As filed with the Securities and Exchange Commission on June 30, 2009


  UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
 
Washington, D.C. 20549

FORM 20-F
(Mark One)

£             REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
S                        ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2008
OR
£                        TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

OR
£             SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of event requiring this shell company report . . . . . . . . . . . . . . . .
 
Commission file number:  001-33042
 

 
 
ROSETTA GENOMICS LTD.
(Exact name of Registrant as specified in its charter)

Not Applicable
(Translation of Registrant’s Name into English)

Israel
(Jurisdiction of incorporation or organization)

10 Plaut Street, Science Park
Rehovot 76706 POB 4059, Israel
(Address of principal executive offices)

Amir Avniel, CEO and President
3711 Market St., Suite 740
Philadelphia, PA, 19104, USA
Tel: 215-382-9000
Fax: 215-382-0815
(Name, Telephone, E-mail and or Facsimile number and Address of Company Contact Person)
 

 
Securities registered or to be registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange on which registered
Ordinary shares, par value NIS 0.01 per share
The NASDAQ Stock Market LLC
 
Securities registered or to be registered pursuant to Section 12(g) of the Act.  None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.  None
 
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the Annual Report:    As of December 31, 2008, the issuer had 12,171,932 ordinary shares outstanding and no preferred shares outstanding.
 
Indicate by check mark if the registrant is a well known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes   £     No   S
 
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or (15)(d) of the Securities Exchange Act of 1934.   Yes   £     No   S
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter periods that the registrant was required to file such reports), and (2) has been subject to such reporting requirements for the past 90 days.   Yes   S     No   £
 
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).   Yes   £   No   £
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):
 
Large Accelerated Filer £                                         Accelerated Filer £                                          Non-Accelerated Filer    S
 
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
 
S U.S. GAAP
 
£ International Financial Reporting Standards as issued by the International Accounting Standards Board
 
£ Other
 
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.Item 17   £      Item 18   £
 
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes £       No S

 

 

TABLE OF CONTENTS
 
 
Page
INTRODUCTION
ii
   
FORWARD-LOOKING STATEMENTS
ii
   
PART I
1
Item 1. Identity of Directors, Senior Management and Advisers
1
Item 2. Offer Statistics and Expected Timetable
1
Item 3. Key Information
1
Item 4. Information on the Company
16
Item 4A. Unresolved Staff Comments
  36
Item 5. Operating and Financial Review and Prospects
  37
Item 6. Directors, Senior Management and Employees
  45
Item 7. Major Shareholders and Related Party Transactions
  55
Item 8. Financial Information
  56
Item 9. The Offer and Listing
  57
Item 10. Additional Information
  57
Item 11. Quantitative and Qualitative Disclosures about Market Risk
  69
Item 12. Description of Securities Other than Equity Securities
  69
   
PART II
 
Item 13. Defaults, Dividend Arrearages and Delinquencies
  70
Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds
  70
Item 15T. Controls and Procedures
  70
Item 16. Reserved
  71
Item 16A. Audit Committee Financial Expert
  71
Item 16B. Code of Ethics
  71
Item 16C. Principal Accountant Fees and Services
  71
Item 16D. Exemptions from the Listing Standards for Audit Committees
  71
Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers
  71
Item 16F. Change in Registrant s Certifying Accountant
72
Item 16G. Corporate Governance
72
   
PART III
 
Item 17. Financial Statements
  73
Item 18. Financial Statements
  73
Item 19. Exhibits
  73
   
SIGNATURE
  75
   
INDEX TO FINANCIAL STATEMENTS
F-1

 
i

 

INTRODUCTION
 
As used in this Annual Report on Form 20-F (hereinafter referred to as this “Annual Report”), references to “we”, “our”, “us”, “Rosetta” or the “Company” are references to Rosetta Genomics Ltd., a company organized under the laws of the State of Israel, and its subsidiaries.
 
Our consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP. Except as otherwise specified, financial information is presented in U.S. dollars. All references in this Annual Report to “U.S. dollars,” “dollars” or “$” are to United States dollars and all references in this Annual Report to “NIS” or “shekels” are to New Israeli Shekels.
 
FORWARD LOOKING STATEMENTS
 
This Annual Report contains forward looking statements. These forward looking statements include, in particular, statements about our plans, strategies and prospects and may be identified by terminology such as “may,” “will,” “should,” “expect,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “aim,” “potential,” or “continue” or the negative of those terms or other comparable terminology. These forward looking statements are subject to risks, uncertainties and assumptions about us. Although we believe that our plans, intentions and expectations are reasonable, we may not achieve our plans, intentions or expectations.
 
Important factors that could cause actual results to differ materially from the forward looking statements we make in this annual report are set forth in “Item 3. Key Information - D. Risk Factors.” All forward looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements in “Risk Factors,” in which we have disclosed the material risks related to our business. These forward looking statements involve risks and uncertainties, and the cautionary statements identify important factors that could cause actual results to differ materially from those predicted in any forward looking statements. We undertake no obligation to update any of the forward looking statements after the date of this Annual Report to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.
 
You should read this Annual Report and the documents that we reference in this Annual Report and have filed as exhibits to this Annual Report, that we have filed with the Securities and Exchange Commission (the “SEC”), completely and with the understanding that our actual future results, levels of activity, performance and achievements may be materially different from what we expect. We qualify all of our forward looking statements by these cautionary statements.

 
ii

 

PART I
 
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
 
Not Applicable.
 
ITEM 2.  OFFER STATISTICS AND EXPECTED TIMETABLE
 
Not Applicable.
 
ITEM 3.  KEY INFORMATION
 
A.  SELECTED CONSOLIDATED FINANCIAL DATA
 
We have prepared our historical consolidated financial statements in accordance with generally accepted accounting principles in the United States (U.S GAAP). The following financial data for the years ended December 31, 2006, 2007 and 2008, for the period from March 9, 2000 (date of inception) through December 31, 2008 and as of December 31, 2007 and 2008 have been derived from our audited financial statements which are included elsewhere in this Annual Report. The following financial data for the years ended December 31, 2004 and 2005 and as of December 31, 2004, 2005 and 2006 have been derived from our audited financial statements which are not included in this Annual Report. You should read this information in conjunction with our consolidated financial statements, including the related notes, and “Item 5. Operating and Financial Review and Prospects” included elsewhere in this Annual Report. Our historical results for any prior period are not necessarily indicative of results to be expected for any future period.
 
   
Year Ended December 31,
   
Period from
March 9, 2000
(date of
inception)
through
December 31,
 
   
2008
   
2007
   
2006
   
2005
   
2004
   
2008
 
   
(In thousands, except share and per share data)
 
Consolidated Statement of Income:
                                   
Revenues:
  $ 1,511     $ -     $ -     $ -     $ -     $ 1,511  
                                                 
Cost of revenues
    774       -       -       -       -       774  
Gross profit
    737       -       -       -       -       737  
                                                 
Consolidated Statements of Operations:
                                               
Operating expenses:
                                               
Research and development
    8,705       6,400       4,781       3,173       2,041       28,204  
Marketing and business development
    2,368       1,742       1,504       865       431       6,909  
General and administrative
    3,703       2,903       1,860       1,145       512       11,040  
Goodwill   impairment
    850       -       -       -       -       850  
Total operating expenses
    15,626       11,045       8,145       5,193       2,984       47,003  
Operating loss
    14,889       11,045       8,145       5,193       2,984       46,266  
Financial expenses (income), net
    (5,449 )     3,616       (538 )     660       (2 )     (1,334 )
Loss before tax income
    9,440       14,661       7,607       5,843       2,982       44,932  
Taxes on income
    23       -       -       -       -       23  
Net loss
  $ 9,463     $ 14,661     $ 7,607     $ 5,843     $ 2,982     $ 44,955  
Basic and diluted net loss per ordinary share
  $ 0.79     $ 1.32     $ 2.98     $ 2.35     $ 1.19          
Weighted average number of ordinary shares used to compute basic and diluted net loss per ordinary share
    12,038,295       11,142,149       2,551,860       2,495,366       2,462,603          

 
1

 
 
   
As of December 31,
 
   
2008
   
2007
   
2006
   
2005
   
2004
 
   
(In thousands)
 
Consolidated Balance Sheet Data:
                             
Cash and cash equivalents
  $ 14,454     $ 13,590     $ 5,228     $ 4,917     $ 1,514  
Short-term bank deposits
    840       112       5,149              
Marketable securities
    426       8,251       386             102  
Trade receivable
    502                          
Working capital
    14,059       20,385       11,141       3,645       969  
Total assets
    20,145       26,038       13,243       5,369       2,081  
Convertible loan
    750                   6,230        
Long-term liabilities
    1,547       568       601       122       42  
Total shareholders’ equity (deficiency)
    16,100       23,605       11,099       (2,323 )     1,291  
Capital stock     61,052       59,011       31,975       11,008       8,394  
 
B.  CAPITALIZATION AND INDEBTEDNESS
 
Not applicable.
 
C.  REASONS FOR THE OFFER AND USE OF PROCEEDS
 
Not applicable.
 
D.  RISK FACTORS
 
If any of the following risks occurs, our business, business prospects, financial condition, results of operations, or cash flows could be materially harmed.
 
Risks Related to Our Business, Our Financial Results and Need for Financing
 
The approach we are taking to discover and develop novel diagnostics and therapeutics is new and may never lead to commercially accepted products.
 
We have concentrated our efforts on research on diagnostics and therapeutics in the new field of microRNAs. To date we have commercialized only three diagnostic tests, miRview™ mets, miRview™ meso and miRview™ squamous.  To date, these tests have achieved very limited commercial success. The scientific discoveries that form the basis for our efforts to develop diagnostics and therapeutics are relatively new. The scientific evidence to support the feasibility of developing products based on these discoveries is limited. Further, our focus solely on developing microRNA-based diagnostics and therapeutics as opposed to multiple or more proven technologies for the development of diagnostics and therapeutics increases the risks associated with the ownership of our ordinary shares. We are currently devoting substantially all of our research and development efforts to the development of a minimally-invasive, blood-based colon cancer screening test. There are many risks involved in developing this test and there is no guarantee that we will be able to successfully develop this test in the time frame that we intend, or at all.  If we or a collaborative partner are not successful in developing any additional microRNA-based tests or products, including the colon cancer screening test, and commercializing new and existing microRNA-based tests or products, our business may fail.
 
Because we have a short operating history, there is a limited amount of information about us upon which our business and prospects can be evaluated.
 
Our operations began in 2000 and we have only a limited operating history upon which our business and prospects can be evaluated. In addition, as an early-stage company, we have limited experience and have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biotechnology area. For example, to execute our business plan, we will need to successfully:
 
 
·
build and maintain a strong intellectual property portfolio;
 
 
·
execute development activities using an unproven technology;
 
 
·
execute marketing and distribution activities;
 
 
·
continue to develop and maintain successful strategic relationships;
 
 
2

 

 
·
manage our spending while costs and expenses increase as we expand our efforts to discover, develop and commercialize diagnostics and therapeutics based on microRNAs; and
 
 
·
gain regulatory and commercial acceptance of our tests and products.
 
If we are unsuccessful in accomplishing these objectives, we may not be able to raise capital, develop tests or products, expand our business or continue our operations.
 
We have a history of losses and may never be profitable.
 
We have experienced significant operating losses since our inception in 2000, and as of December 31, 2008, we had an accumulated deficit of $45.0 million. We had a net loss of $9.5 million for the year ended December 31, 2008. Furthermore, we do not expect to generate any significant revenues from the sale of diagnostics or therapeutics in the near future. We expect our annual operating losses to increase over the next several years as we expand our efforts to discover, develop and commercialize diagnostics and therapeutics based on microRNAs. We anticipate that the majority of any revenues we generate over the next several years will be from our existing and future collaborations and licensing arrangements and the sale of diagnostic tests using our microRNA technology, including our currently marketed tests that may be commercialized. We cannot be certain, however, that our existing collaborations will be successful or that we will be able to secure any collaborations or achieve any milestones that may be required to receive payments or that diagnostic tests based on our technologies, including our currently marketed tests, will achieve market acceptance. If we are unable to secure significant revenues from collaborations and the sale of tests or products, we may be unable to continue our efforts to discover, develop and commercialize microRNA-based diagnostics and therapeutics without raising additional funds from other sources.
 
We will require substantial additional funds to complete our research and development activities and, if additional funds are not available, we may need to significantly scale back or cease our operations.
 
We have used substantial funds to discover, develop and protect our microRNA tests and technologies and will require substantial additional funds to conduct further research and development, including any required preclinical testing and clinical trials of any diagnostic test or therapeutic product, and to manufacture and market any tests or products that are approved for commercial sale. Because the successful development and commercialization of microRNA-based diagnostics and therapeutics is uncertain, we are unable to estimate the actual funds we will require to develop, obtain required regulatory approval and commercialize them. The timing of our need for additional funds will depend on a number of factors, many of which are difficult to predict or are outside of our control, including:
 
 
·
progress in our research and development programs, in particular our program to develop a non-invasive, blood-based colon cancer screening test;
 
 
·
the resources, time and costs required to initiate and complete development and any required preclinical studies and clinical trials, and obtain any required regulatory approvals;
 
 
·
the timing, receipt, and amount of milestone, royalty and other payments from present and future collaborators, if any;
 
 
·
costs necessary to protect our intellectual property; and
 
 
·
the timing, receipt and amount of sales, if any, by us of any approved tests or products.
 
If our estimates and predictions relating to these factors are incorrect, we may need to modify our operating plan. We will be required to seek additional funding in the future and intend to do so through collaborative arrangements and public or private equity offerings and debt financings. However, additional funds may not be available to us when needed on acceptable terms, or at all. In addition, the terms of any financing may adversely affect the holdings or the rights of our existing shareholders. For example, if we raise additional funds by issuing equity securities, further dilution to our then-existing shareholders may result. Debt financing, if available, may involve restrictive covenants that could limit our flexibility in conducting future business activities. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail one or more of our research or development programs. We also could be required to seek funds through arrangements with collaborators or others that may require us to relinquish rights to some of our technologies, tests or products in development or approved tests or products that we would otherwise pursue on our own.
 
Continuing unfavorable United States and global economic conditions could have a material adverse effect on our business, operating results and financial condition.
 
The recent crisis in the financial and credit markets in the United States, Europe and Asia has led to a global economic slowdown, with the economies of the United States and Europe showing significant signs of weakness.  If the economies in any part of the world continue to be weak or weaken further, the demand for our tests and technology may decrease as a result of continued constraints on capital spending by our customers. This would likely harm our business, operating results and financial condition.  If global economic and market conditions, or economic conditions in the United States, Europe or Asia or other key markets, remain uncertain, persist, or deteriorate further, our business, operating results and financial condition may be materially adversely affected.
 
Fluctuations in currency exchange rates of the New Israeli Shekel vs. the U.S. dollar may have a significant impact on our reported results of operations.
 
Fluctuations in currency exchange rates may have a significant impact on our reported results of operations. Although our reporting currency is the U.S. dollar, significant portions of our expenses are denominated in New Israeli Shekels, or NIS. In periods when the U.S. dollar is devalued against the NIS, our reported results of operations may be adversely affected.  In addition, fluctuations in currencies may result in valuation adjustments in our assets and liabilities which could affect our reported results of operations.

 
3

 

Risks Related to Our Intellectual Property
 
If we are not able to obtain and enforce patent protection for our discoveries, our ability to develop and commercialize microRNA-based diagnostics and therapeutics will be harmed.
 
Our success depends, in large part, on our ability to protect proprietary methods and technologies that we develop under the patent and other intellectual property laws of the U.S., Israel and other countries, so that we can prevent others from unlawfully using our inventions and proprietary information. As of June 10, 2009, our patent portfolio included a total of two issued U.S. patents, 80 pending patent applications worldwide, consisting of 43 U.S. patent applications, five of which received notice of allowance, 14 PCT applications, six applications that were nationalized in Europe, five applications nationalized in Israel, three applications nationalized in Japan and Australia, and two applications that were nationalized in Canada, China and India. There can be no assurance, however, that any of these pending patent applications will result in issued patents. The patent position of pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves complex legal and factual considerations. The standards that the U.S. Patent and Trademark Office, or PTO, and its foreign counterparts use to grant patents are not always applied predictably or uniformly and may change. There is also no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents. Furthermore, the field of microRNAs is new and developing. Accordingly, there is significant uncertainty about what patents will be issued, and what their claims may cover. It is likely that there will be significant litigation and other proceedings, such as interference proceedings and opposition proceedings, in certain patent offices, relating to patent rights in the microRNA field. Others may attempt to invalidate our intellectual property rights. Even if our rights are not directly challenged, disputes among third parties could lead to the weakening or invalidation of our intellectual property rights. Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others. Additionally, the mere issuance of a patent does not guarantee that it is valid or enforceable, so even issued patents may not be valid or enforceable against third parties.
 
In addition, we cannot be certain that we hold the rights to the technology covered by our pending patent applications or to other proprietary technology required for us to commercialize our proposed tests and products. Because certain U.S. patent applications are confidential until patents issue, such as applications filed prior to November 29, 2000, or applications filed after this date which will not be filed in foreign countries, third parties may have filed patent applications for technology covered by our pending patent applications without our being aware of those applications, and our patent applications may not have priority over those applications. For this and other reasons, we may be unable to secure desired patent rights, thereby losing desired exclusivity. Thus, it is possible that one or more organizations will hold patent rights to which we will need a license. If those organizations refuse to grant us a license to such patent rights on reasonable terms, we will not be able to market our tests and products.
 
If we become involved in patent litigation or other proceedings related to a determination of rights, we could incur substantial costs and expenses, substantial liability for damages or be required to stop our development and commercialization efforts.
 
A third party may sue us for infringing its patent rights. Likewise, we may need to resort to litigation to enforce a patent issued or licensed to us or to determine the scope and validity of third-party proprietary rights. In addition, a third party may claim that we have improperly obtained or used its confidential or proprietary information. The cost to us of any litigation or other proceeding relating to intellectual property rights, even if resolved in our favor, could be substantial, and the litigation would divert our management’s efforts. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources, and we may not have sufficient resources to adequately enforce our intellectual property rights. Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue our operations.
 
If we are found to infringe upon intellectual property rights of third parties, we could be forced to pay damages, potentially including treble damages, if we are found to have willfully infringed on such parties’ patent rights. In addition to any damages we might have to pay, a court could require us to stop the infringing activity or obtain a license. We are aware of a U.S. patent application, a license to which may become necessary in the future for one or more of our tests. Although we believe that we can design our tests around this patent application if a valid patent is issued, we are currently in the process of negotiating a license for this patent. However, we can provide no assurance that such a license or any license required under any other patent will be made available on commercially acceptable terms, if at all. In addition, such licenses may be non-exclusive and, therefore, our competitors may have access to the same technology licensed to us. If we fail to obtain a required license and are unable to design around a patent, we may be unable to effectively market some of our technology, tests and products, which could limit our ability to generate revenues or achieve profitability and possibly prevent us from generating revenues sufficient to sustain our operations. Moreover, we expect that a number of our collaborations will provide that royalties payable to us for licenses to our intellectual property may be offset by amounts paid by our collaborators to third parties who have competing or superior intellectual property positions in the relevant fields, which could result in significant reductions in our revenues from tests or products developed through collaborations.

 
4

 

We license patent rights 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.
 
We are a party to license agreements that give us rights to third-party intellectual property that we believe may be necessary or useful for our business, such as our agreements with The Rockefeller University, Max Planck Innovation GmbH, or Max Planck, and Johns Hopkins University. We intend to enter into additional licenses of intellectual property with third parties in the future. Our success will depend in part on the ability of our licensors to obtain, maintain and enforce patent protection for our licensed intellectual property, in particular, those patents to which we have secured exclusive rights. Our licensors may not successfully prosecute the patent applications which we have licensed. Even if patents issue in respect of these patent applications, our licensors may fail to maintain these patents, may determine not to pursue litigation against other companies that are infringing these patents, or may pursue such litigation less aggressively than we would. Without protection for the intellectual property we license, other companies might be able to offer substantially identical tests or products for sale, which could adversely affect our competitive business position and harm our business prospects. Under our license agreements with The Rockefeller University, if Rockefeller University fails to enforce the patents we licensed, we have the right to enforce the patents and pursue litigation against any infringement of such patents. Under our license agreement with Max Planck for diagnostic purposes, we have the responsibility to assist in the prosecution of any patent infringement actions undertaken by Max Planck. Under our license agreement with Max Planck for research purposes, Max Planck controls the filing, prosecution, maintenance and abandonment of all patents. Under our agreement with Johns Hopkins University, Johns Hopkins is responsible for prosecution and maintenance of patents, and we have the right but not the obligation to enforce the patents against any infringement by third parties.
 
If we fail to comply with our obligations under any licenses or related agreements, we could lose license rights that may be necessary for developing microRNA-based diagnostics and therapeutics.
 
Our current licenses impose, and any future licenses we enter into are likely to impose, various development, commercialization, funding, royalty, diligence, sublicensing, insurance and other obligations on us. Such obligations may include:
 
 
·
royalty payments;
 
 
·
annual maintenance fees;
 
 
·
payment of fees relating to patent prosecution, maintenance and enforcement;
 
 
·
maintaining insurance coverage; and
 
 
·
using commercially reasonable efforts to develop tests and products using the licensed technology.
 
If we breach any of our obligations under our licenses, the licensor may have the right to terminate the license, which could result in our being unable to develop, manufacture and sell tests or products that are covered by the licensed technology or a competitor’s gaining access to the licensed technology.
 
Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information.
 
We also rely on trade secrets, know-how and technology, which are not protected by patents, to maintain our competitive position. In order to protect our proprietary technology and processes, we also rely in part on confidentiality agreements with our collaborators, employees, consultants, outside scientific collaborators and sponsored researchers and other advisors. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover trade secrets and proprietary information, and in such cases we could not assert any trade secret rights against such party. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.
 
Risks Related to Development, Clinical Testing and Regulatory Approval of Diagnostics and Therapeutics
 
We, our collaborators and third-party licensees developing diagnostic tests applying our microRNA technology are subject to a variety of regulatory frameworks.
 
We, our collaborators and third-party licensees developing diagnostic tests applying our microRNA technology are subject to a variety of regulatory laws enforced by both the federal government and the states in which they, and we conduct, or will conduct, business, including the Clinical Laboratory Improvement Amendments of 1988, or CLIA, and state clinical laboratory licensure laws and regulations, and the Federal Food, Drug, and Cosmetic Act and related regulations.

 
5

 

The growth of our business may increase the potential of violating these laws. The risk of us, our collaborators or third-party licensees being found in violation of these laws and regulations is further increased by the fact that many of these laws and regulations have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Any action brought against us, or any business partners, for violation of these laws or regulations, even if we or they successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If their or our operations are found to be in violation of any of these laws and regulations, they or we may be subject to any applicable penalty associated with the violation, including civil and criminal penalties, damages and fines, and they or we could be required to curtail or cease operations. Any of the foregoing consequences could seriously harm our business and our financial results.
 
If we do not comply with governmental regulations applicable to our CLIA-certified laboratory, we may not be able to continue our operations.
 
The establishment and operation of our laboratory in Philadelphia, as well as our ongoing research and development activities occurring in this laboratory, are subject to regulation by numerous federal, state and local governmental authorities in the United States. The laboratory holds a CLIA certificate of compliance and is licensed by the state of Pennsylvania, which enables us to provide testing services to residents of most other states.  We have also obtained licenses from California, Maryland and Rhode Island, and plan to obtain licenses from other states as required.
 
Failure to maintain state regulatory compliance, or changes in state regulatory schemes, could result in a substantial curtailment or even prohibition of the operations of our laboratory and could have a material adverse effect on our business. CLIA is a federal law that regulates clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease. To renew CLIA certification, laboratories are subject to survey and inspection every two years. Moreover, CLIA inspectors may make random inspections of these laboratories. If we were to lose our CLIA certification or our state licenses, whether as a result of a revocation, suspension or limitation, we would no longer be able to continue our testing operations which would have a material adverse effect on our business.

Any diagnostic tests that may be developed by us or others using our microRNA technology may be subject to regulatory approval, which can be lengthy, costly and burdensome.
 
Clinical laboratory tests that are developed and validated by a CLIA–certified laboratory for its own use are known as laboratory developed tests, or LDTs.  Our currently marketed tests were launched as LDTs by our CLIA–certified clinical laboratory operating in Philadelphia, Pennsylvania. We expect that our future LDTs will be launched as well at our CLIA-certified laboratory. While in vitro diagnostic tests and test kits that are sold and distributed through interstate commerce are subject to clearance or approval by the U.S. Food and Drug Administration, or FDA, most LDTs currently are not subject to this type of FDA regulation.  While we believe that our currently marketed tests and our future LDTs should not be subject to regulation under current FDA policies, these policies may change which may result in these tests becoming subject to more extensive FDA regulation.
 
Although our currently marketed tests were, and future clinical laboratory tests applying our microRNA technology are being, developed as LDTs regulated under CLIA and state laboratory laws, these tests may fall under more extensive FDA regulation in the future.  In September 2006, the FDA issued draft guidance on a new class of tests called “In Vitro Diagnostic Multivariate Index Assays,” or IVDMIAs. Under this draft guidance, some LDTs, including our currently marketed tests and other tests that may be developed by applying our microRNA technology, may be determined to be IVDMIAs and could be classified as Class II or Class III medical devices, which would require FDA pre-market review or approval depending upon intended use and on the level of control necessary to assure the safety and effectiveness of the test.  In July 2007, the FDA posted revised draft guidance on IVMDIAs that includes an 18-month transition. The comment period for this revised guidance expired in October 2007, and it is not clear whether or when FDA will finalize this draft guidance.
 
We cannot provide any assurance that FDA regulation, including pre-market review or approval, will not be required in the future for LDTs applying our microRNA technology. If pre-market review or approval is required, our business could be negatively impacted because our CLIA-certified laboratory and other CLIA-certified laboratories offering LDTs based on our microRNA technology may be required to stop offering these LDTs pending pre-market clearance or approval.

 
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Diagnostic tests based on our microRNA technology may require clinical trial testing, which can be lengthy, costly and burdensome.
 
If the FDA decides to require pre-market clearance or approval of tests based on our microRNA technology, it may require us to perform clinical trials prior to submitting a regulatory marketing application. If we or laboratories licensing our microRNA technology are required to conduct pre-market clinical trials, whether using prospectively acquired samples or archival samples, delays in the commencement or completion of clinical testing could significantly increase development costs and delay commercialization. The commencement of clinical trials may be delayed due to insufficient patient enrollment, which is a function of many factors, including the size of the patient population and the nature of the disease or condition being studied.
 
It also may be necessary to engage contract research organizations, or CROs, to perform data collection and analysis and other aspects of these clinical trials, which might increase the cost and complexity.
 
We may be unable to obtain regulatory approval of any therapeutic product that we or a collaborator may develop.
 
Any therapeutic product that we or our collaborators may develop will be subject to extensive governmental regulations relating to development, clinical trials, manufacturing and commercialization. Rigorous preclinical testing and clinical trials and an extensive regulatory review process are required to be successfully completed in the United States and in many foreign jurisdictions before a new therapeutic product can be sold. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays. The time required to obtain FDA and other approvals for therapeutic products is unpredictable but typically exceeds several years. It is possible that none of the therapeutic products we or our collaborators may develop will obtain the appropriate regulatory approvals necessary for us or our collaborators to begin selling them.
 
Furthermore, the FDA has not yet established any definitive policies, practices or guidelines in relation to the newly discovered class of therapeutic products we seek to develop. The lack of such policies, practices or guidelines may hinder or slow review by the FDA of any regulatory filings that we or our collaborators may submit. Moreover, the FDA may respond to these submissions by defining requirements we may not have anticipated. Such responses could lead to significant delays in the development of therapeutic products. Any delay or failure in obtaining required approvals could have a material adverse effect on our ability to generate revenues from a particular therapeutic product.
 
Furthermore, any regulatory approval to market a therapeutic product may be subject to limitations on the indicated uses. These limitations may limit the size of the market for the therapeutic product. Any therapeutic product that we or our collaborators may develop will also be subject to numerous foreign regulatory requirements governing the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process includes all of the risks associated with FDA approval described above as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions. Therefore, approval by the FDA of a therapeutic product does not assure approval by regulatory authorities outside the United States or vice versa.
 
We have no experience in conducting, managing or sponsoring clinical trials for potential therapeutic products.
 
We have no experience in conducting and managing the clinical trials necessary to obtain regulatory approvals for any therapeutic product, and we intend to rely on third parties such as CROs, medical institutions and clinical investigators to perform these functions.  Our reliance on third parties for clinical development activities reduces our control over these activities.  Third-party contractors may not complete activities on schedule, or may not conduct clinical trials in accordance with regulatory requirements or our trial design. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we might be required to replace them, which may result in a delay of the affected trial.
 
If we or our collaborators, or any third-party manufacturers with which we may enter into agreements in the future, fail to comply with regulatory requirements, we or they could be subject to enforcement actions, which could affect our ability to market and sell microRNA-based diagnostics and therapeutics and may harm our reputation.
 
If we or our collaborators, or any third-party manufacturers with which we may enter into agreements in the future fail to comply with applicable federal, state or foreign laws or regulations, we could be subject to enforcement actions, which could affect the ability to successfully develop, market and sell diagnostic tests or therapeutic products using our microRNA technology and could harm our reputation and lead to reduced acceptance of such tests or products by the market. These enforcement actions include:
 
 
·
warning letters;
 
 
·
recalls, public notification or medical product safety alerts;
 
 
·
restrictions on, or prohibitions against, marketing such tests or products;
 
 
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·
restrictions on importation of such tests or products;
 
 
·
suspension of review or refusal to approve new or pending applications;
 
 
·
withdrawal of product approvals;
 
 
·
product seizures;
 
 
·
injunctions;
 
 
·
civil and criminal penalties and fines; and
 
 
·
debarment or other exclusions from government programs.
 
If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
 
Our research and development activities involve the use of hazardous and chemicals materials, and we maintain quantities of various flammable and toxic chemicals in our facilities in Israel and the United States. We believe our procedures for storing, handling and disposing these materials in our Israel and U.S. facilities comply with the relevant guidelines of the State of Israel and the United States. Although we believe that our safety procedures for handling and disposing of these materials comply with the standards mandated by applicable regulations, the risk of accidental contamination or injury from these materials cannot be eliminated.  If an accident occurs, we could be held liable for resulting damages, which could be substantial. We are also subject to numerous environmental, health and workplace safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and the handling of biohazardous materials. We may incur substantial costs to comply with, and substantial fines or penalties if we violate, any of these laws or regulations.
 
Risks Related to Competition and Commercialization
 
The intensely competitive biotechnology market could diminish demand for our tests and products.
 
The biopharmaceutical market is intensely competitive and rapidly changing.  Many diagnostic, pharmaceutical and biotechnology companies, academic institutions, governmental agencies and other public and private research organizations are pursuing the research of technologies and development of novel diagnostic tests and therapeutic products for the same diseases that we, our collaborators, or third-party licensees are targeting or expect to target. We and they will face intense competition from tests and products that have already been approved and accepted by the medical community for the diseases for which we or they may develop tests or products. We, our collaborators, or third-party licensees also expect to face competition from new tests or products that enter the market. We believe a significant number of tests and products are currently under development, and may become commercially available in the future, for the diseases for which we our collaborators, or third-party licensees may try to develop tests and products. In addition to the competition we face from existing tests and products in development, we, our collaborators, or third-party licensees also face competition from other companies working to develop novel tests and products using technology that competes more directly with our microRNA technologies. We are aware of several other companies that are working to develop microRNA-based diagnostics and therapeutics, including Combimatrix Corporation, Alnylam Pharmaceuticals, Inc., Asuragen, the Celera Group of Applera Corporation, Exiqon A/S, Invitrogen Corporation, Isis Pharmaceuticals, Merck & Co., Inc., Santaris Pharma A/S, Sirna Therapeutics, Inc., Regulus Therapeutics and others. Any of these companies may develop microRNA-based tests or products more rapidly and more effectively than we or our collaborators will.  If we are unable to compete effectively with existing tests and products, new treatment methods and new technologies, we, our collaborators or third-party licensees may be unable to commercialize any diagnostic tests or therapeutic products that we or they develop.
 
Many of our competitors have:
 
 
·
much greater financial, technical and human resources than we have at every stage of the discovery, development, manufacture and commercialization process;
 
 
·
more extensive experience in preclinical testing, conducting clinical trials, obtaining regulatory approvals, and in manufacturing and marketing diagnostics and therapeutics;
 
 
·
tests or products that have been approved or are in late stages of development; and
 
 
·
collaborative arrangements in our target markets with leading companies and research institutions.
 
Our competitors may develop or commercialize tests or products with significant advantages over any diagnostic tests or therapeutic products we, our collaborators or third-party licensees may develop. Our competitors may therefore be more successful in commercializing their tests and products than we, our collaborators, or third party licensees are, which could adversely affect our competitive position and business.

 
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Reimbursement for microRNA-based diagnostics and therapeutics may be difficult to obtain and maintain at levels consistent with our business plans.
 
Physicians and patients may decide not to order our tests or products unless third-party payors, such as managed care organizations, as well as government payors, such as Medicare and Medicaid, pay all or a substantial portion of the price. In addition, there is significant uncertainty concerning third-party reimbursement of any test or product incorporating new technology, including tests or other products applying our microRNA technology. Reimbursement by a third-party payor may depend on a number of factors, including a payor’s determination that diagnostics or therapeutics using our microRNA technology are:
 
 
·
not experimental or investigational,
 
 
·
medically necessary,
 
 
·
appropriate for the specific patient,
 
 
·
cost-effective, and
 
 
·
supported by peer-reviewed publications.
 
Since each payor makes its own decision as to whether to establish a policy to cover LDTs, and may establish a policy regarding new technologies, seeking these approvals is a time-consuming and costly process. To date, we have not been paid by any third-party payors for any test applying our microRNA technology. We cannot be certain that coverage or adequate payments for any of diagnostic tests applying our microRNA technology or for any therapeutic products will be available in the future or that the amounts paid for any of our tests or products will be adequate.
 
The market may not be receptive to any diagnostic tests or therapeutic products using our microRNA technology upon their commercial introduction.
 
Any diagnostic tests or therapeutic products using our microRNA technology that we, our collaborators or third-party licensees have developed or are developing are based upon new technologies or diagnostic or therapeutic approaches. Key participants in pharmaceutical marketplaces, such as physicians, third-party payors and consumers, may not accept a microRNA-based approach. As a result, it may be more difficult for us, our collaborators or third-party licensees to convince the medical community and third-party payors to accept and use such tests and products. Other factors that we believe will materially affect market acceptance of diagnostic tests or therapeutic products using our microRNA technology include:
 
 
·
the timing of any marketing approvals, the terms of any approvals and the countries in which approvals are obtained;
 
 
·
the success of physician education programs;
 
 
·
the availability of alternative diagnostics and therapeutics; and
 
 
·
the pricing of such tests or products, particularly as compared to alternatives.
 
Risks Related to Our Dependence on Third Parties
 
We are largely dependent upon Prometheus and Teva for the success of commercialization of our three current diagnostic tests, miRview™ mets, miRview™ meso and miRview™ squamous.
 
In April 2009, we entered into a license and collaboration agreement with Prometheus Laboratories Inc. pursuant to which Prometheus has the exclusive right to develop and commercialize miRview™ mets, miRview™ meso and miRview™ squamous tests in the United States.  In addition, in December 2008, we entered into an agreement with Teva Pharmaceutical Industries Ltd., pursuant to which Teva has the exclusive right to commercialize these tests in Turkey and Israel. Accordingly, we are largely dependent upon Prometheus and Teva for the commercial success of these tests.
 
The potential revenues from these agreements consist of contingent payments, including milestone and royalty payments.  These payments will depend upon our collaborators’ ability to devote the necessary resources to successfully commercialize these tests. In addition, if either Prometheus or Teva were to breach or terminate its agreement with us, the commercialization of these tests could be adversely affected because we may not have sufficient financial resources or capabilities to successfully commercialize these tests on our own or find other partners. Under our agreement with Prometheus, Prometheus can terminate the agreement (either entirely or as to one or more licensed tests) by providing six months’ written notice to us.

 
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If Prometheus or Teva does not devote sufficient time and resources to the collaboration or if either collaboration is breached or terminated, we may not realize the potential commercial benefits of the arrangement, and our results of operations may be adversely affected.
 
We face a number of risks related to our license and collaboration arrangement with Prometheus.
 
In addition to the risks described above relating to our dependence on Prometheus for the commercialization of certain diagnostic tests in the United States, we face some additional risks relating to our agreement with Prometheus.  Under the terms of the agreement, we have agreed not to participate in the commercialization of any directly competitive diagnostic tests in the United States.  We share decision making authority with Prometheus with respect to all matters pertaining to the development of diagnostic tests by Rosetta outside the United States that would affect the tests licensed to Prometheus inside the United States, which could potentially include certain regulatory and development matters. If Prometheus or we become aware of third party patents that could block the commercialization of the licensed diagnostic tests in the United States, we may be required either to modify the tests to avoid potential infringement or obtain, or assist Prometheus in obtaining, a patent license.  Prometheus may be permitted to reduce its royalty payments to us if Prometheus must make payments to a third party in connection with the licensed diagnostic tests.
 
We may not be able to execute our business strategy if we are unable to enter into additional collaborations with other companies that can provide capabilities and funds for the development and commercialization of our microRNA-based diagnostics and therapeutics.
 
We have limited capabilities for sales, marketing, distribution and product development, including obtaining regulatory approval of therapeutic products. Accordingly, we may enter into additional collaborations with pharmaceutical, biotechnology or diagnostic companies to jointly develop specific tests or products and to jointly commercialize them if they are approved. In such collaborations, we would expect our collaborators to provide substantial capabilities in clinical development, regulatory affairs, marketing and sales. While such agreements could provide us with an opportunity to develop and commercialize tests and products, they may necessitate a reliance on our collaboration partner in numerous aspects of the research and development, regulation, manufacturing, marketing and sales of these tests and products. We may not be successful in entering into any additional collaborations on favorable terms or maintaining any such collaborations into which we enter.  In addition, while such agreements would provide us with opportunities, they would also require us to share the down-stream profits with our collaborators, thereby reducing our ability to fully capitalize on sales.
 
If any collaborator terminates or fails to perform its obligations under agreements with us, the development and commercialization of our tests and products could be delayed or terminated.
 
Our expected dependence on collaborators for certain capabilities and funding means that our business would be adversely affected if any collaborator terminates its collaboration agreement with us or fails to perform its obligations under that agreement. Our current or future collaborations, if any, may not be scientifically or commercially successful. Disputes may arise in the future with respect to the ownership of rights to tests or products developed with collaborators, which could have an adverse effect on our ability to develop and commercialize any affected test or product. If a collaborator terminates its collaboration with us, for breach or otherwise, it would be difficult for us to attract new collaborators and it could adversely affect how we are perceived in the business and financial communities. In addition, a collaborator could determine that it is in its financial interest to:
 
 
·
pursue alternative technologies or develop alternative tests or products, either on its own or jointly with others, that may be competitive with the tests or products on which it is collaborating with us or which could affect its commitment to the collaboration with us;
 
 
·
pursue higher priority programs or change the focus of their development programs, which could affect the collaborator’s commitment to us; or
 
 
·
if it has marketing rights and obligations, choose to devote fewer resources to the marketing of our tests or products, than they do for tests or products of their own development, or of their co-development with third parties.
 
If any of these occur, we may not have sufficient financial resources or capabilities to continue the development and commercialization of such test or product on our own.

 
10

 

We rely on third parties for tissue samples and other materials required for our research and development activities and if we are unable to reach agreements with these third parties our research and development activities would be delayed.
 
We rely on third parties, primarily hospitals, health clinics and academic institutions, for the provision of tissue samples and other materials required in our research and development activities. Obtaining these materials requires various approvals as well as reaching a commercial agreement on acceptable terms with the hospital or other provider of the materials. We may not be able to reach agreements with a sufficient number of suppliers or do so on terms acceptable to us. If we are unable to reach acceptable agreements with a sufficient number of suppliers of research materials, our research and development activities will be delayed and our ability to implement our business plan will be compromised.
 
We currently have limited sales, marketing or distribution experience and may depend significantly on third parties to commercialize microRNA-based diagnostic tests or therapeutic products we may develop.
 
We currently have limited sales, marketing or distribution experience. We will need to rely on our collaborators or other third parties (including Teva and Prometheus) to commercialize our current tests and any future LDTs we may develop, or we will need to internally develop such capabilities. We have limited control over the sales, marketing and distribution activities of our collaborators, and our future revenues will depend on the success of the efforts of our collaborators. To develop internal sales, distribution and marketing capabilities, we will have to invest significant amounts of financial and management resources, and we will face a number of additional risks, including:
 
 
·
we may not be able to attract and build a significant marketing or sales force;
 
 
·
the cost of establishing a marketing or sales force may not be justifiable in light of the revenues generated by any particular test or product; and
 
 
·
our direct sales and marketing efforts may not be successful.
 
Risks Related to Our Operations
 
If we are unable to attract and retain qualified key management and scientists, staff consultants and advisors, our ability to implement our business plan may be adversely affected.
 
We are highly dependent upon certain of our senior management and scientific staff. The loss of the service of these persons may significantly delay or prevent our achievement of product development and other business objectives. Our employment agreements with our key personnel are terminable by the employee at any time with notice. Additionally, although we have generally been successful in our recruiting efforts, we face intense competition for qualified individuals from numerous pharmaceutical and biotechnology companies, universities, governmental entities and other research institutions. We may be unable to attract and retain suitably qualified individuals, and our failure to do so could have an adverse effect on our ability to implement our business plan.
 
We may have difficulty managing our growth and expanding our operations successfully as we seek to evolve from a company primarily involved in discovery into one that develops and commercializes microRNA-based diagnostic tests and therapeutic products.
 
We will need to expand our development, regulatory, manufacturing, marketing and sales capabilities or enter into strategic collaborations or contract with other organizations to provide these capabilities for us. As our operations expand, we expect that we will need to manage additional relationships with various collaborators, suppliers and other organizations. Our ability to manage our operations and growth will require us to continue to improve our operational, financial and management controls, reporting systems and procedures in at least two different countries. We may not be able to implement improvements to our management information and control systems in an efficient or timely manner and may discover deficiencies in existing systems and controls.
 
There is a substantial risk of product liability claims in our business. If we are unable to obtain sufficient insurance, a product liability claim against us could adversely affect our business.
 
Our business exposes us to significant potential product liability risks that are inherent in the development, manufacturing and marketing of diagnostics and therapeutics. Product liability claims could delay or prevent completion of our clinical development programs. We currently have insurance for our cancer programs covering liability in an amount up to $1 million per incident and up to $3 million in the aggregate. We also have product liability insurance covering our current commercial tests in an amount up to $5 million in the aggregate. We plan to obtain insurance for all research programs at appropriate levels prior to initiating any required clinical trials and at higher levels prior to marketing any new tests or approved therapeutic products. Any insurance we obtain may not provide sufficient coverage against potential liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused by product liability claims that could have a material adverse effect on our business.

 
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If we are unable to manage the challenges associated with our international operations, the growth of our business could be limited.
 
In addition to our operations in Rehovot, Israel, our wholly owned subsidiary, Rosetta Genomics Inc., operates an office in Jersey City, New Jersey, and our CLIA-certified laboratory in Philadelphia, Pennsylvania. We are subject to a number of risks and challenges that specifically relate to these international operations. Our international operations may not be successful if we are unable to meet and overcome these challenges, which could limit the growth of our business and may have an adverse effect on our business and operating results. These risks include:
 
 
·
fluctuations in foreign currency exchange rates that may increase the U.S. dollar cost of our international operations;
 
 
·
difficulty managing operations in multiple locations, which could adversely affect the progress of our development programs and business prospects;
 
 
·
local regulations that may restrict or impair our ability to conduct pharmaceutical and biotechnology-based research and development;
 
 
·
foreign protectionist laws and business practices that favor local competition;
 
 
·
failure of local laws to provide the same degree of protection against infringement of our intellectual property, which could adversely affect our ability to develop tests or products or reduce future product or royalty revenues, if any, from tests or products we may develop;
 
 
·
laws and regulations governing U.S. immigration and entry into the United States that may restrict free movement of our employees between Israel and the United States; and
 
 
·
laws and regulations governing U.S. immigration and entry into the United States that may restrict employment of Israeli citizens in our U.S. facilities.
 
We are exposed to risks relating to evaluations of controls required by Section 404 of the Sarbanes-Oxley Act of 2002.
 
Under the current rules of the SEC, we are now required to comply with the management assessment of internal control over financial reporting requirement of Section 404 of the Sarbanes-Oxley Act of 2002. We have evaluated our internal control systems to allow management to report on our internal control over financial reporting. We have not identified any internal control deficiencies that constitute a “material weakness” under applicable SEC and Public Company Accounting Oversight Board rules and regulations or that otherwise would materially affect internal controls over financial reporting. A “material weakness” is a control deficiency, or combination of control deficiencies that results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected. We cannot guarantee that we or our auditors will not identify material weaknesses or significant control deficiencies in the future. Any failure to maintain or implement required new or improved controls, or any difficulties we encounter in their implementation, could result in significant deficiencies or material weaknesses and cause us to fail to meet our periodic reporting obligations or result in material misstatements in our financial statements, which in turn could lead to a decline in our stock price. Any such failure could also adversely affect the results of periodic management evaluations and annual auditor attestation reports regarding the effectiveness of our internal control over financial reporting.
 
Risks Related to Israeli Law and Our Operations in Israel
 
For the years ended December 31, 2006 and 2007, we were a passive foreign investment company, or PFIC, for U.S. federal income tax purposes, and there may be negative tax consequences for holders of our ordinary shares who are U.S. residents and do not make certain timely tax elections.
 
We are deemed to be a passive foreign investment company, or PFIC, if 75% or more of our gross income in a taxable year, including our pro rata share of the gross income of any company, U.S. or foreign, in which we are considered to own, directly or indirectly, 25% or more of the shares by value, is passive income. Alternatively, we are also deemed to be a PFIC if at least 50% of our assets in a taxable year, averaged over the year and ordinarily determined based on fair market value, including our pro rata share of the assets of any company in which we are considered to own, directly or indirectly, 25% or more of the shares by value, are held for the production of, or produce, passive income. We believe that we were a PFIC in 2003, but not in 2004 or 2005. We were a PFIC in 2006 and 2007. We believe that we should not be treated as a PFIC for 2008. We nevertheless recognize that there are significant areas of uncertainty in the PFIC rules, and the IRS may not agree with our belief. Accordingly, for any U.S. shareholders who held our ordinary shares during 2006 or 2007, or holds shares in any subsequent year that we are deemed a PFIC that does not make an election to treat us as a “qualified electing fund,” or QEF, or make a “mark-to-market” election, then “excess distributions” to a U.S. shareholder, and any gain recognized by a U.S. shareholder on a disposition of our ordinary shares, would be taxed in an unfavorable way. Among other consequences, “excess distributions” and gains on a disposition of our ordinary shares would be taxed at the highest rates applicable to ordinary income, rather than the potential 15% maximum rate applicable to certain dividends received by an individual from a qualified foreign corporation and to long-term capital gais to non-corporate taxpayers. PFIC status is determined annually and cannot be definitively determined until the close of the year in question. In addition, if the U.S. Internal Revenue Service determines that we are a PFIC for a year with respect to which we have determined that we were not a PFIC, it might be too late for a U.S. shareholder to make a timely QEF or mark-to-market election. U.S. shareholders who held or hold ordinary shares during a period when we are a PFIC (including 2006 and 2007) will be subject to the foregoing rules, even if we cease to be a PFIC in subsequent years, subject to exceptions for U.S. shareholders who made a timely QEF or mark-to-market election.

 
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We are headquartered in Israel and therefore our results may be adversely affected by political, economic and military instability in Israel.
 
Our principal executive offices and research and development facilities and many of our suppliers are located in Israel. Accordingly, political, economic and military conditions in Israel may directly affect our business. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its Arab neighbors, as well as incidents of civil unrest. During the winter of 2008, Israel was engaged in an armed conflict with Hamas in the Gaza Strip. This conflict involved missile strikes against civilian targets in central Israel that resulted in economic losses. Although Israel has entered into various agreements with the Palestinian Authority, Israel has been and is subject to related civil unrest and Palestinian terrorist activity, with varying levels of severity, since September 2000. Tension among the different Palestinian factions may create additional unrest and uncertainty.
 
We can give no assurance that security and political conditions will have no impact on our business in the future. Hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners could adversely affect our operations and could make it more difficult for us to raise capital. Ongoing and revived hostilities or other adverse political or economic developments in Israel or the region could harm our operations and product development and cause sales of any approved products to decrease. In addition, Israel and companies doing business with Israel have, in the past, been subject to economic boycotts. Several countries, principally those in the Middle East, still restrict business with Israel and Israeli companies. These restrictive laws and policies may seriously limit our ability to sell any approved products in these countries.
 
Our business insurance does not cover losses that may occur as a result of events associated with the security situation in the Middle East. Although the Israeli government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, there can be no assurance that this government coverage will be maintained. Any losses or damages incurred by us could have a material adverse effect on our business. Any armed conflicts or political instability in the region would likely negatively affect business conditions and could harm our results of operations.
 
Our operations could be disrupted as a result of the obligation of management or key personnel to perform military service in Israel.
 
Many of our male employees in Israel, including members of senior management, are obligated to perform military reserve duty annually for extended periods of time through the age of 45 (or older for citizens with certain occupations) and, in the event of a military conflict, could be called to active duty. In response to increases in terrorist activity, there have been periods of significant call-ups of military reservists, and recently some of our employees have been called up in connection with armed conflicts. It is possible that there will be additional call-ups in the future. Our operations could be disrupted by the absence of a significant number of our employees related to military service or the absence for extended periods of military service of one or more of our key employees.
 
The government tax benefits that we are currently eligible to receive require us to meet several conditions and may be terminated or reduced in the future, which would increase our costs.
 
Some of our operations in Israel have been granted “approved enterprise” status by the Investment Center in the Israeli Ministry of Industry, Trade and Labor that resulted in our currently being eligible for tax benefits under the Israeli Law for Encouragement of Capital Investments, 1959. These benefits will commence in the first year in which we produce taxable income. Pursuant to these benefits, undistributed income that we generate from our “approved enterprise” will be tax exempt for two years and, thereafter, will be subject to a tax rate of 10%-25% for an additional five to eight years, depending on the extent of foreign investment in us. The availability of these tax benefits, however, is subject to certain requirements, including, among other things, making specified investments in fixed assets and equipment, financing a percentage of those investments with our capital contributions, compliance with our marketing program which was submitted to the Investment Center, filing of certain reports with the Investment Center and compliance with Israeli intellectual property laws. If we do not meet these requirements in the future, these tax benefits may be cancelled. The tax benefits that we anticipate receiving under our current “approved enterprise” program may not be continued in the future at their current levels or at all. If these tax benefits were reduced or eliminated, the amount of taxes that we pay would likely increase, which could adversely affect our results of operations. See “Israeli Tax Considerations and Government Programs” for additional information concerning these tax benefits.

 
13

 

Provisions of Israeli law may delay, prevent or impede an acquisition of us, which could prevent a change of control.
 
Israeli corporate law regulates mergers, requires tender offers for acquisitions of shares above specified thresholds, requires special approvals for transactions involving directors, officers or significant shareholders and regulates other matters that may be relevant to these types of transactions. For example, a merger may not be completed unless at least 50 days have passed from the date that a merger proposal was filed by each merging company with the Israel Registrar of Companies and at least 30 days from the date that the shareholders of both merging companies approved the merger. In addition, the approval of a majority of each class of securities of the target company is required to approve a merger.
 
Furthermore, Israeli tax considerations may make potential transactions unappealing to us or to our shareholders whose country of residence does not have a tax treaty with Israel exempting such shareholders from Israeli tax. For example, Israeli tax law does not recognize tax free share exchanges to the same extent as U.S. tax law. With respect to mergers, Israeli tax law allows for tax deferral in certain circumstances but makes the deferral contingent on the fulfillment of numerous conditions, including a holding period of two years from the date of the transaction during which sales and dispositions of shares of the participating companies are restricted. Moreover, with respect to certain share swap transactions, the tax deferral is limited in time, and when the time expires, tax then becomes payable even if no actual disposition of the shares has occurred.
 
These provisions could delay, prevent or impede an acquisition of us, even if such an acquisition would be considered beneficial by some of our shareholders.
 
It may be difficult to enforce a U.S. judgment against us, our officers and directors or to assert U.S. securities law claims in Israel.
 
We are incorporated in Israel. Most of our executive officers and directors are not residents of the United States, and a majority of our assets and the assets of these persons are located outside of the United States Therefore, it may be difficult to enforce a judgment obtained in the United States, against us or any of these persons, in U.S. or Israeli courts based on the civil liability provisions of the U.S. federal securities laws. Additionally, it may be difficult to enforce civil liabilities under U.S. federal securities laws in original actions instituted in Israel. Furthermore, if a foreign judgment is enforced by an Israeli court, it will be payable in Israeli currency.
 
Being a foreign private issuer exempts us from certain SEC and NASDAQ requirements.
 
We are a foreign private issuer within the meaning of rules promulgated by the SEC. As such, we are exempt from certain provisions applicable to U.S. public companies including:
 
 
·
the rules under the Securities Exchange Act of 1934, as amended, or Exchange Act, requiring the filing with the SEC of quarterly reports on Form 10-Q and current reports on Form 8-K;
 
 
·
the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act;
 
 
·
the provisions of Regulation FD aimed at preventing issuers from making selective disclosures of material information; and
 
 
·
the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and establishing insider liability for profits realized from any “short-swing” trading transaction (a purchase and sale, or sale and purchase, of the issuer’s equity securities within less than six months).
 
In addition, under the rules and regulations of The NASDAQ Stock Market, a foreign private issuer may follow its home country practice in lieu of certain NASDAQ listing requirements.  For example, in November 2007, our Board of Directors authorized an increase of 500,000 ordinary shares for issuance under our Global Share Incentive Plan (2006), or 2006 Plan.  Generally, under NASDAQ’s continued listing requirements, such an increase would require shareholder approval.  However, we chose to follow our home country practice, which does not require shareholder approval, and did not seek or receive shareholder approval for the increase in shares under the 2006 Plan.  Because of these SEC and NASDAQ exemptions, investors are not afforded the same protections or information generally available to investors holding shares in public companies organized in the United States.

 
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Risks Related to Our Ordinary Shares
 
Insiders own a significant percentage of our outstanding ordinary shares and could delay or prevent a change in corporate control.
 
Our directors and executive officers, together with their affiliates, beneficially own, in the aggregate, approximately 16.4% of our outstanding ordinary shares. This concentration of ownership may harm the market price of our ordinary shares by:
 
 
·
delaying, deferring or preventing a change in control of our company;
 
 
·
entrenching our management and/or board of directors;
 
 
·
impeding a merger, consolidation, takeover or other business combination involving our company; or
 
 
·
discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of our company.
 
 
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ITEM 4. INFORMATION ON THE COMPANY
 
A.           HISTORY AND DEVELOPMENT OF THE COMPANY
 
History
 
We were incorporated under the laws of the State of Israel on March 9, 2000 as Rosetta Genomics Ltd., an Israeli company. The principal legislation under which we operate is the Israeli Companies Law, 5759-1999, as amended. Our principal executive office is located at 10 Plaut Street, Science Park, Rehovot 76706 Israel, and our telephone number is + 972-73-222-0700. Our wholly owned subsidiary, Rosetta Genomics Inc., which was incorporated in Delaware on April 21, 2005, is located at 15 Exchange Place, Suite 500, Jersey City, New Jersey 07302-3914, and its telephone number is (201) 946-0561. Rosetta Genomics Inc. serves as our agent for service of process in the United States. Our web site address is www.rosettagenomics.com. The information on our web site is not incorporated by reference into this Annual Report and should not be considered to be a part of this Annual Report.
 
On July 22, 2008, through Rosetta Genomics Inc., we purchased all of the shares of Parkway Clinical Laboratories, Inc., a privately held Pennsylvania corporation owning a CLIA-certified laboratory, for an aggregate purchase price of $2,900,000 (not including $207,000 of transaction expenses), consisting of $1,900,000 in cash and $1,000,000 of our ordinary shares, plus an additional $300,000 payable upon the achievement of certain milestones, which were not met.  Parkway remained an indirect wholly owned subsidiary until May 18, 2009, when we sold Parkway for up to $2,500,000, to be paid as a fixed percentage from the revenues over six years.   With its CLIA certification, Parkway helped us to obtain CLIA certification for our laboratory in Philadelphia, Pennsylvania..
 
We completed the initial public offering of our ordinary shares in the United States on March 2, 2007. In connection with the initial public offering, on October 4, 2006, we (i) effected a 1-for-3.9822 reverse split of our capital shares and (ii) recapitalized our authorized share capital so that each share has a par value of NIS 0.01. In addition, upon the completion of our initial public offering, all of our outstanding preferred shares and ordinary A shares were converted into 7,107,730 ordinary shares.
 
Principal Capital Expenditures
 
We had net capital expenditures and repayment of capital lease of $403,000 in 2008, $784,000 in 2007, and $267,000 in 2006. Our capital expenditures during 2008, 2007 and 2006 consisted primarily of laboratory equipment, computer equipment and leasehold improvements. We have financed our capital expenditures with cash generated from financing activities.
 
B.  BUSINESS OVERVIEW
 
Overview
 
We are seeking to develop and commercialize new diagnostic tests based on a recently discovered group of genes known as microRNAs. microRNAs are naturally expressed, or produced, using instructions encoded in DNA and are believed to play an important role in normal function and in various pathologies. We have established a CLIA-certified laboratory in Philadelphia, which enables us to develop and validate our own diagnostic tests applying our microRNA technology and to offer diagnostic testing services.

We believe that we were the first commercial enterprise to focus on the emerging microRNA field, and that as a result, we have developed an early and strong intellectual property position related to the development and commercialization of microRNA-based diagnostics. Using our intellectual property, collaborative relationships with leading commercial enterprises and academic and medical institutions, and expertise in the field of microRNAs, we have initiated microRNA-based diagnostic programs for various cancers. In late-2008, we launched our first three diagnostic tests applying our microRNA technology:
 
1.      miRview TM mets: For identification of  the origin of the primary tumor of metastases;
2.      miRview TM squamous: For differentiating squamous from non squamous non-small cell lung cancer; and
3.      miRview TM meso: For differentiating mesothelioma from other carcinomas in the lung and pleura.
 
In April 2009, we entered into a license and collaboration agreement with Prometheus Laboratories Inc. pursuant to which Prometheus has the exclusive right to commercialize these tests in the United States.  In addition, in December 2008, we entered into an agreement with Teva Pharmaceutical Industries Ltd., pursuant to which Teva has the exclusive right to distribute these tests in Turkey and Israel.
 
Beyond these three commercialized tests, we are focusing on the development of minimally/non-invasive, blood or serum-based tests, which we believe have the potential for greater acceptance by healthcare professionals. We believe that the sensitive and specific methods we have developed to extract and profile the expression of microRNAs in serum and plasma will enable the development of minimally/non-invasive, blood or serum-based molecular diagnostics tests. We are currently focusing substantially all of our research and development efforts on the development of a minimally-invasive, blood-based colon cancer screening test.  If we are successful in developing this test, we expect that it could be launched in late 2009 or early 2010 as an LDT, by our CLIA-certified laboratory in Philadelphia.

 
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In addition, microRNAs also represent potential targets for the development of novel drugs. We are currently working with Regulus Inc. on the development of a liver cancer therapeutic based on inhibiting a microRNA. We have identified a microRNA target, and have shown in in-vivo studies that inhibiting this microRNA significantly reduces tumor growth. We are currently conducting further in-vivo studies.
 
Background
 
Rosetta Genomics was founded in 2000 with the belief that junk DNA actually contains hundreds, possibly thousands, of tiny RNA genes that encode small RNA molecules, later termed microRNAs, which play an important role in the regulation of protein production, and hence the onset and progression of disease. In the cell, genes are expressed through information carried from our DNA by messenger RNAs, or mRNAs, which is in turn translated into proteins. Proteins are the building blocks of all living cells. The type of cell, its function, and the timing of its death are determined by which proteins are produced in the cell, and at what quantities and time they are produced. However, the proteins are the end product of a complex process which begins with the genetic code present in DNA. Before a protein is expressed, or produced, relevant parts of the DNA are copied into a mRNA. Each mRNA holds a code with instructions on how to build a specific protein using a process called translation. Although one messenger RNA molecule is capable of translating hundreds of thousands of protein molecules, the number it actually produces is regulated by microRNAs. MicroRNAs have been found to regulate the expression of other genes by binding to the mRNA.
 
MicroRNAs have been shown to have varying expression levels across various pathological conditions, and have significant potential as a new class of highly sensitive and tissue specific biomarkers. We have developed a microRNA discovery process and have demonstrated, in a work published by us in Nature Genetics that the number of human microRNAs is significantly higher than what was previously believed. We have discovered hundreds of biologically validated human microRNAs and dozens of validated viral microRNAs and filed extensive patent applications with claims potentially covering these microRNAs.
 
To leverage the potential of microRNAs as a novel diagnostic platform, we have developed proprietary methods to extract microRNAs from a wide range of tissue and body fluid samples and to quantify specific microRNA expression signatures, which may be used as diagnostic panels to potentially diagnose cancers, their subtypes, as well as the origin of metastases. We have already developed and launched three diagnostic tests based on our platforms and have published several papers demonstrating how our methods can be used to develop such diagnostics (E.g.: Rosenfeld et. al., Nature Biotechnology 26 2008; Rosenfeld et. al., Brain Pathology , July 2008).
 
We believe that microRNAs are stable, sensitive and specific markers, and we are advancing diagnostic development programs in cancer, to potentially enable accurate diagnosis and improve patient care management worldwide.
 
Our Strategy
 
Rosetta’s goal is to become a leader in the development and commercialization of microRNA-based diagnostic tests. Our key business strategies to achieve this goal are as follows:
 
 
·
Focus on the development of minimally/non-invasive, blood or serum-based tests with potential for greater acceptance by healthcare professionals. We believe that the sensitive and specific methods we have developed to extract and profile the expression of microRNAs in serum and plasma will enable the development of minimally/non-invasive, blood or serum-based molecular diagnostics tests. We are currently focusing most of our research and development efforts on the development of minimally-invasive, blood-based colon cancer screen.  While we can provide no assurance that we will be successful in developing this test, if we are successful, we would expect to launch this test in late 2009 or early 2010 as a laboratory-based test, by our CLIA-certified clinical laboratory in Philadelphia.
 
 
·
Build and maintain a strong intellectual property position. We believe that we were the first commercial enterprise to focus on the emerging field of microRNAs. We also believe we have an early and strong intellectual property position (both patents we own and those we have exclusively licensed) in the area of developing and commercializing microRNA-based diagnostic tests. Our patent strategy is to seek broad coverage on all of our identified microRNA sequences, followed by the filing of patent applications claiming composition-of-matter on microRNAs of commercial interest. We have also filed, and intend to continue to file, patent applications that claim method-of-use for specific diagnostic applications.
 
 
·
Leverage our intellectual property position and microRNA expertise to continue to establish strategic collaborations. We intend to continue to establish strategic collaborations with leading clinical diagnostic and pharmaceutical companies to further develop and commercialize microRNA-based diagnostics. We believe that our strong intellectual property position and expertise in the field of microRNAs will be very attractive to additional collaboration partners.
 
 
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·
Maximize sales of our first three commercial tests through geographic partners.   In addition to our focus on the development of microRNA-based minimally/non-invasive, blood or serum-based tests, we plan to maximize revenues from our three current commercial tests via corporate partnerships.  In April 2009, we entered into a license and collaboration agreement with Prometheus Laboratories Inc. pursuant to which Prometheus has the exclusive right to commercialize miRview TM mets, miRview TM squamous and miRview TM meso in the United States.  In addition, in December 2008, we entered into an agreement with Teva Pharmaceutical Industries Ltd., pursuant to which Teva has the exclusive right to commercialize these tests in Turkey and Israel. We intend to support the work of these partners while pursuing other partnerships for additional geographies.
 
 
·
Partner selectively to enhance the overall value of our tests .  In order to maximize value for our microRNA-based diagnostic tests and promote their commercial success, we intend to selectively collaborate with partners with proven success in the diagnostic field, sales and marketing abilities and success of securing reimbursement for tests and products in the molecular diagnostic field. We cannot assure you, however, that we will be successful in entering into any such collaborations on commercially reasonable terms, or at all.
 
Our Diagnostic Tests
 
The Role of MicroRNAs in Diagnostic Products
 
Ideally, diagnostic tests provide physicians and their patients with information relating to one or more of the following:
 
 
·
the existence or the probability of developing disease;
 
 
·
the exact type of the disease;
 
 
·
the severity of the disease;
 
 
·
the potential efficacy of specific therapies, such as different drugs or therapeutic procedures;
 
 
·
the monitoring of success of a chosen therapy; and
 
 
·
the likelihood of disease recurrence.
 
We believe that using microRNAs as diagnostic biomarkers will enable the development of diagnostic products that can provide more accurate and comprehensive information to doctors and patients. Currently, many diagnostic tests are designed to detect abnormal levels of messenger RNAs or proteins. MicroRNA-based tests may prove superior to these tests because it is believed that microRNAs are closer to the biological origin of disease and many studies have shown their involvement in disease processes, including the demonstration that microRNAs are both diagnostic and prognostic markers. A change in the expression level of a single microRNA may affect the activity of dozens of messenger RNA genes, which in turn may affect the concentration of hundreds of proteins. In addition, microRNAs are very tissue specific and very stable in body fluids and tissue samples. Thus, we expect that by focusing our efforts on microRNAs, we can develop a less complex biomarker panel, resulting in a more specific and sensitive test. Furthermore, extracting microRNAs from tissue and body fluid samples is more reliable than extracting messenger RNAs because of the greater stability of microRNAs. In addition, amplification technologies, such as PCR, can potentially increase the sensitivity of a microRNA-based diagnostic test by generating millions of copies of a particular microRNA and thereby making it easier for the test to detect the presence of the microRNA. Since amplification technologies cannot be used with proteins, we believe microRNA-based diagnostic tests have the potential to be more sensitive than protein-based diagnostic tests.
 
Our Diagnostic Product Development Process
 
Our development process for diagnostic products consists of the following important steps:
 
 
·
Access to samples. As a prerequisite for clinical validation of diagnostics products, evaluation of clinical samples is critical. Accordingly, we have entered into collaborations with several institutions in Israel and in the United States that provide us high quality clinical samples. These relationships provide us the opportunity to study thousands of well-characterized samples of lung, colorectal, breast, brain, bladder, lymphoma, leukemia, liver and others. The sample collections include solid tumor samples, healthy tissue samples, and various body fluids such as blood, urine and sputum, as well as high quality tissue samples from archival pathology banks. Where relevant, samples are accompanied by a database of medical history and clinical information, such as diagnosis, treatment and response to treatment, recurrence and survival, which for the samples from the archival pathology banks can be as long as 20 years.
 
 
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·
RNA extraction. We utilize both commercial and our proprietary technologies to extract relevant microRNA from both tissue and body fluid samples.
 
 
·
Expression profiling. The identification of microRNA biomarkers requires sensitive and specific measurements of the levels of the microRNAs extracted from the tissue or body fluid samples. We have developed proprietary methods to rapidly, robustly and accurately perform these measurements. Our methods allow us to perform simultaneous profiling of multiple samples, and we believe result in more accurate measurements of expression levels for each of the analyzed samples.
 
 
·
Analysis. We analyze expression profiles to identify microRNA signatures which detect the existence of disease and provide information on certain disease parameters, such as tumor subtype, tumor origin, tumor aggressiveness, response to treatment and risk of recurrence. Identifying microRNA signatures is a complex task, and we believe our analytical expertise is one of our key advantages.
 
Current Commercial Tests
 
In late 2008, we launched the following three tests based on our proprietary microRNA technologies:
 
 
·
miRview™ mets – This test, designed with cancer of unknown primary, or CUP, patients in mind, can accurately identify the primary tumor site in patients presenting with metastatic cancer.  Accurate identification of the primary origin is critical for determining treatment.  Current diagnostic methods to identify the origin of a metastasis include a range of costly, time-consuming and at times inefficient tests, and still, in about  5% of all cancer patients, the origin of the primary tumor is never identified.  miRview™ mets offers physicians a fast, accurate and easy-to-interpret diagnosis of the predicted primary origin.
 
 
·
miRview™ squamous – This test differentiates squamous from non-squamous non-small cell lung cancer (NSCLC).  Current methods for differentiating squamous from non-squamous NSCLC are not standardized, are difficult to reproduce and have an unacceptable level of variability between pathologists and laboratories, as indicated in numerous peer review publications.  miRview™ squamous produces a single score that clearly indicates whether a sample is squamous or non-squamous NSCLC.  It is estimated that about 60,000 lung cancer patients who are candidates for targeted therapy may potentially use this test.
 
 
·
miRview™ meso – The test leverages microRNA’s high-specificity as biomarkers to differentiate mesothelioma, a cancer connected to asbestos exposure and other risk factors, from other carcinomas in the lung and pleura, a medically and legally important differential diagnosis.  As mesothelioma patients require specific treatment regimens, an accurate diagnosis is critical.  Pathological diagnosis may suffer from significant inter-observer variability, and in the absence of a single specific and reliable test, mesothelioma can be difficult to identify from other cancers.
 
In April 2009, we entered into a license and collaboration agreement with Prometheus Laboratories Inc. pursuant to which Prometheus has the exclusive right to commercialize these tests in the United States.  In addition, in December 2008, we entered into an agreement with Teva Pharmaceutical Industries Ltd., pursuant to which Teva has the exclusive right to commercialize these tests in Turkey and Israel.
 
Our Pipeline
 
We are currently focusing on the development and commercialization of minimally and non-invasive, blood and serum-based diagnostic tests based on microRNAs for use in oncology.  We have already demonstrated that microRNAs are stable in serum and other body fluids, and can be extracted and quantified using our proprietary methods. We have reported in a paper published in PLoS ONE in 2008, that our underlying serum-microRNA platform demonstrates detection sensitivity on the order of a single molecule, single nucleotide specificity and up to 700-fold test-to-control increase of certain serum-microRNA biomarkers. We are focusing substantially all of our research and development efforts on the development of miRscreen™ colon, a minimally invasive, blood-based screen for colon cancer.
 
miRscreen™ colon
 
We are developing a microRNA-based colon cancer screening test to potentially target more than 90 million people in the United States annually. This test is being designed to differentiate individuals with colon cancer from those without by detecting microRNA biomarkers in a test that is based on a standard blood draw.  To date, we have worked on the sera of more than 100 colorectal cancer patients and controls and have found that certain microRNAs present in different amounts in sera of colorectal cancer patients compared with healthy controls.

 
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Colon cancer is the second leading cause of cancer-related death, killing almost 50,000 Americans in 2008, and yet, it is a treatable disease if caught early.  If cancer of the colon is detected and treated before it has spread, more than 90% of patients will survive. Current medical recommendations are that every man and woman over the age of 50 be screened regularly for colon cancer, and according to the U.S. Census Bureau, there are approximately 94 million people in the United States over the age of 50. Unfortunately, many people over the age of 50 do not have a colonoscopy, which is effective but costly and very unpleasant.  Many also avoid the much simpler test for the detection of fecal occult blood.  We believe minimally-invasive colon cancer screening test based on a simple blood draw can make a significant difference. We believe that many individuals over the age of 50, who now neglect to undergo colonoscopy or even fecal occult blood test, would be receptive to a potentially life-saving test that is based on a simple blood draw.
 
The following represents our current expected timing with respect to three key milestones related to the development and commercialization of miRscreen™ colon:

·
First, by the end of the second quarter of 2009, we intend to conclude the discovery phase, in which we expect to finalize the microRNA content of the test.  In this phase, we will continue screening dozens of samples from colon cancer patients of various stages, as well as age-matched controls.  In the past several months, we have improved our microRNA panel for high-throughput screening to include additional potential markers, specifically focusing on more novel cancer and colon cancer related microRNAs we have discovered.

·
Second, by the end of the third quarter of 2009, we intend to complete the assay development phase.  In this phase, we expect to translate the discovery results into an assay.  This means we intend to finalize the list of biomarkers, the design of the plate, the various controls and QC parameters, as well as the optimal interpretation of the assay results for a colon cancer detection test.

·
And third, should we be successful in developing this test, we believe it will be commercially available in the U.S. through our CLIA-certified lab in late 2009 or early 2010.  Within this timeframe we also expect to publicly present scientific data on the accuracy of this test.

From a technical perspective, this is a complicated test and would be the first test of its kind to be developed.  We can provide no assurance that we will be able to successfully develop and offer this test in this timeframe, or at all.
 
Other miRscreen™ Tests
 
We believe that noninvasive screening tests for cancer are the future of the diagnostics industry and that our highly sensitive and specific platforms are suitable for development of such tests. Thus, we expect to continue to develop miRscreen™ tests for other cancers.
 
Therapeutic Products
 
MicroRNAs are important regulators of protein production, and as such, they represent potential targets for the development of drugs. Important information about the role of microRNA in a disease can be deduced by mimicking or inhibiting its activity and examining the impact this has on the behavior of the cell or organism. If mimicking or inhibiting microRNA leads to improvement in disease symptoms, this implies that the target microRNA plays an important role in the disease.
 
The pharmaceutical industry has traditionally focused on the development of drugs that inhibit specific protein activity because of the difficulties in developing drugs that enhance protein activity or increase protein levels. Even siRNAs, a novel class of drugs, are limited to the inhibition of protein production. In contrast, because microRNAs are natural regulators of protein production, we believe it is possible to develop microRNA-based therapeutic products which can either increase or decrease the levels of proteins. A drug that mimics microRNA should result in decreased levels of the proteins naturally regulated by that microRNA, while a drug that inhibits the microRNA should result in increased levels of those proteins.
 
We believe that microRNAs can serve as a basis for a new class of therapeutic products and that we can leverage our microRNA diagnostic capabilities to help develop drugs targeting microRNAs.
 
Liver Cancer
 
Market opportunity. According to Pharmaceutical and Diagnostic Innovation , 2005, hepatocellular carcinoma, or HCC, more commonly referred to as liver cancer, is the fifth most common cancer in the world. The 2009 ACS Report estimated that in 2009, approximately 22,620 new cases would be diagnosed in the United States and approximately 18,160 people would die of the disease. The incidence of HCC is rising principally as a result of the spread of chronic hepatitis C infection, or HCV, a chronic viral infection of the liver that can remain asymptomatic for years but can lead to liver cancer if left untreated. The World Health Organization estimates that more than 180 million people in the world, including 3.9 million in the United States, are infected with HCV.
 
Current treatment. HCC patients have a very low survival rate, estimated by the 2006 ACS Report to be less than 10% at five years post-diagnosis. Aside from a liver transplant, the best available treatment for liver cancer is to surgically remove the entire tumor with a margin of healthy tissue included. However, according to Pharmaceutical and Diagnostic Innovation, 2005 , this option is available only to between approximately 5% and 10% of HCC patients. In November 2007, the FDA approved Nexavar (sorafenib) for use in patients with inoperable HCC. In clinical trials, patients who received Nexavar survived a median of 10.7 months while patients who received the control survived a median of 7.9 months. All other available medical treatments, including chemotherapy, chemoembolization, ablation, and proton beam therapy, remain disappointing. As a consequence of the increasing incidence of the disease, the market for novel HCC drugs represents a high unmet need.
 
Our strategy. In order to develop a microRNA-based treatment for HCC, we entered into a collaboration with Isis Pharmaceuticals in January 2006 that had an initial period of two years. In August 2008, Isis assigned the agreement to Regulus Therapeutics LLC, and we signed an amendment to the agreement according to which the initial research period was extended until June 30, 2009.  Isis and Regulus have significant intellectual property rights and expertise relating to technologies for inhibiting RNA molecules, including microRNAs. Isis has demonstrated its ability to inhibit microRNAs by administering to mice a synthetic molecule designed to inhibit a liver-specific microRNA. Isis showed that the synthetic molecule reached the liver and reduced the level of this microRNA with no observable toxicological effects.
 
The first step of this program was to identify candidate microRNA targets for inhibition. This was done by profiling the expression levels of all microRNAs in healthy and tumorous liver tissue samples in order to identify microRNAs which are overexpressed in the tumor samples. We have identified a total of 100 microRNAs, for which we performed in vitro assays to assess the role of these microRNAs in tumor development. From the 100 microRNAs that were tested by introducing into cancer cell lines the antisense molecules which were synthesized by Isis to inhibit the candidate microRNAs, seven microRNA specific antisense molecules inhibited cell proliferation by inducing apoptosis and one microRNA-specific antisense inhibited cell proliferation by possibly stopping cell cycle progression.
 
 
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In addition, we established two different mouse models of HCC (xenograft & orthotropic models) and we conducted in vivo experiments to further test the effect of these microRNA inhibitors on liver cancer, resulting in positive results for 3 out of 4 tested microRNA inhibitors. We are currently concentrating on one microRNA inhibitor as our lead candidate, aiming at understanding the underlying pathway of its activity.  This program is still in the early stages of development, and we can provide no assurance that we will be successful in developing, receiving regulatory approval for and commercializing a therapeutic product for the treatment of liver cancer. The “initial research period” of the collaboration agreement expires on June 30 2009.  We have initiated preliminary discussions as to the future of this project, however, we can provide no assurance as to the outcome of such discussions.
 
Other Potential Indications
 
Our strategy is to collaborate with leading academic and medical institutions to provide us with additional research capabilities in the field of microRNAs. For example, we have signed an agreement with the CBR Institute for Biomedical Research, an academic affiliate of the Harvard Medical Center, to study the role of microRNAs in hematopoeisis. We have also signed an agreement with Yeda Research and Development Company, Ltd., the technology transfer company of the Weizmann Institute of Science, to investigate at the Weizmann Institute the role of microRNAs in a variety of cancers. We have the exclusive right to commercialize the results of this research, and this collaboration resulted a paper in a leading journal (see Raver-Shapira, N. et al. Transcriptional Activation of miR-34a Contributes to p53-Mediated Apoptosis. Mol Cell (2007).
 
Rosetta Green
 
Rosetta Green is a project we have established to leverage our capabilities into the areas of cleantech and plant biotech by using our proprietary microRNA technologies to develop plants and algae more suitable for various applications such as improved feedstocks for biofuels and advanced agriculture. Research at Rosetta Green has been shown to develop algal strains with potentially increased oil content, to discover potential novel microRNAs from commercially-important algae and to identify drought-regulated microRNAs in plants. In the future, we intend to establish a wholly owned Israeli subsidiary to be named Rosetta Green Ltd.

On September 24, 2008, we signed a convertible note purchase agreement with certain private investors in order to provide separate funding for Rosetta Green, in an amount of up to $2,500,000. To date, the investors have invested a total amount of $1,500,000, in two tranches. Once we establish Rosetta Green Ltd., the convertible notes we issued to the investors will convert into a number of Rosetta Green Ltd. ordinary shares as is obtained by dividing the principal amount of the note by a price per share reflecting a fully-diluted pre-money valuation equal to $5,000,000. If Rosetta Green Ltd. is not established within 24 months as of the initial closing, which took place on or about September 24, 2008, or if the Rosetta’s Board resolves not to establish Rosetta Green, the notes will convert into our ordinary shares at a price per share equal to the average of the closing prices over the five consecutive trading days ending on the last trading day prior to the date of conversion, provided that such conversion price shall not be lower than $2.00 per share.
 
Collaborations and Partnerships
 
License and Collaboration Agreement with Prometheus Laboratories Inc.
 
On April 10, 2009, we entered into a license and collaboration agreement with Prometheus Laboratories Inc., under which we agreed to exclusively license and sublicense to Prometheus certain rights related to our current microRNA-based cancer diagnostic tests: miRview™  mets, miRview™ squamous and miRview™ meso (hereinafter referred to as the “Cancer Diagnostic Tests”), including the rights to certain software developed by us and related to the miRview ™ mets product. We also agreed to collaborate with Prometheus in order to further develop the Cancer Diagnostic Tests and to develop two new microRNA-based gastroenterology tests (hereinafter referred to as the “GI Products”). Under this agreement, Prometheus has the exclusive right to develop and commercialize the Cancer Diagnostic Tests and the GI Products in the United States, and we have agreed not to participate in the commercialization of any directly competitive products in the United States. The license agreement also gives Prometheus a right of first negotiation to take a license for certain diagnostic tests or products that are under development by us.

Prometheus will contribute to a development fund that will be used to further develop the Cancer Diagnostic Tests and to develop the GI Products. In addition, Prometheus will pay us additional amounts upon reaching certain publication requirements for the Cancer Diagnostic Tests and achieving certain product profiles for the GI Products. We are also entitled to receive certain payments upon the achievement of commercial milestones. The total amount potentially payable to us under these provisions is $17.0 million.

We are also entitled to royalties on the sale of the Cancer Diagnostic Tests and the GI Products, subject to reductions in certain instances.

We control the prosecution, maintenance and enforcement of all the licensed patent rights owned by us, and we will use commercially reasonable efforts in order to obtain prosecution and maintenance rights from our licensors of certain patent rights sublicensed to Prometheus. Prometheus will contribute a partial amount of past and future associated patent prosecution costs. Also, if we or our licensor elect not to take action against an infringement of the licensed or sublicensed patent rights, Prometheus may undertake such action at its own expense with relation to our licensed patents and we will use commercially reasonable efforts to obtain for Prometheus equivalent enforcement rights from our licensors.

 
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We are obligated to indemnify Prometheus against any liabilities arising from (i) our breach of a representation, warranty or a covenant of the agreement; (ii) any third party claim that we have made available to Prometheus any intellectual property right in violation of an obligation owed to such third party; (iii) the exploitation by us outside the United States of a product that is licensed to Prometheus within the United States; (iv) certain claims arising under our upstream licenses covering the products sublicensed to Prometheus and (v) certain potential contractual obligations to third parties. Prometheus is obligated to indemnify us against any liabilities arising from (i) Prometheus’ breach of a representation, warranty or covenant of the agreement; and (ii) the exploitation by Prometheus of the licensed products.
 
The agreement will terminate upon the later of the expiration or abandonment of the last licensed patent to expire or become abandoned, or, if a licensed product involves certain sublicensed technical information, until the end of such additional period as is required under the applicable upstream license. Either party has the right to terminate the agreement if the other party is in material breach and has not cured such material breach within 60 days as of the receipt of a written notice notifying it of such breach, except for payment obligations, in which case the notice period is 30 days. Prometheus can terminate the agreement for convenience (either entirely or as to one or more licensed products) by providing six months’ written notice to us.  Under certain circumstances, Rosetta must make payments to Prometheus if Rosetta commercializes the licensed products in the United States after Prometheus has terminated the agreement.
 
In addition, effective April 10, 2009, we also entered into a laboratory services agreement with Prometheus.  Under this agreement, we perform the Cancer Diagnostic Tests and the GI Tests (hereinafter referred to collectively as the “Diagnostic Tests”) on behalf of Prometheus.  The laboratory services for the Diagnostic Tests are performed in Rosetta’s CLIA-certified laboratory in Philadelphia, Pennsylvania.  Prometheus is responsible for marketing, sales and most customer service activities relating to the Diagnostic Tests. The services agreement has an initial term of one year and can be renewed by Prometheus.  Either party can terminate the services agreement if the other party is in material breach and has not cured such material breach within 60 days as of the receipt of a written notice notifying it of such breach, except for payment obligations, in which case the notice period is thirty days. Prometheus can terminate the services agreement for convenience (either entirely or as to one or more Diagnostic Tests) by providing 60 days’ written notice to us.  After the third anniversary of the effective date of the services agreement, we can terminate the agreement for convenience (either entirely or as to one or more Diagnostic Tests) by providing 90 days’ written notice to Prometheus.
 
On April 10 2009, we also entered into a stock purchase agreement with Prometheus. Under this agreement, on April 27, 2009, Prometheus purchased 2,000,000 of our ordinary shares at a price of $4.00 per share in a private placement transaction. In addition, under the terms of the purchase agreement, so long as Prometheus or its affiliates continue to hold at least 50% of these shares, Prometheus is entitled to information rights, pre-emptive rights and board observer rights. Pursuant to the pre-emptive rights, Prometheus has the right to participate in future offerings of our securities to purchase up to its pro rata share in any such offering on the same terms and conditions as other investors.
 
Exclusive Testing and Administrative Services Agreement with Teva Pharmaceutical Industries Ltd.
 
In December 2008, we entered into a testing and administrative services agreement with Teva Pharmaceutical Industries Ltd.  The agreement covers the territory of Israel and Turkey and is exclusive for that territory.  Under this agreement, Teva provides us with marketing, sale and distribution services and we provide testing services for the Cancer Diagnostic Tests (miRview™ mets, miRview™ squamous and miRview™ meso).  Teva pays Rosetta for the performance of the testing services at a discount from Rosetta’s list price.
 
This agreement has an initial term of 24 months with automatically renewable terms of an additional 12 months unless earlier terminated by providing three months written notice. The agreement is terminable within a specified period of time of an uncured material breach.
 
Teva is obligated amongst other things to market the Cancer Diagnostic Tests, to obtain applicable regulatory and/or governmental licenses, to handle all inquiries and to inform Rosetta of any irregularities regarding our tests. We are obligated to assist Teva in their marketing efforts by providing them with all reasonable support to enable them to adequately offer the Cancer Diagnostic Tests. We are obligated to indemnify Teva against any liabilities arising from (i) infringement of third parties rights by the Cancer Diagnostic Tests; (ii) our negligent or willful misconduct in providing the Cancer Diagnostic Tests (iii) our breach of any term of the agreement; and (iv) any misrepresentation in marketing materials prepared by us. Teva is obligated to indemnify us against any liabilities arising from (i) Teva’s negligent or willful misconduct in providing the marketing services; (iii) Teva’s breach of any term of the agreement; and (iv) misrepresentations or warranties made by Teva concerning the Cancer Diagnostic Tests.

 
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Our Intellectual Property Strategy and Position
 
Our success will depend significantly on our ability to:
 
 
·
obtain and maintain patent and other proprietary protection for the technology, inventions and improvements we consider important to our business;
 
 
·
defend our patents;
 
 
·
preserve the confidentiality of our trade secrets; and
 
 
·
operate without infringing the patents and proprietary rights of third parties.
 
We believe that we were the first commercial enterprise to focus on the emerging microRNA field, and as a result, we have developed an early and strong intellectual property position related to the development and commercialization of research, diagnostic and therapeutic products and other applications based on microRNAs. Our patent strategy is to seek broad coverage on all of our identified microRNA sequences and then later file patent applications claiming composition-of-matter on individual microRNAs of commercial interest. We also filed applications which claim groups of microRNAs which are grouped for example by chromosomal locations of the microRNA genes. We have filed, and will continue to file, patent applications that claim method-of-use for specific diagnostic and therapeutic applications as we or our collaborators develop them. We believe this approach will provide strong and broad patent protection for a large number of microRNAs that we have discovered and may provide us with a competitive advantage over new entrants to the field.
 
As of June 10, 2009, we had two issued U.S. patents and 80 pending patent applications in the microRNA field: 43 U.S. applications, five of which have received a notice of allowance, fourteen PCT applications, six applications that were nationalized in Europe, five applications nationalized in Israel, three applications nationalized in Japan, and Australia, and two applications that were nationalized in China, Canada and India. Of these patent applications, 25 claim human microRNAs, 17 claim viral microRNAs, six contain claims related to our discovery process, and two plant applications. Twenty-six applications contain claims directed to lung, liver, bladder, small intestine, breast, colon, ovarian, thyroid, melanoma, lymphoma, kidney, urothelial, adrenal, gastric, mesothelioma, prostate, testicular, stomach and pancreas cancer diagnostic applications; and five contain claims directed to glioblastoma, liver cancer, hematopoietic malignancies therapeutic applications.
 
Nucleic acids related to genes are patentable under U.S. and generally under foreign patent laws. To date, patent protection related to numerous human genes has been obtained in the United States and elsewhere. MicroRNAs are derived from naturally occurring genes, and as such, we believe, are similarly patentable under U.S. and foreign patent laws.
 
In order to obtain maximum patent protection for microRNAs in the U.S. and foreign jurisdictions, our patent applications:
 
 
·
provide for utility, function and disease targets for each microRNA sequence;
 
 
·
claim specific microRNA sequences as opposed to general mechanism or concept; and
 
 
·
identify the functional fragment of each microRNA sequence.
 
We believe this approach avoids common mistakes made by others in the past with respect to attempts to patent genes and, if patents are issued, will make it more difficult for competitors to design around our patents.
 
Our intellectual property strategy is closely coordinated with our research and development plan and we have an ongoing three-tier approach to obtaining patent protection, which is illustrated and described below:
 
First Tier: Composition-of-Matter Patents on Informatically Identified MicroRNAs
 
We have filed a first tier of “master” patent applications claiming composition-of-matter for microRNAs that we have predicted and identified by nucleotide sequences using our discovery process. Our patent applications claim approximately 10,000 microRNAs that were identified using this approach and that we believe are microRNA candidates. For each of the potential microRNAs claimed in these patent applications, a specific function and utility are described based on informatically identified targets of these potential microRNAs that are known to be associated with a disease. Based on our understanding of their sequences and identified targets, we have applied for patent protection on each of our predicted proprietary microRNAs and their variants.
 
Second Tier: Composition-of-Matter Patents on Biologically Validated MicroRNAs
 
We have filed a second tier of patent applications claiming patent coverage for the composition-of-matter of microRNAs that we have either detected by microarray or biologically validated by sequencing or qRT-PCR. In addition to the function and utility based on informatically calculated targets, microRNAs claimed in these patent applications are further described as potential markers of a disease, as supported by differential expression of these microRNAs in healthy versus diseased tissue. We have filed 42 patent applications with composition-of-matter claims related to validated microRNAs and we expect to file additional second tier applications in the future.

 
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Third Tier: Method-of-Use Patents
 
We have filed a third tier of patent applications claiming patent coverage for the method-of-use of microRNAs, including diagnostic and therapeutic uses for specific diseases. In the future, we expect that this tier of patent applications will include applications which we will file ourselves and those that we will file jointly with academic, medical and commercial partners with whom we collaborate. We have filed 31 patent applications with method of use claims related to diagnostic and therapeutic uses of microRNAs and we expect to file additional third tier applications in the future.
 
Individual patents extend for varying periods depending on the effective date of filing of the patent application or the date of patent issuance, and the legal term of the patents in the countries in which they are obtained. Generally, patents issued in the United States are effective for:
 
 
·
the longer of 17 years from the issue date or 20 years from the earliest effective filing date, if the patent application was filed prior to June 8, 1995; and
 
 
·
20 years from the earliest effective filing date, if the patent application was filed on or after June 8, 1995.
 
All of our current patent applications were filed after June 8, 1995.
 
The term of foreign patents varies in accordance with provisions of applicable local law, but typically is 20 years from the earliest effective filing date. In addition, in some instances, a patent term in the United States and outside of the United States can be extended to recapture a portion of the term effectively lost as a result of the health authority regulatory review period. These extensions, which may be as long as five years, are directed to the approved product and its approved indications. We intend to seek such extensions as appropriate. Because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that a patent may remain in force for a short period following commercialization, thereby reducing the advantage of the patent to our business and products.
 
The patent positions of companies like ours are generally uncertain and involve complex legal and factual questions. Our ability to maintain and solidify our proprietary position for our technology will depend on our success in obtaining effective claims and enforcing those claims once granted. We do not know whether any of our patent applications will result in the issuance of any patents or if issued will assist our business. Any patents that may issue in the future may be challenged, invalidated or circumvented. This could limit our ability to stop competitors from marketing related products and reduce the length of term of patent protection that we may have for any products. In addition, the rights granted under any patents which may issue may not provide us with proprietary protection or competitive advantages against competitors with similar technology. Our competitors may develop similar technologies, duplicate any technology developed by us, or use their patent rights to block us from taking full advantage of the market.
 
In addition to patents, we may rely, in some circumstances, on trade secrets to protect our technology. However, trade secrets are difficult to protect. We seek to protect the trade secrets in our proprietary technology and processes, in part, by entering into confidentiality agreements with commercial partners, collaborators, employees, consultants, scientific advisors and other contractors and into invention assignment agreements with our employees and some of our commercial partners and consultants. These agreements are designed to protect our proprietary information and, in the case of the invention assignment agreements, to grant us ownership of the technologies that are developed. These agreements may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors.
 
In-Licensed Intellectual Property
 
License Agreement with The Rockefeller University (Diagnostics)
 
In May 2006, we signed a royalty-bearing, co-exclusive, worldwide license agreement with The Rockefeller University. Under this agreement, we were granted the right to make, use and sell Rockefeller’s proprietary microRNAs for diagnostic purposes including a limited right to sublicense. Our right to sublicense is limited to sublicenses we grant as part of a license that includes other technology or patent rights of ours. The agreement covers microRNAs and microRNA candidates, including approximately 80 biologically validated human microRNAs and approximately 30 biologically validated viral microRNAs discovered by researchers at The Rockefeller University and for which it has filed patent applications. These microRNAs can be licensed by Rockefeller in the diagnostics field to three additional parties. In consideration for this license, we paid an initiation fee and will pay a fixed annual license maintenance fee, royalties based on net sales and a percentage of our revenues from any sublicenses. Rockefeller is obligated to notify us of any license it grants to a third party at a lower royalty rate and we will have the right to modify the terms of our license to adopt all of the material terms and conditions of that license.

 
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Rockefeller controls prosecution, maintenance and enforcement of all the licensed patent rights; however, we are responsible for a pro rata share of associated costs. Also, if Rockefeller elects not to take action against a claim of infringement of the licensed patent rights, we may undertake such action at our own expense. We are obligated to indemnify Rockefeller against any liabilities arising from our development and use of the licensed microRNAs and any actions brought by third parties or related to clinical trials or studies. We are also required to maintain comprehensive insurance coverage.
 
The agreement will terminate upon the later of the expiration or abandonment of the last patent to expire or become abandoned. If no patent ever issues, the agreement will terminate ten years after the first commercial sale of the first licensed product. Based on an estimate of the date of expiration of the last patent to expire, we estimate that we will pay a minimum of approximately $840,000 in aggregate annual license maintenance fees over the term of this agreement. Rockefeller has the right to terminate the agreement if we are more than 30 days late in meeting our payment obligations and do not pay in full within ten days of Rockefeller’s written demand; or upon our uncured material breach. We can terminate the agreement by providing sixty days written notice to Rockefeller, ceasing all use of the licensed products, terminating any sublicenses granted under the agreement and paying all amounts owed to Rockefeller through the date of termination.
 
License Agreement with The Rockefeller University (Therapeutics)
 
In May 2007, we signed a royalty-bearing, co-exclusive, worldwide license agreement with The Rockefeller University. Under this agreement, we were granted the right to make, use and sell Rockefeller’s proprietary microRNAs for therapeutic purposes, including a limited right to sublicense. Our right to sublicense is limited to sublicenses that are for research and development of products and that are granted as part of a license that includes other technology or patent rights of ours. The agreement covers microRNAs and microRNA candidates, including approximately 80 biologically validated human microRNAs and approximately 30 biologically validated viral microRNAs discovered by researchers at The Rockefeller University for which it has filed patent applications. These microRNAs can be licensed by Rockefeller in the therapeutics field to three additional parties. In consideration for this license, we paid an initiation fee and are required to pay a fixed annual license maintenance fee, milestone payments and royalties based on net sales and a percentage of our revenues from any sublicenses. Rockefeller is obligated to notify us of any license it grants to a third party at a lower royalty rate, and we will have the right to modify the terms of our license to adopt all of the material terms and conditions of that license.
 
Rockefeller controls prosecution, maintenance and enforcement of all the licensed patent rights; however, we are responsible for a pro rata share of associated costs. Also, if Rockefeller elects not to take action against a claim of infringement of the licensed patent rights, we may undertake such action at our own expense. We are obligated to indemnify Rockefeller against any liabilities arising from our development and use of the licensed microRNAs and any actions brought by third parties or related to clinical trials or studies. We are also required to maintain comprehensive insurance coverage.
 
The agreement will terminate upon the later of the expiration or abandonment of the last patent to expire or become abandoned. If no patent ever issues, the agreement will terminate ten years after the first commercial sale of the first licensed product. Based on an estimate of the date of expiration of the last patent to expire, we estimate that we will pay a minimum of approximately $630,000 in aggregate annual license maintenance fees over the term of this agreement. Rockefeller has the right to terminate the agreement if we are more than 30 days late in meeting our payment obligations and do not pay in full within ten days of Rockefeller’s written demand; or upon our uncured material breach. We can terminate the agreement by providing sixty days written notice to Rockefeller, ceasing all use of the licensed products, terminating any sublicenses granted under the agreement and paying all amounts owed to Rockefeller through the date of termination.
 
License Agreement with The Rockefeller University (Research)
 
In January 2008, we signed a royalty-bearing, nonexclusive, worldwide license agreement with The Rockefeller University. Under this agreement, we were granted the right to make, use import, sell and offer for sale Rockefeller’s proprietary microRNAs for research purposes including a limited right to sublicense. Our right to sublicense is limited to sublicenses we grant as part of a license that includes other technology or patent rights of ours. The agreement covers microRNAs and microRNA candidates, including approximately 80 biologically validated human microRNAs and approximately 30 biologically validated viral microRNAs discovered by researchers at The Rockefeller University and for which it has filed patent applications.  In consideration for this license, we paid an initiation fee and will pay a minimum annual royalty, based on net sales and a percentage of our revenues from any sublicenses. Rockefeller is obligated to notify us of any license it grants to a third party at a lower royalty rate and we will have the right to modify the terms of our license to adopt all of the material terms and conditions of that license.

 
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Rockefeller controls preparation, prosecution and maintenance of the licensed patent rights and the selection of patent council with our input; however, we are responsible for a pro rata share of associated costs. Also, if Rockefeller elects not to take action against a claim of infringement of the licensed patent rights, we may undertake such action at our own expense. We are obligated to indemnify Rockefeller against any liabilities arising from our development, testing, use, manufacture, manufacture, promotion, sale of other disposition of the licensed microRNAs and any actions brought by third parties.  We are also required to maintain comprehensive insurance coverage.
 
The agreement will terminate upon the later of the expiration or abandonment of the last patent to expire or become abandoned. If no patent ever issues, the agreement will terminate ten years after the first commercial sale of the first licensed product. Based on an estimate of the date of expiration of the last patent to expire, we estimate that we will pay a minimum of approximately $420,000 in aggregate minimum annual royalty over the term of this agreement. Rockefeller has the right to terminate the agreement if we are more than 30 days late in meeting our payment obligations and do not pay in full within ten days of Rockefeller’s written demand; or upon our uncured material breach. We can terminate the agreement by providing 60 days written notice to Rockefeller, ceasing all use of the licensed products, terminating any sublicenses granted under the agreement and paying all amounts owed to Rockefeller through the date of termination.
 
License Agreement with Max Planck Innovation GmbH (Diagnostics)
 
In June 2006, we entered into a royalty-bearing, co-exclusive, worldwide license agreement with Max Planck Innovation GmbH, or Max Planck, the technology transfer agency of the Max Planck Society. Under this agreement, we licensed from Max Planck the rights to its proprietary microRNAs for diagnostics purposes. The agreement covers microRNAs and microRNA candidates, including approximately 110 biologically validated human microRNAs, discovered by the researchers of the Max-Planck-Institute for Biophysical Chemistry in Goettingen. In consideration for this license, we paid an initiation fee, and are required to pay a fixed annual license maintenance fee, royalties based on net sales and a percentage of our revenues from any sublicenses.
 
These microRNAs can be licensed by Max Planck for diagnostics purposes to three other parties. Max Planck is obligated to notify us of any more favorable license in the diagnostics field it grants for these microRNAs, in which event we shall have the right to adopt all material terms of such license. We have the right to enter sublicenses, only in the event that the granted sublicense includes a license to microRNAs owned by us as well, is reasonably necessary for us in order to further develop and/or commercialize a specific product, and Max Planck has given its prior consent to such sublicense.
 
Max Planck is responsible, in its sole discretion, to apply for, seek issuance of, maintain and prosecute the licensed patent rights, and we have the right to comment on the documents to be filed by the patent office. We are required, however, to pay a pro rata share of associated costs. We are obligated to indemnify Max Planck against any liabilities arising from any use by us, our affiliates, sublicensees and sales partners of the patent rights, the development and use of any product, process or service under the agreement, and the use by third parties of any products, processes or services sold by us. We are also required to maintain comprehensive insurance coverage.
 
The agreement terminates upon the expiration or abandonment of all issued and filed licensed patents. Based on an estimate of the date of expiration of the last patent to expire, we estimate that we will pay a minimum of approximately $543,000 in aggregate annual license maintenance fees over the term of this agreement. We have the right to terminate the agreement with three months’ prior written notice. We have the obligation to use commercially reasonable efforts to develop and commercialize the products and services based on the licensed patents in the field of diagnostics. In the event we cease carrying out our business related to the agreement we must notify Max Planck and then both parties have the right to terminate the agreement with three months’ prior notice. Max Planck also has the right to terminate the agreement if we challenge one of the licensed patents; if we fail to cure a breach within 60 days of receiving notice of such breach; or if we fail to pay within 30 days of a notice requiring a payment. The agreement will terminate automatically upon filing of bankruptcy or insolvency proceedings by or against us, or upon the assignment of all or a substantial portion of our assets for the benefit of creditors.
 
License Agreement with Max Planck Innovation GmbH (Research)
 
In December 2006, we entered into a royalty-bearing, non-exclusive, worldwide license agreement with Max Planck. Under this agreement, we licensed from Max Planck the rights to its proprietary microRNAs for research purposes. The agreement covers microRNAs and microRNA candidates, including approximately 110 biologically validated human microRNAs, discovered by the researchers of the Max-Planck-Institute for Biophysical Chemistry in Goettingen. In consideration for this license, we will pay an initiation fee, and are required to pay a fixed annual license maintenance fee, royalties based on net sales and a percentage of our revenues from any sublicenses.

 
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Max Planck is obligated to notify us of any more favorable license in the research field it grants for these microRNAs, in which event we shall have the right to adopt all material terms of such license. We have the right to enter into sublicense agreement, but only if the granted sublicense includes a license to microRNAs owned by us as well.
 
Max Planck is responsible, in its sole discretion, to apply for, seek issuance of, maintain and prosecute the licensed patent rights, and we have the right to comment on the documents to be filed with the patent office. We are obligated to indemnify Max Planck against any liabilities arising from any use by us, our affiliates, sublicensees and sales partners of the patent rights, the development and use of any product, process or service under the agreement, and the use by third parties of any products, processes or services sold by us. We are also required to maintain comprehensive insurance coverage.
 
The agreement terminates upon the later of the expiration or abandonment of the last patent to expire or become abandoned of the patent rights contemplated under the agreement, or, if no patent ever issues from the patent rights, ten years after the first commercial sale of the first licensed product, as contemplated under the agreement. Based on an estimate of the date of expiration of the last patent to expire, we estimate that we will pay a minimum of approximately $293,000 in aggregate annual license maintenance fees over the term of this agreement. We have the right to terminate the agreement with 60 days prior written notice. Max Planck also has the right to terminate the agreement if we fail to cure a breach within 60 days of receiving notice of such breach; or if we fail to pay within 30 days of a notice requiring a payment.
 
License Agreement with Johns Hopkins University
 
In August 2006, we signed a royalty-bearing, exclusive, worldwide license agreement with Johns Hopkins University. Under this agreement, we have exclusively licensed from Johns Hopkins the rights to its proprietary microRNAs for all fields and applications. The agreement covers approximately 130 biologically validated microRNAs. We also have the right to further sublicense these rights, provided that such sublicense is consistent with the terms of our license agreement. In consideration for this license we paid an initiation fee, and are required to pay minimum annual royalties, royalties based on net sales and a percentage of our revenues from any sublicense.
 
We are obligated to perform commercially reasonable diligent efforts in the development of products, including or using the licensed microRNAs. In the event that Johns Hopkins has clinical evidence demonstrating the feasibility of a certain use of the microRNAs, and a commercially reasonable offer from a third party for a license for such use, then upon notice from Johns Hopkins, we are obligated to either initiate development of such use, or sublicense such use to a third party. If within six months of the notice, we have neither initiated development nor sublicensed or been working diligently to sublicense such use, Johns Hopkins may terminate the license for such use.
 
Johns Hopkins is responsible for filing, prosecuting and maintaining the licensed patent rights, and we have the right to comment on and advise Johns Hopkins with respect to such matters. We are required to pay all expenses related to filing, prosecution and maintenance of the licensed patent rights; unless we provide Johns Hopkins notice that we elect not to do so. If we so elect, Johns Hopkins may file, prosecute or maintain such patent rights at its own expense and any license we have with respect to such patent rights shall terminate. We have the right but not the obligation to enforce the patent rights against infringement. No patent applications covering these microRNAs have been filed yet.
 
We are obligated to indemnify Johns Hopkins against any liabilities arising out of use by us, our affiliates or sublicensees of the licensed microRNAs. We are also obligated to establish and maintain product liability or other appropriate insurance prior to initial human testing or first commercial sale of any product incorporating the licensed microRNAs.
 
The agreement terminates with respect to each country in which a patent has issued upon the expiration of the last to expire patent covered by the terms of the agreement in such country. If no patents ever issue in a country but patent applications are filed in such country, the agreement will expire with respect to such country upon the cancellation, abandonment, withdrawal or disallowance of all claims under all patent applications in that country or at such time as there is no claim that has been pending in such country for less than six years from the date such claim was filed in a non-provisional patent application in that country. Based on an estimate of the date of expiration of the last patent to expire, we estimate that we will pay a minimum of approximately $2,250,000 in aggregate annual royalties over the term of the agreement. In addition, either party may terminate the agreement (1) upon the filing of bankruptcy or insolvency proceedings with respect to the other party or (2) if the other party is in material breach of the agreement and such breach is not cured within 30 days of notice. We also have the right to terminate the agreement for any reason upon 90 days notice.

 
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Competition
 
Our industry is highly competitive and subject to rapid and significant technological change. All of the tests and products we are developing or may develop in the future, if approved, will compete against existing non-microRNA-based diagnostic tests and therapies. In addition, we believe a significant number of non-microRNA-based diagnostic tests and drug candidates are currently under development and may become available for the diseases we are targeting or may target. In addition to the competition we face from non-microRNA-based competing tests and products, we also face competition from other companies working to develop novel tests and products using technology that competes more directly with our microRNAs. We are aware of several other companies that are working to develop microRNA diagnostics and therapeutics, including Combimatrix Corporation, Alnylam Pharmaceuticals, Asuragen, Exiqon, Isis Pharmaceuticals, Merck, Santaris, Regulus Therapeutics and others. We believe the key competitive factors affecting the commercial success of our potential tests and products will be:
 
 
·
the safety and effectiveness of our products;
 
 
·
the timing and scope of regulatory approvals for these tests and products;
 
 
·
the availability and cost of manufacturing, marketing and sales capabilities;
 
 
·
reimbursement coverage; and
 
 
·
patent position.
 
Many of our potential competitors, either alone or with their collaborative partners, have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of diagnostics and therapeutics, obtaining FDA and other regulatory approvals of tests and products and the commercialization of those tests and products. Accordingly, our competitors may be more successful than we may be in obtaining FDA approval and achieving widespread market acceptance. Our competitors’ tests or products may be more effective, or more effectively marketed and sold, than any test or product we may commercialize and may render our tests and products obsolete or non competitive before we can recover the expenses of developing and commercializing them. We anticipate that we will face intense and increasing competition as advanced technologies become available.
 
Manufacturing
 
We currently intend to rely on contract manufacturers or our collaborative partners to produce materials for diagnostic tests and drug substances and drug products required for preclinical studies and clinical trials. We plan to continue to rely upon contract manufacturers and collaboration partners to manufacture commercial quantities of these materials for any marketed diagnostic or therapeutic.
 
Regulatory
 
Diagnostics
 
CLIA and Other Laboratory Licensure
 
Laboratories that perform testing on human specimens for the purpose of providing information for diagnosis, prevention or treatment of disease or assessment of health are subject to the Clinical Laboratory Improvement Amendments of 1988, or CLIA. This law imposes quality standards for laboratory testing to ensure the accuracy, reliability and timeliness of patient test results. The FDA is responsible for the categorization of commercially marketed IVD tests under CLIA into one of three categories based upon the potential risk to public health in reporting erroneous results. The categories were devised on the basis of the complexity of the test include waived tests, tests of moderate complexity, and tests of high complexity. Laboratories performing moderate- or high-complexity testing must meet the FDA requirements for proficiency testing, patient test management, quality control, quality assurance and personnel.
 
Under CLIA, certified laboratories are required to hold a certificate applicable to the type of work they perform and to comply with standards covering personnel, facilities administration, quality systems and proficiency testing.  CLIA-certified laboratories are typically subject to survey and inspection every two years to assess compliance with program standards.
 
In addition to CLIA certification, laboratories offering clinical testing services are required to hold certain federal, state and local licenses, certifications and permits.  For example, may CLIA-certified laboratories also seek accreditation by the College of American Pathologists, or CAP, and licensure by states that require that state specific licensure for a laboratory that intends to test clinical samples from residents of that state. The CAP Laboratory Accreditation Program is an internationally recognized program that utilizes teams of practicing laboratory professionals as inspectors, and accreditation by CAP can often be used to meet CLIA and state certification requirements.

 
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Food and Drug Administration
 
Laboratory Developed Tests

Although the FDA has consistently claimed that it has the regulatory authority to regulate laboratory-developed tests that are validated by the developing laboratory and has imposed labeling requirements for the results of tests utilizing analyte-specific reagents, it has generally exercised enforcement discretion in not otherwise regulating most tests performed by high complexity CLIA-certified laboratories.  In recent years, the FDA indicated that it was reviewing the regulatory requirements that will apply to laboratory-developed tests, and in September 2006, the FDA published a draft guidance document, which it revised in September 2007, or the Draft Guidance, that may be relevant to tests we develop.  The Draft Guidance describes the FDA’s current position regarding potential regulation of In Vitro Diagnostic Multivariate Index Assays, or IVDMIAs, and the revision provided additional examples of the types of tests that would be subject to the Draft Guidance. If the Draft Guidance is finalized in its current form, manufacturers of  laboratory-developed IVDMIAs that were being marketed at the time of publication of the final guidance document would be required to submit a 510(k) or PMA within 12-months of that publication. An IVDMIA is a test system that employs data, derived in part from one or more in vitro assays, and an algorithm that usually, but not necessarily, runs on software, to generate a result that diagnoses a disease or condition or is used in the cure, mitigation, treatment, or prevention of disease.
 
The first version of the Draft Guidance and related discussions about IVDMIAs attracted the attention of the U.S. Congress, and in March 2007, the Laboratory Test Improvement Act was introduced in the U.S. Senate.  The bill, which was not enacted into law, would have mandated that all providers of laboratory-developed tests provide evidence to the FDA that verifies the analytical validity of such tests.  It would also have required the development of a mechanism for the enhanced reimbursement of cleared and approved IVD products and laboratory-developed tests.  It is possible that Congress will consider similar bills in the future.
 
In December 2008, Genentech, Inc. submitted a Citizen Petition to the FDA in which it argued that all in vitro diagnostic tests intended for use in therapeutic decision making be held to the same scientific and regulatory standards.  Since that time, a number of other companies and organizations have submitted comments supporting or opposing the Citizen Petition.  The FDA is required to rule upon each appropriately filed petition within 180 days of receipt and may approve it in whole or in part, deny it, or provide a tentative response indicating why it has been unable to reach a decision on the petition.  To date, the FDA has not taken any public action with respect to this Citizen Petition, but if it grants the petition, it will likely promulgate regulations which could increase the amount of FDA regulation to which laboratory-developed tests will be subjected.

In Vitro Diagnostics

The type of regulation to which our tests and diagnostics will be subject will depend in large part on how we intend to commercialize them. Diagnostics that will be commercialized through direct product sales as in vitro diagnostic kits will be subject to review by the FDA and must be cleared or approved before they can be marketed. Tests that are available as clinical laboratory services have generally not been subject to regulation by the FDA but are subject to other requirements.
 
The FDA regulates the sale or distribution of medical devices, including in vitro diagnostic test kits and some in vitro diagnostic tests. The information that must be submitted to the FDA in order to obtain clearance or approval to market a new medical device varies depending on how the medical device is classified by the FDA. Medical devices are classified into one of three classes on the basis of the controls deemed by the FDA to be necessary to reasonably ensure their safety and effectiveness. Class I devices are subject to general controls, including labeling, pre-market notification and adherence to FDA’s quality system regulation, which are device-specific good manufacturing practices. Class II devices are subject to general controls and special controls, including performance standards and post-market surveillance. Class III devices are subject to most of the previously identified requirements as well as to pre-market approval. Most in vitro diagnostic kits are regulated as Class I or II devices and are either exempt from pre-market notification or require a 510(k) submission as described below.

510(k) Pre-Market Notification. A 510(k) notification requires the sponsor to demonstrate that a medical device is substantially equivalent to another marketed device that is legally marketed in the United States and for which a pre-market approval, or PMA, was not required. It does not generally require supporting clinical data. A device is substantially equivalent to a predicate device if it has the same intended use and technological characteristics as the predicate; or has the same intended use but different technological characteristics, where the information submitted to the FDA does not raise new questions of safety and effectiveness and demonstrates that the device is at least as safe and effective as the legally marketed device.
 
The FDA may require information regarding clinical data in order to make a decision regarding the claims of substantial equivalence. If the FDA does not believe the device is substantially equivalent to a predicate device, it will issue a “Not Substantially Equivalent” letter and designate the device as Class III, which will require approval of a PMA application in order to be marketed.

 
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Pre-Market Approval. The PMA process consists of a scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. The PMA process is considerably more time consuming and expensive than the 510(k) route, and the application must be supported by scientific evidence, including clinical data, to demonstrate the safety and efficacy of the medical device for its intended purpose.
 
Questions from the FDA, requests for additional data and referrals to advisory committees may delay the process considerably. Indeed, the total process may take several years and there is no guarantee the PMA will ever be approved, or if approved, the FDA may limit the market to which the device may be marketed. The FDA may also request additional clinical data as a condition of approval or after the PMA is approved.
 
Therapeutics
 
In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state and local statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. The process required by the FDA before a drug may be marketed in the United States generally involves the following:
 
 
·
completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s Good Laboratory Practices or other applicable regulations;
 
 
·
submission to the FDA of an investigational new drug application, or IND, which must become effective before human clinical trials may begin;
 
 
·
approval by an institutional review board, or IRB, at each institution participating in a clinical trial, which must review and approve the plan for any clinical trial before it commences at that institution;
 
 
·
performance of adequate and well-controlled human clinical trials in accordance with Good Clinical Practices, or GCPs, to establish the safety and efficacy of the proposed drug for its intended use;
 
 
·
submission to the FDA of a new drug application, or NDA, if the drug is a small molecule, or a biologics license application, or BLA, if the drug is a biologic;
 
 
·
satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with current Good Manufacturing Practice, or cGMP, to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; and
 
 
·
FDA review and approval of the NDA or BLA.
 
Once a pharmaceutical candidate is identified for development it enters the nonclinical testing stage. Nonclinical tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the nonclinical tests, together with manufacturing information and analytical data, and applicable clinical data or literature, among other things, to the FDA as part of the IND. The sponsor will also include a protocol detailing, among other things, the objectives of the first phase of the clinical trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated, if the first phase lends itself to an efficacy evaluation. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also may be imposed by the FDA at any time before or during studies due to, among other things, safety concerns or non-compliance.
 
All clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with GCP regulations. An IRB at each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution. An IRB considers, among other things, whether the risks to individuals participating in the trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the information regarding the trial and the consent form that must be provided to each trial subject or his or her legal representative and must monitor the study until completed.

 
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Each new clinical protocol must be submitted for FDA review, and to the IRBs for approval. Protocols detail, among other things, the objectives of the study, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety.
 
Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:
 
 
·
Phase 1: The drug is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.
 
 
·
Phase 2: Involves studies in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.
 
 
·
Phase 3: Involves studies undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites. These studies are intended to establish the overall risk-benefit ratio of the product and provide an adequate basis for product labeling.
 
Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and safety reports must be submitted to the FDA and the investigators for serious and unexpected adverse events. The FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.
 
Concurrent with clinical trials, companies usually complete additional nonclinical studies and must also finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the drug within required specifications and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final drug. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the drug does not undergo unacceptable deterioration over its shelf life.
 
United States Review and Approval Processes
 
The results of product development, nonclinical studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the drug, proposed labeling, and other relevant information are submitted to the FDA as part of an NDA or BLA requesting approval to market the product for one or more indications.  The FDA initially reviews all NDAs and BLAs submitted to ensure that they are sufficiently complete for substantive review before it accepts them for filing. The FDA may request additional information rather than accept an NDA or BLA for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA may refer the NDA or BLA to an advisory committee for review, evaluation and recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendation of an advisory committee.
 
The review process is lengthy and the FDA may refuse to approve an NDA or BLA if the applicable regulatory criteria are not satisfied or may require additional clinical or other data and information. Even if such data and information are submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval.
 
If a product receives regulatory approval, the approval may be limited to specific diseases and dosages or the approved indications for use may otherwise be limited, which could restrict the commercial value of the product. In addition, the FDA may require a company to conduct post-approval testing, including Phase 4 clinical trials, to further assess a drug’s safety and effectiveness after NDA or BLA approval, and may require testing and surveillance programs to monitor the safety of approved products which have been commercialized.

 
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Post-approval Requirements
 
Approved drugs are subject to extensive and continuing regulation by the FDA, including, among other things, cGMP compliance, record-keeping requirements, reporting of adverse experiences with the drug, providing the FDA with updated safety and efficacy information, and complying with FDA promotion and advertising requirements. Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory standards is not maintained or if problems occur after the product reaches the market.  Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.
 
HIPAA and Other Privacy Laws
 
The Health Insurance Portability and Accountability Act of 1996, or HIPAA, established for the first time comprehensive United States protection for the privacy and security of health information. The HIPAA standards apply to three types of organizations, or “Covered Entities”: health plans, healthcare clearing houses, and healthcare providers which conduct certain healthcare transactions electronically. Covered Entities must have in place administrative, physical, and technical standards to guard against the misuse of individually identifiable health information. Additionally, some state laws impose privacy protections more stringent than HIPAA. Most of the institutions and physicians from which we obtain biological specimens that we use in our research and validation work are Covered Entities and must obtain proper authorization from their patients for the subsequent use of those samples and associated clinical information. We are not presently a Covered Entity subject to HIPAA; however, we may become a Covered Entity in the future.
 
Our activities must also comply with other applicable privacy laws. For example, there are also international privacy laws that impose restrictions on the access, use, and disclosure of health information. All of these laws may impact our business. Our failure to comply with these privacy laws or significant changes in the laws restricting our ability to obtain tissue samples and associated patient information could significantly impact our business and our future business plans.
 
European Regulations
 
In addition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our tests and products outside the United States. Whether or not we obtain FDA approval for a product, we must obtain the necessary approvals by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, the approval process, product licensing, pricing and reimbursement vary greatly from country to country.
 
Reimbursement
 
United States
 
In the United States, revenue for diagnostic tests comes from several sources, including commercial health insurers, such as insurance companies and health maintenance organizations; government health programs, such as Medicare and Medicaid; and patients. If we offer our diagnostic tests as a service through our own certified laboratory or contract laboratory, we would be responsible for billing and collection of fees for the tests. Otherwise, billing and collection would be the responsibility of the companies that purchase or license our products.
 
Code Assignment. In the United States, a third-party payor’s decisions regarding coverage and payment are driven, in large part, by the specific Current Procedural Terminology, or CPT, code used to identify a test. The American Medical Association, or AMA, publishes the CPT, which is a listing of descriptive terms and identifying codes for reporting medical services and procedures. The purpose of the CPT is to provide a uniform language that accurately describes medical, surgical, and diagnostic services and therefore to ensure reliable nationwide communication among healthcare providers, patients, and third-party payors.
 
A manufacturer of in vitro diagnostic kits or a provider of laboratory services may request establishment of a Category I CPT code for a new product. Assignment of a specific CPT code ensures routine processing and payment for a diagnostic test by both private and government third-party payors. The AMA has specific procedures for establishing a new CPT code and, if appropriate, for modifying existing nomenclature to incorporate a new test into an existing code. If the AMA concludes that a new code or modification of nomenclature is unnecessary, the AMA will inform the requestor how to use one or more existing codes to report the test.
 
While the AMA’s decision is pending, billing and collection may be sought under an existing, non-specific CPT code. A manufacturer or provider may decide not to request assignment of a CPT code and instead use an existing, non-specific code for reimbursement purposes. However, use of such codes may result in more frequent denials and/or requests for supporting clinical documentation from the third-party payor and in lower reimbursement rates, which may vary based on geographical location.

 
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Coverage Decisions. When deciding whether to cover a particular diagnostic test, private and government third-party payors generally consider whether the test is a covered benefit and, if so, whether it is reasonable and necessary for the treatment of illness and injury. Most third-party payors do not cover experimental services. Coverage determinations often are influenced by current standards of practice and clinical data, particular at the local level. The Centers for Medicare & Medicaid Services, or CMS, which is the government agency responsible for overseeing the Medicare program, has the authority to make coverage determinations on a national basis, but most Medicare coverage decisions are made at the local level by the contractors, known as “carriers” and “fiscal intermediaries”, that administer the Medicare program in specified geographic areas. Private and government third-party payors have separate processes for making coverage determinations, and private third-party payors may or may not follow Medicare’s coverage decisions. If a third-party payor has a coverage determination in place for a particular diagnostic test, billing for that test must comply with the established policy. Otherwise, the third-party payor makes reimbursement decisions on a case-by-case basis.
 
Payment . Payment for covered diagnostic tests is determined based on various methodologies, including prospective payment systems and fee schedules. In addition, private third-party payors may negotiate contractual rates with participating providers or set rates as a percentage of the billed charge. Diagnostic tests furnished to Medicare inpatients generally are included in the bundled payment made to the hospital under Medicare’s Inpatient Prospective Payment System. Payment for diagnostic tests furnished to Medicare beneficiaries in most other circumstances is made based on the Clinical Laboratory Fee Schedule, under which a payment amount is assigned to each covered CPT code. The law technically requires fee schedule amounts to be adjusted annually by the percentage increase in the consumer price index, or CPI, for the prior year, but Congress has frozen payment rates through 2008. In addition, the law imposes a ceiling on fee schedule amounts. Currently, the ceiling for established tests is set at 74% of the median of all carrier fee schedule amounts for a particular test and 100% of the median for diagnostic tests for which no limitation amount was established prior to 2001. Medicaid programs generally pay for diagnostic tests based on a fee schedule, but reimbursement varies by state.
 
European Union
 
In the European Union the reimbursement mechanisms used by private and public health insurers vary by country. For the public systems reimbursement is determined by guidelines established by the legislator or responsible national authority. As elsewhere, inclusion in reimbursement catalogues focuses on the medical usefulness, need, quality and economic benefits to patients and the health-care system. Acceptance for reimbursement comes with cost, use and often volume restrictions, which again can vary by country.
 
Scientific Advisors
 
We seek advice from our scientific advisory board, which consists of a number of leading scientists and physicians, on scientific and medical matters. Our scientific advisory board meets regularly to assess:
 
 
·
our research and development programs;
 
 
·
our patent and publication strategies;
 
 
·
new technologies relevant to our research and development programs; and
 
 
·
specific scientific and technical issues relevant to our business.
 
The current members of our scientific advisory board are:
 
Name
 
Position/Institutional Affiliation
     
Prof. J. Aaron Ciechanover, M.D., D.Sc. Chairman
 
Prof. Ciechanover is a Nobel Prize laureate in Chemistry (2004) and a recipient of the prestigious Lasker Award (2000) for the discovery and recognition of the significance of the ubiquitin system of regulated protein degradation. Prof. Ciechanover is the Director of the Rappaport Family Institute for Research in the medical sciences and professor of biochemistry at the Technion - Israel Institute of Technology.
 
 
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Prof. Zvi Bentwich, M.D., Deputy Chairman
 
Prof. Bentwich has served as our Chief Scientist since June 2002 until April 2009, and as Chairman and Deputy Chairman of our Scientific Advisory Board since 2003. He is a world-renowned authority in AIDS research and is considered one of the leaders and founders of the discipline of Clinical Immunology. Prof. Bentwich founded and headed Israel’s largest AIDS center. He is the author of more than 250 scientific publications and has been a member of leading editorial boards and professional bodies, including Chair of the Clinical Immunology Committee of the International Union of Immunological Societies, President of the Israeli Society of Clinical Immunology and Allergy and of the Israel Society of STD. He has been a professor of medicine at the Hebrew University since 1981, and a professor of virology and head of a new center for Infectious Diseases and AIDS at Ben-Gurion University of the Negev since 2004. Prof. Bentwich is the father of our founder and board member, Dr. Isaac Bentwich.
     
Prof. Michael Sela, Ph.D.
 
Prof. Sela, an Israel Prize laureate, was the President of the Weizmann Institute of Science from 1975 to 1985 and has served as Deputy Chairman of the Board of Governors of the Weizmann Institute since 1985. Prof. Sela is a member of Teva Pharmaceuticals’ board of directors and led the development efforts for Copaxone, Teva’s multiple sclerosis drug. He is a professor of immunology at the Weizmann Institute of Science and is the author of 19 patents. He has published more than 450 articles in leading scientific journals, including abstracts and book reviews.
     
Prof. Yinon Ben Nerya, M.D., Ph.D.
 
Prof. Ben-Nerya serves as Professor and Chair in the Department of Immunology, Hebrew University, Hadassah Medical School and as Visiting Professor, Department of Systems Biology, Harvard Medical School. Prof. Ben-Neriah is also a member of the European Cancer Forum (EMBO),  and Head of the Proteomics and Drug Design Program at Hebrew University Medical School.
     
Prof. Gideon Rechavi M.D., Ph.D.
 
Prof. Rechavi is one of Israel’s most honored cancer researchers and an internationally known scientist, He  is the head of the Sheba Cancer Research Center in Israel. Prof. Rechavi is the author of numerous papers that have been published in the most distinguished scientific journals such as Nature Medicine, Nature Genetics, Nature Biotechnology, Nature Cell Biology and the Proceedings of the National Academy of Science.
 
Medical Advisors
 
We have assembled clinicians in the fields of oncology and women’s health to advise the company on our microRNA-based programs to develop laboratory tests to address the issues facing oncologists and pathologists.
 
 The current members of our medical advisory board are:
 
Name
 
Position/Institutional Affiliation
     
Prof. Moshe Hod, M.D., Chairman
 
Prof. Moshe Hod is Director of the Division of Maternal Fetal Medicine in the Helen Schneider Hospital for Woman at Rabin Medical Center in Tel Aviv University in Israel. Author of more than 200 articles and recognized as an international authority on diabetes and pregnancy, Prof. Hod received the World Fellowship Award for Outstanding Research from the 12th World Congress of the Israel Medical Association and a prize from the 12th European Congress of Perinatal Medicine for his paper on the effects of hyperglycemia on sorbitol and myo-inositol content. Prof. Hod served as Chairman of the Committee on Diabetes and Pregnancy for The National Council of Diabetes in the Israeli Ministry of Health and as Chairman of the Board for the Diabetic Pregnancy Study Group of the European Association for the Study of Diabetes. Prof. Hod was educated at Technion, Israel Institute of Technology, Faculty of Medicine, Haifa, Israel.
 
 
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Prof. Harvey I. Pass, M.D., Vice Chairman
 
Prof. Pass, is Professor of Cardiothoracic Surgery and Surgery, Director of Surgical Research, and Division Chief for Thoracic Surgery and Thoracic Oncology for the NYU School of Medicine. Prof. Pass received his undergraduate education from Johns Hopkins University and graduated from Duke University Medical School. He trained in Cardiothoracic Surgery at the Medical University of South Carolina in Charleston. He was a senior staff fellow in the Thoracic Oncology Section at the National Cancer Institute/NIH in Bethesda, Maryland from 1983 to 1986 and became Head of Thoracic Oncology at NCI from 1986 to 1996. Before moving to New York, he was Professor of Surgery and Oncology for Wayne State University and the Karmanos Cancer Institute. He is internationally recognized as an expert in the multidisciplinary management of lung cancer, mesothelioma, esophageal cancer, and the management of pulmonary metastases. He is known for his development of novel clinical trials for the treatment of thoracic malignancies as well as building a strong translational component to his programs with benchwork investigations. Dr. Pass has received the NIH Directors Award, the Presidents Award for Clinical Research at Karmanos Cancer Institute, and the Wagner Medal from the International Mesothelioma Interest Group. He is presently a Board Member of the International Association for the Study of Lung Cancer, the International Mesothelioma Interest Group, the Mesothelioma Foundation, and the Lung Cancer Alliance. Dr. Pass has been recognized as an America’s Top Doctor and Best Cancer Doctor by Castle Connoly’s Guide for the last seven years.
     
David Sidransky, M.D.
 
Dr. Sidransky is a renowned oncologist and research scientist named and profiled by TIME magazine in 2001 as one of the top physicians and scientists in America, recognized for his work with early detection of cancer. He is Professor of Oncology, Otolaryngology, Cellular & Molecular Medicine, Urology, Genetics, and Pathology at John Hopkins University and Hospital. Dr. Sidransky has written over 300 peer-reviewed publications, and has contributed more than 40 cancer reviews and chapters. Dr. Sidransky is a founder of a number of biotechnology companies and holds numerous biotechnology patents. He has been the recipient of many awards and honors, including the 1997 Sarstedt International prize from the German Society of Clinical Chemistry, 1998 Alton Ochsner Award Relating Smoking and Health by the American College of Chest Physicians and the 2004 Hinda Rosenthal Award presented by the American Association of Cancer Research. Dr. Sidransky has served as Vice Chairman of the Board of Directors, and presently is a director of ImClone. He is Chairman of Alfacell and serves on the Board of Directors of Xenomics. He is serving and has served on scientific advisory boards of MedImmune, Roche, Amgen and Veridex, LLC (a Johnson & Johnson diagnostic company), among others. In Addition, Dr. Sidransky served as Director of American Association for Cancer Research (AACR) from 2005 to 2008. Dr. Sidransky received his bachelor’s degree from Brandeis University and his medical degree from the Baylor College of Medicine.
     
Prof. Jack Baniel, M.D.
 
Dr. Baniel is an internationally renowned authority on testicular and bladder cancer. Currently, he is Professor of Urology and Acting Chief of the Urological Section at Rabin Medical Center and Deputy-Head of the Davidoff Comprehensive Cancer Center in Israel. Dr. Baniel is the author of numerous peer-reviewed papers in the field of Urological Oncology. As a member of the EORTC – GU Group, he is involved in clinical studies and the development of new medical technologies. Dr. Baniel trained in Urology at the Rabin Medical Center and Witwatersrand University in Johannesburg, South Africa. He was a Graduate Fellow in Urological Oncology at Indiana University.
 
 
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Prof. Raphael Catane, M.D.
 
Dr. Catane is Professor and Chairman of the Division of Oncology at The Chaim Sheba Medical Center, Tel Hashomer, Israel. He is the author of more than 120 scholarly articles dealing with such matters as the central action of regitine on blood pressure and MR-guided focused surgery for the palliation of pain in patients with bone cancer. In addition, Dr. Çatane has written dozens of review articles, case reports and book chapters and is a member of the American Association of Cancer Research and many other leading professional societies involving oncology, radiotherapy and immunology. Previously, Dr. Catane was Director of Clinical Cancer Research at Bristol-Myers Squibb’s Pharmaceutical Research Institute, and Acting Head of the Sharett Institute of Oncology at the Hadassah University Hospital in Jerusalem, Israel. He was educated at Hadassah Medical School in Hebrew University.
     
Dr. Isaac Yaniv, M.D.
 
Dr. Yaniv is the chairman of the Pediatric Hematology Oncology Division at the Schneider Children’s Medical Center of Israel. He established the first dedicated pediatric bone marrow transplantation unit in Israel and played a leading role as a member of the EUROCORD Group in promoting the field of umbilical cord blood transplantation. Furthermore, Dr. Yaniv established a stem cell research center focusing on homing and seeding as well as pluripotency of stem cells. Dr. Yaniv is Senior Lecturer at the Sackler Faculty of Medicine at the Tel Aviv University and medical director of the Ezer Mizion bone marrow donor registry. Dr. Yaniv has published more than 120 articles in peer-reviewed journals and conducts clinical and molecular research in the field of pediatric malignancies.
     
Dr. Maya Gottfried, M.D.
 
Dr. Gottfried has earned distinction for her extensive clinical and academic experience. A specialist in medical oncology and radiotherapy, she is currently Head of the Lung Oncology Unit at the Meir Medical Center in Kfar-Saba, Israel. Dr. Gottfried is a member of the Israel Society of Clinical Oncology & Radiotherapy, the European Association for Cancer Research, the European Society of Medical Oncology and the International Association for the Study of Lung Cancer. She has been a valued participant in many clinical trials, several as principal investigator, and has made presentations in major scientific meetings, including the 21st ESMO Congress in Vienna, the ASCO meeting in New Orleans, the 11th World Conference on Lung Cancer in Barcelona, the 1st Congress of Lung Cancer Experts in Hamburg and the Global Cancer Group in Lisbon.
 
C.  ORGANIZATIONAL STRUCTURE
 
Rosetta Genomics Ltd. is organized under the laws of the State of Israel and has a wholly owned subsidiary, Rosetta Genomics Inc., which is a Delaware corporation.
 
D.  PROPERTY, PLANTS AND EQUIPMENT
 
We currently rent approximately 11,550 square feet of office and laboratory space in Rehovot, Israel, under a lease that expires in December 2010. Our wholly owned subsidiary, Rosetta Genomics Inc., rents approximately 4,000 square feet of office space in Jersey City, New Jersey under a lease that expires in March 2013, of which we sublet approximately 2,000 square feet under a sublease that expires in February 2013.  In addition, Rosetta Genomics Inc. rents approximately 6,233 square feet of laboratory space in Philadelphia, Pennsylvania under a lease that expires in December 2013. We believe that we will require additional space as our business grows, but expect that alternate facilities will be available on reasonable terms as and when needed.
 
ITEM 4.A UNRESOLVED STAFF COMMENTS
 
None.

 
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ITEM 5.   OPERATING AND FINANCIAL REVIEW AND PROSPECTS
 
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with “Item 3. Key Information — A .  Selected Consolidated Financial Data” and our consolidated financial statements and the related notes to those statements included elsewhere in this Annual Report. In addition to historical consolidated financial information, the following discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results and timing of selected events may differ materially from those anticipated in these forward-looking statements as a result of many factors, including those discussed under “Forward-Looking Statements,” “Item 3. Key Information — D. Risk Factors” and elsewhere in this Annual Report.
 
Overview
 
We are seeking to develop and commercialize new diagnostic products based on a recently discovered group of genes known as microRNAs. MicroRNAs are naturally expressed, or produced, using instructions encoded in DNA and are believed to play an important role in regulating protein production. Proteins control most biological processes and thus we believe that microRNAs as their regulators have the potential to form the basis of a novel class of diagnostic tests and therapies for many serious illnesses.

Since our inception in March 2000, we have generated significant losses. As of December 31, 2008, we had an accumulated deficit of $45 million. We have funded our operations to date primarily through proceeds received from the sale of equity securities to investors in the aggregate amount of approximately $61 million, including $30.2 million in gross proceeds from the sale of an aggregate of 4,312,500 ordinary shares at $7.00 per share in our initial public offering in March 2007. Net proceeds from the initial public offering after deducting underwriters’ discounts and expenses were approximately $26 million. We are a development-stage company, and as such, have focused our efforts since inception primarily on research and development, building and maintaining our intellectual property, business planning and raising capital. We have not achieved profitability and we expect to incur significant additional losses over the next several years. We expect our net losses to increase primarily due to research and development activities relating to our internal product development, collaborations, business development and other general corporate activities. We anticipate that our operating results will fluctuate for the foreseeable future. Therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods. Our sources of potential funding for the next several years are expected to include our existing cash, cash equivalents, short and long term bank deposits and marketable securities of $15.7 million as of December 31, 2008, additional equity and/or debt financings, royalties, license and other fees, funded research and development payments, and milestone payments under existing and future collaborative arrangements.
 
Research and development expenses represented 56%, 58% and 59% of our total operating expenses for the years ended December 31, 2008, 2007 and 2006, respectively. We have not tracked our historical research and development costs on a project-by-project basis because the majority of our efforts have been focused on the development of capabilities associated with our microRNA discovery process rather than on specific projects. Major components of the $8.7 million in research and development expenses for the year ended December 31, 2008 included payroll and related expenses, research materials and related expenses, costs associated with license fees and intellectual property-related costs.
 
On July 2008, through Rosetta Genomics Inc., we purchased all of the shares of Parkway Clinical Laboratories, Inc., a privately held Pennsylvania corporation owning a CLIA-certified laboratory, for an aggregate purchase price of $2,900,000 (not including $207,000 of transaction expenses), consisting of $1,900,000 in cash and $1,000,000 of our ordinary shares, plus an additional $300,000 payable upon the achievement of certain milestones, which were not met.  Parkway remained an indirect wholly owned subsidiary until May  2009, when we sold Parkway for up to $2,500,000, to be paid as a fixed percentage of revenues over six years.
 
Financial Operations Overview
 
Reportable segments
 
We have two reportable segments related to continuing operations that commenced with the acquisition of Parkway Clinical Laboratories, Inc. in July 2008 until we sold Parkway in May 2009: The core technology division develops and commercializes molecular diagnostic products and the drug screening laboratory services division related to Parkway provides drug abuse and pre-employment drug testing services.
 
The segments are managed separately because each segment provides different laboratory services.
 
100% of our revenues derived from the drug screening laboratory services division.  Operating loss for the year ended December 2008, in an amount of $ 0.8 million and $ 14.1 million related to the drug screening laboratory services division and the core technology division, respectively.

 
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Revenues
 
As of December 31, 2008, we have generated revenues in an amount of $1.5 million; all the revenues derive from the drug screening laboratory services segment related to parkway, which was sold in may 2009. Our first diagnostic products applying our microRNA technology that were launched in late 2008 began generating revenues only in 2009.
 
Our ability to continue to operate is dependent on the completion of the development of our products, the ability to market and sell our products and additional financing until profitability is achieved; therefore we believe that we are still in the development stage.
 
Research and Development Expenses
 
We expense research and development costs as incurred. Our research and development expenses currently include costs of salaries and related expenses, activities related to intellectual property and licensing, tissue samples and other research materials, supplies, equipment depreciation, outsourced clinical and other research activities, consultants, utilities expenses and an allocation of corporate administrative costs. We are currently conducting a number of studies analyzing microRNA expression profiles in healthy and diseased samples and expect and we will continue to initiate such studies in 2009. As a result, we expect that our expenses related to the purchase of tissue and body fluid samples, as well as other research consumables, will increase in the future. We have entered into several license agreements for rights to utilize certain technologies. The terms of the licenses provide for up-front payments, annual maintenance payments and royalties on product sales. Costs to acquire and maintain licensed technology that has not reached technological feasibility and does not have alternative future use are charged to research and development expanse as incurred. We expect to continue to devote substantial resources to research and development, and as a result, we expect such expenses to increase substantially in the future.
 
Marketing and Business Development Expenses
 
Marketing and business development expenses consist primarily of salaries and related expenses, and expenses related to travel, legal and general business development activities. As we continue to explore new collaborations to develop and commercialize diagnostic and therapeutic products based on microRNAs, we anticipate that these expenses will increase. We also expect an increase in marketing and business development expenses in 2009 following the launch of the first diagnostic products using our microRNA technology.
 
General and Administrative Expenses
 
General and administrative expenses consist primarily of salaries and related expenses, professional fees and expenses related to general corporate activities. We anticipate that general and administrative expenses will increase as a result of the expected expansion of our operations (both in Israel and in the United States), an increase in legal and other professional fees in connection with general corporate matters and additional costs associated with our continued operation as a public company.
 
Financial Expenses (Income)
 
Financial expenses consist of interest and fees payable on outstanding loans from banks, gains related to the sale of investment in marketable securities. Financial income includes interest income, which interest is earned on deposits and marketable securities we maintain with banks and realized gains on marketable securities. In addition, financial expenses and income include expenses and income related to the impact of fluctuations in the exchange rate between the NIS and the U.S. dollar.
 
Critical Accounting Policies and Estimates
 
Our discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in conformity with U.S. generally accepted accounting principles, or U.S. GAAP. The preparation of our consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and could have a material impact on our reported results.
 
While our significant accounting policies are more fully described in the notes to our consolidated financial statements included in this prospectus, we believe the following accounting policies to be the most critical in understanding our consolidated financial statements and the assumptions management used.
 
Revenue Recognition
 
Revenues from sales of Rosetta core technology products are recognized in accordance with Staff Accounting Bulletin No. 104, "Revenue Recognition in Financial Statements" or "SAB No. 104", when delivery has occurred, persuasive evidence of an agreement exists, the vendor's fee is fixed or determinable, no further obligation exists and collectability is probable.

 
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To the extent future obligations are included in a multi-element arrangement; revenue is recognized upon delivery, provided fair value for the elements exists. In multi-element arrangements that include future obligations, if fair value does not exist for all undelivered elements, revenue for the entire arrangement is deferred until all elements are delivered or when fair value can be established according to EITF Issue No. 00-21, "Accounting for Revenue Arrangements with Multiple Deliverables" or "EITF 00-21".

Royalties from licensing the right to use our products will be recognized when earned and when written sales confirmation from the licensee is received and no future obligation exists. Non-refundable, up-front advancements of royalties from licensing the right to use our products, which are fully chargeable against royalties, are recorded as deferred revenue until the above mentioned criteria for recognizing revenue are met.

Deferred revenues represent payments received in advance, where not all revenue recognition criteria is met. As of December 31, 2008, we have deferred revenue in an amount of $ 228,000.

Revenues from laboratory services are recognized when persuasive evidence of an arrangement exists, services have been rendered, the fee is determinable and collectability is reasonably assured. We primarily recognize revenue for services rendered upon completion of the testing process. Billing for services reimbursed by third-party payers are recorded as revenues net of allowance for differences between amounts billed and the estimated receipts from such payers. Adjustments to the estimated receipts, based on final settlement with the third-party payers, are recorded upon settlement. Unbilled receivables are recorded for services rendered during, but billed subsequent to, the reporting period.

As of December 31, 2008, we had recognized $1,511,000 as revenues from the drug screening laboratory services division.
 
Accounting for Stock-Based Compensation
 
We accounts for stock-based compensation in accordance with SFAS No. 123 (revised 2004), "Share-Based Payment” or "SFAS No. 123(R)". SFAS No. 123(R) requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model.

We recognize compensation expenses for the value of awards granted based on the straight line method over the requisite service period of each of the awards, net of estimated forfeitures. SFAS No. 123(R) requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Estimated forfeitures are based on actual historical pre-vesting forfeitures. The term “forfeitures” is distinct from “cancellations” or “expirations” and represents only the unvested portion of the surrendered option. We currently expect, based on an analysis of our historical forfeitures, that approximately 94.62% of our options will actually vest, and therefore have applied an annual forfeiture rate of 5.38% to all options that are not vested as of December 31, 2008. Ultimately, the actual expenses recognized over the vesting period will only be for those shares that vest.

We selected the Black-Scholes option pricing model as the most appropriate fair value method for our stock-options awards and values restricted stock based on the market value of the underlying shares at the date of grant. The option-pricing model requires a number of assumptions, of which the most significant are the expected stock price volatility and the expected option term. The computation of expected volatility is based on realized historical stock price volatility of peer data as well as historical volatility of the Company's stock starting from the IPO date. As a result of the above-mentioned calculations, the volatility used for the twelve months ended December 31, 2008 and 2007 was between 75%-85% and between 85%-90%, respectively. The risk-free interest rate assumption is the implied yield currently available on United States treasury zero-coupon issues with a remaining term equal to the expected life term of the Company's options. The Company determined the expected life of the options according to the simplified method, average of vesting and the contractual term of the Company's stock options.

We apply SFAS No. 123(R) and EITF No. 96-18 "Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring or in Conjunction with Selling, Goods or Services", with respect to options and warrants issued to non-employees. SFAS No. 123(R) requires the use of option valuation models to measure the fair value of the options and warrants at the measurement date.

Our net loss includes stock-based compensation costs in the amount of $1.08 million, $1.035 million and $943,000 for the years ended December 31, 2008, 2007 and 2006, respectively. As of December 31, 2008, the total amount of unrecognized stock-based compensation expense was $1,949,000, which will be recognized over a weighted average period of 2.82 years.

 
39

 

In connection with options granted to non-employees for services during the years ended December 31, 2008, 2007 and 2006 and our determination of the fair value of our ordinary shares, we have recorded stock-based compensation expense of approximately  $70,000, $155,000 and $128,000 and, respectively, which represents the fair value of non-employee grants. At the end of each financial reporting period prior to vesting, the value of these options, as calculated using the Black-Scholes option pricing model, was re-measured using the then current fair value of our ordinary shares. Since the fair market value of the ordinary shares to non-employees is subject to change in the future, the compensation expense recognized during the years ended December 31, 2008, 2007 and 2006 may not be indicative of future compensation charges.
 
Goodwill

Under Statement of Financial Accounting Standard No. 142, “Goodwill and Other Intangible Assets”, or SFAS 142, goodwill acquired in a business combination is deemed to have indefinite life and will not be amortized. SFAS 142 requires goodwill to be tested for impairment at least annually and between annual tests in certain circumstances, and written down when impaired. Goodwill is tested for impairment by comparing the fair value of each reporting units with its carrying value.
 
Our reporting units for purposes of the impairment test are our two operating segments, the core technology, and drug screening laboratory services. We compare the fair value of each reporting unit to its carrying value, including goodwill. We estimate the fair value of each reporting unit by estimating the present value of the reporting unit's future cash flows. If the fair value exceeds the carrying value, no impairment loss is recognized. If the carrying value exceeds the fair value, the goodwill of the reporting unit is considered potentially impaired and the second step is completed in order to measure the impairment loss. Under the second step goodwill is reduced to its implied fair value through an adjustment to the goodwill balance, resulting in an impairment charge.

As of December 31, 2008, the net book value of  goodwill was $2.8 million. In accordance with SFAS 142, we performed an annual assessment of goodwill impairment as of December 31, 2008 for the laboratory services segment. This was undertaken due to certain indicators of impairment such as a decline in fair value of publicly traded competitive companies our recent operating results and the determination in 2008 that goodwill have been impaired. We performed the impairment analysis based on estimated discounted future cash flow. As a result of this analysis, we determined that goodwill impairment related to the laboratory services had occurred and recognized a non-cash impairment charge of $850,000.

Intangible Assets

Intangible assets acquired in a business combination are recorded at fair value at the date of acquisition. Following initial recognition, intangible assets are carried at cost less any accumulated amortization and any accumulated impairment losses. The useful lives of intangible assets are assessed to be either finite or indefinite. Intangible assets with finite lives are amortized over their useful economic life using a method of amortization that reflects the pattern in which the economic benefits of the intangible assets are consumed or otherwise used up and are assessed for impairment whenever there is an indication that the intangible asset may be impaired. The amortization period and the amortization method for an intangible asset with a finite useful life are reviewed at least at each financial year-end.

Impairment of Long-Lived Assets

The long-lived assets of us and of our subsidiaries and all identifiable intangible assets that are subject to amortization are reviewed for impairment in accordance with Statement of Financial Accounting Standard No. 144 "Accounting for the Impairment or Disposal of Long-Lived Assets" or "SFAS No. 144", whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. As of December 31, 2008 and 2007, no impairment losses have been identified.

 
40

 

Convertible Notes

On September 24, 2008, we signed a convertible note agreement with certain private investors in order to provide separate funding for Rosetta Green. Under this agreement, the investors may purchase convertible notes in an amount up to $ 2.5 million. To date, the investors have invested a total amount of $1,500,000, in two tranches. Once we establish Rosetta Green Ltd., the convertible notes we issued to the investors will convert into a number of Rosetta Green Ltd. ordinary shares as is obtained by dividing the principal amount of the note by a price per share reflecting a fully-diluted pre-money valuation equal to $5,000,000. If Rosetta Green Ltd. is not established within 24 months as of the initial closing, which took place on or about September 24, 2008, or if the Rosetta’s Board resolves not to establish Rosetta Green, the notes will convert into our ordinary shares at a price per share equal to the average of the closing prices over the five consecutive trading days ending on the last trading day prior to the date of conversion, provided that such conversion price shall not be lower than $2.00 per share. We plan to establish the green energy project during 2010. Please see “Item 4. Information on the Company — B. Business Overview — Rosetta Green” for a description of this project.
 
Convertible notes are accounted for in accordance with the provisions of Emerging Issues Task Force ("EITF") Issue No. 00-19, "Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company's Own Stock" or "EITF 00-19". The Company has also considered Statements of Financial Accounting Standard No.133, "Accounting for Derivatives, Instruments and Hedging Activities" or "SFAS 133", APB 14, "Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants" and EITF 05-2 "The Meaning of "Conventional Convertible Debt Instrument" in Issue No. 00-19", We, where applicable, recorded an embedded derivative instrument classified as a liability.

Recently Issued Accounting Standards
 
In November 2007, the EITF issued EITF Issue No. 07-1 , "Accounting for Collaborative Arrangements Related to the Development and Commercialization of Intellectual Property."
 
Companies may enter into arrangements with other companies to jointly develop, manufacture, distribute, and market a product. Often the activities associated with these arrangements are conducted by the collaborators without the creation of a separate legal entity (that is, the arrangement is operated as a "virtual joint venture"). The arrangements generally provide that the collaborators will share, based on contractually defined calculations, the profits or losses from the associated activities. Periodically, the collaborators share financial information related to product revenues generated (if any) and costs incurred that may trigger a sharing payment for the combined profits or losses. The consensus requires collaborators in such an arrangement to present the result of activities for which they act as the principal on a gross basis and report any payments received from (made to) other collaborators based on other applicable GAAP or, in the absence of other applicable GAAP, based on analogy to authoritative accounting literature or a reasonable, rational, and consistently applied accounting policy election.
 
EITF 07-1 is effective for collaborative arrangements in place at the beginning of the annual period beginning after December 15, 2008. The Company is currently evaluating the impact that the adoption of EITF 07-1 could have on the Company's financial statement.
 
In December 2007, the FASB issued SFAS 141(R), ''Business Combinations'' or "SFAS 141(R)''. This Statement replaces SFAS No. 141, ''Business Combinations'' , and requires an acquirer to recognize the assets acquired, the liabilities assumed, including those arising from contractual contingencies, any contingent consideration and any noncontrolling interest in the acquiree at the acquisition date, measured at their fair values as of that date, with limited exceptions specified in the statement. SFAS 141(R) also requires the acquirer in a business combination achieved in stages (sometimes referred to as a step acquisition) to recognize the identifiable assets and liabilities, as well as the noncontrolling interest in the acquiree, at the full amounts of their fair values (or other amounts determined in accordance with SFAS 141(R)). In addition, SFAS 141(R)'s requirement to measure the noncontrolling interest in the acquiree at fair value will result in recognizing the goodwill attributable to the noncontrolling interest in addition to that attributable to the acquirer.
 
SFAS 141(R) applies prospectively to business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. As such, the adoption of SFAS 141(R) is not expected to have a material effect on accounting for our current subsidiaries.
 
A.   OPERATING RESULTS
 
Years Ended December 31, 2008 and 2007
 
Revenues. As of December 31, 2008, we had recognized $1,511,000 as revenues, all of which are related to the drug screening laboratory services segment, which was sold in May 2009. Accordingly, we do not expect any further revenues from this segment after May 2009. We expect the first diagnostic products applying our microRNA technology that were launched in late 2008 to start generating revenues in 2009.

 
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Research and development expense, net. Research and development expenses were $8.7 million for the year ended December 31, 2008, including $288,000 of non-cash stock-based compensation, as compared to $6.4 million for the year ended December 31, 2007, which included $260,000 of non-cash deferred stock-based compensation. Research and development expenses for the year ended December 31, 2008 increased as we made progress with our proprietary diagnostic pipeline, and as a result of an increase in costs related to salaries due to an increase in employees, and expenses related to the opening of our new laboratory. We expect research and development expenses to increase in 2009 as we add more products to our pipeline.
 
Marketing and business development expenses. Marketing and business development expenses were $2.4 million for the year ended December 31, 2008, including $239,000 of non-cash stock-based compensation, as compared to $1.7 million for the year ended December 31, 2007, including $225,000 of non-cash stock-based compensation. This increase resulted primarily from marketing expenses related to the launch of the new products at the end of 2008. We expect marketing and business development expenses to increase in 2009 as we search for distributors and partners and in preparation for the launch of additional products.
 
General and administrative expenses. General and administrative expenses were $3.7 million for the year ended December 31, 2008, including $481,000 of non-cash stock-based compensation, as compared to $2.9 million for the year ended December 31, 2007, which included $550,000 of non-cash stock-based compensation. This increase resulted primarily from costs associated with the acquisition of Parkway in addition to an increase in expenses to operate as a public company.
 
Financial expenses (income), net. Net financial income was $5.5 million for the year ended December 31, 2008, as compared to net financial expense of $3.6 million for the year ended December 31, 2007.  Financial income in 2008 included gain of  $5.6 million related to the sale of the ARS. Financial expenses in 2007 included $5 million impairment charge of marketable securities offset by $1.4 million derived from interest income on bank deposits and realized income from marketable securities.
 
Years Ended December 31, 2007 and 2006
 
Revenues. As of December 31, 2007, we had not recognized any revenues.
 
Research and development expense, net. Research and development expenses were $6.4 million for the year ended December 31, 2007, including $260,000 of non-cash stock-based compensation, as compared to $4.8 million for the year ended December 31, 2006, which included $247,000 of non-cash deferred stock-based compensation. Research and development expenses for the year ended December 31, 2007 increased as we made progress with our proprietary diagnostic pipeline,  and as a result of an increase in costs related to salaries and related expenses for the hiring of additional research and development personnel, the filing, prosecution and maintenance of our intellectual property portfolio, and license fees.
 
Marketing and business development expenses. Marketing and business development expenses were $1.7 million for the year ended December 31, 2007, including $225,000 of non-cash stock-based compensation, as compared to $1.5 million for the year ended December 31, 2006, including $49,000 of non-cash stock-based compensation. This increase resulted primarily from an increase in salaries and related expenses from the addition of business development and marketing personnel to support our alliances and expanding research and development collaborations.
 
General and administrative expenses. General and administrative expenses were $2.9 million for the year ended December 31, 2007, including $550,000 of non-cash stock-based compensation, as compared to $1.9 million for the year ended December 31, 2006, which included $696,000 of non-cash deferred stock-based compensation. This increase resulted primarily from an increase in costs relating to our operation as a public company.
 
Financial expenses (income), net. Net financial expense was $3.6 million for the year ended December 31, 2007, as compared to net financial income of $538,000 for the year ended December 31, 2006.  Financial expenses in 2007 included $5 million impairment charge of marketable securities offset by $1.4 million derived from interest income on bank deposits and realized income from marketable securities.
 
B.   LIQUIDITY AND CAPITAL RESOURCES
 
Since our inception, we have generated significant losses and expect to continue to generate losses for the foreseeable future. As of December 31, 2008, we had an accumulated deficit of $45 million. We have funded our operations primarily through the proceeds from the sales of our equity securities. Through December 31, 2008, we had received aggregate gross proceeds of approximately $60.7 million from the sales of our equity securities. As of December 31, 2008, we had cash, cash equivalents, short-term bank deposit and marketable securities of $15.7 million, compared to $24.3 million as of December 31, 2007.
 
As of December 31, 2007, we had $7.4 million of principal invested in Auction Rate Securities, or ARS, ranked AAA/Aaa at the time of purchase. All of these securities retained at least AAA or Aaa rating as of December 31, 2007. All securities continue to pay interest in accordance with their stated terms as of December 31, 2007. However, since these ARS had experienced multiple failed auctions due to a lack of liquidity in the market for these securities, we revalued our ARS portfolio. As a result, we recorded an impairment charge of $5.0 million in our statement of operations to reflect other than temporary decline in the value of the investment in ARS. During 2008, we recorded an additional impairment of $631,000 related to the ARS.

During the fourth quarter of 2008, we received $7.4 million from the repurchase of the ARS following an unexpected offer to settle the ARS and recorded gain in the amount of $5.6 million upon receiving the funds.
 
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On April 10, 2009, we entered into a stock purchase agreement with Prometheus Laboratories, pursuant to which on April 27, 2009, Prometheus purchased 2,000,000 of our ordinary shares at a price of $ 4.00 per share in a private placement transaction, resulting in gross proceeds of $8 million to us.
 
Cash Flows
 
Net cash used in operating activities. Net cash used in operating activities was $12 million in 2008, compared to $8 million in 2007 and $6.4 million in 2006. These amounts were used to fund our net losses for these periods, adjusted for non-cash expenses and changes in operating assets and liabilities. The increase in the net cash used for operating activities between the years was primarily the result of the reversal of impairment of the ARS securities of $5.6 million.
 
Net cash used in investing activities. Net cash provided from investing activities was $12.1 million in 2008, compared to net cash used in investing activities of $11.1 million in 2007 and $5.6 million in 2006. Net cash used in investing activities in 2007 and 2006 consisted primarily of investment of our cash in short terms bank deposits and marketable securities and the purchase of property and equipment. Net cash provided from investing activities in 2008 is primarily from sales of marketable securities, including the ARS, offset by the purchase of Parkway in July 2008.
 
Net cash provided by financing activities. Net cash provided by financing activities was $689,000 in 2008, compared to $27.3 million in 2007 and $12.3 million in 2006. In 2008, net cash provided from financing activities consisted primarily from proceeds from the issuance of convertible loan. The principal sources of net cash provided by financing activities in 2007 was net proceeds from the sale and issuance of equity securities, including our initial public offering, and proceeds from the exercise of warrants. The principal sources of net cash provided by financing activities in 2006 was net proceeds from the sale and issuance of equity securities, and proceeds from the exercise of warrants.
 
Funding Requirements
 
We expect to incur continuing and increasing losses from operations for at least the next several years. In particular, as described above, we expect to incur increasing research and development expenses, marketing and business development expenses and general and administrative expenses in the future as we expand our operations and product development efforts and continue operating as a public company. We believe that our existing cash, cash equivalents, short term bank deposits and marketable securities, and funding we expect to receive under our current collaboration and license agreements will be sufficient to fund our operations through at least the first quarter of 2011. However, our funding requirements may change and will depend upon numerous factors, including but not limited to:
 
 
·
progress in our research and development programs;
 
 
·
the resources, time and costs required to initiate and complete development and any required preclinical studies and clinical trials, and obtain regulatory approvals for our products;
 
 
·
the timing, receipt, and amount of milestone, royalty and other payments from present and future collaborators, if any;
 
 
·
costs necessary to protect our intellectual property;
 
 
·
the timing, receipt and amount of sales, if any, by us of any approved products.
 
We anticipate that we will require substantial additional funding and expect to augment our cash balance through financing transactions, including the issuance of debt or equity securities and further strategic collaborations. No arrangements have been entered into for any future financing, and there can be no assurance that we will be able to obtain adequate levels of additional funding on favorable terms, if at all. If adequate funds are not available, we may be required to:

 
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·
delay, reduce the scope of or eliminate certain research and development programs;
 
 
·
obtain funds through arrangements with collaborators or others on terms unfavorable to us or that may require us to relinquish rights to certain technologies or products that we might otherwise seek to develop or commercialize independently;
 
 
·
or pursue merger or acquisition strategies.
 
C.   RESEARCH AND DEVELOPMENT, PATENTS AND LICENSES, ETC.
 
Our research and development expenditures were $8.7 million, $6.4 million and $4.8 million, in the years ended December 31, 2008, 2007 and 2006, respectively. See also “Item 5. Operating and Financial Review and Prospects - Financial Operations Overview - Research and Development Expenses.”
 
D.   TREND INFORMATION
 
See “Item 5. Operating and Financial Review and Prospects.”
 
E.   OFF-BALANCE SHEET ARRANGEMENTS
 
We are not party to any material off-balance-sheet arrangements.
 
F.   TABULAR DISCLOSURE OF CONTRACTUAL OBLIGATIONS
 
Set forth below is a description of our contractual cash obligations as of December 31, 2008. Operating and capital lease obligations consist of rent payable under our existing facility leases and lease payments for company automobiles and equipment. Other long-term obligations consist of cash obligations under various license agreements.
 
   
Total
   
2009
   
2010
   
2011
   
2012
   
2013
   
Thereafter
 
   
(In thousands)
 
Operating and capital lease obligations
  $ 2,756     $ 985     $ 750     $ 403     $ 372     $ 246     $ -  
Other long-term liabilities
  $ 4,977     $ 150     $ 189     $ 228     $ 253     $ 253     $ 3,904  
 

* Under our license agreements as of December 31, 2008, we are obligated to pay an aggregate amount of approximately $253,000 annually after 2013 and until 2022, $190,000 annually after 2022 and until 2029 and $100,000 annually after 2029 and until 2032. Each of these agreements terminates upon the expiration of all patents relating to such agreement, including patents to be filed and potentially issued at an indeterminable date in the future, and, thus, such termination dates cannot be determined at this time. Accordingly, we are also unable to determine the aggregate amount of such payments due after 2013 at this time. However, based on current facts and circumstances, we estimate that our obligations under these agreements will be through at least 2032. See “Item 4. Information on the Company” for more information on our contractual obligations.
 
The above table does not include obligations for accrued severance pay, which as of December 31, 2008 was $520,000, of which $131,000 was funded through deposits into severance pay funds, leaving a net obligation of $389,000.  In addition, the table does not include obligations for convertible notes on the amount of $750,000 as of December 31, 2008 and $1,500,000 as of to date.
 
 
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ITEM 6.  DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
 
A.  DIRECTORS AND SENIOR MANAGEMENT
 
The following table sets forth information regarding our executive officers and directors:
 
Name
 
Age
 
Position
Amir Avniel
 
36
 
Chief Executive Officer and President
Ronen Tamir
 
42
 
Chief Commercialization Officer
Dalia Cohen, Ph.D.
 
57
 
Chief Scientific Officer
Ranit Aharonov, Ph.D.
 
39
 
Executive Vice President, R&D, Head of Computational Biology
Ayelet Chajut, Ph.D.
 
46
 
Executive Vice President, R&D, Head of Molecular Biology
Limor Zur-Stoller
 
40
 
Vice President Finance
Tami Fishman Jutkowitz
 
33
 
General Counsel
Yoav Chelouche(2)(3)
 
55
 
Chairman of the Board
Isaac Bentwich, M.D.
 
47
 
Director
Prof. Moshe Many, M.D.(1)
 
80
 
Director
Simcha Sadan, Ph.D.
 
68
 
Director
Joshua Rosensweig, Ph.D.
 
56
 
Director
Gerald Dogon(1)(2)(3)
 
69
 
External Director
Tali Yaron-Eldar(1)
 
45
 
External Director
 

(1)           Member of our Audit Committee
 
(2)           Member of our Compensation Committee
 
(3)           Member of our Nominating and Corporate Governance Committee
 
Amir Avniel has served as our Chief Executive Officer since April 2006 and as President since May 2005. Mr. Avniel joined us in May 2001 and previously held other senior management positions, including Chief Technology Officer and Chief Operating Officer. Mr. Avniel is responsible for the overall planning and execution of our operations, business development, technology and research and development efforts. He also coordinates the development of agreements and collaborations between us and other industry leaders. He has been named co-author of 20 patent applications. Mr. Avniel studied computer science at the Academic College of Tel Aviv - Jaffa, Israel. Prior to his academic studies, he served as an officer in the Israel Defense Force, where he was awarded four commendations for excellence.
 
Ronen Tamir has served as our Chief Commercialization Officer since September 2008. Mr. Tamir joined us in December 2007 and held the position of Vice President, Marketing and Communication until September 2008. Prior to joining us, he was Vice President, Investor Relations for North America at Novartis AG. While Mr. Tamir was at Novartis, Novartis significantly increased its North American shareholder base and his team won numerous awards, including the “Best European IR Team in North America for 2005” by IR magazine, the “Silver Anvil” award by the Public Relations Society of America, and the “Big Apple - Best of the Best” award by the Institution of Public Relations, for an investor relations campaign in 2006. Prior to joining Novartis in 2004, Mr. Tamir held several key positions at Serono, including Director of Business Intelligence for North America and Global Product Manager, Neurology, in Geneva, Switzerland, where he oversaw the global launch of Rebif, the leading therapy for Multiple Sclerosis. In addition, Mr. Tamir was the Regional Product Manager for Neurology and Metabolism for Serono’s Intercontinental Business Operations. Ronen holds a degree in Biology from Bar-Ilan University in Israel and an MBA from Warwick Business School in the UK.
 
Dalia Cohen, Ph.D. has served as our Chief Scientific Officer since February 2008. Dr. Cohen joined us in August 2006 and held the position of Executive Vice President, Global Head of Research and Development until February 2008. Prior to joining us, Dr. Cohen served in several executive positions at Novartis AG. From May 2005 to June 2006, Dr. Cohen served as Vice President and Global Head for Strategic and Enabling Technologies and Molecular Medicine, at the Novartis Institute for Biomedical Research. From October 1998 to April 2005, Dr. Cohen established and served as Vice President and Global Head of the Functional Genomics Department at the Novartis Institute for Biomedical Research. From 1997 to 1998, Dr. Cohen served as Executive Director and Senior Expert of Molecular and Cellular Biology at Novartis Pharma Research. From 1992 to 1996, Dr. Cohen was a Research Fellow in the Oncology Department at Sandoz Pharmaceutical Corporation, and from 1986 to 1992, Dr. Cohen was a Research Associate in the Department of Molecular Pharmacology at the Albert Einstein College of Medicine. In addition, Dr. Cohen is an Adjunct Professor at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School. Dr. Cohen received her Ph.D. in Cell Biology from the Faculty of Medicine at Technion, Israel Institution of Technology and has published more than 70 scientific articles.

 
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Ranit Aharonov, Ph.D. has served as our Executive Vice President, R&D, Head of Computational Biology since February 2008. Dr. Aharonov joined us in March 2003 and previously held other positions, including Executive Vice President of IP and Computational Biology, Vice President of Research and Product Strategy, Vice President, Research and Director, Algorithms. Prior to joining us, from October 1998 until September 2002, Dr. Aharonov taught Neural Computation-related courses at the Hebrew University of Jerusalem. She is the author of nine papers published in peer reviewed journals and the co-author of 31 patent applications, and was an adjunct lecturer in Neural Network Theory and Applications at the Brain Science Institute of Bar-Ilan University. Dr. Aharonov earned her Ph.D. in Neural Computation from the Hebrew University in Jerusalem.
 
Ayelet Chajut, Ph.D. has served as our Executive Vice President, R&D, Head of Molecular Biology since February 2008. Dr. Chajut joined us on June 2006 and previously held several positions including Vice President of Genomics and Vice President of Diagnostics . Prior to joining us, from February 1999 until May 2005, Dr. Chajut held different positions at Quark Biotech, Inc., including Vice President of Research from March 2003 until May 2005. Dr. Chajut continued to serve as a general consultant to Quark Biotech, Inc. from May 2005 until December 2005. From May 2005 until April 2006, Dr. Chajut was the Director of Research and Development at Quantomix. She is the author of ten papers published in peer reviewed journals and the co-author of 4 patent applications. Dr. Chajut earned her Ph.D. in Molecular Biology of Lenti-viruses from the Department of Human Microbiology, Tel-Aviv University and did her Post Doctoral studies from 1994 through 1997 in the Department of Cell Research and Immunology, Faculty of Life Sciences, Tel-Aviv University.
 
Limor Zur-Stoller has served as our Vice President of Finance since November 2008. Prior to joining us, Ms. Zur-Stoller  served as GammaCan International Inc.'s Chief Financial Officer from March 2008 until November 2008. From November 2001 until March 2008, Ms. Zur-Stoller worked at RadView Software Ltd., including as Vice President of Finance (August 2006 - March 2008). Director of Finance (July 2004 - August 2006) and Controller (November 2001 -July 2004).  From December 1997 until June 2001, Ms. Zur-Stoller served as the International Controller at Check Point Software Technologies Ltd.  From June 1994 until December 1997, Ms. Zur-Stoller was an auditor with the accounting firm of Deloitte Brightman Almagor, a member of Deloitte Touche Tohmatsu.  Ms. Zur-Stoller received a B.A. in accounting and economics from Tel Aviv University and an M.B.A. in finance and accounting from The College of Management in Israel and is a Certified Public Accountant.
 
Tami Fishman Jutkowitz has served as our General Counsel since February 2006. Previous to joining us, she served as legal counsel to Applied Materials Inc, the Israeli subsidiary of Applied Materials Inc. from December 2004 until February 2006. From August 2000 until December 2004, Ms. Jutkowitz was an associate in the law firm Tulchinski Stern and Co.  Ms. Jutkowitz has an LLB in law studies from the Bar Ilan University and an M.B.A. in finance from the Bar Ilan University.
 
Yoav Chelouche has served as Chairman of our board of directors since April 2006, and as a member of our board of directors since 2003. Mr. Chelouche has over 20 years of experience in leadership and management within the high technology sector. Since 2001, Mr. Chelouche has been a managing partner of Aviv Venture, an Israel-based technology venture capital fund. From 1995 to 2001, he served as President and Chief Executive Officer of Scitex Corp., a leader in digital imaging and printing systems. From 1980 to 1995, he held several management positions at Scitex, including Vice President, Strategy and Business Development, Vice President Marketing and Vice President, Finance - Europe. Mr. Chelouche holds an MBA from INSEAD, Fontainebleau, France and a B.A. in Economics and Statistics from Tel Aviv University, Israel.
 
Isaac Bentwich, M.D. , our founder, has been a member of our board of directors since our inception in 2000. He also served as our Chief Executive Officer from inception to May 2005, as the Chairman of our board of directors from inception to April 2006 and as our Chief Architect from May 2005 to May 2009 . Dr. Bentwich is a physician by training and an entrepreneur. Prior to founding Rosetta Genomics, Dr. Bentwich was Executive Vice President of Physician’s Solutions at HBOC, now a part of McKesson Corporation, a healthcare services company. Dr. Bentwich joined HBOC in 1995, when it acquired Pegasus Medical Ltd., an Israeli medical-informatics company he founded and led. He is the co-author of 45 patent applications. Dr. Bentwich holds an M.D. from Ben-Gurion University of the Negev.
 
Prof. Moshe Many, M.D., Ph.D . has served as a member of our board of directors since December 2003. A surgeon by training, Prof. Many has served as Chairman of the Research and Development Committee of Teva Pharmaceutical’s board of directors since 1991. He formerly served as Chairman of Surgery and Chief of Urology at the Sheba Medical Center, after which he was appointed to serve as President of Tel Aviv University from 1983 through 1991. He now serves as President of Ashkelon Academic College. Prof. Many holds an M.D. from the Geneva University, and a Ph.D. from Tufts University.
 
Simcha Sadan, Ph.D. has served as a member of our board of directors since December 2006. Dr. Sadan has been serving as the Chairman of the Board of Club Hotel Europe Ltd. and of Premier Club Ltd. Dr. Sadan has also served as an alternate director at several public companies, such as, Shaniv Household Paper Industry Limited, Haribua Hakachol, Telkoor Telecom Ltd. and others. Dr. Sadan also held different executive and consultancy positions and was also a member of governmental and professional committees. Dr. Sadan had been a member of the Faculty of Management at Tel Aviv University. Dr. Sadan holds a Ph.D. in Business Administration from the University of California, Berkeley, M.B.A. majoring in accounting and finance and B.A in Economics and Statistics from the Hebrew University and an L.L.B. from the Faculty of Law at Tel-Aviv University.

 
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Joshua Rosensweig has served as a member of our board of directors since May 2004. From September 2003 to September 2006, Dr. Rosensweig served as the Chairman of the board of directors of the First International Bank of Israel. Since 2003, he has also served as member of the board of directors of Plastro Irrigation Systems Ltd. From 1998 to July 2005, Dr. Rosensweig was a senior partner at Gornitzky and Co., a law firm where he specialized in international transactions and taxation, and where he now serves as of counsel. Dr. Rosensweig lectured at Bar-Ilan University, Law School from 1980 to 1995 and at Tel Aviv University, School of Business from 1983 to 1995. Dr. Rosensweig received his J.S.D. (International Taxation), and LL.M. (Taxation) from New York University Law School.
 
Gerald Dogon has served as a member of our board of directors since February 2007. Since December 2007, Mr. Dogon has served as a member of the board of directors of Fundtech Ltd. and also serves as member of its Audit and Nominating Committees. From December 2004 to December 2006, Mr. Dogon served as a director and a member of the audit, investment and nomination committees of Scailex Corporation (previously Scitex Corporation). From October 2005 until it was acquired by PMC-Sierra, Inc. in May 2006, he served as member of the board of directors of Passave, Inc., a semiconductor company. From 1999 to 2000, he served as a director and as chairman of the audit committee of Nogatech, Inc. From 1994 to 1998, Mr. Dogon served as Executive Vice President and Chief Financial Officer of DSPC Inc., and from November 1997 until December 1999, he served as a director of DSPC Inc. Mr. Gerald holds a B.A. in Economics from the University of Cape Town.
 
Tali Yaron-Eldar has served as a member of our board of directors since February 2007. Since January 2004, Ms. Yaron-Eldar has served as the Chief Executive Officer of Arazim Investment Company. In addition, since March 2007, she has been a partner with the law firm of Tadmor & Co. From January 2004 to March 2007, Ms. Yaron-Eldar was a partner with the law firm Cohen, Yaron-Eldar & Co. Ms. Yaron-Eldar, has also served in a variety of public positions, including as the Chief Legal Advisor of the Customs and V.A.T department of the Finance Ministry of the State of Israel from 1998 to 2001 and as the Commissioner of Income Tax and Real Property Tax Authority of the State of Israel from 2002 to 2004. Ms. Yaron-Eldar holds an MBA specializing in finance and an LL.M. from Tel Aviv University and is a member of the Israeli Bar Association
 
B.  COMPENSATION
 
The aggregate direct compensation we paid to our executive officers as a group (nine persons) for the year ended December 31, 2008 was approximately $1,422,000 of which approximately $105,000 was set aside or accrued to provide for pension, retirement, severance or similar benefits. These amounts do not include expenses we incurred for other payments, including dues for professional and business associations, business travel and other expenses, and other benefits commonly reimbursed or paid by companies in Israel. We also paid one-time bonuses to five of our executive officers in the aggregate amount of $209,000 upon performance during 2008. During 2008 we paid $221,000 direct compensation to Dr. Isaac Bentwich, our founder and a member of our board of directors, of which approximately $24,080 was set aside or accrued to provide for pension, retirement, severance or similar benefits.
 
We paid an aggregate of $109,300 in direct compensation to our directors other than our Chairman, Yoav Chelouche, for their services as directors for the year ended December 31, 2008. We paid $84,000 to Mr. Chelouche in 2008 for services rendered in 2008 as the Chairman of our board of directors. We have entered into an agreement with Yoav Chelouche to serve as Chairman of our board of directors. Under this agreement, Mr. Chelouche receives a monthly retainer fee of $7,000, as well as options to purchase our ordinary shares. Each of our non-executive directors, other than Mr. Chelouche and Dr. Bentwich, receives an annual fee of $10,000. An additional annual fee of $10,000 is paid to each non-executive director for serving on one of our committees.
 
As of June 1, 2009, there were outstanding options to purchase 879,182 ordinary shares that were granted to 14 of our directors and officers, at a weighted average exercise price of $3.92 per share.
 
C.  BOARD PRACTICES
 
We are incorporated in Israel, and, therefore, subject to various corporate governance practices under Israeli law relating to such matters as independent directors, the audit committee and the internal auditor. These matters are in addition to the requirements of The NASDAQ Global Market and other relevant provisions of U.S. securities laws. Under The NASDAQ Global Market rules, a foreign private issuer may generally follow its home country rules of corporate governance in lieu of the comparable NASDAQ Global Market requirements, except for certain matters such as composition and responsibilities of the audit committee and the independence of its members. For U.S. domestic companies, NASDAQ Global Market rules specify that the board of directors must contain a majority of independent directors within 12 months of its initial public offering. We currently comply with this requirement as well as the committee composition and responsibility requirements with respect to our audit committee and our other committees. In addition, under the Israeli Companies Law, 5759-1999, as amended (the “Companies Law”), we are required to appoint at least two external directors, and this appointment must be confirmed by our shareholders no later than three months after the closing of an initial public offering. We have appointed Gerald Gogon and Tali Yaron-Eldar as our external directors, each of whom is also independent under the rules of The NASDAQ Global Market. The appointment of Mr. Dogon and Ms. Yaron-Eldar was confirmed by our shareholders at an extraordinary general meeting held on May 30, 2007.

 
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Board of Directors
 
Our board of directors currently consists of eight directors, including two external directors. Certain of our current directors were appointed by certain of our shareholders or by our founding shareholders pursuant to board appointment rights granted to such shareholders in connection with their purchase of our shares. These rights terminated after the initial public offering, and from now on, our directors, apart from the external directors, will be elected by a vote of the holders of a majority of the voting power represented at a meeting of our shareholders and voting on the election of directors. Our articles of association provide that we may have no less than two and up to 11 directors.
 
Each director will hold office until the annual general meeting of our shareholders for the year in which his or her term expires or until his or her successor shall be elected and qualified. The approval of at least 75% of the voting rights represented at a general meeting is generally required to remove any of our directors from office. A simple majority of our shareholders at a general meeting may elect directors in their stead or fill any vacancy, however created, in our board of directors. In addition, vacancies on the board of directors, other than vacancies created by an external director, may be filled by a vote of a majority of the directors then in office. Our board of directors may also appoint additional directors up to the maximum number permitted under our articles of association. A director so chosen or appointed will hold office until the next general meeting of our shareholders. See “— External Directors” below for a description of the procedure for election of external directors.
 
In accordance with our amended and restated articles of association, our board of directors, apart from our external directors, are divided into three classes with staggered three-year terms. At each annual general meeting of shareholders, the successors to directors whose terms then expire will be elected to serve from the time of election and qualification until the third annual meeting following election. Our directors are divided among the three classes as follows:
 
 
·
the Class I director is Yoav Chelouche, and his term expires at the annual general meeting of shareholders to be held in 2011;
 
 
·
the Class II directors are Dr. Simcha Sadan, and Dr. Joshua Rosensweig, and their terms expire at the annual general meeting of shareholders to be held in 2009; and
 
 
·
the Class III directors are Prof. Moshe Many and Dr. Isaac Bentwich, and their terms expire at the annual general meeting of shareholders to be held in 2010.
 
In addition, our two external directors, Gerald Dogon and Tali Yaron-Eldar, were appointed by our shareholders on May 30, 2007 for three-year terms. See “External Directors” below.
 
Any additional directorships resulting from an increase in the number of directors will be distributed among the three classes so that, as nearly as possible, each class will consist of one-third of the directors.
 
Our articles of association provide, as allowed by Israeli law, that any director may, by written notice to us, appoint another person to serve as an alternate director (subject to the approval of a majority of the other directors in a written resolution or at the next meeting of the board of directors) and may cancel such appointment. The term of appointment of an alternate director may be for one meeting of the Board of Directors, or for a specified period, or until notice is given of the termination of the appointment. To our knowledge, no director currently intends to appoint any other person as an alternate director. The Companies Law stipulates that a person not qualified to be appointed as a director, shall not be appointed and shall not serve as alternate director. In addition, a person who serves as a director shall not be appointed and shall not serve as an alternate director except under very limited circumstances. An alternate director has the same responsibilities as a director.
 
External Directors
 
Qualifications of External Directors
 
Companies incorporated under the laws of the State of Israel whose shares are listed on a stock exchange, including The NASDAQ Global Market, are required to appoint at least two external directors. We have appointed Gerald Dogon and Tali Yaron-Eldar, who qualify as external directors under the Companies Law. The appointment of our external directors was  confirmed by our shareholders at an extraordinary general meeting held on May 30, 2007. The Companies Law provides that a person may not be appointed as an external director if the person, or the person’s relative, partner, employer or any entity under the person’s control, has or had during the two years preceding the date of appointment any affiliation with the company or any entity controlling, controlled by or under common control with the company.

 
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The term affiliation includes:
 
 
·
an employment relationship;
 
 
·
a business or professional relationship maintained on a regular basis;
 
 
·
control; and
 
 
·
service as an office holder, excluding service as a director in a private company prior to the first offering of its shares to the public if such director was appointed as a director of the private company in order to serve as an external director following the public offering.
 
The term “office holder” is defined in the Companies Law as a director, general manager, chief business manager, deputy general manager, vice general manager, executive vice president, vice president, any other manager directly subordinate to the general manager or any other person assuming the responsibilities of any of the foregoing positions, without regard to such person’s title.
 
No person can serve as an external director if the person’s position or other business creates, or may create, a conflict of interest with the person’s responsibilities as an external director or may otherwise interfere with the person’s ability to serve as an external director. If at the time an external director is appointed all current members of the board of directors are of the same gender, then that external director must be of the other gender.
 
An amendment to the Companies Law in January 2006 provides that a person may be appointed as an external director if he or she has professional qualifications or if he or she has accounting and financial expertise. In addition, at least one of the external directors must have accounting and financial expertise. In determining the number directors required to have such expertise, the members of the board of directors must consider, among other things, the type and size of the company and the scope and complexity of its operations. The board of directors has determined that our company requires at least one director with the requisite accounting and financial expertise, who is Mr. Dogon, and that both of our external directors possess the requisite professional qualifications.
 
Until the lapse of two years from termination of office, a company may not appoint an external director as an office holder and cannot employ or receive services from that person for pay, either directly or indirectly, including through a corporation controlled by that person.
 
Election of External Directors
 
External directors are elected by a majority vote at a shareholders’ meeting, provided that either:
 
 
·
at least one-third of the shares of non-controlling shareholders that voted at the meeting, vote in favor of the election of the external director (disregarding abstentions); or
 
 
·
the total number of shares of non-controlling shareholders that voted against the election of the external director does not exceed one percent of the aggregate voting rights in the company.
 
The initial term of an external director is three years and he or she may be reelected to one additional term of three years. Thereafter, he or she may be reelected by our shareholders for additional periods of up to three years each, in each case provided that the audit committee and the board of directors confirm that, in light of the external director’s expertise and special contribution to the work of the board of directors and its committees, the reelection for such additional period(s) is beneficial to the company. An external director may only be removed by the same percentage of shareholders as is required for his or her election, or by a court, and then only if the external director ceases to meet the statutory requirements for his or her appointment or if the external director violates his or her duty of loyalty to the company. If an external directorship becomes vacant, a company’s board of directors is required under the Companies Law to call a shareholders’ meeting immediately to appoint a new external director.
 
Each committee of a company’s board of directors that has the right to exercise a power delegated by the board of directors is required to include at least one external director and our audit committee is required to include all of the external directors. An external director is entitled to compensation only as provided in regulations adopted under the Companies Law and is otherwise prohibited from receiving any other compensation, directly or indirectly, in connection with services provided as an external director.

 
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Board Committees
 
Our board of directors has established an audit committee, a compensation committee and a nominating and corporate governance committee.
 
Audit Committee
 
Under the listing requirements of The NASDAQ Global Market, a foreign private issuer is required to maintain an audit committee that operates under a formal written charter and has certain responsibilities and authority, including being directly responsible for the appointment, compensation, retention and oversight of the work of the issuer’s independent auditors. The members of the audit committee are required to meet the independence requirements established by the SEC in accordance with the requirements of the Sarbanes-Oxley Act. The rules of The NASDAQ Global Market also require that at least one member of the audit committee be a financial expert. Our audit committee is comprised of three members and meets the listing requirements of The NASDAQ Global Market and the SEC.
 
Under the Companies Law, the board of directors of a public company must establish an audit committee. The audit committee must consist of at least three directors and must include all of the company’s external directors. The audit committee may not include the chairman of the board, any director employed by the company or providing services to the company on an ongoing basis, a controlling shareholder or any of a controlling shareholder’s relatives.
 
Our audit committee provides assistance to the board of directors in fulfilling its legal and fiduciary obligations in matters involving our accounting, auditing, financial reporting, internal control and legal compliance functions by pre-approving the services performed by our independent accountants and reviewing their reports regarding our accounting practices and systems of internal control over financial reporting. The audit committee also oversees the audit efforts of our independent accountants and takes those actions as it deems necessary to satisfy itself that the accountants are independent of management. Under the Companies Law, the audit committee is also required to identify deficiencies in the administration of the company, including by consulting with the internal auditor, and recommending remedial actions with respect to such deficiencies, and is responsible for reviewing and approving related party transactions.
 
The approval of the audit committee is required to effect certain specified actions and transactions with office holders and controlling shareholders. A controlling shareholder is a shareholder who has the ability to direct the activities of a company, including a shareholder that owns 25% or more of the voting rights if no other shareholder owns more than 50% of the voting rights, but excluding a shareholder whose power derives solely from his or her position on the board of directors or any other position with the company. The audit committee may not approve an action or a transaction with a controlling shareholder or with an office holder unless at the time of approval the two external directors were serving as members of the audit committee and at least one of them was present at the meeting at which the approval was granted.
 
Our written audit committee charter, a copy of which is available on the “Corporate Governance” section of our website, states that in fulfilling this role, the committee is entitled to rely on interviews and consultations with our management, our internal auditor and our independent public accountant. However, it is not obligated to conduct any independent investigation or verification.
 
Our audit committee consists of Gerald Dogon (Chairman), Prof. Moshe Many and Tali Yaron-Eldar. Our board of directors has determined that Mr. Dogon qualifies as an “audit committee financial expert” as defined under the rules and regulations of the SEC, applicable NASDAQ Global Market rules and the Companies Regulations (Conditions and Criteria for Directors with Accounting and Financial Expertise and with Professional Qualifications) - 2005.
 
Compensation Committee
 
Our compensation committee reviews and recommends policies relating to compensation and benefits of our officers and employees. The compensation committee reviews corporate goals and objectives set by our board that are relevant to compensation of the Chief Executive Officer and other executive officers, evaluates the performance of these officers in light of those goals and objectives, and sets the compensation of these officers based on such evaluations. The compensation committee also administers the issuance of options and other awards under our stock plans. The compensation committee reviews and evaluates, at least annually, the goals and objectives of our incentive compensation plans and monitors the results against the approved goals and objectives. The compensation committee operates under a written compensation committee charter, a copy of which is available on the “Corporate Governance” section of our website. The members of our compensation committee are Yoav Chelouche (Chairman) Tali Yaron Eldar and Gerald Dogon. Our board of directors has determined that both members of our compensation committee are independent under the applicable NASDAQ Global Market rules.

 
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Nominating and Corporate Governance Committee
 
The nominating and corporate governance committee is responsible for making recommendations to the board of directors regarding candidates for directorships and the size and composition of our board. In addition, the nominating and corporate governance committee is responsible for overseeing our corporate governance guidelines and reporting and making recommendations to the board concerning governance matters. The nominating and corporate governance committee operates under a written charter, a copy of which is available on the “Corporate Governance” section of our website. The members of our nominating and corporate governance committee are Yoav Chelouche (Chairman) and Gerald Dogon. Our board of directors has determined that both members of our nominating and corporate governance committee are independent under the applicable NASDAQ Global Market rules.
 
Under the Companies Law, the nominations for director are generally made by our directors but may be made by one or more of our shareholders. However, any shareholder or shareholders holding at least 5% of the voting rights in our issued share capital may nominate one or more persons for election as directors at a general meeting only if a written notice of such shareholder’s intent to make such nomination or nominations has been given to our secretary and each such notice sets forth all the details and information as required to be provided under our articles of association.

Internal Auditor
 
Under the Companies Law, the board of directors must appoint an internal auditor nominated by the audit committee. On May, 7, 2007, we appointed Yardeni Gelfend as our internal auditor.  The role of the internal auditor is to examine whether a company’s actions comply with applicable law and orderly business procedure. Under the Companies Law, the internal auditor may not be an interested party or an office holder, or affiliate, or a relative of an interested party or an office holder, nor may the internal auditor be the company’s independent accountant or its representative. An interested party is defined in the Companies Law as a 5% or greater shareholder, any person or entity who has the right to designate one director or more or the chief executive officer of the company or any person who serves as a director or as a chief executive officer. The internal auditor also can not be terminated without his or her consent, nor can he or she be suspended from such position unless the board of directors has so resolved after hearing the opinion of the audit committee and after giving him or her opportunity to present his or her case to the board and to the audit committee.

Approval of Specified Related Party Transactions Under Israeli Law

See Item 10.B – "Memorandum and Articles of Association — Fiduciary Duties of Office Holders", "– Disclosure of Personal Interests of an Office Holder" and "—Transactions Requiring Special Approval" for a discussion of the requirements of Israeli law regarding the fiduciary duties of the office holders of the Company, including directors and executive officers, and their duties to disclose any personal interest that such person may have and all related material information known to him or her relating to any existing or proposed transaction by the company, as well as transactions that require special approval.

D.  EMPLOYEES
 
As of December 31, 2008, 2007 and 2006, we had 111, 70 and 41 full-time employees, respectively. Of the 111 full-time employees as of December 31, 2008, 57 were engaged in research and development and 54 were engaged in management, administration, business development, marketing and finance. Of the 111 full-time employees as of December 31, 2008, 42 were located in the United States and 69 were located in Israel.
 
The Israeli labor law governs the length of the workday, minimum daily wages for workers, procedures for hiring and dismissing employees, determination of severance pay, annual leave, sick days and other conditions of employment. Israeli law generally requires severance pay upon the retirement or death of an employee or termination of employment without cause (as defined in the law). Severance pay may be funded by Managers’ Insurance described below. The payments to Managers’ Insurance on account of severance pay amount to approximately 8.33% of the employee’s wages. Furthermore, Israeli employees and employers are required to pay predetermined sums to the National Insurance Institute, which is similar to the U.S. Social Security Administration. Such amounts also include payments by the employee for national health insurance. The total payments to the National Insurance Institute are equal to approximately 17.4% of the wages (up to a specified amount), of which the employee contributes approximately 12% and the employer contributes approximately 5.4%.
 
We contribute funds on behalf of all our employees (typically following a trial period of three months) to a fund known as “Managers’ Insurance.” This fund provides a combination of savings plan, insurance and severance pay benefits to the employee, giving the employee payments upon retirement or death and securing the payment of severance pay, if legally required, upon termination of employment. We decide whether each employee is entitled to participate in the plan and each employee who agrees to participate contributes an amount equal to 5% of his or her salary and we, the employer, contribute between 13.3% and 15.8% of his or her salary.
 
We have never experienced labor-related work stoppages and believe that our relations with our employees are good.

 
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E.  SHARE OWNERSHIP
 
The following table sets forth, as of June 1, 2009, the number of our ordinary shares beneficially owned by (i) each of our directors and executive officers and (ii) our directors and executive officers as a group. The information in this table is based on 14,174,443 ordinary shares outstanding as of June 1, 2009. Beneficial ownership of shares is determined in accordance with the rules of the SEC and generally includes any shares over which a person exercises sole or shared voting or investment power. Ordinary shares that are subject to convertible securities, warrants or options that are currently convertible or exercisable or convertible or exercisable within 60 days of June 1, 2009 are deemed to be outstanding and beneficially owned by the person holding the convertible securities, warrants or options for the purpose of computing the percentage ownership of that person, but are not treated as outstanding for the purpose of computing the percentage of any other person.
 
Name of Beneficial Owner
 
Number of Shares
Beneficially
Owned
   
Percentage of
Outstanding
Ordinary Shares
 
Amir Avniel (1)
    143,812       1.0 %
Ronen Tamir (2)
    44,540       *  
Dalia Cohen, Ph.D.(3)
    18,730       *  
Ranit Aharonov, Ph.D. (4)
    34,645       *  
Ayelet Chajut, Ph.D.(5)
    18,781       *  
Limor Zur-Stoller
    -       *  
Tami Fishman Jutkowitz (6)
    10,498       *  
Yoav Chelouche (7)
    199,360       1.4 %
Isaac Bentwich, M.D. (8)
    1,655,401       11.7 %
Prof. Moshe Many, M.D. (9)
    46,522       *  
Simcha Sadan, Ph.D. (10)
    59,195       *  
Joshua Rosensweig.(11)
    157,849       1.1 %
Gerald Dogon (12)
    9,510       *  
Tali Yaron-Eldar (13)
    9,510       *  
Directors and executive officers as a group (14 persons) (14)
    2,408,253       16.4 %
 

*
Represents beneficial ownership of less than 1% of ordinary shares.
 
(1)
Consists of options currently exercisable or exercisable within 60 days of June 1, 2009 to purchase 75,336 ordinary shares (which have an exercise price of $0.00 per share and expire in May 2013), 1,429 ordinary shares (which have an exercise price of $0.00 per share and expire in May 2014), 37,668 ordinary shares (which have an exercise price of $0.00 per share and expire in December 2014),  829 ordinary shares (which have an exercise price of $0.00 per share and expire in June 2015) and 28,550 ordinary shares (which have an exercise price of $5.68  per share and expire in September 2016).
 
(2)
Consists of options currently exercisable or exercisable within 60 days of June 1, 2009 to purchase 44,540  ordinary shares (which have an exercise price of $5.45 per share and expire in December 2017),
 
(3)
Consists of options currently exercisable or exercisable within 60 days of June 1, 2008 to purchase 18,730 ordinary shares (which have an exercise price of $6.59 per share and expire in August 2016).
 
(4)
Consists of options currently exercisable or exercisable within 60 days of June 1, 2009 to purchase 3,516 ordinary shares (which have an exercise price of $0.00 per share and expire in June 2013), 251 ordinary shares (which have an exercise price of $0.00 per share and expire in January 2014), 1,308 ordinary shares (which have an exercise price of $0.00 per share and expire in May 2014), 4,771 ordinary shares (which have an exercise price of $0.00 per share and expire in December 2014), 659 ordinary shares (which have an exercise price of $0.00 per share and expire in June 2015), 16,265 ordinary shares (which have an exercise price of $3.50 per share and expire in January 2016) and 7,875 ordinary shares (which have an exercise price of $4.16 per share and expire in June 2018).
 
(5)
Consists of options currently exercisable or exercisable within 60 days of June 1, 2009 to purchase 5,650 ordinary shares (which have an exercise price of $4.37 per share and expire in June 2016), 1,256 ordinary shares (which have an exercise price of $4.37 per share and expire in January 2017), 11,875 ordinary shares (which have an exercise price of $4.16 per share and expire in June 2018),
 
 
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(6)
Consists of options currently exercisable or exercisable within 60 days of June 1, 2009 to purchase 6,123 ordinary shares (which have an exercise price of $3.50 per share and expire in April 2016) and 4,375 ordinary shares (which have an exercise price of $4.7 per share and expire in July 2018).
 
(7)
Consists of (i) 17,137 ordinary shares held by Yunsan Ltd., a company controlled by Mr. Chelouche, the chairman of our board of directors, (ii) 14,228 ordinary shares and (iii) options currently exercisable or exercisable within 60 days of June 1, 2009 to purchase 10,288 ordinary shares (which have an exercise price of $0.00 per share and expire in April 2012) and 157,707 ordinary shares (which have an exercise price of $3.50 per share and expire in July 2016).
 
(8)
Consists of (i) 1,105,870 ordinary shares directly owned by Dr. Bentwich, (ii) 549,531 ordinary shares held by Harmonia 2000. Harmonia 2000 is an Israeli non-profit association, of which Dr. Bentwich is one of seven members, and one of three members of its managing board. The members of Harmonia 2000’s managing board control the securities held by Harmonia 2000, and Dr. Bentwich may therefore be deemed to beneficially own the securities owned by Harmonia 2000. Dr. Bentwich disclaims any beneficial ownership of the securities owned by Harmonia 2000.
 
(9)
Consists of (i) 26,932 ordinary shares held by Prof. Many and (ii) options currently exercisable or exercisable within 60 days of June 1, 2009 to purchase 6,908 ordinary shares (which have an exercise price of $3.50 per share and expire in July 2016) and 12,682 ordinary shares (which have an exercise price of $6.15 per share and expire in July 2016).
 
(10)
Consists of (i) 4,923 ordinary shares held by Dr. Sadan, (ii) 43,705 ordinary shares held by SMB Ltd., a company controlled by Dr. Sadan and (iii) options currently exercisable or exercisable within 60 days of June 1, 2009 to purchase 10,567 ordinary shares (which have an exercise price of $6.03 per share and expire in January 2017).
 
(11)
Consists of (i) 138,259 ordinary shares held by Dr. Rosensweig, (ii) options currently exercisable or exercisable within 60 days of June 1, 2009 to purchase 6,908 ordinary shares (which have an exercise price of $3.50 per share and expire in July 2016) and 12,682 ordinary shares (which have an exercise price of $6.15 per share and expire in July 2016).
 
(12)
Consists of options currently exercisable or exercisable within 60 days of June 1, 2009 to purchase 9,510 ordinary shares (which have an exercise price of $8.8 per share and expire in March 2017).
 
(13)
Consists of options currently exercisable or exercisable within 60 days of June 1, 2009 to purchase 9,510 ordinary shares (which have an exercise price of $8.8 per share and expire in March 2017).
 
(14)
See notes 1 through 13 above.
 
Employee Benefit Plans
 
2003 Israeli Share Option Plan
 
In March 2003, we adopted the Rosetta Genomics Ltd. 2003 Israeli Share Option Plan, or the 2003 Plan. The 2003 Plan provided for the grant of options to our directors, employees, consultants and service providers, and to the directors, employees, consultants and service providers of our subsidiaries and affiliates. Upon shareholder approval of the 2006 Global Share Incentive Plan, or 2006 Plan, in July 2006, the 2003 Plan was terminated and the 321,773 ordinary shares that were available for issuance under the 2003 Plan were transferred to the 2006 Plan. However, all outstanding options granted under the 2003 Plan remain outstanding and subject to the terms of the 2003 Plan. Any options that were granted under the 2003 plan and that are canceled are transferred to the 2006 Plan. As of June 1, 2009, options to purchase 321,375 ordinary shares have been granted and are still outstanding under the 2003 Plan and 241,450 shares have been issued pursuant to the exercise of options granted under the 2003 Plan.
 
2006 Global Share Incentive Plan
 
The 2006 Global Share Incentive Plan, or the 2006 Plan, was approved in July 2006. In November 2007, our board of directors approved an additional 500,000 shares under the 2006 Plan.  As of June 1, 2009, there were 199,075 shares available for grant under the 2006 Plan, 8,164 shares have been issued pursuant to the exercise of options granted under the 2006 Plan and options to purchase 1,148,761 ordinary shares have been granted and are outstanding under the 2006 Plan. The 2006 Plan, and its corresponding sub-plans for grantees subject to U.S. taxation and grantees subject to Israeli taxation, provides for the grant of options to our directors, employees, consultants and service providers, and to the directors, employees, consultants and service providers of our subsidiaries and affiliates.

 
53

 

Administration of Our Employee Benefit Plans
 
Our employee benefit plans are administered by our compensation committee, which makes recommendations to our board of directors regarding the grant of options and the terms of the grant, including, exercise price, method of payment, vesting schedule, acceleration of vesting and the other matters necessary in the administration of these plans. Options granted under the 2003 Plan and the 2006 Plan to eligible employees and office holders who are Israeli residents may be granted under Section 102(b)(2) of the Israel Income Tax Ordinance pursuant to which the options or the ordinary shares issued upon their exercise must be allocated or issued to a trustee and be held in trust for the lesser of (a) 30 months, or (b) two years following the end of the tax year in which the options are granted, provided that options granted after January 1, 2006 are only subject to being held in trust for two years. Under Section 102, any tax payable by an employee from the grant or exercise of the options is deferred until the transfer of the options or ordinary shares by the trustee to the employee or upon the sale of the options or ordinary shares and gains are subject to a capital gains tax of 25%.
 
Options to be granted under the 2006 Plan to U.S. residents may qualify as incentive stock options within the meaning of Section 422 of the Code. The exercise price for incentive stock options must not be less than the fair market value on the date the option is granted, unless otherwise approved by our board of directors and shareholders, or 110% of the fair market value if the optionholder holds more than 10% of our share capital.
 
Options granted under our employee benefit plans generally vest over three or four years, and they expire ten years from the date of grant. If we terminate an employee for cause, all of the employee’s vested and unvested options expire no later than five days from the time of delivery of the notice of discharge, unless determined otherwise by the compensation committee. Upon termination of employment for any other reason, including due to death or disability of the employee, vested options may be exercised within three months of the date of termination, unless otherwise determined by the compensation committee. Vested options not exercised within the prescribed period and unvested options return to the 2006 plan for reissuance.
 
In the event of a merger, consolidation, reorganization or similar transaction in which our ordinary shares are exchanged for shares of another corporation, each optionholder will be entitled to purchase the number of shares of the other corporation as it would have received if he or she had exercised its option immediately prior to such transaction. In the event of a change of control, or merger, consolidation, reorganization or similar transaction resulting in the acquisition of at least 50% of our voting power, or the sale of all or substantially all of our assets, each optionholder is required to participate in the transaction and sell or exchange their shares received pursuant to the exercise of an option.

 
54

 

ITEM 7.  MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
 
A.  MAJOR SHAREHOLDERS
 
The following table sets forth, as of June 1, 2009, the number of ordinary shares beneficially owned by each person or entity known by us to be the beneficial owner of more than 5% of our outstanding ordinary shares. The information in this table is based on 14,174,443 ordinary shares outstanding as of June 1, 2009. Beneficial ownership of shares is determined in accordance with the rules of the SEC and generally includes any shares over which a person exercises sole or shared voting or investment power. Ordinary shares that are subject to convertible securities, warrants or options that are presently convertible or exercisable or convertible or exercisable within 60 days of June 1, 2009 are deemed to be outstanding and beneficially owned by the person holding the convertible securities, warrants or options for the purpose of computing the percentage ownership of that person, but are not treated as outstanding for the purpose of computing the percentage of any other person. None of the persons or entities that we know beneficially owns more than 5% of our outstanding ordinary shares, has different voting rights. Except as indicated in the footnotes to this table, each shareholder in the table has sole voting and investment power for the shares shown as beneficially owned by them.
 
Name and Address of Beneficial Owner (1)
 
Number of Shares
Beneficially
Owned(5)
   
Percentage of
Outstanding
Ordinary Shares
 
Prometheus Laboratories Inc. (2)
    2,000,000       14.1 %
Isaac Bentwich, M.D. (3)
    1,655,401       11.7 %
Far West Capital Management (4)
    855,650       6.0 %
 

(1)
Unless otherwise noted, the address for each of the individuals noted above is c/o Rosetta Genomics Ltd., 10 Plaut Street, Science Park, Rehovot 76706 Israel.
(2)
Based solely on a Schedule 13G filed by Prometheus with the SEC on May 4, 2009. Prometheus’ address is 9410 Carroll Park Drive, San Diego, California 92121.
(3)
Consists of (i) 1,105,870 ordinary shares directly owned by Dr. Bentwich, (ii) 549,531 ordinary shares held by Harmonia 2000. Harmonia 2000 is an Israeli non-profit association, of which Dr. Bentwich is one of seven members, and one of three members of its managing board. The members of Harmonia 2000’s managing board control the securities held by Harmonia 2000, and Dr. Bentwich may therefore be deemed to beneficially own the securities owned by Harmonia 2000. Dr. Bentwich disclaims any beneficial ownership of the securities owned by Harmonia 2000.
(4)
Based solely on a Schedule 13G filed by Far West Capital Management with the SEC on May 18, 2009. Far West capital Management’s address is 4749 Nicasio Valley Road, Nicasio, California 94946.
(5)
Our ordinary shares are traded on the NASDAQ Global Market in the United State. A significant portion of our shares are held in street name, therefore we generally have no way of determining who our shareholders are, their geographical location or how many shares a particular shareholder owns.

Significant Changes in Share Ownership

The following table shows changes over the last three years in the percentage ownership by major shareholders:

Name of Beneficial Owner
 
Percentage of
Outstanding
Ordinary
Shares Owned
as of March 31,
2007
   
Percentage of
Outstanding
Ordinary Shares
Owned as of
June 1, 2008
   
Percentage of
Outstanding
Ordinary Shares
Owned as of 
June 1, 2009
 
Amir Avniel
    5.5 %     5.6 %     1.0 %
Isaac Bentwich, M.D.
    16.0 %     15.9 %     11.7 %
Highbridge International LLC (1)
    6.5 %     6.7 %     -  
Entities and Persons affiliated with Davidson Kempner Partners (2)
    -       5.3 %     -  
Prometheus Laboratories Inc. (3)
    -       -       14.1 %
Far West Capital Management (4)
    -       -       6.0 %
 
 
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(1)
Based solely on (i) a Schedule 13G filed with the SEC on March 5, 2007 and (ii) a Schedule 13G/A filed with the SEC on January 30, 2008.
(2)
Based solely on (i) a Schedule 13G filed with the SEC on January 17, 2008 and (ii) a Schedule 13G/A filed with the SEC on February 17, 2009.
(3)
Based solely on a Schedule 13G filed with the SEC on May 4, 2009.
(4) 
Based solely on a Schedule 13G filed with the SEC on May 18, 2009.

Control of Registrant
 
To our knowledge, we are not directly or indirectly owned or controlled by another corporation, by any foreign government, or by any other natural or legal person. As of June 1, 2009, our officers and directors as a group beneficially owned 2,408,253 ordinary shares, or 16.4% of the then outstanding ordinary shares.
 
B.  RELATED PARTY TRANSACTIONS
 
We have, from time to time, entered into agreements with our shareholders and affiliates. We describe these related party transactions entered into since January 1, 2008 below:
 
Exclusive Testing and Administrative Services Agreement with Teva Pharmaceutical Industries Ltd.
 
On December 24, 2008, we entered into an Exclusive Testing and Administrative Services Agreement with Teva Pharmaceutical Industries Ltd. Prof. Moshe Many, M.D., Ph.D., one of our directors has served as Chairman of the Research and Development Committee of Teva’s board of directors since 1991.  Please see “Item 4. Information on the Company — B. Business Overview — Collaborations and Partnerships” for a description of this agreement.
 
Consulting Agreement with a Related Party
 
In April 2007, we entered into a consulting agreement with Prof. Moshe Hod, the brother of Nathan Hod, a member of our board of directors until December 18, 2008 , for a monthly fee of $10,000. In 2008, we paid Prof. Hod $ 140,000 under this agreement.
 
Exculpation, Indemnification and Insurance
 
Our articles of association permit us to exculpate, indemnify and insure our directors and officers to the fullest extent permitted by the Companies Law. We have entered into agreements with each of our office holders undertaking to indemnify them to the fullest extent permitted by law, including with respect to liabilities resulting from our initial public offering to the extent that these liabilities are not covered by insurance. We have obtained director and officer insurance for each of our officers and directors.
 
C.  INTERESTS OF EXPERTS AND COUNSEL
 
Not applicable.
 
ITEM 8.  FINANCIAL INFORMATION
 
A.  CONSOLIDATED STATEMENTS AND OTHER FINANCIAL INFORMATION
 
Consolidated Financial Statements
 
Our consolidated financial statements and related notes are included in this Annual Report beginning on page F-1. See also Item 18.
 
Legal Proceedings
 
We are currently not a party to any legal proceedings.
 
Dividend Policy
 
To date, we have not declared or paid cash dividends on any of our shares, and we have no current intention of paying any cash dividends in the near future.
 
The Companies Law also restricts our ability to declare dividends. We can only distribute dividends from profits (as defined in the Companies Law), or, if we do not meet the profits test, with court approval provided in each case that there is no reasonable concern that the dividend distribution will prevent the company from meeting its existing and foreseeable obligations as they come due. The payment of dividends may be subject to Israeli withholding taxes.

 
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B.  SIGNIFICANT CHANGES
 
See “Note 18.  Subsequent Events” to our consolidated financial statements included in this Annual Report beginning on page F-1 for a discussion of significant events that have occurred since December 31, 2008.
 
ITEM 9. THE OFFER AND LISTING
 
A.  OFFER AND LISTING DETAILS
 
Our ordinary shares began trading on The NASDAQ Global Market on February 27, 2007 under the symbol “ROSG.” Prior to that time, there was no established public trading market for our ordinary shares. The high and low sales prices per share of our ordinary shares on The NASDAQ Global Market for the periods indicated are set forth below:
 
 
 
High
   
Low
 
Year Ended
           
December 31, 2007
  $ 10.33     $ 4.75  
December 31, 2008
  $ 6.25     $ 1.08  
                 
Quarter Ended
               
March 31, 2007
  $ 10.33     $ 6.20  
June 30, 2007
  $ 8.94     $ 6.30  
September 30, 2007
  $ 7.90     $ 4.95  
December 31, 2007
  $ 7.00     $ 4.75  
March 31, 2008
  $ 6.25     $ 3.41  
June 30, 2008
  $ 5.44     $ 4.00  
September 30, 2008
  $ 5.07     $ 2.46  
December 31, 2008
  $ 3.00     $ 1.08  
March 31, 2009
  $ 3.80     $ 1.18  
                 
Month Ended
               
December 31, 2008
  $ 2.51     $ 1.08  
January 31, 2009
  $ 3.11     $ 1.18  
February 28, 2009
  $ 3.80     $ 2.47  
March 31, 2009
  $ 3.07     $ 2.04  
April 30, 2009
  $ 3.80     $ 2.69  
May 31, 2009
  $ 3.60     $ 2.91  
 
B.  PLAN OF DISTRIBUTION
 
Not applicable.
 
C.  MARKETS
 
Our ordinary shares are traded only in the United States on The NASDAQ Global Market.
 
D.  SELLING SHAREHOLDERS
 
Not applicable.
 
E.  DILUTION
 
Not applicable.
 
F.  EXPENSES OF THE ISSUE
 
Not applicable.
 
ITEM 10. ADDITIONAL INFORMATION
 
A.  SHARE CAPITAL
 
Not applicable.

 
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B.  MEMORANDUM AND ARTICLES OF ASSOCIATION
 
Objects and Purposes
 
We were first registered under Israeli law on March 9, 2000. Our registration number with the Israel Registrar of Companies is 51-292138-8. The objective stated in Section 3 of our articles of association is to engage in any lawful activity.
 
Fiduciary Duties of Office Holders
 
An “office holder” is defined in the Companies Law as a director, general manager, chief business manager, deputy general manager, vice general manager, executive vice president, vice president, any other manager directly subordinate to the general manager or any other person assuming the responsibilities of any of the foregoing positions, without regard to such person’s title.
 
The Companies Law imposes a duty of care and a duty of loyalty on all office holders of a company. The duty of care requires an office holder to act with the level of care which a reasonable office holder in the same position would have acted under the same circumstances. The breach of such duty is governed by Israeli contract laws. The duty of care includes a duty to use reasonable means to obtain:
 
 
·
information on the appropriateness of a given action brought for his approval or performed by him by virtue of his position; and
 
 
·
all other important information pertaining to the previous actions.
 
The duty of loyalty requires an office holder to act in good faith for the interests of the company and includes a duty to:
 
 
·
refrain from any conflict of interest between the performance of his duties in the company and his personal affairs;
 
 
·
refrain from any activity that is competitive with the company;
 
 
·
refrain from exploiting any business opportunity of the company to receive a personal gain for himself or others; and
 
 
·
disclose to the company any information or documents relating to a company’s affairs which the office holder has received due to his position as an office holder.
 
Each person listed in the table under “Item 6 - Directors, Senior Management and Employees - A. Directors and Senior Management” is an office holder.

Disclosure of Personal Interests of an Officer Holder
 
The Companies Law requires that an office holder disclose to the company any personal interest that he or she may have, and all related material information known to him or her, in connection with any existing or proposed transaction by the company. The disclosure is required to be made promptly and in any event, no later than the board of directors meeting in which the transaction is first discussed. “Personal interest”, as defined by the Companies Law, includes a personal interest of any person in an act or transaction of the company, including a personal interest of his relative or of a corporate body in which that person or a relative of that person is a 5% or greater shareholder, a holder of 5% or more of a company’s outstanding shares or voting rights, a director or general manager, or in which he or she has the right to appoint at least one director or the general manager. “Personal interest” does not apply to a personal interest stemming merely from the fact that the office holder is also a shareholder in the company.  The Companies Law defines a relative as a spouse, sibling, parent, grandparent, descendent, spouse’s descendant and the spouse of any of the foregoing.

If the transaction is an extraordinary transaction, the office holder must also disclose any personal interest held by his or her relative.

Transactions Requiring Special Approval

Under the Companies Law, an extraordinary transaction is a transaction:
 
 
·
not in the ordinary course of business;
 
 
·
not on market terms; or
 
 
·
likely to have a material impact on the company’s profitability, assets or liabilities.
 
 
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Under the Companies Law, once an office holder complies with the above disclosure requirement, the board of directors may approve the transaction, between the company and that office holder, or a third party in which the office holder has a personal interest, unless the company’s articles of association provide otherwise. A transaction that is adverse to the company’s interest may not be approved. If the transaction is an extraordinary transaction, then it also must be approved by the audit committee, before the board approval, and under certain circumstances, by the shareholders of the company. Exculpation, indemnification, insurance or compensation of a director would generally require shareholder approval. A director who has a personal interest in a matter which is considered at a meeting of the board of directors or the audit committee may not be present at this meeting or vote on this matter, unless a majority of the board of directors or the audit committee also has a personal interest in the transaction. If a majority of the directors has a personal interest in a transaction, shareholder approval is also required.
 
Under the Companies Law, the disclosure requirements which apply to an office holder also apply to a controlling shareholder of a public company. For these purposes, a controlling shareholder is any shareholder that has the ability to direct the company’s actions, including any shareholder holding 25% or more of the voting rights if no other shareholder owns more than 50% of the voting rights in the company. Two or more shareholders with a personal interest in the approval of the same transaction are deemed to be one shareholder.   Extraordinary transactions of a public company with a controlling shareholder or in which a controlling shareholder has a personal interest, and the terms of compensation of a controlling shareholder who is an office holder, require the approval of the audit committee, the board of directors and the shareholders of the company. The shareholder approval must satisfy either of the following criteria:
 
 
·
the majority of the votes for the approval includes the votes of at least one-third of the total votes of shareholders who are present at the meeting and who have no personal interest in the transaction; the votes of abstaining shareholders shall not be included in the number of the said total votes; or
 
 
·
the total number of votes against the approval, among the shareholders who are present at the meeting and who have no personal interest in the transaction shall not exceed 1% of the aggregate voting rights in the company.
 
For information concerning the direct and indirect personal interests of certain of our office holders and principal shareholders in certain transactions with us, see “Item 7 - Major Shareholders and Related Party Transactions - B. Related Party Transactions.”
 
Directors’ Compensation
 
Under the Companies Law, all arrangements as to compensation of office holders who are not directors require approval of the board of directors, unless the articles of association provide otherwise. Arrangements as to compensation of directors, as well as indemnification and insurance of directors, also generally require audit committee approval, before board approval, and shareholder approval.  Our compensation committee generally is required to approve the compensation of office holders.

Directors Borrowing Powers
 
Our board of directors may from time to time, in its discretion, cause the Company to borrow or secure the payment of any sum or sums of money for the purposes of the Company. Such borrowing powers may be exercised by a majority of the board in accordance with our articles of association.

Rights Attached to Our Shares
 
Dividend Rights. Our articles of association provide that our board of directors may, subject to the applicable provisions of the Companies Law, from time to time, declare such dividend as may appear to the board of directors to be justified by the profits of the Company. Subject to the rights of the holders of shares with preferential or other special rights that may be authorized in the future, holders of ordinary shares are entitled to receive dividends according to their rights and interest in our profits. Under the Companies Law, a company may distribute a dividend only if the distribution does not create a reasonable risk that the company will be unable to meet its existing and anticipated obligations as they become due. A company may only distribute a dividend out of the company’s profits, as defined under the Companies Law. If the company does not meet the profit requirement, a court may allow it to distribute a dividend, as long as the court is convinced that there is no reasonable risk that such distribution might prevent the company from being able to meet its existing and anticipated obligations as they become due.

Voting Rights. Holders of ordinary shares have one vote for each ordinary share held on all matters submitted to a vote of shareholders. These voting rights may be affected by the grant of any special voting rights to the holders of a class of shares with preferential rights that may be authorized in the future. The ordinary shares do not have cumulative voting rights in the election of directors. As a result, holders of ordinary shares that represent more than 50% of the voting power at the general meeting of shareholders, in person or by proxy, have the power to elect all the directors whose positions are being filled at that meeting to the exclusion of the remaining shareholders. However, external directors are elected by a majority vote at a shareholders’ meeting, on the condition that either:

 
59

 
 
 
·
the majority of shares voted for the election includes at least one-third of the shares of non-controlling shareholders voted at the meeting (excluding abstaining votes); or
 
 
·
the total number of shares of non-controlling shareholders voted against the election of the external director does not exceed one percent of the aggregate voting rights in the company.

 
Liquidation Rights. In the event of our liquidation, after satisfaction of liabilities to creditors, our assets will be distributed to the holders of ordinary shares in proportion to their respective holdings. This liquidation right may be affected by the grant of preferential dividends or distribution rights to the holders of a class of shares with preferential rights that may be authorized in the future.
 
Redemption Provisions. We may, subject to applicable law, issue redeemable preference shares and redeem the same.
 
Capital Calls. Under our articles of association and the Companies Law, the liability of our shareholders is limited to the par value of the shares held by them.
 
Transfer of Shares. Fully paid ordinary shares are issued in registered form and may be transferred pursuant to our articles of association, unless such transfer is restricted or prohibited by another instrument and subject to applicable securities laws.
 
Modification of Rights
 
Unless otherwise provided by our articles of association, rights attached to any class may be modified or abrogated by a resolution adopted in a general meeting approved by a majority of 75% of the voting power represented at the meeting in person or by proxy and voting thereon, subject to the sanction of a resolution passed by majority of the holders of 75% a majority of the shares of such class present and voting as a separate general meeting of the holders of such class.
 
Shareholders’ Meetings and Resolutions
 
The quorum required for an ordinary meeting of shareholders consists of at least two shareholders present in person or by proxy, who hold or represent between them at least 25% of the outstanding voting shares, unless otherwise required by applicable rules. A meeting adjourned for lack of a quorum generally is adjourned to the same day in the following week at the same time and place or any time and place as the chairman of the board may designate. At such reconvened meeting, the required quorum consists of any two shareholders present in person or by proxy.
 
Under the Companies Law, each shareholder of record will be provided at least 21 calendar days’ prior notice of any general shareholders meeting.
 
Under the Companies Law and our articles of association, all resolutions of our shareholders require a simple majority of the shares present, in person or by proxy, and voting on the matter, subject to certain exceptions provided for under the Companies Law, which require a majority of at least 75% of the shares present.
 
Under the Companies Law, each and every shareholder has a duty to act in good faith in exercising his rights and fulfilling his obligations towards us and other shareholders, such as in voting in the general meeting of shareholders on the following matters:
 
 
·
any amendment to the articles of association;
 
 
·
an increase of our authorized share capital;
 
 
·
a merger; or
 
 
·
approval of certain actions and transactions that require shareholder approval.
 
In addition, each and every shareholder has the general duty to refrain from depriving other shareholders of their rights as a shareholder. In addition, any controlling shareholder, any shareholder who knows that it possesses the power to determine the outcome of a shareholder or class vote and any shareholder who, pursuant to the company’s articles of association has the power to appoint or prevent the appointment of an office holder in the company is under a duty to act with fairness towards the company. The Companies Law does not describe the substance of this duty of fairness.

Our annual general meetings are held once in every calendar year at such time (within a period of not more than fifteen months after the last preceding annual general meeting) and at such place determined by our board. All general meetings other than annual general meetings shall be called extraordinary general meetings.

 
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Our board of directors may, in its discretion, convene additional meetings as “special general meetings.” In addition, the board must convene a special general meeting upon the demand of two of the directors, one fourth of the nominated directors, one or more shareholders having at least 5% of outstanding share capital and at least 1% of the voting power in the company, or one or more shareholders having at least 5% of the voting power in the company. The chairperson of the board of directors presides at each of our general meetings. The chairperson of the board of directors is not entitled to a vote at a general meeting in his capacity as chairperson.

Limitation on Owning Securities

The ownership of our ordinary shares by nonresidents of Israel is not restricted in any way by our memorandum of association and articles of association or the laws of the State of Israel, except for citizens of countries, which are in a state of war with Israel, who may not be recognized as owners of our ordinary shares.

Mergers and Acquisitions and Tender Offers under Israeli Law
 
The Companies Law includes provisions that allow a merger transaction and requires that each company that is a party to a merger have the transaction approved by its board of directors and the majority of each party’s shares voted on the proposed merger at a shareholders’ meeting called on at least 21 days’ prior notice. Under the Companies Law, merger transactions may be approved by holders of a simple majority of our shares present, in person or by proxy, at a general meeting and voting on the transaction. In determining whether the required majority has approved the merger, if shares of a company are held by the other party to the merger, or by any person holding at least 25% of the outstanding voting shares or 25% of the means of appointing directors of the other party to the merger, then a vote against the merger by holders of the majority of the shares present and voting, excluding shares held by the other party or by such person, or anyone acting on behalf of either of them, is sufficient to reject the merger transaction. If the transaction would have been approved but for the exclusion of the votes of certain shareholders as provided above, a court may still approve the merger upon the request of holders of at least 25% of the voting rights of a company, if the court holds that the merger is fair and reasonable, taking into account the value of the parties to the merger and the consideration offered to the shareholders. Upon the request of a creditor of either party of the proposed merger, the court may delay or prevent the merger if it concludes that there exists a reasonable concern that as a result of the merger, the surviving company will be unable to satisfy the obligations of any of the parties to the merger. In addition, a merger may not be completed unless at least 50 days have passed from the time that a proposal for the approval of the merger has been filed with the Israel Registrar of Companies and 30 days have passed from the time that the approval of the merging parties’ shareholders has been received.
 
The Companies Law also provides that an acquisition of shares of a public company must be made by means of a tender offer if as a result of the acquisition the purchaser would become a 25% shareholder of the company and there is no existing 25% or greater shareholder in the company. If there is no existing 45% or greater shareholder in the company, the Companies Law provides that an acquisition of shares of a public company must be made by means of a tender offer if as a result of the acquisition the purchaser would become a 45% shareholder of the company.
 
If following any acquisition of shares, the acquirer will hold 90% or more of the company’s shares or of a class of shares, the acquisition may not be made other than through a tender offer to acquire all of the shares of such class. If the shareholders who declined or do not respond to the tender offer hold 5% or less of the company’s outstanding share capital or class of shares, all the shares that the acquirer offered to purchase will be transferred to the acquirer by operation of law. However, the tendered shareholders may seek to alter the consideration by court order.
 
C.  MATERIAL CONTRACTS
 
Please see “Item 4. Information on the Company — B. Business Overview — Collaborations and Partnerships” and “Item 4. Information on the Company — B. Business Overview — Our Intellectual Property Strategy and Position — In-Licensed Intellectual Property” for a discussion of our material strategic alliances and research and license agreements. Please see “Item 7. Major Shareholders and Related Party Transactions— B. Related Party Transactions” for a discussion of other material contracts entered into other than in the ordinary course of business.
 
D.  EXCHANGE CONTROLS
 
Under Israeli Law, Israeli non-residents who purchase ordinary shares with certain non-Israeli currencies (including U.S. dollars) may freely repatriate in such non-Israeli currencies all amounts received in Israeli currency in respect of the ordinary shares, whether as a dividend, as a liquidating distribution, or as proceeds from any sale in Israel of the ordinary shares, provided in each case that any applicable Israeli income tax is paid or withheld on such amounts. The conversion into the non-Israeli currency must be made at the rate of exchange prevailing at the time of conversion. Under Israeli law, both residents and non-residents of Israel may freely hold, vote and trade ordinary shares.

 
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E.  TAXATION
 
ISRAELI TAX CONSIDERATIONS AND GOVERNMENT PROGRAMS
 
The following also contains a description of material relevant provisions of the current Israeli income tax structure applicable to companies in Israel, with special reference to its effect on us. To the extent that the discussion is based on new tax legislation which has not been subject to judicial or administrative interpretation, we cannot assure you that the views expressed in the discussion will be accepted by the appropriate tax authorities or the courts.
 
This discussion does not address all of the tax consequences that may be relevant to purchasers of our ordinary shares in light of their particular circumstances or certain types of purchasers of our ordinary shares subject to special tax treatment. Examples of this kind of investor include residents of Israel and traders in securities who are subject to special tax regimes not covered in this discussion. Because individual circumstances may differ, you should consult your tax advisor to determine the applicability of the rules discussed below to you and the particular tax effects of the offer, including the application of Israeli or other tax laws. The discussion below is not intended, and should not be construed, as legal or professional tax advice and is not exhaustive of all possible tax considerations.
 
Taxation of Companies
 
General Corporate Tax Structure
 
Generally, Israeli companies are subject to “Corporate Tax” on their taxable income at the rate of 27% for the 2008 tax year and 26% for the 2009 year tax . Following an amendment to the Tax Ordinance, which came into effect on January 1, 2006, the Corporate Tax rate is scheduled to decrease to 25% for the 2010 tax year and thereafter.  Israeli companies are generally subject to Capital Gains Tax at a rate of 25% for capital gains (other than gains deriving from the sale of listed securities) derived after January 1, 2003. However, the effective tax rate payable by a company which derives income from an approved enterprise (as further discussed below) may be considerably less.

Tax Benefits for Research and Development
 
Israeli tax law allows, under specified conditions, a tax deduction for R&D expenditures, including capital expenditures, for the year in which they are incurred. These expenses must relate to scientific research and development projects and must be approved by the relevant Israeli government ministry, determined by the field of research. Furthermore, the research and development must be for the promotion of the company and carried out by or on behalf of the company seeking such tax deduction. However, the amount of such deductible expenses is reduced by the sum of any funds received through government grants for the finance of such scientific research and development projects. Expenditures not so approved are deductible over a three-year period.
 
Tax Benefits Under the Law for the Encouragement of Industry (Taxes), 1969
 
Under the Law for the Encouragement of Industry (Taxes), 1969, industrial companies, as defined under the law, are entitled to the following tax benefits, among others:
 
 
·
Deduction of purchases of know-how and patents over an eight-year period for tax purposes;
 
 
·
Right to elect, under specified conditions, to file a consolidated tax return with additional related Israeli Industrial Companies;
 
 
·
Accelerated depreciation rates on equipment and buildings; and
 
 
·
Deductions over a three-year period of expenses involved with the issuance and listing of shares on a stock market.
 
Eligibility for benefits under the Law for the Encouragement of Industry is not subject to receipt of prior approval from any governmental authority. Under the law, an “industrial company” is defined as a company resident in Israel, at least 90.0% of the income of which, in any tax year, determined in Israeli currency, exclusive of income from government loans, capital gains, interest and dividends, is derived from an “industrial enterprise” owned by it. An “industrial enterprise” is defined as an enterprise whose major activity in a given tax year is industrial production activity.
 
We believe that we currently qualify as an industrial company within the definition under the Law for the Encouragement of Industry. No assurance can be given that we will continue to qualify as an industrial company or that the benefits described above will be available in the future.

 
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Special Provisions Relating to Taxation under Inflationary Conditions

According to the law, until 2007, the results for tax purposes were measured based on the changes in the Israeli CPI.

In February 2008, the "Knesset" (Israeli parliament) passed an amendment to the Income Tax (Inflationary Adjustments) Law, 1985, which limits the scope of the law starting 2008 and thereafter. Starting 2008, the results for tax purposes are measured in nominal values, excluding certain adjustments for changes in the Israeli CPI carried out in the period up to December 31, 2007. The amendment to the law includes, inter alia, the elimination of the inflationary additions and deductions and the additional deduction for depreciation starting 2008.

Tax Benefits under the Law for the Encouragement of Capital Investments, 1959
 
The Law for the Encouragement of Capital Investment, 1959 (the “Investment Law”) provides that a proposed capital investment in production facilities or other eligible facilities may be designated as an “Approved Enterprise.” To obtain “Approved Enterprise” status, an application to the Investment Center of the Ministry of Industry and Trade (the “Investment Center”) needs to be submitted. Each instrument of approval for an Approved Enterprise relates to a specific investment program that is defined both by the financial scope of the investment, including sources of funds, and by the physical characteristics of the facility or other assets.
 
The tax benefits available under any instrument of approval relate only to taxable profits attributable to the specific program and are contingent upon meeting the criteria set out in the instrument of approval. If a company has more than one approval or only a portion of its capital investments are approved, its effective tax rate is the weighted average of the applicable rates. Subject to certain qualifications, however, if a company with one or more approvals distributes dividends, the dividends are deemed attributable to the entire enterprise. As explained below, following the amendment of the Investment Law which became effective on April, 1, 2005, companies may receive tax benefits under the law without applying for an Approved Enterprise status.
 
Tax Benefits for Income from Approved Enterprises Approved Before April 1, 2005
 
Before April 1, 2005 an Approved Enterprise was entitled to either receive a grant from the Government of Israel or an alternative package of tax benefits (“Alternative Benefits”). We have elected to forego the entitlement to grants and have applied for the Alternative Benefits, under which undistributed income that we generate from our Approved Enterprises will be completely tax exempt (a “tax exemption”) for two years commencing from the year that we first produce taxable income and will be subject to a reduced tax rate of 10%-25% for an additional five to eight years, depending on the extent of foreign investment in the Company.
 
Alternative Benefits are available until the earlier of (i) seven consecutive years, commencing in the year in which the specific Approved Enterprise first generates taxable income, (ii) 12 years from commencement of production and (iii) 14 years from the date of approval of the Approved Enterprise status. This limitation does not apply to the exemption period.
 
Dividends paid out of income generated by an Approved Enterprise (or out of dividends received from a company whose income is generated by an Approved Enterprise) are generally subject to withholding tax at the rate of 15%. This withholding tax is deductible at source by the Approved Enterprise. The 15% tax rate is limited to dividends and distributions out of income derived during the benefits period and actually paid at any time up to 12 years thereafter. Since we elected the Alternative Benefits track, we will be subject to pay corporate tax at the rate of 10% - 25% in respect of the gross amount of the dividend that we may distribute out of profits which were exempt from corporate tax in accordance with the provisions of the Alternative Benefits track.
 
Since we have elected the Alternative Benefits package, we are not obliged to attribute any part of dividends that we may distribute to exempt profits, and we may decide from which year’s profits to declare dividends. We currently intend to reinvest any income that we may in the future derive from our Approved Enterprise programs and not to distribute the income as a dividend.
 
If we qualify as a “Foreign Investors’ Company” or “FIC”, our Approved Enterprises will be entitled to additional tax benefits. Subject to certain conditions, a FIC is a company with a level of foreign investment of more than 25%. The level of foreign investment is measured as the percentage of rights in the company (in terms of shares, rights to profits, voting and appointment of directors), and of combined share and loan capital, that are owned, directly or indirectly, by persons who are not residents of Israel. Such a company will be eligible for an extension of the period during which it is entitled to tax benefits under its Approved Enterprise status (so that the benefit periods may be up to ten years) and for further tax benefits if the level of foreign investment exceeds 49%. The tax rate for the remainder of the benefits period will be 25%, unless the level of foreign investment exceeds 49%, in which case the tax rate will be 20% if the foreign investment is more than 49% and less than 74%; 15% if more than 74% and less than 90%; and 10% if 90% or more. The benefits available to an Approved Enterprise are subject to the fulfillment of conditions stipulated in the Investment Law and its regulations and the criteria in the specific certificate of approval, as described above. If a company does not meet these conditions, it would be required to refund the amount of tax benefits, together with consumer price index linkage adjustment and interest.

 
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Tax Benefits under an Amendment that became effective on April 1, 2005
 
On April 1, 2005, a significant amendment to the Investment Law became effective (the “Amendment”). The Investment Law provides that terms and benefits included in any certificate of approval that was granted before the Amendment came into effect will remain subject to the provisions of the Investment Law as they were on the date of such approval.
 
The amendment to the Investments Law, which was published on April 1, 2005 (the “Amendment”), has changed certain provisions of the Law. As a result of the Amendment, a company is no longer obliged to acquire Approved Enterprise status in order to receive the tax benefits previously available under the Alternative Benefits provisions, and therefore generally there is no need to apply to the Investment Center for this purpose (Approved Enterprise status remains mandatory for companies seeking grants). Rather, the Company may claim the tax benefits offered by the Investments Law directly in its tax returns, provided that its facilities meet the criteria for tax benefits set out by the Amendment. A company is also granted a right to approach the Israeli Tax Authority for a pre-ruling regarding their eligibility for benefits under the Amendment.

Tax benefits are available under the Amendment to production facilities (or other eligible facilities), which are generally required to derive more than 25% of their business income from export (referred to as a “Benefited Enterprise”). In order to receive the tax benefits, the Amendment states that the company must make an investment which meets all the conditions set out in the Amendment for tax benefits and exceeds a minimum amount specified in the Law. Such investment allows the company to receive a “Benefited Enterprise” status, and may be made over a period of no more than three years ending at the end of the year in which the company requested to have the tax benefits apply to the Benefited Enterprise (the “Year of Election”). Where the company requests to have the tax benefits apply to an expansion of existing facilities, only the expansion will be considered to be a Benefited Enterprise and the company’s effective tax rate will be the weighted average of the applicable rates. In this case, the minimum investment required in order to qualify as a Benefited Enterprise is required to exceed a certain amount or certain percentage of the value of the company’s production assets before the expansion.
 
The duration of tax benefits is subject to a limitation of the earlier of 7 to 10 years from the commencement year, or 12 years from the first day of the Year of Election. The tax benefits granted to a Benefited Enterprise are determined, as applicable to its geographic location within Israel, according to one of the following new tax routes, which may be applicable to us:
 
·
Similar to the currently available alternative route, exemption from corporate tax on undistributed income for a period of two to ten years, depending on the geographic location of the Benefited Enterprise within Israel, and a reduced corporate tax rate of 10% to 25% for the remainder of the benefits period, depending on the level of foreign investment in each year.  Benefits may be granted for a term of seven to ten years, depending on the level of foreign investment in the company.  If the company pays a dividend out of income derived from the Benefited Enterprise during the tax exemption period, such income will be subject to corporate tax at the applicable rate (10%-25%). The company is required to withhold tax at the source at a rate of 15% from any dividends distributed from income derived from the Benefited Enterprise; and
 
·
A special tax route, which enables companies owning facilities in certain geographical locations in Israel to pay corporate tax at the rate of 11.5% on income of the Benefited Enterprise. The benefits period is ten years. Upon payment of dividends, the company is required to withhold tax at source at a rate of 15% for Israeli residents and at a rate of 4% for foreign residents.
 
Generally, a company that is Abundant in Foreign Investment (as defined in the Investments Law) is entitled to an extension of the benefits period by an additional five years, depending on the rate of its income that is derived in foreign currency.
 
Dividends paid out of income derived by a Benefited Enterprise will be treated similarly to payment of dividends by an Approved Enterprise under the Alternative Benefits track. Therefore, dividends paid out of income derived by a Benefited Enterprise (or out of dividends received from a company whose income is derived from a Benefited Enterprise) are generally subject to withholding tax at the reduced rate of 15% (deductible at source). The reduced rate of 15% is limited to dividends and distributions out of income derived from a Benefited Enterprise during the benefits period and actually paid at any time up to 12 years thereafter. A company qualifying for tax benefits under the Amendment which pays a dividend out of income derived by its Benefited Enterprise during the tax exemption period will be subject to tax in respect of the gross amount of the dividend at the otherwise applicable rate of 10%-25%.
 
The Amendment changes the definition of “foreign investment” in the Investments Law so that the definition now requires a minimal investment of NIS 5 million by foreign investors. Furthermore, such definition now also includes the purchase of shares of a company from another shareholder, provided that the company’s outstanding and paid-up share capital exceeds NIS 5 million. Such changes to the aforementioned definition are retroactive from 2003.

 
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As a result of the Amendment, tax-exempt income generated under the provisions of the new law will subject us to taxes upon distribution of the tax-exempt income to shareholders or liquidation of the company, and we may be required to record a deferred tax liability with respect to such tax-exempt income.
 
As of December 31, 2008 the Company did not generate income under any of the above mentioned laws.
 
Israeli Transfer Pricing Regulations
 
On November 29, 2006, Income Tax Regulations (Determination of Market Terms), 2006, promulgated under Section 85A of the Tax Ordinance, came into effect (the “TP Regs”). Section 85A of the Tax Ordinance and the TP Regs generally requires that all cross-border transactions carried out between related parties be conducted on an arm’s length principle basis and will be taxed accordingly.  The TP Regs are not expected to have a material effect on the Company.
 
Taxation of our Shareholders
 
Israeli law generally imposes a capital gains tax on the sale of capital assets located in Israel, including shares in Israeli resident companies, unless a specific exemption is available or unless a treaty between Israel and the country of the non-resident provides otherwise.
 
On January 1, 2006, an amendment to the Israeli tax regime became effective (the “2006 Tax Reform”). The 2006 Tax Reform significantly changed the tax rates applicable to income derived from shares. According to the 2006 Tax Reform, an individual is subject to a 20% tax rate on real capital gains derived from the sale of shares, unless such shareholder claims a deduction for financing expenses in connection with such shares in which case the gain will generally be taxed at a rate of 25%. Additionally, if such shareholder is considered a “substantial shareholder” (generally a shareholder who holds directly or indirectly 10% or more of the right to profits, right to nominate a director and voting rights) of the company issuing the shares, the tax rate is 25%.
 
The determination of whether the individual is a substantial shareholder will be made on the date that the securities are sold. In addition, the individual will be deemed to be a substantial shareholder if at any time during the 12 months preceding this date he had been a substantial shareholder. However, the foregoing tax rates will not apply to dealers in securities.
 
Corporations are subject to corporate tax rates in respect of capital gains from the sale of shares in Israeli companies. The 2006 Tax Reform provides that the corporate tax rate will be reduced gradually from 29% in 2007 to 27% in 2008, 26% in 2009 and 25% in 2010. However, between 2006 and 2009, corporations whose taxable income was not determined immediately before the 2006 Tax Reform was published, pursuant to part B of the Israeli Income Tax Law (Inflationary Adjustments), 1985 or pursuant to the Income Tax Regulations (Rules on Bookkeeping by Foreign Invested Companies and Certain Partnership and Determination of their Chargeable Income), 1984 (“Dollar Regulations”) will generally be taxed at a rate of 25% on their capital gains from the sale of their shares.
 
Non-residents of Israel, including corporations, will generally be exempt from any capital gains tax from the sale of shares traded on a recognized stock exchange outside of Israel (including NASDAQ), provided that such shareholders did not acquire their shares prior to an initial public offering, that the gains are not derived through a permanent establishment that the non-resident maintains in Israel, and that such shareholders are not subject to the Inflationary Adjustment Law. However, non-Israeli corporations will not be entitled to such exemption if an Israeli resident (i) has a controlling interest of 25% or more in such non-Israeli corporation, or (ii) is the beneficiary or is entitled to 25% or more of the revenues or profits of such non-Israeli corporation, whether directly or indirectly. In any case, these tax rates are subject to the provisions of any applicable tax treaty.
 
In addition, pursuant to the Convention Between the U.S. Government and the Government of Israel with Respect to Taxes on Income, as amended (the “United States-Israel Tax Treaty”), the sale, exchange or disposition of ordinary shares by a person who qualifies as a resident of the United States within the meaning of the United States-Israel Tax Treaty and who is entitled to claim the benefits afforded to such person by the United States-Israel Tax Treaty (a “Treaty United States Resident”) generally will not be subject to the Israeli capital gains tax unless such “Treaty United States Resident” holds, directly or indirectly, shares representing 10% or more of our voting power during any part of the 12-month period preceding such sale, exchange or disposition, subject to certain conditions. However, under the United States-Israel Tax Treaty, such “Treaty United States Resident” would be permitted to claim a credit for such taxes against the U.S. federal income tax imposed with respect to such sale, exchange or disposition, subject to the limitations in U.S. laws applicable to foreign tax credits. The United States-Israel Tax Treaty does not relate to U.S. state or local taxes.

 
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Non-residents of Israel are subject to income tax on income accrued or derived from sources in Israel. These sources of income include passive income, including dividends, royalties and interest, as well as non-passive income from services rendered in Israel. On distribution of dividends other than bonus shares or stock dividends by a publicly traded company, income tax is withheld at source, at the rate of 20% for dividends paid to an individual or foreign corporation, and 15% for dividends generated by an Approved Enterprise, unless in each case a different rate is provided in a treaty between Israel and shareholder’s country of residence. Under the U.S.-Israel tax treaty, the maximum tax on dividends paid to a holder of ordinary shares who is a U.S. resident will be 25%. However, the maximum tax rate on dividends not generated by an approved enterprise paid to a U.S. corporation holding at least 10% of our voting power is 12.5%.
 
A non-resident of Israel who receives dividends from which tax was withheld is generally exempt from the duty to file returns in Israel in respect of such income, provided such income was not derived from a business conducted in Israel by the taxpayer, and the taxpayer has no other taxable sources of income in Israel.
 
CERTAIN MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS
 
General
 
The following is a summary of certain material U.S. federal income tax consequences to U.S. persons holding our ordinary shares (referred to herein as U.S. holders) of purchasing, owning, and disposing of such shares. For this purpose, a U.S. person is, in each case as defined for U.S. federal income tax purposes: (a) an individual who is a citizen or resident of the United States; (b) a corporation or other entity taxable as a corporation under federal income tax laws created or organized in or under the laws of the United States, any state of the United States or the District of Columbia; (c) an estate the income of which is subject to U.S. federal income tax regardless of its source; or (d) a trust that is subject to the primary supervision of a court over its administration and one or more U.S. persons control all substantial decisions, or a trust that has validly elected to be treated as a domestic trust under applicable Treasury Regulations. This summary does not address any tax consequences to persons other than U.S. persons.
 
This discussion is a general summary and does not address all aspects of U.S. federal income taxation that may be relevant to particular U.S. holders based on their particular investment or tax circumstances. It does not address any tax consequences to certain types of U.S. holders that are subject to special treatment under the U.S. federal income tax laws, such as insurance companies, tax-exempt organizations, financial institutions, or broker-dealers, dealers in securities or currencies, traders in securities that elect to use the mark-to-market method of accounting for their securities, partnerships or other pass-through entities for U.S. federal tax purposes, regulated investment companies, real estate investment trusts, expatriates, persons liable for alternative minimum tax, persons owning, directly or by attribution, 10% or more, by voting power or value, of our ordinary shares, persons whose “functional currency” is not the U.S. dollar, persons holding ordinary shares as part of a hedging, constructive sale or conversion, straddle, or other risk-reducing transaction, or persons acquiring an interest in our shares in exchange for services.
 
This summary addresses only ordinary shares that (a) are held as capital assets, and (b) were acquired upon original issuance at their initial offering price.
 
This summary relates only to U.S. federal income taxes. It does not address any other tax, including but not limited to state, local, or foreign taxes, or any other U.S. federal taxes other than income taxes.
 
The statements in this summary are based on the current U.S. federal income tax laws as contained in the Internal Revenue Code, Treasury Regulations, and relevant judicial decisions and administrative guidance. The U.S. federal tax laws are subject to change, and any such change may materially affect the U.S. federal income tax consequences of purchasing, owning, or disposing of our ordinary shares. We cannot assure you that new laws, interpretations of law or court decisions, any of which may take effect retroactively, will not cause any statement in this summary to be inaccurate. No ruling or opinions of counsel will be sought in connection with the matters discussed herein. There can be no assurance that the positions we take on our tax returns will be accepted by the Internal Revenue Service.
 
This section is not a substitute for careful tax planning. Prospective investors are urged to consult their own tax advisors regarding the specific U.S. federal, state, foreign and other tax consequences to them, in light of their own particular circumstances, of the purchase, ownership and disposition of our ordinary shares and the effect of potential changes in applicable tax laws.
 
Dividends
 
A U.S. holder will be required to take into account as dividends any distributions with respect to our ordinary shares made out of our current or accumulated earnings and profits. The dividends received deduction will not be available to a U.S. holder that is taxed as a corporation. With certain exceptions (including but not limited to dividends treated as investment income for purposes of investment interest deduction limitations), qualified dividends received by a non-corporate U.S. holder generally will be subject to tax at the maximum tax rate accorded to capital gains, if certain holding period and other conditions are satisfied, through December 31, 2010, after which the rate applicable to dividends is scheduled to return to the tax rate generally applicable to ordinary income. Dividends will generally be from a non-U.S. source and treated as “passive income” for U.S. foreign tax credit purposes.

 
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Although, to the extent we pay dividends in the future, we intend to pay dividends to U.S. holders in U.S. dollars, the amount of any dividend paid in Israeli currency will equal its U.S. dollar value for U.S. federal income tax purposes, calculated by reference to the exchange rate in effect on the date the dividend is received by the U.S. holder, regardless of whether the Israeli currency is converted into U.S. dollars. If the Israeli currency is not converted into U.S. dollars on the date of receipt, the U.S. holder will have a basis in the Israeli currency equal to its U.S. dollar value on the date of receipt. Any subsequent gain or loss upon the conversion or other disposition of the Israeli currency will be treated as ordinary income or loss, and generally will be income or loss from U.S. sources.
 
A U.S. holder will not incur tax on a distribution with respect to our ordinary shares in excess of our current and accumulated earnings and profits if the distribution does not exceed the adjusted basis of the U.S. holder’s ordinary shares. Instead, the distribution will reduce the adjusted basis of the shares. Any such distribution in excess of both our current and accumulated earnings and profits and the U.S. holder’s adjusted basis will be treated as capital gain, long-term if the U.S. holder has held the shares for more than one year, and generally will be gain or loss from U.S. sources. See “Disposition of Ordinary Shares” below for a discussion of capital gains tax rates and limitations on deductions for losses.
 
Disposition of Ordinary Shares
 
In general, a U.S. holder must treat any gain or loss recognized upon a taxable disposition of our ordinary shares as capital gain or loss, long-term if the U.S. holder has held the shares for more than one year. In general, a U.S. holder will recognize gain or loss in an amount equal to the difference between the sum of the fair market value of any property and the amount of cash received in such disposition and the U.S. holder’s adjusted tax basis. A U.S. holder’s adjusted tax basis generally will equal the U.S. holder’s acquisition cost less any return of capital. Long-term capital gain realized by a non-corporate U.S. holder generally will be subject to a reduced maximum rate of 15% through December 31, 2010, after which the maximum capital gains rate is scheduled to return to 20%. The deduction of capital losses is subject to limitations, as are losses upon a taxable disposition of our ordinary shares if the U.S. holder purchases, or enters into a contract or option to purchase, substantially identical stock or securities within 30 days before or after any disposition. Gain or loss from the disposition of our ordinary shares will generally be from U.S. sources, but such gain or loss may be from a non-U.S. source under some circumstances under the U.S.-Israel Tax Treaty. U.S. holders should consult their own independent tax advisors regarding the sourcing of any gain or loss on the disposition of our ordinary shares, as well as regarding any foreign currency gain or loss in connection with such a disposition.
 
Credit for Foreign Taxes Paid or Withheld
 
Payments to U.S. holders as dividends or consideration for ordinary shares may in some circumstances be subject to Israeli withholding taxes. See “Israeli Tax Considerations and Government Programs” above. Generally, such withholding taxes in lieu of Israeli income taxes imposed on such transactions are creditable against the U.S. holder’s U.S. tax liability, subject to numerous U.S. foreign tax credit limitations, including additional limitations in the case of qualified dividends eligible for the maximum rate accorded to capital gains. A corporate U.S. holder may also be eligible for an “indirect” foreign tax credit on dividends to take account of certain Israeli taxes we previously paid to Israel.  A U.S. holder should consult its own independent tax advisor regarding use of the U.S. foreign tax credit and its limitations. A U.S. holder (except an individual who does not itemize deductions) may elect to take a deduction rather than a credit for foreign taxes paid.
 
Controlled Foreign Corporation
 
For U.S. federal income tax purposes, a “controlled foreign corporation” is a foreign corporation in which U.S. holders who own at least 10% of the voting power (directly or by constructive ownership through certain related persons) collectively own more than 50% of the voting power or value. If we are or become a controlled foreign corporation, such 10% U.S. holders must include in their current U.S. taxable income their share of the corporation’s undistributed “Subpart F income” (i.e., certain passive income, sales or service income, insurance, shipping, ocean activity, or oil-related income, and income from specified disfavored activities or from ostracized foreign countries) and the amount of the corporation’s investments in U.S. property. These income inclusions are not eligible for the maximum capital gains tax rate on qualified dividends to non-corporate tax payers. We believe that the corporation is not and has not been, and we expect that the corporation will not become, a controlled foreign corporation. There can be no assurance, however, that the corporation will not become a controlled foreign corporation in the future.

 
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Passive Foreign Investment Company
 
We were a passive foreign investment company, or PFIC for the years ended December 31, 2006 and 2007. We believe that we should not be treated as a PFIC for 2008. We nevertheless recognize that there are significant areas of uncertainty in the PFIC rules, and the IRS may not agree with our belief. We are a passive foreign investment company, or PFIC, if 75% or more of our gross income in a taxable year, including the pro rata share of the gross income of any company in which we are considered to own 25% or more of the shares by value, is passive income. Alternatively, we are a PFIC if at least 50% of our assets in a taxable year, averaged over the year and ordinarily determined based on fair market value, including the pro rata share of the assets of any company in which we are considered to own 25% or more of the shares by value, are held for the production of, or produce, passive income.
 
PFIC status is determined annually and cannot be definitively determined until the close of the year in question. If we qualify as a PFIC at any time during a U.S. holder’s holding period of our ordinary shares, any subsequent distributions to, or disposition of the shares by, the U.S. holder will be subject to the excess distribution rules (described below), regardless of whether we are a PFIC in the year of distribution or disposition, unless the U.S. holder: (1) made the qualified electing fund (“QEF”) election (described below); (2) made the mark-to-market election (described below); or (3) during a year in which the corporation is no longer a PFIC, elected to recognize all gain inherent in the shares of the last day of the last taxable year in which the corporation was a PFIC. Therefore, for example, if a U.S. holder acquired our ordinary shares in 2007, such ordinary shares will henceforth be considered shares in a PFIC, regardless of whether we meet the PFIC tests in future years, unless the U.S. holder makes a timely QEF or mark-to-market election, or makes the deemed gain election in a year in which the corporation is no longer a PFIC.
 
If we are a PFIC, each U.S. holder, upon certain excess distributions by us and upon disposition of our ordinary shares at a gain, would be liable to pay tax at the highest then-prevailing income tax rate on ordinary income plus interest on the tax, as if the distribution or gain had been recognized ratably over the holder’s holding period for the ordinary shares. Additionally, if we are a PFIC, a U.S. holder who acquires ordinary shares from a deceased person who was a U.S. holder would not receive the step-up of the income tax basis to fair market value for such ordinary shares. Instead, such U.S. holder would have a tax basis equal to the deceased’s tax basis, if lower.
 
If a U.S. holder has made a QEF election covering all taxable years during which the holder holds ordinary shares and in which we are a PFIC, distributions and gains will not be taxed as described above, nor will denial of a basis step-up at death described above apply. Instead, a U.S. holder that makes a QEF election is required for each taxable year to include in income the holder’s pro rata share of the ordinary earnings of the QEF as ordinary income and a pro rata share of the net capital gain of the QEF as capital gain, regardless of whether such earnings or gain have in fact been distributed. Undistributed income is subject to a separate election to defer payment of taxes. If deferred, the taxes will be subject to an interest charge. Where earnings and profits that were included in income under this rule are later distributed, the distribution is not a dividend. The basis of a U.S. shareholder’s shares in a QEF is increased by amounts that are included in income, and decreased by amounts distributed but not taxed as dividends. In addition, if a U.S. holder makes a timely QEF election, our ordinary shares will not be considered shares in a PFIC in years in which we are not a PFIC, even if the U.S. holder had held ordinary shares in prior years in which we were a PFIC.
 
In order to comply with the requirements of a QEF election, a U.S. holder must receive certain information from us. The QEF election is made on a shareholder-by-shareholder basis and can be revoked only with the consent of the IRS. A shareholder makes a QEF election by attaching a completed IRS Form 8621, including the information provided in the PFIC annual information statement, to a timely filed U.S. federal income tax return and by filing a copy of the form with the IRS. There is no assurance that we will provide such information as the IRS may require in order to enable U.S. holders to make the QEF election. Moreover, there is no assurance that we will have timely knowledge of our status as a PFIC in the future. Even if a shareholder in a PFIC does not make a QEF election, if such shareholder is a U.S. holder, such shareholder must annually file with the shareholder’s tax return and with the IRS a completed Form 8621.
 
If our ordinary shares are “regularly traded” on a “qualified exchange or other market,” as provided in applicable Treasury Regulations, a U.S. holder of our shares may elect to mark the shares to market annually, recognizing as ordinary income or loss each year an amount equal to the difference between the shareholder’s adjusted tax basis in such shares and their fair market value. Losses would be allowed only to the extent of net mark-to-market gain previously included by the U.S. holder under the election in previous taxable years. As with the QEF election, a U.S. holder who makes a mark-to-market election would not be subject to the general PFIC regime and the denial of basis step-up at death described above.
 
If we are a PFIC and, at any time, have a non-U.S. subsidiary that is classified as a PFIC, U.S. holders of our ordinary shares generally would be deemed to own, and also would be subject to the PFIC rules with respect to, their indirect ownership interests in that lower-tier PFIC. If we are a PFIC and a U.S. holder of our ordinary shares does not make a QEF election in respect of a lower-tier PFIC, the U.S. holder could incur liability for the deferred tax and interest charge described above if either (1) we receive a distribution from, or dispose of all or part of our interest in, the lower-tier PFIC or (2) the U.S. holder disposes of all or part of its ordinary shares. There is no assurance that any lower-tier PFIC will provide to a U.S. holder the information that may be required to make a QEF election with respect to the lower-tier PFIC. A mark-to-market election under the PFIC rules with respect to our ordinary shares would not apply to a lower-tier PFIC, and a U.S. holder would not be able to make such a mark-to-market election in respect of its indirect ownership interest in that lower-tier PFIC. Consequently, U.S. holders of our ordinary shares could be subject to the PFIC rules with respect to income of the lower-tier PFIC the value of which already had been taken into account indirectly via mark-to-market adjustments. Similarly, if a U.S. holder made a mark-to-market election under the PFIC rules in respect of our ordinary shares and made a QEF election in respect of a lower-tier PFIC, that U.S. holder could be subject to current taxation in respect of income from the lower-tier PFIC the value of which already had been taken into account indirectly via mark-to-market adjustments. U.S. holders are urged to consult their own tax advisers regarding the issues raised by lower-tier PFICs.
 
68

 
THE RULES DEALING WITH PFICS AND WITH THE QEF AND MARK-TO-MARKET ELECTIONS ARE VERY COMPLEX AND ARE AFFECTED BY VARIOUS FACTORS IN ADDITION TO THOSE DESCRIBED ABOVE, INCLUDING OUR OWNERSHIP OF ANY NON-U.S. SUBSIDIARIES. AS A RESULT, U.S. HOLDERS OF ORDINARY SHARES ARE STRONGLY ENCOURAGED TO CONSULT THEIR TAX ADVISERS ABOUT THE PFIC RULES IN CONNECTION WITH THEIR PURCHASING, HOLDING OR DISPOSING OF ORDINARY SHARES.
 
Backup Withholding and Information Reporting
 
A U.S. holder (excepting most corporations) may, under certain circumstances, be subject to information reporting requirements and backup withholding at a rate of 28% on payments of dividends, interest, and other reportable payments. A non-corporate U.S. holder should consult its own independent tax advisor regarding the possibility of information reporting and backup withholding on payments in connection with the purchase, ownership, or disposition of our ordinary shares.
 
F.  DIVIDENDS AND PAYING AGENTS
 
Not applicable.
 
G.  STATEMENT BY EXPERTS
 
Not applicable.
 
H.  DOCUMENTS ON DISPLAY
 
We file annual and special reports and other information with the SEC. You may inspect and copy such material at the public reference facilities maintained by the SEC’s Public Reference Room at 100 F Street, NE, Washington, D.C. 20549. You may also obtain copies of such material from the SEC at prescribed rates by writing to the SEC’s Public Reference Room at 100 F Street, NE, Washington, D.C. 20549. Information on the operation of the Public Reference Room can be obtained by calling the SEC at 1-800-SEC-0330. Our SEC filings also are available to the public from the SEC’s website at www.sec.gov. In addition, our annual and special reports and other information filed with the SEC is available free of charge through the Investors section of our website as soon as reasonably practicable after such materials have been electronically filed with, or furnished to, the SEC.
 
I.  SUBSIDIARY INFORMATION
 
Not applicable.
 
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
Interest Rate Risk
 
We are exposed to market risk related to changes in interest rates primarily from our investments in certain short-term investments. We maintain an investment portfolio consisting mainly of U.S. money markets and government grade securities, directly or through managed funds. We do not utilize derivative financial instruments, derivative commodity instruments or other market risk-sensitive instruments to manage exposure to interest rate changes. Accordingly, we believe that, while the securities we hold are subject to changes in the financial standing of the issuer of such securities, we are not subject to any material risks arising from changes in interest rates, foreign currency exchange rates, commodity prices, equity prices or other market changes that affect market risk sensitive instruments.
 
Exchange Rate Risk
 
We hold most of our cash, cash equivalents and marketable securities in U.S. dollars but incur a significant portion of our expenses, principally salaries and related personal expenses, in NIS. As a result, we are exposed to the risk that the U.S. dollar will be devalued against the NIS.  The following table illustrates the effect of the changes in exchange rates on our operation loss for the periods indicated: 

   
Year ended December 31,
 
   
2006
   
2007
   
2008
 
   
Actual
   
At 2005
Exchange
rates (1)
   
Actual
   
At 2006
Exchange
rates (1)
   
Actual
   
At 2007
Exchange
rates (1)
 
   
(In thousands)
 
Operating loss
  $ 8,125     $ 8,058     $ 11,042     $ 9,673     $ 14,889     $ 13,633  
 

(1) Based on average exchange rates during the period
 
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
 
Not applicable.

 
69

 

PART II
 
ITEM 13.  DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
 
None.
 
ITEM 14.  MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
 
Material Modifications to the Rights of Security Holders
 
Upon completion of our initial public offering in March 2007, all of our outstanding preferred shares and ordinary A shares were converted into ordinary shares. Our second amended articles of association also became effective upon the completion of our initial public offering. The material provisions of our second amended articles of association are described under “Item 10. Additional Information — B. Memorandum and Articles of Association.” Since our initial public offering, no instruments defining the rights of holders of our ordinary shares have been modified.
 
Use of Proceeds
 
The Registration Statement on Form F-1 (Reg. No. 333-137095) in connection with our initial public offering was declared effective by the SEC on February 26, 2007. In the initial public offering, we sold 4,312,500 ordinary shares at an initial public offering price per share of $7.00. The net offering proceeds to us after deducting total expenses were $26,008,011. As of December 31, 2008, approximately $15.5 million of the net proceeds of the offering had been used to fund operations and capital expenditures. The remaining net proceeds have been invested in bank deposits and marketable securities. There has been no material change in the planned use of proceeds from our initial public offering as described in our final prospectus dated February 26, 2007 filed with the SEC pursuant to Rule 424(b)(4).
 
ITEM 15T.  CONTROLS AND PROCEDURES
 
A.  DISCLOSURE CONTROLS AND PROCEDURES
 
Our principal executive officer and principal financial officer evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this Annual Report on Form 20-F. In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their desired control objectives. Based on the evaluation of our disclosure controls and procedures as of December 31, 2008, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
 
B.  MANAGEMENT’S ANNUAL REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING
 
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended. Our internal control system was designed to provide reasonable assurance to our management and board of directors regarding the preparation and fair presentation of published financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
 
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2008. In making this assessment, it used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework. Based on our assessment we believe that, as of December 31, 2008, our internal control over financial reporting is effective at a reasonable assurance level based on those criteria.
 
This Annual Report on Form 20-F does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting.  Management’s report was not subject to attestation by our registered public accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit us to provide only management’s report in the Annual Report.

 
70

 

C.  CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING
 
There were no changes in our internal control over financial reporting, identified in connection with the evaluation of such internal control that occurred during the period covered by this Annual Report, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
 
ITEM 16. RESERVED
 
ITEM 16A.  AUDIT COMMITTEE FINANCIAL EXPERT
 
Our audit committee consists of Gerald Dogon (Chairman), Prof. Moshe Many and Tali Yaron-Eldar, all of whom are independent under the rules and regulations of NASDAQ. Our board of directors has determined that Mr. Dogon qualifies as an “audit committee financial expert” as defined in the instructions to Item 16A of Form 20-F.
 
ITEM 16B.  CODE OF ETHICS
 
We have adopted a code of conduct and ethics that applies to all of our employees, including our principal executive officer and principal accounting and financial officer, and our directors. The text of the code of conduct and ethics is posted on the “Corporate Governance” section of our website at www.rosettagenomics.com . Disclosure regarding any amendments to, or waivers from, provisions of the code of conduct and ethics that apply to our directors, principal executive and financial and accounting officers will be included in a Form 6-K within four business days following the date of the amendment or waiver, unless website posting of such amendments or waivers is then permitted by the rules of The NASDAQ Stock Market, LLC.
 
ITEM 16C.  PRINCIPAL ACCOUNTANT FEES AND SERVICES
 
Accounting Fees and Services
 
The following table presents fees for professional audit services rendered by Kost Forer Gabbay & Kasierer, a member of Ernst & Young Global, independent registered public accountants, for the audit of our consolidated financial statements and services  normally provided by the independent auditor in connection with statutory and regulatory filings or engagements for the years ended December 31, 2008 and December 31, 2007 and fees billed for other services rendered by Kost Forer Gabbay & Kasierer during those periods.
 
   
2008
   
2007
 
Audit fees (1)
  $ 105,000     $ 75,000  
Audit-related fees
    18,560       -  
Tax fees (2)
    10,000       15,600  
All other fees (3)
    -       750  
Total
  $ 133,560     $ 91,350  
 

(1)           Audit services were comprised of services associated with the audit of our consolidated financial statements and services normally provided by the independent auditor in connection with statutory and regulatory filings or engagements and registration statements.
(2)           Tax services were comprised of tax compliance, tax advice and tax planning services.
(3)           All other services were comprised of business related consultation.
 
Policy on Audit Committee Pre-Approval of Audit and Permissible Non-audit Services of Independent Auditors
 
Our audit committee was established effective upon the completion of our initial public offering in March 2007. Consistent with policies of the Securities and Exchange Commission regarding auditor independence, the audit committee has responsibility for appointing, setting compensation and overseeing the work of the independent auditor. The audit committee operates under a written charter which provides that the committee must approve in advance all audit services and all permitted non-audit services, except where such services are determined to be de minimis under the Exchange Act. The audit committee may delegate, to one or more designated members of the audit committee, the authority to grant such pre-approvals. The decision of any member to whom such authority is delegated is to be presented to the full audit committee at each of its scheduled meetings.
 
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
 
Not applicable.
 
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
 
Not applicable.

 
71

 

ITEM 16F.  CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
 
Not applicable.
 
ITEM 16G.  CORPORATE GOVERNANCE
 
There are no significant differences between our corporate governance practices and those required of a U.S. domestic issuer under the rules of The NASDAQ Stock Market. However, pursuant to the rules and regulations of The NASDAQ Stock Market, a foreign private issuer may follow its home country practice in lieu of certain NASDAQ listing requirements. We have in the past elected to follow home country practice in lieu of certain NASDAQ requirements as follows:
 
 
·
NASDAQ rules require that the quorum for meetings of a company’s shareholders be not less than 33 1/3% of the outstanding voting stock of the company.  We have, however, chosen to follow home country practice with respect to shareholder meeting quorum and our articles of association provide that the quorum required for any meeting of our shareholders shall consist of at least two shareholders present, in person or by proxy, who hold or represent between them at least 25% of the voting power of our issued share capital.
 
 
·
In November 2007, our Board of Directors authorized an increase of 500,000 ordinary shares for issuance under our Global Share Incentive Plan (2006), or 2006 Plan.  Generally, under NASDAQ’s requirements, such an increase would require shareholder approval.  However, we chose to follow our home country practice, which does not require shareholder approval, and did not seek or receive shareholder approval for the increase in shares under the 2006 Plan.
 
 
72

 

PART III
 
ITEM 17. FINANCIAL STATEMENTS
 
See Item 18.
 
ITEM 18. FINANCIAL STATEMENTS
 
Our consolidated financial statements and related notes are included in this Annual Report beginning on page F-1.
 
ITEM 19. EXHIBITS
 
The following is a list of exhibits filed as part of this Annual Report.
 
Exhibit Number
 
Description of Exhibit
     
1.1(5)
 
Second Amended and Restated Articles of Association, as amended on May 30, 2007.
     
2.1(1)
 
Form of Share Certificate for Ordinary Shares.
     
2.2(1)
 
Investor Rights Agreement dated April 4, 2006.
     
2.3*
 
Convertible Note Agreement, dated as of September 24, 2008, by and among Rosetta Genomics Ltd. and the entities identified in the Schedule of Investors thereto and form of Convertible Promissory Notes.
     
4.1(1)@
 
Research Collaboration Agreement, dated as of January 31, 2006, by and between Rosetta Genomics Ltd., and Isis Pharmaceuticals, Inc.
     
4.2(1)@
 
License Agreement, dated as of May 4, 2006, by and between Rosetta Genomics Ltd. and The Rockefeller University.
     
4.3(3)@
 
License Agreement, dated effective as of May 1, 2007, by and between Rosetta Genomics Ltd. and The Rockefeller University.
     
4.4(1)
 
License Agreement, dated as of June 23, 2003, by and between Rosetta Genomics Ltd. and Maimonides Innovative Technologies Ltd.
     
4.5(1)
 
Lease Agreement, dated August 4, 2003, by and between Rosetta Genomics Ltd., as tenant, and Rorberg Contracting and Investments (1963) Ltd. and Tazor Development Ltd., as landlords, as amended in April 2004 and as extended on April 9, 2006 (as translated from Hebrew).
     
4.6(5)
 
Lease, dated December 2, 2007, between 15 Exchange Place Corp. and Rosetta Genomics Inc.
     
4.7*
 
Lease Agreement from Wexford-UCSC II, L.P. to Rosetta Genomics Inc., dated July 7, 2008, and First Amendment thereto, dated August 11, 2008.
     
4.8(1)
 
2003 Israeli Share Option Plan.
     
4.9(4)
 
2006 Employee Incentive Plan (Global Share Incentive Plan).
     
4.10(1)
 
Form of Director and Officer Indemnification Agreement.
     
4.11(1)@
 
License Agreement, dated as of June 28, 2006, by and between Rosetta Genomics Ltd. and Max Planck Innovation GmbH.
     
4.12(1)@
 
License Agreement, dated August 2, 2006, by and between The Johns Hopkins University and Rosetta Genomics Ltd.
     
4.13(1)@
 
License Agreement, dated as of December 22, 2006, by and between Rosetta Genomics Ltd. and Max Planck Innovation GmbH.
     
4.14(1)@
 
Cooperation and Project Funding Agreement, dated effective as of May 1, 2006, by and among Rosetta Genomics Ltd., the Israel-United States Binational Industrial Research and Development Foundation and Isis Pharmaceuticals, Inc.
 
 
73

 

4.15(5)@
 
License Agreement, dated effective as of January 8, 2008, by and between Rosetta Genomics Ltd. and The Rockefeller University.
     
4.16*@
 
Exclusive Testing and Administrative Services Agreement between Rosetta Genomics Ltd. And Teva Pharmaceutical Industries Ltd., dated December 24, 2008
     
4.17*@
 
License Agreement by and between Prometheus Laboratories Inc. and Rosetta Genomics Ltd., dated April 10, 2009.
     
4.18*@
 
Laboratory Services Agreement, effective as of April 10, 2009, by and between Prometheus Laboratories Inc. and Rosetta Genomics Ltd.
     
4.19(6)
 
Stock Purchase Agreement by and between Prometheus Laboratories Inc. and Rosetta Genomics Ltd., dated April 10, 2009.
     
4.20*
 
Stock Purchase Agreement by and among Rosetta Genomics Ltd., Rosetta Genomics Inc., Parkway Clinical Laboratories, Inc. and Dr. Raza Bokhari, dated July 22, 2008.
     
4.21*
 
Stock Purchase Agreement by and among Sanra Laboratories, LLC, Parkway Clinical Laboratories, Inc. and Rosetta Genomics Inc., dated May 15, 2009.
     
8.1(1)
 
Subsidiaries.
     
12.1*
 
Certification of Principal Executive Officer required by Rule 13a-14(a) or Rule 15d-14(a).
     
12.2*
 
Certification of Principal Accounting and Financial Officer required by Rule 13a-14(b) or Rule 15d-14(b).
     
13.1*
 
Certification of the Principal Executive Officer and the Principal Accounting and Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002.
     
15.1*
  
Consent of Kost Forer Gabbay & Kasierer, a member of Ernst & Young Global.
 

(1)
Incorporated by reference from the Registrant’s Registration Statement on Form F-1 (Reg. No. 333-137095), initially filed with the SEC on September 1, 2006.
 
(2)
Incorporated by reference from the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2006 (Reg. No. 001-33042), filed with the SEC on May 21, 2007.
 
(3)
Incorporated by reference from the Registrant’s Form 6-K dated August 2, 2007 (Reg. No. 001-33042), filed with the SEC on August 3, 2007.
 
(4)
Incorporated by reference from the Registrant’s Registration Statement on Form S-8 (Reg. No. 333-147805), filed with the SEC on December 3, 2007.
 
(5)
Incorporated by reference from the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2007 (Reg. No. 001-33042), filed with the SEC on June 26, 2008.
 
(6)
Incorporated by reference from the Registrant’s Form 6-K dated April 2009 (Reg. No. 001-33042), filed with the SEC on April 14, 2009.
 
*
Filed herewith.
 
@
Confidential portions of these documents have been filed separately with the SEC pursuant to a request for confidential treatment.
 
 
74

 

SIGNATURE
 
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.
 
 
ROSETTA GENOMICS LTD.
   
Dated: June 30, 2009
By: 
/s/ Amir Avniel
   
Amir Avniel, Chief Executive Officer and
   
President
 
 
75

 
 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)


CONSOLIDATED FINANCIAL STATEMENTS


AS OF DECEMBER 31, 2008

 

U.S. DOLLARS IN THOUSANDS

 

 

 

INDEX

 

 
Page
   
Report of Independent Registered Public Accounting Firm
F-2
   
Consolidated Balance Sheets
F-3 - F-4
   
Consolidated Statements of Operations
F-5
   
Statements of Changes in Shareholders' Equity (Deficiency)
F-6 - F-9
   
Consolidated Statements of Cash Flows
F-10 - F-11
   
Notes to Consolidated Financial Statements
F-12 - F-44





 
F-1

 
 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Shareholders of

ROSETTA GENOMICS LTD.
(A development stage company)


 
We have audited the accompanying consolidated balance sheets of Rosetta Genomics Ltd. (a development stage company) ("the Company") and its subsidiaries as of December 31, 2008 and 2007, and the related consolidated statements of operations, changes in shareholders' equity (deficiency) and cash flows for each of the three years in the period ended December 31, 2008 and for the period from March 9, 2000 (date of inception) through December 31, 2008. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatements. We were not engaged to perform an audit of the Company's and its subsidiaries internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company's and its subsidiaries internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, based on our audits, the consolidated financial statements referred to above, present fairly, in all material respects, the consolidated financial position of the Company and its subsidiaries as of December 31, 2008 and 2007, and the consolidated results of their operations and cash flows for each of the three years in the period ended December 31, 2008 and for the period from March 9, 2000 (date of inception) through December 31, 2008 in conformity with accounting principles generally accepted in the United States.
 
 
/s/ KOST FORER GABBAY & KASIERER
   
Tel-Aviv, Israel
KOST FORER GABBAY & KASIERER
June 11, 2009
A Member of Ernst & Young Global
 
F-2

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands
 
         
December 31,
 
   
Note
   
2008
   
2007
 
ASSETS
                 
 
                 
CURRENT ASSETS:
                 
Cash and cash equivalents
        $ 14,454     $ 13,590  
Short-term bank deposit
 
4
      840       112  
Marketable securities
 
5
      426       8,251  
Trade receivables, net
          502       -  
Other accounts receivable and prepaid expenses
          335       297  
 
                     
Total current assets
          16,557       22,250  
                       
LONG-TERM INVESTMENT
 
6
      -       2,391  
SEVERANCE PAY FUND
          131       144  
PROPERTY AND EQUIPMENT, NET
 
7
      1,301       1,253  
OTHER INTANGIBLE ASSETS
 
8
      251       -  
GOODWILL
 
9
      1,905       -  
                       
            3,588       3,788  
                       
Total assets
        $ 20,145     $ 26,038  
 
The accompanying notes are an integral part of the consolidated financial statements.
 
F-3

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands (except share and per share data)
 
         
December 31,
 
   
Note
   
2008
   
2007
 
LIABILITIES AND SHAREHOLDERS' EQUITY
                 
                   
CURRENT LIABILITIES:
                 
Short-term bank loan, current maturities of capital lease and long-term bank loan
 
12a
    $ 81     $ 247  
Trade payables
          1,030       516  
Other accounts payable and accruals
 
10
      1,387       1,102  
                       
Total current liabilities
          2,498       1,865  
                       
LONG-TERM LIABILITIES:
                     
Long-term bank loan and capital lease
 
12a
      49       16  
Convertible loan
 
11
      750       -  
Deferred revenue
          228       228  
Accrued severance pay
          520       324  
                       
Total long-term liabilities
          1,547       568  
                       
COMMITMENTS AND CONTINGENT LIABILITIES
 
12
                 
                       
SHAREHOLDERS' EQUITY :
                     
Share capital:
 
13
                 
Ordinary shares of NIS 0.01 par value: 17,578,370 shares authorized at December 31, 2008 and 2007; 12,367,303 and 12,106,115 shares issued at December 31, 2008 and 2007, respectively, and 12,171,932 and 11,910,744 shares outstanding at December 31, 2008 and 2007, respectively
          34       27  
Additional paid-in capital
          61,018       58,984  
Other comprehensive income
          3       86  
Deficit accumulated during the development stage
          (44,955 )     (35,492 )
                       
Total shareholders' equity
          16,100       23,605  
                       
Total liabilities and shareholders' equity
        $ 20,145     $ 26,038  
 
The accompanying notes are an integral part of the consolidated financial statements.
 
F-4

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
CONSOLIDATED STATEMENTS OF OPERATIONS

U.S. dollars in thousands (except share and per share data)
 
         
Year ended December 31,
   
Period from March 9, 2000 (date of inception) through December 31,
 
   
Note
   
2008
   
2007
   
2006
   
2008
 
                               
Revenues
        $ 1,511     $ -     $ -     $ 1,511  
Cost of revenues
          774       -       -       774  
                                       
Gross profit
          737       -       -       737  
                                       
Operating expenses:
                                     
Research and development, net
          8,705       6,400       4,781       28,204  
Marketing and business development
          2,368       1,742       1,504       6,909  
General and administrative
          3,703       2,903       1,860       11,040  
Goodwill impairment
          850       -       -       850  
                                       
Total operating expenses
          15,626       11,045       8,145       47,003  
                                       
Operating loss
          14,889       11,045       8,145       46,266  
Financial expenses (income), net
 
15
      (5,449 )     3,616       (538 )     (1,334 )
                                       
Loss before taxes on income
          9,440       14,661       7,607       44,932  
                                       
Taxes on income
 
14
      23       -       -       23  
                                       
Net loss
        $ 9,463     $ 14,661     $ 7,607     $ 44,955  
                                       
Basic and diluted net loss per Ordinary share
        $ 0.79     $ 1.32     $ 2.98          
                                       
Weighted average number of Ordinary shares used to compute basic and diluted net loss per Ordinary share
          12,038,295       11,142,149       2,551,860          
 
The accompanying notes are an integral part of the consolidated financial statements.
 
F-5

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (DEFICIENCY)

U.S. dollars in thousands (except share data)
 
   
Number of Ordinary shares
   
Number of Preferred shares
   
Number of Ordinary A shares
   
Share capital
   
Additional paid-in capital
   
Receipts on account of shares
   
Accumulated other comprehensive income
   
Deferred stock compensation
   
Deficit accumulated during the development
stage
   
Total
 
                                                             
Balance as of March 9, 2000 (date of inception)
    -       -       -     $ -     $ -     $ -     $ -     $ -     $ -     $ -  
                                                                                 
Issuance of shares, net
    2,522,496       -       -       6       34       -       -       -       -       40  
Net loss
    -       -       -       -       -       -       -       -       (145 )     (145 )
                                                                                 
Balance as of December 31, 2000
    2,522,496       -       -       6       34       -       -       -       (145 )     (105 )
Issuance of shares, net in July-December 2001
    38,421       -       -       *) -       153       -       -       -       -       153  
Treasury shares
    (195,371 )     -       -       *) -       -       -       -       -       -       -  
Net loss
    -       -       -       -       -       -       -       -       (367 )     (367 )
                                                                                 
Balance as of December 31, 2001
    2,365,546       -       -       6       187       -       -       -       (512 )     (319 )
Exercise of stock options
    10,184       -       -       *) -       -       -       -       -       -       -  
Deferred stock compensation
    -       -       -       -       196       -       -       (196 )     -       -  
Amortization of deferred stock compensation
    -       -       -       -       -       -       -       72       -       72  
Forfeiture of options granted to employees
    -       -       -       -       (6 )     -       -       6       -       -  
Net loss
    -       -       -       -       -       -       -       -       (1,582 )     (1,582 )
                                                                                 
Balance as of December 31, 2002
    2,375,730       -       -       6       377       -       -       (118 )     (2,094 )     (1,829 )
Issuance of series A Preferred shares, net in July 2003
    -       535,084       -       1       2,652       -       -       -       -       2,653  
Conversion of convertible loan to series A Preferred shares in October 2003
    -       621,835       -       2       2,689       -       -       -       -       2,691  
Exercise of warrants to series A Preferred shares
    -       180,850       -       *) -       660       -       -       -       -       660  
Exercise of stock options
    37,816       -       -       -       -       -       -       -       -       -  
Deferred stock compensation
    -       -       -       -       174       -       -       (174 )     -       -  
Amortization of deferred stock compensation
    -       -       -       -       -       -       -       177       -       177  
Forfeiture of options granted to employees
    -       -       -       -       (22 )     -       -       22       -       -  
Expenses related to warrants granted to non-employees
    -       -       -       -       194       -       -       -       -       194  
Net loss
    -       -       -       -       -       -       -       -       (2,305 )     (2,305 )
                                                                                 
Balance as of December 31, 2003
    2,413,546       1,337,769       -       9       6,724       -       -       (93 )     (4,399 )     2,241  

*)           Represents an amount lower than $ 1.

The accompanying notes are an integral part of the consolidated financial statements.
 
F-6

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (DEFICIENCY)

U.S. dollars in thousands (except share data)
 
   
Number of Ordinary shares
   
Number of Preferred shares
   
Number of Ordinary A shares
   
Share capital
   
Additional paid-in capital
   
Receipts on account of shares
   
Accumulated other comprehensive income
   
Deferred stock compensation
   
Deficit accumulated during the development stage
   
Total
 
                                                             
Balance as of December 31, 2003
    2,413,546       1,337,769       -       9       6,724       -       -       (93 )     (4,399 )     2,241  
                                                                                 
Issuance of series B Preferred shares, net in September 2004
    -       265,747       -       1       1,394       -       -       -       -       1,395  
Issuance of Ordinary shares in May 2004
    56,914       -       -       *) -       -       -       -       -       -       -  
Exercise of stock options
    17,033       -       -       -       -       -       -       -       -       -  
Deferred stock compensation
    -       -       -       -       239       -       -       (239 )     -       -  
Amortization of deferred stock compensation
    -       -       -       -       -       -       -       92       -       92  
Forfeiture of options granted to employees
    -       -       -       -       (25 )     -       -       25       -       -  
Receipts on account of shares
    -       -       -       -       -       493       -       -       -       493  
Expenses related to shares and warrants granted to non-employees
    -       -       -       -       52       -       -       -       -       52  
Net loss
    -       -       -       -       -       -       -       -       (2,982 )     (2,982 )
                                                                                 
Balance as of December 31, 2004
    2,487,493       1,603,516       -       10       8,384       493       -       (215 )     (7,381 )     1,291  
                                                                                 
Issuance of series B Preferred shares, net in February 2005
    -       392,087       -       1       2,164       (493 )     -       -       -       1,672  
Conversion of shareholders loan to series B Preferred shares
    -       20,802       -       *) -       122       -       -       -       -       122  
Exercise of stock options
    55,394       -       -       -       -       -       -       -       -       -  
Deferred stock compensation
    -       -       -       -       32       -       -       (32 )     -       -  
Amortization of deferred stock compensation
    -       -       -       -       -       -       -       124       -       124  
Forfeiture of options granted to employees
    -       -       -       -       (16 )     -       -       16       -       -  
Cost related to shares and warrants granted to non-employees
    -       -       -       -       161       -       -       -       -       161  
Cost related to warrants granted as finders' fee
    -       -       -       -       138       -       -       -       -       138  
Expenses related to accelerations of vesting of stock options
    -       -       -       -       12       -       -       -       -       12  
Net loss
    -       -       -       -       -       -       -       -       (5,843 )     (5,843 )
                                                                                 
Balance as of December 31, 2005
    2,542,887       2,016,405       -       11       10,997       -       -       (107 )     (13,224 )     (2,323 )

*)           Represents an amount lower than $ 1.

The accompanying notes are an integral part of the consolidated financial statements.
 
F-7

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (DEFICIENCY)

U.S. dollars in thousands (except share data)

   
Number of Ordinary shares
   
Number of Preferred shares
   
Number of Ordinary A shares
   
Share capital
   
Additional paid-in capital
   
Accumulated other comprehensive income
   
Deferred
stock compensation
   
Deficit accumulated during the development stage
   
Total
 
                                                       
Balance as of December 31, 2005
    2,542,887       2,016,405       -       11       10,997       -       (107 )     (13,224 )     (2,323 )
                                                                         
Conversion of convertible loan into series B Preferred shares
    -       1,033,382       -       2       6,228       -       -       -       6,230  
Issuance of series C Preferred shares, net
    -       1,822,422       -       4       13,292       -       -       -       13,296  
Exercise of warrants to purchase series B Preferred shares in April 2006
    -       76,395       -       *) -       447       -       -       -       447  
Exercise of stock options
    11,148       -       -       *) -       -       -       -       -       -  
Amortization of deferred stock compensation
    -       -       -       -       -       -       59       -       59  
Issuance of shares to non-employee
    9,240       -       -       *) -       61       -       -       -       61  
Unrealized gain from marketable securities
    -       -       -       -       -       3       -       -       3  
Cancellation of restricted Ordinary shares
    (1,581 )     -       -       *) -       -       -       -       -       -  
Compensation related to shares and warrants granted to non-employees
    -       -       -       -       177       -       -       -       177  
Stock based compensation to employees
    -       -       -       -       756       -       -       -       756  
Net loss
    -       -       -       -       -       -       -       (7,607 )     (7,607 )
                                                                         
Balance as of December 31, 2006
    2,561,694       4,948,604       -       17       31,958       3       (48 )     (20,831 )     11,099  
                                                                         
Conversion of Ordinary shares   into Ordinary A shares
    (2,159,126 )     -       2,159,126       -       -       -       -       -       -  
Adjustment from conversion into Ordinary shares
    -       306,962       (306,962 )     -       -       -       -       -       -  
Conversion into Ordinary shares in March 2007
    7,107,730       (5,255,566 )     (1,852,164 )                     -       -       -       -  
Issuance of Ordinary shares, net of $4,180 issuance cost in March 2007
    4,312,500       -       -       10       25,998       -       -       -       26,008  
Exercise of stock options
    83,999       -       -       -       41       -       -       -       41  
Exercise of warrants
    3,947       -       -       -       -       -       -       -       -  
Amortization of deferred stock compensation
    -       -       -       -       -       -       33       -       33  
Forfeiture of options granted to employees
    -       -       -       -       (15 )     -       15       -       -  
Stock based compensation to non-employees
    -       -       -       -       155       -       -       -       155  
Stock based compensation to employees
    -       -       -       -       847       -       -       -       847  
Unrealized gain from hedging activities
    -       -       -       -       -       83       -       -       83  
Net loss
    -       -       -       -       -       -       -       (14,661 )     (14,661 )
                                                                         
Balance as of December 31, 2007
    11,910,744       -       -       27       58,984       86       -       (35,492 )     23,605  

*)           Represents an amount lower than $ 1.

The accompanying notes are an integral part of the consolidated financial statements.
 
F-8

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (DEFICIENCY)

U.S. dollars in thousands (except share data)

   
Number of Ordinary shares
   
Number of Preferred shares
   
Number of Ordinary A shares
   
Share capital
   
Additional paid-in capital
   
Accumulated other comprehensive income
   
Deficit accumulated during the development stage
   
Total
 
                                                 
Balance as of December 31, 2007
    11,910,744       -       -       27       58,984       86       (35,492 )     23,605  
Exercise of stock options
    31,527       -       -       *) -       33       -       -       33  
Issuance of shares in July 2008
    229,661       -       -       7       993       -       -       1,000  
Stock based compensation to non-employees
    -       -       -       -       70       -       -       70  
Stock based compensation to employees
    -       -       -       -       938       -       -       938  
Realized loss from hedging activities
    -       -       -       -       -       (83 )     -       (83 )
Net loss
    -       -       -       -       -       -       (9,463 )     (9,463 )
                                                                 
Balance as of December 31, 2008
    12,171,932       -       -     $ 34     $ 61,018     $ 3     $ (44,955 )   $ 16,100  
 
Accumulated other comprehensive income

   
Year ended December 31,
 
   
2008
   
2007
 
             
Accumulated unrealized gains from available-for-sale- marketable securities, net of taxes
  $ 3     $ 3  
Accumulated unrealized gains from hedging activity
    -       83  
                 
    $ 3     $ 86  

*)           Represents an amount lower than $ 1.

The accompanying notes are an integral part of the consolidated financial statements.
 
F-9

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands
 
   
Year ended December 31,
   
Period from March 9, 2000 (date of inception) through December 31,
 
   
2008
   
2007
   
2006
   
2008
 
Cash flows from operating activities:
                       
Net loss
  $ (9,463 )   $ (14,661 )   $ (7,607 )   $ (44,955 )
Adjustments to reconcile net loss to net cash used in operating activities:
                               
Depreciation
    334       179       161       1,119  
Amortization of other  intangible assets and impairment of goodwill
    936       -       -       936  
Foreign currency adjustments
    (39 )     12       4       (49 )
Amortization of discount on convertible loan
    -       -       -       405  
Income related to embedded derivative
    -       -       -       (236 )
Interest on short-term bank deposit
    (5 )     -       (149 )     (154 )
Modification of convertible loan
    -       -       -       360  
Capital loss from sale of property and equipment
    2       4       20       55  
Accrued interest on marketable securities
    (36 )     (98 )     (14 )     (193 )
Accrued severance pay, net
    209       (66 )     165       389  
Amortization of deferred stock compensation
    -       33       59       557  
Stock-based compensation to employees
    938       847       756       2,541  
Compensation related to shares and warrants granted to non-employees
    70       155       177       947  
Cost related to acceleration of stock options' vesting
    -       -       -       12  
Decrease in marketable securities
    -       -       -       42  
Gain from sale of marketable securities
    (5,640 )     -       -       (5,640 )
Impairments of investments in marketable securities
    631       5,009       -       5,640  
Increase in trade receivables
    (233 )     -       -       (233 )
Increase in other accounts receivable and prepaid expenses
    (62 )     (80 )     (66 )     (276 )
Increase in trade payables
    221       248       61       925  
Increase in deferred revenue
    -       -       -       228  
Increase in other accounts payable and accruals
    176       352       19       1,081  
                                 
Net cash used in operating activities
    (11,961 )     (8,066 )     (6,414 )     (36,499 )
                                 
Cash flows from investing activities:
                               
Purchase of property and equipment
    (298 )     (975 )     (301 )     (2,451 )
Proceeds from sale of property and equipment
    -       -       2       62  
Decrease (increase) in bank deposits
    (723 )     5,037       (5,000 )     (686 )
Purchase of marketable securities
    (8,491 )     (68,430 )     (750 )     (77,671 )
Proceeds from sale of marketable securities
    23,755       53,263       381       77,399  
Acquisition of Parkway (b)
    (2,107 )     -       -       (2,107 )
                                 
Net cash provided by (used in) investing activities
    12,136       (11,105 )     (5,668 )     (5,454 )
                                 
Cash flows from financing activities:
                               
Repayment of capital lease
    (239 )     (70 )     (37 )     (346 )
Proceeds from (repayment of) short-term bank loan
    25       -       (72 )     28  
Receipt of long-term bank loan and capital lease
    134       261       114       583  
Repayment of long-term bank loan
    (14 )     (17 )     (6 )     (109 )
Proceeds from convertible loans
    750       -       -       9,142  
Shareholders loans, net
    -       -       (109 )     148  
Issuance of shares, net
    -       27,318       13,326       47,050  
Exercise of warrants and options
    33       41       447       1,181  
Increase in deferred issuance costs
    -       -       (1,270 )     (1,270 )
                                 
Net cash provided by financing activities
    689       27,533       12,393       56,407  
                                 
Increase in cash and cash equivalents
    864       8,362       311       14,454  
Cash and cash equivalents at beginning of period
    13,590       5,228       4,917       -  
                                 
Cash and cash equivalents at end of period
  $ 14,454     $ 13,590     $ 5,228     $ 14,454  
 
The accompanying notes are an integral part of the consolidated financial statements.
 
F-10

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands
 
     
Year ended December 31,
   
Period from March 9, 2000 (date of inception) through December 31,
 
     
2008
   
2007
   
2006
   
2008
 
Supplemental disclosure:
                       
                           
(a)
Non-cash transactions:
                       
                           
 
Conversion of convertible loan
  $ -     $ -     $ 6,230     $ 6,230  
                                   
 
Issuance of shares in return for Parkway's shares
  $ 1,000     $ -     $ 61     $ 1,061  
                                   
 
Issuance expenses - initial public offering
  $ -     $ 40     $ 517     $ -  
                                   
(b)
Parkway acquisition:
                               
                                   
 
Working capital (excluding cash)
  $ 71     $ -     $ -     $ 71  
 
Property & equipment
    (86 )     -       -       (86 )
 
Backlog
    (193 )     -       -       (193 )
 
CLIA certification
    (144 )     -       -       (144 )
 
Goodwill
    (2,755 )     -       -       (2,755 )
                                   
        (3,107 )     -       -       (3,107 )
 
Issuance of shares
    1,000       -       -       1,000  
                                   
      $ (2,107 )   $ -     $ -     $ (2,107 )
                                   
(c)
Cash paid during the year:
                               
                                   
 
Income taxes
  $ 72     $ 36     $ 20     $ 183  
                                   
 
Interest
  $ 3     $ 4     $ 7     $ 20  
 
The accompanying notes are an integral part of the consolidated financial statements.
 
F-11

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 1:-
GENERAL

 
a.
Rosetta Genomics Ltd. (the "Company") commenced operations on March 9, 2000. The Company develops microRNA-based diagnostic and therapeutic products. The Company is focused on developing and commercializing these products, establishing strategic alliances with leading biotechnology and pharmaceutical companies, and establishing and maintaining a strong intellectual property position in the microRNA field.

 
b.
The Company holds a wholly-owned subsidiary in the U.S., Rosetta Genomics Inc. The principal business activity of the subsidiary is to expand the research, development and the business development of the Company in the U.S.

 
c.
On March 2, 2007, the Company consummated an initial public offering (the "IPO") on The NASDAQ Global Market and issued an aggregate of 4,312,500 Ordinary shares for net proceeds of $ 26 million (see Note 13a for further information).

 
d.
Acquisition of Parkway Clinical Laboratories, Inc. (“Parkway”)
 
On July 22, 2008 ("the closing date"), the Company, through its subsidiary Rosetta Genomics Inc., acquired all of the issued and outstanding capital stock of a company in the U.S., Parkway Clinical Laboratories Inc. ("the Parkway transaction").

Parkway is a national, full-service Clinical Laboratories Improvement Amendments ("CLIA") certified clinical laboratory service company, which specializes in oral drug screening in the workplace environment and genetics testing services. Parkway provides services to correctional facilities, health systems, rehabilitation centers, corporations and individuals. Parkway operates a laboratory, for which it bills facilities, third party payers and individuals on a fee-for-service basis.

The consideration included (i) $ 1,900 in cash (ii) issuing 229,661 Ordinary shares of the Company equal in value to $ 1,000 (iii) issuing expenses of $ 207. In addition the Company will pay $ 200 and issue a number of Ordinary shares of the Company equal in value to $ 100 if either of the following milestones is achieved within 12 months following the closing date: The Company reaches and holds for a period of 30 consecutive days a market cap of at least $ 100,000, or the consolidated revenues of the Company and Parkway equal $ 8,000. As of the date of the financial statements, the Company did not achieve the milestones.

Parkway became a wholly-owned subsidiary of the Company, and accordingly, its results of operations have been included in the consolidated financial statements since the closing date.

This acquisition was accounted for under the purchase method of accounting, in accordance with SFAS 141, and accordingly, the purchase price was allocated to the assets acquired and liabilities assumed based on their relative fair values as of the acquisition date, as follows:
 
       
Working capital
  $ (71 )
Property & equipment, net
    86  
Intangible assets
       
Backlog
    193  
CLIA certification
    144  
Goodwill
    2,755  
         
Net assets acquired
  $ 3,107  
 
F-12

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 1:-
GENERAL (Cont.)

The value assigned to the tangible assets, intangible assets and liabilities has been determined as follows:

1.
Tangible assets:

The acquired working capital consisted of Parkway's non cash components of current assets less other current liabilities as of the acquisition date.

Parkway's current assets and liabilities were recorded at their carrying amounts. The carrying amounts of the current assets and liabilities were reasonable proxies for their market values due to their short-term maturity.
 
Property and equipment were presented at current replacement cost.
 
2.
Backlog:

The fair value of the backlog was determined using the income approach.

3.
CLIA certification:

The fair value of the license was determined using the cost approach, which is the cost that a non-CLIA certified laboratory would have to pay in order to become CLIA certified.
 
Unaudited pro forma results:

The following table for the year ended December 31, 2008 presents certain combined unaudited statements of income data as if the acquisitions of the Parkway transaction occurred on January 1, 2008, after giving effect to purchase accounting adjustments, including amortization of identifiable intangible assets:

   
Year ended December 31,
 
   
2008
 
   
Unaudited
 
       
Net revenues
  $ 3,161  
         
Net loss
  $ 9,760  
         
Basic and diluted net loss per share
  $ 0.8  

The pro forma financial information is not necessarily indicative of the combined results that would have been attained had the acquisitions taken place at the beginning of 2008, nor is it necessarily indicative of future results.

During the fourth quarter of 2008, the Company recorded goodwill impairment in the amount of $ 850 (see also Note 2j). On May 18, 2009, the Company sold Parkway (see also Note 18b).
 
F-13

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 1:-
GENERAL (Cont.)

 
e.
The Company's accumulated deficit during the development stage totaled $ 44,955 for the period from March 9, 2000 (date of inception) to December 31, 2008.
 
The Company is in the development stage and, as such, its ability to continue to operate is dependent on the completion of the development of its products, the ability to market and sell its products and additional financing until profitability is achieved.
 
NOTE 2:-
SIGNIFICANT ACCOUNTING POLICIES

The consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles ("U.S. GAAP").

 
a.
Use of estimates:
 
The preparation of financial statements, in conformity with U.S. GAAP, requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
 
 
b.
Financial statements in U.S. dollars:
 
The Company's financing activities are incurred in U.S. dollars. A portion of the Company's costs is incurred in U.S. dollars. The Company's management believes that the U.S. dollar is the primary currency of the economic environment in which the Company operates. Thus, the functional and reporting currency of the Company is the U.S. dollar.

Accordingly, monetary accounts maintained in currencies other than the dollar are remeasured into U.S. dollars in accordance with Statement No. 52 of the Financial Accounting Standards Board ("FASB"), "Foreign Currency Translation". All transaction gains and losses from the remeasurement of monetary balance sheet items are reflected in the statements of operations as financial income or expenses, as appropriate.
 
 
c.
Principles of consolidation:
 
The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. Intercompany transactions and balances have been eliminated upon consolidation.
 
 
d.
Cash equivalents:
 
Cash equivalents include short-term highly liquid investments that are readily convertible to cash with original maturities of three months or less from time of deposit.
 
 
e.
Short-term bank deposits:
 
Short-term bank deposits are deposits with maturities of more than three months but less than one year. The short-term deposits are presented at their cost. The accrued interest is included in other receivables and prepaid expenses.
 
F-14

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 2:-    
SIGNIFICANT ACCOUNTING POLICIES (Cont.)

 
f.
Marketable securities:
 
The Company accounts for investments in debt and equity securities in accordance with Financial Accounting Standards No. 115, "Accounting for Certain Investments in Debt and Equity Securities" ("SFAS 115"). Management determines the appropriate classification of its investments in debt and equity securities at the time of purchase and reevaluates such determination at each balance sheet date.

At December 31, 2008 and 2007, all marketable securities are designated as available-for-sale. Accordingly, these securities are stated at fair value, with unrealized gains and losses reported in accumulated other comprehensive income (loss), a separate component of shareholders' equity, realized gains and losses on sales of investments, as determined on a specific identification basis, are included in the consolidated statement of operations.

FASB Staff Position ("FSP") No. 115-1, "The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investment" ("FSP 115-1") provides guidance for determining when an investment is considered impaired, whether impairment is other-than-temporary, and for measurement of an impairment loss. An investment is considered impaired if the fair value of the investment is less than its cost. If, after consideration of all available evidence to evaluate the realizable value of its investment, impairment is determined to be other-than-temporary, then an impairment loss should be recognized equal to the difference between the investment's cost and its fair value.

As of December 31, 2007, the Company had $7,400 of principal invested in Auction Rate Securities (ARS) ranked AAA/Aaa at the time of purchase. All of these securities retained at least AAA or Aaa rating as of December 31, 2007. All securities continue to pay interest in accordance with their stated terms as of December 31, 2007. However, since these ARS have experienced multiple failed auctions due to a lack of liquidity in the market for these securities, the Company has revalued its ARS portfolio. As a result, it has recorded an impairment charge of $ 5,009 in its statement of operation to reflect other than temporary decline in the value of its investment in ARS. During 2008 the Company recorded an additional impairment of $ 631 related to the ARS.

During the fourth quarter of 2008, the Company received $ 7,400 from the repurchase of the ARS following an unexpected offer to settle the ARS and recorded gain in the amount of $ 5,640 upon receiving the funds (See Note 6).
 
 
g.
Trade receivables:
 
Trade receivables are reported, net of allowance for doubtful accounts, which is estimated and recorded in the period the related revenues recorded. Management provides for probable uncollectible amounts through a provision for bad debt expense and an adjustment to a valuation allowance based on its assessment of the current status of individual accounts. Balances that are still outstanding after management has used reasonable collection efforts are written-off through a charge to the valuation allowance and a credit to accounts receivable. As of December 31, 2008 the allowance for doubtful accounts is $ 5.
 
F-15

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 2:-    
SIGNIFICANT ACCOUNTING POLICIES (Cont.)

 
h.
Property and equipment:
 
Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated by the straight-line method over the estimated useful lives of the assets.
 
The annual depreciation rates are as follows:
 
 
%
   
Computer equipment
33
Office furniture and laboratory equipment
7 - 15 (mainly 15)
Leasehold improvement
Over the shorter of the lease term or useful economic life

 
i.
Intangible assets:
 
Intangible assets acquired in a business combination are recorded at fair value at the date of acquisition. Following initial recognition, intangible assets are carried at cost less any accumulated amortization and any accumulated impairment losses. The useful lives of intangible assets are assessed to be either finite or indefinite. Intangible assets with finite lives are amortized over their useful economic life using a method of amortization that reflects the pattern in which the economic benefits of the intangible assets are consumed or otherwise used up and are assessed for impairment whenever there is an indication that the intangible asset may be impaired. The amortization period and the amortization method for an intangible asset with a finite useful life are reviewed at least at each financial year-end.

The Company's intangible assets consist of CLIA certification and backlog. The backlog's estimated useful life is one year; the CLIA certification has indefinite useful life and therefore, is not subject to amortization, but rather reviewed for impairment at least annually in accordance with the provision of SFAS 142.

In accordance with SFAS 144, The Company's management has assessed whether there has been an impairment of the Company's intangible assets during 2008. This was undertaken due to certain indicators of impairment such as a decline in fair value of publicly traded competitive companies the Company's recent operating results and the determination in 2008 that intangible assets have been impaired. Impairment is considered to exist if total estimated future cash flows on an undiscounted basis are less than the carrying value of the asset or asset group tested for impairment.

In performing that test, the Company's management estimated the sum of the undiscounted future cash-flows, expected to be derived from its asset group. The Company's management used significant assumptions and estimates, including but not limited to projected future revenues and cash flows, growth rates, future gross margins and operating results, future working capital needs and future capital expenditures, as well as appropriate discount rates. The assumptions developed by the Company's management were based upon historical trends and estimates of future economic conditions.

The management assisted by a third party valuator in applying the customary valuation techniques and required economic models. These assumptions may differ from actual results due to, among other things, technological change, economic conditions, changes to its business models or changes in operating performance and an impairment charge may be required in the future.
 
F-16

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 2:- 
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
   
   
The analysis showed that the sum of the undiscounted cash-flow derived from the asset group exceeded its carrying amount and accordingly, the Company's management concluded that impairment of the intangible assets with finite useful lives is not required.
     
 
j.
Goodwill:
 
Goodwill is measured as the excess of the cost of an acquired company over the sum of the amounts assigned to tangible and identifiable intangible assets acquired less liabilities assumed. Goodwill is not amortized, but rather reviewed for impairment at least annually in accordance with the provisions of SFAS No. 142. The goodwill impairment test under SFAS No. 142 involves a two-step approach. Under the first step, the Company determines the fair value of each reporting unit to which goodwill has been assigned.

The reporting units of the Company for purposes of the impairment test are the Company's two operating segments, the core technology, and laboratory services, as these are the components of the business for which discrete financial information is available and segment management regularly reviews the operating results of those components. The Company then compares the fair value of each reporting unit to its carrying value, including goodwill. The Company estimates the fair value of each reporting unit by estimating the present value of the reporting unit's future cash flows. If the fair value exceeds the carrying value, no impairment loss is recognized. If the carrying value exceeds the fair value, the goodwill of the reporting unit is considered potentially impaired and the second step is completed in order to measure the impairment loss. Under the second step goodwill is reduced to its implied fair value through an adjustment to the goodwill balance, resulting in an impairment charge.

In accordance with SFAS No. 142, the Company performed an annual assessment of goodwill impairment as of December 31, 2008 for the laboratory services segment. This was undertaken due to certain indicators of impairment such as a decline in fair value of publicly traded competitive companies the Company's recent operating results and the determination in 2008 that goodwill have been impaired. The Company performed the impairment analysis based on estimated discounted future cash flow. As a result of this analysis, the Company determined that goodwill impairment related to the laboratory services had occurred and recognized a non-cash impairment charge of $ 850.
 
 
k.
Impairment of long-lived assets:
 
The long-lived assets of the Company and its subsidiaries and all identifiable intangible assets that are subject to amortization are reviewed for impairment in accordance with Statement of Financial Accounting Standard No. 144 "Accounting for the Impairment or Disposal of Long-Lived Assets"("SFAS No. 144"), whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. As of December 31, 2008 and 2007, no impairment losses have been identified.
 
F-17

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 2:-
SIGNIFICANT ACCOUNTING POLICIES (Cont.)

 
l.
Convertible notes:
 
Convertible notes are accounted for in accordance with the provisions of Emerging Issues Task Force ("EITF") Issue No. 00-19, "Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company's Own Stock" ("EITF 00-19"). The Company has also considered Statements of Financial Accounting Standard No.133, "Accounting for Derivatives, Instruments and Hedging Activities" ("SFAS 133"), APB 14, "Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants" and EITF 05-2 "The Meaning of "Conventional Convertible Debt Instrument" in Issue No. 00-19", the Company, where applicable, recorded an embedded derivative instrument classified as a liability.
 
 
m.
Revenue recognition:
 
Revenues from sales of Rosetta core products are recognized in accordance with Staff Accounting Bulletin No. 104, "Revenue Recognition in Financial Statements" ("SAB No. 104"), when delivery has occurred, persuasive evidence of an agreement exists, the vendor's fee is fixed or determinable, no further obligation exists and collectability is probable.

To the extent future obligations are included in a multi-element arrangement; revenue is recognized upon delivery, provided fair value for the elements exists. In multi-element arrangements that include future obligations, if fair value does not exist for all undelivered elements, revenue for the entire arrangement is deferred until all elements are delivered or when fair value can be established according to EITF Issue No. 00-21, "Accounting for Revenue Arrangements with Multiple Deliverables" ("EITF 00-21").

Royalties from licensing the right to use the Company's products will be recognized when earned and when written sales confirmation from the licensee is received and no future obligation exists. Non-refundable, up front advancements of royalties from licensing the right to use the Company's products which are fully chargeable against royalties, are recorded as deferred revenue until the above mentioned criteria for recognizing revenue are met.

Deferred revenues represent payments received in advance, where not all revenue recognition criteria are met. As of December 31, 2008, the Company has deferred revenue in an amount of $ 228.

Revenues from laboratory services are recognized, when persuasive evidence of an arrangement exists, services have been rendered, the fee is determinable and collectability is reasonably assured. The Company primarily recognizes revenue for services rendered upon completion of the testing process. Billing for services reimbursed by third-party payers are recorded as revenues net of allowance for differences between amounts billed and the estimated receipts from such payers. Adjustments to the estimated receipts, based on final settlement with the third party payers, are recorded upon settlement. Unbilled receivables are recorded for services rendered during, but billed subsequent to, the reporting period.
 
F-18

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 2:-
SIGNIFICANT ACCOUNTING POLICIES (Cont.)

 
n.
Research and development expenses, net:
 
Research and development expenses include costs of salaries and related expenses, activities related to intellectual property, research materials and supplies and equipment depreciation. All research and development costs are expensed as incurred. The Company has entered into several license agreements for rights to utilize certain technologies. The terms of the licenses may provide for upfront payments, annual maintenance payments and royalties on product sales. Costs to acquire and maintain licensed technology that has not reached technological feasibility and does not have alternative future use are charged to research and development expense as incurred. During the years ended December 31, 2008, 2007 and 2006, the Company charged to research and development expense $ 162, $ 253 and $ 453 of costs associated with license fees, respectively. (Note 12e-12j).

Royalty bearing grants from the Bi-national Industrial Research and Development Foundation ("BIRD") for funding approved research and development projects, are presented as a reduction from the research and development expenses (Note 12k). The Company received grants in an amount of $ 143, $ 143 and $ 71, in the years 2008, 2007 and 2006, respectively.
 
 
o.
Accounting for stock-based compensation:
 
The Company accounts for stock-based compensation in accordance with SFAS No. 123 (revised 2004), "Share-Based Payment" ("SFAS No. 123(R)"). SFAS No. 123(R) requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service periods in the Company's consolidated income statements.

The Company recognizes compensation expenses for the value of its awards granted based on the straight line method over the requisite service period of each of the awards, net of estimated forfeitures. SFAS No. 123(R) requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Estimated forfeitures are based on actual historical pre-vesting forfeitures.

The Company selected the Black-Scholes-Merton option pricing model as the most appropriate fair value method for its stock-options awards and values restricted stock based on the market value of the underlying shares at the date of grant. The option-pricing model requires a number of assumptions, of which the most significant are the expected stock price volatility and the expected option term.

The weighted-average estimated fair value of employee stock options granted during the 12 months ended December 31, 2008, 2007 and 2006 was $ 3.14, $ 5.12 and $ 5.01, respectively per share using the Black-Scholes option pricing model with the following weighted-average assumptions (annualized percentages):
 
   
Year ended December 31,
   
2008
 
2007
 
2006
             
Dividend yield
 
0%
 
0%
 
0%
Expected volatility
 
75%-85%
 
85%-90%
 
90%
Risk-free interest
 
3.53%
 
4.17%
 
4.8%
Expected life
 
6.25 years
 
6.25 years
 
6-6.25 years
 
F-19

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 2:-  
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
 
 
 
The Company is required to assume a dividend yield as an input in the Black-Scholes model. The dividend yield assumption is based on the Company's historical experience and expectation of future dividend payouts. The Company has historically not paid dividends and has no foreseeable plans to pay dividends. The dividend yield used for the twelve months ended December 31, 2008 and 2007 was 0%.

The computation of expected volatility is based on realized historical stock price volatility of peer data as well as historical volatility of the Company's stock starting from the IPO date. As a result of the above-mentioned calculations, the volatility used for the twelve months ended December 31, 2008 and 2007 was between 75%-85% and between 85%-90%, respectively.

The risk-free interest rate assumption is the implied yield currently available on United States treasury zero-coupon issues with a remaining term equal to the expected life term of the Company's options.

The Company determined the expected life of the options according to the simplified method, average of vesting and the contractual term of the Company's stock options.

The Company applies SFAS No. 123(R) and EITF No. 96-18 "Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring or in Conjunction with Selling, Goods or Services", with respect to options and warrants issued to non-employees. SFAS No. 123(R) requires the use of option valuation models to measure the fair value of the options and warrants at the measurement date.
 
 
p.
Net loss per share:
 
Basic earnings per share are computed based on the weighted average number of Ordinary shares outstanding during each year. Diluted earnings per share are computed based on the weighted average number of Ordinary shares outstanding during each year, plus dilutive potential Ordinary shares considered outstanding during the year, in accordance with Statement of Financial Accounting Standards No. 128, "Earnings per Share" ("SFAS No. 128").

Basic and diluted net loss per share is computed using the weighted average number of Ordinary shares outstanding during the period.

For the years ended December 31, 2008, 2007 and 2006, all outstanding options, warrants and Preferred shares, if any, have been excluded from the calculation of the diluted net loss per share since their effect was anti-dilutive.
 
 
q.
Income taxes:
 
The Company and its subsidiaries account for income taxes in accordance with Statement of Financial Accounting Standards No. 109, "Accounting for Income Taxes" ("SFAS No. 109"). This Statement prescribes the use of the liability method whereby deferred tax assets and liability account balances are determined based on the differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.

The Company and its subsidiaries provide a valuation allowance, if necessary, to reduce deferred tax assets to the amounts that are more likely-than-not to be realized.

F-20

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 2:-  
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
 
 
 
On January 1, 2007, the Company adopted FASB Interpretation No. 48, "Accounting for Uncertainty in Income Taxes, an Interpretation of FASB Statement No. 109" (FIN 48). FIN 48 contains a two-step approach to recognizing and measuring uncertain tax positions accounted for in accordance with SFAS No. 109. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement.
 
 
r.
Severance pay:
 
A majority of the employees are included under section 14 of the Israeli Severance Compensation Law ("Section 14"). Under Section 14, the Israeli employees are entitled only to monthly deposits, at a rate of 8.33% of their monthly salary, made on their behalf with insurance companies. Payments in accordance with Section 14 release the Israeli subsidiary from any future severance payments in respect of those employees. Deposits under Section 14 are not recorded as an asset in the Company's balance sheet.

For those Israeli employees who are not included under Section 14, the liability for severance pay is calculated pursuant to Israel's Severance Pay Law based on the most recent salary of the employees multiplied by the number of years of employment, as of the balance sheet date. Employees are entitled to one month's salary for each year of employment or a portion thereof. The Israeli subsidiary's liability for all of its employees, is fully provided by monthly deposits with insurance policies and by an accrual. The value of these policies is recorded as an asset in the Company's balance sheet.

The deposited funds may be withdrawn only upon the fulfillment of the obligation pursuant to Israel's Severance Pay Law or labor agreements. The value of the deposited funds is based on the cash surrendered value of these policies, and includes immaterial profits.

The Subsidiary’s and Parkway’s employees have a 401(K) defined contribution plan covering certain employees in the U.S.

Severance expenses for the years ended December 31, 2008, 2007 and 2006 were $ 478, $ 171 and $ 333, respectively, and $ 1,292 from March 9, 2000 (date of inception) through December 31, 2008.
 
 
s.
Concentrations of credit risk:
 
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents, short term bank deposits, marketable securities and trade receivables.

As a result of the recent turmoil in capital markets, the Company has tightened its control and monitoring over its marketable securities portfolio in order to minimize potential risks stemming from current capital markets environment. Such measures included among others: reducing credit exposure to financial sector securities and increasing the overall credit quality of the portfolio.
 
F-21

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 2:-  
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
 
 
 
As of December 31, 2008, the Company's marketable securities include an investment in a U.S. Agency security. Management believes that minimal credit risk exists with respect to these marketable securities.

The Company has no off-balance-sheet concentration of credit risk other than foreign exchange contracts or other foreign hedging arrangements to hedge is operating activities.
 
 
t.
Fair value of financial instruments:
 
The carrying amounts of our financial instruments, including cash and cash equivalents, short-term bank deposits, marketable securities, accounts receivable, accounts payable and accrued liabilities, approximate fair value because of their generally short maturities.

Effective January 1, 2008, the Company adopted SFAS 157, "Fair Value Measurements" and, effective October 10, 2008, adopted FSP No. SFAS 157-3, "Determining the Fair Value of a Financial Asset When the Market for That Asset Is Not Active", except as it applies to the nonfinancial assets and nonfinancial liabilities subject to FSP 157-2. SFAS 157 clarifies that fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. As a basis for considering such assumptions, SFAS 157 establishes a three-tier value hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value:
 
Level 1 -    Observable input that reflects quoted prices (unadjusted) for identical assets or liabilities in active markets.
 
Level 2 -     Include other inputs that are directly or indirectly observable in the marketplace.
 
Level 3 -     Unobservable inputs which are supported by little or no market activity.
 
The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.

The following methods were used by the Company and its subsidiaries in estimating their fair value disclosures for financial instruments:
 
1.    The fair value of short-term marketable securities is based on quoted market prices.
 
2.    The fair value of derivative instruments is estimated by obtaining quotes from brokers.
 
F-22

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 2:-   
SIGNIFICANT ACCOUNTING POLICIES (Cont.)

 
u.
Derivative instruments:
 
The Company sometimes uses derivative financial instruments to manage its exposure to fluctuations in foreign exchange rates. The Company accounts for derivative financial instruments in accordance with SFAS 133, "Accounting for Derivative Instruments and Hedging Activities" ("SFAS No. 133"). Under SFAS No. 133, all derivatives are recorded as either assets or liabilities in the consolidated balance sheet, and periodically adjusted to fair value. The classification of gains and losses resulting from changes in the fair value of derivatives is dependent on the intended use of the derivative and its resulting designation. Adjustments to reflect changes in fair of values of derivatives not designated as hedging instruments are reflected in earnings. For derivative instruments that are designated and qualify as a cash flow hedge, the effective portion of the gain or loss on the derivative instrument is reported as a component of other comprehensive income and reclassified into earnings in the same line item associated with the forecasted transaction in the same period during which the hedge transaction affects earnings.

During 2008, the Company recognized income from derivative instruments of $ 182, which was offset against the payroll expenses in the statement of income and recorded financial expenses from derivative instruments of $ 87. As of December 31, 2008 the Company has no unrecognized income from derivative instruments.
 
 
v.
Reclassification:
 
Certain comparative figures have been reclassified to conform to the current year presentation.
 
 
w.
Impact of recently issued Accounting Standards:

 
1.
In February 2008, the FASB issued FSP No. FAS 157-1, "Application of FASB Statement No. 157 to FASB Statement No. 13 and Other Accounting Pronouncements That Address Fair Value Measurements for Purposes of Lease Classification or Measurement under Statement 13", and FSP No. FAS 157-2, "Effective Date of FASB Statement No. 157". Collectively, the Staff Positions defer the effective date of Statement 157 to fiscal years beginning after November 15, 2008 for nonfinancial assets and nonfinancial liabilities except for items that are recognized or disclosed at fair value on a recurring basis at least annually, and amend the scope of Statement 157. As described in Note 2(r), the Company adopted Statement 157 and the related FASB staff positions except for those items specifically deferred under FSP No. FAS 157-2.

 
2.
In March 2008, the FASB issued Statement 161 "Disclosures about Derivative Instruments and Hedging Activities" ("SFAS 161") an amendment to FASB No. 133.  This statement changes the disclosure requirements for derivative instruments and hedging activities.  Entities are required to provide enhanced disclosures about (a) how and why and entity uses derivative instruments, (b) how derivative instruments and related hedged items are accounted for under Statement 133 and its related interpretations, and (c) how derivative instruments and related hedged items affect an entity's financial position, financial performance, and cash flows.  This statement is effective for financial statements issued for fiscal years and interim periods beginning after November 15, 2008.   The Company does not expect the adoption of SFAS 161 to have a material impact on its financial position, results of operations or cash flows.
 
F-23

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 2:- 
SIGNIFICANT ACCOUNTING POLICIES (Cont.)

 
3.
In November 2007, the EITF issued EITF Issue No. 07-1, Accounting for Collaborative Arrangements Related to the Development and Commercialization of Intellectual Property.
 
Companies may enter into arrangements with other companies to jointly develop, manufacture, distribute, and market a product. Often the activities associated with these arrangements are conducted by the collaborators without the creation of a separate legal entity (that is, the arrangement is operated as a "virtual joint venture"). The arrangements generally provide that the collaborators will share, based on contractually defined calculations, the profits or losses from the associated activities. Periodically, the collaborators share financial information related to product revenues generated (if any) and costs incurred that may trigger a sharing payment for the combined profits or losses. The consensus requires collaborators in such an arrangement to present the result of activities for which they act as the principal on a gross basis and report any payments received from (made to) other collaborators based on other applicable GAAP or, in the absence of other applicable GAAP, based on analogy to authoritative accounting literature or a reasonable, rational, and consistently applied accounting policy election.

EITF 07-1 is effective for collaborative arrangements in place at the beginning of the annual period beginning after December 15, 2008. The Company is currently evaluating the impact that the adoption of EITF 07-1 could have on the Company's financial statement.
 
 
4.
In December 2007, the FASB issued SFAS 141(R), ''Business Combinations'' (''SFAS 141(R)''). This Statement replaces SFAS No. 141, ''Business Combinations'', and requires an acquirer to recognize the assets acquired, the liabilities assumed, including those arising from contractual contingencies, any contingent consideration and any noncontrolling interest in the acquiree at the acquisition date, measured at their fair values as of that date, with limited exceptions specified in the statement. SFAS 141(R) also requires the acquirer in a business combination achieved in stages (sometimes referred to as a step acquisition) to recognize the identifiable assets and liabilities, as well as the noncontrolling interest in the acquiree, at the full amounts of their fair values (or other amounts determined in accordance with SFAS 141(R)). In addition, SFAS 141(R)'s requirement to measure the noncontrolling interest in the acquiree at fair value will result in recognizing the goodwill attributable to the noncontrolling interest in addition to that attributable to the acquirer.
 
SFAS 141(R) applies prospectively to business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. As such, the adoption of SFAS 141(R) is not expected to have a material effect on accounting for our current subsidiaries.
 
F-24

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 2:-
SIGNIFICANT ACCOUNTING POLICIES (Cont.)

 
5.
In December 2007, the FASB issued SFAS 160, ''Non-controlling Interests in Consolidated Financial Statements'' (''SFAS 160''). SFAS 160 amends ARB 51, ''Consolidated Financial Statements'', to establish accounting and reporting standards for the non-controlling interest in a subsidiary and for the deconsolidation of a subsidiary. It also clarifies that a non-controlling interest in a subsidiary is an ownership interest in the consolidated entity that should be reported as equity in the consolidated financial statements. SFAS 160 also changes the way the consolidated income statement is presented by requiring consolidated net income to be reported at amounts that include the amounts attributable to both the parent and the non-controlling interest. It also requires disclosure, on the face of the consolidated statement of income, of the amounts of consolidated net income attributable to the parent and to the non-controlling interest. SFAS 160 requires that a parent recognize a gain or loss in net income when a subsidiary is deconsolidated and requires expanded disclosures in the consolidated financial statements that clearly identify and distinguish between the interests of the parent owners and the interests of the non-controlling owners of a subsidiary.
 
SFAS 160 is effective for fiscal periods, and interim periods within those fiscal years, beginning on or after December 15, 2008. The adoption of SFAS 160 is not expected to have a material effect on accounting for current subsidiaries.
 
NOTE 3: -
FAIR VALUE MEASURMENTS

In accordance with SFAS 157, the Company measures its marketable securities and foreign currency derivative contracts at fair value. Marketable securities are classified within Level 2. This is because these assets are valued using quoted market prices for similar assets or alternative pricing sources and models utilizing market observable inputs. Foreign currency derivative contracts are classified within Level 2 as the valuation inputs are based on quoted prices and market observable data of similar instruments.

The Company's financial assets (liabilities) measured at fair value on a recurring basis, excluding accrued interest components, consisted of the following types of instruments as of December 31, 2008:

   
Fair value measurements using input type
 
   
Level 1
   
Level 2
   
Level 3
   
Total
 
Assets:
                       
                         
Marketable securities
  $ -     $ 426     $ -     $ 426  
                                 
Total Assets
    -       426       -       426  
                                 
Liabilities:
                               
                                 
Convertible loan
    -       -       750       750  
Foreign currency derivative contracts
    -       65       -       65  
 
                               
Total liabilities
  $ -     $ 65     $ 750     $ 815  

The Company values the Level 3 convertible loan based on the fair value (see Note 11).
 
F-25

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 4:-
SHORT-TERM BANK DEPOSIT

As of December 31, 2008 the Company holds two deposits as follows:

Amount
 
Maturity date
 
Interest
         
$ 723
 
March 2, 2009
 
2%
$ 117
 
December 3, 2009
 
2.25%


NOTE 5:-
MARKETABLE SECURITIES

As of December 2008 and 2007, the Company holds $ 426 and $ 8,251 in marketable securities, respectively, designated as available-for-sale.

Accordingly, the balance of these available-for-sale securities as of December 31, 2008 and 2007 is stated at fair value, with unrealized gains and losses reported in accumulated other comprehensive income (loss).

   
Cost
   
Unrealized gains
   
Market value
 
Available-for-sale:
                 
                   
December 31, 2008:
                 
U.S. Government Securities
  $ 423     $ 3     $ 426  
                         
                         
December 31, 2007:
                       
U.S. Government and Agencies Securities
  $ 8,248     $ 3     $ 8,251  

 
Proceeds from maturity and sales of available-for-sale securities during 2008 were $ 23,755. Net realized gains from the sales of available-for-sale securities in the year 2008 are $ 62.


NOTE 6:-
LONG-TERM INVESTMENT

At December 31, 2007, the Company had $ 7,400 of principal invested in ARS. The ARS held by the Company are private placement securities with long-term nominal maturities for which the interest rates are reset through an auction each one or three month. The monthly auctions historically have provided a liquid market for these securities. Some of the underlying collateral for the ARS held by the Company consists of sub-prime mortgages.

Consistent with the Company's investment policy guidelines, the ARS investments held by the Company all had AAA/Aaa credit ratings at the time of purchase. With the liquidity issues experienced in global credit and capital markets, the ARS held by the Company at December 31, 2007 have experienced multiple failed auctions as the amount of securities submitted for sale has exceeded the amount of purchase orders. All of these securities retained at least AAA or Aaa rating as of December 31, 2007.
 
F-26

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 6:-
LONG-TERM INVESTMENT (Cont.)

The estimated market value of the Company's ARS holdings at December 31, 2007 was $ 2,391, which reflects a $ 5,009 adjustment to the principal value of $ 7,400. Although the ARS continue to pay interest according to their stated terms, based on valuation models and an analysis of other-than-temporary impairment factors, the Company has recorded a pre-tax impairment charge of $ 5,009 and $ 631 in 2007 and in the first median of 2008, respectively, reflecting the ARS holdings that the Company has concluded have other-than-temporary decline in value.

During the fourth quarter of 2008, the Company received $ 7,400 from the repurchase of the ARS following an unexpected offer to settle the above mentioned ARS. The impairment charge that was recorded in 2007 and 2008 was reversed in the fourth quarter of 2008, and the Company recorded a financial income of $ 5,640 on these Securities.

   
Cost
   
Other than temporary impairment
   
Market value
 
December 31, 2008:
                 
                   
Total available-for-sale marketable securities
  $ -     $ -     $ -  
                         
December 31, 2007:
                       
                         
Total available-for-sale marketable securities
  $ 7,400     $ 5,009     $ 2,391  
 
NOTE 7:-
PROPERTY AND EQUIPMENT

   
December 31,
 
   
2008
   
2007
 
Cost:
           
Computer equipment
  $ 459     $ 383  
Office furniture and laboratory equipment
    1,384       1,144  
Leasehold improvements
    288       230  
                 
      2,131       1,757  
Accumulated depreciation:
               
Computer equipment
    333       273  
Office furniture and laboratory equipment
    407       197  
Leasehold improvements
    90       34  
                 
      830       504  
                 
Depreciated cost
  $ 1,301     $ 1,253  

Depreciation expenses for the years ended December 31, 2008, 2007 and 2006 were $ 334, $ 179 and $ 161, respectively, and $ 1,119 from March 9, 2000 (date of inception) through December 31, 2008. Those expenses include depreciation expenses of capital lease equipment for the years ended December 31, 2008, 2007 and 2006 were $ 29, $ 17 and $ 10, respectively.
 
F-27

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 8:-
INTANGIBLE ASSETS

 
a.
Comprised as follows:

   
December 31,
 
   
2008
   
2007
 
Cost:
           
CLIA certification
  $ 144     $ -  
Backlog
    193       -  
                 
      337       -  
Accumulated amortization:
               
CLIA certification
    -       -  
Backlog
    86       -  
                 
      86       -  
                 
Amortized cost
  $ 251     $ -  

 
b.
Amortization expense amounted to $ 86 for the year ended December 31, 2008.

 
c.
Estimated amortization expenses for the year 2009 are $ 107, (see also Note 18b).


NOTE 9:-
GOODWILL

   
December 31,
 
   
2008
 
       
Balance as of December 31, 2007
    -  
         
Acquisition of Parkway
    2,755  
Goodwill impairment
    (850 )
         
Balance as of December 31, 2008
  $ 1,905  
 
NOTE 10:-
OTHER ACCOUNTS PAYABLE AND ACCRUALS

   
December 31,
 
   
2008
   
2007
 
             
Employees salary and payroll accruals
  $ 739     $ 942  
Accrued expenses and other
    485       118  
Deferred revenues and advances from customers
    163       42  
                 
    $ 1,387     $ 1,102  
 
F-28

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 11:- 
CONVERTIBLE LOANS

On September 24, 2008, the Company signed a convertible note agreement with private investors ("Purchasers") in an initiative for development of microRNA-based algae feedstocks for biofeuls. The Company intends to establish a separately operated business unit by forming a wholly owned Israeli subsidiary to be named Rosetta Green Ltd. ("RG"). Under the agreement the Purchasers may purchase convertible notes in an amount up to $ 2,500. The notes will convert to RG Ordinary shares nominal value NIS 0.01, once RG is established as is obtained by dividing the principal amount of the note by a price per RG share reflecting a fully-diluted pre-money valuation of RG equal to $ 5,000. If RG is not established the Notes shall convert into Ordinary shares of the Company at a price per share reflecting the average of the closing prices over the fine consecutive trading days ending on the last trading day prior to the date of conversion, such purchase price shall not be lower than $ 2.00 per share. Up to $ 1,250 were to be paid at the closing and up to $ 1,250 were to be paid upon satisfaction of the first of two milestones. The Company plans to establish the green energy project during 2010. (See also Note 18c).

In September 2008, the Company issued a convertible loan in a principal amount of $ 750.

The convertible loan is a hybrid instrument that contains an embedded conversion option to the Company's common shares or RG's common shares, depending on the formation of RG, as detailed above. The embedded conversion option was separated from the host contract and accounted for a derivative under FAS 133. According to EITF 00-19 the derivative was classified as a liability and was measured at fair value. Due to the limitation of the conversion share price as mentioned above, the fair value of the note is equal to the invested amount.
 
NOTE 12: -
COMMITMENTS AND CONTINGENT LIABILITIES

 
a.
Capital lease and operating lease:
 
During 2008 and 2007, the Company leased laboratory equipment and computer equipment under several capital and operating lease agreements in a total amount of $ 351, $ 400 respectively, to be paid in 10 to 60 monthly payments.
 
The commitments under the lease and loan agreements are as follows:
 
   
December 31,
2008
 
       
Due until December 31, 2009
  $ 157  
Due until December 31, 2010
    63  
Due until December 31, 2011
    9  
 
       
    $ 229  
 
F-29

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 12: -
COMMITMENTS AND CONTINGENT LIABILITIES (Cont.)

 
b.
The facilities and motor vehicles of the Company are rented under operating leases. Aggregate minimum rental commitments under the non-cancelable rent and lease agreements as of December 31, 2008 are as follows:
 
2009
  $ 828  
2010
    687  
2011
    394  
2012
    372  
2013
    246  
         
Total
  $ 2,527  

 
 
Total rent and lease expenses for the years ended December 31, 2008, 2007 and 2006, were $ 641, $ 333 and $ 287, respectively, and $ 1,486 for the period from March 9, 2000, (date of inception) through December 31, 2008.
 
 
c.
As of December 31, 2008 and 2007, the Company provided a bank guarantee for the fulfillment of its lease commitments in the amount of approximately $ 137 and $ 112, respectively.
 
As of December 31, 2008, the bank restricted $ 45 of the Company's deposit, against a loan the Company received from the bank.
 
 
d.
In June 2003, the Company entered into a license agreement with a related party to use its intellectual property for a period of 20 years in consideration of up to $ 100. According to the agreement, the Company is obligated to pay an aggregate consideration of up to $ 100, of which $ 20 was paid in cash and $ 80 shall be paid as quarterly royalties equal to 5% of the net income of the Company resulting from this agreement.

 
e.
In May 2006, the Company signed a royalty-bearing, co-exclusive, worldwide license agreement with a third party. Under this agreement, the Company was granted the right to make, use and sell the third party's proprietary microRNAs for diagnostic purposes including a limited right to sublicense. In consideration for this license the Company paid an initiation fee and will pay a fixed annual license maintenance fee, royalties based on net sales and a percentage of the Company's revenues from any sublicense. The Company estimates that the minimum aggregate license maintenance fees over the term of this agreement will be approximately $ 840 until 2029. During the years ended December, 31, 2008, 2007 and 2006, the Company paid fees in the amount of $ 40, $ 72 and $ 83, respectively, to the third party. The Company recorded the payments as research and development expenses since the licensed technology has not reached technological feasibility and does not have alternative future use.
 
 
f.
In June 2006, the Company signed a royalty-bearing, co-exclusive, worldwide license agreement with a third party. Under this agreement, the Company licensed from this third party the rights to its proprietary microRNAs for diagnostic purposes. In consideration for this license the Company paid an initiation fee and will pay a fixed annual license maintenance fee, royalties based on net sales and a percentage of the Company's revenue from any sublicense.   The Company estimates that the minimum aggregate license maintenance fees over the term of this agreement will be approximately $ 543 until 2022. During the year ended December 31, 2006, the Company paid fees in the amount of $ 219, to the third party.
 
No payments in respect to this agreement were made during the years 2007 and 2008. The Company recorded the payments as research and development expenses since the licensed technology has not reached technological feasibility and does not have alternative future use.
 
F-30

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 12:-
COMMITMENTS AND CONTINGENT LIABILITIES (Cont.)

 
g.
In August 2006, the Company signed a royalty-bearing, exclusive, worldwide license agreement with a third party. Under this agreement, the Company has exclusively licensed from this third party the rights to its proprietary microRNAs for all fields and applications including a limited right to sublicense. In consideration for this license the Company paid an initiation fee and will pay minimum annual royalties, royalties based on net sales and a percentage of the Company's revenues from any sublicense. The Company estimates that the aggregate minimum royalties over the term of this agreement will be approximately $ 2,250 until 2032. During the years ended December 31, 2008, 2007 and 2006, the Company paid fees in the amount of $ 15, $ 43 and $ 125, respectively to the third party. The Company recorded the payments as research and development expenses since the licensed technology has not reached technological feasibility and does not have alternative future use.

 
h.
In December 2006, the Company signed a royalty-bearing, non-exclusive, worldwide license agreement with a third party. Under this agreement the Company licensed from the third party its proprietary microRNAs for research purposes. In consideration for this license the Company will pay an initiation fee and will be required to pay a fixed annual license maintenance fee, royalties based on net sales and a percentage of the Company's revenues from any sublicenses. The Company estimates that the minimum aggregate license maintenance fees over the term of this agreement will be approximately $ 293 until 2022. During the years ended December 31, 2008, 2007 and 2006, the Company paid the third party an aggregate of $ 22, $ 20 and $ 26, respectively under this agreement. The Company recorded the payments as research and development expenses since the licensed technology has not reached technological feasibility and does not have alternative future use.

 
i.
In May 2007, the Company signed a royalty-bearing, co-exclusive, worldwide license agreement with a third party. Under this agreement, the Company has licensed from this third party the rights to its proprietary microRNAs for therapeutic purposes including a limited right to sublicense. In consideration for this license the Company paid an initiation fee and will pay a fixed annual license maintenance fee, payments based on milestones and royalties based on net sales and a percentage of the Company's revenues from any sublicense. The Company estimates that the minimum aggregate maintenance fees over the term of this agreement will be approximately $ 630 until 2029. During the years ended December 31, 2008 and 2007, the Company paid fees in the amount of $ 51 and $ 118, respectively, to the third party. The Company recorded the payments as research and development expenses since the licensed technology has not reached technological feasibility and does not have alternative future use.

 
j.
In January 2008, the Company signed a royalty-bearing, co-exclusive, worldwide license agreement with a third party. Under this agreement, the Company was granted the right to make, use and sell the third party's proprietary microRNAs for research purposes including a limited right to sublicense. In consideration for this license the Company paid an initiation fee and will pay a fixed annual license maintenance fee, royalties based on net sales and a percentage of the Company's revenues from any sublicense. The Company estimates that the minimum aggregate license maintenance fees over the term of this agreement will be approximately $ 420 until 2029. During the year ended December, 31, 2008, the Company paid initiation fees in the amount of $ 40, to the third party. The Company recorded the payments as research and development expenses since the licensed technology has not reached technological feasibility and does not have alternative future use.
 
F-31

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 12:-
COMMITMENTS AND CONTINGENT LIABILITIES (Cont.)

 
k.
Under the BIRD royalty-bearing program, the Company is not obligated to repay any amounts received from BIRD if the development work being carried out by the Company does not continue beyond the investigational new drug ("IND") stage. If the development works which is being carried out by the Company continues beyond the IND stage, the Company is required to repay BIRD 100% of the grant that the Company received provided that the repayment to BIRD is made within the first year following project completion. For every year that the Company does not make these repayments, the amount to be repaid incrementally increases up to 150% in the fifth year following project completion. All amounts to be repaid to BIRD are linked to the U.S. consumer price Index.
 
As of December 31, 2008, the Company had received $ 357 from BIRD, which was offset against research and development expenses. As of December, 31 2008 no liability was recorded since the Company did not reach technological feasibility for this project.
 
NOTE 13:-
SHARE CAPITAL

 
a.
Initial public offering:
 
On March 2, 2007, the Company completed the initial public offering (the "IPO") of its Ordinary shares. The IPO consisted of the sale of 4,312,500 Ordinary shares at a price of $ 7.00 per share, including 562,500 shares pursuant to the exercise of the over-allotment option granted by the Company to the underwriters. Net proceeds from the initial public offering were $ 26 million. In addition, upon completion of the IPO, all outstanding Preferred shares were converted into 7,107,730 Ordinary shares.
 
 
b.
Reverse stock split:
 
On August 31, 2006, the Company's Board of Directors approved, subject to shareholder approval which occurred on September 3, 2006, a 1-for-3.9822 reverse stock split and, accordingly, all shares, options, warrants and earnings (losses) per share amounts have been retroactively adjusted for all periods presented to reflect this reverse stock split. On September 3, 2006, the shareholders also approved a recapitalization of the Company's authorized share capital so that each share has a par value of NIS 0.01. The reverse stock split and the recapitalization became effective on October 4, 2006.
 
 
c.
Ordinary shares:
 
Ordinary shares confer upon the holders the right to receive notice to participate and vote in the general meetings of the Company, the right to receive dividends, if declared.

In March 2007 all the Preferred shares were converted into Ordinary shares by dividing the applicable original issue price of such Preferred share by the applicable conversion price of such Preferred share, as defined in the Amended and Restated Articles of Association of the Company. The original issue prices of series A Preferred shares are $ 3.65, $ 4.08 and $ 5.29, of series B Preferred shares is $ 5.86 and of series C Preferred shares is $ 7.68. The initial conversion price of each of the series A, B and C Preferred shares is identical to the original issue price of such series, and is subject to adjustment for stock splits and other reclassifications and will also be adjusted in accordance with the standard weighted-average anti-dilution provisions contained in the Company's Amended and Restated Articles of Association in the event of a subsequent issuance of securities, subject to certain exceptions, at a price per share less than the applicable original issue price. The conversion ratio for each Preferred share was 1:1.
 
F-32

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 13:-
SHARE CAPITAL (Cont.)

 
d.
Investment agreements:

 
1.
During 2000, the Company signed investment agreements and issued 2,522,496 Ordinary shares to investors and founders, in consideration of $ 40. The Company repurchased 195,371 of those shares and holds it as treasury shares.

 
2.
During 2001, the Company signed investment agreements and issued 38,421 Ordinary shares in consideration of $ 153.

 
3.
In July 2003, the Company signed an investment agreement with existing and new investors, pursuant to which the Company issued 535,084 Preferred A shares, at a price per share of $ 5.29, for consideration of $ 2,653, net of issuance expenses of $ 177.

 
4.
In October 2003, the Company issued 457,952 Preferred A shares at a price per share of $ 3.65 upon conversion of a convertible loan made available in 2002, and an additional 180,850 Preferred A shares were issued to the lenders of the loan upon exercise of warrants.
 
In addition, 163,883 Preferred A shares were issued upon conversion of a convertible loan received by the Company in March 2003 at a price per share of $ 4.08.
 
 
5.
In May 2004, the Company issued 56,914 restricted Ordinary shares to four of its board members at no consideration, to be held by a trustee. Each director is entitled to 1/36 of the shares for each month starting September 2003, in which he serves as a board member. In the event that a board member ceases to serve as a board member prior to the end of three years, the shares will remain with the trustee. As of December 31, 2007, two of those board members still serve as directors. Compensation expenses related to this grant amounted to $ 49 for the year ended December 31, 2006. No compensation expenses related to this grant were recorded during 2008 and 2007.
 
In May 2006, 1,581 restricted Ordinary shares were canceled.
 
 
6.
In September 2004, the Company signed an investment agreement with existing and new investors, pursuant to which the Company issued 265,747 Preferred B shares, at a price per share of $ 5.86, for total consideration of $ 1,395, net of issuance expenses of $ 162.
 
In addition, the Company granted the investors warrants to purchase 80,492 Preferred B shares at an exercise price of $ 5.86 per share, exercisable upon the earlier of June 30, 2006 or the closing of a financing of at least $ 5,000 at a pre-money valuation of at least $ 40,000.

76,395 warrants were exercised into Preferred B shares in 2006. The remaining warrants were cancelled on April 23, 2006.
 
 
7.
Pursuant to the investment agreement signed in September 2004, in February 2005, the Company issued 392,087 Preferred B shares, for total consideration of $ 2,165, net of issuance expenses of $ 132. In addition, $ 122 of the shareholder's loan was converted into 20,802 Preferred B shares.

 
8.
On January 15, 2006 the Company issued 1,033,382 series B Preferred shares at a price of $ 5.86 from the conversion of 2005 convertible loan.
 
F-33

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 13:-
SHARE CAPITAL (Cont.)

 
9.
In January 2006, the Company paid a finder's fee of $ 31 by issuing to a non-employee 5,335 Ordinary shares at a price of $ 5.86 per share, for services rendered to the Company.

 
10.
In March 2006, the board of directors and the shareholders of the Company approved an increase of 9,668,104 shares to the authorized share capital and a recapitalization of the authorized share capital of the Company as follows: The authorized share capital of the Company shall be 17,578,370 shares divided into: (i) 12,304,859 Ordinary shares; (ii) 1,381,158 Preferred A shares; (iii) 1,883,397 Preferred B shares and (iv) 2,008,957 Preferred C shares.

 
11.
In April 2006, the Company issued 1,822,422 Preferred C shares at a price per share of $ 7.68 for gross proceeds of $ 14,000 (the "Series C Financing").

 
12.
In connection with the Series C Financing, the Company paid $30 by issuing 3,905 Ordinary shares at a price of $ 7.68 per share.

 
13.
On March 2, 2007, the Company consummated an initial public offering (the "IPO") on The NASDAQ Global Market and issued an aggregate of 4,312,500 Ordinary shares at price per share of $ 7 for net proceeds of $ 26 million. (Refer to Note 13a for further information).

 
14.
In July 2008, as a part of the consideration of Parkway's acquisition (see also Note 1d), the Company issued to Parkway's former sole owner 229,661 Ordinary shares which are equal in value to $ 1,000 based on the weighted- average closing price of the Company's Ordinary shares during the 10 trading days immediately preceding the date of issuance.
     
   
All of the shares have NIS 0.01 par value as of December 31, 2008 and 2007.
 
 
e.
Finders' fee warrants:
 
Under finders' fee agreements, the following warrants are outstanding as of December 31, 2008:
 
Issuance date
 
Number of warrants
 
Exercisable
into shares
 
Exercise
price
 
Exercisable through
                 
April 2006
    33,585  
Ordinary
  $ 7.68  
April 23, 2009
 
 
 
The fair value of the warrants granted was estimated using the Black-Scholes option-pricing model with the following weighted-average assumptions; risk-free interest rates of 4.4%, dividend yields of 0%, volatility factors of the expected market price of the Company's shares of 90%, and a weighted-average expected life of the warrants of three years.

During 2007, 8,432 warrants with expiration date of January 31, 2008, were exercised using a cashless method, into 3,947 of Ordinary shares. Additional 25,683 and 39,660 warrants with January 31, 2008 and July 15, 2008, respectively, expiration date, expired on those dates. 33,585 warrants with April 23, 2009 expiration date, were expired on that date.
 
F-34

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 13:-
SHARE CAPITAL (Cont.)

 
f.
Stock option plans:

 
1.
During 2001 the Company adopted the 2001 Israeli Share Option Plan (the "2001 Plan"), pursuant to which options may be granted to the Company's officers, directors, employees and consultants.
 
Pursuant to the plan, the Company has reserved a total of 376,679 shares for this plan and for any other option plans, which may be adopted by the Company in the future.

In March 2003, the Company adopted the 2003 Israeli Share Option Plan (the "2003 Plan"), pursuant to which options may be granted to the Company's officers, directors, employees and consultants. Pursuant to the plan, the Company has reserved an additional 188,340 shares for the 2003 Plan and for any other share option plans that have previously been, or in the future may be, adopted by the Company.

In March 2005, the Company's board of directors approved an increase in the shares available under the 2003 Plan of 401,791 shares to a total of 966,810 shares (including the 376,679 shares reserved under the 2001 Plan).

In July 2006, the Company adopted the 2006 Israeli Share Option Plan (the "2006 Plan"), pursuant to which options may be granted to the Company's officers, directors, employees and consultants. Pursuant to the 2006 Plan, the Company has reserved an additional 452,024 shares for the 2006 Plan and for any other share option plans that have previously been, or in the future may be, adopted by the Company. In November, 2007 the Board of Directors of the Company approved an additional 500,000 shares for the 2006 plan.

The total number of options authorized for grant under the plans amounted to 1,918,825. As of December 31, 2008, an aggregate of 199,627 options of the Company are available for future grants.

Options granted under the 2001 and 2003 Plans typically vest, as set forth in each optionee's option agreement, over three years. Options granted under the 2006 Plan typically vest, as set forth in each optionee's option agreement, over 4 years. All Options are exercisable until ten years from the grant of the option. Any options which are forfeited or unexercised become available for future grants. The exercise price equals the share price on the grant date.
 
 
2.
In September 2005, the Company's Board of Directors approved the acceleration of vesting of 5,274 unvested options, held by a former employee. As a result, the Company recorded additional compensation costs of $ 12.
 
F-35

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 13:-
SHARE CAPITAL (Cont.)

 
3.
A summary of the Company's stock option activity and related information for the year ended December 31, 2008, is as follows:
 
   
Number of options
   
Weighted-average exercise price
   
Weighted- average remaining contractual term (in years)
   
Aggregate intrinsic value
 
Outstanding at January 1, 2008
    881,107     $ 4.19              
Granted
    372,104     $ 4.22              
Exercised
    (10,365 )   $ 3.15              
Forfeited
    (31,111 )   $ 4.93              
 
                           
Outstanding at December 31, 2008
    1,211,735     $ 4.19       7.78     $ 162  
 
                               
Vested or expected to vest
    1,088,785     $ 4.16       7.94     $ 162  
 
                               
Exercisable at December 31, 2008
    524,163     $ 3.55       6.94     $ 162  
 
 
 
The weighted-average grant-date fair value of options granted during the twelve months ended December 31, 2008, 2007 and 2006 was $ 3.14, $ 5.12 and $ 5.01, respectively. The aggregate intrinsic value in the table above represents the total intrinsic value (the difference between the fair market value of the Company Ordinary shares on December 31, 2008 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on December 31, 2008. This amount changes based on the fair market value of the Company's shares. Total intrinsic value of options exercised for the twelve months ended December 31, 2008 was $ 22. As of December 31, 2008, there was $ 1,949 of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the Company's stock option plans. The cost is expected to be recognized over a weighted average period of 2.82 years.
 
The following table summarizes information about options to employees outstanding at December 31, 2008 under the plans:
 
Exercise
price
   
Options outstanding at December 31,
2008
   
Weighted average remaining contractual life (years)
   
Weighted average exercise price
   
Options exercisable at December 31, 2008
   
Average exercise price of options exercisable
 
                                 
$ 0       137,372       4.97     $ 0       137,372     $ 0  
$ 2.31-$4.70       682,448       8.22     $ 3.92       209,361     $ 3.55  
$ 5.45-$6.59       342,851       7.98     $ 5.87       152,277     $ 6.00  
$ 7.098-$8.8       49,064       8.20     $ 7.98       25,153     $ 8.10  
                                             
          1,211,735                       524,163          
 
F-36

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 13:-
SHARE CAPITAL (Cont.)
 
The following table sets forth the total stock-based compensation expense resulting from stock options granted to employees and directors included in the Company's consolidated statement of operations:

   
Year ended December 31
 
   
2008
   
2007
 
             
Research and development cost
  $ 218     $ 135  
Marketing and business development expenses
    239       225  
General and administrative expenses
    481       520  
                 
Total stock-based compensation expense
  $ 938     $ 880  

 
g.
Options issued to non-employees:

 
1.
The Company's outstanding options to non-employees as of December 31, 2008, are as follows:
 
Issuance date
 
Options for
Ordinary
shares
   
Exercise
price
   
Options
exercisable
 
Exercisable
through
                     
April 2002
    30,864     $ -       30,864  
April 2012
May 2002
    10,288     $ -       10,288  
May 2012
July 2002
    10,288     $ -       10,288  
July 2012
September 2002
    11,651     $ 3.65       11,651  
September 2012
September 2002
    7,534     $ -       7,323  
September 2012
January 2004
    5,022     $ -       5,233  
January 2014
November 2004
    14,228     $ -       14,228  
November 2014
December 2004
    2,511     $ -       2,511  
December 2014
August 2006
    3,767     $ 6.59       3,767  
August 2016
July 2007
    38,940     $ 7.30       12,168  
July 2017
July 2007
    10,000     $ 6.84       3,124  
July 2017
November 2007
    25,000     $ 5.96       6,250  
November 2017
January 2008
    15,000     $ 5.70       -  
January 2018
August 2008
    25,000     $ 3.80       -  
August 2018
                           
      210,093               117,695    

 
2.
The Company had accounted for its options to non-employees under the fair value method of SFAS No. 123(R) and EITF 96-18. The fair value of options granted with an exercise price of $0, was equal to the share price at the date of grant. The fair value of options granted during 2008 with an exercise price other than $0 was estimated using the Black-Scholes option-pricing model with the following weighted-average assumptions: risk-free interest rates of 2.42%, dividend yields of 0%, volatility factors of the expected market price of the Company's Ordinary shares of 85%, and a weighted-average expected life of the options of 10 years.
 
F-37

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 13:-
SHARE CAPITAL (Cont.)

 
3.
The following table sets forth the total stock-based compensation expense resulting from stock options granted to non-employees included in the Company's consolidated statement of operations:

   
Year ended December 31,
 
   
2008
   
2007
 
             
Research and development cost
  $ 70     $ 125  
General and administrative expenses
    -       30  
                 
Total stock-based compensation expense
  $ 70     $ 155  
 
NOTE 14:-
INCOME TAXES

 
a.
Measurement of taxable income under the Income Tax (Inflationary Adjustments) Law, 1985:
 
Results for tax purposes in Israel are measured and reflected in real terms in accordance with the change in the Consumer Price Index (CPI). As explained in Note 2b, the consolidated financial statements are presented in dollars. The differences between the change in the Israeli CPI and in the NIS/dollar exchange rate causes a difference between taxable income or loss and the income or loss before taxes reflected in the consolidated financial statements. In accordance with paragraph 9(f) of SFAS No. 109, "Accounting for Income Taxes" ("SFAS No. 109"), the Company has not provided deferred income taxes on this difference between the reporting currency and the tax bases of assets and liabilities.

According to the law, until 2007, the results for tax purposes were measured based on the changes in the Israeli CPI.

In February 2008, the "Knesset" (Israeli parliament) passed an amendment to the Income Tax (Inflationary Adjustments) Law, 1985, which limits the scope of the law starting 2008 and thereafter. Starting 2008, the results for tax purposes are measured in nominal values, excluding certain adjustments for changes in the Israeli CPI carried out in the period up to December 31, 2007. The amendment to the law includes, inter alia, the elimination of the inflationary additions and deductions and the additional deduction for depreciation starting 2008.
 
 
b.
Tax benefits under Israel's Law for the Encouragement of Industry (Taxes), 1969 (the "Tax Law"):
 
The Company is currently qualified as an "industrial company", as defined by the Tax Law, and as such, is entitled to certain tax benefits, mainly amortization of costs relating to know-how and patents over eight years, the right to claim public issuance expenses over three years, and accelerated depreciation.
 
F-38

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 14:-
INCOME TAXES (Cont.)

 
c.
Tax benefits under the Law for the Encouragement of Capital Investments, 1959 ("the Law"):
 
The Company's facilities in Israel have been granted "Approved Enterprise" status under the Law, and elected the "Alternative Benefits Track". The main benefit arising from such status is the reduction in tax rates on income derived from "Approved Enterprises". Consequently, the Company is entitled to a two-year tax exemption and five years of tax at a reduced rate (25%). Additionally, if the Company becomes a "foreign investors company", as defined by the Law, as such it will be entitled to a reduced tax rate of 10%-25% (based on the percentage of foreign ownership in each tax year) and an extension of three years for the benefit period. Since the Company has had no taxable income, the benefits have not yet commenced for any of the programs.

The period of tax benefits, detailed above, is subject to a limit of 12 years from the commencement of production, or 14 years from the approval date, whichever is earlier. The year's limitation does not apply to the exemption period.

The entitlement to the above benefits is conditional upon the Company's fulfilling the conditions stipulated by the Law, regulations published thereunder and the letters of approval for the specific investments in "Approved Enterprises". In the event of failure to comply with these conditions, the benefits may be canceled and the Company would be required to refund the amount of tax benefits, plus a consumer price index linkage adjustment and interest. As of December 31, 2008, management believes that the Company will be able to meet all of the aforementioned conditions.

If these retained tax-exempt profits attributable to the "Approved Enterprise" are distributed in a manner other than in the complete liquidation of the Company, they would be taxed at the corporate tax rate applicable to such profits as if the Company had not elected the "Alternative Benefits Track", currently between 10%-25% for an "Approved Enterprise". The Company did not generate income under the provision of the law.

Income from sources other than the "Approved Enterprise" during the benefit period will be subject to tax at the regular corporate tax rate.

On April 1, 2005, an amendment to the Investment Law came into effect ("the Amendment") and has significantly changed the provisions of the Investment Law. The Amendment limits the scope of enterprises, which may be approved by the Investment Center by setting criteria for the approval of a facility as a Beneficiary Enterprise such as provision generally requiring that at least 25% of the Beneficiary Enterprise's income will be derived from export. Additionally, the Amendment enacted major changes in the manner in which tax benefits are awarded under the Investment Law so that companies no longer require Investment Center approval in order to qualify for tax benefits.

If the Company pays a dividend out of income derived from the Benefited Enterprise during the tax exemption period, such income will be subject to corporate tax at the applicable rate (10%-25%) in respect of the gross amount of the dividend that the Company may be distributed. The Company is required to withhold tax at the source at a rate of 15% from any dividends distributed from income derived from the Benefited Enterprise. Under the amendment the benefit period for the Company will extend until the earlier of (1) seven years from the commencement year or (2) twelve years from the first day of the year of election. This period may be extended for Benefited Enterprise owned by a "foreign investor's company" during all or part of the benefit period.
 
F-39

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 14:-
INCOME TAXES (Cont.)
 
 
  However, the Amendment provides that terms and benefits included in any letter of approval already granted will remain subject to the provisions of the law as they were on the date of such approval.
 
As of December 31, 2008, the Company did not generate income under any of the above-mentioned laws.
 
 
d.
Tax rates applicable to the income of the Company:
 
Corporate tax in Israel:

Taxable income of Israeli companies is subject to tax at the rate of: 31% in 2006, 29% in 2007, 27% in 2008, 26% in 2009 and 25% in 2010 and thereafter.

Following an additional amendment to the tax ordinance, which came into effect on January 1, 2009, an Israeli corporation, may elect a 5% rate of corporate tax (instead of 25%) for dividends distributions received from a foreign subsidiary which is used in Israel in 2009, or within one year after actual receipt of the dividend, whichever is later. The 5% tax rate is subject to various conditions, which include conditions with regard to the identity of the corporation that distributes the dividends, the source of the dividend, the nature of the use of the dividend income, and the period which the dividend income will be used in Israel.
 
 
e.
Deferred income taxes:
 
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company's deferred tax assets are as follows:
 
   
December 31,
 
   
2008
   
2007
 
             
Operating loss carryforward and deductions
  $ 12,551     $ 9,022  
Reserves, allowances and other
    85       212  
                 
Net deferred tax asset before valuation allowance
    12,636       9,234  
Valuation allowance
    (12,636 )     (9,234 )
                 
Net deferred tax asset
  $ -     $ -  
 
 
 
As of December 31, 2008 and 2007, the Company has provided valuation allowances of $ 12,551 and $ 9,022, respectively, in respect of deferred tax assets resulting from tax loss carryforward, other temporary differences and tax withholding. Management currently believes that since the Company has a history of losses it is more likely than not that the deferred tax regarding the loss carryforward and the other temporary differences will not be realized in the foreseeable future.
 
 
f.
The main reconciling item between the statutory tax rate of the Company and the effective tax rate is the recognition of valuation allowances in respect of deferred taxes relating to accumulated net operating losses carried forward among the various subsidiaries worldwide due to the uncertainty of the realization of such deferred taxes and the effect of the "Approved Enterprise".
 
F-40

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 14:-
INCOME TAXES (Cont.)

 
g.
Net operating losses carryforward:
 
The Company has estimated accumulated losses for tax purposes as of December 31, 2008, in the amount of approximately $ 38,743 which may be carried forward and offset against taxable income in the future for an indefinite period. The Company's subsidiary in the United States have estimated total available carry-forward tax losses as of December 31, 2008 of approximately $ 2,447 to offset against future tax profits for periods of 20 years.
 
 
h.
Income taxes for the twelve months ended December 31, 2008 and 2007:
 
The Company and its subsidiary in the United States have not recorded any tax expenses during the twelve months ended December 31, 2008 and 2007, as the Company has losses.

Parkway recorded tax expenses starting on the closing date until December 31, 2008 in the amount of $ 23.
 
 
i.
The Company adopted the provisions of FIN 48 as of January 1, 2007, and there was no effect on the financial statements. As a result, the Company did not record any cumulative effect related to adopting FIN 48. The Company did not record a liability deriving from the implementation of FIN 48.

NOTE 15:-
FINANCIAL EXPENSES (INCOME)
   
Year ended December 31,
 
   
2008
   
2007
   
2006
 
Financial income:
                 
Interest income on short-term deposits
  $ 185     $ 380     $ 486  
Foreign currency adjustments gains
    -       -       45  
Interest and realized gain on marketable securities
    *) 6,115       1,230       14  
                         
      6,300       1,610       545  
Financial expenses:
                       
Bank and Interest expenses
    (109 )     (24 )     (7 )
Foreign currency adjustments losses
    (11 )     (50 )     -  
realized loss on marketable securities
    (13 )     -       -  
Impairment of investment in marketable securities
    (631 )     (5,009 )     -  
Loss related to derivative instruments
    (87 )     (143 )     -  
                         
      (851 )     (5,226 )     (7 )
                         
    $ 5,449     $ (3,616 )   $ 538  

*)             Including gain from the sale of ARS in the amount of $ 5,640 (see also note 6).

NOTE 16:-
RELATED PARTY TRANSACTIONS

 
a.
In June 2003, the Company entered into a license agreement with a shareholder of the Company to use its intellectual property for a period of 20 years for consideration of up to $ 100 (see Note 12d). During the years 2008 and 2007, no expenses were recorded.

 
b.
In April 2007, the Company entered into a consulting agreement with a related party for a monthly fee of $ 10. In Addition the Company granted the consultant 38,940 options at an exercise price of $ 7.3. During 2008 and 2007 the Company paid $ 140 and $ 78, respectively, to this related party.
 
F-41

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 17:-
SEGMENTS OF THE COMPANY AND RELATED INFORMATION

The Company has two reportable segments related to continuing operations. The core technology division develops and commercializes molecular diagnostic products.

The drug screening laboratory services division provides drugs of abuse and pre-employment drug testing services.

The segments are managed separately because each segment provides different laboratory services.

 
a.
The table below presents financial information for the Company's two reportable segments:

   
Year ended December 31, 2008
 
Revenues from external customers:
     
Core technology
  $ -  
Laboratory services
    1,511  
         
Consolidated revenues
  $ 1,511  
         
Gross profit:
       
Core technology
  $ -  
Laboratory services
    737  
         
Consolidated gross profit
  $ 737  
         
Operating loss:
       
Core technology
  $ 14,070  
Laboratory services
    819  
         
Consolidated operating loss
  $ 14,889  
         
Depreciation and amortization:
       
Core technology
  $ 291  
Laboratory services
    979  
         
Consolidated depreciation and amortization
  $ 1,270  
         
Expenditure for segments assets:
       
Core technology
  $ 63  
Laboratory services
    101  
         
Consolidated expenditure
  $ 164  
         
Segment goodwill:
       
Core technology
  $ -  
Laboratory services
    1,905  
         
Consolidated goodwill
  $ 1,905  
         
Segment assets:
       
Core technology
  $ 17,300  
Laboratory services
    2,845  
         
Consolidated assets
  $ 20,145  
 
F-42

 
 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 17:-
SEGMENTS OF THE COMPANY AND RELATED INFORMATION (Cont.)

In 2008 two customers from the drug screening laboratory services division accounted for 28% and 24% of the Company's revenues.
 
Long-lived assets:

   
December 31
 
   
2008
 
       
Israel
  $ 1,163  
U.S.A
    2,294  
         
    $ 3,457  
 
NOTE 18:-
SUBSEQUENT EVENTS

 
a.
1.
License and collaboration agreement with Prometheus:
 
On April 10, 2009 the Company entered into a license and collaboration agreement (the "License Agreement") with Prometheus Laboratories Inc. ("PL") under which the Company agreed to exclusively license and sublicense to PL certain rights related to the Company's microRNA-based cancer diagnostic tests: miRview™  mets, miRview™ squamous and miRview™ meso ("Cancer Diagnostics Products"), including the rights to certain software developed by the Company and related to the miRview ™ mets product. The Company also agreed to collaborate with Prometheus in order to further develop the Cancer Diagnostics Products and to develop two new microRNA-based gastroenterology tests ("GI Products"). Under the License Agreement, PL has the exclusive right to develop and commercialize the Cancer Diagnostics Products and the GI Products in the U.S. The License Agreement also gives PL a right of first negotiation to take a license for certain diagnostic tests or products that are under development by the Company.

PL will contribute to a development fund that will be used to further develop the Cancer Diagnostic Products and to develop the GI Products. In addition, PL will pay the Company additional amounts upon reaching certain publication requirements for the Cancer Diagnostic Products and achieving certain product profiles for the GI Products. The Company is also entitled to receive certain payments upon the achievement of commercial milestones. The total amount potentially payable to the Company under these provisions is $ 17,000.

The Company is also entitled to royalties on the sale of the Cancer Diagnostic Products and the GI Products, subject to reductions in certain instances.

F-43

 
ROSETTA GENOMICS LTD. AND ITS SUBSIDIARIES
(A development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)
 
 
NOTE 18:-
SUBSEQUENT EVENTS (Cont.)
 
 
The agreement will terminate upon the later of the expiration or abandonment of the last licensed patent to expire or become abandoned, or, if a licensed product involves certain sublicensed technical information, until the end of such additional period as is required under the applicable upstream license. PL can terminate the agreement (either entirely or as to one or more licensed products) by providing six months' written notice to the Company.
 
 
2.
Prometheus stock purchase agreement:
 
On April 10, 2009 the Company entered into a stock purchase agreement with PL (the "Purchase Agreement"). Under the Purchase Agreement, on April 27, 2009 ("the closing date"), PL purchased 2,000,000 Ordinary shares of the Company (the "Shares") at a price of $ 4.00 per share in a private placement transaction. Under the terms of the Purchase Agreement, so long as PL or its affiliates continue to hold at least 50% of these Shares, PL is entitled to information rights, pre-emptive rights and board observer rights. Pursuant to the pre-emptive rights, PL has the right to participate in future offerings of the Company's securities to purchase up to its pro rata share in any such offering on the same terms and conditions as other investors.  Under the terms of the Purchase Agreement, the Company is also required to prepare and file with the SEC a Registration Statement on Form F-3 (the "Registration Statement") covering the resale of the Shares. The Registration Statement should be filed within 45 days from the closing date and should be declared effective within 90 days of the closing date if it is not reviewed by the SEC or within 180 days of the closing date if it is reviewed by the SEC.  If the Registration Statement is not declared effective within the required timeframe, the Company will be required to pay liquidated damages equal to 1% of the aggregate purchase of the Shares for each month that effectiveness is delayed, up to a maximum of 8% of the aggregate purchase price.
 
 
b.
Sale of Parkway:
 
On May 18, 2009, the Company sold Parkway in a management buy-out for up to maximum amount of $ 2,500 to be paid as a fixed percentage of revenues (15%) over six years. As a result of the transaction, the Company recorded a loss in the second quarter of 2009, in the amount of approximately $ 2,250, since future proceeds are contingent upon parkway's revenues.
 
 
c.
Green Energy Initiative:
 
On March 11, 2009, the Company received the second milestone payment from the private investors who invested up to $ 1,500 in the green energy initiative. The project leverages the Company's proprietary microRNA technologies and strong IP position to develop a wide range of plant-based applications (see Note 11).
 


F-44


Exhibit 2.3














































Exhibit 4.7




























































































































Exhibit 4.16

 
EXCLUSIVE TESTING AND ADMINISTRATIVE SERVICES AGREEMENT
 
between
 
ROSETTA GENOMICS LTD.
A limited liability company under the laws of Israel,
of 10 Plaut St., Rehovot, Israel, 76706
(“ Rosetta ”)
 
and
 
TEVA PHARMACEUTICAL INDUSTRIES LTD.
of P.O. Box 3190 Petah-Tiqua 49131, Israel
 
THIS EXCLUSIVE TESTING AND ADMINISTRATIVE SERVICES AGREEMENT (this “ Agreement ”) is made as of the 24th day of December, 2008, by and between: Rosetta, Ltd., through its offices located at 10 Plaut St., Rehovot, Israel, 76706 (“Rosetta”); and Teva Pharmaceutical Industries Ltd., through its offices located at 12 Hatrufa St., Netanya, Israel (“Teva”).
 
WHERESA
Rosetta has developed the Tests (as such term is hereinafter defined), and is intending to initiate the offering of the Testing Services to patients through physicians worldwide;
 
WHEREAS
Rosetta desires that its Testing Services be made available to patients and physicians in the Territory (as hereinafter defined) and that Teva assist Rosetta in that effort by and the Administrative Services (as such terms is hereinafter defined) for and on behalf of Rosetta in and for the Territory;
 
WHEREAS
Teva desires to exclusively market and purchase Testing Services from Rosetta and exclusively provide certain Administrative Services for and on behalf of Rosetta in and for the Territory;
 
WHEREAS
Rosetta will exclusively in and for the Territory provide the Testing Services ordered by Teva;
 
WHEREAS
Teva agrees to pay Rosetta for Testing Services ordered by Teva in accordance with the fees identified in Section 7 herein.
 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

NOW THEREFORE THE PARTIES AGREE AS FOLLOWS:
 
1.            INTERPRETATION AND DEFINITIONS
 
 
1.1
The preamble to this Agreement forms an integral part hereof and is incorporated herein by reference.
 
 
1.2
Clause headings in this Agreement are intended solely for convenience of reference and shall be given no effect in the interpretation of this Agreement.
 
 
1.3
All signed appendices to this Agreement, whether attached at the time of signature hereof or at any time thereafter, shall be construed as an integral part of this Agreement.
 
 
1.4
In this Agreement, the following expressions shall bear the meanings assigned to them below and cognate expressions shall bear corresponding meanings:
 
 
1.4.1
" Administrative Services " – shall mean the sole and exclusive marketing sale and distribution and logistic services solely provided by Teva with respect to the Tests, all as detailed in clause 4.
 
 
1.4.2
Affiliate ” - with respect to either party, means any person, corporation, company, partnership or other entity controlling, controlled by or under common control with such party. For such purpose the term “ control ” means the holding of 50% or more of the common voting stock or ordinary shares in, or the right to appoint 50% or more of the directors of, the said corporation, company, partnership or entity.
 
 
1.4.3
Business Day ”- shall mean working days, not including Saturdays and Sundays and/or public holidays and bank holidays in the US and Israel.
 
 
1.4.4
Effective Date ” – shall mean the date of signature of this Agreement by the last of the parties.
 
 
1.4.5
Instructions ” – shall mean the written instructions provided to Teva by Rosetta with respect to the receipt of samples from its patients and physicians, shipment and delivery of samples for testing, provide customers with the Testing Services written reports and results, as provided by Rosetta.
 
 
1.4.6
Territory ” – shall mean Israel and Turkey. For the purpose of clarity, Israel and Turkey shall be regarded as separate territories, and termination in relation to the Turkey Territory (according to the terms of section 8) shall not affect the Israeli Territory. In case of termination in relation to the Israeli Territory the entire Agreement will be terminated unless otherwise agreed in writing by the parties.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

 
1.4.7
Tests ” – "miRview™ squamous", "miRview™ meso" and "miRview™ mets", as conducted by Rosetta or, its Affiliated and/or other third parties on behalf of Rosetta subject to the provisions of Section 5.1.
 
 
1.4.8
" Testing Services ” - as provided by Rosetta, its Affiliates and/or other third parties on behalf of Rosetta subject to the provisions of Section 5.1 shall include the conduct of the Tests, the provision of Test reports and results to Teva, and the return of the paraffin blocks, when supplied. It is agreed by both parties that other oncology testing services may be added to the above definition upon agreement of the parties in writing.
 
 
1.4.9
" Samples " – paraffin embedded tissues and/or unstained slides processed from paraffin embedded tissues provided from pathologists from different medical institutions.
 
2.            APPOINTMENT AND DURATION
 
 
2.1
Rosetta hereby appoints Teva as an exclusive reseller of the Testing Services and the provider of the Administrative Services in and for the Territory in accordance with the terms of this Agreement, and Teva accepts such appointment.
 
 
2.2
This Agreement shall commence on the Effective Date and, unless terminated earlier in accordance with Clause 8 below, shall continue for an initial term of 24 months (" The Term "). The Term shall be automatically renewed for an additional periods of 12 months each unless either party gives a prior written notice of its intention not to renew the agreement not later than 3 months before any renewal.
 
 
2.3
Teva shall be entitled at any time during the term of this Agreement in its absolute discretion to cease the resale or marketing of the Testing Services in the Territory (whole or part) for reasons of medical safety or on legal or regulatory grounds; if Teva ceases resale or marketing of the Testing Services pursuant to this Section 2.3 for a period exceeding three (3) months then Rosetta shall have the right to terminate this Agreement by providing Teva a ten (10) days prior written notice .
 
 
2.4
Rosetta shall be entitled at any time during the term of this Agreement in its absolute discretion to cease providing Testing Services to Teva, in whole or in part, for reasons of medical safety or on legal or regulatory grounds.
 
3.            REGISTRATION
 
Within 60 days after the Effective Date, Rosetta undertakes to provide Teva with copies of Rosetta’s CAP and CLIA licenses and certificates. In addition, at Teva’s request, Rosetta will provide Teva with one copy of other existing and readily available documentation to the extent required by Teva for any and all regulatory purposes.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

4.            ADMINISTRATIVE SERVICES
 
Teva undertakes and agrees with effect from the Effective Date and at all subsequent times during the term of this Agreement, in connection with the provision of Administrative Services for and on behalf of Rosetta:
 
 
4.1
to use all reasonable endeavours to market the Testing Services in the Territory subject to the terms and conditions of this Agreement and to perform at its own expense, all tasks and duties and assume all responsibilities customarily associated with marketing of the Testing Services;
 
 
4.2
to market Testing Services only from Rosetta, subject to Rosetta’s ability to carry out the Testing Services in accordance with this Agreement, all pursuant to section 2.3 herein;
 
 
4.3
further to marketing the Testing Services, Teva shall be responsible for the receipt of samples in accordance with Instructions from its customers, shipment and delivery of the Testing Services kit according to the Instructions to Rosetta for testing, and upon completion of testing, to provide its customers the Testing Services written reports and results, as provided by Rosetta, according to the Instructions.
 
 
4.4
to obtain and maintain all government licenses, approvals and permissions necessary in connection with the marketing, resale and provision of the Testing Services to persons in the Territory;
 
 
4.5
to inform Rosetta of any matter in the Territory of which it is aware that is likely to affect, significantly, the marketing of the Testing Services;
 
 
4.6
to provide Rosetta with market and sales information in a timely fashion including information relating to the sales and marketing activities of Teva with respect to the Testing Services,;
 
 
4.7
to handle all physician, patient and other inquiries, whether via telephone or in writing, regarding Rosetta’s provision of Testing Services, including information relating to the results of such Testing Services;
 
 
4.8
to inform Rosetta of any reports of irregularities, complaints or other adverse information received by Teva relating to the Tests, its use or quality and/or the Testing Services, and not to take any action with regard thereto, unless required by law or the regulatory authorities in the Territory, without obtaining Rosetta’s prior written consent, such consent to be provided promptly and not unreasonably withheld by Rosetta;
 
 
4.9
to conduct its marketing activities in a manner that reflects favorably at all times on the Testing Services and the name, goodwill and reputation of Rosetta; to refrain from engaging in deceptive, misleading or unethical practices, including but not limited to, disparagement of Rosetta or the Testing Services, and acceptance or payment of bribes, kickbacks or secret profits; to make no representations, warranties, guarantees or covenants, with respect to the Testing Services, other than those set forth in the Promotional Materials, as defined thereafter, provided to Teva by Rosetta; and not to modify any Promotional Materials without Rosetta’s prior written consent;
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

 
 
4.10
not to modify in any manner whatsoever the Test reports and results or disclaimers associated with such reports;
 
 
4.11
unless otherwise mutually agreed in writing, to be solely responsible for all expenses, costs, liabilities and obligations Teva incurs in connection with its resale of the Testing Services and the provision of the Administrative Services identified herein.
 
5.            ROSETTA’S UNDERTAKINGS
 
Rosetta undertakes and agrees with effect from the Effective Date and at all subsequent times during the term of this Agreement:
 
 
5.1
to provide either by itself or through third parties all of Teva’s requirements solely and exclusively to Teva for Testing Services ordered by licensed physicians in the Territory for persons located in the Territory; Rosetta shall not knowingly provide commercial Testing Services for a fee to physicians located in the Territory other than through Teva. All other activities for research purposes only in the Territories will be coordinated between Teva and Rosetta, and will be conducted according to applicable law and regulations. Rosetta shall have the right to perform the Testing Services via third parties subject to the following: (i) Rosetta being the responsible party; (ii) the Third Party shall have at least the same capabilities of Rosetta. In the event that Teva shall refuse the transfer of performance of Services to a third Party due to the fact that such third Party does not have the same capabilities of Rosetta, then this agreement at the sole discretion of Teva will be either terminated or modified to a non exclusive agreement.
 
 
5.2
to assist and financially share all expenses relating to and/or resulting from conferences, seminars etc, all as will be mutually agreed (agreement to be made at the sole discretion of each party) and the details with respect to such events (including without limitation the details of the financial aspects of such event) will be added, from time to time, as an Appendix to this Agreement.
 
 
5.3
to provide [***] to be [***] from signing this Agreement.
 
 
5.4
to provide Teva with a minimum of [***] Testing Services for compassionate use programs, upon Teva's sole discretion.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

 
5.5
to provide all of Teva’s requirements for the Testing kits to collect the samples, and to deliver Test report and results within [***] of receipt of all relevant, complete and sufficient patient information and materials, including without limitation, Samples, from Teva. The report and results may be delivered to Teva by telefax or electronic mail.
 
 
5.6
if paraffin blocks are provided, to return the remainder of the paraffin blocks to Teva within 1 month, of the conduct of the Tests, unless otherwise requested by Teva; the cost of such shipments shall be borne by Rosetta;
 
 
5.7
if Teva provides a Sample, in accordance with the Instructions, and Rosetta performs the Testing Services on such Sample, but is unable to provide a report with respect to such Sample, then, at, Rosetta’s expense, Rosetta will either retest the Sample at its sole expense, or notify Teva that such Sample will not be retested. If such Sample will not be retested, Rosetta will not charge Teva for the testing of such Sample;
 
 
5.8
If Teva provides a Sample, not according to the Instructions, Rosetta will notify Teva that such Sample will not be tested. Rosetta will charge Teva only for cost of kit shipment to Rosetta’s lab and cost of pathologist review (if applicable);
 
 
5.9
if Teva provides a Sample according to the Instructions with respect thereto, and Rosetta performs the Testing Services on such Sample, and Rosetta becomes aware that there was an error made in the Testing Services which affected the Test results, then, at Rosetta’s expense, Rosetta will either retest the Sample at its sole expense, or notify Teva that such Sample will not be retested. If such Sample will not be retested, Rosetta will either not charge, or credit, as applicable, Teva for the Testing of such Sample.
 
 
5.10
In order to ensure the fulfillment of Rosetta’s responsibilities and obligations in accordance with this Agreement, Rosetta is obligating to insure in its own responsibility itself and its employees, in a suitable and known insurance company commencing as of the Effective Day and shall maintain for the duration of this Agreement and [***] at its expense the following insurances, and to provide Teva with proof in a form of certificate of insurance attached as an Exhibit C of such insurances.
 
 
5.11
Fulfilling the above mentioned insurance, based on this agreement and the payment of the insurance sum in accordance, are considered the basic condition of this agreement.
 
 
5.12
None of the above insurance obligation will reduce Rosetta’s obligations, in accordance with this Agreement and in accordance with any law.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

 
5.13
Rosetta is obligated to inform Teva about any cancellation and/or reduction in coverage of the Insurance policy and/or modification which shall negatively effect Teva pursuant to this Agreement
 
 
5.14
Rosetta undertakes to provide Teva, free-of-charge, all reasonable support and marketing expertise, including copies of such promotional material as may be available from time to time, specific to the Testing Services necessary or useful for Teva in order to assist Teva in promoting and marketing the Testing Services in the Territory. Teva shall have the right to consult Rosetta regarding the nature and usage of these promotional materials. Teva will be responsible for all regulatory compliance of the promotional material in the Territory.
 
 
5.15
Other than as expressly provided in this agreement, the Testing Services are provided ‘as is’ without warranty of any kind, whether express or implied, including without limitation warranties of merchantability, fitness for a particular purpose and non-infringements, and Rosetta disclaims any and all such warranties. Rosetta may decline to provide Testing Services on a specimen received from Teva that does not meet the Instructions.
 
6.            TRADEMARKS
 
 
6.1
The Testing Services shall be marketed by Teva under only such trademarks, service marks and/or other insignia of origin registered in Israel under Rosetta’s name or anyone on its behalf, as will be decided upon by Rosetta, in its sole discretion (the “Rosetta Marks”).
 
 
6.2
During the term, and subject to the terms and conditions, of this Agreement and for the Territory only, Rosetta hereby grants to Teva a non-exclusive, non-transferable, limited license to use the Rosetta Marks solely in connection with the marketing of the Testing Services and the provision of Administrative Services in the Territory, provided that:
 
 
6.2.1
Teva’s use of the Rosetta Marks must comply with the Trademark Usage Guidelines as provided by Rosetta to Teva and attached as an Exhibit A to this Agreement, as may be amended by Rosetta from time to time upon sufficient prior written notice to Teva.
 
 
6.2.2
Teva shall ensure that all marketing materials or other documents on which the Rosetta Marks are placed by Teva (the “Marked Materials”) shall not reflect adversely upon the name, goodwill or reputation of Rosetta. Teva agrees that the Marked Materials shall be of such nature, style, appearance and quality as shall be adequate and suited to the protection of the Rosetta Marks and the goodwill associated therewith.
 
 
6.2.3
Teva shall submit to Rosetta, free of cost, two samples of Marked Materials prior to the dissemination or distribution of the Marked Materials. Rosetta, in Rosetta’s sole discretion, shall have the right to review the Marked Materials submitted by Teva to confirm compliance with this Agreement. If Rosetta disapproves of any sample of the Marked Materials, Rosetta shall provide Teva with the specific reasons for such disapproval. Teva shall promptly make all such changes to the Marked Materials as Rosetta shall request to protect the value of the Rosetta Marks.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

 
 
6.2.4
Teva shall not use the Rosetta Marks, or any part thereof, as part of or in combination with any other names or trademarks except with Rosetta’s prior written approval. Teva shall not use any confusingly similar or diluting mark, term or design, and shall not attempt to register or aid any third party in using or attempting to register any such mark, term or design. Teva shall not use any of the Rosetta Marks in any manner that indicates that it is using such mark other than as a licensee.
 
 
6.2.5
If Teva refuses to submit such samples, after being requested by Rosetta to do so in writing or violates the provisions of this Clause 6 and/or the Rosetta Trademark Usage Guidelines and does not submit the samples, or cure the violation within 30 days after being notified of the same, Rosetta shall have the right to revoke the license granted to Teva pursuant to this Clause 6.
 
 
6.2.6
The Rosetta Marks and the goodwill associated therewith are and remain Rosetta’s exclusive property. Teva shall acquire no right, title or interest in the Rosetta Marks or the goodwill associated therewith, other than the limited license and right to use the Rosetta Marks set forth in this Clause 6. All usage of the Rosetta Marks by Teva shall inure to Rosetta’s benefit. Teva shall not knowingly do or suffer to be done any act which would impair the Rosetta Marks or the goodwill associated therewith. Teva shall take any actions reasonably requested by Rosetta, and upon Rosetta sole expense, including the execution of instruments, that may be necessary or appropriate to register or otherwise confer or perfect Rosetta’s rights in the Rosetta Marks in the Territory in Rosetta’s name. Teva agrees to take no action inconsistent with Rosetta’s ownership of and interest in the Rosetta Marks, or assist any third party in doing any of the same.
 
 
6.2.7
Teva was advised that the Rosetta Marks, are and shall remain Rosetta’s. Teva shall have no claim with regard to the said Rosetta Marks and shall not challenge Rosetta’s title to the Rosetta Marks or the validity of their registration, if they are registered.
 
 
6.2.8
Under no circumstances will anything in this Agreement be construed as granting, by implication, estoppel or otherwise, any licenses or rights in the Rosetta Marks not expressly granted to Teva in this Clause 6.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

 
 
6.3
Rosetta is aware that “Teva” is a registered trade-name/mark of Teva (the “Teva Trademark”). It is agreed that the Teva Trademark shall not include the trademarks of Rosetta, whether registered or not (and visa versa).
 
 
6.4
The Teva Trademark is or shall be registered in the Territory in Teva’s name, and at its expense.
 
 
6.5
The Teva Trademark, whether registered or not, is and shall remain Teva’s. Rosetta shall have no claim with regard to the said Teva Trademark and shall not challenge Teva’s title to the Teva Trademark or the validity of its registration, if it is registered, even after termination of this Agreement for any reason.
 
7.            PRICE AND TERMS OF PAYMENT
 
 
7.1
Teva shall pay to Rosetta a fee per Test for the Testing Services that Rosetta performs under this Agreement in the amount as set forth in Exhibit B. Any change based on the review shall be made only upon the written agreement of the parties to be provided at their sole discretion.
 
 
7.2
Terms of payment - [***], except that Teva may withhold any amounts that are the subject of a good faith dispute until such dispute is resolved. All payments shall be made in full and without setoff, upon order, by bank transfer in U.S. dollars available at Rosetta’s U.S. bank, or otherwise as Rosetta may direct in advance.
 
 
7.3
Teva shall be solely responsible for setting the pricing for its clients, and for collecting payment from its clients, for the Testing Services, and Teva’s delay in collecting, or failure to collect, shall not affect Teva’s obligation to pay Rosetta the applicable fees in any way.
 
8.            TERMINATION
 
 
8.1
Notwithstanding the above, and without prejudice to any other rights to which it may be entitled, either party may terminate this Agreement upon written notice of termination to the other party:
 
 
8.1.1
if the other party is in material breach of any of the material terms hereof and fails to remedy such breach [***] of that party being notified of such breach; or
 
 
8.1.1.1
if the other party is, admits to being or is declared insolvent, or voluntary or involuntary proceedings are instituted by or against it in bankruptcy, or receivership, or for a winding-up or for the dissolution or re-organization of its assets; or
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

 
 
8.1.1.2
based on medical safety or legal or regulatory reasons.
 
 
8.2
In the event that the Agreement is terminated with respect to the Turkey territory then the Agreement will continue to be applicable with regard to the Israeli territory. In the event that the Agreement is terminated with regard to the Israeli Territory then the entire Agreement will be terminated, unless otherwise agreed between the Parties in writing.
 
 
8.3
Termination for breach will have no effect on any performance obligations which have accrued up to the effective date of such termination.
 
9.            EFFECTS OF TERMINATION
 
 
9.1
Termination of this Agreement howsoever caused shall be without prejudice to any other rights or liabilities accrued at the date of termination.
 
 
9.2
Upon termination of this Agreement, all rights and licenses granted to Teva hereunder shall immediately terminate, and Teva shall immediately cease marketing and distributing the Testing Services, except as expressly provided in Clause 9.3.
 
 
9.3
Upon termination of this Agreement, Teva shall notify Rosetta of any outstanding unstained slides or paraffin blocks it has in its possession, and Rosetta shall notify Teva of any outstanding Teva’s customers’ Tests it has, which have not been sent to Teva (whether completed or not). Subject to Teva’s advance payment of the applicable fees, Rosetta undertakes to complete the relevant Testing Services. Notwithstanding the foregoing, Rosetta will not be obligated to complete the Testing Services if Rosetta terminates this Agreement due to Teva’s breach or due to reasons of medical safety or legal or regulatory grounds.
 
 
9.4
Neither party shall have any liability to the other for claims based on termination of this Agreement in accordance with Clause 8, including without limitation for compensation, reimbursement or damages for the loss of prospective profits, anticipated sales or goodwill. If a Party is entitled under local law or otherwise to any special payment or termination remedy or indemnity as a consequence of the expiration or termination of this Agreement, such Party hereby waives and disclaims, to the fullest extent permitted by law, any right to such payment, remedy or indemnity.
 
 
9.5
Clauses 1, 5.8, 6.5, 10, 11, 13, 18, 22 and 24 shall survive any expiration or termination of this Agreement.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 
 
10.
HOLDING HARMLESS & INDEMNIFICATION
 
 
10.1
Teva shall be solely responsible for any false or misleading statements, false or misleading representations or false or misleading warranties, whether oral or written, made by Teva to its clients. Without limiting the generality of the foregoing, Teva agrees and undertakes that it will not make any false or misleading statement, representation or warranty, oral or written, concerning the Tests and/or the Testing Services. In the event that Teva should make any false or misleading statements, representations or warranties, and claims should arise therefrom, Teva shall defend, indemnify and hold Rosetta, its affiliates, employees and agents (including successors and assigns) harmless from and against any and all costs, damages, expenses and liabilities arising out of or related to such statement, representation or warranty.
 
 
10.2
Rosetta shall be solely responsible for any false or misleading statements, false or misleading representations or false or misleading warranties made in the Promotional Materials provided by Rosetta to Teva. In the event that the Promotional Materials shall contain any false or misleading statements, representations or warranties, and claims should arise therefrom, Rosetta shall defend, indemnify and hold Teva, its affiliates, employees and agents (including successors and assigns) harmless from and against any and all costs, damages, expenses and liabilities arising out of or related to such statement, representation or warranty.
 
 
10.3
Rosetta agrees to defend, indemnify and hold Teva, its affiliates, employees and agents (including successors and assignees) harmless from and against any claim by a third party and any and all costs, damages, expenses (including attorneys’ fees and other costs of litigation) and liabilities directly resulting therefrom arising out of infringement of third party intellectual property rights by the Testing Services, Rosetta’s negligence or willful misconduct in Rosetta’s provision of the Testing Services, or any breach by Rosetta of any of the terms of this Agreement, provided , however , that this indemnity shall not extend to any claim, demand, or legal action to the extent arising from any negligent act or omission or willful misconduct of Teva (including successors and assignees if applicable).
 
 
10.4
Teva agrees to defend, indemnify and hold Rosetta, its affiliates, employees, agents (including successors and assignees) harmless from and against claim by a third party and any and all costs, damages, expenses (including attorneys’ fees and other costs of litigation) and liabilities directly resulting therefrom arising out of Teva’s negligence or willful misconduct in Teva’s provision of the Testing Services, or as result of any breach by Teva of any of the terms of this Agreement, provided , however , that this indemnity shall not extend to any claim, demand, or legal action to the extent arising from any negligent act or omission or willful misconduct of Rosetta (including successors and assignees if applicable).
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

 
 
10.5
The indemnity obligations under this Clause 10 are contingent upon: The party seeking indemnification (the “Indemnified Party”) (a) notifying the Indemnifying Party as soon as reasonably possible in reasonable detail of any claim, demand, action or proceeding for which indemnification is sought (the “Indemnified Claim”), (b) allowing the Indemnifying Party to control the defense and/or settlement of the Indemnified Claim, and (c) providing the Indemnifying Party with assistance in any defense and/or settlement thereof at the Indemnifying Party’s expense.
 
 
10.6
The Indemnifying Party shall at its expense, assume the defense thereof using counsel reasonably acceptable to the Indemnified Party. The Indemnified Party shall have the right to participate at its own expense, in the defense and/or settlement of any third party claim, demand, action or proceeding. In connection with any such third party claim, demand, action or proceeding, the parties shall cooperate with each other and provide each other with access to relevant books and records in their possession. No such third party claim, demand, action or proceeding shall be settled without the prior written consent of the parties, which consent shall not be unreasonably withheld. The Indemnifying Party shall reimburse the Indemnified Party upon demand for any payments made based upon a conclusive judgment of any court of competent jurisdiction or pursuant to a bona fide compromise or settlement of claims agreed and accepted by the Indemnifying Party, in respect to any damages related to any claim under this Clause 10. In the event that the parties agree to settle a claim or action, such settlement shall not be publicized without the prior written consent of the parties, which consent shall not be unreasonably withheld.
 
 
10.7
The provisions of this Clause shall survive the expiration or termination of this Agreement for any reason.
 
11.            CONFIDENTIALITY
 
 
11.1
All Proprietary Information disclosed by one Party to the other Party hereunder shall be maintained in confidence and shall not be disclosed to any Third Party or used for any purpose except as expressly permitted herein without the prior written consent of the Party that disclosed the Proprietary Information to the other Party for a period of five (5) years from the date hereof. The foregoing non-disclosure and non-use obligations shall not apply to the extent that such Proprietary Information:
 
(i)
is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by contemporaneous written records;
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
 

 
 
 
(ii)
is in the public domain or knowledge;
 
 
(iii)
is subsequently disclosed to a receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or
 
 
(iv)
is developed by the receiving Party independently of Proprietary Information received from the other Party, as documented by contemporaneous research and development records.
 
 
11.2
Notwithstanding Section 11.1, a Party receiving Proprietary Information of the other Party may disclose such Proprietary Information:
 
(i)
to governmental or other regulatory agencies in order to obtain patents, or to gain approval to conduct clinical trials or to market the Tests and/or the Testing Services to the extent permitted hereunder, but such disclosure may be only to the extent reasonably necessary to obtain such patents or authorizations;
 
(ii)
to its respective agents, consultants, Affiliates, potential and actual sublicensees, and/or other Third Parties for the research and development, manufacturing and/or marketing of the Tests and/or the Testing Services (or for such Third Parties to determine their interests in performing such activities) on the condition that such Third Parties agree to be bound by the confidentiality obligations contained in this Agreement;
 
 
(iii)
to actual or prospective acquirers or sources of financing on the condition that such Third Parties agree to be bound by the confidentiality obligations contained in this Agreement; or
 
 
(iv)
if required to be disclosed by law or court order, provided that, to the extent permitted by law, notice is promptly delivered to the disclosing Party in order to provide an opportunity to challenge or limit the disclosure obligations; provided, however, without limiting any of the foregoing, it is understood that either Party or its Affiliates may make disclosure of this Agreement and the terms hereof in any filings required by the SEC (or any applicable stock exchange or regulatory organization), may file this Agreement as an exhibit to any filing with the SEC (or any applicable stock exchange or regulatory organization) and may distribute any such filing in the ordinary course of its business. However, to the maximum extent allowable by SEC (or any applicable stock exchange or regulatory organization) rules and regulations, the Parties shall be obligated to maintain the confidentiality obligations set forth herein and shall redact any confidential information set forth in such filings as may be reasonably requested by the disclosing Party.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

 
 
11.1
The provisions of this Clause shall survive the expiration or termination of this Agreement for any reason.
 
12.            FORCE MAJEURE
 
 
12.1
The obligations of each party under this Agreement shall be suspended during the period of this Agreement and to the extent that such party is prevented or hindered from complying herewith by any cause beyond its reasonable control including (insofar as they are beyond such control but without prejudice to the generality of the foregoing expression) strike, act of God, war, riot, civil commotion, malicious damage, compliance with any law or governmental order, rule, regulation or direction, accident, breakdown of plant or machinery, fire, flood, storm, difficulty or increased expense in obtaining workmen, materials or transport or other circumstances affecting the supply of goods or of raw materials therefor.
 
 
12.2
In the event of either party being so hindered or prevented, such party shall give notice of suspension as soon as reasonably possible to the other party stating the date and extent of such suspension and the cause thereof. The failure to give such notice shall forfeit the rights of such party to relief under this Clause.
 
 
12.3
Any party whose obligations have been suspended as aforesaid shall resume the performance of such obligations as soon as reasonably possible after the removal of the cause and shall so notify the other party. In the event that such cause continues for more than six months either party may terminate this Agreement on thirty days notice to the other party.
 
13.            GOVERNING LAW
 
This Agreement shall be governed and interpreted according to the laws and regulations of Israel. Any dispute between the parties shall be referred to the applicable court of Tel Aviv, Israel.
 
14.            ENTIRE AGREEMENT
 
This Agreement constitutes the entire understanding between the parties hereto with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements, negotiations and discussions between the parties hereto relating thereto.
 
15.            EXECUTION AND DELIVERY OF THIS AGREEMENT
 
 
15.1
Rosetta hereby represents and warrants that the execution and delivery by Rosetta of this Agreement and the performance by Rosetta of its obligations hereunder have been duly authorized by all necessary corporate action on the part of Rosetta, and do not conflict with the terms of any other contract, agreement, arrangement or understanding to which Rosetta is a party.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

 
 
 
15.2
Teva hereby represents and warrants the execution and delivery by Teva of this Agreement and the performance by Teva of its obligations hereunder have been duly authorized by all necessary corporate action on the part of Teva, and do not conflict with the terms of any other contract, agreement, arrangement or understanding to which Teva is a party.
 
16.            INDEPENDENT CONTRACTORS
 
All work performed by the parties under this Agreement shall be as independent contractors. None of the parties hereto are an agent, employee, partner, representative or joint venturer of the other party and nothing in this Agreement shall be construed to create such a relationship. None of the parties hereto shall have the power or right to bind or obligate the other. The parties hereby represent and warrant that each of them have the power and authority to undertake the contractual commitments set forth in this Agreement and that the execution of this Agreement and its performance of the services shall not constitute a breach or default under any agreement which any of the parties have entered into with any third party.
 
17.            TERMS AND CONDITIONS
 
The Testing Services supplied to Teva shall be supplied upon the terms and conditions contained herein and any standard terms and conditions of sale or conditions of purchases shall be of no effect, unless the parties otherwise agree expressly and in a writing signed by both parties.
 
18.            AMENDMENTS
 
No amendment or variation of this Agreement shall be effective unless in writing and signed by duly authorized representatives of the parties.
 
19.            ASSIGNMENT
 
None of the Parties hereto shall without the prior written consent of the other Parties, assign, sub-license, sub-contract, delegate, charge or part with or otherwise dispose of this Agreement or the benefit thereof or any right or obligation hereunder or grant any sub-license or sub-contract, save that any Party shall be entitled to assign this Agreement to one of its Affiliates. provided, however, that either Party may assign this Agreement and its rights and obligations hereunder without the consent of the other Party hereto to an Affiliate or in connection with the transfer or sale of all or substantially all of its assets related to Licensed Product or its business in the event of its merger or consolidation or change in control or similar transactions. Any permitted assignee shall assume all obligations of its assignor under this Agreement. and, inter alia will be responsible to provide the other party with an amended certificate of insurance in the exact wording as attached to this Agreement Exhibit C. Any assignment or attempted assignment contrary to the provisions hereof shall be null and void. In this respect, if the above mentioned assignment will have a financial or commercial negative effect on Teva's activities in Israel or abroad, which such effect will be examined under a test of reasonability, Teva will have the right to terminate this Agreement upon notice of termination to Rosetta within thirty (30) days.

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

 
20.            SEVERABILITY
 
The invalidity or unenforceability of any term of or any right arising pursuant to this Agreement shall not in any way affect the remaining terms or rights unless the invalid provision goes to the essence of this Agreement. Rosetta and Teva hereby each undertakes to cooperate in good faith and to use all reasonable endeavors to replace any legally unenforceable provision with (as far as practicable) provisions which will effect for the parties the same commercial results as were intended by the original provisions.
 
21.            WAIVER
 
The failure of a party hereto to exercise or enforce any right under this Agreement shall not be deemed to be a waiver thereof nor operate so as to bar the exercise or enforcement thereof at any time or times thereafter.
 
22.            SURVIVAL OF INDEMNITY
 
Each indemnity in this Agreement is a continuing obligation separate and independent from the other obligations of Rosetta and Teva and survives termination of this Agreement.
 
23.            NOTICES
 
All notices shall be in writing and shall be given by delivery by hand, by first class mail postage prepaid, by air courier, or by transmission by fax to the address or to the fax number of the relevant party set out at the beginning of this Agreement or such other address or fax number as either party may notify to the other from time to time and shall be addressed to the representatives of the parties set out below:
 
If to Rosetta:
 
Attention: Mr. Ronen Tamir
Chief Commercialization Officer
Rosetta Genomics Inc.
15 Exchange Place, suite 500, Jersey City NJ 07302
Tel: 201.946.0561
Fax: 201.946.0562
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

With a copy to:
 
General Counsel
Rosetta Genomics Ltd.
10 Plaut St.
Rehovot
Tel: +972.73.222.0700
Fax: +972.73.222.0701
 
If to Teva:
 
Attention: [***]
[***]
Teva Pharmaceutical Industries Ltd.
[***]
[***]
[***]
[***]

With a copy to:
 
Teva Pharmaceutical Industries Ltd.
5 Basel Street, Petah Tiqva 49131, Israel
Attention: Legal Department
Fax: 972-3-9267429
 
The parties shall inform the other within 7 Business Days of any change in address or fax number. Any such notice given as aforesaid shall be deemed to have been given (i) if mailed, 7 days after being dispatched by mail postage prepaid; (ii) if by air courier, 4 days after delivery to the air courier company; (iii) if by facsimile with confirmed transmission, 48 hours after transmission. An additional copy of all notices issued by either party to the other relating to breach or termination of this Agreement shall be sent, in cases of notices to Rosetta, to Rosetta’s business development department, facsimile number __________, and in cases of notices to Teva, to : 972-3-9267429.
 
24.            LIMITATION OF LIABILITY
 
In no event will either party be liable for any consequential, indirect, incidental, punitive, exemplary or special damages under or related to this Agreement, however caused and under any theory of liability, including without limitation, breach of contract, breach of warranty or tort.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

25.            PRESS RELEASE
 
Following the execution of this Agreement the Parties will jointly word a press release regarding the execution of this Agreement. The press release will be released as a joint release of the two parties.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

IN WITNESS WHEREOF , the parties hereto have hereunto set their hands as of the date first set forth above.
 
ROSETTA GENOMICS LTD.
 
By: /s/ Tami Fishman
Title General Counsel
Date January 9, 2009
 
By: /s/ Ranit Aharonov
Title EVP R &D
Date January 9, 2009
 

 
TEVA PHARMACEUTICAL INDUSTRIES LTD.
 
By: /s/                                                                        
[***]
[***]
[***] - Teva Pharmaceutical Industries Ltd.

Date
 
By: /s/                                                                         
[***]
 
Date
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

EXHIBIT A
[***]
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

EXHIBIT B
[***]
 
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 

 

EXHIBIT C
[***]
 
 
 
 
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

Exhibit 4.17













License Agreement
 
by and between
 
Prometheus Laboratories Inc.
 
and
 
Rosetta Genomics Ltd.

 
April 10, 2009
 
 
 
 




Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 CONFIDENTIAL
 
 

 

TABLE OF CONTENTS

Page
1.
DEFINITIONS
1
     
2.
GRANT OF RIGHTS; NON-COMPETE
11
       
 
2.1
Licenses
11
 
2.2
Right to Sublicense.
15
 
2.3
Ongoing Disclosure and Delivery of Licensed Intellectual Property
16
 
2.4
Non-Compete in Prometheus Territory.
17
 
2.5
Compliance with Upstream License Agreements.
17
 
2.6
After-acquired Rights
18
     
3.
DEVELOPMENT AND COMMERCIALIZATION MATTERS
19
       
 
3.1
Development Oversight Committee
19
 
3.2
Development Program.
22
 
3.3
Improvements.
25
 
3.4
Commercialization.
28
 
3.5
Patent Marking
28
     
4.
PAYMENTS
28
       
 
4.1
Up-Front Equity
28
 
4.2
Milestone Payments.
28
 
4.3
Royalty.
29
 
4.4
Permitted Reductions.
29
 
4.5
Payment and Reports
30
 
4.6
Record Keeping
31
 
4.7
Audit Rights
31
 
4.8
Withholding Taxes
31
     
5.
INTELLECTUAL PROPERTY RIGHTS
32
       
 
5.1
Patent Prosecution and Maintenance; Product Technical Information.
32
 
5.2
Infringement or Misappropriation of Licensed Intellectual Property.
33
 
5.3
Resolution of Potential Blocking Positions
36
     
6.
CONFIDENTIAL INFORMATION
39
       
 
6.1
Confidentiality.
39
 
6.2
Publicity and Permitted Disclosures
40
     
7.
REPRESENTATIONS, WARRANTIES AND COVENANTS
41
       
 
7.1
Corporate Existence and Power
41
 
7.2
Authority
41
 
7.3
Intellectual Property
41
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- i -

 
 
 
7.4
Regulatory Matters
44
 
7.5
Compliance with Laws.
44
 
7.6
Existing Research Agreements
44
 
7.7
Legal Proceedings
44
 
7.8
Financial Condition
45
     
8.
INDEMNIFICATION
45
       
 
8.1
Indemnification by Rosetta
45
 
8.2
Indemnification by Prometheus
45
 
8.3
Indemnification Procedures
46
 
8.4
Insurance
46
     
9.
TERM AND TERMINATION
46
       
 
9.1
Term
46
 
9.2
Termination of Agreement for Breach
46
 
9.3
Termination of Agreement for Insolvency
47
 
9.4
Termination of Agreement for Convenience by Prometheus
47
 
9.5
Termination for Challenge to Licensed Patents
47
 
9.6
Procedure upon Termination or Expiration of Agreement
48
 
9.7
Survival
48
     
10.
LIMITATION OF LIABILITY
48
     
11.
DISPUTE RESOLUTION
49
       
 
11.1
Informal Resolution
49
 
11.2
Arbitration
49
 
11.3
Escrow
49
 
11.4
Governing Law
50
     
12.
MISCELLANEOUS
50
       
 
12.1
Unenforceability
50
 
12.2
Compliance with Law
50
 
12.3
No Waiver
50
 
12.4
Drafting; Fairness of Agreement
50
 
12.5
Assignment
50
 
12.6
Relationship of the Parties
50
 
12.7
Injunctive Relief
51
 
12.8
Notices
51
 
12.9
Entire Agreement
52
 
12.10
Force Majeure
52
 
12.11
Headings
52
 
12.12
Right of Set-Off
52
 
12.13
Costs and Expenses
53
 
12.14
Applicability of Section 365(n) of the Bankruptcy Code.
53
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- ii -

 
 
 
12.15
Counterparts
53
     
13.
CLOSING.
53
       
 
13.1
Closing Date
53
 
13.2
Deliverables at Closing by Rosetta
53
 
13.3
Deliverables at Closing by Prometheus
54
 
13.4
Conditions Precedent to Obligations of Prometheus
54
 
13.5
Conditions Precedent to Obligations of Seller
54
 
13.6
Waiver of Conditions
55
 
13.7
Notifications.
55
 
13.8
No Negotiation.
55
 
Annex A
Licensed Intellectual Property
 
Annex B
Development Plan
 
Annex C
Services Agreement
 
Annex D
Service Agreement Profits
 
Annex E
Estimate for Additional Development Expenses
 
Annex F
Existing Research Agreements
 
Annex G
Select Provisions of JHU Agreement
 
Annex H
Rosetta Press Release
 
Annex I
Form of THM Written Statement
 


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
- iii -

 

LICENSE AGREEMENT
 
This License Agreement (“ Agreement ”) is entered into as of April 10, 2009 (the “ Execution Date ”), and is by and between Prometheus Laboratories Inc. , a California corporation having its principal place of business at 9410 Carroll Park Drive, San Diego, CA 92121 USA   (“ Prometheus ”) and Rosetta Genomics Ltd. , a corporation organized under the laws of Israel, having its principal place of business at 10 Plaut St., Rehovot, Israel, 76706 (“ Rosetta ”).
 
RECITALS
 
Whereas , Rosetta is the owner of all right, title and interest in or otherwise has the right to license certain Patents and Technical Information related to certain Diagnostic Tests (each as hereinafter defined); and
 
Whereas , Rosetta desires to grant, and Prometheus desires to accept, a License (as hereinafter defined) under such Patents and Technical Information to research, develop, practice and commercialize Licensed Products for use in the Field and in the Prometheus Territory (each as hereinafter defined) on the terms and conditions set forth herein.
 
AGREEMENT
 
Now, Therefore , for and in consideration of the above-described recitals, the mutual promises and covenants of the parties hereinafter contained and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by the parties, the parties hereto (each a “ Party ” and together the “ Parties ”), intending to be legally bound, enter into the agreements contained herein.
 
1.
DEFINITIONS
 
For purposes of this Agreement, the following terms shall have the meanings set forth below:
 
Affiliate ” shall mean, with respect to either Party, any person or entity which, directly or indirectly, controls, is controlled by, or is under common control with, the specified Party.  For the purposes of this definition, the term “ control ”, as applied to any person or entity, means the ownership or control, directly or indirectly, of (a) more than fifty percent (50%) or (b) the maximum percentage, if equal to or less than fifty percent (50%), allowed by law in the country of the controlled person or entity, of all of the voting power of the shares (or other securities or rights) entitled to vote for the election of directors or other governing authority; provided that such entity shall be considered an “Affiliate” only during the time that such “control” exists.
 
Agreement ” shall have the meaning set forth in the Introduction.
 
Alliance Manager ” shall have the meaning set forth in Section 3.1.1.
 
Budget ” shall have the meaning set forth in Section 3.2.2.
 
Claim ” shall mean any charge, allegation, notice, civil, criminal or administrative claim, demand, complaint, cause of action, suit, Proceeding, arbitration, hearing or investigation.
 
CLIA ” shall mean the Clinical Laboratory Improvement Amendments of 1988.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
- 1 -

 

Clinical Development Subcommittee ” shall have the meaning set forth in Section 3.1.5.
 
Closing ” shall have the meaning set forth in Section 13.1.
 
Commercial Technology Platforms ” shall mean the Real-Time PCR Technology, MGB Probes, microarrays or other generally commercially available technology platforms used to provide any Services under the Services Agreement or used by Prometheus or its Affiliates or Sublicensees to perform any Diagnostic Test.
 
Combination Product ” shall have the meaning set forth in Section 4.4.2.
 
Commercially Reasonable Efforts ” shall have the meaning set forth in Section 3.2.6(c), except that in the context of any request that Rosetta is required hereunder to make to an Upstream Licensor with respect to an amendment, modification or waiver of any provision of an Upstream License Agreement or any matter that is outside the scope of such Upstream Licensor’s obligations thereunder, Commercially Reasonable Efforts shall be limited to Rosetta’s making such request once in a good-faith manner to a representative of such Upstream Licensor who is responsible for administering the relevant Upstream License Agreement, and negotiating in good faith with such Upstream Licensor only if the initial request is not rejected.
 
Committee ” shall have the meaning set forth in Section 3.1.1.
 
Competitor ” shall mean any Third Party with (a) a molecular diagnostics business that generates at least [***] of such Third Party’s total revenue from sales or services, (b) an oncology diagnostics business, and/or (c) a gastrointestinal diagnostics business.
 
Control ” or “ Controlled ” shall mean, subject to Section 2.6, with respect to Technical Information or Patents, that Rosetta and/or its Affiliates has licensed (or otherwise obtained rights to or under) such Technical Information or Patents from a Third Party and Rosetta and/or its Affiliates has the right to grant sublicenses to such Technical Information or Patents.
 
Development Fund ” shall mean a ring-fenced account maintained by Rosetta and dedicated solely to meeting the costs and expenses required to complete the Development Program.
 
Development Plan ” shall have the meaning set forth in Section 3.2.2.
 
Development Program ” shall have the meaning set forth in Section 3.2.1.
 
Diagnostic Tests ” shall mean each of the following diagnostic tests and any Improvements agreed by the parties to be incorporated therein: (a) the Squamous Test, (b) the Mesothelioma Test, (c) the Mets Test, (d) the Second Generation Mets Test, (e) the IBS Test, and (f) the IBD Test.
 
Dispute ” shall have the meaning set forth in Section 11.1.
 
Effective Date ” shall have the meaning set forth in Section 13.1.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
- 2 -

 

Encumbrance ” shall mean any lien, pledge, security interest, right of first refusal, option, title defect, Claim, license, restriction, or other adverse claim or interest or encumbrance of any kind or nature whatsoever, whether or not perfected, including any restriction on use, transfer, receipt of income or exercise of any other attribute of ownership.
 
Escrow Account ” shall have the meaning set forth in Section 11.3.
 
Escrow Agent ” shall have the meaning set forth in Section 11.3.
 
Excluded Acquisition Patents ” shall mean any Patents which (a) are acquired by Rosetta or its Affiliates after the Effective Date and (b) are useful or necessary for the Exploitation of a Diagnostic Test, and which Rosetta is unable, despite using Commercially Reasonable Efforts, to license or sublicense (as applicable) to Prometheus due to the grant of prior exclusive rights to such Patents to Third Parties prior to the applicable acquisition thereof by Rosetta and/or its Affiliates.
 
Excluded Acquisition Technical Information ” shall mean any Technical Information which (a) is acquired by Rosetta or its Affiliates after the Effective Date and (b) is useful or necessary for the Exploitation of a Diagnostic Test, and which Rosetta is unable, despite using Commercially Reasonable Efforts, to license or sublicense (as applicable) to Prometheus due to the grant of prior exclusive rights to such Technical Information to Third Parties prior to the applicable acquisition thereof by Rosetta and/or its Affiliates or prior to the time at which it is determined that such Technical Information is useful or necessary for the Exploitation of a Diagnostic Test.
 
Execution Date ” shall have the meaning set forth in the Introduction.
 
Existing Research Agreements ” shall have the meaning set forth in Section 2.1.3(b).
 
Expert ” shall have the meaning set forth in Section 5.3.2(b).
 
Exploit ,” “ Exploiting ” or “ Exploitation ” shall mean to develop, make, have made, use, sell, have sold, offer for sale, have offered for sale, market, promote, distribute and import.  For clarity, the performance of a Diagnostic Test shall constitute an Exploitation thereof.
 
FDA ” shall mean the U.S. Food and Drug Administration of the U.S. Department of Health and Human Services and any successor agencies.
 
FDA Act ” shall mean the United States Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder, as they may be amended or supplemented from time to time, or an equivalent application under any successor laws or regulations.
 
FDA Clearance ” shall mean any approval, certification or clearance that may be required at any time during the Term by the FDA in connection with the marketing, offer for sale, sale, performance, provision or transfer from one laboratory to another of any Licensed Product.
 
Field ” shall mean the diagnosis of any disease or any human condition. For the purposes of this definition, “diagnosis” shall mean use (a) where the medical management of a human  is involved, for (i) the measurement, observation or determination of (x) the presence of a human disease, (y) the stage, progression or severity of a human disease, (z) the risk of contracting a human disease, and/or (ii) the selection of patients for a particular treatment with respect to a disease; and/or (b) in a clinical laboratory for tracking, testing or quality controlling of human body fluids or tissue samples; and/or (c) designated and regulated by the FDA as a diagnostic test or analyte specific reagent, to the extent used according to (a) and/or (b) above.

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
- 3 -

 

 
Force Majeure Event ” shall mean any cause or contingency beyond a Party’s reasonable control, including, strikes or other labor disturbances, lockouts, riots, quarantines, communicable disease outbreaks, wars, acts of terrorism, fires, floods, storms, or compliance with any order or regulation of any Regulatory Authority acting within color of right and, for purposes of Section 3.2.6(a), any circumstances caused by the other Party.
 
GAAP ” shall mean generally accepted accounting principles in the United States, consistently applied.
 
HHMI ” shall have the meaning set forth in Section 2.5.2.
 
IBD Test ” shall mean a diagnostic test for the aggressiveness and predictive response to biologics in patients with inflammatory bowel disease (IBD).
 
IBS Test ” shall mean a diagnostic test for the identification of irritable bowel syndrome (IBS) subtypes IBS-d, IBS-c and IBS-a, as such subtypes are further defined by the Committee in the course of the Development Program.
 
Improvements ” shall mean new improvements, discoveries, inventions, developments, enhancements, updates to and new features of the Mets Software, derivative works, technology, Technical Information and other intellectual property, whether or not patentable or protectable, necessary or useful for the Exploitation of the Licensed Products.
 
Indemnifying Party ” shall have the meaning set forth in Section 8.3.
 
Indemnitee ” shall have the meaning set forth in Section 8.3.
 
JHU ” shall mean Johns Hopkins University.
 
Joint Improvement ” shall have the meaning set forth in Section 3.3.2.
 
Law ” shall mean any federal, state (including the State of New York) or local law, statute or ordinance, or any rule, regulation, or published final guidelines promulgated by any governmental or regulatory authority, including the laws of the State of New York, the laws of the State of Pennsylvania, the FDA Act, CLIA, and the College of American Pathologists Accreditation 15189.
 
License ” shall mean the licenses set forth in Sections 2.1.1, 2.1.2 and 2.1.4 of this Agreement.
 
Licensed Intellectual Property ” shall mean the Licensed Patents, the Product Technical Information and the Mets Software.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
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Licensed Patents ” shall mean the Platform Patents and the Product Patents.
 
Licensed Process ” shall mean any process that, absent the License granted herein, would infringe a Valid Claim.
 
Licensed Product ” shall mean any Diagnostic Test (a) the Exploitation of which, or of any process, method, material, composition or assay used therein or for the performance thereof, would infringe a Valid Claim but for the licenses granted herein, (b) which was developed or manufactured using a Licensed Process, or (c) which incorporates or is developed using Royalty-Bearing Technical Information.
 
Limited Exclusive ” shall mean with respect to the License granted to Prometheus hereunder, exclusive even as against Rosetta and its Affiliates, but subject to any co-exclusivity terms and other retained rights of Upstream Licensors and their licensees (other than Rosetta and its Affiliates) of the Upstream Licensed Patents and/or any Upstream Licensed Technical Information.
 
Litigation Costs ” shall have the meaning set forth in Section 8.1.
 
Losses ” shall have the meaning set forth in Section 8.1.
 
Mesothelioma Test ” shall mean a diagnostic test for the differentiation of mesothelioma from adenocarcinoma.
 
Mets Software ” shall mean the source code and object code forms of a certain software application which contains, among other things, an algorithm created by or on behalf of Rosetta for the purpose of processing the results of the Mets Test, in the forms that such software exists as of the Effective Date, and any updates and Improvements adopted by Rosetta for the Mets Test and distributed by Rosetta to Prometheus during the Term.
 
 “ Mets Test ” shall mean Rosetta’s current diagnostic test for the identification of the origin of the primary tumor of metastases.
 
 “ MGB Probe shall mean certain quantitative gene expression probe technology that, as of the Effective Date, is commercialized and licensed out by Nanogen, Inc., or its licensees and used in conjunction with the Real-Time PCR Technology in the performance of certain of the Diagnostic Tests.
 
Modification Development Period ” shall have the meaning set forth in Section 5.3.2.
 
Mutual Confidentiality Agreement ” shall have the meaning set forth in Section 6.1.6.
 
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
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Net Sales ” shall mean for any period, the gross sales price or fee for performance of Licensed Products sold or otherwise supplied or performed by Prometheus and/or its Affiliates in the Prometheus Territory to Third Parties that are not Affiliates and/or sublicensees of the selling party (unless any such Affiliate is the end user of such Licensed Product, in which case the gross sales price therefore shall be deemed to be the amount that would be billed to a Third Party in an independent arm’s-length transaction) during such period, less the following items, as allocable to such Licensed Products:  (a) discounts, including cash and quantity discounts, chargeback payments and rebates granted to managed healthcare organizations or to federal, state or local governments (or their respective agencies, purchasers and reimbursers) or to trade customers , in each case, as estimated in accordance with Prometheus’ normal accounting procedures consistently applied, (b) credits or refunds for claims, (c) freight, postage, shipping and insurance charges actually allowed or paid for delivery of Licensed Products, to the extent identified on the invoice, (d) taxes, duties or other governmental charges (other than income taxes) levied on, absorbed or otherwise imposed on sales of Licensed Products to the extent identified on the invoice, and (e) bad debts in accordance with Prometheus’ normal accounting procedures consistently applied.  Accordingly, such definition of Net Sales shall be equivalent to net sales and bad debt expense as recorded on Prometheus’ (or its Affiliates and/or sublicensees) books and accounting records in compliance with GAAP, and, in the event that Prometheus becomes a publicly listed corporation, consistent with Prometheus’ audited financial statements filed with the US Securities and Exchange Commission.  For purposes of clarification, in no event shall Licensed Products used by Prometheus in quality control testing or distributed as free (at or below cost) research samples or charitable contributions be included in calculating Net Sales.
 
Overall Time Period ” shall have the meaning set forth in Section 5.3.2.
 
Patent(s) ” shall mean (a) patents or patent applications; and (b) any divisionals, continuations, substitutions, continuations-in-part, extensions, supplementary protection certificates, renewals, re-examinations or reissues of such patents or applications, as applicable.
 
Permitted Successor ” has the meaning set forth in Section 12.5.
 
Plan B Notice ” shall have the meaning set forth in Section 5.3.4.
 
Plan C Notice ” shall have the meaning set forth in Section 5.3.5.
 
Platform Improvement ” shall mean any Improvement which is covered by one or more claims of a Platform Patent that is independently developed or otherwise acquired by Prometheus or its Affiliates during the Term.  For the avoidance of doubt, an Improvement microRNA sequence is excluded from the definition of Platform Improvements unless such microRNA sequence is a specifically disclosed sequence in the Platform Patents.
 
Platform Patent(s) ” shall mean all Patents in the Prometheus Territory now or in the future owned or Controlled by Rosetta and/or its Affiliates that are necessary or useful for the Exploitation of a Licensed Product and cover one or more compositions of matter or technologies which can be used across two or more products, including but not limited to (a) the Patents listed on Annex A-2 as may be amended from time to time by the Parties; and (b) all Patents in the Prometheus Territory (i) to which any of the Patents set forth on Annex A-2 claim priority or (ii) for which any of the Patents on Annex A-2 form a basis for priority, including any divisionals, continuations, substitutions, continuations-in-part, extensions, renewals, re-examinations or reissues of such Patents listed on Annex A-2 , provided that Platform Patents(s) shall not include the Excluded Acquisition Patents.  For the avoidance of doubt, the Platform Patents include all composition of matter claims directed to microRNAs within the Licensed Patents.
 
Potential Blocking Patent ” shall have the meaning set forth in Section 5.3.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
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Proceeding ” shall mean any action, arbitration, audit (to the knowledge of such Party), hearing, investigation (to the knowledge of such Party), litigation or suit (whether civil, criminal, administrative, investigative or informal) commenced, brought, conducted or heard by or before, or otherwise involving any governmental entity or arbitrator.
 
Product Improvement ” shall mean any Improvement which is covered by one or more claims of a Product Patent that is independently developed or otherwise acquired by Prometheus or its Affiliates during the Term.
 
Product Patent(s) ” shall mean all Patents in the Prometheus Territory now or in the future owned or Controlled by Rosetta and/or its Affiliates that are necessary or useful for any of the Diagnostic Tests and are specifically directed to one or more elements of any of the Diagnostic Tests that are unique to such Diagnostic Test (as contrasted to methods of performance in general of tests based on microRNAs or composition of matter claims that are relevant to multiple indications), including but not limited to (a) the Patents listed on Annex A-1 as may be amended from time to time by the Parties; and (b) all Patents in the Prometheus Territory (i) to which any of the Patents set forth on Annex A-1 claim priority or (ii) for which any of the Patents on Annex A-1 form a basis for priority, including any divisionals, continuations, substitutions, continuations-in-part, extensions, renewals, re-examinations or reissues of such Patents listed on Annex A-1 , provided that Product Patents(s) shall not include the Excluded Acquisition Patents or the Platform Patents. For the avoidance of doubt, subject to Section 5.1.1(e), the Product Patents include all methods of use claims directed to the use of microRNAs for the indications that are the targets of the Diagnostic Tests, but exclude all composition of matter claims directed to microRNAs.
 
Product Technical Information ” shall mean any Technical Information which is necessary or useful to Exploit the Licensed Products in the Prometheus Territory and owned or otherwise Controlled by Rosetta or any of its Affiliates as of the Effective Date or during the Term, including Rosetta Improvements incorporated into the Licensed Products, if any, but excluding any Excluded Acquisition Technical Information and any Technical Information that is claimed or disclosed in the Licensed Patents.
 
Prometheus ” shall have the meaning set forth in the Introduction.
 
Prometheus Confidential Information ” shall have the meaning set forth in Section 6.1.2.
 
Prometheus Development Contribution ” shall have the meaning set forth in Section 3.2.4.
 
Prometheus Product Improvement ” shall have the meaning set forth in Section 3.3.3.
 
Prometheus Indemnitee ” shall have the meaning set forth in Section 8.1.
 
Prometheus Territory ” shall mean the United States of America, including all of its territories, commonwealths and possessions (including but not limited to Puerto Rico) and military bases (provided that for military bases, the specimen required for the performance of a Diagnostic Test is taken from a patient that is entitled to treatment under a US military health plan, and is processed through military channels, including such specimens collected by a civilian medical facility under contract with the US military).
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
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PTO ” shall have the meaning set forth in Section 5.1.2.
 
Real-Time PCR Technology ” shall mean certain real-time polymerase chain reaction technology that, as of the Effective Date, is commercialized and licensed out by F. Hoffmann-La Roche Ltd (or its affiliates or its or their licensees) and used in the performance of the Diagnostic Tests.
 
Regulatory Approval ” shall mean with respect to the Licensed Products or any Improvements thereto, any clearance or approval required by a Regulatory Authority and any other governmental clearances or approvals required in any jurisdiction in the Prometheus Territory to Exploit such Licensed Products or Improvements thereto, including any FDA Clearance.
 
Regulatory Authority ” shall mean any Federal (including, to the extent applicable, the FDA), State (including the State of New York), or other governmental authority in the Prometheus Territory which has asserted its right to regulate Exploitation of the Licensed Products.
 
Regulatory Filing ” shall mean any filing with a Regulatory Authority relating to or to permit or request, as applicable, the validation, clinical evaluation or Regulatory Approval of a Licensed Product.
 
Repurchase Right ” shall have the meaning set forth in Section 2.1.6.
 
ROFN ” shall have the meaning set forth in Section 2.1.5.
 
ROFN Period ” shall have the meaning set forth in Section 2.1.5.
 
Rosetta ” shall have the meaning set forth in the Introduction.
 
Rosetta Confidential Information ” shall have the meaning set forth in Section 6.1.1.
 
Rosetta Improvement ” shall have the meaning set forth in Section 3.3.1.
 
Rosetta Indemnitee ” shall have the meaning set forth in Section 8.2.
 
Rosetta Owned Technical Information ” shall mean all Product Technical Information which is owned by Rosetta and/or its Affiliates, excluding any Excluded Acquisition Technical Information.
 
Rosetta Owned Patents ” shall mean all Licensed Patents which are owned by Rosetta and/or its Affiliates other than the Excluded Acquisition Patents.
 
Royalty ” shall have the meaning set forth in Section 4.3.1.
 
Royalty-Bearing Technical Information ” shall mean any Upstream Licensed Technical Information which, if incorporated into a Licensed Product or used in the development thereof would result in a Royalty being payable to such Upstream Licensor.  
 
Royalty Reporting Quarter ” shall have the meaning set forth in Section 4.5.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
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Second Generation Mets Test ” shall mean a version of the Mets Test to be developed under this Agreement that is adapted to be performed using a microarray or another alternative to the Real-Time PCR Technology and with the objective to include (a) indications within cancer of unknown primary that are additional to those targeted by the Mets Test, or (b) other enhancements to the Mets Test.
 
Services ” shall have the meaning set forth in the Services Agreement.
 
Services Agreement ” shall mean that certain laboratory services agreement, attached hereto as Annex C , to be entered into by the Parties at the Closing.
 
Services Agreement Profits ” shall mean, with respect to each Diagnostic Test performed on Prometheus’ behalf as part of the Services, the actual amount received by Rosetta from Prometheus and/or its Affiliates for the performance of such Diagnostic Test less the applicable cost of goods (inclusive of reasonable overhead which shall be no more than [***] of the total costs of goods) for performing such Diagnostic Test specified in Annex D .
 
Significant Direct Competitor ” shall mean any microRNA diagnostic-based product which competes directly with a Diagnostic Test and that tests for the same indication that is the target of such Diagnostic Test.
 
Specified Diagnostics Rights ” shall have the meaning set forth in Section 2.1.5.
 
Squamous Test ” shall mean a diagnostic test for the differentiation of squamous from non-squamous non-small cell lung caner.
 
Sublicense ” shall have the meaning set forth in Section 2.2.
 
Sublicensee ” shall mean any person or entity other than an Affiliate of Prometheus that is granted a Sublicense by Prometheus.
 
Technical Information ” shall mean any and all information and materials, including, but not limited to, discoveries, improvements, processes, algorithms (but excluding specific software that implements such algorithms and which is otherwise licensed under Section 2.1.4), methods, protocols, formulas, data, inventions (including without limitation information and inventions contained in the Licensed Patents), know-how and trade secrets, whether or not patentable or protectable.
 
Term ” shall have the meaning set forth in Section 9.1.
 
Third Party ” shall mean any person or entity other than Rosetta, Prometheus, or their Affiliates or any Sublicensee of Prometheus.
 
Third Party License Negotiation Period ” shall have the meaning set forth in Section 5.3.2.
 
Third Party Royalty Cap ” shall mean:
 
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(a) with respect to Licensed Products other than the IBS Test or IBD Test, an amount equivalent to [***] of Net Sales; provided that: (i) if no further consideration is required to be paid for the Real-Time PCR Technology, then the Third Party Royalty Cap shall mean an amount equivalent to [***] of Net Sales, (ii) if no further consideration is required to be paid for MGB Probes, then the Third Party Royalty Cap shall mean an amount equivalent to [***] of Net Sales, and (iii) if no further consideration is required to be paid pursuant to either the Real-Time PCR Technology or the MGB Probes, then the Third Party Royalty Cap shall mean an amount equivalent to [***] of Net Sales;
 
(b) with respect to the IBS Test and IBD Tests only, an amount equivalent to [***] of Net Sales; provided that: (i) if no further consideration is required to be paid for the Real-Time PCR Technology, then the Third Party Royalty Cap shall mean an amount equivalent to [***] of Net Sales, (ii) if no further consideration is required to be paid for MGB Probes, then the Third Party Royalty Cap shall mean an amount equivalent to [***] of Net Sales, and (iii) if no further consideration is required to be paid pursuant to either the Real-Time PCR Technology or the MGB Probes, then the Third Party Royalty Cap shall mean an amount equivalent to [***] of Net Sales, provided that;
 
(c) notwithstanding anything herein, in the event that the IBS Test or the IBD Test includes microRNAs licensed under the JHU Agreement, the Third Party Royalty Cap applied to such Licensed Product shall be increased by an amount equivalent to [***] of Net Sales.
 
THM ” shall mean Tel Hashomer Medical Research Infrastructure and Services Ltd.
 
Up-Front Stock Issuance ” shall have the meaning set forth in Section 4.1.
 
Upstream License Agreement ” shall mean, subject to Section 2.6, any license agreements between Rosetta and a Third Party pursuant to which certain Licensed Intellectual Property Controlled by Rosetta is licensed to Rosetta by such Third Party, as may be amended from time to time, including but not limited to the following: (a) License Agreement between Garching Innovation GmbH and Rosetta, dated June 30, 2006 (the “ Max Planck Agreement ”); (b) Diagnostic License Agreement between The Rockefeller University and Rosetta, dated May 4, 2006 (the “ Rockefeller Agreement ”); (c) Amended and Restated Research Collaboration Agreement between Tel Hashomer Medical Research Infrastructure and Services Ltd and Rosetta, dated June 30, 2008 (the “ THM Agreement ”), and, if and to the extent that the Committee determines by a unanimous, formal decision documented in writing that the Second Generation Mets Test will include any microRNAs subject thereto, the (d) Exclusive License Agreement between Johns Hopkins University and Rosetta, dated August 2, 2006 (the “ JHU Agreement ”).   Notwithstanding the foregoing, the Upstream License Agreements exclude any Commercial Technology Platform agreements.
 
Upstream Licensed Patent ” means a Licensed Patent Controlled but not owned by Rosetta that is licensed to Rosetta pursuant to an Upstream License Agreement.
 
 “ Upstream Licensed Technical Information ” shall mean all Product Technical Information Controlled but not owned by Rosetta that is licensed to Rosetta pursuant to the Upstream License Agreements.
 
Upstream Licensor ” shall mean each of the licensors pursuant to the Upstream License Agreements.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
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Valid Claim ” shall mean either (a) a claim in an issued Patent included within the Licensed Patents, which claim has not lapsed, been revoked, cancelled or become abandoned and has not been declared invalid, unpatentable or unenforceable by any unreversed decision or judgment of a court or other body of competent jurisdiction, and which has not been admitted to be invalid or unenforceable through reissue, disclaimer, settlement or otherwise, or (b) a claim of a pending Patent application included in the Licensed Patents, which claim has not been abandoned or disallowed and has been pending for less than seven (7) years from the date such claim was filed with the PTO and has not been cancelled, withdrawn from consideration, denied or abandoned.  Notwithstanding the foregoing, in the case of a claim within any Upstream Licensed Patent, the definition of “Valid Claim” with respect to each such claim shall be the definition thereof set forth in the applicable Upstream License Agreement.
 
Validation Subcommittee ” shall have the meaning set forth in Section 3.1.6.
 
1.1.1           Unless the context of this Agreement otherwise requires:  (a) words of any gender include each other gender; (b) words using the singular or plural number also include the plural or singular number, respectively; (c) the terms “hereof,” “herein,” “hereby,” and derivative or similar towards refer to this entire Agreement; (d) the terms “Section” or “Annex” refer to the specified Section or Annex of this Agreement; (e) the term “or” has, except where otherwise indicated, the inclusive meaning represented by the phrase, “and/or”; (f) the term “including” means “including, without limitation”; (g) “days” refers to calendar days; and (h) the term “not to unreasonably withhold approval” includes not to unreasonably delay or condition such approval. All accounting terms used but not otherwise defined herein shall have the meanings ascribed to such terms under GAAP.  All references to “$” amounts hereunder shall be deemed to be U.S. Dollars, and all payments due hereunder shall be made in U.S. Dollars.  All reference to the “knowledge” of Rosetta means the actual knowledge of the following executive officers and key employees of the Company or any successors to their positions: Yoav Chelouche, Amir Avniel, Limor Zur Stoller, Dalia Cohen, Ph.D., Ronen Tamir, Ranit Aharonov Gal, Ph.D., Ayelet Chajut, Ph.D., Tami Fishman Jutkowitz and Tzipora Shoshani Kofitz, Ph.D., after conducting a reasonable investigation of the subject matter thereof, and each statement will be deemed to include a representation that such investigation has been conducted.  For the avoidance of doubt, Rosetta shall not be required to obtain any freedom to operate opinions in order to meet the standard of having conducted a “reasonable investigation.”
 
2.
GRANT OF RIGHTS; NON-COMPETE
 
2.1            Licenses .
 
2.1.1            Patent License .   Subject to the terms and conditions set forth herein, Rosetta on behalf of itself and its Affiliates hereby grants to Prometheus and, subject to Section 2.1.8, Prometheus’ Affiliates, a Limited Exclusive, sublicensable (in accordance with Section 2.2), royalty-bearing (in accordance with Section 4) license under the Licensed Patents to Exploit the Licensed Products in the Field in the Prometheus Territory during the Term through any and all means and channels of distribution now known or hereinafter discovered.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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2.1.2            Technical Information License .   Subject to the terms and conditions set forth herein, Rosetta on behalf of itself and its Affiliates hereby grants to Prometheus and, subject to Section 2.1.8, Prometheus’ Affiliates, a Limited Exclusive, sublicensable (in accordance with Section 2.2), royalty-bearing (in accordance with Section 4) license under Rosetta’s intellectual property rights in the Product Technical Information to Exploit the Licensed Products in the Field in the Prometheus Territory during the Term through any and all means and channels of distribution now known or hereinafter discovered.
 
2.1.3            Restrictions on Use of Specimens .
 
(a)           Prometheus agrees and acknowledges that, notwithstanding the License granted to it pursuant to Sections 2.1.1, 2.1.2 and 2.1.4, Prometheus, its Affiliates and its Sublicensees shall not knowingly (after using Commercially Reasonable Efforts to determine the same) conduct Diagnostic Tests using specimens that were initially collected from patients at a facility outside the Prometheus Territory.
 
(b)           Subject to Section 2.2, Rosetta agrees and acknowledges that during the Term, it and its Affiliates shall not knowingly (after using Commercially Reasonable Efforts to determine the same), except for the benefit of Prometheus, nor shall it or its Affiliates grant any Third Party the right to, conduct Diagnostic Tests using specimens that were initially collected from patients at a facility inside the Prometheus Territory, except in connection with a collaboration or other research agreement between Rosetta or its Affiliates and an academic or other not-for-profit research institution, which collaboration or other agreement (i) was entered into prior to the Execution Date of this Agreement and listed on Annex F (the “ Existing Research Agreements ”), or (ii) is with an academic or other not-for-profit research institution located inside or outside the Prometheus Territory and has been approved by Prometheus via the Committee.
 
(c)           The parties shall use Commercially Reasonable Efforts to work together to ensure that the intent of the restrictions set forth in this Section 2.1.3 are adhered to.  Prometheus shall be solely responsible for providing instructions to US military bases and civilian hospitals that contract with such bases with respect to the processing through military channels of the specimens collected from a patient that is entitled to treatment under a US military health plan.  Notwithstanding anything herein, neither Rosetta nor its licensees or distributors shall have any liability to Prometheus arising from Rosetta’s, its licensees’ or distributors’ processing of a sample that is initially obtained outside the Prometheus Territory through US military channels and that is mistakenly sent to Rosetta, its licensees or distributors.
 
2.1.4            Software License .  Subject to the terms and conditions set forth herein, Rosetta on behalf of itself and its Affiliates hereby grants to Prometheus and, subject to Section 2.1.8, Prometheus’ Affiliates, a non-exclusive, sublicensable (in accordance with Section 2.2), royalty-free license under Rosetta’s intellectual property rights in the Mets Software to install on an unlimited number of computers and/or servers and have an unlimited number of end users execute, use, perform, and display the Mets Software solely for the purpose of performing a Mets Test in the Field in the Prometheus Territory during the Term.  Prometheus shall comply with Sections 2.1.4(a), (b) and (c), and shall impose substantially equivalent restrictions on any of its Affiliates or Sublicensees to which Prometheus provides the Mets Software:
 
(a)           Prometheus and its Affiliates may make a reasonable number of copies of the Mets Software as necessary for installation, use and back-up, disaster recovery and archival purposes, provided that, in connection with any copy of the Mets Software, Prometheus reproduces all confidentiality and proprietary notices on such copies. Prometheus shall have the right to modify (directly or through a Third Party software developer subject to a reasonable confidentiality agreement) the Mets Software, provided that it promptly provides a copy of such modifications (in object and source code form) and any documentation relating thereto to Rosetta, grants Rosetta a perpetual, worldwide, royalty-free, fully paid up, sublicensable license to Exploit such modifications in conjunction with the Mets Software, and in the case of modifications to the Mets Software made by a Third Party software developer on Prometheus’ behalf, obtains from such Third Party an assignment to Prometheus or a Prometheus Affiliate of all intellectual property rights that such Third Party may have in such modifications.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(b)           Prometheus and its Affiliates will not distribute, provide or otherwise make the Mets Software available to any Third Party (other than Sublicensees subject to Section 2.2, Third Parties performing software development services on Prometheus’ behalf, and Third Party backup or disaster recovery service providers subject to reasonable confidentiality and non-use restrictions), in whole or in part, through any medium or process.
 
(c)           Rosetta shall use Commercially Reasonable Efforts during Israeli business hours to provide via telephone to an appropriately skilled member of Prometheus’ information technology support department, (i) initial training and guidance regarding the installation, implementation, configuration, use and operation of the Mets Software (excluding any modifications thereto made by Prometheus), and (ii) a reasonable amount of ongoing consultation regarding specific problems encountered by Prometheus or its Affiliates or Sublicensees that Prometheus is unable to address by consulting the Mets Software documentation supplied by Rosetta.  Prometheus shall be solely responsible for providing any further internal training or support required by it, its Affiliates or its Sublicensees.
 
(d)           Rosetta shall provide up to [***] hours of work, using no more than [***] of its internal resources, to modify the Mets Software as reasonably requested by Prometheus.  In addition, Rosetta shall use good-faith efforts, using its then-existing internal resources, to attempt to correct defects in the Mets Software upon receipt of Prometheus’ written request and a reasonably detailed description of the defect, but excluding any defect in or arising from any modifications to the Mets Software made by Prometheus or its Third Party software developers.  Notwithstanding anything herein, Rosetta does not guarantee that it will be able to correct and shall have no obligation to correct defects in the Mets Software or to make Improvements to the Mets Software.
 
(e)           Prometheus acknowledges that the Mets Software is provided strictly on an “as-is” basis with no warranty of any kind.  TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, ROSETTA DISCLAIMS ALL WARRANTIES WITH RESPECT TO THE METS SOFTWARE, WHETHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, THAT THE METS SOFTWARE WILL OPERATE UNINTERRUPTED OR BE FREE FROM DEFECTS, OR THAT IT WILL MEET PROMETHEUS’ REQUIREMENTS.  Rosetta acknowledges that any modifications to the Mets Software provided by Prometheus pursuant to Section 2.1.4(a) is provided strictly on an “as-is” basis with no warranty of any kind.  TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, PROMETHEUS DISCLAIMS ALL WARRANTIES WITH RESPECT TO ANY SUCH MODIFICATIONS TO THE METS SOFTWARE, WHETHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, THAT THE MODIFICATIONS TO THE METS SOFTWARE WILL OPERATE UNINTERRUPTED OR BE FREE FROM DEFECTS, OR THAT IT WILL MEET ROSETTA’S REQUIREMENTS.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(f)           If Rosetta provides any software (in addition to the Mets Software and Improvements thereto) to Prometheus during the Term, such software shall be deemed to be licensed to Prometheus on the terms and conditions ( mutatis mutandis ) set forth in Section 2.14 unless otherwise agreed in writing by the Parties.
 
2.1.5            Right of First Negotiation for Specified Diagnostics Rights . Rosetta hereby grants to Prometheus a right of first negotiation (“ ROFN ”) to acquire or license from Rosetta rights to the following diagnostic tests or programs under development by Rosetta: (a) colorectal cancer prognosis regarding the risk of reoccurrence, (b) ovarian cancer responsiveness to carboplatin, and (c) lung cancer diagnostic tests regarding small cell versus non-small cell lung cancer (collectively, the “ Specified Diagnostics Rights ”).  In the event that Rosetta proposes to sell, license, offer for sale, offer for license or agree to sell or license any of its Patent rights or assets relating to the Specified Diagnostic Rights (other than as part of a single disposition of all or substantially all of Rosetta’s assets, which for the avoidance of doubt must include all of Rosetta’s rights in the Licensed Products), and prior to Rosetta offering such Patent rights or assets for sale, it shall first provide Prometheus with (a) a summary of all material economic and financial terms upon which such Specified Diagnostic Rights are available (such terms to be commercially reasonable and provided by Rosetta to Prometheus in good faith), and (b) a period of [***] to negotiate with Rosetta with respect to a definitive agreement for an acquisition or license of the offered Patent rights and/or assets (the “ ROFN Period ”). During the ROFN Period, Rosetta shall not negotiate with or enter into any definitive agreement with any Third Party regarding the applicable Specified Diagnostic Rights.  In the event that the Parties do not agree, after using good faith efforts, to definitive terms within such ROFN Period, then solely with respect to such Specified Diagnostic Rights, Rosetta shall be free to sell or license the applicable Specified Diagnostics Rights to a Third Party on either (a) if less than [***] from the time initially offered to Prometheus in accordance with this Section 2.1.5, terms not (i) less favorable than the terms last offered by Prometheus to Rosetta in writing prior to the expiration of the ROFN Period nor (ii) more favorable than those offered by Rosetta to Prometheus in writing prior to the expiration of the ROFN Period, or (b) if more than [***] after the time initially offered to Prometheus, on any terms which Rosetta so desires.  If Rosetta has provided Prometheus with at least one (1) written offer proposing terms for Prometheus’ acquisition of the Specified Diagnostic Rights and Prometheus has rejected such offer and declined to make any other written offer during the ROFN Period, Rosetta shall be relieved of all obligations under this Section 2.1.5 upon the expiry of the ROFN Period. For the avoidance of doubt, (a) the ROFN shall not apply to Rosetta’s or its Affiliates’ own development or commercialization of the Specified Diagnostic Rights, and (b) neither Rosetta nor its Affiliates shall have any obligation to research or develop any of the Specified Diagnostic Rights, which activities shall be at Rosetta’s sole discretion.
 
2.1.6            Repurchase Right .  Except to the extent covered by a Force Majeure Event or Rosetta’s failure to comply with its obligations under this Agreement, subject to the terms and conditions of this Agreement and compliance therewith by Rosetta, Rosetta shall have the right to repurchase from Prometheus (in accordance with the terms hereof) and terminate the License if Net Sales of the Licensed Products by Prometheus and/or its Affiliates for the entire 2013 calendar year are less than [***] US dollars [***] in the aggregate (the Repurchase Right ”). Rosetta may elect to exercise such Repurchase Right by (a) providing written notice to Prometheus within thirty (30) days of Prometheus’ notification to Rosetta of the Royalties earned for the fourth (4 th ) calendar quarter of the 2013 calendar year, and (b) payment to Prometheus of an amount equal to [***] the aggregate Net Sales for the 2013 calendar year within five (5) business days of such election.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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2.1.7            Retained Rights .  Notwithstanding the licenses granted in Sections 2.1.1, 2.1.2 and 2.1.4, Rosetta retains the right for itself and its Affiliates under the Licensed Intellectual Property in the Prometheus Territory (a) to provide the Services pursuant to the Services Agreement for such period as Rosetta has any obligations to provide Services thereunder; (b) to conduct Diagnostic Tests or perform in the Prometheus Territory on a non-commercial, pre-commercial or non-clinical basis   any validation studies or other support for research and development, in each case consistent with, and as limited by, Section 2.1.3(b); and (c) to conduct Diagnostic Tests on a commercial basis at its laboratory facilities located inside the Prometheus Territory using specimens initially collected from patients at a facility located outside the Prometheus Territory.
 
2.1.8            Prometheus Affiliates .  In the event that Prometheus wishes any of its Affiliates to benefit from the licenses granted in Sections 2.1.1, 2.1.2 or 2.1.4 , Prometheus shall (a) notify Rosetta in writing of such fact and provide Rosetta with the full name and primary business address of the relevant Affiliate, and (b) require such Affiliate to confirm in writing to Rosetta that it has read and will comply with the following Articles and Sections of this Agreement, mutatis mutandis :  2.1.1, 2.1.2, 2.1.3, 2.1.4, 2.1.9, 2.4.2, 2.5, 3.3.3, 3.3.4, 6 and 12.2, and all definitions used in the foregoing.  Any breach by a Prometheus Affiliate of the foregoing provisions shall be deemed to be a breach by Prometheus. In no event shall any Prometheus Affiliate have the right to grant sublicenses or assign its rights hereunder.  Except as otherwise set forth in Section 8.1, neither Rosetta nor Prometheus intend that Rosetta shall have any contractual liability directly with any Prometheus Affiliate in connection with this Agreement, but in the event that such direct contractual liability may nonetheless arise (other than pursuant to Section 8.1), Article 10 shall apply thereto.  Any license granted hereunder to a Prometheus Affiliate shall terminate immediately and automatically if such entity ceases to qualify under the definition of “Affiliate” provided in Article 1.
 
2.1.9            No Implied Licenses .  For the avoidance of doubt, the License excludes any Exploitation of the Licensed Intellectual Property for the research or development of any products or services other than the Licensed Products or for general research or development of microRNA technology that is not specifically related to the Licensed Products.  Without limiting the foregoing, no right or license, either express or implied, is granted hereunder by implication, estoppel or otherwise, with respect to any Patent, trade secret, know-how, other information or intellectual property rights of either Party or its licensors except as expressly stated in this Agreement.
 
2.2            Right to Sublicense .
 
2.2.1           Prometheus shall have the right to grant sublicenses (individually, a “ Sublicense ”) under the License solely to Third Party laboratories solely for the purposes of such laboratories conducting the Diagnostic Tests for Prometheus, subject at all times to the consent of any applicable Upstream Licensors if and only if such consent is required pursuant to the Upstream License Agreements.  Prior to receipt of any Rosetta Confidential Information, each such Sublicensee shall enter into a confidentiality agreement with Rosetta in a form reasonably acceptable to Rosetta. Any such Sublicensee shall be required by Prometheus to comply with the applicable restrictions set forth in this Agreement with respect to (a) the rights granted to the Licensed Intellectual Property and restrictions on the use thereof, including Section 2.5, and (b) Rosetta Confidential Information.  For the avoidance of doubt, (i) Prometheus shall have no right to grant sublicenses under the License except to Sublicensees as set forth in this Section 2.2.1, and (ii) Sublicensees shall have no right to sell Diagnostic Tests (or to charge for the performance thereof) to customers, end users or any intermediary other than Prometheus and/or its Affiliates.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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2.3            Ongoing Disclosure and Delivery of Licensed Intellectual Property .
 
2.3.1           Rosetta shall provide Prometheus with copies of any Patents that become Rosetta Owned Patents at any time during the Term.  Rosetta shall provide Prometheus with copies of any Patents that Rosetta is aware have become Upstream Licensed Patents at any time during the Term.
 
2.3.2           Within thirty (30) days following the Effective Date, Rosetta shall promptly provide Prometheus with object code and source code copies (both in print and, where available, electronic copies) of the Mets Software and documentation therefor in the form it exists at such time.  If Rosetta makes or otherwise acquires Control of any Improvements to the Mets Software during the Term, Rosetta shall notify Prometheus of the existence of such Improvement and shall supply Improvements to Prometheus, free of charge, upon written request.
 
2.3.3           Within thirty (30) days following the Effective Date, Rosetta shall promptly disclose to Prometheus and provide Prometheus with copies (both in print and, where available, electronic copies) of the Product Technical Information necessary to Exploit the Diagnostic Test and existing as of the Effective Date in English and in sufficient detail in order for a reasonably-skilled person to practice and Exploit such Product Technical Information.  Rosetta shall update the Product Technical Information previously transferred to Prometheus on a frequent and regular basis, including in connection with all Committee meetings or at any time upon Prometheus’ request and, in any case, not to exceed thirty (30) calendar days following the acquisition or creation by Rosetta of any additional Product Technical Information or Improvements to the Product Technical Information.  Without limiting the foregoing, such transfer of Product Technical Information shall include:
 
(a)           transfer of copies of the results of and data from any studies conducted prior to and as of the Effective Date relating to the Licensed Products (including all regulatory information, clinical data, training and validation data, hard-copy case report forms and reports to the extent disclosure thereof to Prometheus is not prohibited by applicable Laws or regulations outside the Prometheus Territory);
 
(b)           transfer of copies of any written communications with any Regulatory Authorities in the Prometheus Territory and any relevant written communications with other Regulatory Authorities, and the minutes of any meetings with any such Regulatory Authority, in each case relating to the Licensed Products; and
 
(c)           providing Prometheus with reasonable access to Rosetta personnel (through, or directly as approved by, Rosetta’s senior management) with relevant clinical, validation and regulatory expertise to explain the Product Technical Information transferred hereunder.
 
For the avoidance of doubt, and notwithstanding the foregoing, it is anticipated that any data to be transferred from Rosetta to Prometheus will be anonymous or de-identified and not personal data within the meaning of applicable data protection Laws.  In the event that any such transferred data is deemed to be or constitutes personal data, the Parties will collaborate to comply with such Laws, including obtaining exemptions therefrom or constructing cross-border transfer solutions.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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2.4            Non-Compete in Prometheus Territory .
 
2.4.1            By Rosetta .  During the Term of this Agreement, neither Rosetta nor any of its Affiliates shall, directly or indirectly, Exploit a Significant Direct Competitor in the Prometheus Territory or  assist, transfer or license rights to any business that Rosetta knows intends to use such assistance or rights to Exploit a Significant Direct Competitor in the Prometheus Territory.  Each of the Parties hereto recognizes that the restrictions contained in, and the terms of, this Section 2.4.1 are properly required for the adequate protection of Prometheus’ rights hereunder, and agree that if any provision in this Section 2.4.1 is determined by any court to be unenforceable by reason of its extending for too great a period of time or over too great a geographic area, or by reason of its being too extensive in any other respect, such covenant shall be interpreted to extend only for the longest period of time and over the greatest geographic area, and to otherwise have the broadest application as shall be enforceable.  [***].  If Rosetta or any of its Affiliates are acquired by or merge with a Third Party that has a Significant Direct Competitor, neither Rosetta nor any of its Affiliates will have any obligations under this Section 2.4.1 with respect to such Significant Direct Competitor; provided that the division, subsidiary or business group of the surviving party in such change of control that pursues such Significant Direct Competitor shall not have access to, and shall not refer to, rely upon or use in any manner, the Licensed Intellectual Property with respect to such Significant Direct Competitor.
 
2.4.2            By Prometheus .  During the Term of this Agreement, neither Prometheus nor any of its Affiliates shall, directly or indirectly, Exploit a Significant Direct Competitor that is not a Licensed Product in the Prometheus Territory, or otherwise assist or transfer or license rights to any business that Prometheus knows intends to use such assistance or rights to Exploit a Significant Direct Competitor in the Prometheus Territory.  Each of the Parties hereto recognizes that the restrictions contained in, and the terms of, this Section 2.4.2 are properly required for the adequate protection of Rosetta’s rights hereunder, and agree that if any provision in this Section 2.4.2 is determined by any court to be unenforceable by reason of its extending for too great a period of time or over too great a geographic area, or by reason of its being too extensive in any other respect, such covenant shall be interpreted to extend only for the longest period of time and over the greatest geographic area, and to otherwise have the broadest application as shall be enforceable.  [***].  If Prometheus or any of its Affiliates are acquired by or merge with a Third Party that has a Significant Direct Competitor that is not a Licensed Product, neither Prometheus nor any of its Affiliates will have any obligations under this Section 2.4.2 with respect to such Significant Direct Competitor; provided that the division, subsidiary or business group of the surviving party in such change of control that pursues such Significant Direct Competitor shall not have access to, and shall not refer to, rely upon or use in any manner, the Licensed Intellectual Property with respect to such Significant Direct Competitor, except with Rosetta’s prior written consent and on the condition that such Significant Direct Competitor be treated as a Licensed Product hereunder.
 
2.5       Compliance with Upstream License Agreements .
 
2.5.1           Prometheus acknowledges its receipt prior to the Effective Date of copies of the Max Planck Agreement, Rockefeller Agreement, THM Agreement and JHU Agreement.  Prometheus agrees to accept and comply, and to ensure that its Sublicensees and any Affiliates that receive the benefits of the Licenses accept and comply, with the following:
 
(a)           Sections 3.2, 4.2, 4.3, 4.5, 4.6, 5.5 and 8 of the Max Planck Agreement.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(b)           All terms and conditions of the Rockefeller Agreement except for Rosetta’s payment and reporting obligations.
 
(c)           Article 8 of the THM Agreement.
 
(d)           Prometheus agrees that neither it nor its Affiliates or Sublicensees shall have any claims and/or demands of whatever type and nature against THM or its Affiliates, including in the event of termination of the THM Agreement by THM according to its terms.
 
(e)           Prometheus acknowledges and accepts that, subject to the direct license to be provided by THM to Prometheus pursuant to that certain letter agreement to be executed by Rosetta, THM and Prometheus on or before the Closing, the sublicense of THM’s rights under Sections 2.1.1 and 2.1.2 hereof shall expire automatically upon the termination of the THM Agreement for any reason, provided that, THM’s termination of such sublicense license shall in no way affect any Co-Exclusive rights Prometheus may have obtained or obtain in the future by virtue of Rosetta’s joint ownership to inventions which were developed under the THM Agreement.
 
2.5.2           In the event that the Committee determines by a unanimous, formal decision documented in writing that any microRNAs that are subject to the JHU Agreement will be included in the Second Generation Mets Test (which determination shall automatically result in the JHU Agreement becoming an Upstream License Agreement hereunder), the following terms and conditions shall apply ( mutatis mutandis ) effective as of the date of such determination:
 
(a)           The terms and conditions of the JHU Agreement are hereby incorporated by reference, including the terms and conditions reproduced in Annex G to this Agreement.
 
(b)           JHU and Howard Hughes Medical Institute (“ HHMI ”) shall be deemed to be third party beneficiaries of the obligations of Prometheus hereunder without imposition of obligation or liability on the part of JHU, HHMI or their Inventors (as defined in the JHU Agreement) to Prometheus.
 
Prior to a final determination by the Committee that any microRNAs that are subject to the JHU Agreement will be included in the Second Generation Mets Test, Rosetta shall use Commercially Reasonable Efforts to procure JHU’s consent to an amendment to the JHU Agreement that (at a minimum) expressly relieves Prometheus and its Affiliates of any obligation with respect to Rosetta’s payment and reporting obligations under the JHU Agreement that might otherwise be deemed to apply to Prometheus or its Affiliates as a consequence of Section 2.5.2(a).
 
2.6            After-acquired Rights .  In order for an Upstream License Agreement entered into by Rosetta after the Effective Date to be deemed to be Controlled by Rosetta, Prometheus also must first accept in writing any obligations thereunder that are required by the Upstream Licensor to be imposed upon sublicensees (other than Rosetta’s own payment and reporting obligations) as a condition of the grant of a sublicense thereunder.   Rosetta will use Commercially Reasonable Efforts to avoid the inclusion in an Upstream License Agreement entered into after the Effective Date of any term or condition that would require Prometheus or its Affiliates to make payments or supply reports directly to the Upstream Licensor.  Notwithstanding the foregoing, any technology covered by the rights licensed to Rosetta under such future Upstream License Agreements shall only be incorporated into the Licensed Products in accordance with Section 3.3.1 and the sections cross referenced therein.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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3.
DEVELOPMENT AND COMMERCIALIZATION MATTERS
 
3.1            Development Oversight Committee
 
3.1.1            General .  To facilitate communication between the Parties with respect to the development of the Licensed Products in the Prometheus Territory, each Party will assign three (3) of its employees to serve as regular members of the Development Oversight Committee (the “ Committee ”).  Each Party may replace its Committee representatives at any time upon prior written notice to the other Party.  Prometheus shall have the right to designate the chairperson of the Committee.  Each Party shall designate one of its three (3) Committee representatives as the alliance manager (the “ Alliance Manager ”) for such Party.  Each Alliance Manager shall be responsible for assuring that his or her company is meeting the operating obligations of this Agreement and for monitoring the overall performance of the operating relationship.
 
3.1.2            Meetings .  Unless otherwise agreed between the Parties, the Committee shall meet in person or via teleconference or video link at least quarterly, on such dates and at such times and places as agreed to by the Committee representatives.  Each Party’s advisors may be permitted to attend meetings of the Committee as the Committee determines, subject to such advisors agreeing to keep confidential the subject matter of, and any confidential information disclosed by the other Party at, such meeting.  Each Party shall be responsible for its own expenses for participating in the Committee.  Meetings of the Committee shall be effective only if at least one (1) representative of each Party is present or participating.  The Committee chairperson shall be responsible for (a) preparing and circulating an agenda for each meeting at a reasonable time prior to the meeting (which agenda shall include any item considered important by either Party), and (b) appointing a secretary for such meeting from one of the attendees of such meeting who shall be responsible for the preparation and circulation of minutes of the meeting within a reasonable time of its conclusion.
 
3.1.3            Responsibilities .  The Committee shall have the responsibility and authority to:
 
(a)           Advise on the development and any Regulatory Approvals of the Licensed Products in the Prometheus Territory;
 
(b)           Review any proposed amendments or updates to the Development Plan, subject to Section 3.1.4;
 
(c)           Allocate between the Parties responsibility for activities and completion dates under the Development Plan;
 
(d)           Monitor the development of the Licensed Products in the Prometheus Territory against the Development Plan;
 
(e)           Discuss and make decisions regarding the findings of the Clinical Development Subcommittee and the Validation Subcommittee relating to clinical development and validation of the Licensed Products;
 
(f)           Subject to any confidentiality obligations that Rosetta may have to any Third Party, discuss and advise upon all development, regulatory and commercialization activities outside the Prometheus Territory which may have an impact on the Exploitation of the Licensed Products inside the Prometheus Territory;
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(g)           Discuss and consider any Improvements to any Licensed Products (including the Mets Software);
 
(h)           Determine whether any microRNAs that are subject to the JHU Agreement will be included in the Second Generation Mets Test; and
 
(i)           Perform such other functions as the Parties may agree in writing.
 
3.1.4            Decision Making .
 
(a)           The Parties shall have joint decision making authority with respect to all matters pertaining to the development of the Licensed Products inside the Prometheus Territory that would affect the Licensed Products outside the Prometheus Territory, which Prometheus acknowledges could potentially include certain regulatory matters and changes to the Development Plan.  Except as set forth in the preceding sentence or in Sections 4.4.2 or 5, as between the Parties, Prometheus shall retain final decision-making authority with respect to all matters pertaining to the Licensed Products inside the Prometheus Territory, including development, regulatory and commercialization strategy and changes to the Development Plan.  For clarification purposes, the Parties agree that the Development Plan shall be modified as necessary from time to time to include all activities and deliverables by each of the Parties necessary to adequately meet the requirements for obtaining any necessary Regulatory Approvals in the Prometheus Territory, provided that Prometheus shall (i) keep the Committee reasonably informed with respect to Prometheus’ regulatory strategy related to the Licensed Products inside the Prometheus Territory and otherwise keep the Committee reasonably involved through good faith discussions with respect to such activities, (ii) provide Rosetta with copies of any relevant written or otherwise material correspondence received by Prometheus from and to be provided by Prometheus to, Regulatory Authorities inside the Prometheus Territory concerning the Licensed Products, and (iii) consider in good faith all reasonable suggestions and comments provided by the Committee with respect to Prometheus’ correspondence and other communications with Regulatory Authorities inside the Prometheus Territory, and (iv) use Commercially Reasonable Efforts to allow the Committee reasonable advance opportunity to comment on initial submissions by Prometheus and subsequent amendments by Prometheus with respect to the Regulatory Approvals inside the Prometheus Territory.  Notwithstanding the foregoing, in order to ensure timely progress with respect to Regulatory Approvals, Rosetta’ members of the Committee shall provide any suggestions and comments with respect to the subject matter of subsections 3.1.4(a)(iii) and (iv) within fifteen (15) business days after receipt of the relevant correspondence, communication, initial submission or amendment, failing which Prometheus shall be relieved of its obligations thereunder to consider Rosetta’s suggestions and comments solely with respect to that item.
 
(b)           The Parties shall have joint decision making authority with respect to all matters pertaining to the development of the Licensed Products by Rosetta outside the Prometheus Territory that would affect the Licensed Products inside the Prometheus Territory, which Rosetta acknowledges could potentially include certain regulatory matters and development matters.  Except as set forth in the preceding sentence or in Section 5, as between the Parties, Rosetta shall retain final decision-making authority with respect to all matters pertaining to the Licensed Products outside the Prometheus Territory, including development, regulatory and commercialization strategy; provided that Rosetta shall (i) keep the Committee reasonably informed with respect to Rosetta’s (and its other licensees to the extent Rosetta has obtained similar rights from such other licensees) regulatory strategy related to the Licensed Products outside the Prometheus Territory and otherwise keep the Committee reasonably involved through good faith discussions with respect to such activities, (ii) provide Prometheus with copies of any relevant written or otherwise material correspondence received by Rosetta (and its other licensees to the extent Rosetta has obtained similar rights from such other licensees) from and to be provided by Rosetta to, Regulatory Authorities outside the Prometheus Territory concerning the Licensed Products, and (iii) consider in good faith all reasonable suggestions and comments provided by the Committee with respect to Rosetta’s (and its other licensees to the extent Rosetta has obtained similar rights from such other licensees) correspondence and other communications with Regulatory Authorities outside the Prometheus Territory, and (iv) use Commercially Reasonable Efforts to allow the Committee reasonable advance opportunity to comment on initial submissions by Rosetta and subsequent amendments by Rosetta (and, in each case, its other licensees to the extent Rosetta has obtained similar rights from such other licensees) with respect to the Regulatory Approvals outside the Prometheus Territory.  Notwithstanding the foregoing, in order to ensure timely progress with respect to Regulatory Approvals, Prometheus’ members of the Committee shall provide any suggestions and comments with respect to the subject matter of subsections 3.1.4(b)(iii) and (iv) within fifteen (15) business days after receipt of the relevant correspondence, communication, initial submission or amendment, failing which Rosetta shall be relieved of its obligations thereunder to consider Prometheus’ suggestions and comments solely with respect to that item.  Rosetta shall use Commercially Reasonable Efforts to include similar provisions as those set forth in (i) through (iv) above in its license agreements with third parties.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(c)           The Parties acknowledge and agree that any changes to the Development Plan or the allocation of the work thereunder that increase a Party’s costs under the applicable project budget by more than the [***] shall be outside the authority of the Committee and escalated for discussion and approval to an executive officer of each Party, or their delegate, in accordance with the Party’s respective internal budgetary approvals processes.
 
3.1.5            Clinical Development Subcommittee .  The Committee shall form a subcommittee which shall have primary responsibility for considering, investigating and reporting to the Committee on all matters related to the clinical development of the Licensed Products (the “ Clinical Development Subcommittee ”).  The Clinical Development Subcommittee shall be comprised of two (2) representatives of each Party, and unless otherwise agreed by the Committee, the Clinical Development Subcommittee shall meet in person or via teleconference or video link at least monthly, on such dates and at such times and places as agreed to by the Clinical Development Subcommittee representatives.  The Clinical Development Subcommittee shall not have any final or binding decision-making authority, but rather shall be responsible for investigating matters associated with the clinical development of the Licensed Products and reporting to the Committee so as to enable the Committee to make decisions on such clinical development matters in accordance with Section 3.1.4
 
3.1.6            Validation Subcommittee .  The Committee shall form a subcommittee which shall have primary responsibility for considering, investigating and reporting to the Committee on all matters related to the validation of the Second Generation Mets Test, the IBS Test and the IBD Test (the “ Validation Subcommittee ”).  The Validation Subcommittee shall be comprised of two (2) representatives of each Party, and unless otherwise agreed by the Committee, the Validation Subcommittee shall meet in person or via teleconference or video link at least monthly, on such dates and at such times and places as agreed to by the Validation Subcommittee representatives.  The Validation Subcommittee shall not have any final or binding decision-making authority, but rather shall be responsible for investigating matters associated with the validation of the Second Generation Mets Test and reporting to the Committee so as to enable the Committee to make decisions on such validation matters in accordance with Section 3.1.4.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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3.2            Development Program .
 
3.2.1            Development Program .  Within one hundred twenty (120) days of the Effective Date, the Parties shall commence a development and feasibility assessment program for the purposes of:
 
(a)           developing the Licensed Products for use with microarray technology as an alternative to Real-time PCR Technology;
 
(b)           obtaining Regulatory Approval for the Mets Test; and
 
(c)           designing, developing, testing, refining, and obtaining Regulatory Approval for each of the IBD Test, the IBS Test and the Second Generation Mets Test (collectively, the “ Development Program ”).
 
3.2.2            Development Plan .  As soon as reasonably practicable following the Effective Date, the Committee shall agree upon a development plan to carry out and complete the Development Program which shall be substantially in the form set forth in Annex B , as may be amended by agreement of the Parties from time to time (the “ Development Plan ”), acting reasonably.  The Development Plan shall include Rosetta’s good-faith estimate of the time and actual costs required to conduct the Development Program (the “ Budget ”).
 
3.2.3            Responsibility .  Subject to oversight by the Committee and in accordance with the Development Plan, Rosetta shall assume primary responsibility for the validation of the Licensed Products in the Prometheus Territory in accordance with the Development Plan.
 
3.2.4            Development Expenses .
 
(a)           Prometheus shall contribute, subject to the offsetting provided in Section 3.2.4(c), up to a maximum of [***] US dollars [***] to the Development Fund, which amount shall be paid in accordance with the Budget (the “ Prometheus Development Contribution ”).  The Prometheus Development Contribution shall be comprised of an initial payment of [***] US dollars [***], which Prometheus has committed to pay at the commencement of the Development Program to support transition of the Licensed Products from a Real-Time PCR Technology-based platform to a microarray platform, and up to [***] additional payments of [***] US dollars [***], subject to attainment of certain development milestones to be mutually agreed upon by the Parties and set forth in the Development Plan . In addition,

(i)           if an FDA Clearance is required in order for Rosetta to perform the Services with respect to a Licensed Product, and Rosetta requires the benefit of such FDA Clearance for its activities with respect to such Licensed Product in the Prometheus Territory as permitted hereunder, Rosetta shall so notify Prometheus in writing and the Parties shall share the costs of obtaining such FDA Clearance.
 
(ii)           if an FDA Clearance is required in order for Rosetta to perform the Services with respect to a Licensed Product, but Rosetta does not require the benefit of such FDA Clearance for its activities with respect to such Licensed Product in the Prometheus Territory as permitted hereunder, Rosetta shall so notify Prometheus in writing and Rosetta shall obtain such FDA Clearance on Prometheus’ behalf, provided that Prometheus shall reimburse Rosetta for all of Rosetta’s reasonable costs of obtaining such FDA Clearance at such time as the FDA Clearance is transferred to Prometheus;
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(iii)           if an FDA Clearance is not required in order for Rosetta to perform the Services with respect to a Licensed Product, but Rosetta nonetheless requires the benefit of such FDA Clearance for its own activities with respect to such Licensed Product in the Prometheus Territory as permitted hereunder, Rosetta shall bear [***] of the costs of obtaining such FDA Clearance;
 
(iv)           if an FDA Clearance is required for a Licensed Product in order to transfer such Licensed Product to a laboratory owned or operated by Prometheus, Rosetta shall bear [***] of the costs of obtaining such FDA Clearance up to a maximum of [***] US dollars [***] and any costs in excess of that amount shall be borne solely by Prometheus; and/or
 
(v)           if an FDA Clearance is required for a Licensed Product during any period in which Prometheus is performing Diagnostic Tests in laboratories owned or operated by Prometheus, Prometheus shall bear [***] of the costs of obtaining such FDA Clearance.
 
Each Party shall work together to minimize the costs and expenses of the other Party when such other Party is seeking to obtain FDA Clearance (including, without limitation, by taking advantage of and sharing any applicable existing data, documents and/or reports which such Party may have in its possession and is necessary or useful in order to receive FDA Clearance).  Each Party shall bear the cost of any CLIA certifications or approvals or other state or local Regulatory Approvals required for the operation of its own laboratories.  With respect to any other Regulatory Filings and/or Regulatory Approvals not expressly addressed in this Section 3.2.4(a) that are required to be submitted or obtained by either Party, the Party in whose name such Regulatory Approvals are to be submitted and obtained shall bear all costs and expenses associated therewith, unless otherwise agreed by the Parties pursuant to the applicable Development Plan.  Prometheus shall be responsible for obtaining, at its expense, all samples required for the research and development of the IBS Test and IBD Test. Except as expressly provided herein or in the Development Plan, all other additional costs and expenses required to conduct the Development Plan shall be borne solely by Rosetta, provided that Rosetta shall receive compensation, in the form of an increase to the Royalty, equal to [***] of Prometheus’ net savings in cost of goods resulting from developing the Licensed Products with an alternative technology to Real-Time PCR Technology. By way of example only, if Prometheus’ net costs to utilize Real-Time PCR Technology are equal to [***] of Net Sales (including but not limited to Prometheus’ direct cost of goods and any amounts which Prometheus or Rosetta is required to pay to a Third Party in royalties or other consideration), and through the success of the Development Plan, a Diagnostic Test no longer relies on Real-Time PCR Technology, such that Prometheus’ net costs are reduced to [***], then the Royalty due to Rosetta shall be increased from the Royalty stated in Section 4.3.1 by [***].  For the avoidance of doubt, unless otherwise agreed in writing by the Parties, the costs of any freedom to operate opinions desired after the Effective Date are outside the scope of the Development Program and shall not be payable from the Development Fund.
 
(b)           In addition, Prometheus shall contribute to the Development Fund, subject to the offsetting provided in Section 3.2.4(c), up to an additional [***] US dollars [***] in funding for the development and validation of the Licensed Products over a [***] period following the Effective Date (of which up to [***] US dollars [***] may be used to develop the Second Generation Mets Test) to the extent that such additional development and validation work is deemed to be required by the Committee.  The Parties acknowledge and agree that, as of the Effective Date, Annex E sets forth the good-faith pre-estimate of the Parties regarding the amount of additional funding required to conduct the further development and validation of the Licensed Products described in Annex E .
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(c)           Rosetta shall contribute to the Development Fund [***] (such contribution to be made no later than five (5) business days after receiving [***] from Prometheus) up to an initial maximum of [***] US dollars [***], and up to a total maximum of [***] US dollars [***] if the Committee determines that the amounts contributable by Prometheus pursuant to Section 3.2.4(b) should be contributed.  Prometheus shall be entitled to reduce its contributions to the Development Fund under Sections 3.2.4(a) and (b) by [***] contributed to the Development Fund.
 
3.2.5            Development Program Payments.
 
(a)           In partial consideration of the development and validation of the Mets Test and Second Generation Mets Test, Prometheus (or a designated Affiliate) shall pay to Rosetta:
 
(i)           a one-time payment of [***] US dollars [***] upon the publication of clinical utility data from a clinical utility study ( i.e. the MD Anderson study) supporting the current product profile related to the Mets Test or the Second Generation Mets Test in a scientific peer-reviewed journal that is recognized by the scientific community in the Prometheus Territory as reputable.  Notwithstanding the foregoing, if the clinical utility data is not submitted by Rosetta for publication on or prior to [***], then the aforementioned payment shall be reduced to [***].
 
(ii)           a one-time payment of [***] US dollars [***] upon the publication of a pharmacoeconomics study supporting the current product profile related to the Mets Test or the Second Generation Mets Test in a scientific peer-reviewed journal that is recognized by the scientific community in the Prometheus Territory as reputable.
 
(b)           In partial consideration of the development and validation of the IBS Test and IBD Test, Prometheus (or a designated Affiliate) shall pay to Rosetta a one-time payment of [***] US dollars [***] upon the achievement of the preferred product profile for the IBS Test and a one-time payment of [***] US dollars [***] upon the achievement of the preferred product profile for the IBD Test.   The preferred profile for each of the IBS Test and the IBD Test shall be defined in advance by the Committee and documented in the Development Plan prior to Rosetta’s commencement of development work relating thereto.  In addition, Prometheus (or a designated Affiliate) shall pay to Rosetta a one-time payment of [***] US dollars [***] if the preferred product profile for the IBS Test is achieved by the target date defined in advance by the Committee and documented in the Development Plan.
 
3.2.6            Diligence Obligations .
 
(a)           The Parties shall use Commercially Reasonable Efforts to adequately and timely comply with, execute and complete the tasks set forth in the Development Plan and in accordance with the Budget. Rosetta shall consider any comments provided by Prometheus through the Committee with respect to such development activities, including the submission of Regulatory Filings.
 
(b)           If, during the Term, Prometheus notifies the Committee that any other Regulatory Approval is required for any Licensed Product anywhere in the Prometheus Territory, then the Parties shall use Commercially Reasonable Efforts to obtain Regulatory Approval for such Licensed Product with the applicable Regulatory Authority in the Prometheus Territory.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(c)           The term “ Commercially Reasonable Efforts ” shall mean that level of effort as is customary in the laboratory services industry for carrying out in a reasonably sustained manner a particular task or obligation to develop and commercialize diagnostic products in the United States, taking into consideration the market potential, regulatory pathways and cost of development in the United States.  Notwithstanding the foregoing, a Party’s achievement, by itself or through its Affiliates or Sublicensees, of any diligence milestone set forth in the Development Plan by the date set forth therein shall be deemed sufficient to satisfy the requirement to use Commercially Reasonable Efforts under this Section 3.2 as of such date provided all previous diligence milestones set forth in the Development Plan have also been satisfied or waived in writing by that date, but the failure to do so shall not, in and of itself, be deemed a failure to satisfy the requirement of Commercially Reasonable Efforts.
 
3.3            Improvements .
 
3.3.1            Rosetta Improvements .  From time to time during the Term, Rosetta or its Affiliates or its licensees outside the Prometheus Territory may independently develop or otherwise acquire Improvements to one or more Licensed Products for use in the Field over which Rosetta obtains ownership or Control (a “ Rosetta Improvement ”).  In such case, Rosetta shall promptly present to Prometheus any such Rosetta Improvement for potential inclusion in the Licensed Products.  Prometheus shall consider such proposal in good faith (including making the appropriate personnel of Prometheus available to discuss any such proposal with Rosetta); provided that Prometheus shall solely control and retain final decision-making authority with respect to incorporating any such Rosetta Improvements into the Licensed Products.  Prometheus shall notify Rosetta of its decision to include or exclude such Rosetta Improvement in a signed writing.  To the extent Rosetta owns or Controls any Patents with Valid Claims covering the subject matter of a Rosetta Improvement and such Rosetta Improvement is incorporated by Prometheus into the Licensed Products during the Term, such Patents shall be deemed Licensed Patents and added to Annex A and as such shall be licensed to Prometheus according to the License in Section 2.1 subject to all terms and conditions hereunder applicable to Licensed Patents including those set forth in Article 5, and the Term shall be extended accordingly.  Any incremental costs in sublicensing to Prometheus Rosetta Improvements which were licensed by Rosetta pursuant to an Upstream License shall be borne by the parties consistent with the terms of Section 4.4.1(a).  In connection with the foregoing, when Rosetta enters into any agreement or other arrangement with a Third Party, an Affiliate or a licensee that may result in the development, creation or acquisition by Rosetta, its Affiliates or licensees of any Improvements relating to the Licensed Products for use in the Field, Rosetta will use Commercially Reasonable Efforts not to limit or otherwise restrict Rosetta’s ability to grant a license or sublicense to any such Improvements as provided for herein without violating the terms of any such agreement or other arrangement and shall use Commercially Reasonable Efforts to minimize any sublicense fees or pass through royalties which will be owed to the Upstream Licensor thereunder.
 
3.3.2            Ownership of Improvements .   The Parties acknowledge that Prometheus and Rosetta have collaborated and intend to continue to collaborate in the development of Licensed Products, and that such collaboration may generate Improvements whether or not patentable.   In order to permit and encourage a successful collaboration and protect the key business interests of both Parties, the Parties agree that, as between the Parties, ownership of any Improvements to Licensed Products arising from the development of the Licensed Products in the Prometheus Territory made by one or both of the Parties shall be determined in accordance with United States laws of inventorship. To the extent any Improvements are deemed by applicable Law to be jointly owned by the Parties (“ Joint Improvements ”), then notwithstanding any rights of the Parties under the United States laws of inventorship, and notwithstanding any rights of the Parties under laws of any jurisdiction regarding the use or licensing of jointly owned Patents, Prometheus shall have the royalty-free sole and exclusive right (even as against Rosetta and its Affiliates) to Exploit and license such Joint Improvements for Licensed Products inside the Prometheus Territory during the Term and Rosetta shall have the royalty-free sole and exclusive right (even as against Prometheus and its Affiliates) to Exploit and license such Joint Improvements for Licensed Products outside the Prometheus Territory during the Term, provided that Rosetta shall retain the right to Exploit such Joint Improvements inside the Prometheus Territory for the purposes set forth in Section 2.1.7.   For the avoidance of doubt, either Party shall remain free to Exploit and license such Joint Improvements anywhere in the world in connection with products and services other than the Licensed Products.  Notwithstanding this Section 3.3.2 (but subject to Section 9), as between the Parties:
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(a)           Prometheus shall exclusively own: (i) all data generated by or on behalf of Prometheus in connection with Licensed Products, except as set forth in Section 3.3.2(c); (ii) any and all Regulatory Approvals filed or awarded (y) in any jurisdiction in the Prometheus Territory related to the Licensed Products, all of which shall be filed by Rosetta for and on behalf of Prometheus in Prometheus’ name, and (z) in any jurisdiction inside the Prometheus Territory related to Prometheus’ laboratory facilities; (iii) any Prometheus Confidential Information; and (iv) as between the Parties, the Prometheus Product Improvements.   Rosetta shall have a non-exclusive right of reference to the Regulatory Approvals for use outside the Prometheus Territory for any products and services, and inside the Prometheus Territory for products and services that are not Licensed Products.
 
(b)           Rosetta shall exclusively own: (i) all data generated by or on behalf of Rosetta in connection with the Licensed Products, except as set forth in Section 3.3.2(c); (ii) any and all Regulatory Approvals filed or awarded (y) in any jurisdiction outside the Prometheus Territory related to the Licensed Products, or (z) in any jurisdiction inside the Prometheus Territory related to Rosetta’s laboratory facilities; (iii) any Rosetta Confidential Information; and (iv) as between the Parties, the Rosetta Improvements.  Prometheus shall have a non-exclusive right to use all data generated by Rosetta on behalf of itself, its other licensees (to the extent permitted) and Prometheus in connection with the Licensed Products and a right of reference to the Regulatory Approvals for use inside the Prometheus Territory in connection with the Licensed Products.
 
(c)           Data relating to the Mets Test or the Second Generation Mets Test that is generated by either Party under the Development Program will be jointly owned by the Parties.  Data relating to the IBS Test or the IBD Test that is generated by either Party under the Development Program will be solely owned by Prometheus.
 
3.3.3            Prometheus Product Improvements .  Prometheus agrees that any research or development activities that it wishes to pursue using the Licensed Intellectual Property shall be brought to the attention of the Committee and, subject to the approval of the Committee, shall be pursued solely through the Development Program.   Nevertheless, if during the Term Prometheus or its Affiliates or its Sublicensees independently develop or otherwise acquire Improvements (other than a Platform Improvement, which shall be subject to Section 3.3.4) to one or more Licensed Products for use in the Field over which Prometheus obtains ownership or Control (a “ Prometheus Product Improvement ”) this Section 3.3.3 shall apply.  In such case, Prometheus shall promptly after any decision to incorporate such Prometheus Product Improvement into a Licensed Product inside the Prometheus Territory present to Rosetta any such Prometheus Product Improvement for potential inclusion in the Licensed Products outside the Prometheus Territory.  Rosetta shall consider such proposal in good faith (including making the appropriate personnel of Rosetta available to discuss any such proposal with Prometheus); provided that Rosetta and its licensees shall solely control and retain final decision-making authority with respect to incorporating any such Prometheus Product Improvements into the Licensed Products outside the Prometheus Territory.  To the extent Prometheus owns or Controls any Patents with Valid Claims covering the subject matter of a Prometheus Product Improvement and such Prometheus Product Improvement is incorporated by Rosetta or its licensees into the Licensed Products outside the Prometheus Territory during the Term, such Patents shall be licensed to Rosetta (with the right to sublicense to the extent permitted by any applicable Third Party license agreement) on a royalty-free basis (other than amounts due to any Third Party that has licensed such Prometheus Product Improvement to Prometheus, to the extent that such amounts are due to Prometheus’ grant of a sublicense to Rosetta, and the payment by Rosetta of [***] of all of Prometheus’s development costs incurred in connection with the applicable licensed Prometheus Product Improvements and [***] of all patent prosecution and maintenance expenses (including attorney fees) for such Patents outside of the Prometheus Territory, provided that Rosetta shall only be entitled to grant sublicensees to its licensees that  have granted a reciprocal license option to Prometheus under such licensee’s Improvements to Licensed Products, which, for clarity, may include development cost reimbursement and patent prosecution contributions substantially similar to the foregoing.  In connection with the foregoing, when Prometheus enters into any agreement or other arrangement with a Third Party, an Affiliate or a Sublicensee that may result in the development, creation or acquisition by Prometheus, its Affiliates or licensees of any Prometheus Product Improvements for use in the Field, Prometheus will use Commercially Reasonable Efforts not to limit or otherwise restrict Prometheus’s ability to grant a license or sublicense to any such Prometheus Product Improvements as provided for herein without violating the terms of any such agreement or other arrangement and shall use Commercially Reasonable Efforts to minimize any sublicense fees or pass through royalties which will be owed to the licensor thereunder.  Notwithstanding anything to the contrary herein, if a Prometheus Product Improvement Patent has been licensed by Prometheus from a Third Party, then neither Rosetta nor any of its sublicensees shall receive a license under such Prometheus Product Improvement Patent unless and until Rosetta and its sublicensees, as applicable, have agreed in writing to be bound by any and all applicable restrictions set forth in the license agreement between Prometheus and such Third Party and a copy of such agreement to be bound has been provided to Prometheus.  Any breach by a sublicensee of any of the applicable obligations under such Third Party license agreement shall be deemed to be a breach by Rosetta of this Agreement.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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3.3.4            Prometheus Platform Improvements .  Prometheus shall notify Rosetta in writing of any Platform Improvements conceived and reduced to practice by Prometheus and/or its Affiliates promptly upon Prometheus’ senior management or patent counsel being notified of the same.  Rosetta shall solely own all intellectual property rights in and to the Platform Improvements developed by Prometheus and/or its Affiliates.  Prometheus, on behalf of itself and its Affiliates, hereby makes all assignments, and agrees to execute, at Rosetta’s costs and expense, all documents, necessary to perfect Rosetta’s ownership of such intellectual property rights as set forth in the preceding sentence.  Prometheus shall have the right to elect to include such Platform Improvements in the Licensed Products.  To the extent Rosetta owns or Controls any Patents with Valid Claims covering the subject matter of a Platform Improvement and such Platform Improvement is incorporated by Prometheus into the Licensed Products during the Term, such Patents shall be deemed Licensed Patents and added to Annex A and as such shall be licensed to Prometheus on according to the License in Section 2.1 subject to all terms and conditions hereunder applicable to Licensed Patents including those set forth in Article 5, and the Term shall be extended accordingly, provided that if such Patents constitute the only Licensed Patent for which there is a Valid Claim covering the Licensed Product the royalty set forth in 4.3.1 shall be reduced by [***].
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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3.4            Commercialization .
 
3.4.1            Control .  Prometheus shall solely control and assume all responsibility, at its own cost, for conducting all commercialization activities within the Prometheus Territory relating to the Licensed Products, including marketing, promotion, sales detailing and any other activities relating to the Exploitation of the Licensed Products or Sublicense of rights to perform Diagnostic Tests for Prometheus.  Notwithstanding the foregoing, Rosetta shall have the right to participate separately (or if the Parties mutually desire, with Prometheus) in industry conferences, industry exhibitions and industry events within the Prometheus Territory for purposes of promoting the Licensed Products outside of the Prometheus Territory.
 
3.4.2            Marketing Plans .  Each Party may, in its sole discretion, share marketing plans and materials with the other Party with the object of coordinating a world-wide marketing effort to maximize the commercial potential of the Licensed Products.
 
3.4.3            Diligence Obligations .  Prometheus shall use Commercially Reasonable Efforts to commercialize each of the Licensed Products in the Prometheus Territory during the Term, provided that neither Prometheus’ failure to reach any particular sales level by any particular time, nor Prometheus’ failure to market or continue to market any Licensed Product(s) due to any Potential Blocking Patents, shall, in and of itself, be deemed a failure to satisfy the requirement of Commercially Reasonable Efforts.
 
3.4.4            Regulatory Action Letters .  The Parties shall promptly notify each other in writing of the receipt of any action letters from any Regulatory Authority in connection with quality or other issues concerning the Licensed Products.  Within a reasonable time frame prior to submission of responses to any Regulatory Authority on such quality or other issues concerning the Licensed Products, a copy of a near final draft response will be provided to the other Party for review.  Final copies of responses submitted to any Regulatory Authority will be provided to the other Party within two (2) weeks of submission.  Furthermore, Prometheus shall promptly notify Rosetta in writing of any complaints received by Prometheus regarding any Licensed Product, including the performance of any Diagnostic Test or the results thereof, in the Prometheus Territory.
 
3.5            Patent Marking .  Subject to applicable laws and regulations, labeling on all Licensed Products sold by or on behalf of Prometheus or its Affiliates pursuant to this Agreement and on all product literature will (a) identify Rosetta as licensor of the Licensed Patents where required by applicable Law, (b) display any specific patent and patent application numbers as identified by Rosetta, and (c) comply with all patent marking requirements as specified in 35 U.S.C. § 287.
 
4.
PAYMENTS
 
4.1            Up-Front Equity .  In partial consideration of the License granted hereunder and upon the terms and subject to the conditions set forth in that certain Stock Purchase Agreement entered into between the Parties concurrently with this Agreement, Rosetta shall sell, convey, assign and deliver to Prometheus, and Prometheus shall purchase and accept from Rosetta, two million (2,000,000) ordinary shares at a price of four US dollars ($4.00) per share for the aggregate purchase price of eight million US dollars ($8,000,000) (the “ Up-Front Stock Issuance ”).
 
4.2            Milestone Payments .
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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4.2.1            Commercial Milestone Payments .  In partial consideration of the License granted hereunder and subject to the terms and conditions stated herein, Prometheus (or a designated Affiliate) shall make the following one-time payments to Rosetta subject to the occurrence of the corresponding milestone events specified below.  Such payments shall be allocated at the time of payment among the Diagnostic Tests according to the proportion of total Net Sales attributable to each Diagnostic Test for the period to which the milestone payment relates.
 
(a)   Cumulative Net Sales during the Term of [***]
[***] US dollars [***]
(b)   First calendar year during the Term in which annual Net Sales exceed [***]
[***] US dollars [***]
 
Such milestone payments shall be paid by Prometheus, or its designated Affiliate within thirty (30) days after the occurrence of the applicable milestone event set forth above.  Notwithstanding anything to the contrary in this Agreement, only one (1) milestone payment due pursuant to this Section 4.2.1 shall be payable in any single calendar year during the Term. In the event that two (2) or more milestone payments become due to Rosetta in any single calendar year during the Term pursuant to this Section 4.2.1, the first milestone payment shall be due and payable by Prometheus as set forth herein, and the payment date for any subsequent milestone payments accrued during the applicable calendar year shall be automatically delayed until the date that is thirty (30) days after the last day of the calendar year in which the immediately preceding accrued milestone payment has been paid.
 
4.3            Royalty .
 
4.3.1           In partial consideration of the License granted hereunder and subject to the terms and conditions stated herein, until the expiration of the Term, Prometheus shall pay to Rosetta a royalty (“ Royalty ”) on Net Sales by Prometheus, its Affiliates and Sublicensees at the royalty rate, in each case subject to the permitted reductions set forth in Section 4.4, of:
 
(a)           [***] on annual Net Sales of all Licensed Products within the Prometheus Territory other than the IBS Test and the IBD Test; and
 
(b)           [***] on annual Net Sales of the IBS Test and the IBD Test.
 
4.3.2           The annual Net Sales set forth above shall be measured from the beginning of each calendar year.  Royalties payable under this Section 4.3 will be payable only once with respect to a particular Licensed Product, regardless of the number of Licensed Patents, if any, with claims covering a Licensed Product.
 
4.4            Permitted Reductions .
 
4.4.1            License of Third Party Intellectual Property .
 
(a)           As between the Parties, Prometheus shall be responsible for obtaining all necessary licenses for any Commercial Technology Platform used in connection with the Exploitation of Licensed Products.  However, if Rosetta is required to obtain a license under any Commercial Technology Platform which is necessary to perform the Services, Rosetta (and, unless otherwise also required, not Prometheus) shall be responsible for obtaining such license during the period in which Rosetta is providing the Services.  Prometheus shall be responsible for paying directly to Third Parties, or increasing its Royalty payments to Rosetta (if and to the extent Rosetta is required to make payments directly to a Third Party), any amounts due from Rosetta or Prometheus to any Third Parties under any Commercial Technology Platform license agreements or due from Prometheus or Rosetta under any Upstream License Agreements, but solely to the extent, in each case, such amounts due arise directly from the performance of the Services on Prometheus’ behalf or Prometheus’, its Affiliates’ and/or its Sublicensees’ Exploitation of the Products in the Prometheus Territory, and in each case, solely up to a maximum aggregate amount of the Third Party Royalty Cap.  To the extent such amounts due exceed the Third Party Royalty Cap, the excess costs shall be borne by and timely paid by Rosetta.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(b)           Except when Prometheus has elected to proceed under Section 5.3, the Royalty during the Term may be reduced in the Prometheus Territory by [***] of any and all royalties paid by Prometheus, its Affiliates and/or Sublicensees to any Third Party (other than amounts for which Prometheus is responsible pursuant to Section 4.4.1(a) above), [***].  Prometheus shall use Commercially Reasonable Efforts to minimize any such royalties or other payments to Third Parties on account of sales of Licensed Products hereunder.  For the avoidance of doubt, no reduction shall be available with respect to a Combination Product if the actual, alleged or potential infringement that Prometheus wishes to avoid would not occur if the Licensed Product component of such Combination Product was Exploited without the other diagnostically active components, or in the case of (iii), the Third Party intellectual property rights are primarily useful or necessary for the other diagnostically active components.
 
4.4.2            Combination Products .  Prometheus shall not promote, offer for sale or sell any Licensed Product in combination with another diagnostically active product or products that are not Licensed Products (each a “ Combination Product ”) unless such Combination Product has first received the unanimous consent of the Committee, which consent shall not be unreasonably withheld.  If the sale of such a Combination Product is permitted by the Committee, the Royalty payable by Prometheus to Rosetta with respect to such Combination Product shall be reduced by an amount which is calculated based on the following formula:
 
[***]
 
[***].  The amount included in Net Sales with respect to each Combination Product for which the Licensed Products and other components, products, processes or systems contained therein do not have established, stand-alone CPT value in a particular jurisdiction in the Prometheus Territory, shall be based on the actual price of such items when sold separately or the relative fair market value of each if not sold separately or, if none of the foregoing can be reasonably determined, based on the relative cost of goods (determined according to GAAP).  Any disagreement between the parties regarding the value for any aspect of a Combination Product shall be determined by the parties through good faith negotiations.
 
4.5             Payment and Reports .  Within forty-five (45) days after the final calendar quarter of each year during the Term, and within thirty (30) days after the end of each other calendar quarter during the Term (each such quarter, a “ Royalty Reporting Quarter ”), Prometheus shall provide Rosetta with an updated written report setting forth on product-by-product basis the Net Sales during such Royalty Reporting Quarter and the calculation of the Royalty payable to Rosetta for such Net Sales pursuant to this Section 4, including the allowances for bad debt and any other any reductions to or deductions from gross sales taken by Prometheus in accordance with this Agreement.  Such report shall be accompanied by a payment equal to the total Royalty due, if any, to Rosetta pursuant to this Section 4.  All payments shall be made to Rosetta on or before the due date for each such report following the end of the Royalty Reporting Quarter in United States Dollars.  Sales made in currencies other than United States Dollars shall be converted to United States Dollars in accordance with GAAP, treating United States dollars as the reporting currency.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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4.6            Record Keeping . Prometheus shall keep, and shall cause its Affiliates and Sublicensees to keep, complete and accurate books of accounts of record in connection with the sublicensing and sale of Licensed Products to permit verification of payments made hereunder.  Such records shall be maintained for the period equal to the later of (a) three (3) years from the date on which they were generated, or (b) as required by applicable Law.
 
4.7            Audit Rights .  Rosetta shall have the right to have an independent Third Party nationally-recognized accounting firm reasonably acceptable to Prometheus access the books and records of Prometheus, its Affiliates and Sublicensees solely to the extent necessary to verify the accuracy of the reports and payments made hereunder.  Such audit shall be conducted upon at least thirty (30) days advanced written notice to Prometheus and shall commence on a date reasonably acceptable to both Parties, not to be later than one (1) calendar quarter after Rosetta’s notice.  Such audit shall only be during Prometheus’ normal business hours.  Such audit shall not be more frequent than once (1) per calendar year, may occur only with respect to the immediately preceding three (3) calendar years, may not audit less than a full calendar year, and may not be conducted more than once with respect to any particular calendar year.  The auditing party shall be required to sign a confidentiality agreement for the benefit of, and in a form reasonably acceptable to, Prometheus.  Prometheus shall be provided the opportunity to discuss any discrepancies found during such audit with the auditors prior to such auditor issuing its final report.  In addition, the auditors shall redact any confidential information disclosed in the proposed final report identified by Prometheus as confidential and not necessary for purposes of calculating the Royalty owed.  The final report shall be shared with both of the Parties and may be shared with any Upstream Licensors if its interests are affected by the findings in such report, or if the audit was performed at its request or in fulfillment of a contractual obligation of Rosetta under the applicable Upstream License Agreement, provided that the applicable Upstream Licensor must at all times agree to maintain the confidentiality of such information on terms no less restrictive than those set forth in Section 6.  If any audit discloses any underpayments by Prometheus to Rosetta, then unless contested by Prometheus within thirty (30) days after receipt of the necessary documentation of the amount owed, any underpayment shall be paid by Prometheus to Rosetta within thirty (30) days of it being so disclosed.  If any audit discloses any overpayments by Prometheus to Rosetta, then unless contested by Rosetta within thirty (30) days after receipt of the necessary documentation of the amount owed, Prometheus shall have the right to credit the amount of the overpayment against each subsequent quarterly payment due to Rosetta until the overpayment has been fully applied.  If the overpayment is not fully applied prior to the final quarterly payment of Royalties due hereunder, Rosetta shall promptly refund an amount equal to any such remaining overpayment. If Rosetta’s audit demonstrates an underpayment of more than [***] for the payment due to Rosetta during the audited period, Prometheus shall be liable for Rosetta’s reasonable cost of the audit that discovered such underpayment.  Otherwise, Rosetta shall bear the costs of such audits.  Any contested amounts shall be subject to the dispute resolution procedures set forth in Section 11.
 
4.8            Withholding Taxes .    Where required to do so by applicable Law or order of a governmental body, a Party making payments hereunder shall withhold taxes required to be paid to a taxing authority in connection with any payments to the other Party hereunder, and, upon request of the Party to which the payment is due, the paying Party shall furnish the receiving Party with satisfactory evidence of such withholding and payment.  Any amounts withheld pursuant to this Section 4.8 shall be treated as having been paid by the Party making such withholding for all purposes under this Agreement.  To the extent any payments are made hereunder without withholding (at the request of the Party which was to receive such payment), and withholding is later determined to have been required, or is assessed, by an governmental entity, the Party receiving such payments shall indemnify the other Party, including, without limitation, for any withholding tax, interest and/or penalties thereon, and any other reasonable expenses related thereto.  The Parties shall give reasonable assistance to each other in obtaining exemption from withholding taxes where available under applicable Law, or recovering the same where an exemption is not available.  
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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5.
INTELLECTUAL PROPERTY RIGHTS
 
5.1            Patent Prosecution and Maintenance; Product Technical Information .
 
5.1.1            Prosecution and Maintenance of Licensed Patents .
 
(a)           As between the Parties, Rosetta shall have the right and obligation, at its sole cost and expense (subject to Section 5.1.3), to conduct and control prosecution, maintenance, challenges against validity and unenforceability or patentability with respect to the Licensed Patents in the Prometheus Territory, or to cause its Upstream Licensors to do the same, to the extent that Rosetta has the right to do so under the applicable Upstream License Agreement (and if not Rosetta shall use Commercially Reasonable Efforts to obtain such rights pursuant to an amendment to such Upstream License Agreement).  At Rosetta’s request, Prometheus shall reasonably cooperate with and assist Rosetta in connection with such activities.
 
(b)           Rosetta shall not abandon, and, to the extent that Rosetta has the right to do so under the applicable Upstream License Agreement (and if not Rosetta shall use Commercially Reasonable Efforts to obtain such rights pursuant to an amendment to such Upstream License Agreement), shall not permit its Upstream Licensors to abandon (i) any Platform Patent in the Prometheus Territory, but only to the extent that, considering the Licensed Patents as a whole, such abandonment would materially reduce Prometheus’ ability to protect any Licensed Product from competition in the Prometheus Territory, or (ii) any of the Product Patents in the Prometheus Territory, without providing in each case reasonable prior written notice to Prometheus of such intention to surrender (which notice shall, in any event and to the extent Rosetta receives such notice from its applicable Upstream Licensor, be given no later than sixty (60) days prior to the loss of any rights in such Licensed Patent) and, to the extent permitted by any applicable Upstream License Agreement, providing Prometheus an opportunity to assume responsibility for the prosecution and maintenance of such Licensed Patent and obtain reimbursement from Rosetta for such payments in the amounts set forth in paragraph (d) below.
 
(c)           If Prometheus reasonably believes that Rosetta or its Upstream Licensor may fail to make any required payments or take any action required for the preparation, filing, prosecution, defense or maintenance of any Upstream Licensed Patent in the Prometheus Territory within a reasonable time, but solely in cases where Prometheus would have the right to assume responsibility for prosecution and maintenance pursuant to paragraph (b) above, Prometheus shall provide Rosetta with written notice of such deficiency.  If, having received such notice, Rosetta or the Upstream Licensor fails to take the required action at least five (5) business days before the deadline for taking such action, Prometheus shall have the right (but with respect to Controlled Patents, solely to the extent that Rosetta has the right to do so under the applicable Upstream License Agreement, and if not Rosetta shall use Commercially Reasonable Efforts to obtain such rights pursuant to an amendment to such Upstream License Agreement)  to thereafter make any such required payments or take any such required action and obtain reimbursement from Rosetta for such payments in the amounts set forth in paragraph (d) below
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(d)           In the event Prometheus elects to assume responsibility for any Licensed Patent in accordance with Section 5.1.1(b) or incurs any costs and expenses in accordance with Section 5.1.1(c), Rosetta shall reimburse Prometheus, within thirty (30) days after the date of a reasonably detailed invoice and back-up therefor provided by Prometheus: (i) [***] of Prometheus’ expenses associated with the prosecution and maintenance of any Platform Patents, and (ii) [***] of Prometheus’ expenses associated with the prosecution and maintenance of any Product Patents.
 
(e)           The Parties acknowledge that it is not the intention of either Party for any Platform Patent to include any method of use claim directed to the use of microRNAs for any indication that is a target of a Diagnostic Test.  In the event that an application for a Platform Patent nevertheless includes a method of use claim directed to the use of microRNAs for an indication that is a target of a Diagnostic Test, Rosetta shall promptly upon notice of the existence of such claim file a divisional application for such method of use and abandon the correlative claim in the Platform Patent application, provided that if such method of use claim is needed to preserve the viability of the Platform Patent application prior to a showing of the utility of a composition of matter therein, no such divisional or abandonment shall be required until such showing of utility is made.
 
5.1.2            Co-operation and Exchange of Information .  Except to the extent restricted by any of the Upstream License Agreements, Rosetta shall (a) use counsel reasonably acceptable to Prometheus for the prosecution and maintenance of the Product Patents in the Prometheus Territory, (b) keep Prometheus reasonably informed as to the status of any of the Licensed Intellectual Property in the Prometheus Territory, (c) consider in good faith the reasonable requests, suggestions and advice of Prometheus with respect to the prosecution, maintenance and defense of the Licensed Patents in the Prometheus Territory, and (d) promptly provide Prometheus with copies of correspondence and materials (both received and filed from/with) the receiving office of any PCT application, the U.S. Patent and Trademark Office (“ PTO ”) and/or other equivalent intellectual property regulatory authority within the Prometheus Territory to the extent they relate exclusively to the Licensed Patents.
 
5.1.3            Reimbursement of Rosetta’s Costs .   Prometheus shall reimburse Rosetta for its prosecution and maintenance expenses for the Licensed Patents incurred prior to the Effective Date and during the Term as follows: [***].  Any payment due to Rosetta pursuant to this Section 5.1.3 for prosecution and maintenance expenses incurred prior to the Effective Date shall be due and payable by Prometheus within thirty (30) days after the Effective Date.  Any payment due to Rosetta pursuant to this Section 5.1.3 for prosecution and maintenance expenses incurred during the Term shall be due and payable by Prometheus within thirty (30) days after the date of a reasonably detailed invoice and back-up therefor provided by Rosetta, provided Rosetta shall not invoice Prometheus more than once (1) per calendar quarter.
 
5.2            Infringement or Misappropriation of Licensed Intellectual Property .
 
5.2.1            Notice of Infringement by Third Parties .  If either Party should become aware of any infringement or misappropriation or threatened infringement or misappropriation of the Licensed Intellectual Property by a Third Party, it shall promptly notify the other Party in writing and provide any information available to that Party relating to such alleged infringement.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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5.2.2            Responsibility for Enforcement .
 
(a)           Rosetta shall have the initial right (but not the obligation) to bring or control, at its own expense, any enforcement action directed to an alleged infringement or misappropriation of the Rosetta Owned Patents and/or the Rosetta Owned Technical Information by a product or service that competes with a Licensed Product in the Field in the Prometheus Territory, but shall consult Prometheus in good faith with regard to all significant decisions, including without limitation, joining Prometheus as a co-party ( e.g., if Prometheus believes it will need to be joined in order for the party plaintiffs to have standing and/or a viable claim for lost profit damages).
 
(b)           To the extent permitted by the applicable Upstream License Agreement, Rosetta shall have the initial right to bring or control, at its own expense, any enforcement action directed to an alleged infringement or misappropriation of the Upstream Licensed Patents and/or the Upstream Licensed Technical Information by a product or service that competes with a Licensed Product in the Field in the Prometheus Territory, but shall consult Prometheus in good faith with regard to all significant decisions, including without limitation, joining Prometheus as a co-party ( e.g., if Prometheus believes it will need to be joined in order for the party plaintiffs to have standing and/or a viable claim for lost profit damages).
 
(c)           In the event that the enforcement of any Upstream Licensed Patent and/or any Upstream Licensed Technical Information is the responsibility of the applicable Upstream Licensor pursuant to Upstream License Agreements or an enforcement action cannot be brought by Rosetta for lack of standing, Rosetta agrees that, to the maximum extent that Rosetta has the right to do so under the Upstream License Agreement (and if not permitted Rosetta shall use Commercially Reasonable Efforts to obtain such rights pursuant to an amendment to such Upstream License Agreement), Rosetta (i) shall cause such Upstream Licensor to bring or control, at such Upstream Licensor’s and/or Rosetta’s own expense, any enforcement action directed to an alleged infringement or misappropriation of the Upstream Licensed Patents and/or the Upstream Licensed Technical Information by a product or service that competes with a Licensed Product in the Field in the Prometheus Territory, (ii) shall consult Prometheus in good faith with regard to all significant decisions, including without limitation, joining Prometheus and/or Rosetta as co-parties, and (iii) shall not permit such Upstream Licensor to settle (or make any stipulation during) such enforcement action in a manner that would negatively affect Prometheus’ License without first obtaining Prometheus’ prior written consent, which consent shall not be unreasonably withheld, delayed or conditioned.
 
(d)           In the event that Rosetta or an Upstream Licensor does not file suit against or commence and conclude settlement negotiations with the party responsible for an alleged infringement of any Licensed Intellectual Property within [***] days of receipt of a written demand from Prometheus that Rosetta and/or its Upstream Licensor bring suit, and it is determined by Prometheus after good faith consultation with Rosetta that a suit should be filed by Rosetta and/or the applicable Upstream Licensor, but Rosetta and/or the applicable Upstream Licensor does not file suit or commence settlement negotiations forthwith against the infringer, then Prometheus shall have the right, at [***] expense, to bring or control, at [***] expense, any enforcement action directed to the alleged infringement on behalf of itself,  Rosetta, and/or the Upstream Licensor, to the extent permitted by the relevant Upstream License Agreement (and if not permitted Rosetta shall use Commercially Reasonable Efforts to obtain such rights pursuant to an amendment to such Upstream License Agreement).
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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5.2.3            Cooperation and Joinder .
 
(a)           Prometheus shall reasonably cooperate in any enforcement action brought by Rosetta or an Upstream Licensor pursuant to Section 5.2.2(a), (b) or (c) above, and, as necessary (or requested by Prometheus), be permitted to join or be joined as a party therein, provided Rosetta or the Upstream Licensor, as applicable, agrees to reimburse Prometheus for all out-of-pocket costs, damages and expenses, (excluding reasonable attorneys’ fees unless the Parties are unable to utilize the same legal counsel due to an ethical conflict), that it may incur in connection with such assistance or joinder, including any award of costs against it.
 
(b)           Rosetta shall reasonably cooperate in any enforcement brought by an Upstream Licensor pursuant to Section 5.2.2(c), and as necessary join or be joined as a party therein, provided the Upstream Licensor agrees to reimburse Rosetta for all out-of-pocket costs, damages and expenses, (excluding reasonable attorneys’ fees unless the Parties are unable to utilize the same legal counsel due to an ethical conflict), that it may incur in connection with such assistance or joinder, including any award of costs against it.
 
(c)           Rosetta shall and shall cause the applicable Upstream Licensor to the extent permitted by the relevant Upstream License Agreement (and if not permitted Rosetta shall use Commercially Reasonable Efforts to obtain such rights pursuant to an amendment to such Upstream License Agreement) to reasonably cooperate in any enforcement brought by Prometheus pursuant to Section 5.2.2(d), and as necessary join or be joined as a party therein, provided Prometheus agrees to reimburse Rosetta for all out-of-pocket costs, damages and expenses, (excluding reasonable attorneys’ fees unless the Parties are unable to utilize the same legal counsel due to an ethical conflict), that it may incur in connection with such assistance or joinder, including any award of costs against it.
 
(d)           Any costs, expenses or damages hereunder to be reimbursed by one Party to the other shall be paid by the owing Party within thirty (30) days of receipt of evidence that such costs, expenses or damages have been incurred.
 
5.2.4            Retention of Amounts Recovered .  Except as otherwise required by the terms of any applicable Upstream License Agreements, any amount recovered in any action or suit brought in accordance with Section 5.2, whether by judgment or settlement, shall be applied as follows, unless otherwise agreed in writing by the Parties:
 
(a)                 First, to reimburse the Parties for their respective costs and expenses (including reasonable attorneys’ fees and costs) incurred in prosecuting such infringement action;
 
(b)                 Second, if and to the extent lost sales are specifically determined by the adjudicating authority, to Prometheus in reimbursement for lost sales (net of royalties) associated with Products and to Rosetta in reimbursement for lost royalties owing hereunder based on such lost sales;
 
(c)                 Third, any amounts remaining shall be allocated [***] to the Party that controlled the prosecution of the infringement action and [***] to the non-controlling Party.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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In the absence of any conflict of interest, the Parties shall use commercially reasonable efforts to utilize the same legal counsel. In the event of any inconsistency between the terms of this Section 5.2.4 and the terms of any Upstream License Agreement, amounts recovered in any enforcement action or suit brought in accordance with Section 5.2 that pertain to the Upstream License Agreement shall be paid or retained in accordance with the terms of the applicable Upstream License Agreement.
 
5.2.5            Notification of Infringement by a Party .  If the Exploitation of the Licensed Products results in a claim alleging Patent infringement against either Party (or its Affiliates, licensees or sublicensees), such Party shall promptly notify the other Party hereto in writing.  As between the Parties, Prometheus shall have the initial right to defend and control the defense of any infringement claim pertaining primarily to infringement inside the Prometheus Territory, and Rosetta shall have the initial right to defend and control the defense of any infringement claim pertaining primarily to infringement outside the Prometheus Territory.  Each Party (a) may use counsel of its own choice as applicable, and (b) shall keep the other Party informed of all material developments in connection with any such claim.  Notwithstanding the foregoing, if the other Party (or its Affiliates or Sublicensees) is joined in any such action, then it shall have the right to defend such action and be represented by separate legal advisors.
 
5.2.6            Settlement .  Without prejudice to the foregoing, neither Party shall settle or compromise any legal action referred to in Section 5.2 without the prior written consent of the other Party (not to be unreasonably withheld), provided that Rosetta shall not be required to obtain Prometheus’ consent to the settlement or compromise of an infringement claim or action subject to Section 5.2.5 to which Prometheus has not been joined and which pertains solely to infringement outside the Prometheus Territory.
 
5.3           Resolution of Potential Blocking Positions .
 
If a claim alleging Patent infringement arises that is subject to Section 5.2.5, or if the senior management of either Party become aware of a Third Party Patent that, if issued, is likely to provide a basis for such a claim in the Prometheus Territory (collectively, a “ Potential Blocking Patent ”), the following provisions shall apply:
 
5.3.1           To the extent such notice has not been provided pursuant to Section 5.2.5, the Party that first becomes aware of such Potential Blocking Patent shall provide written notice that such a situation may exist to the other Party, following which the Parties shall discuss and determine whether they wish to enter into a commonality of interest agreement and to conduct any further discussion through their respective US counsel before proceeding to discuss the Potential Blocking Patent.
 
5.3.2           The Parties shall enter into good faith discussions for a period of up to [***] with the objective of determining whether a license under the Potential Blocking Patent or a modification or redesign (hereinafter “modification”) to one or more of the Licensed Products is necessary for the Exploitation of one or more of the Licensed Products in the Prometheus Territory, taking into account considerations such as, without limitation, the time required to obtain a license versus the time required to modify the Licensed Product to make it non-infringing, and the cost of obtaining a license versus the cost of modifying the affected Licensed Product.  During such [***] period, the Parties shall discuss and agree upon the appropriate parameters for obtaining such license and/or developing such modification, [***] (the “ Third Party License Negotiation Period ”) and  develop such modification (the “ Modification Development Period ”) as well as the overall time limit for attempting both options should the first chosen option fail, provided that in no event shall such overall time period exceed [***] (the “ Overall Time Period ”).  To the extent necessary, the parties shall discuss in good faith extending the term of any of the aforementioned periods for a reasonable duration to conclude any negotiations or development work than in progress.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(a)           If the Parties agree that such a license or modification is necessary, the Parties shall immediately proceed as set forth in Section 5.3.3 below, without regard to Section 5.3.2(b).
 
(b)           If the Parties fail to agree as to the necessity of such a license or modification, the Parties shall within five (5) business days after the conclusion of the foregoing [***] discussion period select a mutually acceptable Third Party neutral patent expert with expertise in patent damages and licensing (the “ Expert ”) to determine whether it is more likely than not that the patent would be infringed, where such standard is interpreted in accordance with standard jury instructions for United States Federal Courts in cases dealing with patent infringement, by the unlicensed Exploitation of the Licensed Product(s) in the Prometheus Territory.  Prior to any substantive communications to the Expert, the Parties and the Expert shall enter into a suitable confidentiality agreement, and take measures to preserve to the maximum extent possible each Party’s legal privilege concerning the subject matter of the determination.  The Expert will determine the procedures for his decision making, including procedures for presenting information to him and the Parties agree to provide to the Expert all information and documents that are requested.  The Expert’s final decision shall be made no more than [***] after initiating the proceeding.  If the Expert determines that it is more likely than not (applying the standard described above) that the Potential Blocking Patent would be infringed by the unlicensed Exploitation of the Licensed Product(s) in the Prometheus Territory, the Parties shall proceed as set forth below.  If the Expert determines that it is not more likely than not that the Potential Blocking Patent would be infringed by the unlicensed Exploitation of the Licensed Product(s) in the Prometheus Territory, neither Party shall have any further obligation under the following subsections of this Section 5.3 solely with respect to the Potential Blocking Patent in question (without prejudice to any right of Prometheus to avail itself of Section 4.4.1(b)).  The cost of the Expert shall be borne equally by the parties.
 
5.3.3           Prometheus shall within a reasonable time determine whether it wishes to avail itself of the royalty reductions available to it pursuant to Section 4.4.1(b), or to continue to proceed under this Section 5.3.  Prometheus shall notify Rosetta in writing of such election, and any election to proceed under Section 4.4.1(b) shall discharge Rosetta of any further obligations under this Section 5.3 solely with respect to the Potential Blocking Patent in question.
 
5.3.4           If Prometheus elects to proceed under this Section 5.3 and the parties have agreed on Rosetta initially attempting to obtain a license over developing a modification (taking into account the discussions set forth in Section 5.3.2), Rosetta shall use best commercial endeavors to promptly obtain a license to the Potential Blocking Patent, [***].  Rosetta shall keep Prometheus reasonably informed as to the progress of Rosetta’s negotiations with the Third Party that owns or controls the Potential Blocking Patents.  Prometheus shall not engage in any discussions or negotiations with such Third Party relating to the Potential Blocking Patent prior to the expiration of the Overall Time Period except (a) with Rosetta’s prior written consent, not to be unreasonably withheld, and subject to a joint negotiation strategy, or (b) after giving written notice to Rosetta that Prometheus wishes to enter into sole negotiations with such Third Party and is electing to proceed under Section 4.4.1(b), which election to proceed under Section 4.4.1(b) shall discharge Rosetta of any further obligations under this Section 5.3 solely with respect to the Potential Blocking Patent in question.  If Rosetta is unable, despite using best commercial endeavors, to obtain a license to the Potential Blocking Patent, and provided that there is still sufficient time to successfully modify the Licensed Product and obtain a non-infringement opinion from reputable outside patent counsel to the effect that the Licensed Product, as so modified, does not infringe the Potential Blocking Patent within the Overall Time Period, Rosetta may notify Prometheus, via a signed writing given to Prometheus no more than five (5) business days after the expiration of the Third Party License Negotiation Period (the “ Plan B Notice ”), that it desires to develop the necessary modifications in accordance with the procedures set forth in Section 5.3.5.
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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5.3.5           If Prometheus elects to proceed under this Section 5.3 and either (a) the parties have agreed on developing a modification prior to first attempting to obtain a license (taking into account the discussions set forth in Section 5.3.2) or (b) Rosetta has properly provided Prometheus with a Plan B Notice, Rosetta shall promptly modify the affected Licensed Product and obtain a non-infringement opinion from reputable outside patent counsel to the effect that the Licensed Product, as so modified, does not infringe the Potential Blocking Patent prior to the expiration of the Modification Development Period and/or the Overall Time Period, which ever comes first.  Prometheus shall reimburse [***] of the costs for developing such modification and obtaining such opinion upon successfully completion of the modification and obtainment of said non-infringement opinion.  In return, Prometheus shall be entitled to reduce its royalty payments hereunder to Rosetta by [***] until Prometheus has recouped in full its contributions to such development costs, at which time no further reduction shall be available under this Section 5.3.5.  If Rosetta is unable, despite using best commercial endeavors, to successfully modify the Licensed Product or to obtain a non-infringement opinion from reputable outside patent counsel to the effect that the Licensed Product, as so modified, does not infringe the Potential Blocking Patent within the Third Party License Negotiation Period within the Third Party License Negotiation Period, and provided that Rosetta has not provided Prometheus with a Plan B Notice and there is still sufficient time to successfully license the Potential Blocking Patent from a Third Party within the Overall Time Period, Rosetta may notify Prometheus, via a signed writing given to Prometheus no more than five (5) business days after the expiration of the Third Party License Negotiation Period (the “ Plan C Notice ”), that it desires to license the Potential Blocking Patent from a Third Party in accordance with the procedures set forth in Section 5.3.4.
 
5.3.6           If Rosetta is unable, despite using best commercial endeavors to either modify the Licensed Product and obtain a non-infringement opinion from outside patent counsel to the effect that the Licensed Product, as so modified, does not infringe the Potential Blocking Patent or to obtain a license under the Potential Blocking Patent within the Overall Time Period, Rosetta shall so notify Prometheus in writing within five (5) business days after making such determination.  [***].  Prometheus shall use Commercially Reasonable Efforts to minimize any such royalties to Third Parties.
 
5.3.7           If (a) Rosetta is unable to modify the Licensed Product and obtain a non-infringement opinion from outside patent counsel to the effect that the Licensed Product, as so modified, does not infringe the Potential Blocking Patent and neither Party is able to obtain a license under the Potential Blocking Patent within the Overall Time Period and (b) Prometheus stops selling, or its Board determines to stop selling, the affected Licensed Product (notice of which decision shall be promptly given to Rosetta), the Parties may mutually agree to terminate the license with respect to the affected Licensed Product(s), provided that prior to the effective date of such termination the parties shall negotiate a reasonable royalty (and if such royalty cannot timely be agreed upon by the parties, such royalty may be determined pursuant to the Dispute Resolution procedures set forth in Section 11) which Rosetta shall pay to Prometheus in connection with Rosetta’s or its Affiliates’ Exploitation of such Licensed Product(s) in the Prometheus Territory for a period of [***] subsequent to termination.  For clarification purposes, unless otherwise agreed upon by the parties, Rosetta shall have no obligation to Exploit the Licensed Product in the Prometheus Territory. Upon the effective date of termination of such Licensed Product(s) Rosetta shall also reimburse Prometheus the development costs for such Licensed Product(s) which were actually paid to Rosetta pursuant to Section 3.2.4 (crediting to Prometheus any offsets actually taken thereunder), excluding any performance-based incentives.  Development costs for development work that benefited more than one Licensed Product shall be reasonably apportioned between or among the applicable Licensed Products.  In addition, if subsequent to the effective date of termination, Rosetta and/or any of its Affiliates license any Third Party the right to Exploit any Licensed Product(s) subject to this Section 5.3.7 in the Prometheus Territory, Prometheus shall receive [***] of all consideration (including, without limitation, all upfront fees, milestone fees and royalties, whether monetary or otherwise) received by Rosetta and/or its Affiliates but excluding investments in Rosetta made at fair market value, loans made at reasonable commercial terms and amounts paid for research funding under a written agreement with a research project and a budget.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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6.
CONFIDENTIAL INFORMATION
 
6.1            Confidentiality .
 
6.1.1           Prometheus agrees to maintain secret and confidential the Product Technical Information, any Rosetta Improvements and all other confidential information that it may acquire or has acquired from Rosetta in the course of this Agreement (“ Rosetta Confidential Information ”), to use the same exclusively as permitted under this Agreement, and to disclose the same only to those of its employees, Affiliates, contractors and Sublicensees appointed pursuant to this Agreement (if any) to whom and to the extent that such disclosure is reasonably necessary for the purposes of this Agreement.
 
6.1.2           Rosetta agrees to maintain secret and confidential all Prometheus Product Improvements and all other confidential information that it may acquire or has acquired from Prometheus in the course of this Agreement (“ Prometheus Confidential Information ”)   and to disclose the same only to those of its employees, Affiliates, contractors and licensees of the Licensed Products to whom and to the extent that such disclosure is reasonably necessary for the purposes of this Agreement.
 
6.1.3           The foregoing obligations of Sections 6.1.1 and 6.1.2 shall not apply to Technical Information or other confidential information which:
 
(a)           prior to receipt thereof from one Party was in the possession of the recipient Party and at its free disposal, as can be demonstrated by the recipient Party through written evidence;
 
(b)           is subsequently disclosed to the recipient Party without any obligations of confidence by a Third Party who has not derived it directly or indirectly from the disclosing Party;
 
(c)           is or becomes generally available to the public through no act or default of the recipient Party or its Affiliates, employees, contractors, agents, or Sublicensees;
 
(d)           is independently developed by the receiving Party by its employees or contractors without access to or the benefit of any disclosure hereunder, as demonstrated by documented evidence prepared contemporaneously with such independent development; or
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(e)           is required to be disclosed by law, regulation or action of any governmental agency or authority or to comply with the requirements of any securities exchange or to any governmental or regulatory agency.
 
6.1.4           Each Party shall procure that all its employees, contractors and licensees, who have access to any information of the other Party to which the obligations of clauses 6.1.1 or 6.1.2 as the case may be apply, shall be made aware of, subject to, and comply with the above obligations.
 
6.1.5           Rosetta shall use Commercially Reasonable Efforts to identify in writing any Rosetta Confidential Information disclosed by Rosetta to Prometheus that is proprietary to an Upstream Licensor.  To the extent Rosetta properly identifies in writing at the time of disclosure to Prometheus the Upstream Licensor whose Confidential Information Rosetta is disclosing, and provided further that, Rosetta has also disclosed to Prometheus the applicable confidentiality terms and restrictions under Rosetta’s Upstream License Agreement, then the confidentiality terms of such Upstream License Agreement shall supersede the terms of this Section 6 with respect to Prometheus use and disclosure of such Upstream Licensor Confidential Information.
 
6.1.6           The obligations of confidentiality herein shall survive for a period of [***] following the date of expiration or termination of this Agreement, and shall apply to Rosetta Confidential Information and Prometheus Confidential Information exchanged between the Parties, both prior to and after entering into this Agreement.  This Agreement supersedes the mutual confidentiality agreement between the Parties dated   August 27, 2008 (the “ Mutual Confidentiality Agreement ”).  All information exchanged between the Parties under the Mutual Confidentiality Agreement shall be deemed to have been disclosed under this Agreement on a going-forward basis and shall be subject to the terms of this Article 6 as of the Effective Date.
 
6.2            Publicity and Permitted Disclosures .  Each of the following provisions of this Section 6.2 shall apply except as otherwise required by Law or court order or as otherwise permitted under this Agreement:  Prometheus shall not use the name of any Upstream Licensor, or any variant thereof, in any promotional materials or other public announcement or disclosure without the prior written consent of such Upstream Licensor.  All publicity, press releases and public announcements, in each case relating to the Licensed Products as licensed hereunder in the Prometheus Territory and/or the transactions contemplated hereby shall be reviewed in advance by, and shall be subject to the written approval (such approval not to be unreasonably withheld) of both Parties; provided that such publicity, press releases and other public announcements shall not disclose any confidential information of the other Party hereunder and shall give appropriate attribution to the other Party’s role(s) in the project contemplated herein.  Each Party shall provide the other Party an opportunity to review and comment on the language of such attribution prior to first use thereof in a press release or other public disclosure.  Furthermore, each Party shall notify the other Party prior to the first public disclosure of any data generated by it, its Affiliates, Sublicensees or licensees (as applicable) relating to the Licensed Products in the Prometheus Territory, and shall provide the other Party an opportunity to review and comment on the language of such disclosure.  Any information that is contained in an approved disclosure as described in the preceding sentences may be disclosed subsequently by either Party without the need to seek any further approval, subject to any restrictions that apply to the original disclosure.  Prometheus hereby approves the Rosetta press release attached hereto as Annex H for release on or after the Effective Date.  Either Party may disclose the existence of this Agreement and the terms and conditions hereof, without the prior written consent of the other Party, as may be required by applicable Law (including, without limitation, disclosure requirements of the SEC, NYSE, or any other stock exchange or NASDAQ), in which case the Party seeking to disclose the information shall give the other Party reasonable advance notice and review of any such disclosure and shall seek confidential treatment of such information to the extent possible under applicable Law.   Furthermore, either Party may disclose the other Party’s Confidential Information, the existence of this Agreement and the terms and conditions hereof, to its legal advisers subject to a duty of confidentiality.  Finally, either Party may disclose the existence of this Agreement and the terms and conditions hereof under a written confidentiality agreement to its Affiliates, actual and prospective investors, other financing sources, or acquirers, and in the case of Rosetta, the Upstream Licensors.  Notwithstanding the foregoing, neither Party shall have the right to disclose such information to a Competitor of the other Party except if such Competitor is an acquirer or investor receiving at least [***] of the Party’s voting shares and either (a) the other Party has consented in writing to the disclosure to such Competitor, or (b) the disclosure is made to the Competitor after the full execution (but not necessarily after the closing) of a definitive agreement for such acquisition or investment.  Prometheus may disclose Rosetta’s Confidential Information to its Sublicensees solely on a need-to-know basis subject to Section 2.2.1.  Rosetta may disclose to its other actual or prospective licensees Section 3.3.3 (Prometheus Product Improvements) of this Agreement and the definitions of terms used therein in connection with Rosetta’s negotiation or enforcement of reciprocal obligations and rights relating to Improvements on the part of such other actual or prospective licensees.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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7.
REPRESENTATIONS, WARRANTIES AND COVENANTS
 

7.1       Corporate Existence and Power .  Each Party hereto represents and warrants to the other Party that, (a) it is a corporation duly organized, validly existing and in good standing under the laws of the state or jurisdiction in which it is incorporated or organized; and (b) it has full power and authority and the legal right to own or license and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement.
 
7.2            Authority .  Each Party hereto represents and warrants to the other Party that (a) it has the power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (b) it has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; (c) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid and binding obligation of such Party and is enforceable against it in accordance with its terms; (d) as of the Effective Date, all necessary consents, approvals and authorizations of all governmental authorities, Upstream Licensors and other persons or entities required to be obtained by such Party in connection with entry into this Agreement have been obtained; and (e) the execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (i) do not conflict with or violate any requirement of applicable Law in existence as of the Effective Date or any provisions of such Party’s charter documents in any material way, and (ii) do not conflict with, violate or breach or constitute a default or require any consent under, any contractual obligation or court or administrative order in existence as of the Effective Date by which such Party is bound.
 
7.3            Intellectual Property .  Rosetta represents and warrants to Prometheus that:
 
7.3.1           Rosetta has disclosed to Prometheus, or provided Prometheus with copies of, all Rosetta Owned Patents in existence as of the Effective Date, and covenants that it shall thereafter continue to provide Prometheus with copies of any Patents that become Rosetta Owned Patents at any time during the Term.  In the event that Rosetta becomes aware of any Rosetta Owned Patent in existence as of the Effective Date that was not disclosed to Prometheus, Rosetta covenants that it shall promptly disclose such Rosetta Owned Patent to Prometheus.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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7.3.2           To Rosetta’s knowledge, Rosetta has disclosed to Prometheus, or provided Prometheus with copies of, all Upstream Licensed Patents in existence as of the Effective Date.
 
7.3.3           As of the Effective Date, Annex A-1A and Annex A-2A sets forth a true, correct and complete list of all Patents owned by Rosetta or its Affiliates necessary or required to Exploit the Licensed Products in the Prometheus Territory;
 
7.3.4           To Rosetta’s knowledge as of the Effective Date, Annex A-1B and Annex A-2B sets forth a true, correct and complete list of all Patents Controlled by Rosetta or its Affiliates necessary or required to Exploit the Licensed Products in the Prometheus Territory;
 
7.3.5           Rosetta has the right to grant the licenses to Prometheus that are set forth in this Agreement and owns or Controls all right, title and interest in and to the Licensed Intellectual Property;
 
7.3.6           Rosetta has not granted any rights in the Licensed Intellectual Property that are inconsistent with or that limit the rights granted to Prometheus under this Agreement;
 
7.3.7           Rosetta has secured written statements from each entity that is an Upstream Licensors as of the Effective Date declaring that, to each such Upstream Licensor’s knowledge, neither it nor Rosetta is in material breach of such Upstream License Agreement. In instances where an Upstream License Agreement in existence as of the Effective Date does not already provide the following right, Rosetta has secured written statements from each entity that is an Upstream Licensor as of the Effective Date declaring that, should the Upstream License Agreement be terminated, the applicable Upstream Licensor shall provide prompt notice thereof to Prometheus and provided that Prometheus is not in material breach of this Agreement at the time the Upstream License Agreement is terminated as to Rosetta, the Upstream Licensor shall provide prompt notice thereof to Prometheus and shall be deemed to have granted a direct license to Prometheus on the same terms as those set forth in (a) this Agreement, or (b) the Upstream License Agreement, in each case which apply to the Upstream Licensor’s intellectual property that is sublicensed to Prometheus under the Upstream License Agreement, provided that such direct license shall be granted solely in the Prometheus Territory, and provided further that any upfront or other payments which were paid by Rosetta to the Upstream Licensor prior to the date of termination of the Head License shall be deemed to have been paid by Prometheus under the direct license.   Rosetta further represents and warrants that, during the Term, Rosetta shall maintain each of the Upstream License Agreements in good standing and shall not take any action, or omit or fail to take any action, which would result in a breach or early termination of any of the Upstream License Agreements or any rights thereunder, unless Prometheus’ license with respect to the Diagnostic Test to which such Upstream License Agreement pertains has been terminated.  Rosetta represents and warrants that it shall not amend, modify or supplement the terms of, or waive any rights under, any Upstream License Agreement without the prior written consent of Prometheus where and to the extent that any such amendment or waiver would adversely affect the rights and licenses granted to Prometheus pursuant to this Agreement.  Rosetta shall promptly notify Prometheus upon receipt by Rosetta of any notice from any Upstream Licensor of any actual or alleged breach under any Upstream License Agreement that could result in the termination of such agreement or reduction or other limitation in Rosetta’s rights thereunder, and Rosetta shall promptly cure any such breach within the allotted cure period.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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7.3.8           As of the Effective Date, Rosetta has not assigned, licensed, sublicensed, granted any interest in or options to the Licensed Intellectual Property or the Licensed Products in the Prometheus Territory to any Third Party in violation of this Agreement and shall not do so during the Term.
 
7.3.9           The Rosetta Owned Patents and, to Rosetta’s knowledge, the Rosetta Upstream Licensed Patents are free and clear of all Encumbrances that could (if foreclosed upon or otherwise) (a) restrict Prometheus’ Limited Exclusive license thereunder as granted under this Agreement or use thereof as otherwise permitted under this Agreement or (b) provide a Third Party with rights in the Licensed Patents which conflict with Prometheus’ Limited Exclusive License.  Rosetta shall ensure that the Rosetta Owned Patents and its license rights under the Rosetta Upstream Licensed Patents remain free and clear of such Encumbrances during the Term of this Agreement.
 
7.3.10       Product Technical Information .
 
(a)          It has taken commercially reasonable measures to protect the secrecy, confidentiality and value of the Product Technical Information.
 
(b)           To Rosetta’s knowledge, no event has occurred as of the Effective Date which has resulted in the unauthorized use or disclosure of any Product Technical Information or which otherwise resulted in any Product Technical Information falling into the public domain.
 
(c)           Rosetta has the right to grant Prometheus the Limited Exclusive license to the Product Technical Information in the Prometheus Territory as provided hereunder.
 
(d)           As of the Effective Date, the Product Technical Information is, and will at all times thereafter remain, free and clear of all Encumbrances that could restrict Prometheus’ rights to use such Product Technical Information as granted under this Agreement.
 
7.3.11       Exploitation of Licensed Intellectual Property .
 
(a)           As of the Effective Date, Rosetta has not received any written   Claim alleging that Rosetta’s or its licensees’ development, use or Exploitation of the Licensed Intellectual Property or the Licensed Products infringe, or misappropriate any intellectual property rights of any Third Party (including any Claim that Rosetta or its licensees must license or refrain from using any intellectual property rights of any Third Party in order to Exploit the Diagnostic Tests).
 
(b)           As of the Effective Date, to Rosetta’s knowledge, except as may be disclosed in the Stock Purchase Agreement, there are no facts which would form a reasonable basis for any Claim of infringement or misappropriation of any intellectual property rights of any Third Party related to the development or use of the Licensed Intellectual Property or the Diagnostic Tests, and Rosetta shall promptly notify Prometheus if it receives notice of any claim or other information at any time during the Term that would render this representation untrue.
 
(c)           As of the Effective Date, to Rosetta’s knowledge, no Third Party has interfered with, infringed upon, or misappropriated the Licensed Intellectual Property, and Rosetta shall promptly notify Prometheus if it receives notice of any claim or other information at any time during the Term that would render this representation untrue.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(d)           As of the Effective Date, to Rosetta’s knowledge, no Claim is pending or is threatened which challenges the legality, validity, enforceability, use, or ownership of any Licensed Intellectual Property, and to Rosetta’s knowledge, there are no facts which would form a reasonable basis for any such Claim.
 
(e)           As of the Effective Date, to Rosetta’s knowledge, the Exploitation of the Diagnostic Tests, in the form (if any) in which they exist as of the Effective Date, in the Prometheus Territory as currently contemplated in this Agreement does not and will not interfere with, infringe upon, or misappropriate, any intellectual property rights of any Third Party.
 
(f)           As of the Effective Date, The Mets Software does not and will not infringe the copyrights or misappropriate the trade secrets of any Third Party.
 
7.4            Regulatory Matters .  Rosetta represents and warrants to Prometheus that  Rosetta holds, and is operating in material compliance with, such exceptions, permits, licenses, franchises, authorizations and clearances of all Regulatory Authorities required in connection with the development up to the Effective Date of the Diagnostic Tests.  Rosetta further represents and warrants to Prometheus that it has not received any warning letters or written correspondence from any governmental entity requiring the termination, suspension or modification of any studies or tests with respect to the Diagnostic Tests.  
 
7.5            Compliance with Laws .
 
7.5.1           Each Party represents and warrants to that other Party that it is in compliance in all material respects with all Laws that are applicable to its ownership interest in, or the operation or use of the Diagnostic Tests, and there are no events, conditions, circumstances, activities, practices, incidents or actions known to such Party relating thereto that would interfere with or prevent compliance or continued compliance with or give rise to any liabilities or investigative, corrective or remedial obligations under applicable Laws, except as set forth in the following sentence.  The Parties acknowledge that as of the Effective Date there are certain state license applications in New York, Florida, Maryland and California which are currently pending that may be required to be issued prior to Rosetta’s performance of the Diagnostic Tests under the Services Agreement on specimens from patients in such states.  Rosetta shall use commercially reasonable efforts to obtain all such licenses and upon their issuance, Rosetta shall maintain such state license in good standing for the remainder of the term of the Services Agreement.
 
7.5.2           Prometheus represents and warrants that the Exploitation of the Licensed Products in the Prometheus Territory by it or its Affiliates, and any performance of the Diagnostic Tests by Sublicensees, shall comply in all material respects with all applicable Laws.
 
7.6            Existing Research Agreements .  Rosetta represents and warrants that a true and complete copy of each Existing Research Agreement and any and all amendments thereto as of the Effective Date have been provided to Prometheus.
 
7.7            Legal Proceedings .  Rosetta represents and warrants to Prometheus that there is no pending Proceeding (a) that has been commenced by or against Rosetta or any of its Affiliates or that otherwise relates to or may affect the Licensed Intellectual Property, or (b) that challenges, or may have the effect of preventing, delaying, making illegal, or otherwise interfering with, any of the transactions contemplated by this Agreement.  To the knowledge of Rosetta, (i) no such Proceeding has been threatened, and (ii) no event has occurred or circumstance exists that may give rise to or serve as a basis for the commencement of any such Proceeding.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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7.8            Financial Condition .  Rosetta represents and warrants to Prometheus that, as of the Effective Date, (a) it has not initiated a voluntary proceeding under any applicable bankruptcy code, and (b) there is no involuntary proceeding under any applicable bankruptcy code pending against Rosetta.
 
8.           INDEMNIFICATION
 
8.1            Indemnification by Rosetta .  Rosetta shall indemnify and hold harmless Prometheus and its Affiliates, Sublicensees and each of their respective employees, officers, directors and agents (each a “ Prometheus Indemnitee ”) from and against (a) any and all fines, sanctions, liabilities, losses and damages (“ Losses ”) finally awarded to a Third Party by a court of competent jurisdiction or finally imposed by any government agency that result from any Claim made or brought against a Prometheus Indemnitee by or on behalf of such Third Party or such government agency, and (b) subject to Section 8.3, any direct out-of-pocket costs and expenses (including reasonable attorneys’ fees) (“ Litigation Costs ”) incurred by a Prometheus Indemnitee while investigating or conducting the defense of such Claim, in any such case (a) and (b), solely to the extent such Claim is based on or arises out of (i) the breach by Rosetta of any representation, warranty or covenant contained in this Agreement; (ii) any Third Party Claim that Rosetta misappropriated, willfully disclosed or made available to Prometheus any Licensed Intellectual Property in violation of an obligation of Rosetta to such Third Party; (iii) the Exploitation of a Licensed Product or a Prometheus Improvement by Rosetta, its Affiliates or its licensees outside the Prometheus Territory; (iv) a Rosetta Indemnitee’s breach of any Upstream License Agreement or any indemnification claim by an Upstream Licensor to the extent that such breach or indemnification claim did not arise from a Prometheus Indemnitee’s breach of Section 2.5 (Compliance with Upstream License Agreements) or any requirements binding on sublicensees under an Upstream License Agreement arising after the Effective Date and accepted by Prometheus pursuant to Section 2.6; (v) a Claim by an Upstream Licensor for breach of confidentiality arising from such Prometheus Indemnitee’s use, in strict accordance with this Agreement, of Rosetta Confidential Information that is proprietary to such Upstream Licensor but which was not timely identified as such by Rosetta   pursuant to Section 6.1.5, or (vi) a breach by a Rosetta Indemnitee or Rosetta sublicensee of any applicable term of a Third Party license agreement entered into between Prometheus and such Third Party concerning a Prometheus Product Improvement sublicensed to Rosetta hereunder,   provided, however, in each case that such indemnification right shall not apply to any Claims, Losses or Litigation Costs (x) to the extent directly attributable to the negligence, reckless misconduct, or intentional misconduct of a Prometheus Indemnitee or Prometheus’ breach of this Agreement, or (y) for which Prometheus is obligated to indemnify Rosetta under Section 8.2.
 
8.2            Indemnification by Prometheus .  Prometheus shall indemnify and hold harmless Rosetta and its Affiliates, and the Upstream Licensors and each of their respective employees, officers, directors and agents (each a “ Rosetta Indemnitee ”) from and against (a) any and all Losses finally awarded to a Third Party by a court of competent jurisdiction or finally imposed by any government agency that result from any Claim made or bought against an Rosetta Indemnitee by or on behalf of such Third Party or such government agency, and (b) subject to Section 8.3, any Litigation Costs incurred by an Rosetta Indemnitee while investigating or conducting the defense of such Claim, in any such case (a) and (b), solely to the extent such Claim is based on or arises out of (i) the breach by Prometheus of any representation, warranty or covenant contained in this Agreement; or (i) the Exploitation of the Licensed Products by Prometheus, its Affiliates or its Sublicensees; provided, however, that such indemnification right shall not apply to any Claims, Losses or Litigation Costs (x) to the extent directly attributable to the negligence, reckless misconduct, or intentional misconduct of an Rosetta Indemnitee or Rosetta’s breach of this Agreement, (y) for which Rosetta is obligated to indemnify Prometheus under Section 8.1, or (z) based on or arising out of a breach of any Upstream License Agreement or any indemnification claim by an Upstream Licensor to the extent that such breach or indemnification claim did not arise from a Prometheus Indemnitee’s breach of Section 2.5 (Compliance with Upstream License Agreements) or any requirements binding on sublicensees under an Upstream License Agreement arising after the Effective Date and accepted by Prometheus pursuant to Section 2.6.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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8.3            Indemnification Procedures .  Promptly after receipt by a party seeking indemnification under this Section 8 (an “ Indemnitee ”) of notice of any pending or threatened Claim against it, such Indemnitee shall give written notice thereof to the Party from whom the Indemnitee is entitled to seek indemnification pursuant to this Section 8 (the “ Indemnifying Party ”); provided that the failure so to notify the Indemnifying Party shall not relieve it of any liability that it may have to any Indemnitee hereunder, except to the extent the Indemnifying Party demonstrates that it is materially prejudiced thereby.  The Indemnifying Party shall be entitled to participate in the defense of such Claim and, to the extent that it elects within ten (10) business days of its receipt of notice of the Claim from the Indemnitee, to assume control of the defense of such Claim (unless (i) the Indemnifying Party is also a party to such proceeding and the Indemnifying Party has asserted a cross claim against the Indemnitee or a court has otherwise determined that such that joint representation would be inappropriate, or (ii) the Indemnifying Party fails to provide reasonable assurance to the Indemnitee of its financial capacity to defend the Indemnitee in such Proceeding) with counsel reasonably satisfactory to the Indemnitee and, after notice from the Indemnifying Party to the Indemnitee of its election to assume the defense of such Claim, the Indemnifying Party shall not, as long as it diligently conducts such defense, be liable to the Indemnitee for any Litigation Costs subsequently incurred by the Indemnitee.  The Indemnitee shall provide the Indemnifying Party with such information and assistance as the Indemnifying Party may reasonably request with regard to the Claim.  No compromise or settlement of any Claim may be effected by the Indemnifying Party without the Indemnitee’s written consent, which consent shall not be unreasonably withheld or delayed, unless (a) there is no finding or admission of any violation of Law or any violation of the rights of any person and no effect on any other claims that may be made against the Indemnitee, (b) the sole relief provided is monetary damages that are paid in full by the Indemnifying Party, and (c) the Indemnitee’s rights under this Agreement are not restricted by such compromise or settlement.
 
8.4            Insurance .  Each of Rosetta and Prometheus shall have and maintain such type and amounts of liability insurance covering its activities under this Agreement as is normal and customary in the clinical laboratory industry generally for parties similarly situated.  Each Party shall, upon request of the other Party, provide the requesting Party with a copy of the foregoing policies of insurance, along with any amendments and revisions thereto.  
 
9.
TERM AND TERMINATION
 
9.1            Term .  The term of this Agreement shall begin upon the Effective Date and shall continue through the date upon which the last Valid Claim covering a Licensed Product expires, or solely with respect to Royalty-Bearing Technical Information, such additional duration as is required by the applicable Upstream License Agreement (the “ Term ”).
 
9.2           Termination of Agreement for Breach .  Either Party may terminate this Agreement and the License for material breach of this Agreement by the other Party by giving sixty (60) days’ written notice to the breaching Party (specifying in reasonable detail the basis for such termination) and such breaching Party has not cured such breach within such sixty (60) day period, except in the case of a payment default as to which the breaching Party shall have only a thirty (30) day notice and cure period.  For the avoidance of doubt, and without limitation, any material breach by either Party of its diligence obligations under Section 3.2 to use Commercially Reasonable Efforts, Prometheus’ material breach of its payment obligations under Section 4, Rosetta’s material breach of its Limited Exclusive license grant under Section 2.1, and Prometheus’ material breach of its diligence obligations under Section 3.4.3, shall be deemed a material breach of this Agreement for the purposes of this Section 9.2.  Notwithstanding the foregoing, if any material breach relates to one or more Licensed Products but not all of the Licensed Products then the non-breaching party shall only be permitted to terminate this Agreement on a product-by-product basis with the rights and obligations with respect to unaffected Licensed Products remaining in full force and effect, provided that, notwithstanding the foregoing, the non-breaching party shall be entitled to terminate the Mesothelioma Test and the Squamous Test together if the material breach related to either one.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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9.3            Termination of Agreement for Insolvency .  A Party may terminate this Agreement and the License upon the occurrence of one or more of the following:
 
9.3.1           immediately upon written notice to the other Party in the event that the other Party initiates a voluntary proceeding under any applicable bankruptcy code; or
 
9.3.2           immediately upon written notice to the other Party in the event that the other Party becomes the subject of an involuntary proceeding under any applicable bankruptcy code and such proceeding is not dismissed or stayed within ninety (90) days of its commencement.
 
9.4            Termination of Agreement for Convenience by Prometheus .   Prometheus may terminate this Agreement upon not less than [***] written notice to Rosetta in its entirety or as to one or more of the Licensed Products only, provided that any termination as to the Mesothelioma Test shall be deemed also to be a termination as to the Squamous Test, and vice versa.  Upon notice by Prometheus of its intent to terminate, Prometheus shall work with Rosetta in good faith to avoid devaluing the Licensed Products during such notice period and to complete any work in progress during such time but Prometheus shall not be obligated to make material expenditures during such notice period.
 
9.5            Termination for Challenge to Licensed Patents .   This Agreement, and all licenses granted to Prometheus hereunder, may be terminated by Rosetta on [***] prior written notice (or with respect to any Upstream Licensed Patent, any shorter period to the extent required under its Upstream License Agreements) in the event that Prometheus or a Prometheus Affiliate directly or indirectly opposes or disputes, or willingly ( e.g., it shall not be deemed willing if Prometheus is required to participate in an opposition pursuant to a subpoena or court order or a proceeding is otherwise initiated by the United States Patent and Trademark office other than at the instigation of Prometheus, and not by Prometheus) assists any Third Party to oppose or dispute, the validity or enforceability of any of the Licensed Patents in a court of competent jurisdiction or in proceedings before the United States Patent and Trademark Office or any other national patent office or supra-national patent authority established pursuant to international treaty, including under the auspices of the European Union, provided that (and with respect to any Upstream Licensed Patent, to the extent such an exception is consistent with the applicable Upstream License Agreement) an Upstream Licensor, Rosetta, its Affiliates and/or any of its licensees have not asserted such Licensed Patents against Prometheus.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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9.6            Procedure upon Termination or Expiration of Agreement .  Termination shall not relieve either Party of any obligations which have accrued prior to the effective date of such termination.  In the case of any breach of the terms of the License, a decision not to terminate does not reduce or eliminate any recourse otherwise available to either Party.  Upon the natural expiration or any termination of this Agreement by Rosetta pursuant to Section 9.2, 9.3, or 9.5, or by Prometheus pursuant to Section 9.2 or 9.4, all rights under the License and any license to Rosetta Improvements granted to Prometheus or its Affiliates hereunder shall automatically terminate and revert to Rosetta.  Upon any termination of this Agreement by Prometheus pursuant to 9.3, or the occurrence of any event set forth therein regardless of termination by Prometheus, in addition to any other rights or remedies Prometheus may have at law or in equity for breach, all rights and licenses herein granted to Prometheus in any Licensed Patents shall be irrevocable and shall continue in full force and effect in perpetuity, subject to Prometheus’s payment of all amounts due hereunder, as if this Agreement remained in full force and effect, into the bankruptcy estate or as otherwise directed by a competent legal authority having jurisdiction over such matters.  The Parties agree that the terms of this Agreement are fair and reasonable and have been negotiated in an arms-length transaction between unrelated parties with each Party represented by legal counsel.  If any provision herein is deemed onerous or otherwise unenforceable by any applicable bankruptcy court, the Parties shall use good faith efforts to amend the Agreement ( e.g., removing such onerous provision) so as to avoid any consequences thereof under applicable bankruptcy laws.
 
9.6.1           Upon termination of this Agreement or a Licensed Product by Prometheus for any reason, Prometheus and its Affiliates and Sublicensees shall have the non-exclusive right to continue to supply the terminated Licensed Products within its Control for a period not to exceed [***] from the date of notice of termination.  In addition, upon the termination of this Agreement by Prometheus pursuant to Section 9.4 or by Rosetta pursuant to Section 9.2, Prometheus shall grant Rosetta an exclusive license under and transfer to Rosetta all Prometheus owned rights in the Licensed Products, the Regulatory Filings and Regulatory Approvals (and provide prompt written notice to the applicable Regulatory Authorities of such transfers), any domain names registered to Prometheus or its Affiliates and utilized exclusively in connection with the Licensed Products and not in connection with Prometheus’ and/or its Affiliates’ other products or services, and any Prometheus (or its Affiliates) owned trademarks or trademarks licensed from Third Parties to Prometheus or its Affiliates and utilized exclusively in connection with the Licensed Products and not in connection with Prometheus’ and/or its Affiliates’ other products or services.  The Parties shall negotiate in good faith fair and reasonable license and transfer fees for the foregoing, provided that if the Parties are unable to negotiate such financial terms and execute an addendum or agreement with respect thereto, a fair market value shall be determined pursuant to the dispute resolution provisions set forth in Section 11.
 
9.7            Survival .  Except as expressly provided herein, Articles and Sections 5.3.7, 6 (Confidential Information), 8 (Indemnification), 9.6 (Procedure Upon Termination or Expiration of Agreement), 10 (Limitation of Liability), 11 (Dispute Resolution), 12.7 (Injunctive Relief), 12.8 (Notices) and 12.14 (Applicability of Section 365(n) of the Bankruptcy Code), all definitions used in any of the foregoing articles or sections, and any accrued rights to payment shall survive any expiration or early termination of this Agreement.
 
10.
LIMITATION OF LIABILITY
 
EXCEPT WITH RESPECT TO ANY INDEMNIFICATION OBLIGATION OWED WITH RESPECT TO A THIRD PARTY LOSS, A BREACH OF ARTICLE 6 (CONFIDENTIAL INFORMATION) OR  INFRINGEMENT OF A PARTY’S INTELLECTUAL PROPERTY RIGHTS, NEITHER PARTY SHALL BE LIABLE (NOR SHALL ITS LICENSORS BE LIABLE) TO THE OTHER PARTY UNDER ANY CIRCUMSTANCES OR ANY LEGAL OR EQUITABLE THEORY, WHETHER IN CONTRACT, STRICT LIABILITY OR OTHERWISE, FOR ANY CONSEQUENTIAL DAMAGES OR DAMAGES FOR LOST PROFITS ARISING OUT OF OR RELATED TO THE LICENSED INTELLECTUAL PROPERTY OR TO THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THESE LIMITATIONS SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OR ANY LIMITED REMEDY.  NOTWITHSTANDING THE FOREGOING, THESE LIMITATIONS SHALL NOT APPLY TO ANY THIRD-PARTY CLAIM THAT IS THE SUBJECT OF SECTION 9, TO THE EXTENT SUCH THIRD PARTY HAS BEEN AWARDED SUCH DAMAGES.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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11.
DISPUTE RESOLUTION
 
11.1            Informal Resolution .  Subject to Section 12.7, in the event of any controversy, dispute or claim arising out of, in connection with, or in relation to the interpretation, performance, or alleged breach of this Agreement (the “ Dispute ”), prior to instituting any arbitration on account of such Dispute, the Parties shall attempt in good faith to settle such Dispute first by negotiation and consultation between themselves, including referral of such Dispute to the Chief Executive Officer of Prometheus and the Chief Executive Officer of Rosetta.  In the event said executives are unable to resolve such Dispute or agree upon a mechanism to resolve such Dispute within thirty (30) days of the first written request for dispute resolution under this Section 11.1, then the Parties shall resolve all such Disputes in accordance with Section 11.2.
 
11.2            Arbitration .  Subject to Section 12.7, if any Dispute has not been resolved by good faith negotiations between the Parties pursuant to Section 11.1 above, then the Parties shall settle the Dispute by submitting the matter to binding arbitration in accordance with Rules of the International Chamber of Commerce. The arbitration shall be held in the English language in New York.  In any such arbitration, Prometheus shall select one (1) arbitrator and Rosetta shall select one (1) arbitrator, who, in each case, shall have substantial expertise in the human diagnostics industry and shall be fluent in English.  The arbitrators selected by the Parties shall select a third arbitrator to act as Chairman, who shall be an experienced lawyer or judge (or retired lawyer or judge) and fluent in English.  Judgment upon the award may be entered in any court having jurisdiction.
 
11.3            Escrow .  In the event that any Dispute in excess of [***] is not resolved by the Chief Executive Officers within thirty (30) days after submission of the Dispute to the Executive Officers, and either Party initiates arbitration pursuant to Section 11.2, Prometheus shall have the obligation to pay into an escrow account (the “ Escrow Account ”) with a mutually acceptable, reputable commercial bank in the USA (the “ Escrow Agent ”) the amount of royalties are other amounts allegedly owed hereunder which Prometheus withheld as set-off for Prometheus’ reasonably claimed monetary damages in accordance with Section 12.2, subject to the following conditions:
 
11.3.1      The Parties shall split all costs relating to the Escrow Account, including setting up and maintaining the Escrow Account, provided that, the arbitrator shall have the right to award the costs relating to the Escrow Account to the Party prevailing in such arbitration.
 
11.3.2      All amounts paid into the Escrow Account in excess of any damages awarded to Prometheus shall be paid by the Escrow Agent promptly to Rosetta upon proof of determination of the Dispute, with interest on such amount calculated from the date such royalties were due at the lower of either [***] per year or the maximum amount permitted by applicable Law.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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11.4            Governing Law .  This Agreement shall be governed by the laws of the State of New York, excluding that body of law known as conflicts of law.
 
12.
MISCELLANEOUS
 
12.1            Unenforceability .  Both Parties hereby expressly state that it is the intention of neither Party to violate any Law.  If any of the provisions of this Agreement are held to be void or unenforceable, then the Parties shall use good faith efforts for a period of no more than ten (10) business days to replace such void or unenforceable provisions with valid and enforceable provisions which will achieve as far as possible the economic business intentions of the Parties, failing which, such void or unenforceable provisions shall be deemed to be severed from this Agreement without replacement.
 
12.2            Compliance with Law .  Each Party shall comply with and shall use Commercially Reasonable Efforts to ensure that its and its Affiliates’ and sublicensees’ respective employees, agents, clinical institutions and clinical investigators comply with all applicable Laws in carrying out its rights and obligations under this Agreement.
 
12.3            No Waiver .  The failure by either Party to take any action or assert any right hereunder shall in no way be construed to be a waiver of such right, nor in any way be deemed to affect the validity of this Agreement or any part hereof, or the right of a Party to thereafter enforce each and every provision of this Agreement.
 
12.4            Drafting; Fairness of Agreement .  This Agreement shall not be construed more strictly against one Party than the other because it may have been drafted by one of the Parties or its counsel, each Party having contributed through its counsel substantially and materially to the negotiation and drafting thereof pursuant to an arms-length negotiation.  Furthermore, the Parties acknowledge and agree that the terms and conditions set forth herein and the rights, obligations and consideration afforded to each of the Parties, are fair and reasonable, are not excessively onerous to one Party or the other  and are not materially outside the scope of what can reasonably considered market terms.
 
12.5            Assignment .  This Agreement and the Parties’ rights and obligations hereunder shall not be assignable except with the prior written consent of the other Party, not to be unreasonably withheld, conditioned or delayed, except that  either Party shall have the right to assign this Agreement or its rights and obligations under this Agreement without the other Party’s prior written consent to any of its Affiliates, successors in interest or acquiror of all or substantially all of its assets relating to the Licensed Intellectual Property and the Licensed Products, including any successor in interest by way of any merger, consolidation, reincorporation or other reorganization; provided that such Affiliate, successor in interest or acquiror assumes all of such Party’s obligations under this Agreement (a “ Permitted Successor ”).  In addition, Rosetta covenants and agrees that it shall not assign, without Prometheus’ consent, which shall not be unreasonably withheld, any of the Licensed Intellectual Property to any Third Party other than to a Permitted Successor.
 
12.6            Relationship of the Parties .  In making and performing this Agreement, the Parties are acting, and intend to be treated, as independent entities and nothing contained in this Agreement shall be construed or implied to create an agency, partnership, joint venture, or employer and employee relationship between or among any of the Parties.  Except as otherwise provided herein, no Party may make any representation, warranty or commitment, whether express or implied, on behalf of or incur any charges or expenses for or in the name of any other Party.  No Party shall be liable for the act of any other Party unless such act is expressly authorized in writing by such Party.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- 50 -

 
12.7            Injunctive Relief .  Each of the Parties agrees that in the event of any breach of Article 6 (Confidential Information), (a) severe and irreparable damage would occur, (b) no adequate remedy at law would exist, and (c) damages would be difficult to determine.  Each of the Parties agrees that, in such case, the injured Party shall be authorized and entitled to obtain from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, as well as any other relief permitted by applicable law, and the breaching Party shall waive any requirement that such Party post bond as a condition for obtaining any such relief.
 
12.8            Notices .  Every notice, election, demand, consent, request, approval, report, offer, acceptance, certificate, or other communication required or permitted under this Agreement or by applicable Law shall be in writing and shall be deemed to have been delivered and received (a) when personally delivered, (b) on the seventh (7 th ) business day after which sent by registered or certified mail, postage prepaid, return receipt requested, (c) on the date on which transmitted by facsimile or other electronic means generating a receipt evidencing a successful transmission (provided that, on that same date, a copy of such notice is sent by registered or certified mail, postage prepaid, return receipt requested), or (d) on the third (3 rd ) business day after the business day on which deposited with a regulated public carrier (e.g., Federal Express) for overnight delivery (receipt verified), freight prepaid, addressed to the party for whom intended at the mailing address or facsimile number set forth below, or such other mailing address or facsimile number, notice of which is given in a manner permitted by this Section 12.8.
 
For Rosetta :

Rosetta Genomics Ltd.
10 Plaut St.
Rehovot
Israel, 76706
Attn: CEO
Facsimile: +972.73.222.0701

With a copy (which shall not constitute notice) to :

Office of General Counsel
10 Plaut St.
Rehovot
Israel, 76706
Attn: Tami Fishman Jutkowitz

And a second copy (which shall not constitute notice) to :

Mintz Levin PC
One Financial Center
Boston, MA 02111
USA
Attn: Jeff Wiesen
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- 51 -


For Prometheus :

Prometheus Laboratories Inc.
9410 Carroll Park Drive
San Diego, CA 92121
Attn:  President
Facsimile: (858) 410-1945

With a copy (which shall not constitute notice) to :

Prometheus Laboratories Inc.
9410 Carroll Park Drive
San Diego, CA 92121
Attn:  Legal Department
Facsimile: (858) 332-3393
 
12.9       Entire Agreement .  This Agreement and the Annexes and Schedules hereto (which are hereby incorporated herein) contain the entire understanding between the Parties relating to the subject matter hereof and supersedes any and all prior agreements, understandings and arrangements, whether written or oral, between the Parties hereto relating to such subject matter and to the extent relating to the Licensed Products.  No amendments, changes, modifications, waivers or alterations of the terms and conditions of this Agreement shall be binding upon either Party hereto unless in writing and signed by both Parties.
 
12.10       Force Majeure .  If and to the extent that either Party is prevented or delayed by a Force Majeure Event from performing any of its obligations under this Agreement and promptly so notifies the other Party, specifying the matters constituting the Force Majeure Event together with such evidence in verification thereof as it can reasonably give and specifying the period for which it is estimated that the prevention or delay will continue, then the Party so affected shall be relieved of liability to the other for failure to perform or for delay in performing such obligations (as the case may be), but shall nevertheless use its best endeavours to resume full performance thereof, provided that if the Force Majeure Event continues for a period of ninety (90) days or more following notification, the Party not affected by the Force Majeure Event may terminate this Agreement by giving not less than thirty (30) days prior notice to the other Party.  In addition, neither Rosetta nor Prometheus shall be obligated to make any payments for any part of any services not performed as a result of any Force Majeure Event.
 
12.11       Headings .  The captions to the Sections hereof are not a part of this Agreement, but are merely guides or labels to assist in locating and reading the several Sections hereof.
 
12.12       Right of Set-Off .  Notwithstanding anything to the contrary in this Agreement, Prometheus shall have a right to set-off any Royalties or other amounts due to Rosetta under this Agreement only against any damages incurred by Prometheus and/or its Affiliate under this Agreement, subject to its obligations under Section 11.3.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- 52 -

 
12.13       Costs and Expenses .  Except as otherwise expressly set forth in Section 3.2.3 or 3.2.4 or otherwise in the Development Plan, each Party shall bear its own costs and expenses in performing its obligations under the Development Plan and this Agreement.
 
12.14       Applicability of Section 365(n) of the Bankruptcy Code .
 
12.14.1      In the event Rosetta becomes a debtor under Title 11 of the U.S. Code, this Agreement shall be deemed to be, for purposes of Section 365(n) of Title 11, a license to “Intellectual Property” as defined therein and Prometheus and its Affiliates, and each of their successors and assigns as licensees shall have the rights and elections as specified in Section 365(n) of Title 11 of the U.S. Code.  Without limiting the foregoing, upon termination of this Agreement by a trustee or executor of Rosetta which has rejected this Agreement pursuant to any non-contractual rights afforded to it by applicable bankruptcy law and/or a U.S. or foreign bankruptcy court or other tribunal of competent jurisdiction, all rights and licenses herein granted to Prometheus shall nonetheless continue in full force and effect in accordance with the terms of this Agreement.
 
12.14.2      In the event Prometheus becomes a debtor under Title 11 of the U.S. Code, this Agreement shall be deemed to be, for purposes of Section 365(n) of Title 11, a license to “Intellectual Property” as defined therein and Rosetta and its Affiliates, and each of their successors and assigns as licensees shall have the rights and elections as specified in Section 365(n) of Title 11 of the U.S. Code.  Without limiting the foregoing,, upon termination of this Agreement by a trustee or executor of Prometheus which has rejected this Agreement pursuant to any non-contractual rights afforded to it by applicable bankruptcy law and/or a U.S. or foreign bankruptcy court or other tribunal of competent jurisdiction, all rights and licenses herein granted to Rosetta shall continue in full force and effect in accordance with the terms of this Agreement.
 
12.15       Counterparts .  This Agreement may be executed in counterparts and each such counterpart shall be deemed an original hereof.
 
13.
CLOSING.
 
13.1            Closing Date .  The closing of the transactions, rights and obligations contemplated under this Agreement (the “ Closing ”) shall take place at the offices of Latham & Watkins, LLP, 12636 High Bluff Drive, Suite 400, San Diego, CA 92130 (or at such other place as the parties may designate in writing) at 10:00 a.m. (local time) on a date to be specified by the parties, but no later than April 30, 2009, unless another time or date, or both, are agreed to in writing by the parties hereto.  The date on which the Closing shall be held is referred to in this Agreement as the “ Effective Date .”
 
13.2            Deliverables at Closing by Rosetta .  At or before the Closing, Rosetta shall deliver to Prometheus the items described in clauses 13.2.1 through 13.2.5 below:
 
13.2.1      an executed copy of the Services Agreement to be attached as Annex C ;
 
13.2.2      the pre-estimate of additional funding to be attached as Annex E pursuant to Section 3.2.4(b);
 
13.2.3      an executed copy of the Max Planck written statement referenced in Section 7.3.7;
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- 53 -

 
13.2.4      an executed copy of the Rockefeller written statement referenced in Section 7.3.7; and
 
13.2.5      an executed copy of the THM written statement referenced in Section 7.3.7, in the form set forth in Annex I hereto.
 
13.3            Deliverables at Closing by Prometheus .  At or before the Closing, Prometheus shall deliver to Rosetta the items described in clauses 13.3.1 through 13.3.3 below:
 
13.3.1      an executed copy of the Services Agreement to be attached as Annex C ;
 
13.3.2      an executed copy of the THM written statement referenced in Section 7.3.7.
 
13.4            Conditions Precedent to Obligations of Prometheus .  The obligations of Prometheus under this Agreement to consummate the transactions contemplated hereby at the Closing shall be subject to the satisfaction, at or prior to the Closing, of all of the following conditions:
 
13.4.1      The representations and warranties made by Rosetta in this Agreement or in any annex, exhibit, schedule or document delivered pursuant hereto shall be true and complete in all material respects, in each case when made and as of the Effective Date as if made on and as of that date (other than the representations and warranties that refer to a specific date);
 
13.4.2      All of the terms, covenants and conditions to be complied with and performed by Rosetta on or prior to the Effective Date shall have been complied with or performed in all material respects;
 
13.4.3      There shall not be in effect any Law or court of competent jurisdiction restraining, enjoining or otherwise preventing consummation of the transactions contemplated by this Agreement;
 
13.4.4      Since the Execution Date, no loss or modification of or limitation on any Upstream License Agreement shall have occurred without the written consent of Prometheus in its sole discretion, including, but not limited to, any forfeiture, expiration without renewal, termination or other loss thereof; and
 
13.4.5      Prometheus shall have received a certificate or certificates, dated as of the Closing, executed on behalf of Rosetta, by an authorized executive officer thereof, certifying in such detail as Prometheus may reasonably request that the conditions specified in subsections 13.4.1-13.4.4 hereof have been fulfilled.
 
13.5            Conditions Precedent to Obligations of Seller .  The obligations of Rosetta under this Agreement to consummate the transactions contemplated hereby at the Closing shall be subject to the satisfaction, at or prior to the Closing, of all the following conditions:
 
13.5.1      All representations and warranties of Prometheus made in this Agreement or in any annex, exhibit, schedule or document delivered pursuant hereto shall be true and complete in all material respects, in each case when made and as of the Effective Date as if made on and as of that date (other than representations and warranties that refer to a specific date);
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- 54 -

 
13.5.2      All of the terms, covenants and conditions to be complied with and performed by Prometheus on or prior to the Effective Date shall have been complied with or performed in all material respects; and
 
13.5.3      There shall not be in effect any Law or court of competent jurisdiction restraining, enjoining or otherwise preventing consummation of the transactions contemplated by this Agreement.
 
13.6            Waiver of Conditions .  Prometheus may unilaterally and in its sole discretion waive any of the conditions to Closing set forth herein.  Rosetta may unilaterally and in its sole discretion waive any of the conditions to Closing set forth herein.
 
13.7            Notifications .   Between the Execution Date and the Effective Date, Rosetta, on the one hand, and Prometheus, on the other hand, shall promptly notify the other Party in writing of any fact, change, condition, circumstance or occurrence or nonoccurrence of any event of which it is aware that will or is reasonably likely to result in any of the conditions set forth in Section 13.4 becoming incapable of being satisfied; provided, however , that the delivery of any notice pursuant to this Section shall not limit or otherwise affect the remedies available hereunder to the Party receiving such notice.

13.8            No Negotiation .   Between the Execution Date and the Effective Date, Rosetta shall not directly or indirectly solicit, initiate, encourage or entertain any inquiries or proposals, discuss or negotiate with, provide any information to (other than the publication and dissemination of the press release approved by Prometheus and set forth in Annex H ), or consider the merits of any inquiries or proposals from any person or entity (other than Prometheus) relating to any transaction involving, in whole or in part, the Licensed Products, or that would otherwise compromise Rosetta’s ability to consummate the transactions contemplated in this Agreement or the Services Agreement.
 
[Remainder of Page Left Blank Intentionally]
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
- 55 -

 

In Witness Whereof , the parties hereto have executed this License Agreement as of the date first set forth above.
 
ROSETTA GENOMICS LTD.
 
 
By:  /s/ Y. Chelouche
Name: Y. Chelouche
Title: Chairman
 
 
PROMETHEUS LABORATORIES INC.
 
 
By:  /s/ Joseph M. Limber
Name:  Joseph M. Limber
Title: President and Chief Executive Officer
 


CONFIDENTIAL
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Annex A
Licensed Intellectual Property
 
ANNEX A-1
 
ISSUED AND PENDING PRODUCT PATENTS
 
 
Part A:
 
 
Application
Assignee
Application No.
1
[***]
[***]
[***]
2
[***]
[***]
[***]
3
[***]
[***]
[***]
4
[***]
[***]
[***]
 
 
 
PART B:
 
 
Application
Assignee
Application No.
1
[***]
[***]
[***]

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

ANNEX A-2
 
ISSUED AND PENDING PLATFORM PATENTS
 

Part A:
 
 
Application
Assignee
Application No.
1
[***]
[***]
[***]
2
[***]
[***]
[***]
3
[***]
[***]
[***]
4
[***]
[***]
[***]
 
 
 
PART B:
 
 
Application
Assignee
Application No.
 
[***]
[***]
[***]
 
[***]
[***]
[***]
 

 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Annex B
Development Plan
 
[ to be completed ]



FTE Rate for IBS and IBD Test Development Work

Rosetta FTEs used in the performance of Development Program activities relating to the IBS Test or IBD Test shall be budgeted at [***] US dollars [***] per year.  Rosetta shall be entitled to deduct FTE payments and other amounts from the Development Fund in accordance with the milestones for such deductions set forth elsewhere in the Development Plan.
 


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Annex C
Services Agreement
 
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Annex D
Service Agreement Profits
 

 
Cost of Goods Sold:
 
Mesothelioma Test: [***] plus [***] of the prices stipulated in the Fee Schedule attached as Exhibit 1 to the Services Agreement
 
Squamous Test: [***] plus [***]of the prices stipulated in the Fee Schedule attached as Exhibit 1 to the Services Agreement
 
Mets Test: [***] plus [***] of the prices stipulated in the Fee Schedule attached as Exhibit 1 to the Services Agreement
 
The cost of goods sold for the Second Generation Mets Test, the IBS Test, and the IBD Test shall be determined taking into account the same elements (allowing for changes to the commercial technology platform) as the other Diagnostic Tests set forth above.
 
Either Party shall have the right, no more than once every six (6) months during the Term, to request a review of Rosetta’s cost of goods sold and to make any necessary increase or decrease to the amounts set forth above resulting from such review.  In connection with the foregoing, within thirty (30) days of such request, Rosetta shall provide Prometheus with reasonable written evidence of any actual change in Rosetta’s cost of goods sold.  Unless otherwise disputed by Prometheus in accordance with Section 11 of the Agreement, the adjustment to the costs of goods sold shall take effect ten (10) business days after Rosetta provides Prometheus with reasonable written evidence of such change.
 

 


 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Annex E
Estimate for Additional Development Expenses
 
 
[***]
 
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Annex F
Existing Research Agreements
 
1.
Material Transfer Agreement between University of Iowa Research Foundation and Rosetta Genomics Ltd. Dated February 3, 2009;
 
2.
Research and License Agreement between the University of Texas M.D. Anderson Cancer Center and Rosetta Genomics Ltd. Dated April 2008; and
 
3.
Research Agreement between the Johns Hopkins University and Rosetta Genomics Ltd. Dated August 27, 2008.
 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Annex G
Selected Provisions of JHU Agreement
 
The paragraph numbers below refer to paragraphs in the JHU Agreement as of the Effective Date.  All capitalized terms used in below in this Annex G  have the definitions set forth in the JHU Agreement, provided that references to Company shall be interpreted as applying to Prometheus.

6.2             Representations by JHU .  JHU warrants that it has good and marketable title to its interest in the inventions claimed under PATENT RIGHTS with the exception of certain retained rights of the United States Government, which may apply if any part of the JHU research was funded in whole or in part by the United States Government, and HHMI.  JHU warrants and represents that it has no knowledge of any legal suit, proceeding or claim of ownership by a third party contesting JHU’s ownership or the validity of the PATENT RIGHTS.  JHU does not warrant the validity of any patents or that practice under such patents shall be free of infringement.  EXCEPT AS EXPRESSLY SET FORTH IN THIS PARAGRAPH 6.2, COMPANY, AFFILIATED COMPANIES AND SUBLICENSEE(S) AGREE THAT THE PATENT RIGHTS ARE PROVIDED “AS IS”, AND THAT JHU MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO THE PERFORMANCE OF LICENSED PRODUCT(S) INCLUDING THEIR SAFETY, EFFECTIVENESS, OR COMMERCIAL VIABILITY.  JHU DISCLAIMS ALL WARRANTIES WITH REGARD TO PRODUCT(S) AND SERVICE(S) LICENSED UNDER THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ALL WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE.  NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, JHU ADDITIONALLY DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON THE PART OF JHU AND INVENTORS, FOR DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL, AND CONSEQUENTIAL DAMAGES, ATTORNEYS’ AND EXPERTS’ FEES, AND COURT COSTS (EVEN IF JHU HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE, OR SALE OF THE PRODUCT(S) AND SERVICE(S) LICENSED UNDER THIS AGREEMENT.  COMPANY, AFFILIATED COMPANIES AND SUBLICENSEE(S) ASSUME ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A PRODUCT AND/OR SERVICE MANUFACTURED, USED, OR SOLD BY COMPANY, ITS SUBLICENSEE(S) AND AFFILIATED COMPANIES WHICH IS A LICENSED PRODUCT(S) OR AS DEFINED IN THIS AGREEMENT.

7.1             Indemnification .  JHU, HHMI and the Inventors will have no legal liability exposure to third parties if JHU does not license the LICENSED PRODUCT(S), and any royalties JHU, HHMI and the Inventors may receive is not adequate compensation for such legal liability exposure.  Therefore, JHU requires Company to protect JHU, HMMI and the Inventors from such exposure to the same manner and extent to which insurance, if available, would protect JHU, HHMI and Inventors.  Furthermore, JHU, HHMI and the Inventors will not, under the provisions of this Agreement or otherwise, have control over the manner in which Company or its AFFILIATED COMPANIES or its SUBLICENSEE(S) or those operating for its account or third parties who purchase LICENSED PRODUCT(S) from any of the foregoing entities, develop, manufacture, market or practice the inventions of LICENSED PRODUCT(S).

a)           Company, AFFILIATED COMPANY and SUBLICENSEE shall indemnify, defend with counsel reasonably acceptable to JHU, and hold JHU, The Johns Hopkins Health Systems, their present and former trustees, officers, Inventors of PATENT RIGHTS, agents, faculty, employees and students harmless as against any judgements, fees, expenses, or other costs arising from or incidental to any product liability or other lawsuit, claim, demand or other action brought as a consequence of the practice of said inventions by any of the foregoing entities, whether or not JHU or said Inventors, either jointly or severally, is named as a party defendant in any such lawsuit and whether or not JHU or the Inventors are alleged to be negligent or otherwise responsible for any injuries to persons or property.  Practice of the inventions covered by LICENSED PRODUCT(S) by an AFFILIATED COMPANY or an agent or a SUBLICENSEE(S) or a third party on behalf of or for the account of Company or by a third party who purchases LICENSED PRODUCT(S) from Company, shall be considered Company’s practice of said inventions for purposes of this Paragraph.  The obligation of Company to defend and indemnify as set out in this Paragraph 7.1(a) shall survive the termination of this Agreement, shall continue even after assignment of rights and responsibilities to an AFFILIATED COMPANY or SUBLICENSEE, and shall not be limited by any other limitation of liability elsewhere in this Agreement.
 

 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 


b)           HHMI and its trustees, officers, employees, and agents (collectively, “HHMI Indemnitees”), will be indemnified, defended by counsel acceptable to HHMI, and held harmless by Company, AFFILIATED COMPANY and SUBLICENSEE from and against any claim, liability, cost, expense, damage, deficiency, loss, or obligation, of any kind or nature (including, without limitation, reasonable attorneys’ fees and other costs and expenses of defense) (collectively, “Claims”), based upon, arising out of, or otherwise relating to this Agreement, including without limitation any cause of action relating to product liability.  The previous sentence will not apply to any Claim that is determined with finality by a court of competent jurisdiction to result solely from the gross negligence or wilful misconduct of an HHMI Indemnitee.  The obligation of Company to defend and indemnity as set out in this Paragraph 7.1(b) shall survive the termination of this Agreement, shall continue even after assignment of rights and responsibilities to an AFFILIATED COMPANY and SUBLICENSEE, and shall not be limited by any other limitation of liability elsewhere in this agreement.

10.1             Use of Name .  Company, AFFILIATED COMPANIES and SUBLICENSEE(S) shall not use the name of the Howard Hughes Medical institute, The Johns Hopkins University or The Johns Hopkins Health System or any of their constituent parts, such as the Johns Hopkins Hospital or any contraction thereof or the name of Inventors in any advertising, promotional, sales literature or fundraising documents without prior written consent from an authorized representative of JHU.  Company, AFFILIATED COMPANIES and SUBLICENSEE(S) shall allow at least seven (7) business days notice of any proposed public disclosure for JHU’s and/or HHMI’s review and comment or to provide written consent.  For the purposes of this Paragraph, notice to HHMI should be directed to:

Howard Hughes Medical Institute
4000 Jones Bridge Road
Chevy Chase, Maryland 20815
Attn: Office of the General Counsel

Without limiting any of the foregoing, it is understood that the Company may use the name of the Howard Hughes Medical Institute, The Johns Hopkins University or The Johns Hopkins Health System in any filings as required by the SEC (or any other securities exchange authority), and may distribute any such filing in the ordinary course of its business.

10.4             Product Liability .  Prior to initial human testing or first commercial sale of any LICENSED PRODUCT(S) in any particular country, Company shall establish and maintain, in each country in which Company, an AFFILIATED COMPANY or SUBLICENSEE(S) shall test or sell LICENSED PRODUCT(S), product liability or other appropriate insurance coverage in the minimum amount of [***] dollars [***] per claim and will annually present evidence to JHU that such coverage is being maintained.  Upon JHU’s request, Company will furnish JHU with a Certificate of Insurance of each product liability insurance policy obtained.  JHU and HHMI shall be listed as an additional insureds in Company’s said insurance policies.  If such Product Liability insurance is underwritten on a ‘claims made’ basis, Company agrees that any change in underwriters during the term of this Agreement will require the purchase of ‘prior acts’ coverage to ensure that coverage will be continuous throughout the term of this Agreement.
 
 

 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Annex H
Rosetta Press Release
 
 
   
 
 

Prometheus and Rosetta Genomics Announce License and Collaboration Agreement

MicroRNA-based Molecular Diagnostics to Mark Prometheus’ Entry into Oncology Market; Rosetta to Receive Milestones and Research and Development Funding plus Future Royalties

San Diego, Philadelphia and Rehovot, Israel, April 13, 2009 (tentative) – Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, and Rosetta Genomics Ltd. (Nasdaq: ROSG), an innovative molecular diagnostic company, today announced the execution of a license and collaboration agreement under which Rosetta shall grant Prometheus U.S. rights to three recently introduced, microRNA-based cancer diagnostic tests: miRview™ mets, miRview™ squamous and miRview™ meso.

The terms of the license agreement provide for payments to Rosetta, either as milestones or research and development funding, as well as royalty payments on net sales in the U.S. Under the terms of a separate stock purchase agreement, Prometheus will also make an equity investment in Rosetta of $8 million at $4.00 per ordinary share, representing an approximate 41% premium over the closing price of Rosetta stock over three business days. The license and collaboration agreement and the stock purchase agreement are expected to close before the end of April 2009 and are subject to customary closing conditions.

In addition, Prometheus and Rosetta have agreed to collaborate to develop two new microRNA-based gastroenterology tests, which may result in additional, success-based milestones and royalty payments to Rosetta. Funding for development of these gastroenterology tests will be provided by Prometheus.

“Prometheus has established its position as a leader in the gastroenterology market by building an integrated portfolio of diagnostic and pharmaceutical products as well as a highly trained and efficient sales force,” said Joseph M. Limber, President and Chief Executive Officer of Prometheus. “Leveraging our core strengths, we intend to apply this business model to oncology, where there is an unmet need to guide the use of a growing number of targeted therapies. We believe these three molecular diagnostic tests can help oncologists personalize therapy and are ideally suited to lead our entry into the oncology market, while complementing our emerging internal oncology diagnostics program.”

“We believe that with this agreement Rosetta has proven the great commercial value of its first three products, and has established itself as a leader in the development of novel, molecular diagnostic products based on microRNAs. We are delighted to enter into this comprehensive partnership with Prometheus,” said Amir Avniel, President and Chief Executive Officer of Rosetta Genomics. “With Prometheus these tests now will be available across the U.S., and will be supported by an organization with a proven ability in diagnostic testing services and in launching new products.”
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
About miRview™ mets
 
miRview™ mets is designed to accurately identify the primary tumor site in patients presenting with metastatic cancer, as well as in patients whose tumor has not been identified and consequently has been labeled Cancer of Unknown Primary (CUP). As metastases need to be treated according to their primary origin, accurate identification of the primary origin is critical for determining optimal treatment, enabling better patient outcomes. Current diagnostic methods to identify the origin of a metastasis include a range of costly, time-consuming and at times inefficient tests. miRview™ mets offers physicians a fast, accurate and easy-to-interpret diagnosis of the predicted primary origin.

About miRview™ squamous

Using a single microRNA, miRview™ squamous is designed to differentiate squamous from non-squamous non-small cell lung cancer (NSCLC). When administered targeted therapy, whether currently available or under development, patients with differing histology, i.e. squamous or non-squamous NSCLC, have demonstrated histologic-specific response patterns ranging from a high incidence of severe or fatal bleeding in the lungs to poor response to treatment. Current methods for differentiating squamous from non-squamous NSCLC are not standardized, are difficult to reproduce and can have low accuracy. miRview™ squamous produces a single objective measure that indicates whether a sample is squamous or non-squamous NSCLC.

About miRview™ meso

miRview™ meso leverages microRNA’s high-specificity biomarkers to differentiate mesothelioma, a cancer connected to asbestos exposure, from other carcinomas in the lung and pleura, a medically and legally important differential diagnosis. As mesothelioma patients require specific treatment regimens, an accurate diagnosis is critical. Currently there is no single diagnostic test that is conclusive for this differentiation. In addition, pathological diagnosis may suffer from significant inter-observer variability, and in the absence of a single specific and reliable marker, mesothelioma can be difficult to identify from other cancers. miRview™ meso is a highly accurate test that may also assist physicians in ruling out mesothelioma in patients diagnosed with adenocarcinoma in the lung who have been exposed to mesothelioma-related substances, primarily asbestos particles and heavy metals.

About MicroRNA

MicroRNAs (miRNAs) are recently discovered, naturally occurring, small RNAs that act as master regulators and have the potential to form the basis for a new class of diagnostics and therapeutics. Since many diseases are caused by the abnormal activity of proteins, the ability to selectively regulate protein activity through microRNAs could provide the means to treat a wide range of human diseases. In addition, microRNAs have been shown to have different expression in various pathological conditions. As a result, these differences may provide for a novel diagnostic and therapeutic strategy for many diseases.

About Rosetta Genomics

Rosetta Genomics is a leading molecular diagnostics company committed to develop and commercialize products based on microRNAs for targeted therapy and preventive medicine. Rosetta developed a unique methodology to find microRNAs in body fluids and other clinical samples, and discovered in the past few years hundreds of novel microRNAs that can be used as important biomarkers and drug targets. Rosetta performs its commercial molecular diagnostics tests at Rosetta Laboratories in Philadelphia. Building on its strong intellectual property position and proprietary platform technologies, Rosetta is working on the application of these technologies in the development of novel molecular diagnostics products.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
About Prometheus

Prometheus Laboratories Inc. is a specialty pharmaceutical and diagnostic company committed to developing and commercializing novel pharmaceutical and diagnostic products to help physicians individualize patient care. Prometheus is a leader in applying the principles of personalized medicine to the diagnosis and treatment of gastrointestinal diseases and intends to apply these principles to oncology. Its strategy includes the marketing and delivery of pharmaceutical products complemented by proprietary, high-value diagnostic testing services. By integrating pharmaceutical products and diagnostic testing services, Prometheus believes it can address the full continuum of care, thereby providing physicians with a comprehensive solution to treat chronic diseases. Prometheus’ corporate offices are located in San Diego.

Rosetta Forward-Looking Statements

Various statements in this release concerning Rosetta’s future expectations, plans and prospects, including without limitation, statements regarding the parties’ ability to consummate the transactions, relating to the role of microRNAs in human physiology and disease, the potential of microRNAs in the diagnosis and treatment of disease, the potential for milestone, royalty and other payments under the collaboration with Prometheus, and the potential development of two new microRNA-based gastroenterology tests, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: Rosetta’s approach to discover microRNA technology and to work on the application of this technology in the development of novel diagnostics and therapeutic tools, which is unproven and may never lead to commercially accepted products or services; Rosetta’s ability to obtain, maintain and protect its intellectual property; Rosetta’s ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta’s need and ability to obtain additional funding to support its business activities; Rosetta’s dependence on third parties for development, manufacture, marketing, sales and distribution of products; Rosetta’s ability to successfully develop its candidate tools, products and services; Rosetta’s ability to obtain regulatory clearances or approvals that may be required for its products and services; the ability to obtain coverage and adequate payment from health insurers for the products and services comprising Rosetta’s technology; competition from others using technology similar to Rosetta’s and others developing products for similar uses; Rosetta’s dependence on collaborators; and Rosetta’s short operating history; as well as those risks more fully discussed in the “Risk Factors” section of Rosetta’s Annual Report on Form 20-F for the year ended December 31, 2007 as filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent Rosetta’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.

Contacts:
 
Ron Kamienchick                                                Bruce Voss                                                Pete De Spain
Rosetta Genomics                                                Lippert/Heilshorn & Associates                                                                        Prometheus Laboratories Inc.
646-509-1893                                                310-691-7100                                                858-587-4117
investors@rosettagenomics.com                                                                                               bvoss@lhai.com                                    pdespain@prometheuslabs.com
 
 
 
 
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Annex I
Form of THM Written Statement


[Rosetta letterhead]

[date]


Tel Hashomer Medical Research Infrastructure and Services Ltd.
Tel Hashomer
52621
Israel


Dear [________]:

Rosetta Genomics Ltd. (“Rosetta”) and Tel Hashomer Medical Research Infrastructure and Services Ltd.   (“THM”) are parties to a license agreement effective 30 July 2008 (the “Head License”).  As we have discussed, Rosetta has negotiated the terms of a license agreement  (the “License Agreement”) with Prometheus Laboratories Inc. (“Prometheus”) relating to the exploitation by Prometheus of certain Rosetta intellectual property in the territory for which Prometheus is licensed pursuant to the License Agreement (the “Territory”), including the grant of a sublicense under the Head License.

Prometheus has requested that THM provide a letter confirming and agreeing to the following:

1.  To THM’s knowledge, neither Rosetta nor THM is in material breach of the Head License.

2.  If the Head License is terminated for any reason, THM shall provide prompt notice thereof to Prometheus and, notwithstanding Section 7.04(A)(ii)(a) of the Head License and Section 2.5.1(c) of the License Agreement, provided that at the time the Head License is terminated as to Rosetta, Prometheus is not in breach of either (i) the License Agreement or (ii) the terms of the Head License applicable to sublicensees, THM shall be deemed to have granted a direct license to Prometheus, solely in the Territory but otherwise on the same terms as those set forth in the Head License, including without limitation Article 8 of the Head License ( mutatis mutandis, as set forth in Appendix A hereto).   All capitalized terms used in Appendix A shall have the meanings given them in the Head License.   Prometheus shall notify THM within sixty (60) days of THM notifying Prometheus that the Head License has been terminated, whether or not it accepts the terms of the Head License. For clarity, as a condition of such direct license Prometheus shall assume responsibility for paying directly to THM any unpaid amounts equitably apportioned to the Territory (as set forth above) payable under the Head License by Rosetta to THM prior to the date of termination of the Head License, provided that , any amounts which have been paid by Rosetta to THM under the Head License, equitably apportioned to the Territory (as set forth above) shall be deemed to have been paid by Prometheus under the direct license and, provided further that , if Prometheus elects not to pay THM such amounts payable under the Head License by Rosetta prior to the date of termination, THM’s sole and exclusive recourse against Prometheus shall be termination of the direct license from THM to Prometheus hereunder.  Furthermore, THM’s termination of such direct license shall in no way affect any co-exclusive rights Prometheus may have obtained or obtain in the future by virtue of Rosetta’s joint ownership to inventions which were developed under the Head License.

My signature below confirms that Rosetta agrees with the terms and conditions set forth in this letter.
 

 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

I would appreciate your confirming THM’s agreement with paragraphs 1 and 2 above by signing a copy of this letter in the space indicated below and returning an original signed copy to me.  Thank you for your assistance with this matter.


 [ closing ]

[ Rosetta signatory ]


On behalf of Tel Hashomer Medical Research Infrastructure and Services Ltd., I confirm and agree to paragraphs 1 and 2 above.

____________________________________
(signature)

Name (printed): _______________________
Title: ________________________________
Tel Hashomer Medical Research Infrastructure and Services Ltd.

On behalf of Prometheus Laboratories Inc. I confirm and agree to paragraph 2 above.

____________________________________
(signature)

Name (printed): _______________________
Title: ________________________________
Prometheus Labs Inc.



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

Appendix A

 
8.       Payments for License .
 
8.01.      In consideration for the grant and during the term of the License with respect to each Licensed Product, PROMETHEUS shall pay to THM:
 
(a)      Royalties of [***] of all Net Sales by or on behalf of PROMETHEUS; and (" Royalties ")
 
(b)      [***] of any Sublicense Income (" Sublicense Fees ").
 
8.02       Stacking Protection .
 
( a) In the event that PROMETHEUS becomes obligated to pay to Third Parties Royalties in consideration for the use of Intellectual Property Rights which are necessary in order to develop, manufacture and use the Licensed Product, or in order to provide the Licensed Product as a service test, and the aggregate amount of all royalties (including royalties to THM) shall exceed [***] of Net Sales, then the royalty rate will be reduced as follow: as for each additional percentage of royalties PROMETHEUS is required to pay to Third Party, PROMETHEUS shall be entitled to deduct an amount of [***],  provided that in no event the royalties due to THM under Section 8.01(i) be reduced to less than [***] of Net Sales (for example, if the aggregate royalties are [***], the royalties to THM would be reduced from [***] to [***]).
 
(b) In the event that PROMETHEUS becomes obligated to pay a share of Sublicense Income to  person or entity in consideration for the use of Intellectual Property Rights which are necessary in order to develop or manufacture the Licensed Product, or in order to provide the Licensed Product as a service test, and the aggregate share of Sublicense Income (including the share payable to THM) shall exceed [***] of Sublicense Income, then the share of Sublicense Income payable to THM will be as follow: for each additional percentage out of Sublicense Income PROMETHEUS is required to pay to Third Parties, PROMETHEUS shall be entitled to deduct an amount of [***] from the amount THM is entitled to, provided that in no event shall THM share of Sublicense Income under Section 8.01(ii) be reduced to less than [***] of Sublicense Income.
 
8.03.      For the purpose of computing the royalties due to THM hereunder, the year shall be divided into four parts ending on March 31, June 30, September 30, and December 31.
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 
As of the Date of First Commercial Sale, not later than [***] after each last day of December, March, June, and September in each Calendar Year during the term of the License, PROMETHEUS shall submit to THM a detailed report of royalties or payments due THM under the terms of this Agreement for the preceding quarter year (hereinafter "the Quarter-Year Report").
 
Payment of the full amount of any royalties or other payments due to THM for the preceding quarter year shall accompany each Quarter-Year Report on royalties and payments. PROMETHEUS shall keep for a period of at least five (5) years after the date of entry, full, accurate and compete books and records consistent with sound business and accounting practices and in such form and in such detail as to enable the determination of the amounts due to THM from PROMETHEUS pursuant to the terms of this Agreement.
 
8.04.      PROMETHEUS shall provide THM with the following written reports:  (a) a detailed quarterly report, commencing with the first calendar quarter in which any Net Sales are made, or Sublicense Income is received,  signed by the chief financial officer of PROMETHEUS, specifying all amounts payable to THM under this section 8 in respect of the previous quarter to which the report refers. Such report shall include: (i) [***]; (ii)  [***]; and (iii) [***]; and (b) following the Date of First Commercial Sale - [***], PROMETHEUS will provide THM with a detailed report, certified by its chief financial officer and by its independent auditor, stating all amounts due to THM pursuant to this section 8 in the reported year including relevant Invoices issued and all invoices and all payments received by PROMETHEUS with respect to its Net Sales and to the Sublicense Income as detailed in the quarterly reports.
 
8.05.      On reasonable notice and during regular business hours, the external auditor of THM shall each have the right to inspect the books of accounts, records and other relevant documentation of PROMETHEUS insofar as they relate to the production, marketing and sale of the Licensed Products, in order to ascertain or verify the amount of royalties and other payments due to THM hereunder. The cost of such inspection shall be borne by THM, unless it is determined in such inspection that THM has been underpaid in any period by more than [***] of the amount which THM should have been paid, in which case the cost of such inspection shall be reimbursed to THM by PROMETHEUS.
 

 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 


 
Exhibit 4.18
 
LABORATORY SERVICES AGREEMENT
 
This Laboratory Services Agreement   (“ Agreement ”) is made and entered into effective as of April 10, 2009, (the “ Effective Date ”) by and between   Rosetta Genomics Inc. , a corporation organized under the laws of Delaware, having a principal place of business at 3711 Market St., Suite 740, Philadelphia, PA, 19104 (“ Rosetta ”), and Prometheus Laboratories Inc . , a California corporation, having its principal place of business at 9410 Carroll Park Drive, San Diego, CA 92121 USA (“ Prometheus ”).  Rosetta and Prometheus each may be referred to herein as a “Party” or collectively as the “Parties”.
 
Recitals
 
Whereas , the Parties have entered into that certain License Agreement simultaneously herewith for the license to Prometheus of certain intellectual property rights owned or controlled by Rosetta covering certain Diagnostic Tests which will be exploited by Prometheus in the Prometheus Territory (the “ License Agreement ”; capitalized terms not defined herein shall have the definitions ascribed in the License Agreement);
 
Whereas , Rosetta is capable of performing the Diagnostic Tests; and
 
Whereas , in connection with Prometheus’ Exploitation of its rights under the License Agreement, Prometheus desires that Rosetta provide the Services (as defined below) under the terms and conditions set forth in this Agreement and Rosetta desires to provide the Services for Prometheus.
 
Agreement
 
Now Therefore , in consideration of the mutual promises and covenants set forth herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:
 
1.
THE SCOPE OF THE SERVICES
 
1.1             The Services .  Rosetta shall perform the Diagnostic Tests for Prometheus with respect to specimens sent by Prometheus to Rosetta and obtained from any person inside the Prometheus Territory (the “ Services ”).
 
1.2             SOP.   Rosetta shall perform each Diagnostic Test according to the standard operating procedures (“ SOP ”) agreed upon in writing by the Parties, which may be amended from time to time subject to the Parties’ mutual written consent.  Rosetta agrees not to change or deviate from the SOP without Prometheus’ prior written approval.
 
1.3             Customer Service .  Prometheus shall be solely responsible for all customer service relating to the Services, including opening customer accounts, ordering and disseminating collection kits to customer accounts,  paying for and tracking the shipment of Laboratory Samples (defined below) to Rosetta at the Licensed Facility (defined below), and providing to customer the Test Results (defined below) supplied by Rosetta to Prometheus.
 
1.4             Standard Disclaimers .  Prometheus shall provide in writing to all customers that order Diagnostic Tests the standard disclaimers and collection instructions attached hereto as Exhibit 2 , as such Exhibit may be modified from time to time upon the mutual written agreement of the Parties.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended .
CONFIDENTIAL
 

 
 
2. 
CONDUCT OF DIAGNOSTIC TESTS
 
 
2.1
Performance of Services .
 
a)           Rosetta shall timely perform all Services to meet the requirements of Prometheus and its Affiliates in the Prometheus Territory, in accordance with Rosetta’s maximum turnaround time for the performance of each Diagnostic Test set forth in Section 4.1 and business operating procedures agreed in writing by the Parties from time to time.  Rosetta will process Laboratory Samples in the order received unless otherwise requested in writing by Prometheus, and, notwithstanding anything herein, (unless otherwise agreed to in writing by a duly authorized representative of Rosetta) in no event shall Rosetta be required to process more than [***] Laboratory Samples per business day.
 
b)           Rosetta shall use reasonable care and comply with generally prevailing industry standards in the performance of the Services and in the preparation of all findings, conclusions, assessments and reports in connection therewith.  Rosetta shall perform the Services in compliance with all Laws.
 
2.2             Further Information . After a Diagnostic Test has been completed, Rosetta may be requested by Prometheus to provide additional information concerning any Diagnostic Test performed by Rosetta, including such information and other scientific or technical information reasonably required to be disclosed to fulfill the objectives of  42 C.F.R. 493.1445(9) and as reasonably provided by CLIA certified laboratories.  Upon such a request by Prometheus or a Prometheus customer, Rosetta shall provide the requested information subject to generally accepted industry standards relating to the protection of confidential information.  Under no circumstances shall Rosetta be required to make any clinical decision or offer any clinical interpretation of the Test Results (defined below).  Rosetta shall make available upon reasonable request its laboratory director and a senior scientist to be identified by Rosetta to address questions relating to the Diagnostic Tests which may arise from health professionals from time to time during the Term of this Agreement.  Notwithstanding the foregoing, the Parties shall use reasonable efforts to work together in good faith to protect information which each party considers and has previously protected as strictly confidential information. 
 
2.3             Laboratory Samples .  Prometheus shall be responsible for supplying collection kits to customers and delivering Laboratory Samples to Rosetta for testing.  Rosetta shall dispose of any waste generated from its possession, testing or creation of the Laboratory Samples in accordance with all Laws and the terms of the applicable SOP.  For the purposes of this Section, “ Laboratory Samples ” shall mean any tissue sample that Prometheus furnishes to Rosetta for any purpose related to this Agreement, or that Rosetta creates as a result of performing the Services for Prometheus.
 
2.4             Laboratory Location; Visits . Unless otherwise agreed by Prometheus in writing, all Services to be performed by Rosetta hereunder shall be performed at its licensed laboratory facility located at 3711 Market Street, Suite 740, Philadelphia, PA 19104 (the “ Licensed Facility ”), provided that Rosetta shall have the right to change the location of the Licensed Facility to a substantially equivalent and appropriately licensed laboratory facility within the United States upon one hundred thirty-five (135) days’ prior written notice to Prometheus.  Prometheus’ designated representatives may visit the Licensed Facility upon reasonable advance notice and with reasonable frequency to observe the performance of the Services and to ensure compliance with this Agreement.  Such Prometheus representatives shall be subject to and bound by the applicable confidentiality obligations set forth in Section 6.1.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
CONFIDENTIAL
 
- 2 -

 
 
 
3. 
PERSONNEL
 
Rosetta shall provide a sufficient number of qualified personnel to support Rosetta’s obligations under this Agreement and to timely perform all Services in accordance with this Agreement.  Rosetta shall have the right, in its sole discretion, to engage appropriately qualified, non-employee staff on a contract basis to perform the Services at the Licensed Facility.  Rosetta shall not otherwise subcontract all or any portion of the Services to any third party without Prometheus’ prior written consent.  Rosetta shall obtain all appropriate agreements (e.g. non-disclosure and inventions assignment agreements) from its employees, agents and contractors sufficient to ensure full compliance with all of the provisions of this Agreement.
 
4.
RECORDS AND REPORTS
 
4.1             Test Results .  Rosetta shall use commercially reasonable efforts to furnish a report to Prometheus providing the data and results of the applicable Diagnostic Test as specified in the SOP (the “ Test Results ”) within [***] of the delivery of each Laboratory Sample to Rosetta (with Laboratory Samples received by Rosetta after 12 noon being treated as having been delivered on the following business day), subject to the limit on the number of Laboratory Samples to be processed in any single business day as set forth in Section 2.1.  Each Laboratory Sample will be supplied to Rosetta in two (2) collection tubes containing the  tissue to be tested.  If, having started to run the Diagnostic Test on the first tube, Rosetta determines that the tissue in the first tube is not adequate to complete the Diagnostic Test, Rosetta shall so notify Prometheus in accordance with the SOP, and Rosetta shall be entitled to an extension of an additional [***] to provide the Test Results using the second tube.  All Test Results shall be branded by Prometheus and shall be in the standard format of Rosetta unless otherwise specified in the SOP, and shall be prepared in accordance with all Laws.  All Test Results, Laboratory Samples, slides and tissue shall be owned by Prometheus and shall be Prometheus’ Confidential Information, provided that Rosetta shall be entitled to retain a copy of all Test Results for its records and to discuss the Test Results with Prometheus’ customers pursuant to Section 2.2.  Without prejudice to Section 10 hereof, Rosetta shall maintain ownership of all physical copies of laboratory notebooks and other original records of the work done to produce the Test Results and shall be authorized to use and archive such items for purposes of regulatory compliance, provided that Prometheus shall be entitled to retain a copy of all such notebooks and records and use and disclose the same for Prometheus’ and its Affiliates’ business purposes.
 
4.2       Records .
 
a)           Rosetta shall keep complete and accurate records of the status and progress of each Diagnostic Test, as required by the SOP and all Laws, and shall maintain records covering such Diagnostic Test and all other Services in compliance with all Laws.  Such records shall be owned by Rosetta and shall constitute Prometheus Confidential Information, provided that Rosetta shall be entitled to retain and use such records for the purpose of regulatory compliance.
 
b)           Each Party hereto shall permit, and shall ensure that any subcontractor permits, the United States Department of Health and Human Services and General Accounting Office to review appropriate books and records relating to the performance hereunder to the extent required under Section 1861(v)(1)(I) of the Social Security Act, 42 U.S.C. Section 1395x(v)(1)(I), or any successor law or regulation for a period of four (4) years following the last day such Party provided services hereunder.  The access shall be provided in accordance with the provisions of 42 C.F.R. Part 420, Subpart D.
 
c)           If Rosetta carries out any of the duties of this Agreement through a subcontract, with a value or cost of Ten Thousand Dollars ($10,000) or more over a twelve (12) month period, with a related organization, such subcontract shall contain a clause to the effect that until the expiration of four (4) years after the furnishing of such services pursuant to such subcontract, the related organization shall make available, upon written request to the Secretary of the United States Department of Health and Human Services or upon request to the Comptroller General of the United States, or any of their duly authorized representatives, the subcontract, and books, documents and records of such organization that are necessary to verify the nature and extent of the costs incurred pursuant to such subcontract.
 
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
CONFIDENTIAL
 
- 3 -

 
 
 
5.
COMPENSATION
 
5.1             Compensation .  Prometheus shall pay Rosetta in accordance with the pricing set forth in the fee schedule attached hereto in Exhibit 1 (“ Fee Schedule ”) for the applicable Diagnostic Test.  Rosetta shall invoice Prometheus pursuant to a single invoice at the beginning of each calendar month for all Test Results provided by Rosetta during the prior calendar month.  Invoices are due and payable within thirty (30) days after receipt by Prometheus, and Prometheus agrees to pay all invoices submitted provided that such Services were performed by Rosetta in accordance with the SOP and are not the subject of a bona fide dispute.  All invoices and payments due pursuant to this Agreement shall be in United States Dollars.  Each invoice shall be accompanied by a report specifying, for each Diagnostic Test conducted in the prior month, the type, quantity, and price of each Diagnostic Test conducted.   Any necessary and appropriate changes in the Fee Schedule for any Diagnostic Test, as revised by amendments thereto, will be subject to written approval by authorized representatives of Rosetta and Prometheus.
 
5.2             Delays .  Rosetta shall promptly notify Prometheus if it believes it will be delayed in the provision of any Test Result by more than two (2) business days in excess of the time specified in Section 4.1.
 
6.
PRIVACY; CONFIDENTIALITY
 
6.1             Confidentiality.   The provisions of Section 6 of the License Agreement shall be deemed incorporated herein, with references to the “Agreement” therein being construed as references to this Agreement as well.  Any Prometheus representatives that visit the Licensed Facility will use reasonable efforts to avoid accessing or observing any confidential information of Rosetta unrelated to the Services, or any confidential information of Rosetta’s other licensees, collaborators or customers, and shall follow all reasonable instructions of Rosetta’s personnel with respect to such matters. In the event that Prometheus’ representatives do access or observe any such confidential information, it shall be treated as Rosetta Confidential Information; provided that notwithstanding anything to the contrary in Section 6.1.1 of the License Agreement, Prometheus shall not be entitled to use such information for any purpose or to disclose it to any other of its employees, Affiliates, contractors, Sublicensees or third party except as expressly stated in Section 6.1.3 of the License Agreement .
 
6.2             Privacy .  The Parties acknowledge the applicability of the privacy standards as set forth in the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (" HIPAA ") and all regulations promulgated thereunder by the U.S. Department of Health and Human Services, including 45 C.F.R. §§ 164.500-164.534 (the " Privacy Rule ") and 164.302-164.318 (the " Security Standards ") as the same may be amended from time to time, and agree that each will comply with their respective obligations as required by HIPAA and any other applicable privacy laws.  Further, the Parties agree to take all other reasonable steps to protect the confidentiality of any patient health and medical information in compliance with all Laws.
 
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
CONFIDENTIAL
 
- 4 -

 
 
 
7.
USE OF NAMES
 
Neither Party will use the other Party’s name or the name of any employee of the other Party in any advertising, packaging, or promotional material, except as required or permitted under the License Agreement or agreed in writing by the Parties.
 
8.
WARRANTIES
 
Rosetta hereby represents and warrants that:
 
8.1            the Services provided to Prometheus in connection with each Diagnostic Test conducted under this Agreement shall conform to the SOP for such Diagnostic Test (unless otherwise agreed by the Parties in writing) and shall be in compliance with all Laws; provided, however, that Rosetta makes no representation and gives no warranty that the Diagnostic Tests may be performed in compliance with Law on Laboratory Samples obtained in New York, Florida, Maryland or California until such time as Rosetta’s pending state license applications in such states issue.  Rosetta shall use commercially reasonable efforts to obtain all licenses in New York, Florida, Maryland and California which are necessary to in order perform the Services with respect to Laboratory Samples collected in such states.  Rosetta shall promptly notify Prometheus upon the issuance of each such state license and thereafter Rosetta shall maintain such state license in good standing for the remainder of the Term. Rosetta shall not perform any Diagnostic Tests on any Laboratory Samples obtained from states where it is not properly licensed to provide the Services; provided, however, that Rosetta shall be entitled to rely on the information supplied by Prometheus or its customers as to the state in which a given Laboratory Sample has been obtained.
 
8.2            the Licensed Facility is, and at all times during the Term shall be, licensed or certified according to all applicable Laws.  Rosetta shall provide Prometheus with a copy of each of Rosetta’s licenses and certifications upon request; and
 
8.3            it is not now nor has it ever been sanctioned, debarred, suspended, or excluded from participation in any federally funded health care program, including Medicare or Medicaid, and agrees that it shall notify Prometheus in the event of any adverse action relating to its license, permit, certification or right to receive reimbursement from any federally funded health care program, including Medicare and Medicaid.
 
9.
INDEMNITIES
 
9.1             Indemnification by Rosetta .  Rosetta shall indemnify, defend and hold harmless Prometheus and its officers, directors, employees, agents and representatives (“ Prometheus Indemnitees ”) from and against any and all liabilities, claims, demands, actions, suits, losses, damages, fines, sanctions, costs and expenses (including reasonable attorneys’ fees) arising from third party claims, including investigations or actions by any government agency, to the extent based upon or arising out of Rosetta’s negligence, willful or deliberate misconduct, recklessness or Rosetta’s breach of any covenant, agreement, representation or warranty made by Rosetta in this Agreement; provided, however, that Rosetta shall not be required to indemnify a Prometheus Indemnitee to the extent such claims arise from the negligence, willful or deliberate misconduct, or recklessness of a Prometheus Indemnitee or Prometheus’ breach of this Agreement.
 
9.2             Indemnification by Prometheus.   Prometheus shall indemnify, defend and hold harmless Rosetta and its officers, directors, employees, agents and representatives (“ Rosetta Indemnitees ”) from and against any and all liabilities, claims, demands, actions, suits, losses, damages, fines, sanctions, costs and expenses (including reasonable attorneys’ fees) arising from third party claims, including investigations or actions by any government agency, to the extent based upon or arising out of Prometheus’ negligence, willful or deliberate misconduct, recklessness or Prometheus’ breach of any covenant, agreement, representation or warranty made by Prometheus in this Agreement; provided, however, that Prometheus shall not be required to indemnify a Rosetta Indemnitee to the extent such claims arise from the negligence, willful or deliberate misconduct, or recklessness of a Rosetta Indemnitee or Rosetta’s breach of this Agreement.
 
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
CONFIDENTIAL
 
- 5 -

 
 
 
9.3             Indemnification Procedure . The provisions of Section 8.3 of the License Agreement shall be deemed incorporated herein, with references to the “Agreement” therein being construed as references to this Agreement as well.
 
10.
OWNERSHIP
 
10.1             Ownership of Prometheus IP.   Subject to any provision to the contrary in the License Agreement or this Agreement, all intellectual property rights in any materials, processes, inventions and/or discoveries relating to Prometheus’ performance under this Agreement, shall remain the sole and exclusive property of Prometheus (the “ Prometheus IP ”) and shall be subject to any licenses applicable thereto under the License Agreement.
 
10.2             Ownership of Rosetta IP . Subject to any provision to the contrary in the License Agreement or this Agreement, all intellectual property rights in any inventions and/or discoveries relating to Rosetta’s performance of the Services, including all testing methods and processes employed by Rosetta, and whether created outside of or during the course of Rosetta’s performance of the Services, are and shall remain the sole and exclusive property of Rosetta (the “ Rosetta IP ”) and shall be subject to any licenses applicable thereto under the License Agreement.
 
11.
INSURANCE
 
Without limiting Section 8.4 (Insurance) of the License Agreement, each Party shall carry insurance sufficient to cover its interest or liabilities hereunder including, but not limited to worker’s compensation and comprehensive general liability.  At a minimum, each Party shall obtain and maintain in force during the term of this Agreement, comprehensive general liability insurance in the amount of [***] per occurrence and [***] in the annual aggregate plus professional liability insurance in the amount of [***] per occurrence and [***] in the aggregate.
 
12.
TERM AND TERMINATION
 
12.1             Term .  Unless earlier terminated by the Parties as set forth below, this Agreement will commence on the Effective Date and will continue for one (1) year and from year to year thereafter unless terminated as set forth herein (the “ Term ”).
 
12.2             Termination for Convenience .  Prometheus shall have the right to terminate the Services in their entirety or with respect to any one or more Diagnostic Tests at any time without cause upon sixty (60) days prior written notice to Rosetta.  Rosetta shall have the right to terminate the Services in their entirety or with respect to any one or more Diagnostic Tests at any time without cause upon ninety (90) days prior written notice to Prometheus, to be given no earlier than ninety (90) days prior to the third (3 rd ) anniversary of the Effective Date.
 
12.3             Termination for Breach .  Either Party may terminate this Agreement at any time upon sixty (60) days prior written notice to the other Party (or thirty (30) days in the case of a breach consisting of a failure by a Party to make timely payment of any amount that is not the subject a bona fide dispute and is due under this Agreement pursuant to a properly rendered invoice), for material breach of this Agreement by the other Party where such breach is not remedied to the non-breaching Party’s reasonable satisfaction within the applicable notice period.
 

 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
CONFIDENTIAL
 
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12.4             Termination upon Termination of License Agreem ent .  This Agreement shall automatically terminate in the event that the License Agreement is terminated pursuant to its terms.
 
12.5             Consequences of Termination .  Upon termination of this Agreement for any reason, Rosetta shall complete the performance of any Diagnostic Tests previously ordered by Prometheus and/or its customers and shall submit a final invoice to Prometheus.  Prometheus shall pay such final invoice in accordance with Section 5.1 and otherwise comply with all terms and conditions of this Agreement relating to such Diagnostic Tests and payment therefor as if the Agreement were still in force.
 
12.6             Survival .  Upon expiration or termination of this Agreement, neither Party will have any further obligations under this Agreement, except that (i) the liabilities, including for payment, accrued through the date of termination and (ii) Article and Sections 4.2 (Records), 6 (Privacy; Confidentiality), 9 (Indemnity), 10 (Ownership), 11 (Insurance), 12.5 (Consequences of Termination), 12.6 (Survival), 13 (Dispute Resolution) and 14 (Miscellaneous) shall survive the expiration or termination of this Agreement.
 
13.
EXCLUSIONS OF LIABILITY; DISPUTE RESOLUTION
 
13.1            EXCEPT WITH RESPECT TO ANY INDEMNIFICATION OBLIGATION OWED WITH RESPECT TO A THIRD PARTY LOSS, A BREACH OF ARTICLE 6 (PRIVACY, CONFIDENTIALITY), NEITHER PARTY SHALL BE LIABLE (NOR SHALL ITS LICENSORS BE LIABLE) TO THE OTHER PARTY UNDER ANY CIRCUMSTANCES OR ANY LEGAL OR EQUITABLE THEORY, WHETHER IN CONTRACT, STRICT LIABILITY OR OTHERWISE, FOR ANY CONSEQUENTIAL DAMAGES EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THESE LIMITATIONS SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OR ANY LIMITED REMEDY.  NOTWITHSTANDING THE FOREGOING, THESE LIMITATIONS SHALL NOT APPLY TO ANY THIRD-PARTY CLAIM THAT IS THE SUBJECT OF SECTION 9, TO THE EXTENT SUCH THIRD PARTY HAS BEEN AWARDED SUCH DAMAGES.  NOTWITHSTANDING ANYTHING TO THE CONTRARY HEREIN, THIS SECTION 13.1 SHALL IN NO WAY LIMIT EITHER PARTY’S RIGHTS TO SEEK AND/OR OBTAIN DIRECT DAMAGES, INCIDENTAL DAMAGES AND/OR LOST PROFITS, PROVIDED THAT IN NO EVENT SHALL ROSETTA BE LIABLE FOR THE COSTS OF SETTING UP A SUBSTITUTE LABORATORY TO CONDUCT THE DIAGNOSTIC TESTS, WHETHER SUCH COSTS ARE CHARACTERIZED AS INCIDENTAL OR DIRECT DAMAGES OR ANY OTHER FORM OF DAMAGES.
 
13.2            The provisions of Sections 11 of the License Agreement shall be deemed incorporated herein, with references to the “Agreement” therein being construed as references to this Agreement as well.
 
14.
MISCELLANEOUS
 
14.1       Notices.  The provisions of Section 12.8 of the License Agreement shall be deemed incorporated herein, with references to the “Agreement” therein being construed as references to this Agreement as well
 
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
CONFIDENTIAL
 
- 7 -

 
 
 
14.2             Independent Contractors .  The business relationship of Rosetta and Prometheus established by this Agreement is that of independent contractors, and nothing contained in this Agreement shall be construed to (i) give either Party the power to direct or control the day-to-day activities of the other, (ii) constitute the Parties as partners, joint venturers, employer, employee, co-owners or otherwise as participants in a joint or common undertaking, or (iii) allow either Party to create or assume any obligation on behalf of the other Party for any purpose whatsoever.
 
14.3             Assignment ; Headings .   This Agreement, and the rights and obligations hereunder, may not be assigned or transferred by either Party without the prior written consent of the other Party; provided, however, without such written consent either Party may assign this Agreement in connection with the transfer or sale of all or substantially all of its assets or business to which this Agreement relates or its merger or consolidation with another company, provided that such successor is bound by the terms of this Agreement.  Headings and captions in this Agreement are for convenience only and are not to be used in the interpretation of this Agreement.
 
14.4             Right of Set-Off .   Notwithstanding anything to the contrary in this Agreement, Prometheus shall have a right to set-off any amounts due under this Agreement only against any damages incurred by Prometheus and/or its Affiliates under this Agreement, subject to the obligations under Section 11.3 of the License Agreement.
 
14.5             Entire Agreement .   This Agreement and the License Agreement, together with all attached Annexes and Schedules contain the entire understanding between the Parties relating to the subject matter hereof and supersede any and all prior agreements, understandings and arrangements, whether written or oral, between the Parties relating to such subject matter and to the extent relating to the Services.  In the event that there is a conflict between any provision of the License Agreement and any provision of this Agreement, the License Agreement shall prevail.  No amendments, changes, modifications, waivers or alterations of the terms and conditions of this Agreement shall be binding upon either Party unless in writing and signed by both Parties.
 
14.6             Unenforceability .  Both Parties hereby expressly state that it is the intention of neither Party to violate any Law.  If any of the provisions of this Agreement are held to be void or unenforceable, then the Parties shall use good faith efforts for a period of no more than ten (10) business days to replace such void or unenforceable provisions with valid and enforceable provisions which will achieve as far as possible the economic business intentions of the Parties, failing which, such void or unenforceable provisions shall be deemed to be severed from this Agreement without replacement.
 
14.7             Non-Exclusive Agreement .  Except as otherwise set forth in the License Agreement, this Agreement is not exclusive.  Accordingly, Prometheus and Rosetta shall have the right to enter into one or more agreements relating to the same or similar matters as are covered by this Agreement, and execution by Prometheus and Rosetta of such agreements shall not constitute a breach of this Agreement.
 
14.8             Governing Law; Counterparts .   This Agreement will in all events and for all purposes be governed by, and construed in accordance with, the laws of the State of New York, without regard to any choice of law principle that would dictate the application of the law of another jurisdiction.  This Agreement may be executed in multiple counterparts, each of which shall be deemed an original, but both of which together will constitute one and the same instrument.
 
14.9             Force Majeure.   A “ Force Majeure Event ” shall mean any cause or contingency beyond a Party’s reasonable control which is not reasonably preventable by taking precautions which are customary and/or prudent for a company and/or facility the size of that being operated by the affected Party (the Parties agree that such precautions shall not include maintaining a back-up laboratory facility), including, strikes or other labor disturbances, lockouts, riots, quarantines, communicable disease outbreaks, wars, acts of terrorism, fires, floods, storms, or compliance with any order or regulation of any Regulatory Authority acting within color of right and any circumstances caused by the other Party or, in the case of Prometheus and its Affiliates, their respective customers or any entity in their chain of distribution. If and to the extent that either Party is prevented or delayed by a Force Majeure Event from performing any of its obligations under this Agreement and promptly so notifies the other Party, specifying the matters constituting the Force Majeure Event together with such evidence in verification thereof as it can reasonably give and specifying the period for which it is estimated that the prevention or delay will continue, then the Party so affected shall be relieved of liability to the other for failure to perform or for delay in performing such obligations (as the case may be), but shall nevertheless use commercially reasonable efforts to resume full performance thereof, provided that if the Force Majeure Event continues for a period of ninety (90) days or more following notification, the Party whose performance is not affected by the Force Majeure Event may terminate this Agreement by giving not less than thirty (30) days prior notice to the other Party.
 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
CONFIDENTIAL
 
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In Witness Whereof , duly authorized representatives of the Parties have signed this Agreement as of the Effective Date.
 
 
ROSETTA GENOMICS INC.
 
 
By:  /s/ Amir Avniel
Name: Amir Avniel
Title: CEO
 
 
PROMETHEUS LABORATORIES INC.
 
 
By:  /s/ Joseph M. Limber
Name:  Joseph M. Limber
Title:   President and Chief Executive Officer
 
 

 
 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
Signature Page to Laboratory Services Agreement
CONFIDENTIAL
 

 
 
Exhibit 1
 
Fee Schedule
 
Squamous Test: US $[***]  
METS Test: US $[***]  
Mesothelioma Test: US $[***]  
 
 
         
 
               
 
     
 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
CONFIDENTIAL
 

 
 
Exhibit 2
 
Disclaimers and Collection Instructions
 
Prometheus diagnostic services provide important information to aid in the diagnosis and management of certain diseases and conditions.  How this information is used to guide patient care is the responsibility of the physician.
 
Specimen Instructions
 
The specimen collection instructions are attached hereto.  Such specimen collection instructions may not be modified by either party without the prior written consent of the other party, such consent not to be unreasonably withheld, provided that Prometheus shall have the right to make non-substantive modifications without the prior consent of Rosetta.
 
 
 
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
CONFIDENTIAL


Exhibit 4.20
































































































































Exhibit 4.21













































Exhibit 12.1
 
CERTIFICATIONS
 
I, Amir Avniel, certify that:
 
 
1.
I have reviewed this Annual Report on Form 20-F of Rosetta Genomics Ltd.;
 
 
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
 
 
5.
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)
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.
 
Dated: June 30, 2009
/s/ Amir Avniel
 
Amir Avniel
 
Chief Executive Officer and President
 
(principal executive officer)

 
 

 

Exhibit 12.2
 
CERTIFICATIONS
 
I, Limor Zur Stoller, certify that:
 
 
1.
I have reviewed this Annual Report on Form 20-F of Rosetta Genomics Ltd.;
 
 
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
 
 
5.
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)
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.
 
Dated: June 30, 2009
/s/ Limor Zur Stoller
 
Limor Zur Stoller
 
Vice President Finance
 
(principal accounting and financial officer)

 
 

 

Exhibit 13.1
 
CERTIFICATIONS UNDER SECTION 906
 
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of Rosetta Genomics Ltd., an Israeli corporation (the “Company”), does hereby certify, to such officer’s knowledge, that:
 
The Annual Report on Form 20-F for the year ended December 31, 2008 (the “Form 20-F”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 20-F fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: June 30, 2009
/s/ Amir Avniel
 
Amir Avniel
 
Chief Executive Officer and President
 
(principal executive officer)
   
Dated: June 30, 2009
/s/ Limor Zur Stoller
 
Limor Zur Stoller
 
Vice President Finance
 
 (principal accounting and financial officer)
 
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 
 

 

Exhibit 15.1
 
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
 
We consent to the incorporation by reference in the Registration Statements on Form F-3 (Nos. 333-153115 and 333-159955) and the related prospectuses and Form S-8 (Nos. 333-141525 and 333-147805) of Rosetta Genomics Ltd. of our report dated June 11, 2009 with respect to the consolidated financial statements of Rosetta Genomics Ltd., for the year ended December 31, 2008 included in the this Form 20-F.
 
 
/s/ Kost Forer Gabbay & Kasierer
   
Tel-Aviv, Israel
Kost Forer Gabbay & Kasierer
June 30, 2009
A Member of Ernst & Young Global