered by hand or sent by registered post to the address in clause 18.3 of the party to which the Notice is being given or to such other address as such party shall communicate to the party giving the Notice; or
|
(c)
|
sent by facsimile to the number in clause 18.3 of the party to which it is being sent or to such other number as such party shall communicate to the party giving the Notice.
|
18.2
|
Every Notice given in accordance with this clause shall be deemed to have been received as follows:
|
Means of Dispatch
|
Deemed Received
|
Delivery by hand:
|
the day of delivery;
|
Post:
|
Five Business Days after posting; and
|
Facsimile:
|
when confirmation of its transmission has been recorded by the sender’s fax machine
|
18.3
|
The relevant addressee, address and facsimile number of each party for the purposes of this Agreement, subject to clause 18.1 are:
|
Name of party
|
Address
|
Facsimile No.
|
OPKO Ireland Limited
|
Citywest Business Campus, 3013 Lake Drive, Dublin 24, Ireland
|
|
Patsy Carney (Sellers’ Representative)
|
The Coachyard, Newtown, Tramore, Co. Waterford
|
|
OPKO Health, Inc
.
|
4400 Biscayne Boulevard, Miami, Florida 33137, USA
Attention Legal Department
|
|
18.4
|
A party shall notify the other of a change to its name, relevant addressee, address or facsimile number for the purposes of clause 18.3. Such notification shall only be effective on:
|
(a)
|
the date specified in the notification as the date on which the change is to take place; or
|
(b)
|
if no date is specified or the date specified is less than 5 Business Days after the date on which notice is given, the date falling 5 Business Days after notice of any such change has been given.
|
19.
|
Variation
|
20.
|
Costs and Expenses
|
21.
|
Assignment and Successors
|
21.1
|
No Seller may assign, transfer, grant any Encumbrance over, declare any trust over or deal in any way with its rights under this Agreement without the prior written consent of the Buyer.
|
21.2
|
The Buyer may at any time and on one or more occasions, assign or grant any Encumbrance over its rights under this Agreement to any other member of the Buyer Group and/or agent or trustee of such member of the Buyer’s Group (such agent or trustee being for such member’s benefit only) for the time being and such assignee shall be entitled to and may enforce the benefit and rights of the Buyer under this Agreement as if it had been named as the Buyer under this Agreement provided always that such assignee shall be required to assign and transfer all rights and obligations under this Agreement to another member of the Buyer Group if that assignee or the original assignor (where the assignee is an agent or trustee for that original assignor) ceases to be a member of the Buyer Group (such assignment and transfer to be completed immediately prior to such cessation). In addition to the foregoing OPKO Inc may at any time transfer the Shares it acquires from the Sellers to OPKO Irl.
|
21.3
|
If there is an assignment, transfer, grant, declaration or dealing by a party as permitted by this clause 21:
|
(a)
|
such party shall, as soon as reasonably practicable, give Notice of such dealing to the other parties. However, failure to give such Notice shall not affect the validity of such dealing;
|
(b)
|
the amount of loss or damage recoverable by any assignee or other person entitled to the rights under this Agreement pursuant to this clause 21 shall not be greater than the amount of loss or damage which that party would have been able to recover had (a) such assignment, transfer, grant, declaration or dealing and (b) any related transfer of all or any of the Shares of any Group Company or all or any of the assets or undertaking of any Group Company not taken place.
|
21.4
|
A party may disclose information that it is otherwise required to keep confidential under clause 15 to an assignee permitted by this clause 21 provided they are subject to the same confidentiality obligations as envisaged in this Agreement in respect of the information so disclosed.
|
21.5
|
This Agreement shall be binding on and continue for the benefit of the successors, estate and personal representatives and permitted assignees (as the case may be) of each party.
|
22.
|
Waiver
|
22.1
|
A waiver by a Seller or the Buyer of any breach by the Buyer or a Seller of any of the terms, provisions or conditions of this Agreement or the acquiescence of a Seller or the Buyer in any act (whether commission or omission), which, but for such acquiescence, would be such a breach, shall not constitute a general waiver of such term, provision or condition or of any further similar breach.
|
22.2
|
Completion shall not constitute a waiver by any party of any breach of any provision of this Agreement, whether or not known to such party at the date of Completion.
|
23.
|
Further Assurance
|
24.
|
Effect of Completion
|
25.
|
Rights, Powers and Remedies are Cumulative
|
26.
|
Invalidity
|
(a)
|
the legality, validity or enforceability of any other provision of this Agreement (including the remainder of a provision, where only part of the provision is or has become illegal, invalid or unenforceable); or
|
(b)
|
the legality, validity or enforceability under the law of any other jurisdiction of that or any other provision of this Agreement.
|
27.
|
Entire Agreement
|
28.
|
Counterparts
|
29.
|
Process Agent
|
29.1
|
Ontario hereby irrevocably authorises and appoints the Sellers’ Solicitors as its authorised agent to accept service of all legal process in Ireland on its behalf and service on such appointee shall be deemed to be service on Ontario.
|
29.2
|
Ontario agree that any failure by its process agent to notify it of the legal process shall not invalidate the proceedings concerned.
|
29.3
|
Ontario further agree to maintain the Sellers’ Solicitors as its agent until 31 December 2020 or, if later, the conclusion of any legal proceedings relating to this Agreement.
|
30.
|
Governing Law and Jurisdiction
|
SIGNED
and
DELIVERED AS A DEED
by
THOMAS BRENNAN
in the presence of:
|
__
/s/Thomas Brennan
____________________
|
Signature of Witness
|
__
/s/Andrea O’Caoinh
__________________
|
Name of Witness
|
__
Andrea O’Caoinh
______________________
|
Address of Witness
|
__
2 Grand Canal Square
__________________
|
|
__
D2
___________________________________
|
Occupation of Witness
|
_
Trainee Solicitor
________________________
|
SIGNED
and
DELIVERED AS A DEED
by
PATSY CARNEY
in the presence of:
|
__
/s/Patsy Carney
__________________
|
Signature of Witness
|
____
/s/Andrea O’Caoinh
_____________
|
Name of Witness
|
____
Andrea O’Caoinh
_______________
|
Address of Witness
|
__
2 Grand Canal Square
______________
|
|
__D
2
________________________________
|
Occupation of Witness
|
__
Trainee Solicitor
____________________
|
SIGNED
for and on behalf of
EILEEN RAGGETT
by her lawfully appointed attorney,
BARRIE DAISH
, in the presence of
and
DELIVERED AS A DEED
|
___
/s/Barrie Daish
__________________
|
Signature of Witness
|
___
/s/ Ian Hutchinson
_______________
|
Name of Witness
|
___
Ian Hutchinson
___________________
|
Address of Witness
|
___
2 Grand Canal Square
_____________
|
Occupation of Witness
|
___
Solicitor
__________________________
|
SIGNED
and
DELIVERED AS A DEED
by
BARRIE DAISH
in the presence of:
|
___
/s/Barrie Daish
__________________
|
Signature of Witness
|
___
/s/Ian Hutchinson
_______________
|
Name of Witness
|
___
Ian Hutchinson
___________________
|
Address of Witness
|
___
2 Grand Canal Square
______________
|
|
____________________________________
|
Occupation of Witness
|
__
Solicitor
___________________________
|
EXECUTED
and
DELIVERED AS A DEED
by
1575773 ONTARIO INC.
in the presence of:
|
___
/s/Harcharan Singh
_______________
|
Signature of Witness
|
___
/s/Joshua Seor
____________________
|
Name of Witness
|
___
Joshua Seor_
______________________
|
Address of Witness
|
___
4950 Yonge St., Suite 1800
__________
|
|
___
Toronto, Ontario M2N6K
__________
|
Occupation of Witness
|
___
Lawyer
___________________________
|
Present when the common seal of
OPKO IRELAND LIMITED
was affixed to this deed and this deed was delivered:
|
|
|
_____
/s/ Brian V. Elliott
_____________
Director
____
/s/Jim Gaul
____________________
Director
|
SIGNED
for and on behalf of
OPKO HEALTH, INC.
|
|
|
___
/s/Steven Rubin
__________________
Steven Rubin
|
(1)
|
THE PERSONS
whose names and addresses are set out in Schedule 3
(
together the
“Sellers”
)
and
|
(2)
|
OPKO IRELAND LIMITED
, a company registered in Ireland under number 530936 and having its registered office at Citywest Business Campus, 3013 Lake Drive, Dublin 24, Ireland (the “
Buyer
”).
|
(A)
|
EirGen Pharma Limited (the “
Company
”) is a private limited company incorporated in Ireland under registration number 398605.
|
(B)
|
The Sellers are the owners of the numbers of Shares set opposite their respective names in column 3 of Schedule 3 (the “
Sellers’ Shares
”).
|
(C)
|
The Sellers have agreed to sell and the Buyer has agreed to buy, the Sellers’ Shares on the terms and subject to the conditions of this Agreement.
|
1.
|
Interpretation
|
1.1
|
Definitions
|
(a)
|
the marketing of goods or services, including customer names and lists and other details of customers, sales targets, sales statistics, market share statistics, prices market research reports and surveys and advertising or other promotional materials;
|
(b)
|
product information, know-how, formulas, compositions, manufacturing and production processes and techniques, technical data, designs, plans, drawings, specifications and blueprints;
|
(c)
|
future projects, business development or planning, commercial relationships and negotiations; or
|
(d)
|
any information in relation to which a Group Company is bound by an obligation of confidence to a third party,
|
(a)
|
corporation tax (including any surcharge), advance corporation tax, income tax (including tax or amounts on account of tax required to be deducted or withheld from or accounted for in respect of any payment), capital gains tax, inheritance tax, gift tax, capital acquisition tax, value added tax, dividend (distribution) withholding tax, national insurance contribution, PAYE deductions, pay related social insurance, levies and universal social charge, capital duty, stamp duty, deposit interest retention tax, professional services withholding tax, relevant contracts tax, surtax, duties of customs and excise and import, petroleum revenue tax, environmental levies (including environmental levy on plastic bags), rates and all taxes, duties or similar charges replaced by or replacing any of the foregoing;
|
(b)
|
all other taxes on gross or net income, profits or gains, distributions, receipts, sales, use, occupation, franchise, value added and personal property;
|
(c)
|
all taxes, levies, imposts, duties, charges or withholdings of any nature whatsoever chargeable and/or collectable by any Tax Authorities in any Relevant Jurisdiction; and
|
(d)
|
any payment whatsoever which a Group Company may be or become bound to make to any person as a result of the discharge by that person of any tax which a Group Company has failed to discharge;
|
1.2
|
Construction
|
(a)
|
use of the singular includes the plural and vice versa;
|
(b)
|
a reference to one gender includes a reference to each other gender;
|
(c)
|
the headings are inserted for convenience of reference only and shall not in any way form part of, or affect the construction or interpretation of, this Agreement;
|
(d)
|
the provisions of the Schedules to this Agreement form an integral part of this Agreement and have as full effect as if they were incorporated in the body of this Agreement and the expressions “
this Agreement
” and “
the Agreement
” shall be deemed to include the Schedules to this Agreement;
|
(e)
|
a reference to a person (including a party to this Agreement) includes a reference to that person’s legal personal representatives, successors and permitted assigns;
|
(f)
|
a reference to a document is a reference to that document as from time to time amended, supplemented or varied (in each case, other than in breach of the provisions of this Agreement);
|
(g)
|
any reference to any statute or statutory provision shall include:
|
(i)
|
any statute or statutory provision which:
|
(A)
|
amends, extends, consolidates, re-enacts or replaces any statute or statutory provision; or
|
(B)
|
has been amended, extended, consolidated, re-enacted or replaced (whether before or after the date of this Agreement) by any statute or statutory provision; and
|
(ii)
|
any orders, regulations, instruments or other subordinate legislation made under the relevant statute;
|
(h)
|
words and phrases the definitions of which are contained or referred to in the Companies Acts shall be construed as having the meanings attributed to them in such Acts;
|
(i)
|
a reference to any clause, sub-clause, paragraph, or Schedule shall be a reference to the clause, sub-clause, paragraph, or Schedule of this Agreement unless the context otherwise requires;
|
(j)
|
reference to a “
company
” shall be construed so as to include any company, corporation or body corporate, whenever and however established or incorporated;
|
(k)
|
all references to costs, charges and expenses include any value added tax or similar tax charged or chargeable in respect thereof;
|
(l)
|
references to any tax in respect of income or profits or gains or chargeable gains earned, accrued or received on or before a particular date or in respect of a particular period shall include any tax in respect of income or profits or gains deemed for Tax purposes to have been or treated as earned, accrued or received on or before that date or in respect of that period;
|
(m)
|
any phrase introduced by the terms “
including
”,
“
include
” and “
in particular
” or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms;
|
(n)
|
the rule known as ‘
contra proferentum
” shall not apply; and
|
(o)
|
any reference to an Irish legal term for any action, remedy, method of judicial proceeding, legal document, legal status, court, official or any legal concept or thing shall, in respect of any jurisdiction other than Ireland, be deemed to include a reference to what most nearly approximates in that jurisdiction to the Irish legal term.
|
2.
|
Sale of Sellers’ Shares
|
2.1
|
Subject to the terms of this Agreement, each Seller severally shall sell, and the Buyer shall buy, the Sellers’ Shares with effect from Completion.
|
2.2
|
The Sellers’ Shares shall be sold free from all Encumbrances together with all other rights attached or accruing to the Sellers’ Shares, including the right to receive all dividends or distributions of whatever nature declared, paid or made in respect of any period on or after the Completion Date.
|
2.3
|
Each Seller severally waives any rights of pre-emption or other restriction on transfer to which it is entitled by virtue of the articles of association of the Company or otherwise in respect of the sale of the entire issued share capital of the Company to the Buyer on or about the date hereof.
|
3.
|
Consideration
|
4.
|
Completion Payment
|
5.
|
Completion
|
5.1
|
Completion shall take place at the offices of the Buyer’s Solicitors immediately following the execution of this Agreement.
|
5.2
|
At Completion the Sellers and the Buyer shall do all those things respectively required of them in Schedule 1.
|
5.3
|
The Buyer shall not be obliged to complete this Agreement unless:
|
(a)
|
the Sellers comply with all of their obligations in Schedule 1; and
|
(b)
|
the purchase of all the Sellers’ Shares and the Shares under the Share Purchase Agreements is completed simultaneously.
|
5.4
|
The Sellers shall not be obliged to complete this Agreement unless the Buyer complies with all of its obligations in Schedule 1.
|
5.5
|
Each of the Sellers appoints the Buyer to be that Seller’s attorney for the purposes set out in this clause 5.5 from Completion until the Shares of that Seller are registered in the Buyer's name and on the following terms:
|
(a)
|
the Buyer may do the following in the name of such Seller;
|
(i)
|
exercise any rights, including rights to appoint a proxy or representative and voting rights, attaching to such Seller’s Shares; and
|
(ii)
|
receive any dividend or other entitlement paid or credited to such Seller on or after Completion in respect of such Seller’s Shares;
|
(b)
|
all acts and things done by the Buyer in exercising powers under this power of attorney will be as valid as if they had been done by such Seller;
|
(c)
|
on registration of such Sellers’ Shares in the Buyer's name, the powers conferred on the Buyer under this clause 5.5 in respect of such Seller’s Shares and such Seller immediately cease; and
|
(d)
|
the Buyer shall indemnify such Seller against any loss, liability and cost which it may incur as a result of or in connection with the exercise by the Buyer of the power conferred on the Buyer under this clause.
|
6.
|
Sellers’ Warranties
|
6.1
|
Each Seller severally warrants and undertakes to the Buyer that each of the Warranties is, at the date of this Agreement, true and accurate in respect of that Seller and/or its Shares.
|
6.2
|
Each Seller agrees and acknowledges that the Buyer is entering into this Agreement in reliance on each Warranty.
|
6.3
|
No information of which the Buyer or its agents or advisers has knowledge (actual or constructive) and no investigation by or on behalf of the Buyer prevents any claim made by the Buyer under the Warranties or operates to reduce any liability of the Sellers or the amount recoverable by the Buyer from the Sellers. The Sellers shall not invoke the knowledge of the Buyer or its agents or advisers (actual or constructive) of a fact or circumstance which might make a Warranty untrue or inaccurate as a defence to a claim for breach of clause 6.1.
|
6.4
|
Each Warranty is independent and is not limited by a provision of this Agreement or by another Warranty (except where this Agreement provides otherwise).
|
6.5
|
Each Warranty shall continue in full force and effect notwithstanding Completion.
|
7.
|
Indemnification
|
7.1
|
From and after Completion, each Seller shall severally indemnify and keep indemnified the Buyer and each member of the Buyer’s Group, their respective affiliates and their respective directors, officers, employees and agents from, against and in respect of, the full amount of all Losses incurred directly or indirectly by the Buyer, each member of the Buyer’s Group, their respective affiliates and their respective directors, officers, employees and agents, in respect of:
|
(a)
|
any Warranty warranted and undertaken to be true and accurate by the Seller pursuant to clause 6.1 being untrue or inaccurate; or
|
(b)
|
any fraud or wilful breach of this Agreement or any other Transaction Document by the Seller.
|
7.2
|
From and after Completion, the Buyer shall indemnify and keep indemnified the Sellers, their respective affiliates and their respective agents from, against and in respect of, the full amount of all Losses incurred by the Sellers, their respective affiliates and their respective agents, in respect of:
|
(a)
|
any warranty warranted to be true and accurate by the Buyer under clause 9 being untrue or inaccurate; or
|
(b)
|
any fraud or wilful breach of this Agreement by the Buyer.
|
7.3
|
The indemnifying party under this clause 7 shall have the right to contest any third party claim that may result in a Loss. In no event shall any indemnitee under this clause 7 consent to the entry of any judgment or enter into any settlement with respect to such claim without obtaining the prior written consent of the indemnifying party, not to be unreasonably withheld or delayed. In any event, the indemnifying party and the indemnitee may participate in the contest of such claim at their own expense. The indemnifying party and the indemnitee shall cooperate fully with each other as to all such claims, shall make available to each other as reasonably requested all information, records, and documents relating to such claims, and shall preserve all such information, records and documents until the termination or resolution of any such claim.
|
8.
|
The Buyer’s remedies
|
9.
|
Buyer Warranties
|
9.1
|
The Buyer warrants and undertakes to each of the Sellers that each of the following warranties is true and accurate:
|
(a)
|
it is a company duly incorporated and validly existing under the laws of the jurisdiction of its incorporation;
|
(b)
|
it has and will at Completion have all requisite corporate power and authority to enter into this Agreement to which it is a party and to perform its obligations under the Transaction Documents;
|
(c)
|
the signature (and, where relevant, execution and delivery) of, and the performance by it of its obligations under this Agreement will not:
|
(i)
|
result in a breach of any provision of its articles of association (or equivalent constitutional documents); or
|
(ii)
|
result in a breach of, or constitute a default or require a consent under, any instrument or agreement to which it is a party or a violation of any Laws or any other restrictions of any kind by which it is bound; and
|
(d)
|
this Agreement has been duly and validly authorised and executed by it and constitutes its legal, valid and binding obligations, enforceable in accordance with its terms and conditions.
|
10.
|
Confidentiality
|
10.1
|
Each Seller undertakes to the Buyer not at any time to disclose or cause to be disclosed to any person or use for any purpose any Confidential Information. The Buyer undertakes to each Seller not at any time to disclose or cause to be disclosed to any person the terms of the Transaction Documents.
|
10.2
|
A Seller may disclose Confidential Information, and the Buyer may disclose the terms of the Transaction Documents, to the extent that:
|
(a)
|
disclosure is required by the law of any Relevant Jurisdiction or pursuant to an order of a court of competent jurisdiction;
|
(b)
|
disclosure is required by any securities exchange or regulatory or governmental body to which either party or a holding company is subject, wherever situated, whether or not the requirement for information has the force of law;
|
(c)
|
the information has come into the public domain through (i) no fault of the Seller or, where the context so requires, (ii) no fault of the Buyer or any member of the Buyer’s Group;
|
(d)
|
the information was in the possession of the person receiving it before such disclosure was made; or
|
(e)
|
the information was obtained by the Seller from a third party who was free to divulge it;
|
(i)
|
inform the other of the full circumstances of the disclosure and the information that will be disclosed, and take all such steps as may be reasonable and practicable in the circumstances to agree the content of such disclosure with the other party before making the disclosure;
|
(ii)
|
consult with the other party as to possible steps to avoid or limit disclosure and take those steps where they would not result in significant adverse consequences to the other party; and
|
(iii)
|
where the disclosure is by way of public announcement, agree the wording with the other party in advance.
|
10.3
|
The restrictions contained in this clause 10 shall apply at all times after the date of this Agreement.
|
10.4
|
The parties are entering into this Agreement in consideration of the other party’s undertakings to comply with this clause 10. If any breach or violation of any of the provisions of clause 10 occurs, the parties agree that damages would not be an adequate relief for such breach or violation and that injunctive relief would be reasonable and essential to safeguard the legitimate interests of the parties. Accordingly, each of the Sellers and the Buyer acknowledge to the other that it will be entitled to seek injunctive relief in respect of any actual or threatened breach of clause 10
Error! Reference source not found.
(in addition to any other remedies) by the other party and such other party shall not object to the appropriateness of such relief being sought.
|
11.
|
Announcements
|
11.1
|
Neither party shall make any statement to the press or to the employees of the Group or make any other public announcement in connection with any matters referred to in this Agreement without the prior consent in writing of the other party which consent shall not be unreasonably withheld.
|
11.2
|
Clause 11.1 does not apply to a public announcement, communication or circular to be made or sent by a party or that party’s holding company if it is required by law, a regulation of a stock exchange or by any regulatory body which that party is a member of or is otherwise regulated by or subject to.
|
12.
|
Payments under this Agreement
|
13.
|
Notices
|
13.1
|
Notices or other communications (a “
Notice
”) given in connection with this Agreement shall be:
|
(a)
|
in writing;
|
(b)
|
delivered by hand or sent by registered post to the address in clause 13.3 of the party to which the Notice is being given or to such other address as such party shall communicate to the party giving the Notice; or
|
(c)
|
sent by facsimile to the number in clause 13.3 of the party to which it is being sent or to such other number as such party shall communicate to the party giving the Notice.
|
13.2
|
Every Notice given in accordance with this clause shall be deemed to have been received as follows:
|
Means of Dispatch
|
Deemed Received
|
Delivery by hand:
|
the day of delivery;
|
Post:
|
five Business Days after posting; and
|
Facsimile:
|
when confirmation of its transmission has been recorded by the sender’s fax machine
|
13.3
|
The relevant addressee, address and facsimile number of each party for the purposes of this Agreement, subject to clause 13.1 are:
|
Name of party
|
Address
|
Facsimile No.
|
OPKO Ireland Limited
|
Citywest Business Campus, 3013 Lake Drive, Dublin 24, Ireland
|
|
[____________________]
|
[____________________________]
|
[____________________]
|
[____________________]
|
[____________________________]
|
[____________________]
|
[____________________]
|
[____________________________]
|
[____________________]
|
[____________________]
|
[____________________________]
|
[____________________]
|
[____________________]
|
[____________________________]
|
[____________________]
|
|
|
|
13.4
|
A party shall notify the other of a change to its name, relevant addressee, address or facsimile number for the purposes of clause 13.3. Such notification shall only be effective on:
|
(a)
|
the date specified in the notification as the date on which the change is to take place; or
|
(b)
|
if no date is specified or the date specified is less than 5 Business Days after the date on which notice is given, the date falling 5 Business Days after notice of any such change has been given.
|
14.
|
Variation
|
15.
|
Costs and Expenses
|
16.
|
Assignment and Successors
|
16.1
|
No Seller may assign, transfer, grant any Encumbrance over, declare any trust over or deal in any way with its rights under this Agreement without the prior written consent of the Buyer.
|
16.2
|
The Buyer may at any time and on one or more occasions, assign or grant any Encumbrance over its rights under this Agreement to any other member of the Buyer’s Group, and/or agent or trustee of such person for the time being and such assignee shall be entitled to and may enforce the benefit and rights of the Buyer under this Agreement as if it had been named as the Buyer under this Agreement provided always that such assignee shall be required to assign and transfer all rights and obligations under this Agreement to another member of the Buyer’s Group if that assignee ceases to be a member of the Buyer’s Group (such assignment and transfer to be completed immediately prior to such cessation).
|
16.3
|
If there is an assignment, transfer, grant, declaration or dealing by a party as permitted by this clause 16:
|
(a)
|
such party shall, as soon as reasonably practicable, give Notice of such dealing to the other parties. However, failure to give such Notice shall not affect the validity of such dealing;
|
(b)
|
the amount of loss or damage recoverable by any assignee or other person entitled to the rights under this Agreement pursuant to this clause 16 shall not be greater than the amount of loss or damage which that party would have been able to recover had (a) such assignment, transfer, grant, declaration or dealing and (b) any related transfer of all or any of the Shares of any Group Company or all or any of the assets or undertaking of any Group Company not taken place.
|
16.4
|
A party may disclose information that it is otherwise required to keep confidential under clause 10 to an assignee permitted by this clause 16 provided they are subject to the same confidentiality obligations as envisaged in this Agreement in respect of the information so disclosed.
|
16.5
|
This Agreement shall be binding on and continue for the benefit of the successors, estate and personal representatives and permitted assignees (as the case may be) of each party.
|
17.
|
Waiver
|
17.1
|
A waiver by any Seller or the Buyer of any breach by the Buyer or any Seller of any of the terms, provisions or conditions of this Agreement or the acquiescence of any Seller or the Buyer in any act (whether commission or omission), which, but for such acquiescence, would be such a breach, shall not constitute a general waiver of such term, provision or condition or of any further similar breach.
|
17.2
|
Completion shall not constitute a waiver by any party of any breach of any provision of this Agreement, whether or not known to such party at the date of Completion.
|
18.
|
Further Assurance
|
19.
|
Effect of Completion
|
20.
|
Rights, Powers and Remedies are Cumulative
|
21.
|
Invalidity
|
(a)
|
the legality, validity or enforceability of any other provision of this Agreement (including the remainder of a provision, where only part of the provision is or has become illegal, invalid or unenforceable); or
|
(b)
|
the legality, validity or enforceability under the law of any other jurisdiction of that or any other provision of this Agreement.
|
22.
|
Entire Agreement
|
23.
|
Counterparts
|
24.
|
Governing Law and Jurisdiction
|
|
|
|
|
SIGNED
for and on behalf of [_________________] by his/her lawfully appointed attorney, [_________________] in the presence of:
and
DELIVERED AS A DEED
|
_____________________________________
|
|
Signature of Witness
|
_____________________________________
|
|
Name of Witness
|
_____________________________________
|
|
Address of Witness
|
____________________________________
|
|
|
_____________________________________
|
|
Occupation of Witness
|
_____________________________________
|
|
|
|
|
SIGNED
for and on behalf of [________________] by his/her lawfully appointed attorney, [_________________], in the presence of:
and
DELIVERED AS A DEED
|
______________________________________
|
|
Signature of Witness
|
_____________________________________
|
|
Name of Witness
|
_____________________________________
|
|
Address of Witness
|
_____________________________________
|
|
|
_____________________________________
|
|
Occupation of Witness
|
_____________________________________
|
|
|
|
|
|
|
|
SIGNED
for and on behalf of [___________________]
by his/her lawfully appointed attorney, [___________________], in the presence of:
and
DELIVERED AS A DEED
|
_____________________________________
|
|
Signature of Witness
|
_____________________________________
|
|
Name of Witness
|
_____________________________________
|
|
Address of Witness
|
_____________________________________
|
|
|
_____________________________________
|
|
Occupation of Witness
|
_____________________________________
|
|
|
|
|
|
|
|
SIGNED
for and on behalf of [______________________] by his/her lawfully appointed attorney, [_________________], in the presence of:
and
DELIVERED AS A DEED
|
_____________________________________
|
|
Signature of Witness
|
_____________________________________
|
|
Name of Witness
|
_____________________________________
|
|
Address of Witness
|
_____________________________________
|
|
|
_____________________________________
|
|
Occupation of Witness
|
______________________
______________
|
|
|
|
|
|
|
|
SIGNED
for and on behalf of [_______________] by his/her lawfully appointed attorney, [_______________], in the presence of:
and
DELIVERED AS A DEED
|
___________________
__________________
|
|
Signature of Witness
|
______________________________________
|
|
Name of Witness
|
______________________________________
|
|
Address of Witness
|
_________________
____________________
|
|
|
_____________________________________
|
|
Occupation of Witness
|
______________________________________
|
|
|
|
|
|
|
|
GIVEN under the common seal of
OPKO IRELAND LIMITED
:
and
DELIVERED AS A DEED
|
|
|
|
___________________________________
Director
____________________________________
Director/Secretary
|
(1)
|
I have reviewed this Quarterly Report on Form 10-Q of OPKO Health, Inc.;
|
(2)
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
(3)
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
(4)
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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(5)
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: August 5, 2015
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/s/ Phillip Frost, M.D.
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Phillip Frost, M.D.
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Chief Executive Officer
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(1)
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I have reviewed this Quarterly Report on Form 10-Q of OPKO Health, Inc.;
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(2)
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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(3)
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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(4)
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The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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(a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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(b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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(c)
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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(d)
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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(5)
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: August 5, 2015
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/s/ Adam Logal
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Adam Logal
|
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Senior Vice President, Chief Financial Officer,
Chief Accounting Officer and Treasurer
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Date: August 5, 2015
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/s/ Phillip Frost, M.D.
|
|
Phillip Frost, M.D.
|
|
Chief Executive Officer
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Date: August 5, 2015
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/s/ Adam Logal
|
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Adam Logal
|
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Senior Vice President, Chief Financial Officer
Chief Accounting Officer and Treasurer
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